Clarex 250 mg & 500 mg Tablets – Braod spectrum antibiotic – PIL

Clarex (Clarithromycin) is an antibiotic included in the family of macrolides.

Indications

Clarex is indicated in the treatment of infections caused by susceptible organisms. Indications include: Respiratory-tract infections, mild to moderate skin and soft tissue infections, otitis media and Helicobacter pylori eradication.

Dosage And Administration

Respiratory tract/skin and soft tissue infections Adults: The usual dose is 250mg twice daily for 7 days, although this may be increased to 500mg twice daily for up to 14 days in severe infections.

Children older than 12 years: As for adults.

Eradication of H pylori in patients with duodenal ulcer Adults:

TRIPLE THERAPY: Clarex 500mg twice daily should be given with amoxycillin 1000mg twice daily and omeprazole 20mg daily for 10 days.

Elderly: As for adults.

Renal Impairment: Dosage adjustments are not usually required except in patients with severe renal impairment (creatinine clearance <30ml/min). If adjustment is necessary, the total daily dosage should be reduced by half, e.g., 250mg once daily or 250mg twice daily in more severe infections.

Clarex may be given without regard to meals as food does not affect the extent of bioavailability.

Composition

  • Each film coated tablet contains Clarithromycin (USP) 250 mg.
  • Each film coated tablet contains Clarithromycin (USP) 500 mg.

Inactive Ingredients: Corn starch, Avcel 102, Povidone, Aerosil, Sodium starch Glycolate Talc, Magnesium stearate. Croscarmellose, Opadry, Vanilla flavour.

Contraindications

Clarithromycin is contraindicated in patients hyper sensitive to macrolides. Pregnancy. Breast feeding. Severe liver insufficiency.

Precautions

Clarithromycin, is principally excreted by the liver and kidney. Caution should be exercised in adminis trating this antibiotic to patients with impaired hepatic or renal function.

Prolonged or repeated use of Clarex may result in an overgrowth of non susceptible bacteria or fungi.

If super-infection occurs, Clarex should be discontinued and appropriate therapy instituted. H. pylori organisms may develop resistance to clarithromycin in a small number of patients.

Interactions

  • Antibacterials: Clarithromycin increases plasma concentration of rifabutin (risk of uveitis-reduce rifabutin dose).
  • Anticoagulants: Anti-coagulant effect of acenocoumarol and warfarin enhanced by clarithromycin.
  • Antiepileptics: Clarithromycin inhibits metabolism of carba mazepine and phenytoin (increased plasma carbamazepine and phenytoin concentrations).
  • Antimuscarinics: Avoid concomitant use with tolterodine.
  • Antipsychotics: Risk of arrythmias if clarithromycin given with pimozide.
  • Antivirals: Clarithromycin tablets reduce absorption of zidovudine. Ritonvair increases plasma concentration of clarithromycin (reduce clarithromycin dose in those with renal impairment). Increased risk of rash when efavirenz given with clarithromycin.
  • Anxiolytics and hypnotics: Clarithromycin inhibits metabolism of midazolam (increased plasma midazolam concentrations, with profound sedation)
  • Cardiac glycosides: Effect of digoxin enhanced by macrolides.
  • Ciclosporine: Macrolides inhibit metabolism of ciclosporine (increased plasma ciclosproeine concentration).
  • Dopaminergics: Plasma concentration of bromocriptine and cabergoline increased by macrolides.
  • Ergotamine and Ergometrine: Increased risk of ergotism – avoid concomitant use.
  • 5HT1, Agonists: Clarithromycin increases plasma concentration of eletriptan (avoid concomitant use).
  • Lipid-regulating drugs: Clarithromycin increases risk of myopathy with simvastatin (avoid concomitant use). Clarithromycin increases plasma concentration of atorvastatin.
  • Tacrolimus: Clarithromycin increases plasma-tacrolimus concentration.
  • Theophylline: Clarithromycin inhibits metabolism.

Side Effects

After oral administration of clarithromycin, some cases of G.l. disturbances have been reported (nausea, heartburns, abdominal pain, diarrhea), headache and skin rashes.

Using macrolides, transient increase of SGOT SGPT are possible, normally reversible after therapy withdrawal.

While during clinical studies with clarithromycin more severe problems relevant to the liver have not been experienced, it should be taken into account that with antibiotics of this family, episodes of cholestatic hepatitis can exceptionally happen.

Like with other antibiotics during therapy with clarithromycin super-infections by resistant bacteria or fungi can rarely arise, needing drug withdrawal and adoption of suitable therapies.

Also reported, dyspepsia, smell and taste disturbances, tooth and tongue discoloration, stomatitis, glossitis, pancreatitis, arthralgia, myalgia, dizziness, vertigo, tinnitus, anxiety, insomnia, nightmares, confusion, psychosis, convulsions, paraesthesia, hypoglycaemia, hepatitis, renal failure, leucopenia and thrombocytopenia.

Over dosage

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. Allergic reactions accompanying over dosage should be treated by gastric lavage and supportive measures.

One patient who has a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypo kalemia and hypoxemia. As with other macrolides, clarithromycin serum levels are not expected to be affected by haemodialysis or peritoneal dialysis.

Other Information

Packaging

Clarex 250 & 500: Boxes of 14 film coated tablets of 250mg and 500mg each.

Storage

Store below 30°C. Do not use this drug after the expiry date given on the package.

THIS IS A MEDICAMENT

A drug is a product which acts on your health and its consumption could be dangerous when you do not follow the instructions. Follow strictly the doctor’s prescriptions, the method of use and the instructions of the pharmacist who sold the medicament.

The doctor and the pharmacist know the medicine, its benefits and risks. Do not by yourself interrupt the period of treatment prescribed for you. Do not repeat the same prescription without consulting your doctor. Keep out of the reach of children.

كلاركس أقراص CLAREX TABLET
كلاركس أقراص CLAREX TABLET

CLAREX TABLET  -PATIENT INFORMATION LEAFLET

النشرة الداخلية كلاركس أقراص

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كلاركس ۲٥۰ مجم – ٥۰۰ محم كلاريثرومايسين – مضاد حيوي من عائلة الماكروليدات

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