ORPHENADRINE CITRATE tablet, extended release

Orphenadrine Citrate by

Drug Labeling and Warnings

Orphenadrine Citrate by is a Prescription medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

8282025/0516OS
Rx only

DESCRIPTION

Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. Each orphenadrine citrate tablet contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate tablets also contain ethylcellulose NF, povidone USP, lactose monohydrate NF, and magnesium stearate NF.

ACTIONS

The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate also possesses anticholinergic actions.

INDICATIONS

Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo-skeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.

CONTRAINDICATIONS

Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardiospasm (megaesophagus) and myasthenia gravis. 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 citrate 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.

PREGNANCY

Pregnancy category C

Safe use of orphenadrine citrate has not been established with respect to adverse effects upon fetal development. Therefore, orphenadrine citrate should be used in women of childbearing potential and particularly during early pregnancy only when in the judgement of the physician the potential benefits outweigh the possible hazards.

USAGE IN CHILDREN

Safety and effectiveness in children have not been established; therefore, this drug is not recommended for use in the pediatric age group.

PRECAUTIONS

Confusion, anxiety and tremors have been reported in a 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, or 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.

ADVERSE REACTIONS

Adverse reactions of orphenadrine are mainly due to the mild anticholinergic 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, dilation 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.

DOSAGE AND ADMINISTRATION

TABLETS

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

HOW SUPPLIED

Tablets
100 mg-Each round, white, convex tablet imprinted with "G" on one side and "2011" on the other side.

Unit dose packages of 30 (5 x 6) NDC: 68084-820-25

Store at controlled room temperature 15° to 30°C (59° to 86°F).

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Impax Generics as follows:
(100 mg / 30 UD) NDC: 68084-820-25 packaged from NDC: 0115-2011

Distributed by:
American Health Packaging
Columbus, OH 43217

8282025/0516OS

Package/Label Display Panel – Carton – 100 mg

NDC 68084- 820-25

Orphenadrine Citrate
Extended-Release Tablets

100 mg

30 Tablets (5 x 6)               Rx Only

Usual Dosage: See package insert for full
prescribing information.

Store at controlled room temperature, 15° to 30°C
(59° to 86°F).

Keep this and all drugs out of reach of
children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is
from NDC # 0115-2011, Impax Generics.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

082026
0282025/0719OS

Package/Label Display Panel – Blister – 100 mg

Orphenadrine
Citrate
Extended-Release
Tablet

100 mg

INGREDIENTS AND APPEARANCE

ORPHENADRINE CITRATE 
orphenadrine citrate tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68084-820(NDC:0115-2011)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)	ORPHENADRINE CITRATE	100 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (convex)	Size	9mm
Flavor		Imprint Code	G;2011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68084-820-25	30 in 1 BOX, UNIT-DOSE	09/09/2014	10/31/2020
1	NDC: 68084-820-95	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040368	09/09/2014	10/31/2020

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(68084-820)