Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Orphenadrine Citrate Injection, USP is supplied as follows: NDC Orphenadrine Citrate Injection, USP (30 mg per mL) Package Factor 25021-651-02 60 mg per 2 mL Single-Dose Vial 10 vials per carton Orphenadrine Citrate Injection, USP is an aqueous solution. Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Not to be sold in unbroken box. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2021 Sagent Pharmaceuticals, Inc. Revised: May 2021 SAGENT Pharmaceuticals ®; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label NDC 25021-651-02 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg per mL) For Intravenous or Intramuscular Use 2 mL Single-Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VIAL LABEL
- HOW SUPPLIED Orphenadrine Citrate Injection, USP is supplied as follows: NDC Orphenadrine Citrate Injection, USP (30 mg per mL) Package Factor 25021-651-02 60 mg per 2 mL Single-Dose Vial 10 vials per carton Orphenadrine Citrate Injection, USP is an aqueous solution. Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Not to be sold in unbroken box. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2021 Sagent Pharmaceuticals, Inc. Revised: May 2021 SAGENT Pharmaceuticals ®
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label NDC 25021-651-02 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg per mL) For Intravenous or Intramuscular Use 2 mL Single-Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VIAL LABEL
Overview
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. It has the following structural formula: The empirical formula is C 18 H 23 NO·C 6 H 8 O 7 , representing a molecular weight of 461.50. Orphenadrine Citrate Injection, USP contains 60 mg of orphenadrine citrate in aqueous solution in each vial. Orphenadrine Citrate Injection, USP also contains: sodium metabisulfite NF, 2.0 mg; sodium chloride USP, 5.8 mg; sodium hydroxide NF, to adjust pH; and water for injection USP, q.s. to 2 mL. Orphenadrine citrate structural formula
Indications & Usage
Orphenadrine Citrate Injection is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions.
Dosage & Administration
INJECTION: Adults – One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.
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 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 anti-cholinergic 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. To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Storage & Handling
Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Not to be sold in unbroken box. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2021 Sagent Pharmaceuticals, Inc. Revised: May 2021 SAGENT Pharmaceuticals ®
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