GEMFIBROZIL (Page 4 of 4)
ADVERSE REACTIONS
In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received gemfibrozil for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the gemfibrozil group:
Gallbladder surgery was performed in 0.9% of gemfibrozil and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate group compared to the placebo group of the WHO study. Gallbladder surgery was also performed more frequently in the gemfibrozil group compared to the placebo group (1.9% versus 0.3%, p=0.07) in the secondary prevention component. A statistically significant increase in appendectomy in the gemfibrozil group was seen also in the secondary prevention component (6 on gemfibrozil versus 0 on placebo, p=0.014).
Nervous system and special senses adverse reactions were more common in the gemfibrozil group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among gemfibrozil treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.
From other studies it seems probable that gemfibrozil is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS (see WARNINGS), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see PRECAUTIONS).
Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in gemfibrozil treated patients in other controlled clinical trials of 805 patients. Additional adverse reactions that have been reported for gemfibrozil are listed below by system. These are categorized according to whether a causal relationship to treatment with gemfibrozil is probable or not established:
Additional adverse reactions that have been reported include cholecystitis and cholelithiasis ( see WARNINGS).
DOSAGE AND ADMINISTRATION
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
OVERDOSAGE
There have been reported cases of overdosage with gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil. Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. Symptomatic supportive measures should be taken, should an overdose occur.
HOW SUPPLIED
Gemfibrozil Tablets, USP are supplied as: White to off white, film coated, oval tablets, debossed with “1” with two partial bisects on one side and two partial bisects on other side, each containing 600 mg gemfibrozil, USP are available as follows:
NDC 31722-128-60; Bottles of 60
NDC 31722-128-05; Bottles of 500
Store at controlled room temperature 20° – 25°C (68° – 77°F) [see USP]. Protect from light and humidity.
Manufactured by:
Ascent Pharmaceuticals, Inc.
Central Islip, NY 11722
Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
Rev: 08/21
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| Labeler — Camber Pharmaceuticals, Inc. (826774775) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Ascent Pharmaceuticals, Inc. | 080938961 | analysis (31722-128), manufacture (31722-128), pack (31722-128) | |
Revised: 08/2021 Camber Pharmaceuticals, Inc.
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