KEPPRA

KEPPRA
(levetiracetam)

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DRUG DESCRIPTION

KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration.

The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:

KEPPRA (levetiracetam) Structural Formula Illustration

Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)

KEPPRA tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below:

250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake

500 mg tablets: iron oxide yellow

750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red

KEPPRA

 oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizin ate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.
What are the possible side effects of levetiracetam (Keppra, Keppra XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

    hallucinations;
    fever, chills, body aches, flu...

Read All Potential Side Effects and See Pictures of Keppra »
What are the precautions when taking levetiracetam (Keppra)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (including dialysis treatment), mental/mood disorders (such as depression).

This drug may make you dizzy or drowsy, especially during the first month of treatment. Do not drive, use machinery, ride a bicycle, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about...

Read All Potential Precautions of Keppra »

dicloreum

Dicloreum -

 General Information:
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt. [PubChem]

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Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body. Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis.

Pharmacology:
Dicloreum is an acetic acid nonsteroidal antiinflammatory drug (NSAID) with analgesic and antipyretic properties. Dicloreum is used to treat pain, dysmenorrhea, ocular inflammation, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and actinic keratosis

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Dicloreum for patients

Diclofenac, like other drugs of its class, is not free of side effects. The side effects of these drugs can cause discomfort and rarely, more serious side effects, such as gastrointestinal bleeding, and more rarely, liver toxicity which may result in hospitalization and even fatal outcomes.

NSAIDs are often essential agents in the management of arthritis and have a major role in the management of pain, but they also may be commonly employed for conditions that are less serious.

Physicians may w.s. to discuss with their patients the potential risks and likely benefits of NSAID treatment, particularly when the drugs are used for less serious conditions where treatment without NSAIDs may represent an acceptable alternative to both the patient and physician.

Because serious G.I. tract ulceration and bleeding can occur without warning symptoms, physicians should follow chronically treated patients for the signs and symptoms of ulceration and bleeding and should inform them of the importance of this follow-up. If diclofenac is used chronically, patients should also be instructed to report any signs and symptoms that might be due to hepatotoxicity of dictofenac; these symptoms may become evident between visits when periodic liver laboratory tests are performed
Dicloreum Interactions

Aspirin: Concomitant administration of diclofenac and aspirin is not recommended because diclofenac is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations, peak plasma levels, and AUC values.

Anticoagulants: While studies have not shown diclofenac to interact with anticoagulants of the warfarin type, caution should be exercised, nonetheless, since interactions have been seen with other NSAIDs. Because prostaglandins play an important role in hemostasis, and NSAIDs affect platelet function as well, concurrent therapy with all NSAIDs, including diclofenac, and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.

Digoxin, Methotrexate, Cyclosporine: Diclofenac, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of diclofenac may increase serum concentrations of digoxin and methotrexate and increase cyclosporineís nephrotoxicity. Patients who begin taking diclofenac or who increase their diclofenac dose or any other NSAID while taking digoxin, methotrexate, or cyclosporine may develop toxicity characteristics for these drugs. They should be observed closely, particularly if renal function is impaired. In the case of digoxin, serum levels should be monitored.

Lithium: Diclofenac decreases lithium renal clearance and increases lithium plasma levels. In patients taking diclofenac and lithium concomitantly, lithium toxicity may develop.

Oral Hypoglycemics: Diclofenac does not alter glucose metabolism in normal subjects nor does it alter the effects of oral hypoglycemic agents. There are rare reports, however, from marketing experiences, of changes in effects of insulin or oral hypoglycemic agents in the presence of diclofenac that necessitated changes in the doses of such agents. Both hypo- and hyperglycemic effects have been reported. A direct causal relationship has not been established, but physicians should consider the possibility that diclofenac may alter a diabetic patientís response to insulin or oral hypoglycemic agents.

Diuretics: Diclofenac and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.

Other Drugs: In small groups of patients (7-10/interaction study), the concomitant administration of azathioprine, gold, chloroquine, D-penicillamine, prednisolone, doxycycline, or digitoxin did not significantly affect the peak levels and AUC values of diclofenac. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of diclofenac therapy.

Protein Binding

In vitro, diclofenac interferes minimally or not at all with the protein binding of salicylic acid (20% decrease in binding), tolbutamide, prednisolone (10% decrease in binding), or warfarin. Benzylpenicillin, ampicillin, oxacillin, chlortetracycline, doxycycline, cephalothin, erythromycin, and sulfamethoxazole have no influence in vitro on the protein binding of diclofenac in human serum.

Drug/Laboratory Test Interactions

Effect on Blood Coagulation: Diclofenac increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII. Statistically significant changes in prothrombin and partial thromboplastin times have been reported in normal volunteers. The mean changes were observed to be less than 1 second in both instances, however, and are unlikely to be clinically important. Diclofenac is a prostaglandin synthetase inhibitor, however, and all drugs that inhibit prostaglandin synthesis interfere with platelet function to some degree; therefore, patients who may be adversely affected by such an action should be carefully observed.

Dicloreum Contraindications

Diclofenac in all formulations, Cataflam, Voltaren, and Voltaren-XR, is contraindicated in patients with known hypersensitivity to diclofenac and diclofenac-containing products. Diclofenac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to diclofenac have been reported in such patients.

Additional information about Dicloreum
Dicloreum Indication: For the acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Mechanism Of Action: The antiinflammatory effects of diclofenac are believed to be due to inhibition of both leukocyte migration and the enzyme cylooxygenase (COX-1 and COX-2), leading to the peripheral inhibition of prostaglandin synthesis. As prostaglandins sensitize pain receptors, inhibition of their synthesis is responsible for the analgesic effects of ketoprofen. Antipyretic effects may be due to action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat dissipation.
Drug Interactions: Alendronate Increased risk of gastric toxicity
Anisindione The NSAID increases the anticoagulant effect
Cyclosporine Monitor for nephrotoxicity
Dicumarol The NSAID increases the anticoagulant effect
Warfarin The NSAID increases the anticoagulant effect
Rifampin Decreased levels/effect of the NSAID
Food Interactions: Take with food to reduce irritation.
Avoid alcohol.
Generic Name: Diclofenac
Synonyms: Diclofenac Sodium; Diclofenac Potassium; Diclofenac Acid
Drug Category: Nonsteroidal Antiinflammatory Agents (NSAIDs); Cyclooxygenase Inhibitors
Drug Type: Small Molecule; Approved; Investigational
Other Brand Names containing Diclofenac: Allvoran; Apo-Diclo; Assaren; Benfofen; Cataflam; Delphimix; Dichlofenac; Dichronic; Diclo-Phlogont; Diclo-Puren; Diclobenin; Diclord; Dicloreum; Dolobasan; Duravolten; Ecofenac; Effekton; Kriplex; Neriodin; Novapirina; Novo-Difenac; Novo-Difenac SR; Nu-Diclo; Pennsaid; Primofenac; Prophenatin; Rhumalgan; Solaraze; Solaraze T; Tsudohmin; Valetan; Voldal; Voltaren; Voltaren Ophtha; Voltaren Ophthalmic; Voltaren Rapide; Voltaren SR; Voltaren-XR; Voltarol; Xenid; Dyloject;
Absorption: Completely absorbed from the gastrointestinal tract.
Toxicity (Overdose): Symptoms of overdose include loss of consciousness, increased intracranial pressure, and aspiration pneumonitis. LD50=390mg/kg (orally in mice)
Protein Binding: More than 99%
Biotransformation: Hepatic
Half Life: 2 hours
Dosage Forms of Dicloreum: Tablet Oral
Tablet, extended release Oral
Solution Topical
Tablet, coated Oral
Solution Ophthalmic
Suppository Rectal
Chemical IUPAC Name: 2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetic acid
Chemical Formula: C14H11Cl2NO2
Diclofenac on Wikipedia: http://en.wikipedia.org/wiki/Diclofenac
Organisms Affected: Humans and other mammals

cefixoral

Cefixoral 

- General Information:
Cefixoral, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixoral is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.

