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MIGLUSTAT

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Overview

What is MIGLUSTAT?

Miglustat Capsules, 100 mg are an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Miglustat 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 CHNO 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).

Miglustat capsules are supplied in hard gelatin capsules each containing 100 mg miglustat for oral administration. Each miglustat 100 mg capsule also contains 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, propylene glycol, potassium hydroxide and shellac.



What does MIGLUSTAT look like?



What are the available doses of MIGLUSTAT?

Capsules: 100 mg ()

What should I talk to my health care provider before I take MIGLUSTAT?

How should I use MIGLUSTAT?

Miglustat is a glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option ().

Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease.

The recommended dose for the treatment of adult patients with type 1 Gaucher disease is one 100 mg capsule administered orally three times a day at regular intervals. If a dose is missed, the next miglustat capsule should be taken at the next scheduled time.

It may be necessary to reduce the dose to one 100 mg capsule once or twice a day in some patients due to adverse reactions, such as tremor or diarrhea.


What interacts with MIGLUSTAT?

Sorry No Records found


What are the warnings of MIGLUSTAT?

Sorry No Records found


What are the precautions of MIGLUSTAT?

Sorry No Records found


What are the side effects of MIGLUSTAT?

Sorry No records found


What should I look out for while using MIGLUSTAT?

None


What might happen if I take too much MIGLUSTAT?

Sorry No Records found


How should I store and handle MIGLUSTAT?

Store between 2-8°C (36°-46°F).Miglustat capsules are supplied in hard gelatin capsules containing 100 mg miglustat. Miglustat 100 mg capsules are white to off-white capsule with AMG on the body and 310 on the Cap in black ink.Miglustat capsules100 mg are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton. NDC 43975-310-83: carton containing 90 capsules. Storage: Miglustat capsules are supplied in hard gelatin capsules containing 100 mg miglustat. Miglustat 100 mg capsules are white to off-white capsule with AMG on the body and 310 on the Cap in black ink.Miglustat capsules100 mg are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton. NDC 43975-310-83: carton containing 90 capsules. Storage: Miglustat capsules are supplied in hard gelatin capsules containing 100 mg miglustat. Miglustat 100 mg capsules are white to off-white capsule with AMG on the body and 310 on the Cap in black ink.Miglustat capsules100 mg are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton. NDC 43975-310-83: carton containing 90 capsules. Storage: Miglustat capsules are supplied in hard gelatin capsules containing 100 mg miglustat. Miglustat 100 mg capsules are white to off-white capsule with AMG on the body and 310 on the Cap in black ink.Miglustat capsules100 mg are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton. NDC 43975-310-83: carton containing 90 capsules. Storage:


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Type 1 Gaucher disease is caused by a functional deficiency of glucocerebrosidase, the enzyme that mediates the degradation of the glycosphingolipid glucosylceramide.

Miglustat functions as a competitive and reversible inhibitor of the enzyme glucosylceramide synthase, the initial enzyme in a series of reactions which results in the synthesis of most glycosphingolipids.

Miglustat helps reduce the rate of glycosphingolipid biosynthesis so that the amount of glycosphingolipid substrate is reduced to a level which allows the residual activity of the deficient glucocerebrosidase enzyme to be more effective (substrate reduction therapy). and studies have shown that miglustat can reduce the synthesis of glucosylceramide-based glycosphingolipids.

Non-Clinical Toxicology
None

Therapy should be directed by physicians knowledgeable in the management of patients with Gaucher disease.

The following serious adverse reactions are described below and elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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