Composition
Synclar-250 Tablets
Each film-coated tablet contains ....
Clarithromycin USP 250 mg
Synclar Dry Syrup
Each 5 ml (after reconstitution) contains ....
Clarithromycin USP 125 mg
Description
Clarithromycin is a semi-synthetic derivative of erythromycin
A. It exerts its antibacterial action by binding to
the 50s ribosomal sub-unit of susceptible bacteria
and suppresses protein synthesis. It is highly potent
against a wide variety of aerobic and anaerobic gram
positive and gram negative microorganisms.
Indications
Synclar-250 is indicated for the treatment of mild
to moderate infections due to susceptible organisms.
Upper respiratory tract infections
Pharyngitis, tonsillitis.
Lower respiratory tract infections
Acute and chronic bronchitis, pneumonia
Uncomplicated skin and skin structure infections like
Folliculitis, Cellulitis, Erysipelas.
Dosage and Administration
Adults: Children > 12 years:
The usual dose is one tablet (250 mg) twice daily
for 7 days, although this may be increased to two
tablets (500 mg) twice daily for up to 14 days in
severe infections
Children less than 12 years:
7.5 mg/kg every 12 hours for 10 days.
Infants under 6 months:
Not recommended.
HEPATIC
INSUFFICIENCY
No dosage adjustment is recommended for patients with
mild to moderate hepatic impairment. However, in patients
with significant hepatic disease, clarithromycin should
be given with caution.
RENAL INSUFFICIENCY
Caution should be exercised while administering clarithromycin
to patients with severe renal impairment (creatinine
clearance < 30 ml/min).
Contraindications
Hypersensitivity to macrolide antibiotic drugs. 'Patients
receiving terfenadine therapy who have pre-existing
cardiac abnormalities (arrhythmia, bradycardia, QT
interval prolongation, ischemic heart disease, congestive
heart failure) or electrolyte disturbances.
Warnings
and Precautions
DRUG INTERACTIONS
Ergot: The theoretical possibility of ergotism contraindicates
the concurrent use of clarithromycin with ergot derivatives.
The use of clarithromycin in patients concurrently
taking drugs metabolized by the cytochrome P450 system
may be associated with elevations in serum levels
of these other drugs liketheophylline, carbamazepine,
digoxin, warfarin, terfanidine, cyclosporine..
PREGNANCY
Clarithromycin should not be used in pregnant women
except in clinical circumstances where no alternative
therapy is appropriate. If pregnancy occurs while
taking this drug, the patient should be apprised of
the potential hazard to the foetus.
LACTATION
Caution should be exercised when administering to
a nursing woman.
PAEDIATRIC
USE
The drug is not recommended for use in infants less
than 6 months of age.
Side
Effects
The drug is generally well tolerated. Side effects
include nausea, vomiting, diarrhoea and abdominal
pain. Other rare side effects include headache and
skin rash.
Overdosage
Reports indicate that the ingestion of large amount
of clarithromycin can be expected to produce gastrointestinal
symptoms. Allergic reactions accompanying overdosage
should be treated by gastric lavage and supportive
measures.
Presentation
