"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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Campral® is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.
The efficacy of Campral in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Campral treatment. The efficacy of Campral in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.
DOSAGE AND ADMINISTRATION
The recommended dose of Campral is two 333 mg tablets (each dose should total 666 mg) taken three times daily. A lower dose may be effective in some patients.
Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested in those patients who regularly eat three meals daily.
Treatment with Campral should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. Campral should be used as part of a comprehensive psychosocial treatment program.
Dosage in Renal Impairment
For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤ 30 mL/min) [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
Campral 333 mg tablets are enteric-coated, white, round, biconvex tablets, identified with “333” debossed on one side.
Opaque HDPE bottles of 180 NDC #0456-3330-01
Storage and Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Manufactured by: Merck Santé s.a.s., Subsidiary of Merck KGaA, Darmstadt, Germany, 37, rue Saint-Romain, 69008 LYON FRANCE. Manufactured for: Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO 63045. Revised: January 2012
Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Campral Information
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