S AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Gout Prophylaxis
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fatal Overdose
5.2 Blood Dyscrasias
5.3 Drug Interactions
5.4 Neuromuscular Toxicity
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 CYP3A4
7.2 P-Glycoprotein
7.3 HMG-CoA Reductase Inhibitors and Fibrates
7.4 Drug Interaction Studies
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
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
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 arenot listed
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
GLOPERBA® (colchicine) Oral Solution is indicated for prophylaxis of gout flares in adults.
Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares duringprophylaxis has not been studied. GLOPERBA is not an analgesic medication and should not be used to treatpain from other causes.
2 DOSAGE AND ADMINISTRATION
2.1 Gout Prophylaxis
For prophylaxis of gout flares, the recommended dosage of GLOPERBA is 0.6 mg (5 mL) once or twicedaily. The maximum dose is 1.2 mg/day.
GLOPERBA is administered orally, without regard to meals.
3 DOSAGE FORMS AND STRENGTHS
Ready-to-use solution for oral administration containing 0.6 mg/5 mL of colchicine. The oral solution is aslightly hazy, red liquid with a cherry odor.
4 CONTRAINDICATIONS
Patients with renal or hepatic impairment should not be given GLOPERBA in conjunction with drugs thatinhibit both CYP3A4 and P-gp [see Drug Interactions (7)]. Combining these dual inhibitors with colchicine inpatients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.
Patients with both renal and hepatic impairment should not be given GLOPERBA.
5 WARNINGS AND PRECAUTIONS
5.1 Fatal Overdose
Fatal overdoses, both accidental and intentional, have been reported in adults and children who haveingested colchicine [see Overdosage (10)]. GLOPERBA should be kept out of the reach of children.
5.2 Blood Dyscrasias
Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia and aplastic anemiahave been reported with colchicine used in therapeutic doses.
5.3 Drug Interactions
Because colchicine is a substrate for both the CYP3A4 metabolizing enzyme and the P-gp effluxtransporter, inhibition of either of these pathways may lead to colchicine-related toxicity. Inhibition of bothCYP3A4 and P-gp by dual inhibitors (i.e., clarithromycin) has been reported to produce life-threatening or
fatal colchicine toxicity due to significant increases in systemic colchicine levels. Therefore, concomitantuse of GLOPERBA with inhibitors of both CYP3A4 and P-gp should be avoided. If treatment withcolchicine is necessary, a reduced daily dose should be considered and the patient should be closelymonitored for colchicine toxicity [see |