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Suprax (Cefixime) is a cephalosporin antibiotic used to treat infections caused by bacteria such as pneumonia; bronchitis; gonorrhea; and ear, lung, throat, and urinary tract infections. Antibiotics will not work for colds, flu, or other viral infections.

Pharmacology:
Cefixoral, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixoral is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.

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Cefixoral for patients

Cefixime is a cephalosporin antibiotic used to treat bacterial infections. Take at regular intervals and complete the entire course of therapy. Do not take this medication if you are allergic to any type of penicillin or cephalosporin. Notify your physician if you are pregnant or nursing. This antibiotic may decrease the effectiveness of birth control pills; use another form of birth control while taking this medication. Shake the suspension well before each use and store it in the refrigerator. May cause nausea, vomiting or diarrhea; notify your physician if these occur. Take with food or milk to avoid stomach upset. Cefixime may cause a false-positive reaction for nonspecific urine glucose tests in patients with diabetes. This medication does not interfere with enzyme-based urine glucose tests.
Cefixoral Interactions

Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience when SUPRAX is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

Drug/Laboratory Test Interactions

A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide.

The administration of SUPRAX may result in a false-positive reaction for glucose in the urine using ClinitestÒ**, Benedictís solution, or Fehlingís solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®** or Tes-TapeÒ**) be used. A false-positive direct Coombs test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs test may be due to the drug.

Cefixoral Contraindications

SUPRAXÒ is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Additional information about Cefixoral
Cefixoral Indication: For use in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: (1) uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis, (2) otitis media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella catarrhalis (most of which are beta-lactamase positive), and S. pyogenes, (3) pharyngitis and tonsillitis caused by S. pyogenes, (4) acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains), and (5) uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains).
Mechanism Of Action: Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor.
Drug Interactions: Probenecid Probenecid increases the antibiotic's level
Food Interactions: Preferably on an empty stomach, rate of absorption is decreased but extenet of absorption remains the same: not really problematic.
Generic Name: Cefixime
Synonyms: Cefixima [Spanish]; Cefixime Anhydrous; Cefiximum [Latin]; Cefixim
Drug Category: Anti-Bacterial Agents; Cephalosporins
Drug Type: Small Molecule; Approved
Other Brand Names containing Cefixime: CFIX; Cefixoral; Cefspan; Cephoral; Oroken; Suprax; Unixime;
Absorption: About 40%-50% absorbed orally whether administered with or without food, however, time to maximal absorption is increased approximately 0.8 hours when administered with food.
Toxicity (Overdose): Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting.
Protein Binding: 65% (concentration independent)
Biotransformation: Hepatic. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours.
Half Life: 3-4 hours (may range up to 9 hours). In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours.
Dosage Forms of Cefixoral: Tablet Oral
Powder, for suspension Oral
Chemical IUPAC Name: (6R,7R)-7-[[2-(2-amino-1,3-thiazol-4-yl)-2-(carboxymethyloxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Chemical Formula: C16H15N5O7S2
Cefixime on Wikipedia: http://en.wikipedia.org/wiki/Cefixime
Organisms Affected: Enteric bacteria and other eubacteria

clexane

How does it work?

Clexane injection contains the active ingredient enoxaparin, which is a type of medicine called a low molecular weight heparin. It is used to stop blood clots forming within the blood vessels.

Blood clots normally only form to stop bleeding that has occurred as a result of injury to the tissues. The clotting process is complicated and begins when blood cells called platelets clump together and produce chemicals that activate the clotting process. The final part of this process involves a substance called thrombin being activated to produce a protein called fibrin. Fibrin binds the platelets together, forming a blood clot. This is the body’s natural way of repairing itself.

Sometimes, however, a blood clot can form abnormally within the blood vessels. This is known as a thrombus. It can be dangerous because the clot may detach and travel in the bloodstream, where it becomes known as an embolus. The embolus may eventually get lodged in a blood vessel, thereby blocking the blood supply to a vital organ such as the heart, brain or lungs. This is known as a thromboembolism.

Some people have an increased tendency for blood clots to form within the blood vessels. This is usually due to a disturbance in the blood flow within the blood vessels. For example, in coronary artery disease, fatty deposits (atherosclerosis) on the walls of the coronary arteries can disrupt the blood flow, giving a tendency for platelets to clump together and start off the clotting process. When a clot has formed in a coronary artery this reduces the flow of blood to the heart and causes chest pain (angina). It can also result in a heart attack.

Slow blood flow in the leg and pelvic veins can also result in clots forming in these veins (deep vein thrombosis). These clots can break off and travel to the lungs (pulmonary embolism). Being immobile for long periods of time, for example due to a severe medical condition or following surgery, can increase the risk of these types of blood clot.

Enoxaparin is used to prevent and treat these types of abnormal blood clots. It works by inactivating thrombin in the clotting process described above. This stops the formation of fibrin, the essential component of blood clots. The medicine is administered by injection under the skin (subcutaneous injection).

Enoxaparin can also be used to prevent blood clotting when it is filtered through a kidney dialysis machine.
What is it used for?

    Treatment of blood clots in the veins of the leg (deep vein thrombosis).
    Treatment of blood clots that travel to the lungs (pulmonary embolism).
    Preventing these types of blood clots (thromboembolic disorders), particularly following general surgery or surgery on the bones (orthopaedic surgery), or in people bedridden due to illness.
    Treating blood clots in the coronary arteries in unstable angina and heart attack (myocardial infarction).
    Preventing blood from clotting when it is filtered through an 'artificial kidney' (haemodialysis) machine as part of the management of kidney failure.

Warning!

    During treatment with this medicine you should have regular blood tests to monitor the numbers of blood cells called platelets in your blood.
    Your doctor may also want to monitor the level of potassium in your blood while you are having this medicine, particularly if treatment lasts for longer than 7 days.

Use with caution in

    People over 80 years of age.
    People who are underweight or overweight.
    Decreased kidney function.
    Chronic kidney failure.
    Decreased liver function.
    People who have previously developed a reduced platelet count in the blood due to treatment with heparin or low molecular weight heparin (heparin-associated thrombocytopenia).
    People with problems stopping bleeding.
    History of peptic ulcer.
    Recent stroke caused by a blood clot in the brain (ischaemic stroke).
    Severe uncontrolled high blood pressure (hypertension).
    Diabetes.
    Diabetes affecting the eyes (diabetic retinopathy).
    People who have recently had eye surgery.
    People who have recently had surgery on the brain or spinal cord (neurosurgery).
    People having spinal or epidural anaesthesia.
    High level of potassium in the blood (hyperkalaemia).
    Increase in the acidity of the blood (metabolic acidosis).

