ORPHENADRINE CITRATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

ORPHENADRINE CITRATE

Composition:

ORPHENADRINE CITRATE 60 mg in 2 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

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 Hikma Pharmaceuticals USA Inc. 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: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2019 462-734-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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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:
C
H
NO•C 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
18
23
6
8
7
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 susce