"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(sodium phenylbutyrate) Tablets and Powder
BUPHENYL (sodium phenylbutyrate) Tablets for oral administration and BUPHENYL (sodium phenylbutyrate) Powder for oral, nasogastric, or gastrostomy tube administration contain sodium phenylbutyrate. Sodium phenylbutyrate is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium phenylbutyrate also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C10H11O2Na.
Each tablet of BUPHENYL contains 500 mg of sodium phenylbutyrate and the inactive ingredients microcrystalline cellulose NF, magnesium stearate NF, and colloidal silicon dioxide NF.
Each gram of BUPHENYL Powder contains 0.94 grams of sodium phenylbutyrate and the inactive ingredients calcium stearate NF, and colloidal silicon dioxide NF.
What are the possible side effects of sodium phenylbutyrate (Buphenyl)?
Even with treatment, urea cycle disorders can cause a build-up of ammonia in the blood which can result in life-threatening side effects. Seek emergency medical attention if you notice any signs of ammonia build-up, including mood or behavior changes, memory loss, thinking problems, muscle twitching, back and forth movement of the eyes, vomiting, increasing weakness, slurred speech, seizure (convulsions), and fainting.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or...
What are the precautions when taking sodium phenylbutyrate tablets (Buphenyl)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain heart problem (congestive heart failure), kidney disease, liver disease, swelling (edema).
This medication contains salt (sodium). Before taking this medication, tell your doctor or pharmacist if you are on a low-salt diet.
This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit...
Last reviewed on RxList: 11/12/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Buphenyl Information
Buphenyl - User Reviews
Buphenyl User Reviews
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