Specifications: In-house

Formula
Each film-coated tablet contains clarithromycin 250 mg and excipients q.s. (pregelatinized starch, povidone, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, talc, film coating excipient).

Dosage form
Film-coated tablets.

Presentation
Box of 3 blisters x 4 film-coated tablets (250 mg tablets).

Indications
- Treatment of infections caused by one or more susceptible organisms: 
   . Lower Respiratory Tract Infections: Acute and chronic bronchitis and pneumonia.
   . Upper Respiratory Tract Infections: Sinusitis, pharyngitis and otitis media.
- Mild to moderate skin and soft tissue infections.
- Initial therapy in community-acquired respiratory infections. Clarithromycin has been proved to be active in vitro against common and atypical respiratory pathogens.
- Eradication of H. pylori in patients with proven duodenal ulcers.

Contra-indications
- Patients with hypersensitivity to macrolide antibiotics.
- Co-administration with terfenadine.

Precautions
Clarithromycin is principally excreted by liver and kidney. Caution should be exercised when administering clarithromycin to patients with impaired hepatic or renal function.

Side effects
Reported side effects include nausea, dyspepsia, diarrhea, and abdominal pain. Stomatitis, glossitis and oral Candida have been reported. Other side effects include headache and allergic reactions from urticaria and mild skin eruptions to anaphylaxis and rarely Stevens-Johnson syndrome.
The physician should be informed any side effects during the treatment with CARICIN.

Interactions
- Clarithromycin has been shown not to interact with oral contraceptives.
- As with other macrolide antibiotics, the use of clarithromycin in patients concurrently taking drugs metabolised by the cytochrome P-450 system (eg, warfarin, ergot, alkaloids, triazolam, midazolam, lovastatin, disopyramide, phenytoin and cyclosporin) may be associated with elevations in serum levels of these other drugs. The administration of clarithromycin to patients who are receiving theophylline has been associated with an increase in serum theophylline levels and potential theophylline toxicity.
- The use of clarithomycin in patients receiving warfarin may result in a potentiation of the effects of warfarin. Prothrombin time should be frequently monitored in these patients.
- The effects of digoxin may be potentiated with concomitant administration of clarithromycin. Monitoring of serum digoxin levels should be considered.
- Clarithromycin may potentiate the effects of carbamazepine due to a reduction in the rate of excretion.
- Macrolide has been reported to alter the metabolism of terfenadine resulting in increased levels of terfenadine. This may be associated with cardiac arrhythmias and therefore, the concomitant use of terfenadine and related non-sedating antihistamine, eg astermizole with clarithromycin requires caution.
- Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. This can be largely avoided by staggering the doses of clarithromycin and zidovudine by 1 - 2 hrs. No such reaction has been reported in children.
- Although the plasma concentrations of clarithromycin and omeprazole may be increased when they are administered concurrently, no adjustment to the dosage is necessary. Increase plasma concentrations of clarithromycin may also occur when it is co-administered with maalox or ranitidine. No adjustment to the dosage is necessary.

Dosage and Administration
- Respiratory tract infections, skin and soft tissue infections:
    Usual dose: 250 - 500 mg x 2 times daily for 6-14 days. 
- Eradication of H. pylori in patients with duodenal ulcers:
    Adults and elderly: 500 mg x 2 times daily for 7 days, concomitant with other drugs.
- Renal Impairment: Dosage adjustment is not usually required except in patients with severe renal impairment (creatinine clearance < 30 mL/min). If adjustment is necessary, the total daily dosage should be reduced by half.
CARICIN may be given with or without food as food does not affect its bio-availability.

Shelf-life
36 months.

Storage
Store in a dry and cool place (<30 degree C), protect from light. Keep out of reach of children.

Prescription only medicine.
Read leaflet carefully before use. For more information, consult your physician