cine) Oral Solution is a slightly hazy, red liquid with a cherry odor and the strength of0.6 mg/5 mL. GLOPERBA (150 mL) is provided in a white, oblong, high density polyethylene bottle witha child-resistant cap.
150 mL: NDC 72690-010-05
16.2 Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Dosing Instructions
Patients should be advised to take GLOPERBA as prescribed, even if they are feeling better. Patients should notalter the dose or discontinue treatment without consulting with their doctor. If a dose of GLOPERBA is missed,take the dose as soon as possible and then return to the normal dosing schedule. However, if a dose is skippedthe patient should not double the next dose.
Advise patients and caregivers to measure GLOPERBA with an accurate milliliter measuring device. Ahousehold teaspoon is not an accurate measuring device. Advise patients and caregivers to ask their pharmacistto recommend an appropriate measuring device and for instructions for measuring the correct dose.
Fatal Overdose
Instruct patient that fatal overdoses, both accidental and intentional, have been reported in adults and childrenwho have ingested colchicine. GLOPERBA should be kept out of the reach of children.
Blood Dyscrasias
Patients should be informed that bone marrow depression with agranulocytosis, aplastic anemia andthrombocytopenia may occur with GLOPERBA.
Drug and Food Interactions
Advise patients that many drugs or other substances may interact with GLOPERBA and some interactionscould be fatal. Therefore, patients should report to their healthcare provider all of the current medications theyare taking and check with their healthcare provider before starting any new medications, including short-term
medications such as antibiotics. Patients should also be advised to report the use of nonprescription medicationor herbal products. Grapefruit and grapefruit juice may also interact and should not be consumed duringGLOPERBA treatment.
Neuromuscular Toxicity
Patients should be informed that muscle pain or weakness, tingling or numbness in fingers or toes may occurwith GLOPERBA alone or when it is used with certain other drugs. Patients developing any of these signs orsymptoms must discontinue GLOPERBA and seek medical eva luation immediately.
InfertilityAdvise males of reproductive potential that GLOPERBA may rarely and transiently impair fertility [see Use inSpecific Populations (8.3)].
Rx ONLY
Revised: 1/2019
Manufactured for:
ROMEG Therapeutics, LLC
Woburn, MA 01801 USA
Manufactured by:
Ferndale Laboratories, Inc.
Ferndale, MI 48220 USA |
