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:

image
(click image for full-size original)

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

63187-772-60
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-772(NDC:69097-821)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMFIBROZIL (GEMFIBROZIL) GEMFIBROZIL 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CALCIUM STEARATE
MICROCRYSTALLINE CELLULOSE
METHYLCELLULOSE (15 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code 225;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-772-30 30 TABLET in 1 BOTTLE None
2 NDC:63187-772-60 60 TABLET in 1 BOTTLE None
3 NDC:63187-772-90 90 TABLET in 1 BOTTLE None
4 NDC:63187-772-72 120 TABLET in 1 BOTTLE None
5 NDC:63187-772-78 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 07/08/2016
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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