Bicrolid

Clarithromycin.

Each caplet contains clarithromycin 250 mg.

Pharmacology: BICROLID contains Clarithromycin a semi-synthetic macrolide antibiotic. It exerts its anti-bacterial action by binding to the 50S ribosomal subunit of susceptible organism and inhibiting protein synthesis.
BICROLID is rapidly absorbed from the gastro-intestinal tract after oral administration.
Food does not affect the extent of bioavailability, therefore BICROLID may be given concomitantly with meals.
In fasting healthy human subjects, peak serum concentrations were attained within 2 hours after oral dosing.
Peak serum concentrations were approximately 1 mcg/ml with a 250 mg dose administered every 12 hours and 2-3 mcg/ml with a 500 mg dose administered every 12 hours.
The elimination half-life was about 3 to 4 hours with 250 mg administered every 12 hours but increased to 5 to 7 hours with 500 mg administered every 12 hours.
After a 250 mg dose every 12 hours, approximately 20% of the dose is excreted in the urine as the unchanged parent drug. After a 500 mg dose every 12 hours, the urinary excretion of Clarithromycin is somewhat greater, approximately 30%.
The major metabolite found in urine is 14-OH Clarithromycin which also has clinically significant anti-microbial activity.
Clarithromycin and the 14-OH Clarithromycin metabolite is distributed readily into body tissues and fluids. No data is available on CSF (Cerebro Spinal Fluid) penetration.
BICROLID is active in vitro against a variety of aerobic and anaerobic Gram-positive and Gram-negative organisms.
Against Haemophilus influenzae, 14-OH Clarithromycin is twice as active as the parent compound.
Beta-lactamase production should have no effect on Clarithromycin activity.

BICROLID is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed as follows: Upper respiratory-tract infections: Pharyngitis or tonsillitis due to Streptococcus pyogenes. Acute maxillary sinusitis due to Streptococcus pneumoniae.
Lower respiratory-tract infections: Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxellacatarrhalis, or Streptococcus pneumoniae. Pneumonia due to Mycoplasma pneumoniae or Streptococcus pneumoniae.
Uncomplicated skin and skin structure infections: Due to Staphylococcus aureus, or Streptococcus pyogenes.

BICROLID may be given with or without meals. (See table.)

Click on icon to see table/diagram/image

BICROLID 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 with or without co-existing hepatic impairment, de­creased doses or prolongation of dosing intervals may be appropriate.

Hypersensitivity to Clarithromycin, erythromycin, or any of the macrolide antibiotics.

Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
It should be given with caution in nursing mothers.
Pseudomembranous colitis has occurred with nearly all anti-bacterial agents, including macrolides. It is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of the drug.
Treatment with anti-bacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of anti-biotic-associated colitis.
Safety and effectiveness of Clarithromycin in children under 12 years of age have not been established.
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, therefore caution is required when treating: Patients with congenital or documented QT prolongation, patients currently receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of classes IA and Ill; antipsychotic agents; antidepressants; and fluoroquinolones.
Patients with electrolyte disturbance, particularly in cases of hypokalaemia and hypomagnesemia.
Patients with clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency.
Elderly patients: Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
It should be given with caution in nursing mothers.

The common adverse reactions are diarrhea, nausea, abnormal taste, dyspepsia, abdominal pain, and headache.
They are usually mild or moderate in severity.
Digestive disturbances in Clarithromycin-treated patients occur rarely.

Concurrent use of Clarithromycin with theophylline may be associated with an increase of serum theophylline concentrations.
Single-dose administration of Clarithromycin resulted in increased concentrations of carbamazepine. Blood level monitoring of carbamazepine should be considered.
The following drug interactions have been observed with erythromycin products: Concomitant administration of Clarithromycin and digoxin has been found to result in elevated digoxin levels.
Erythromycin decreases the clearance of triazolam, and thus may increase the pharmacological effect of triazolam.
There have been reports of increased anti-coagulant effects, when erythromycin and oral anticoa-gulant were used concomitantly.

Store at room temperature (25-30°C).

Macrolides

J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

POM