Claromin 250

Claromin 250
17 May

Claromin 250

Antibiotics & Antibacterial

- Clarithromycin is a semi-synthetic macrolide antibiotic with a 
 broad spectrum activity. It is rapidly absorbed from the 
 gastrointestinal tract, The extent of absorption is relatively 
 unaffected by the presence of food , and it undergoes first-pass 
 metabolism; the absolute bioaviability is  about55 %.   
- 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 pneumoniae 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 have anti microbial 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 metabolised 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 500 mg twice daily and the half-life is 
 prolonged in renal impairment.

Indecation

  CLAROMIN®  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 chroric bronchitis, 
 pneumonia.
- Soft tissue and dermal infections: pyoderma, impetigo, cellulitis, 
 folliculitis, legionella and chlamydia infection, eczyma, erysipelas, 
 lymphangitis and infected dermal lesions, also it is used for the 
 treatment of leprosy and prophylaxis and treatment of opportunistic 
 Mycobacterial infection.
- CLAROMIN®  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.

Dosage & Administration

- The usual dosage of CLAROMIN®  tablets is 250 mg every 12 hours. Unless the physician dictates otherwise, the usual duration of  
 CLAROMIN®  therapy is 7- 14 days. 
- Acute sinusitis should be treated for 14 days. 
- Pharyngitis and tonsilitis should be treated for 10 days.
- Eradication of H. pylori in patients with peptic ulcers: the usual dose 
 of  CLAROMIN® is 500 mg three times daily for 14 days with an 
 oral antiulcer drugs.
- In Mycobacterium avium complex disease: the recommended adult 
 dose is 500 mg twice daily.
- Children younger than 12 years: the recommended dose of  
 CLAROMIN®  is 7.5 mg/kg every 12 hours for 5- 10 days.
- Dose adjustment is necessary in patients with severe rena 
 impairmentt  (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

-Each film coated tablet of CLAROMIN® 500 contains:
         Clarithromycin               500  mg 
-Each film coated tablet of CLAROMIN® 250  contains:
         Clarithromycin               250  mg

- Hypersensitivity to Clarithromycin or any macrolide antibotics.
- Concomitant administration of Clarithromycin with Cisapride, 
 Pimozide or  Terfenadine is contraindicated because it results in 
 cardiac arrhythmias.

-CLAROMIN® increase the efficacy of the following drugs, which 
 are metabolized by the cytochrome P450 system: Digoxin, Warfarin, 
 Ergot Alkaloid, Triazolam and Cyclosporins.
-CLAROMIN® increase toxicity in patients receiving clarithromycin 
 and  rifabutin. 
-CLAROMIN® increase plasma concentration of Carbamazepine and   
 Theophylline following concomitant use with single doses of 
 Clarithromycin.

- CLAROMIN® should be used during pregnancy only if the 
 pontential benefit justifies the potential risk to the fetus.

- CLAROMIN® is well tolerated, however, 
gastrointestinal disturbances such as: nausea, vomiting, dyspepsia, diarrhoea, abdominal discomfort, abnormal taste may occur.
- Headache, skin rash, pseudomembranous colitis, allergic reactions 
 have been reported.

- 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.

- CLAROMIN® 500 Film coated tablets 
                                (Blisters of 7 tablet, Pack of two blisters.) 
- CLAROMIN® 250 Film coated tablet 
                                (Blisters of 7 tablet, Pack of two blisters.)

-Store in a dry place  at a temperature  below 30oC.