ORPHENADRINE CITRATE

Main information

  • Trade name:
  • ORPHENADRINE CITRATE- orphenadrine citrate injection
  • Composition:
  • ORPHENADRINE CITRATE 60 mg in 2 mL
  • Administration route:
  • INTRAMUSCULAR
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ORPHENADRINE CITRATE- orphenadrine citrate injection
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus) and myasthenia gravis. 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 Injection, USP is supplied as follows: Cartons of 10 (NDC 0641-6182-10 ) 2 mL vials, each vial containing 60 mg of orphenadrine citrate in aqueous solution. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Single dose vial. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by:   WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Revised February 2016 462-734-00

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 0641-6182-01, 0641-6182-10
  • Last update:
  • 28-05-2019

Summary of Product characteristics: dosage, interactions, side effects

ORPHENADRINE CITRATE- orphenadrine citrate injection

West-Ward Pharmaceuticals Corp.

----------

ORPHENADRINE CITRATE

INJECTION, USP

Rx only

DESCRIPTION

Orphenadrine citrate is the citrate salt of orphenadrine (±)-N,N-dimethyl-2-[(o-methyl-α-

phenylbenzyl)oxy]-ethylamine citrate (1:1). It occurs as a white, crystalline powder having a bitter taste.

It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.

Each vial contains 60 mg of orphenadrine citrate in aqueous solution. Each vial also contains: sodium

metabisulfite, 2 mg; sodium chloride, 5.8 mg; sodium hydroxide, to adjust pH; and water for injection,

q.s. to 2 mL. The structural formula is:

H NOC H O MW 461.50

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 anticholinergic actions.

INDICATIONS AND USAGE

Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief

of discomfort associated with acute painful musculoskeletal conditions.

CONTRAINDICATIONS

Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers,

prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (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.

Orphenadrine citrate injection contains sodium metabisulfite, a sulfite that may cause allergic-type

reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in

certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is

unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic

people.

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

Teratogenic Effects

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 children have not been established; therefore, this drug is not recommended

for use in the pediatric age group.

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.

Rare instances of anaphylactic reaction have been reported associated with the intramuscular injection

of orphenadrine citrate.

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 - One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.

Relief may be maintained by one (100 mg) orphenadrine citrate tablet twice daily.

Parenteral drug products should be inspected visually for particulate matter, whenever solution and

container permit.

HOW SUPPLIED

Orphenadrine Citrate Injection, USP is supplied as follows:

Cartons of 10 (NDC 0641-6182-10) 2 mL vials, each vial containing 60 mg of orphenadrine citrate in

aqueous solution.

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light.

Single dose vial. Discard unused portion.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-

877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

Manufactured by:

WEST-WARD

PHARMACEUTICALS

Eatontown, NJ 07724 USA

Revised February 2016

462-734-00

PRINCIPAL DISPLAY PANEL - CONTAINER

NDC 0641-6182-01 Rx only

Orphenadrine

Citrate Injection, USP

60 mg/2 mL

(30 mg/mL)

FOR IV or IM USE

Discard unused portion

2 mL Single Dose Vial

PRINCIPAL DISPLAY PANEL -SHELF PACK

NDC 0641-6182-10 Rx only

Orphenadrine

Citrate Injection, USP

60 mg/2 mL

(30 mg/mL)

For INTRAVENOUS or INTRAMUSCULAR Use

10 x 2 mL Single Dose Vials

West-Ward Pharmaceuticals Corp.

SERIALIZATION IMAGE

ORPHENADRINE CITRATE

orphenadrine citrate injection

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 6 41-6 18 2

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

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

6 0 mg in 2 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

5.8 mg in 2 mL

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO DIUM METABISULFITE (UNII: 4VON5FNS3C)

2 mg in 2 mL

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 6 41-6 18 2-10

10 in 1 BOX

0 4/28 /20 0 3

1

NDC:0 6 41-6 18 2-0 1

2 mL in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 46 3

0 4/28 /20 0 3

Labeler -

West-Ward Pharmaceuticals Corp. (946499746)

Revised: 12/2018