Not to be used in

    Allergy to heparin or other low molecular weight heparins.
    Bacterial infection of the heart valves and the lining surrounding the heart (bacterial endocarditis).
    Active major bleeding.
    Conditions with a high risk of uncontrolled bleeding, for example the blood clotting disorder haemophilia, or the conditions listed below.
    Active peptic ulcer.
    Recent stroke caused by bleeding in the brain (haemorrhagic stroke).
    Reduced platelet count in the blood (thrombocytopenia).
    This medicine is not recommended for use in children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

    The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. It is not recommended for preventing blood clots in pregnant women with artificial heart valves. Seek medical advice from your doctor.
    It is not known if this medicine passes into breast milk. Mothers who need treatment with this medicine should avoid breastfeeding their infants during the treatment. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

    Bleeding.
    Pain and irritation at the injection site.
    Blood clots which form a solid swelling at the injection site (haematoma).
    Decrease in the number of platelets in the blood (thrombocytopenia).
    Major bleeding (haemorrhage), for example in the abdomen or inside the skull.
    Alteration in results of liver function tests.
    High blood potassium level (hyperkalaemia).
    Death of skin cells (necrosis) at the site of injection.
    Blood clots in the spinal cord (intraspinal haematoma) in people also having spinal or epidural anaesthesia.
    Osteoporosis (a reduction in bone density leading to bones which may fracture easily) has occurred after long-term treatment with a similar medicine called heparin. It is possible that this could happen with Clexane.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to ensure that the combination is safe.

There may be an increased risk of bleeding or increased time taken to stop bleeding, if this medicine is used in combination with medicines that affect blood clotting, such as the following:

    antiplatelet ('blood-thinning') medicines, such as aspirin, dipyridamole, clopidogrel
    clot-busting medicines (fibrinolytics) such as streptokinase, alteplase
    non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac, naproxen
    oral anticoagulants, such as warfarin, nicoumalone, phenindione.

There may be an increased risk of a rise in the amount of potassium in your blood if this medicine is used in combination with any of the following:

    ACE inhibitors, eg captopril, lisinopril
    ciclosporin
    potassium-sparing diuretics, eg spironolactone, triamterene, amiloride
    potassium supplements
    potassium-containing salt substitutes.

The amount of potassium in your blood should be regularly monitored if you are taking any of these during treatment with this medicine.
Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain enoxaparin as the active ingredient.

Read more: http://www.netdoctor.co.uk/heart-and-blood/medicines/clexane.html#ixzz2TY65NrGp
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Oxycodone

Evidence snapshot icon Evidence snapshot
What is known about this drug

Oxycodone-with-naloxone controlled-release (CR) tablets provide equivalent analgesia to that of oxycodone CR tablets of the same oxycodone dose, with a similar adverse-effect profile.

Adding the naloxone component reduces, but does not eliminate, the prevalence of constipation. Compared with oxycodone CR, the number needed to treat (NNT) (for one person using opioids continuously to avoid constipation) was about 4 for people with existing opioid-induced constipation (after 4 weeks), and about 14 for people not selected for constipation symptoms (after 12 weeks).
  
Areas of uncertainty

Efficacy data regarding analgesia and constipation are from 12-week randomised controlled trials. Longer-term data (up to 52 weeks) are from uncontrolled trials. The tablets have not been compared with a regimen of oxycodone and prophylactic laxatives.

There are insufficient data from randomised controlled trials to characterise rare adverse events.
  
What does NPS say?

Switching to the fixed-dose combination tablets may benefit people who experience constipation while taking low to medium doses of oxycodone long term. Everyone taking regular opioids should increase their fluid and fibre intake and exercise levels to reduce the risk of opioid-induced constipation.

Among people without existing constipation, a small proportion will experience a benefit over oxycodone alone.
PBS listing

Restricted benefit

Chronic, severe disabling pain not responding to non-opioid analgesics.

Authorities for increased maximum quantities will be available for patients meeting the criteria listed in the note in the Schedule of Pharmaceutical Benefits.1

Oxycodone is a Controlled Drug (Schedule 8) and so must be prescribed in accordance with State or Territory regulations.
May be prescribed by nurse practitioners (shared care model)

Authorised nurse practitioners may prescribe this medicine as part of a formal care plan with a medical practitioner. See the PBS website for more information on nurse practitioner PBS prescribing.
What is it?

Oxycodone-with-naloxone controlled-release (CR) tablets (Targin) contain a combination of a strong opioid and an opioid antagonist in a controlled-release formulation. The tablets are bioequivalent to oxycodone CR (OxyContin) with regard to their oxycodone content and provide the same duration of action (i.e. approximately 12 hours). The available strengths are oxycodone/naloxone: 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg.

Injected naloxone has long been used to reverse systemic opioid effects, whereas oral naloxone is unsuited for this purpose because it undergoes extensive first-pass metabolism and has low systemic bioavailability. The controlled-release tablets deliver a naloxone dose that blocks opioid receptors in the gut, but not elsewhere (e.g. central nervous system), and therefore reduces gastrointestinal effects with a minimal effect on analgesia.2

See an assessment of oxycodone-with-naloxone CR tablets using a checklist of questions about fixed-dose combination preparations.Web extra: Child–Pugh classification of liver disease
Who is it for?

Oxycodone-with-naloxone CR tablets are indicated for severe chronic cancer or non-cancer pain unresponsive to non-opioid analgesia.* The naloxone component reduces opioid-induced constipation.1,2 Oxycodone, as with all strong opioids, should be offered to people with chronic non-cancer pain only when:

    non-opioid methods of analgesia have been tried and failed
    pain has a significant effect on the patient's quality of life
    there is no psychological contraindication, drug-seeking behaviour or history of drug or alcohol misuse
    prescribing is part of an agreed pain management plan that includes non-drug measures.2,3

See NPS Prescribing Practice Review 51 for information about developing a pain management plan.

Oxycodone-with-naloxone CR tablets are not indicated for acute pain.

* The tablets are also indicated but not PBS listed for moderate pain unresponsive to non-opioid analgesia.

Where does it fit?
An option for people with opioid-induced constipation

Oxycodone-with-naloxone CR tablets cause less constipation than conventional oxycodone CR tablets, but not all patients will benefit (see Less constipation than with oxycodone CR tablets). Switching from low-to-medium doses of oxycodone CR tablets to the fixed-dose combination tablets appears useful for people who suffer from constipation despite an adequate laxative regimen.

For palliative care patients experiencing opioid-induced constipation, adding methylnaltrexone (Relistor) to the existing opioid regimen is an option if laxatives fail (see the NPS RADAR review Methylnaltrexone injection (Relistor) for opioid-induced constipation in palliative care).

Among people without established opioid-induced constipation, a smaller proportion benefit (see Small benefit among people who do not already have opioid-induced constipation).
Laxatives may be required

As for oxycodone alone, advise people starting oxycodone-with-naloxone CR tablets to increase their fluid and fibre intake and exercise levels to reduce the risk of constipation. Recommend or prescribe regular laxatives as necessary (i.e. combined stool softener with stimulant laxative, such as docusate with senna [Coloxyl with Senna; Soflax], or an osmotic laxative, namely, sorbitol or lactulose).4,5

In trials, people taking oxycodone-with-naloxone CR tablets used laxatives only on demand, and 27–49% experienced some degree of constipation (see Less constipation than with oxycodone CR tablets).
Limited usefulness for people who need high doses of opioids

The maximum recommended daily dose of oxycodone-with-naloxone CR tablets is oxycodone 80 mg/naloxone 40 mg; higher doses have not been evaluated. People requiring a daily dose totalling more than oxycodone 80 mg can take additional oxycodone CR tablets 12 hourly, but a beneficial effect on constipation may be lessened.2
Long-term efficacy data regarding effect on constipation are lacking

There are no comparative data to demonstrate that oxycodone-with-naloxone CR tablets continue to prevent constipation for longer than 12 weeks, the length of the three key randomised controlled trials. However, average patient-reported constipation symptoms did not worsen over 52 weeks in open-label uncontrolled extension trials.6
Naloxone may deter intranasal or injected use

Oxycodone-with-naloxone CR tablets contain a dose of naloxone that will antagonise the acute central nervous system effect of oxycodone if used intranasally or injected. In theory, this will reduce the pleasurable effects and provoke unpleasant withdrawal symptoms for people who are opioid tolerant. The tablets may therefore be less appealing for unsanctioned (problematic or illicit) administration, but there is currently no direct evidence to confirm this. The tablets do not deter unsanctioned oral use.

