Abbreviated Prescribing Information
Clarithromycin, ABBOTIC®
Presentation: ABBOTIC®, 500 mg Film coated tablet, each contains clarithromycin 500 mg; ABBOTIC® XL, 500 mg
Modified released tablet, each contains active clarithromycin 500 mg; ABBOTIC® Granules, 125 mg/5 ml Dry syrup,
each contains clarithromycin 125 mg/5 ml, for use primarily in children; ABBOTIC® Granules 250 mg/5 ml Dry syrup,
each contains clarithromycin 250 mg/5 ml, for use primarily in children.
Indication ABBOTIC® is indicated for the treatment of mild to moderate, infections caused by susceptible strains of
the designated microorganisms in the following conditions: upper respiratory tract infections; pharyngitis/tonsillitis due
to Streptococcus pyogenes; acute maxillary sinusitis due to Streptococcus pneumonia, H. influenza, M. catarrhalis;
lower respiratory tract infections; uncomplicated skin and skin structure infections due to Staphylococcus aureus or
Streptococcus pyogenes; disseminated mycobacterial infections due to Mycobacterium avium and Mycobacterium
intracellular. ABBOTIC® in the presence of acid suppression is indicated for the eradication of H. pylori resulting in
decreased recurrence of duodenal ulcer.
Dosage: ABBOTIC®, 500 mg Usual therapy duration is 7 – 14 days. Usual recommended dosage 250 mg twice daily.
More severe infections can be increased to 500 mg twice daily. Treatment of Legionella pneumophila infection 500
mg twice daily for 4 weeks. Patients with renal impairment (creatinine clearance < 30 ml/min) reduced by half (250
mg once daily or 250 mg twice daily in more severe infections, should not be continued beyond 14 days in these
patients). Treatment of haemolytic streptococcal infection should be administered at last ten days; ABBOTIC® XL,
500 mg Usual therapy duration is 7 – 14 days. Usual recommended dosage in adults 500 mg once-daily. More
severe infections can be increased to 1000 mg once-daily (2X500mg); ABBOTIC® Granules, 125 mg/5 ml, ABBOTIC®
Granules, 250 mg/5 ml The prepared suspension can be taken with or without meals, and can be taken with milk.
Recommended daily dosage in children 7.5 mg/kg b.i.d up to maximum dose of 500 mg b.i.d for severe infections.
Usual duration of treatment is 5 – 10 days depending on the pathogen involved and severity of the condition.
Treatment for Streptococcal pharyngitis should be at least 10 days. The following table is a suggested guide for
determining dosage in children.
Based on Body Wt. in Kg Dosage in Standard 5 ml Dosage in Standard 5 ml
Wt* teaspoonful given twice daily – teaspoonful given twice daily
125 mg/5 ml – 250 mg/5 ml
8 – 11 kg 0.5 -
12 – 19 kg 1.0 0.5
20 – 29 kg 1.5 0.75
30 – 40 kg 2.0 1.0
(*) Children < 8 kg should be dosed on a per kg basis (approx.. 7.5 mg/kg DID)
Contraindication: ABBOTIC®, 500 mg, ABBOTIC® Granules, 125 mg/5 ml, ABBOTIC® Granules, 250 mg/5 ml Known
hypersensitivity to macrolide antibiotic drugs; patients receiving terfenadine therapy who have preexisting cardiac
abnormalities or electrolyte disturbances; ABBOTIC® XL, 500 mg Known hypersensitivity to macrolide antibiotic
drugs; patients with creatinine clearance less than 30 ml/min (for this patients, Clarithromycin 500 mg immediate
release tablets may be utilized). Concomitant administration of clarithromycin and any of the following drugs:
cisapride, pimozide, terfenadine and astemizole.
