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Atromid-S Side Effects, and Drug Interactions - Clofibrate

Atromid-S Side Effects, and Drug Interactions - Clofibrate

SIDE EFFECTS

The most common is nausea. Less frequently encountered gastrointestinal reactions are vomiting, loose stools, dyspepsia, flatulence, and abdominal distress. Reactions reported less often than gastrointestinal ones are headache, dizziness, and fatigue; muscle cramping, aching, and weakness; skin rash, urticaria, and pruritus; dry brittle hair, and alopecia.

The following reported adverse reactions are listed alphabetically by systems:

Cardiovascular

Increased or decreased angina.

Cardiac arrhythmias.

Both swelling and phlebitis at site of xanthomas.

Dermatologic

Allergic reactions including urticaria.

Skin rash.

Pruritus.

Dry skin and dry, brittle hair.

Alopecia.

Toxic epidermal necrolysis.

Erythema multiforme.

Stevens-Johnson syndrome.

Gastrointestinal

Gallstones.

Nausea.

Vomiting.

Diarrhea.

Gastrointestinal upset (bloating, flatulence, abdominal distress).

Hepatomegaly (not associated with hepatotoxicity).

Stomatitis and gastritis.

Genitourinary

Findings consistent with renal dysfunction as evidenced by dysuria, hematuria, proteinuria, decreased urine output. One patient's renal biopsy suggested "allergic reaction."

Impotence and decreased libido.

Hematologic

Leukopenia.

Potentiation of anticoagulant effect.

Anemia.

Eosinophilia.

Agranulocytosis.

Musculoskeletal

Myalgia (muscle cramping, aching, weakness).

"Flu-like" symptoms.

Myositis.

Myopathy.

Rhabdomyolysis in the setting of preexisting renal insufficiency.

Arthralgia.

Neurologic

Fatigue, weakness, drowsiness.

Dizziness.

Headache.

Miscellaneous

Weight gain.

Polyphagia.

Laboratory Findings

Abnormal liver-function tests as evidenced by increased transaminase (SGOT and SGPT), BSP retention, and increased thymol turbidity.

Proteinuria.

Increased creatine phosphokinase.

Hyperkalemia in association with renal insufficiency and continuous ambulatory peritoneal dialysis treatment.

Reported adverse reactions whose direct relationship with the drug has not been established: peptic ulcer, gastrointestinal hemorrhage, rheumatoid arthritis, tremors, increased perspiration, systemic lupus erythematosus, blurred vision, gynecomastia, thrombocytopenic purpura.

 

DRUG INTERACTIONS

Caution should be exercised when anticoagulants are given in conjunction with Atromid-S. Usually, the dosage of the anticoagulant should be reduced by one-half (depending on the individual case) to maintain the prothrombin time at the desired level to prevent bleeding complications. Frequent prothrombin determinations are advisable until it has been determined definitely that the prothrombin level has been stabilized.

Atromid-S may displace acidic drugs such as phenytoin or tolbutamide from their binding sites. Caution should be exercised when treating patients with either of these drugs or other highly protein-bound drugs and Atromid-S. The hypoglycemic effect of tolbutamide has been reported to increase when Atromid-S is given concurrently.

Fulminant rhabdomyolysis has been seen as early as three weeks after initiation of combined therapy with another fibrate and lovastatin but may be seen after several months. For these reasons, it is felt that, in most subjects who have had an unsatisfactory lipid response to either drug alone, the possible benefits of combined therapy with lovastatin and a fibrate do not outweigh the risks of severe myopathy, rhabdomyolysis, and acute renal failure. While it is not known whether this interaction occurs with fibrates other than gemfibrozil, myopathy and rhabdomyolysis have occasionally been associated with the use of fibrates alone, including clofibrate. Therefore, the combined use of lovastatin with fibrates should generally be avoided.

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