ORPHENADRINE CITRATE- orphenadrine citrate tablet, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)
Available from:
RxChange Co.
INN (International Name):
ORPHENADRINE CITRATE
Composition:
ORPHENADRINE CITRATE 100 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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. 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. Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.
Product summary:
Orphenadrine citrate extended-release tablets 100 mg are round, white to off-white tablets, debossed NL4 on one side and plain on the other side and are supplied as: NDC 43386-480-24 in bottles of 100 tablets NDC 43386-480-26 in bottles of 500 tablets NDC 43386-480-28 in bottles of 1000 tablets Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 for GAVIS Pharmaceuticals, LLC 400 Campus Drive Somerset, NJ 08873 GIN-480-01 Rev: 02/2011
Authorization status:
Abbreviated New Drug Application
Authorization number:
33358-274-60

ORPHENADRINE CITRATE- orphenadrine citrate tablet, extended release

RxChange Co.

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Orphenadrine Citrate Extended-Release Tablets

Gavis Pharmaceuticals, LLC.

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- -

phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C

H NOC H O 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.

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 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, 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 to off-white tablets, debossed

NL4 on one side and plain on the other side and are supplied as:

NDC 43386-480-24 in bottles of 100 tablets

NDC 43386-480-26 in bottles of 500 tablets

NDC 43386-480-28 in bottles of 1000 tablets

Storage and Handling

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-

resistant container.

Manufactured by

Novel Laboratories, Inc.

Somerset, NJ 08873

for GAVIS Pharmaceuticals, LLC

400 Campus Drive

Somerset, NJ 08873

GIN-480-01

Rev: 02/2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORPHENADRINE CITRATE

orphenadrine citrate tablet, extended release

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:33358 -274(NDC:4338 6 -48 0 )

RxChange Co.

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O RPHENADRINE CITRATE (UNII: X0 A40 N8 I4S) (ORPHENADRINE - UNII:AL8 0 5O9 OG9 )

ORPHENADRINE CITRATE

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:33358 -274-6 0

6 0 in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 28 4

11/15/20 14

Labeler -

RxChange Co. (781126805)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RxChange Co .

78 1126 8 0 5

ma nufa c ture (33358 -274)

Revised: 12/2014

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