Klaz 250/Klaz Suspension

Klaz 250/Klaz Suspension

clarithromycin

Manufacturer:

Amherst Lab

Distributor:

Pediatrica
Concise Prescribing Info
Contents
Clarithromycin
Indications/Uses
Treatment of upper resp tract infections including streptococcal pharyngitis & tonsillitis, acute maxillary sinusitis & acute otitis media. Lower resp tract infections including bronchitis & pneumonia. Uncomplicated skin & skin structure infections including impetigo, folliculitis, cellulitis, abscesses. Disseminated or localized mycobacterial infections due to M. avium or M. intracellulare; localized infections due to M. kansasii, M. chelonae & M. fortuitum. H. pylori infections. Odontogenic infections. Prevention of disseminated M. avium complex (MAC) infection in patients w/ advanced HIV infection.
Dosage/Direction for Use
Klaz 250 Adult 250-500 mg every 12 hr for 5-14 days. Pharyngitis/tonsillitis 250 mg every 12 hr for 10 days. Acute maxillary sinusitis 500 mg every 12 hr for 7-14 days. Acute exacerbation of chronic bronchitis & community-acquired pneumonia 250-500 mg every 12 hr. Uncomplicated skin & skin structure infections 250 mg every 12 hr for 7-14 days. Odontogenic infections 250 mg every 12 hr for 5 days. Treatment of disseminated or localized mycobacterial infection 500 mg every 12 hr. Prevention of disseminated MAC infection in patients w/ advanced HIV infection 500 mg every 12 hr. Treatment should be continued while CD4 count is <100/mm3. H. pylori infections Triple therapy regimen: Clarithromycin 500 mg + amoxicillin 1,000 mg + omeprazole 20 mg bid for 7-10 days. Patients w/ an ulcer present at the time of initiation of treatment, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing & symptom relief. Dual therapy regimen: Clarithromycin 500 mg tid + omeprazole 40 mg once daily for 14 days, followed by omeprazole 20 or 40 mg once daily for an additional 14 days. Klaz Suspension Non-mycobacterial infections 15 mg/kg/day every 12 hr (max: 1,000 g/day). Childn 7-12 yr 125 mg/5 mL: 7.5-10 mL. 250 mg/5 mL: 5 mL, 2-6 yr 125 mg/5 mL: 5 mL. 250 mg/5 mL: 2.5 mL, 6 mth-1 yr 125 mg/5 mL: 2.5 mL. 250 mg/5 mL: 1.25 mL. All to be given every 12 hr. Duration of treatment: 5-10 days depending on severity of infection. Streptococcal pharyngitis: 10 days. Treatment of disseminated or localized mycobacterial infections 7.5 mg/kg every 12 hr. Prevention of disseminated MAC infection in patients w/ advanced HIV infection 7.5 mg/kg every 12 hr.  Renal impairment (CrCl <30 mL/min) Childn Reduce dose by ½ (ie, max of 250 mg once daily or max of 250 mg every 12 hr in more severe infections). Dosage should not be continued beyond 14 days.
Administration
May be taken with or without food: Tab: Swallow whole, do not chew/break/crush. Oral susp: May be given w/ milk.
Contraindications
Hypersensitivity to clarithromycin, erythromycin or any macrolide antiobitics. Patients w/ history of cholestatic jaundice/hepatic dysfunction associated w/ prior use of clarithromycin; QT prolongation or ventricular cardiac arrhythmia including torsades de pointes. Concomitant administration w/ cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin or lovastatin, ticagrelor or ranolazine, colchicine.
Special Precautions
