

Indication
KLARI tab® is used to treat the below listed infections caused by the susceptible micro-organisms:-
- Upper respiratory tract infections: pharyngitis, tonsilitis, sinusitis, acute otitis media.
- Lower respiratory tract infections: Acute and chronic bronchitis, pneumonia.
- Soft tissue and dermal infections: pyoderma, impetigo, cellulitis, folliculitis, legionella and chlamydia infection, ecthyma, erysipelas, lymphangitis and infected dermal lesions, also it is used for the treatment of leprosy and prophylaxis and treatment of opportunistic Mycobacterial infection.
- KLARI tab® in the presence of acid suppression is indicated for the eradication of Helicobacter pylori in pateints with peptic ulcers and it has been tried in protozoal infections including toxoplasmosis.

Composition
Each film coated tablet of KLARI tab® 500 contains:
- Clarithromycin 500 mg.
Each film coated tablet of KLARI tab® 250 contains:
- Clarithromycin 250 mg.

Dosage
1) Adult :
For acute sinusitis:
- 250mg/ 12 hours for 14 days.
For pharyngitis and tonsillitis:
- 250mg/ 12 hours for 10 days.
For eradicate of H.pylori:
- 500mg two times daily for 14 days in combination with an oral anti ulcer
2) Children: (younger than 12 years) :
- 7.5mg/ kg body weight every 12 hours for 5-10 days.
* Dose adjustment is necessary in patients with severe renal impairment
(creatinine clearance < 30 ml/min), the total dosage should be reduced by
half e.g. 250 mg once daily or 250 mg twice daily in more severe infection.
Over dose:-
- Reports indicate that the overdose of Clarithromycin can be expected to produce gastrointestinal symptoms.
- Allergic reaction produced should be treated by gastric lavage and supportive measures.
- Clarithromycin is a semi-synthetic macrolide antibiotic with a broad spectrum activity. It is rapidly absorbed from the gastrointestinal tract, after oral administration. The extent of absorption is relatively unaffected by the presence of food.
- Clarithromycin undergoes first-pass metabolism; the absolute bioaviability is about 55%.
- Clarithromycin is more active than Erythromycin against susceptible Streptococci and Staphylococci in vitro, as well as against some other species including Moraxella catarrhalis, legionella spp., Chlamydia trachomatis and Ureaplasma urealyticum.
- Clarithromycin is more active than Erythromycin or Azithromycin against some Mycobacteria, incluling Mycobacterium avium complex, and against M.Leprae. It is reported to have some in vitro activity against Toxoplasma gondii and may have activity against cryptosporidia.
- Clarithromycin activity may be enhanced by its major metabolite, 14-hydroxy clarithromycin, which has anti microbial activity against Haemophilus influenzae.
- Clarithromycin peak plasma concentrations are attained within 2 hours after oral dosing, and 80% is bound to plasma proteins at therapeutic levels. It is widely distributed, and tissue concentrations exceed those in serum. It has been detected in breast milk.
- Clarithromycin is extensively metabolized in liver and excreted in faeces via the bile. At steady state about 20% and 30% of 250 mg or 500 mg dose as tablets, respectively, is excreted in the urine as unchanged drug.
- The terminal half-life of Clarithromycin is reportedly about 3- 4 hours in patients receiving 250 mg dose twice daily, and about 5 to 7 hours in those receiving 500mg twice daily and the half-life is prolonged in renal impairment.
Each film coated tablet of KLARI tab® 500 contains:
- Clarithromycin 500 mg.
Each film coated tablet of KLARI tab® 250 contains:
- Clarithromycin 250 mg.
KLARI tab® is used to treat the below listed infections caused by the susceptible micro-organisms:-
- Upper respiratory tract infections: pharyngitis, tonsilitis, sinusitis, acute otitis media.
- Lower respiratory tract infections: Acute and chronic bronchitis, pneumonia.
- Soft tissue and dermal infections: pyoderma, impetigo, cellulitis, folliculitis, legionella and chlamydia infection, ecthyma, erysipelas, lymphangitis and infected dermal lesions, also it is used for the treatment of leprosy and prophylaxis and treatment of opportunistic Mycobacterial infection.
- KLARI tab® in the presence of acid suppression is indicated for the eradication of Helicobacter pylori in pateints with peptic ulcers and it has been tried in protozoal infections including toxoplasmosis.
- Hypersensitivity to Clarithromycin or any macrolide antibotics.
- Concomitant administration of Clarithromycin with Cisapride, Pimozide or Terfenadine is contraindicated because it results in cardiac arrhythmias.
- KLARI tab® increased efficacy of the following drugs, which are metabolized by the cytochrome P450 system: Digoxin, Warfarin, Ergot Alkaloid, Triazolam and Cyclosporins.
- KLARI tab® toxicity is increased in patients receiving clarithromycin and rifabutin.
- KLARI tab® increases plasma concentrations of Carbamazepine and Theophylline following concomitant use with single doses of Clarithromycin.
- KLARI tab® should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
- Clarithromycin is well tolerated, gastrointestinal adverse effects with oral clarithromycin therapy are lower than that of conventional macrolides Such as; (Nausea, vomiting, dyspepsia, diarrhoea, abdominal discomfort, and abnormal taste may occur).
- Headache, pseudomembranous colitis, have been reported.
- Allergic reactions ranging from mild urticaria and mild skin eruptions to rare cases of anaphylaxis and Steven - Johnsons syndrome, have occured.
- Hepatic dysfunction may be severe and is usually reversible.
- In very rare instances, hepatic failure has been reported and generally has been associated with serious underlying disease, and /or concomitant medications.
- Rarely, erythromycin and clarithromycin have been associated with ventricular arrhythmia.
1) Adult :
For acute sinusitis:
- 250mg/ 12 hours for 14 days.
For pharyngitis and tonsillitis:
- 250mg/ 12 hours for 10 days.
For eradicate of H.pylori:
- 500mg two times daily for 14 days in combination with an oral anti ulcer
2) Children: (younger than 12 years) :
- 7.5mg/ kg body weight every 12 hours for 5-10 days.
* Dose adjustment is necessary in patients with severe renal impairment
(creatinine clearance < 30 ml/min), the total dosage should be reduced by
half e.g. 250 mg once daily or 250 mg twice daily in more severe infection.
Over dose:-
- Reports indicate that the overdose of Clarithromycin can be expected to produce gastrointestinal symptoms.
- Allergic reaction produced should be treated by gastric lavage and supportive measures.
- In presence of severe renal impairment with or without co-existing impairment, decreased dosing intervals may be appropriate.
- The possibility of superinfection should be kept in mind during therapy. If superinfections occur, the drug should be discontinued and appropriate therapy instituted.
- The safety and effectiveness of Clarithromycin in children under 6 months of age have not been established.
- KLARI tab® 500 Film coated tablets (blister of 7 tablets, Pack of two blisters).
- KLARI tab® 250 Film coated tablets (blister of 7 tablets, Pack of two blisters).
- Store below 30 OC.