ORPHENADRINE CITRATE- orphenadrine citrate tablet, extended release 
Aidarex Pharmaceuticals LLC

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Orphenadrine Citrate Extended-Release Tablets

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:

Orphenadrine Citrate Chemical Structure

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.

CLINICAL PHARMACOLOGY

The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions.

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.

CONTRAINDICATIONS

Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis.

Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

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.

PRECAUTIONS

Confusion, anxiety and tremors have been reported in few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases.

Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias.

Safety of continuous long-term therapy with orphenadrine has not been established. Therefore, if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

Adverse reactions of orphenadrine are mainly due to the mild anti-cholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. No causal relationship has been established.


DRUG ABUSE AND DEPENDENCE

Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

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.

DOSAGE AND ADMINISTRATION

Adults

Two tablets per day; one in the morning and one in the evening.

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 33261-088-07  in bottles of 7 tablets
NDC 33261-088-14  in bottles of 7 tablets
NDC 33261-088-20  in bottles of 7 tablets
NDC 33261-088-28  in bottles of 7 tablets
NDC 33261-088-30  in bottles of 7 tablets
NDC 33261-088-60  in bottles of 7 tablets
NDC 33261-088-84  in bottles of 7 tablets
NDC 33261-088-90  in bottles of 7 tablets
NDC 33261-088-120in bottles of 7 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:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

100 mg Label

Image Label
ORPHENADRINE CITRATE 
orphenadrine citrate tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:33261-088(NDC:43386-480)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ORPHENADRINE CITRATE (ORPHENADRINE) ORPHENADRINE CITRATE100 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code GG931
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33261-088-02120 in 1 BOTTLE
2NDC:33261-088-1010 in 1 BOTTLE
3NDC:33261-088-1414 in 1 BOTTLE
4NDC:33261-088-2020 in 1 BOTTLE
5NDC:33261-088-2828 in 1 BOTTLE
6NDC:33261-088-3030 in 1 BOTTLE
7NDC:33261-088-6060 in 1 BOTTLE
8NDC:33261-088-8484 in 1 BOTTLE
9NDC:33261-088-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04028406/19/1998
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 10/2012
Document Id: 2076f538-fb8b-4bbb-aaff-c50a32e92d07
Set id: 19b31a8f-d07e-43df-a0f0-a9b34406c904
Version: 1
Effective Time: 20121004
 
Aidarex Pharmaceuticals LLC