If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown in the table below.
HIPSTREET 9 FLARE 2 TABLET FULL
Geriatric Use: The recommended dose of colchicine should be based on renal function ( 8.5).įULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Gout Flares 1.2ğamilial Mediterranean Fever (FMF) 2 DOSAGE AND ADMINISTRATION 2.1 Gout Flares 2.2ğMF 2.3 Recommended Pediatric Dosage 2.4ĝose Modification for Coadministration of Interacting Drugs 2.5ĝose Modification in Renal Impairment 2.6ĝose Modification in Hepatic Impairment 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1ğatal Overdose 5.2ělood Dyscrasias 5.3ĝrug Interactions 5.4 Neuromuscular Toxicity 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience in Gout 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 9 DRUG ABUSE AND DEPENDENCE 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.Ĭoadministration of colchicine tablets with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1).
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In FMF patients, start with 0.3 mg/day, and any increase in dose should be done with close monitoring ( 8.6). In patients with severe renal impairment for prophylaxis of gout flares, the starting dose should be 0.3 mg/day for gout flares, no dose adjustment is required, but a treatment course should be repeated no more than once every two weeks.In the presence of mild to moderate renal or hepatic impairment, adjustment of dosing is not required for treatment of gout flare, prophylaxis of gout flare and FMF, but patients should be monitored closely ( 8.6).