Warnings and precautions: ABBOTIC®, 500 mg, ABBOTIC® XL, 500 mg Pseudomembranous colitis has been
reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-
threatening. Antibiotic associated colitis. Consideration to management with fluids and electrolytes, protein
supplementation. Caution to patients with moderate to severe renal impairment. If superinfection occurs,
Abbreviated PI ABBOTIC® Draft
Clarithromycin should be discontinued and appropriate therapy instituted. Safety and effectiveness in children under
6 months of age have not been established and safety profile has not been studied in MAC patients age < 20
months. Geriatric patients. Attention to the possibility of cross resistance with other macrolide drugs, as well as
lincomycin and clindamycin. Doses of clarithromycin greater than 1 g/day sould not be co-administered with
Ribonavir; ABBOTIC® Granules, 125 mg/5 ml, ABBOTIC® Granules, 250 mg/5 ml Caution should be exercised in
patients with impaired hepatic function and patients with moderate to severe renal failure. Attention on the possibility
of cross resistance between clarithromycin and other macrolide drugs as well as lincomycin and clindamycin. If super
infection occurs, clarithromycin should be discontinued and appropriate therapy instituted.
Interactions Theophyline, carbamazepine, drugs metabolized by the cytochrome P-450, cisapride, pimozide, digoxin,
terfenadine, astemizole, zidovudine and dideoxyinosine.
Pregnancy and lactation: ABBOTIC®, 500 mg, ABBOTIC® XL, 500 mg Clarithromycin should not be used in pregnant
woman, except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking
this drug, the patients should be apprised of the potential hazard of the fetus. Caution should be exercised when
Clarithromycin is administered to a nursing women; ABBOTIC® Granules, 125 mg/5 ml, ABBOTIC® Granules, 250
mg/5 ml If ABBOTIC® Granules 125 mg/5ml or ABBOTIC® Granules 250 mg/5ml considered for patients of
postpubertal age, the physician should carefully weigh the benefits against the risk when pregnancy is either
suspected or confirmed.
Undesirable effects: ABBOTIC®, 500 mg Most frequently reported side effects of Clarithromycin in clinical studies in
adults were gastrointestinal-related complaints. Other side effects included headache, altered taste and transient
elevations of liver enzymes. Increased serum creatinine, increased glutaryl transferase (GGT). Allergic reactions.
Transient central nervous system side effects have been reported. Adverse events in immunocompromised patients.
ABBOTIC® XL, 500 mg Most frequently reported side effects of Clarithromycin in clinical studies in adults were
gastrointestinal-related complaints. Hepatic dysfunction. Allergic reactions (including Stevens-Johnsons Syndrome).
Transient central nervous system side effects have been reported. Reversible hearing loss, taste perversion.
Glossitis, stomatis, oral monillia, tongue discoloration and reversible tooth discoloration. Hypoglycemia.
Thrombocytopenia. ABBOTIC® Granules, 125 mg/5 ml, ABBOTIC® Granules, 250 mg/5 ml The safety profile of the
paediatric formulation is similar to that of the 250 mg tablet in adult patients. The majority of adverse events reported
were of gastrointestinal system. Other side effects included headache, altered taste and transient elevations of liver
enzymes. Allergic reactions. Transient central nervous system side effects have been reported, however, a cause
and effect relationship has not been established.Taste perversion may occur and glossitis and stomatitis have been
reported.
Pack size
ABBOTIC® film-coated tablet 500 mg, Box of 3 blisters @10 film-coated tablets. Registration No.: DKL0400202117A2
ABBOTIC® XL500 mg, Box of 5 blisters @ 2 modified release tablets, Registration No.: DKI0075500414A1
ABBOTIC® dry syrup 125 mg/5 ml, Box of Plastic Bottle @ 30 ml. Registration No.: DKL9400202238A1
ABBOTIC® dry syrup 125 mg/5 ml, Box of Plastic Bottle @ 60 ml. Registration No.: DKL9400202238A1
ABBOTIC® dry syrup 250 mg/5 ml, Box of Plastic Bottle @ 50 ml. Registration No.: DKL0800202238B2
HARUS DENGAN RESEP DOKTER
Further information is available on request from
PT Abbott Indonesia
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav. V-TA, Jakarta 12310 - Indonesia
Tel: +62 21 2758 7888; Fax: +62 21 2758 7889
Abbreviated PI ABBOTIC® Draft
