July 1, 2015
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Lioresal Intrathecal

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Lioresal Intrathecal

LIORESAL® Intrathecal
(baclofen) Injection 0.05 mg/mL, 0.5 mg/mL and 2 mg/mL

For intrathecal injection and infusion only

DRUG DESCRIPTION

Drug Substance

LIORESAL (baclofen) Structural Formula Illustration

Baclofen

Chemical Name: 4-amino-3-(p-chlorophenyl) butyric acid

Molecular Formula: C10H12ClNO2

Molecular Weight: 213.67

Description: White to off-white, odorless or practically odorless crystalline powder.

Solubility: Slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform.

pKa: pKa, 1 = 3.87 (carboxyl group) and pKa, 2 = 9.62 (amino group) in water at 20OC.

Composition

The contents of each sterile ampoule are described in the following table.

Dosage mg/mL Total Volume mL Medicinal ingredient Non-medicinal ingredients
Baclofen/mg Sodium chloride/mg Water for injection
0.05 1 0.05 9 up to 1 mL
0.5 20 10 180 up to 20 mL
2 5 10 45 up to 5 mL

Last reviewed on RxList: 1/10/2014
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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