Prescription Drug Information: Gemfibrozil (Page 3 of 3)
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:
GEMFIBROZIL (N = 2046) | PLACEBO (N = 2035) | |
Frequency in percent of subjects | ||
Gastrointestinal reactions | 34.2 | 23.8 |
Dyspepsia | 19.6 | 11.9 |
Abdominal pain | 9.8 | 5.6 |
Acute appendicitis | 1.2 | 0.6 |
(histologically confirmed in most cases where data were available) | ||
Atrial fibrillation | 0.7 | 0.1 |
Adverse events reported by more than 1% of subjects, but without a significant difference between groups: | ||
Diarrhea | 7.2 | 6.5 |
Fatigue | 3.8 | 3.5 |
Nausea/Vomiting | 2.5 | 2.1 |
Eczema | 1.9 | 1.2 |
Rash | 1.7 | 1.3 |
Vertigo | 1.5 | 1.3 |
Constipation | 1.4 | 1.3 |
Headache | 1.2 | 1.1 |
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 vs 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 meal (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
Supplied as White film-coated, capsule shaped, biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect on one side and 225 on the other.
NDC 63187-772-30: Bottles of 30
NDC 63187-772-60: Bottles of 60
NDC 63187-772-90: Bottles of 90
NDC 63187-772-72: Bottles of 120
NDC 63187-772-78: Bottles of 180
Store at controlled room temperature 20° — 25°C (68° — 77°F) [see USP]. Protect from light and humidity.
Manufactured for:
Cipla USA Inc.,
9100 S. Dadeland Blvd., Suite 1500
Miami, FL 33156
Manufactured by:
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Revised: 7/2016
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC NDC 63187-772-60: Bottles of 60
Rx ONLY
GEMFIBROZIL
Tablets, USP
600mg
60 Tablets
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| Labeler — Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Proficient Rx LP | 079196022 | REPACK (63187-772), RELABEL (63187-772) | |
Revised: 04/2022 Proficient Rx LP
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