As with other oxycodone preparations, oxycodone-with-naloxone CR tablets are not recommended for treating opioid withdrawal, and should be prescribed with caution and under close supervision for people who are known or suspected to misuse prescription medicines, alcohol or other substances.2
How does it compare?
Similar analgesia to that of oxycodone CR tablets

A pooled analysis of two 12-week randomised controlled trials found that oxycodone-with-naloxone CR tablets provided analgesia that was no worse than that of conventional oxycodone CR tablets. Participants in the trials had chronic non-cancer pain, mostly of musculoskeletal origin (e.g. osteoarthritis), and the average age was 58 years. The average difference in pain intensity score at 12 weeks was –0.01 (95% CI –0.15 to 0.13) on a pain scale from 0 to 10. There was no statistically significant difference in the amount of supplemental oxycodone used, and average daily oxycodone doses were similar in the two groups.7,8
Efficacy compared with prophylactic laxatives is not known

None of the clinical trials of oxycodone-with-naloxone CR tablets compared them with the combination of oxycodone or another strong opioid and a prophylactic laxative. Prophylactic laxative use is the standard of care when strong opioids are used regularly in chronic pain.4,9
Less constipation than with oxycodone CR tablets

In three comparative trials, oxycodone-with-naloxone CR tablets caused less constipation than oxycodone CR tablets, after 4 weeks and 12 weeks of therapy.10–12 Constipation was measured using the Bowel Function Index (BFI).*

As a secondary outcome, all three trials reported the number of participants with fewer than three complete spontaneous bowel movements per week, a common definition for constipation (see Table 1). Using these results it is possible to estimate for each trial the proportion of patients who avoided constipation by using oxycodone-with-naloxone CR tablets rather than oxycodone CR tablets (responder data are not available for BFI).

* The Bowel Function Index (BFI) is a patient-assessed score on a scale of 0 to 100 (0 = no symptoms). As well as frequency of bowel movements, the BFI incorporates other constipation-related symptoms such as straining and bloating. It was accepted by regulators as an outcome measure in oxycodone-with-naloxone trials but has not been used by other investigators.
Table 1. Proportion of trial participants with fewer than three complete spontaneous bowel movements per week

Trial
  

Oxycodone-with-naloxone CR
  

Oxycodone CR

Patients with existing opioid-induced constipation (OIC)*

OXN3001†11
  

35% (50/144)
  

61% (83/137)

OXN3006†10
  

49% (64/130)
  

74% (100/135)

Patients not selected for existing OIC

OXN3401‡7,12
  

27% (41/154)
  

34% (51/151)

* All trial participants had fewer than three complete spontaneous bowel movements per week at recruitment.

† After 4 weeks of double-blind therapy

‡ After 12 weeks of double-blind therapy. Bowel function variables were secondary outcomes in this study.

Small benefit among people who do not already have opioid-induced constipation

One of the three key trials of oxycodone-with-naloxone CR tablets did not actively select participants with pre-existing opioid-induced constipation. In this trial, 80% of participants had no or mild constipation at randomisation (i.e. a BFI < 50), despite using an opioid analgesic for 2 or more weeks before enrolling in the study.12

In this population, there was a 7-percentage-point difference in constipation rates after 12 weeks of treatment between participants receiving oxycodone-with-naloxone CR tablets and participants receiving oxycodone CR tablets (see Table 1). People receiving oxycodone-with-naloxone CR tablets used laxatives on 7.9% of days, while people receiving oxycodone CR tablets used them on 10.4% of days (statistical significance of comparison not reported).7,12

There are few reliable data regarding the typical incidence of opioid-induced constipation, but the median rate of constipation was 30% in a meta-analysis of opioids for chronic non-cancer pain in older adults.13
No comparison with methylnaltrexone in palliative care population

Methylnaltrexone is an option for treating opioid-induced constipation in people receiving palliative care who have not responded to adequately titrated laxatives [see the NPS RADAR review Methylnaltrexone injection (Relistor) for opioid-induced constipation in palliative care]. A reduction in constipation with oxycodone-with-naloxone CR tablets has been demonstrated with a mean daily oxycodone dose of up to about 70 mg7,10–12; patients with cancer pain or in palliative care may require higher oxycodone doses.
Safety issues

Oxycodone-with-naloxone CR tablets appear to have a similar safety profile to that of oxycodone CR tablets; however, there are insufficient data from randomised controlled trials to characterise rare adverse events.

Report suspected adverse reactions to the Therapeutic Goods Administration (TGA) online or by using the 'Blue Card' distributed three times a year with Australian Prescriber. For information about reporting adverse reactions, see the TGA website.
Diarrhoea may occur

In the three key trials, the incidence of diarrhoea was about 5% with either oxycodone-with-naloxone CR tablets or with oxycodone CR tablets. When switching from long-term higher-dose opioid treatment to oxycodone-with-naloxone CR tablets, people may initially experience diarrhoea.2
Contraindicated in moderate or severe hepatic impairment

People with hepatic impairment experience higher systemic exposure to naloxone, which can antagonise the central nervous system effects of oxycodone.2 This could result in reduced analgesia, and opioid withdrawal symptoms in people who are opioid tolerant.

If prescribing to people with renal impairment or mild hepatic impairment, titrate the dose cautiously and monitor carefully. As with conventional oxycodone CR tablets, renal or hepatic impairment may increase oxycodone plasma concentrations (see Reduce the dose for people with mild hepatic impairment or creatinine clearance < 60 mL per min). Do not prescribe in moderate or severe hepatic impairment.2
Low incidence of withdrawal symptoms in trials

People receiving long-term higher-dose opioid treatment can initially experience opioid withdrawal symptoms when switching to oxycodone-with-naloxone CR tablets.2 In key trials the incidence of withdrawal symptoms was low and similar for oxycodone-with-naloxone CR tablets and oxycodone CR tablets.7
Few data about rare adverse events

Naloxone has been used as a parenteral opioid antagonist for several decades, and appears to cause few adverse effects except for those associated with acute opioid withdrawal.4

There is less experience with long-term oral use of naloxone and insufficient data from randomised controlled trials to characterise rare adverse events with oxycodone-with-naloxone CR tablets. However, oxycodone-with-naloxone CR tablets were first registered in Germany in 2006, and the Australian TGA-approved product information lists adverse events from European postmarketing data.7
Reason for PBS listing

In July 2010, the Pharmaceutical Benefits Advisory Committee (PBAC) rejected a submission requesting the PBS listing of oxycodone-with-naloxone CR tablets because of uncertain cost-effectiveness. The PBAC observed that the benefits appeared modest, especially in the population of patients who were not constipated before starting oxycodone with naloxone.14

A subsequent submission in November 2010 amended the price and also addressed uncertainties identified by the PBAC, including efficacy in the non-constipated population, the use of prophylactic laxatives, and the likely average daily dose of oxycodone. The PBAC recommended listing on the basis that the revised cost-effectiveness estimates were acceptable, relative to oxycodone CR tablets without prophylactic laxatives.

