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Antibiotics

Clarithromycin STADA® 250 mg


Pack size:

Box of 2 blisters x 10 film-coated tablets.
 

Composition:

Each film-coated tablet contains clarithromycin 250 mg.
 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place.

Protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of pharyngitis and tonsillitis, mild to moderate respiratory tract infections (acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, community-acquired pneumonia), uncomplicated skin and skin structure infections, and acute otitis media caused by susceptible organisms.
  • Treatment of disseminated infections caused by Mycobacterium avium complex (MAC) in patients with advanced human immunodeficiency virus (HIV) infection and for prevention of disseminated MAC infection (both primary and secondary prophylaxis) in HIV-infected individuals.
  • Combination with amoxicillin and lansoprazole or omeprazole for the treatment of Helicobacter pylori infection and duodenal ulcer disease; with omeprazole or ranitidine bismuth citrate for the treatment of H. pylori infection in patients with an active duodenal ulcer.
  • Clarithromycin STADA® 250 mg is administered orally and may be given without regard to meals.
  • Usual doses in patients 12 years of age or older:
    250 mg twice daily, increased to 500 mg twice daily if necessary in severe infection; for 7 to 14 days.
    Children may be given 7.5 mg/kg twice daily for 5 to 10 days.
  • For treatment and prophylaxis of disseminated infection due to Mycobacterium avium complex:
    500 mg twice daily; for treatment, it should be given with other antimycobacterials.
  • For the eradication of H. pylori associated with peptic ulcer disease:
    500 mg twice daily, clarithromycin is given with another antibacterial and either a proton pump inhibitor or a histamine H2-receptor antagonist, for 7 to 14 days.
  • In patients with severe renal impairment (creatinine clearance of less than 30 ml/minute):
    Dosage of clarithromycin may need to be halved.


Or as prescribed by physicians.
 

  • Patients with known hypersensitivity to clarithromycin, erythromycin, any other macrolide antibiotic, or to any ingredient of the drug.
  • Concomitant use of clarithromycin with certain drugs, including terfenadine, astemizole, cisapride and pimozide is contraindicated because such use is likely to produce substantially increased plasma concentrations of the drugs and possibly cause serious and/or life-threatening cardiotoxicity.
  • Concomitant use with ergot alkaloids (ergotamine, dihydroergotamine) also is contraindicated because of potentially serious toxicity.

     

  • Gastrointestinal disturbances are the most frequent adverse effect but are usually mild and less frequent with clarithromycin than with erythromycin.
  • Taste disturbances, stomatitis, glossitis, tooth discoloration, and headache have occurred. 
  • There have also been reports of transient CNS effects such as anxiety, dizziness, insomnia, hallucinations, confusion, and convulsions have also occurred. 
  • Other adverse effects include hypoglycaemia, leucopenia, and thrombocytopenia. Interstitial nephritis and renal failure have been reported rarely.
     

  • Prescribing clarithromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
  • Clarithromycin is principally excreted via the liver and kidney. Clarithromycin may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate.
  • Concomitant use of clarithromycin and ranitidine bismuth citrate is not recommended in patients with creatinine clearance less than 25 ml/minute, and should not be used in patients with a history of acute porphyria.
  • As with other anti-infective agents, use of clarithromycin may result in overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, appropriate therapy should be instituted.
  • There are no adequate and well-controlled studies in pregnant women. Clarithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Caution should be exercised when clarithromycin is administered to a nursing woman.
  • There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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