"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"...
(miglustat) Capsules, 100 mg
Zavesca (miglustat capsules, 100 mg) is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Zavesca is an N-alkylated imino sugar, a synthetic analog of D-glucose.
The chemical name for miglustat is 1,5-(butylimino)-1,5-dideoxy-D-glucitol with the chemical formula C10H21NO4 and a molecular weight of 219.28.
Miglustat is a white to off-white crystalline solid and has a bitter taste. It is highly soluble in water ( > 1000 mg/mL as a free base).
Zavesca is supplied in hard gelatin capsules each containing 100 mg miglustat for oral administration. Each Zavesca 100 mg capsule also contains sodium starch glycollate, povidone (K30), and magnesium stearate. Ingredients in the capsule shell include gelatin and titanium dioxide, and the shells are printed with edible ink consisting of black iron oxide and shellac.
What are the possible side effects of miglustat (Zavesca)?
Nerve problems such as numbness, tingling, and tremor (shaking) of the hands have been reported by some people taking miglustat. Contact your doctor immediately if you experience new or worsening numbness, tingling, or burning in the hands, arms, legs, or feet or tremor in the hands.
Seek emergency medical attention if you experience a rare but serious allergic reaction to miglustat including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives.
Other less serious side effects may be more likely to occur. Continue to take miglustat and talk...
Last reviewed on RxList: 2/21/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Zavesca Information
Report Problems to the Food and Drug Administration
Find out what women really need.