Drug Catalog - Product Detail
METAXALONE 800MG TABLETS 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-2341-01 | ACTAVIS PHARMA | 100 | 800MG | TABLET |
PACKAGE FILES
Generic Name
METAXALONE
Substance Name
METAXALONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203695
Description
11 DESCRIPTION Metaxalone tablets, USP contain 800 mg of metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). Metaxalone tablets, USP is a muscle relaxant for oral administration. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C 12 H 15 NO 3 , which corresponds to a molecular weight of 221.25. The structural formula is: Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Meets USP dissolution test 2. 1
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Metaxalone tablets, USP are available as 800 mg capsule-shaped, scored white to off-white tablet, inscribed with “ 31 90 ” on the scored side and “ WPI ” on the other side. Metaxalone tablets USP, 800 mg has functional scoring. Bottles of 12 NDC 85766-011-12 (repackaged from NDC 0591-2341-01) Bottles of 15 NDC 85766-011-15 (repackaged from NDC 0591-2341-01) Bottles of 20 NDC 85766-011-20 (repackaged from NDC 0591-2341-01) Bottles of 30 NDC 85766-011-30 (repackaged from NDC 0591-2341-01) Bottles of 60 NDC 85766-011-60 (repackaged from NDC 0591-2341-01) Bottles of 90 NDC 85766-011-90 (repackaged from NDC 0591-2341-01) Bottles of 100 NDC 85766-011-01 (relabeled from NDC 0591-2341-01) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. Metaxalone tablets are a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of metaxalone tablets in adults and pediatric patients 13 years of age and older is 800 mg orally three to four times a day [see Use in Specific Populations ( 8 )]. Metaxalone tablets 800 mg are not substitutable on a mg to mg basis with metaxalone tablets, 640 mg [see Clinical Pharmacology ( 12.3 )]. When it is appropriate to switch: Switch only in patients who have been taking metaxalone tablets, 640 mg on an empty stomach. Stop metaxalone tablets, 640 mg three times a day and start metaxalone tablets 800 mg three times a day on an empty stomach, OR stop metaxalone tablets 640 mg four times a day and start metaxalone tablets 800 mg four times a day on an empty stomach. Do not switch from metaxalone tablets, 640 mg to metaxalone tablets when the patient is taking food during administration. Recommended dosage of metaxalone tablets in adults and pediatric patients 13 years of age and older is 800 mg orally three to four times a day. ( 2 ) Metaxalone tablets 800 mg are not substitutable on a mg to mg basis with metaxalone tablets, 640 mg. When it is appropriate to switch, see the Full Prescribing Information on switching instructions. ( 2 )