Clarithromycin Tablets USP 500 mg
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory
Each film coated tablet contains:
Clarithromycin USP 500 mg
Colour: Titanium Dioxide BP
Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically it is 6-0 methylerythromycin. Like other macrolides, Clarithromycin binds to the 50S subunit of the 70S ribosome, thereby blocking RNA-mediated bacterial protein synthesis. Clarithromycin can be bacteriostatic or bactericidal in action, depending on the concentration as well as the particular organism and its inoculum. The minimum inhibitory, concentrations (MIC) of clarithromycin are generally two-told lower than the MIC of erythromycin.
1. Highly potent against a wide variety of aerobic and anaerobic gram-positive and gram-negative organisms.
2. Respiratory tract infections.
3. Ear, nose and throat infections.
4. Community acquired pneumonia.
5 Dessminated mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulate.
6. Prevention of dessiminated Mycobacterium avium complex (MAC) disease in patients with advance HIV infection.
7. Treatment of H. Pylori infections in combination with other drugs such as lansoprazole, omeprazole, ranitidine, bismuth, amoxycillin etc.
The usual dosage of clarithromycin is 250 mg twice daily. Although this may be increased to 500mg twice daily for up to 14 days in severe infections.
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg bid. Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. In the treatment of Mycobacterium avium complex clarithromycin should be used in combination with other antimycobacterial drugs. The recommended dose for mycobacterial infections in adults is 500mg bid.
In children the dose is 7.5 rug to 15 mg/kg 12 hourly.
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (creatinine clearance < 30 ml/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing Interval doubled.
Pregnancy and lactation
The safety of clarithromycin during pregnancy and breast feeding of infants has not been established. Clarithromycin should thus not be used during pregnancy or lactation unless the benefit is considered to outweigh the risk. Some animal studies have suggested an embryo toxic effect, but only at dose levels which are clearly toxic to mothers. Clarithromycin has been found in the milk of lactating animals and in human breast milk.
Effects on ability to Drive and use Machines
The medicine is unlikely to produce an effect.
Mutagenicity and Teratogenicity
No evidence of mutagenic potential of clarithromycin was seen during a range of in vitro and in vivo tests.
Clarithromycin is rapidly and well absorbed from the gastro-intestinal tract after oral administration of Clarithromycin. The microbiologically active metabolite 14-hydroxycalrithromycin is formed by first pass metabolism. Clarithromycin may be given without regard to meals as food does not affect the extent of bioavailability of clarithromycin. Food does slightly delay the onset of absorption of clarithromycin and formation of the 14-hydroxymetabolite. The pharmacokinetics of clarithromycin are non linear however, steady state is attained within 2 days of dosing. At 250 mg b.i.d. 15-20% of unchanged drug is excreted in the urine. With 500 mg b.i.d daily dosing urinary excretion is greater (app. 36%). The 14-hydroxycalrithromycin is the major urinary metabolite and accounts for 10-15% of the dose. Most of the remainder of the dose is eliminated in the faeces, primarily via the bile. 5-10% of the parent drug is recovered from the faeces. When clarithromycin 500mg is given three times daily, the clarithromycin plasma, concentrations are increased with respect to the 500mg twice daily dosage.
Clarithromycin provides tissue concentrations that are several times higher than the circulating drug levels. Increased levels have been found in both tonsillar and lung tissue. Clarithromycin is 80% bound to plasma proteins at therapeutic levels. Clarithromycin also penetrates the gastric mucus. Levels of clarithromycin in gastric mucus and gastric tissue are higher when clarithromycin is co-administered with omeparzole than when clarithromycin is administered alone. Clarithromycin penetrates into the middle ear fluid at concentrations greater than in the serum.
The majority of side effects observed in clinical trials were of a mild and transient nature. Fewer than 3% of adult patients without mycobacterial infections and fewer than 2% of pediatric patients without mycobacterial infections and fewer than 2% of pediatric patients without mycobacterial infections discontinued therapy because of drug-related side effects.
The most frequently reported events in adults were diarrhoea, nausea, abnormal taste, dyspepsia, abdominal pain/discomfort, and headache. In paediatric patients, the most frequently reported events were diarrhoea, vomiting, abdominal pain, rash and headache. Most of these events were described as mild or moderate in severity.
H.pylori organisms may develop resistance to clarithromycin in a small number of patients.
Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibiotics. It is also contraindicated in pregnancy. Concomitant administration of clarithromycin with cisapride, pimozide, or terfenadine is contraindicated.
Clarithromycin and ergot derivatives should not to be co-administered. Clarithromycin may potentiate the effects of carbamazepine due to a reduction in the rate of excretion.
Clarithromycin tablets have a shelf – life of 24 months when stored in Alu/ PVC/PVDC blisters in a cool dry place. Do not store above 30°C. Protect from light.
Blister pack of 14 tablets.
Manufactured in India by
Fredun Pharmaceuticals Ltd.
14, 15, 16, Zorabian Industrial Complex,
Veoor, Palghar (E) – 401 404
Dist. Thane. India.
Reals Pharmaceuticals Ltd.
1, AIhaji Junaid Dosunmu Street,
CBD, Alausa, lkeja, Lagos.