Discontinue immediately if severe acute hypersensitivity reactions occur; signs & symptoms of hepatitis occur. Avoid in patients w/ ongoing proarrhythmic conditions eg, CAD, uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia & in patients receiving class I (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. C. difficile-associated diarrhea. Exacerbation of symptoms of myasthenia gravis & new onset of myasthenic syndrome. Treatment or prophylaxis of MAC infection should not exceed 500 mg bid. Cross-resistance w/ other macrolides. Combination w/ ranitidine bismuth citrate should not be used in patients w/ CrCl <25 mL/min & in those w/ history of acute porphyria. Overgrowth of non-susceptible organisms including fungi on long term or repeated use. Monitor vestibular & auditory function during & after treatment. Perform sensitivity testing for skin & soft tissue infections of mild to moderate severity. Perform susceptibility testing for community-acquired pneumonia. May affect ability to drive or operate machinery. Moderate to severe hepatic impairment. Renal impairment. Pregnancy (1st trimester) & lactation. Childn <6 mth & <20 mth w/ MAC. Elderly.
Adverse Reactions
Diarrhea, nausea, vomiting, abnormal taste, dyspepsia, abdominal pain/discomfort, rash & headache.
Drug Interactions
Manifestations of carbamazepine toxicity may occur. Cardiac arrhythmias including QT prolongation, ventricular tachycardia, ventricular fibrillation & torsades de pointes w/ cisapride/pimozide. Ventricular fibrillation, QT interval prolongation & marked increased elimination t½ of disopyramide. Increased conc of HMG-CoA reductase inhibitors. Increased metabolism w/ rifampicin, rifabutin, rifapentine. Increased frequency of uveitis w/ rifabutin. Increased serum level of terfenadine & astemizole. Higher serum conc of tolterodine. Increased exposure & possible related toxicities of quetiapine. Inhibits metabolism of alfentanil, bromocriptine, cilostazole, hexobarbital, ibrutinib, methylprednisolone, phenytoin, sirolimus, valproate & vinblastine. May induce metabolism w/ St. John's wort. Increased conc & AUC of amprenavir. Increased AUC w/ delavirdine. Decreased exposure w/ etravirine. Increased conc of indinavir. Increased conc w/ fixed combination of lopinavir & ritonavir. Decreased plasma conc & AUC w/ nevirapine. Increased plasma conc of saquinavir. Decreased steady-state conc of zidovudine. Increased anticoagulant effect of warfarin & acenocoumarol. Serious risk of CNS effects w/ triazolobenzodiazepines (eg, alprazolam, triazolam) & benzodiazepines (eg, midazolam). Risk of hypotension w/ Ca channel blockers (eg, verapamil, amlodipine, diltiazem, nifedipine). Elevated ciclosporin level. Increased exposure to colchicine. Elevated serum digoxin levels. Fatal toxic epidermal necrolysis & fulminant hepatitis w/ disulfiram. Acute ergot toxicity. Increased steady-state trough serum conc & AUC w/ fluconazole. Delirium w/ fluoxetine. Increased plasma levels w/ itraconazole. Increased Cmax, AUC and elimination t½ of omeprazole. Hypoglycemia w/ certrain hypoglycemic drugs eg, nateglinide, pioglitazone, repaglinide & rosiglitazone. Increased phosphodiesterase inhibtor (eg, sildenafil, tadalafil, vardenafil) exposure). Increased tacrolimus plasma levels. Increased serum theophylline. Darifenacin; erlotinib; eszopiclone; atazanavir.
MIMS Class
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Klaz 250 FC tab 250 mg
Packing/Price
50's
Form
Klaz Suspension oral susp 125 mg/5 mL
Packing/Price
35 mL x 1's;70 mL x 1's
Form
Klaz Suspension oral susp 250 mg/5 mL
Packing/Price
35 mL x 1's;70 mL x 1's
/philippines/image/info/klaz suspension oral susp 250 mg-5 ml/250 mg-5 ml x 35 ml?id=fa50bff5-c955-43f8-a17d-ac5b00ad0d5b
/philippines/image/info/klaz suspension oral susp 250 mg-5 ml/250 mg-5 ml x 70 ml?id=1e7837b2-ce91-4dca-b7dd-ac5b00ad0d5b
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