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ADVERSE REACTIONS
The most frequently reported side effects of clarithromycin in clinical
studies in adults were gastrointestinal-related complaints, i.e., nausea,
dyspepsia, abdominal pain, vomiting and diarrhea. Other side effects
included headache, taste perversion, and transient elevations of liver
enzymes.
Post Marketing Experience
Hepatic dysfunction, including increased liver enzymes, and hepatocellular
and/or cholestatic hepatitis, with or without jaundice, has been
infrequently reported with clarithromycin. This hepatic dysfunction may be
severe and is usually reversible. in very rare instances, hepatic failure
and fatal outcome has been reported and generally has been associated with
serious underlying diseases and/or concomitant medications.
Isolated cases of increased serum creatinine have been reported but an
association has not been established.
Allergic reactions ranging from urticaria and mild skin eruptions to
anaphylaxis and Stevens-Johnson Syndrome/ toxic epidermal necrolysis have
occurred with orally administered clarithromycin. There have been reports of
transient central nervous system effects including dizziness, vertigo,
anxiety, insomnia, bad dreams, tinnitus, confusion, disorientation,
hallucination, psychosis, and depersonalization; however, a cause and effect
relationship has not been established.
There have been reports of hearing loss with clarithromycin which is usually
reversible upon withdrawal of therapy. Reports of alteration of the sense of
smell, usually in conjunction with taste perversion have also been reported.
Glossitis, stomatitis, oral Monilia and tongue discoloration have been
reported with clarithromycin therapy. There have been reports of tooth
discoloration in patients treated with clarithromycin. Tooth discoloration
is usually reversible with professional dental cleaning.
There have been rare reports of hypoglycemia, some of which have occurred in
patients on concomitant oral hypoglycemic agents or insulin.
Isolated cases of leukopenia and thrombocytopenia have been reported.
As with other macrolides, QT prolongation, ventricular tachycardia, and
Torsades de Pointes have rarely been reported with clarithromycin.
There have been rare reports of pancreatitis and convulsions.
There have been reports of interstitial nephritis coincident with
clarithromycin use.
There have been post-marketing reports of colchicine toxicity with
concomitant use of clarithromycin and colchicine, especially in the elderly,
some of which occurred in patients with renal insufficiency. Deaths have
been reported in some such patients. (See DRUG INTERACTIONS: Colchicine and
PRECAUTIONS).
Immunocompromised Patients
In AIDS and other immunocompromised patients treated with the higher doses
of clarithromycin over long periods of time for mycobactenal infections, it
was often difficult to distinguish adverse events possibly associated with
clarithromycin administration from underlying signs of HIV disease or
intercurrent illness.
In adult patients, the most frequently reported adverse events by patients
treated with total daily doses of 1000 mg of clarithromycin were: nausea,
vomiting, taste perversion, abdominal pain, diarrhea, rash. flatulence,
headache, constipation, hearing disturbance, SGOT and SGPT elevations.
Additional lowfrequency events included dyspnea, insomnia, and dry mouth.
In these immunocompromised
patients evaluations of laboratory values were made by analyzing those
values outside the seriously abnormal level (i.e., the extreme high or low
limit) for the specified test. On the basis of this criteria, about 2 to 3%
of these patients who received 1000 mg of clarithromycin daily had seriously
abnormal elevated levels of SCOT and SGPT, and abnormally low white blood
cell and platelet counts. A lower percentage of patients also had elevated
BUN levels.
OVERDOSAGE
Reports indicate the ingestion of large amounts of clarithromycin can be
expected to produce gastrointestinal symptoms. One patient who had a history
of bipolar disorder ingested eight grams of clarithromycin and showed
altered mental status, paranoid behavior, hypokalemia, and hypoxemia.
Adverse reactions accompanying
overdosage should be treated by the prompt elimination of unabsorbed drug
and supportive measures. As with other macrolides, clarithromycin serum
levels are not expected to be appreciably affected by hemodialysis or
peritoneal dialysis.
DOSAGE AND ADMINISTRATION
Patients with respiratory tract/skin and soft tissue infections.
Adults:
The usual dose is 250mg twice daily for 7 days although this may be
increased to 500mg twice daily for up to 14 days in severe infections.
Children older than 12 years:
As for adults.
Children younger than 12 years:
Use Klacid Paediatric Suspension.
Eradication of H. pylori in patients with duodenal ulcers
Adults:
The usual dose of Clarithromycin is 500mg three times daily for 14 days.
Dual Therapy:
Klacid should be administered with oral omeprazole 40mg once daily. The
pivotal study was conducted with omeprazole 40mg once daily for 28 days.
Supportive studies have been conducted with omeprazole 40mg once daily for
14 days.
Triple Therapy:
Klacid 500mg twice daily should be given with amoxycillin 1000mg twice daily
and omeprazole 20mg daily for 10 days.
Elderly:
As for adults.
Renal impairment:
Dosage adjustments are not usually except in patients with severe renal
impairment (creatinine clearance <30ml/min). If adjustment is necessary, the
total daily dosage should be reduced to half, eg. 250mg once daily or 250mg
twice daily in more severe infections.
Klacid may be given without
regard to meals as food does not affect the extent of bioavailabilily.
SHELF LIFE
The recommended shelf life is 36 months stored at room temperature (15° to
30°C)
STORAGE
Store tablets at room temperature (15° to 30°C) in a well-closed container.
Protect from light.
PACKAGE
Tablets in a blister original pack containing 28 tablets. The blisters are
arranged in a carton with a package insert.
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