The PBAC accepted that oxycodone-with-naloxone CR tablets are efficacious in both constipated and non-constipated patients. They considered that availability of the tablets would improve the management of opioid-induced constipation, and may reduce diversion. They noted data indicating that GPs co-prescribed laxatives at a low rate for people receiving opioids, but also noted that many people purchase over-the-counter laxatives.15
Dosing issues

Initiate and dose oxycodone-with-naloxone CR tablets as for oxycodone CR tablets. People already receiving single-ingredient oral oxycodone preparations (immediate or controlled release) may switch to the combination tablets at the same total daily oxycodone dosage, equally divided into two 12-hourly doses.2

If switching from oral morphine, the Targin product information states that oxycodone 10 mg is equivalent to oral morphine 20 mg. Note that guidelines recommend starting with a lower dose than that calculated (e.g. 50% to 75% of the equianalgesic dose) then titrating to response. This is recommended to cater for differences in how people tolerate different opioids.2,4,9

The tablets are registered for use by children and adolescents from 12 years of age2, but oral opioids generally have a very limited role in treating chronic non-cancer pain in children.
Maximum strength is oxycodone 40 mg/naloxone 20 mg

There is no tablet strength corresponding to existing oxycodone CR 80 mg tablets. The maximum recommended dose is one oxycodone 40 mg/naloxone 20 mg tablet 12 hourly, but supplementary oxycodone CR tablets can be added (see Limited usefulness for people who need high doses of opioids).2
Reduce the dose for people with mild hepatic impairment or creatinine clearance < 60 mL per min

For people with mild hepatic impairment or renal impairment and creatinine clearance < 60 mL/min, reduce the dose to one-third to one-half of the usual. Titrate cautiously with careful monitoring. The tablets are contraindicated in moderate or severe hepatic impairment. 2
Advise people to take the tablets whole

Breaking, dissolving, chewing or crushing the tablets can lead to the rapid release of oxycodone and naloxone, and a potential overdose of oxycodone. The tablets are for oral use only.2
Information for patients

Advise patients as follows.

    Swallow the tablets whole with a full glass of water; do not chew, crush, break or dissolve the tablets.
    Take every 12 hours, with or without food.
    Do not take any other pain reliever or opioid, sleeping tablets or muscle relaxants without speaking with a doctor or pharmacist.
    Avoid drinking alcohol.
    The tablets can cause constipation, diarrhoea, nausea, vomiting, dizziness, drowsiness, headache, itching and other side effects.
    Laxatives may still be required — follow the course recommended by your doctor.
    Note carefully which of their existing medicines are being replaced by the combination tablets and return the unneeded medicines to a pharmacy.

Discuss the Targin consumer medicine information (CMI) leaflet with the patient.

Advise patients to reduce the chance of constipation by drinking water regularly throughout the day, increasing their fibre intake and keeping as mobile as they can. Consider recommending or prescribing regular laxatives (e.g. combined stool softener with stimulant laxative, such as docusate with senna [Coloxyl with Senna; Soflax]).4,5

Patients switching from another opioid preparation may need to reduce their laxative intake.

Ciproxin Tablets

Ciproxin Tablets 500mg

Company Details

Bayer plc

Bayer HouseStrawberry HillNewburyBerkshireRG14 1JA

Telephone:+44 (0)1635 563 000

Fax:+44 (0)1635 563 393

WWW:http://www.bayer.co.uk

[view all information leaflets from this company]

Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.

If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciproxin 500 mg film-coated tablets

Ciprofloxacin

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Ciproxin is and what it is used for
2. Before you take Ciproxin
3. How to take Ciproxin
4. Possible side effects
5. How to store Ciproxin
6. Further information

1. WHAT CIPROXIN IS AND WHAT IT IS USED FOR

Ciproxin is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.

Adults

Ciproxin is used in adults to treat the following bacterial infections:

• respiratory tract infections
• long lasting or recurring ear or sinus infections
• urinary tract infections
• genital tract infections in men and women
• gastro-intestinal tract infections and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• to prevent infections due to the bacterium Neisseria meningitidis
• anthrax inhalation exposure

Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciproxin.

Children and adolescents

Ciproxin is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:

• lung and bronchial infections in children and adolescents suffering from cystic fibrosis
• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
• anthrax inhalation exposure

Ciproxin may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

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2. BEFORE YOU TAKE CIPROXIN

Do not take Ciproxin if you are:

• allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciproxin (see section 6)
• taking tizanidine (see Section 2: Taking other medicines)

Take special care with Ciproxin

Before taking Ciproxin

Tell your doctor if you:

• have ever had kidney problems because your treatment may need to be adjusted
• suffer from epilepsy or other neurological conditions
• have a history of tendon problems during previous treatment with antibiotics such as Ciproxin
• have myasthenia gravis (a type of muscle weakness)
• have heart problems. Caution should be taken when using Ciprofloxacin, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section: Taking other medicines).

For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While taking Ciproxin

Tell your doctor immediately, if any of the following occurs while taking Ciproxin. Your doctor will decide whether treatment with Ciproxin needs to be stopped.

• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking Ciproxin and contact your doctor immediately.
• Pain and swelling in the joints and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. Inflammation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of Ciproxin therapy. At the first sign of any pain or inflammation stop taking Ciproxin and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.
• If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop taking Ciproxin and contact your doctor immediately.
• You may experience psychiatric reactions the first time you take Ciproxin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciproxin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciproxin and contact your doctor immediately.
• You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, stop taking Ciproxin and contact your doctor immediately.
• Diarrhoea may develop while you are taking antibiotics, including Ciproxin, or even several weeks after you have stopped taking them. If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking Ciproxin immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements and contact your doctor.
• Tell the doctor or laboratory staff that you are taking Ciproxin if you have to provide a blood or urine sample.
• If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.
• Ciproxin may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, stop taking Ciproxin and contact your doctor immediately.
• Ciproxin may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
• Tell your doctor if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciproxin. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you obtained without a prescription.

Do not take Ciproxin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: "Do not take Ciproxin").

The following medicines are known to interact with Ciproxin in your body. Taking Ciproxin together with these medicines can influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.

Tell your doctor if you are taking:

• Vitamin K antagonists (e.g: warfarin) or other oral anti-coagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• theophylline (for breathing problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)
• glibenclamide (for diabetes)
• other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Ciproxin may increase the levels of the following medicines in your blood:

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage or incontinence)
• lidocaine (for heart conditions or anesthetic use)
• sildenafil (e.g. for erectile dysfunction)

Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or wish to take:

• antacids
• omeprazole
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g. sevelamer)
• medicines or supplements containing calcium, magnesium, aluminium or iron

If these preparations are essential, take Ciproxin about two hours before or no sooner than four hours after them.

Taking Ciproxin with food and drink

Unless you take Ciproxin during meals, do not eat or drink any dairy products (such as milk or yoghurt) or drinks with added calcium when you take the tablets, as they may affect the absorption of the active substance.

Pregnancy and breast-feeding

It is preferable to avoid the use of Ciproxin during pregnancy. Tell your doctor if you are planning to get pregnant.

Do not take Ciproxin during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

Driving and using machines

Ciproxin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciproxin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

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3. HOW TO TAKE CIPROXIN

Your doctor will explain to you exactly how much Ciproxin you will have to take as well as how often and for how long. This will depend on the type of infection you have and how bad it is.

Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

The treatment usually lasts from 5 to 21 days, but may take longer for severe infections. Take the tablets exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciproxin.

a. Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Ciproxin tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice).

Remember to drink plenty of fluids while you are taking Ciproxin.

If you take more Ciproxin than you should

• If you take more than the prescribed dose, get medical help immediately. If possible, take your tablets or the box with you to show the doctor.

If you forget to take Ciproxin

• Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. Be sure to complete your course of treatment.

If you stop taking Ciproxin

• It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.

If you have any more questions about the use of this product, ask your doctor or pharmacist.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, Ciproxin can cause side effects, although not everybody gets them.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Common side effects (between 1 and 10 in every 100 people are likely to get these):

• nausea, diarrhoea
• joint pains in children

Uncommon side effects (between 1 and 10 in every 1,000 people are likely to get these):

• fungal superinfections
• a high concentration of eosinophils, a type of white blood cell
• loss of appetite (anorexia)
• hyperactivity or agitation
• headache, dizziness, sleeping problems, or taste disorders
• vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), or wind
• increased amounts of certain substances in the blood (transaminases and/or bilirubin)
• rash, itching, or hives
• joint pain in adults
• poor kidney function
• pains in your muscles and bones, feeling unwell (asthenia), or fever
• increase in blood alkaline phosphatase (a certain substance in the blood)

Rare side effects (between 1 and 10 in every 10,000 people are likely to get these):

• inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Take special care with Ciproxin)
• changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes)
• allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema)
• increased blood sugar (hyperglycaemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide), or hallucinations
• pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, seizures (see Section 2: Take special care with Ciproxin), or giddiness
• eyesight problems including double vision
• tinnitus, loss of hearing, impaired hearing
• rapid heartbeat (tachycardia)
• expansion of blood vessels (vasodilation), low blood pressure, or fainting
• shortness of breath, including asthmatic symptoms
• liver disorders, jaundice (cholestatic icterus), or hepatitis
• sensitivity to light (see Section 2: Take special care with Ciproxin)
• muscle pain, inflammation of the joints, increased muscle tone, or cramp
• kidney failure, blood or crystals in the urine (see Section 2: Take special care with Ciproxin), urinary tract inflammation
• fluid retention or excessive sweating
• increased levels of the enzyme amylase

Very rare side effects (less than 1 in every 10,000 people are likely to get these):

• a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis ); a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal (see Section 2: Take special care with Ciproxin)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see Section 2: Take special care with Ciproxin)
• mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Take special care with Ciproxin)
• migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure)
• visual colour distortions
• inflammation of the wall of the blood vessels (vasculitis)
• pancreatitis
• death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure
• small, pin-point bleeding under the skin (petechiae); various skin eruptions or rashes (for example, the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, tendon rupture - especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciproxin); worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciproxin)

Frequency not known (cannot be estimated from the available data)

• troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities
• abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG, electrical activity of the heart)
• pustular rash
• influence on blood clotting (in patients treated with Vitamin K antagonists)

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5. HOW TO STORE CIPROXIN

Keep out of the reach and sight of children.

Do not use Ciproxin after the expiry date, which is stated on the blister and carton after "EXP": The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any medicines no longer required. These measures will help to protect the environment.

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6. FURTHER INFORMATION

What Ciproxin contains

The active substance is ciprofloxacin.

Each film-coated tablet contains 500 mg ciprofloxacin (as hydrochloride).

The other ingredients are:
Tablet core: cellulose microcrystalline, crospovidone, magnesium stearate, maize starch, silica colloidal anhydrous.
Film-coat: hypromellose, macrogol 4000, titanium dioxide (E171).

What Ciproxin looks like and contents of the pack

Ciproxin 500 mg tablets: oblong, nearly white to slightly yellowish film-coated tablets marked with "CIP score 500" on one side and "BAYER" on the other side.

The tablets can be divided into equal halves.

Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160, or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

Manufacturer:

Bayer Pharma AG

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Ciproxin

Belgium: Ciproxine

Bulgaria: Ciprobay

Cyprus: Ciproxin

Czech Republic: Ciprobay

Finland: Ciproxin

France: Ciflox; Uniflox

Germany: Ciprobay

Greece: Ciproxin

Hungary: Ciprobay

Ireland: Ciproxin

Italy: Ciproxin

Luxembourg: Ciproxine

Malta: Ciproxin

Norway: Ciproxin

Poland: Ciprobay

Portugal: Ciproxina

Slovenia: Ciprobay

Spain: Baycip

United Kingdom: Ciproxin

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This leaflet was last revised in June 2012

v021_0

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics, you need them precisely for your current illness. Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

- dosages

- schedules

- duration of treatment

Consequently, to preserve the efficacy of this drug:

1 - Use antibiotics only when prescribed.

2 - Strictly follow the prescription.

3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.

4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.

5 - After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly.

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serenase

Serenase - General Information:

A phenyl-piperidinyl-butyrophenone that is used primarily to treat schizophrenia and other psychoses. It is also used in schizoaffective disorder, delusional disorders, ballism, and tourette syndrome (a drug of choice) and occasionally as adjunctive therapy in mental retardation and the chorea of huntington disease. It is a potent antiemetic and is used in the treatment of intractable hiccups. (From AMA Drug Evaluations Annual, 1994, p279)

Pharmacology:

Serenase is a psychotropic agent indicated for the treatment of schizophrenia. It also exerts sedative and antiemetic activity. Serenase has actions at all levels of the central nervous system-primarily at subcortical levels-as well as on multiple organ systems. Serenase has strong antiadrenergic and weaker peripheral anticholinergic activity; ganglionic blocking action is relatively slight. It also possesses slight antihistaminic andk

Serenase for patients

Serenase Interactions

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus HALDOL. A causal relationship between these events and the concomitant administration of lithium and HALDOL has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.

As with other antipsychotic agents, it should be noted that HALDOL may be capable of potentiating CNS depressants such as anesthetics, opiates, and alcohol.

In a study of 12 schizophrenic patients coadministered oral haloperidol and rifampin, plasma haloperidol levels were decreased by a mean of 70% and mean scores on the Brief Psychiatric Rating Scale were increased from baseline. In 5 other schizophrenic patients treated with oral haloperidol and rifampin, discontinuation of rifampin produced a mean 3.3-fold increase in haloperidol concentrations. Thus, careful monitoring of clinical status is warranted when rifampin is administered or discontinued in haloperidol-treated patients.

Serenase Contraindications

Since the pharmacologic and clinical actions of HALDOL Decanoate 50 and HALDOL Decanoate 100 are attributed to HALDOL (haloperidol) as the active medication, Contraindications, Warnings, and additional information are those of HALDOL, modified only to reflect the prolonged action. HALDOL is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinsonís disease.

