orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet
Generic Name: ORPHENADRINE CITRATE
Brand Name: Orphenadrine Citrate
- Substance Name(s):
- ORPHENADRINE CITRATE
WARNINGS
Some patients may experience transient episodes of light-headedness, dizziness or syncope.
Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.
OVERDOSAGE
Orphenadrine is toxic when overdosed and typically induces anticholinergic effects.
In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable.
Treatment for orphenadrine overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.
DESCRIPTION
Orphenadrine citrate is the citrate salt of orphenadrine.
It occurs as a white, crystalline powder having a bitter taste.
It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.
The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C18H23NO•C6H8O7 and molecular weight of 461.51.
It has the following structural formula: Each tablet for oral administration contains 100 mg orphenadrine citrate.
Each Orphenadrine citrate extended-release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate.
Orphenadrine Citrate Chemical Structure
HOW SUPPLIED
Orphenadrine citrate extended-release tablets 100 mg are round, white tablets, debossed GG 931 on one side and plain on the reverse side and are supplied as: NDC 68788-9150-3 in bottles of 30 tablets NDC 68788-9150-6 in bottles of 60 tablets NDC 68788-9150-9 in bottles of 90 tablets NDC 68788-9150-1 in bottles of 100 tablets NDC 68788-9150-8 in bottles of 120 tablets Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container.
01-2010M 8100 GIN-480-00 Manufactured by Sandoz Inc.
Princeton, NJ 08540 for GAVIS Pharmaceuticals, LLC 400 Campus Drive Somerset, NJ 08873 Repackaged By: Preferred Pharmaceuticals, Inc Anaheim, CA 92807
INDICATIONS AND USAGE
Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
PREGNANCY
Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine.
It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Orphenadrine should be given to a pregnant woman only if clearly needed.
DOSAGE AND ADMINISTRATION
Adults Two tablets per day; one in the morning and one in the evening.