Drug Facts
Composition & Profile
Identifiers & Packaging
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. Cartons of 25 ( NDC 0641-6182-25 ) 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 May 2023 462-734-02; PRINCIPAL DISPLAY PANEL - CONTAINER NDC 0641- 6182 -01 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For IV or IM use Discard unused portion 2 mL Single Dose Vial vial; PRINCIPAL DISPLAY PANEL -SHELF PACK NDC 0641- 6182 -10 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For Intravenous or Intramuscular use 10 x 2 mL Single Dose Vials NDC 0641- 6182 -25 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For Intravenous or Intramuscular use 25 x 2 mL Single Dose Vials sp 25 pack label
- 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. Cartons of 25 ( NDC 0641-6182-25 ) 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 May 2023 462-734-02
- PRINCIPAL DISPLAY PANEL - CONTAINER NDC 0641- 6182 -01 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For IV or IM use Discard unused portion 2 mL Single Dose Vial vial
- PRINCIPAL DISPLAY PANEL -SHELF PACK NDC 0641- 6182 -10 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For Intravenous or Intramuscular use 10 x 2 mL Single Dose Vials NDC 0641- 6182 -25 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For Intravenous or Intramuscular use 25 x 2 mL Single Dose Vials sp 25 pack label
Overview
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 18 H 23 NO•C 6 H 8 O 7 MW 461.50 Structural Formula
Indications & 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.
Dosage & 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.
Warnings & Precautions
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.
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.
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.
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