Additional information about Serenase

Serenase Indication: For the treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy also used in Tourette's syndrome and Severe hyperactivity.
Mechanism Of Action: The precise mechanism whereby the therapeutic effects of haloperidol are produced is not known. Its effect on the central nervous system is thought to be associated with the competitive blockade of postsynaptic dopamine D2 receptors in the mesolimbic dopaminergic system and an increased turnover rate of brain dopamine.
Drug Interactions: Anisotropine Methylbromide The anticholinergic increases the risk of psychosis and tardive dyskinesia
Atropine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Belladona The anticholinergic increases the risk of psychosis and tardive dyskinesia
Benztropine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Biperiden The anticholinergic increases the risk of psychosis and tardive dyskinesia
Clidinium The anticholinergic increases the risk of psychosis and tardive dyskinesia
Dicyclomine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Ethopropazine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Glycopyrrolate The anticholinergic increases the risk of psychosis and tardive dyskinesia
Homatropine Methylbromide The anticholinergic increases the risk of psychosis and tardive dyskinesia
Hyoscyamine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Isopropamide The anticholinergic increases the risk of psychosis and tardive dyskinesia
Methantheline The anticholinergic increases the risk of psychosis and tardive dyskinesia
Mepenzolate The anticholinergic increases the risk of psychosis and tardive dyskinesia
Orphenadrine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Oxyphencyclimine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Procyclidine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Propantheline The anticholinergic increases the risk of psychosis and tardive dyskinesia
Trihexyphenidyl The anticholinergic increases the risk of psychosis and tardive dyskinesia
Tridihexethyl The anticholinergic increases the risk of psychosis and tardive dyskinesia
Scopolamine The anticholinergic increases the risk of psychosis and tardive dyskinesia
Thioridazine Increased risk of cardiotoxicity and arrhythmias
Mesoridazine Increased risk of cardiotoxicity and arrhythmias
Rifampin The rifamycin decreases the effect of haloperidol
Rifabutin The rifamycin decreases the effect of haloperidol
Propranolol Increased effect of both drugs
Methyldopa Methyldopa increases haloperidol effect or risk of psychosis
Lithium Possible extrapyramidal effects and neurotoxicity with this combination
Ketoconazole The imidazole increases the effect and toxicity of haloperidol
Itraconazole The imidazole increases the effect and toxicity of haloperidol
Fluconazole The imidazole increases the effect and toxicity of haloperidol
Clozapine Clozapine increases the effect and toxicity of haloperidol
Guanethidine The agent decreases the effect of guanethidine
Atomoxetine The CYP2D6 inhibitor could increase the effect and toxicity of atomoxetine
Carbamazepine Carbamazepine decreases the effect of haloperidol
Food Interactions: Take with food to reduce irritation, limit caffeine intake. Avoid alcohol.
Generic Name: Haloperidol
Synonyms: Not Available
Drug Category: Antidyskinetics; Antipsychotics; Antiemetics; Butyrophenones; Dopamine Antagonists
Drug Type: Small Molecule; Approved
Other Brand Names containing Haloperidol:
Toxicity (Overdose): LD₅₀=165 mg/kg (rats, oral)
Protein Binding: 92%
Biotransformation: Hepatic
Half Life: 3 weeks
Dosage Forms of Serenase: Liquid Oral
Tablet Oral
Solution Oral
Liquid Intramuscular

Levoxacin - General

Levoxacin - General Information:

A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. [PubChem]

Related offer from MedStore:

Generic Levaquin (Levofloxacin) - 250mg 30 pills for $52.65 Levaquin (Levofloxacin) is a fluoroquinolone antibiotic used to treat bacterial infections (e.g., urinary tract infections, skin infections, or respiratory tract infections).

Pharmacology:

Levoxacin, a fluoroquinolone antiinfective, is the optically active L-isomer of ofloxacin. Levoxacin is used to treat bacterial conjunctivitis, sinusitis, chronic bronchitis, community-acquired pneumonia and pneumonia caused by penicillin-resistant strains of Streptococcus pneumoniae, skin and skin structure infections, complicated urinary tract infections and acute pyelonephritis.

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Levoxacin for patients

While taking ofloxacin patient should be advised to:

• to drink fluids liberally;
• that mineral supplements, vitamins with iron or minerals, calcium- , aluminum-, or magnesium-based antacids, sucralfate or Videx, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking ofloxacin;
• that ofloxacin can be taken without regard to meals;
• that ofloxacin may cause neurologic adverse effects (e. g. , dizziness, lightheadedness) and that patients should know how they react to ofloxacin before they operate an automobile or machinery or engage in activities requiring mental alertness and coordination;
• to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded;
• that ofloxacin may be associated with hypersensitivity reactions, even following the first dose, to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e. g. , swelling of the lips, tongue, face; tightness of the throat, hoarseness), or any other symptom of an allergic reaction
• to avoid excessive sunlight or artificial ultraviolet light while receiving ofloxacin and to discontinue therapy if phototoxicity (e. g. , skin eruption) occurs;
• that if they are diabetic and are being treated with insulin or an oral hypoglycemic drug, to discontinue ofloxacin immediately if a hypoglycemic reaction occurs and consult a physician;
• that convulsions have been reported in patients taking quinolones, including ofloxacin, and to notify their physician before taking this drug if there is a history of this condition.

Levoxacin Interactions

Specific drug interaction studies have not been conducted with Levofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.

Levoxacin Contraindications

Levofloxacin solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication.

Additional information about Levoxacin

Levoxacin Indication: For the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species, Staphylococus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Groups C/F/G), Viridans group streptococci, Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens.
Mechanism Of Action: Levoxacin inhibits bacterial type II topoisomerases, topoisomerase IV and DNA gyrase. Levoxacin, like other fluoroquinolones, inhibits the A subunits of DNA gyrase, two subunits encoded by the gyrA gene. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing; DNA replication and transcription is inhibited.
Drug Interactions: Aluminium Formation of non-absorbable complexes
Bismuth Formation of non-absorbable complexes
Calcium Formation of non-absorbable complexes
Iron Formation of non-absorbable complexes
Magnesium oxide Formation of non-absorbable complexes
Magnesium Formation of non-absorbable complexes
Sucralfate Formation of non-absorbable complexes
Zinc Formation of non-absorbable complexes
Amiodarone Increased risk of cardiotoxicity and arrhythmias
Bepridil Increased risk of cardiotoxicity and arrhythmias
Bretylium Increased risk of cardiotoxicity and arrhythmias
Chlorpromazine Increased risk of cardiotoxicity and arrhythmias
Dihydroquinidine barbiturate Increased risk of cardiotoxicity and arrhythmias
Disopyramide Increased risk of cardiotoxicity and arrhythmias
Erythromycin Increased risk of cardiotoxicity and arrhythmias
Fluphenazine Increased risk of cardiotoxicity and arrhythmias
Josamycin Increased risk of cardiotoxicity and arrhythmias
Mesoridazine Increased risk of cardiotoxicity and arrhythmias
Methotrimeprazine Increased risk of cardiotoxicity and arrhythmias
Perphenazine Increased risk of cardiotoxicity and arrhythmias
Prochlorperazine Increased risk of cardiotoxicity and arrhythmias
Quinidine Increased risk of cardiotoxicity and arrhythmias
Propiomazine Increased risk of cardiotoxicity and arrhythmias
Promazine Increased risk of cardiotoxicity and arrhythmias
Promethazine Increased risk of cardiotoxicity and arrhythmias
Procainamide The quinolone increases the effect of procainamide
Quinidine barbiturate Increased risk of cardiotoxicity and arrhythmias
Quinupristin This combination presents an increased risk of toxicity
Sotalol Increased risk of cardiotoxicity and arrhythmias
Thiethylperazine Increased risk of cardiotoxicity and arrhythmias
Thioridazine Increased risk of cardiotoxicity and arrhythmias
Trifluoperazine Increased risk of cardiotoxicity and arrhythmias
Triflupromazine Increased risk of cardiotoxicity and arrhythmias
Warfarin The quinolone increases the anticoagulant effect
Acenocoumarol The quinolone increases the anticoagulant effect
Dicumarol The quinolone increases the anticoagulant effect
Anisindione The quinolone increases the anticoagulant effect
Food Interactions: Take without regard to meals. Take with water, drink lliberally. Taking this product with orange juice can result in reduced quinolone plasma levels.
Generic Name: Levofloxacin
Synonyms: L-Ofloxacin
Drug Category: Anti-Bacterial Agents; Quinolones; Anti-Infective Agents, Urinary
Drug Type: Small Molecule; Approved
Other Brand Names containing Levofloxacin: Cravit; Cravit Ophthalmic; Elequine; Floxel; Iquix; Leroxacin; Lesacin; Levaquin; Levokacin; Levox; Levoxacin; Mosardal; Nofaxin; Quixin; Reskuin; Tavanic; Volequin;
Absorption: Absorption of ofloxacin after single or multiple doses of 200 to 400 mg is predictable, and the amount of drug absorbed increases proportionately with the dose.
Toxicity (Overdose): Side effects include disorientation, dizziness, drowsiness, hot and cold flashes, nausea, slurring of speech, swelling and numbness in the face
Protein Binding: 24-38% (to plasma proteins)
Biotransformation: Not Available
Half Life: 6-8 hours
Dosage Forms of Levoxacin: Solution Intravenous
Tablet Oral
Chemical IUPAC Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate
Chemical Formula: C18H20FN3O4
Levofloxacin on Wikipedia: http://en.wikipedia.org/wiki/Levofloxacin
Organisms Affected: Enteric bacteria and other eubacteria

levoxacin

Levoxacin - General Information:

A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. [PubChem]

Related offer from MedStore:

Generic Levaquin (Levofloxacin) - 250mg 30 pills for $52.65 Levaquin (Levofloxacin) is a fluoroquinolone antibiotic used to treat bacterial infections (e.g., urinary tract infections, skin infections, or respiratory tract infections).

Pharmacology:

Levoxacin, a fluoroquinolone antiinfective, is the optically active L-isomer of ofloxacin. Levoxacin is used to treat bacterial conjunctivitis, sinusitis, chronic bronchitis, community-acquired pneumonia and pneumonia caused by penicillin-resistant strains of Streptococcus pneumoniae, skin and skin structure infections, complicated urinary tract infections and acute pyelonephritis

Levoxacin for patients

While taking ofloxacin patient should be advised to:

• to drink fluids liberally;
• that mineral supplements, vitamins with iron or minerals, calcium- , aluminum-, or magnesium-based antacids, sucralfate or Videx, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking ofloxacin;
• that ofloxacin can be taken without regard to meals;
• that ofloxacin may cause neurologic adverse effects (e. g. , dizziness, lightheadedness) and that patients should know how they react to ofloxacin before they operate an automobile or machinery or engage in activities requiring mental alertness and coordination;
• to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded;
• that ofloxacin may be associated with hypersensitivity reactions, even following the first dose, to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e. g. , swelling of the lips, tongue, face; tightness of the throat, hoarseness), or any other symptom of an allergic reaction
• to avoid excessive sunlight or artificial ultraviolet light while receiving ofloxacin and to discontinue therapy if phototoxicity (e. g. , skin eruption) occurs;
• that if they are diabetic and are being treated with insulin or an oral hypoglycemic drug, to discontinue ofloxacin immediately if a hypoglycemic reaction occurs and consult a physician;
• that convulsions have been reported in patients taking quinolones, including ofloxacin, and to notify their physician before taking this drug if there is a history of this condition.

Levoxacin Interactions

Specific drug interaction studies have not been conducted with Levofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.

Levoxacin Contraindications

Levofloxacin solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication.

Additional information about Levoxacin

Levoxacin Indication: For the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species, Staphylococus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Groups C/F/G), Viridans group streptococci, Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens.
Mechanism Of Action: Levoxacin inhibits bacterial type II topoisomerases, topoisomerase IV and DNA gyrase. Levoxacin, like other fluoroquinolones, inhibits the A subunits of DNA gyrase, two subunits encoded by the gyrA gene. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing; DNA replication and transcription is inhibited.
Drug Interactions: Aluminium Formation of non-absorbable complexes
Bismuth Formation of non-absorbable complexes
Calcium Formation of non-absorbable complexes
Iron Formation of non-absorbable complexes
Magnesium oxide Formation of non-absorbable complexes
Magnesium Formation of non-absorbable complexes
Sucralfate Formation of non-absorbable complexes
Zinc Formation of non-absorbable complexes
Amiodarone Increased risk of cardiotoxicity and arrhythmias
Bepridil Increased risk of cardiotoxicity and arrhythmias
Bretylium Increased risk of cardiotoxicity and arrhythmias
Chlorpromazine Increased risk of cardiotoxicity and arrhythmias
Dihydroquinidine barbiturate Increased risk of cardiotoxicity and arrhythmias
Disopyramide Increased risk of cardiotoxicity and arrhythmias
Erythromycin Increased risk of cardiotoxicity and arrhythmias
Fluphenazine Increased risk of cardiotoxicity and arrhythmias
Josamycin Increased risk of cardiotoxicity and arrhythmias
Mesoridazine Increased risk of cardiotoxicity and arrhythmias
Methotrimeprazine Increased risk of cardiotoxicity and arrhythmias
Perphenazine Increased risk of cardiotoxicity and arrhythmias
Prochlorperazine Increased risk of cardiotoxicity and arrhythmias
Quinidine Increased risk of cardiotoxicity and arrhythmias
Propiomazine Increased risk of cardiotoxicity and arrhythmias
Promazine Increased risk of cardiotoxicity and arrhythmias
Promethazine Increased risk of cardiotoxicity and arrhythmias
Procainamide The quinolone increases the effect of procainamide
Quinidine barbiturate Increased risk of cardiotoxicity and arrhythmias
Quinupristin This combination presents an increased risk of toxicity
Sotalol Increased risk of cardiotoxicity and arrhythmias
Thiethylperazine Increased risk of cardiotoxicity and arrhythmias
Thioridazine Increased risk of cardiotoxicity and arrhythmias
Trifluoperazine Increased risk of cardiotoxicity and arrhythmias
Triflupromazine Increased risk of cardiotoxicity and arrhythmias
Warfarin The quinolone increases the anticoagulant effect
Acenocoumarol The quinolone increases the anticoagulant effect
Dicumarol The quinolone increases the anticoagulant effect
Anisindione The quinolone increases the anticoagulant effect
Food Interactions: Take without regard to meals. Take with water, drink lliberally. Taking this product with orange juice can result in reduced quinolone plasma levels.
Generic Name: Levofloxacin
Synonyms: L-Ofloxacin
Drug Category: Anti-Bacterial Agents; Quinolones; Anti-Infective Agents, Urinary
Drug Type: Small Molecule; Approved
Other Brand Names containing Levofloxacin: ;
Absorption: Absorption of ofloxacin after single or multiple doses of 200 to 400 mg is predictable, and the amount of drug absorbed increases proportionately with the dose.
Toxicity (Overdose): Side effects include disorientation, dizziness, drowsiness, hot and cold flashes, nausea, slurring of speech, swelling and numbness in the face
Protein Binding: 24-38% (to plasma proteins)
Biotransformation: Not Available
Half Life: 6-8 hours
Dosage Forms of Levoxacin: Solution Intravenous
Tablet Oral
Chemical IUPAC Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate
Chemical Formula: C18H20FN3O4
Levofloxacin on Wikipedia: http://en.wikipedia.org/wiki/Levofloxacin
Organisms Affected: Enteric bacteria and other eubacteria