ADVERSE REACTIONS SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

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.

CONTRAINDICATIONS SECTION.

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 previous hypersensitivity to the drug.

DESCRIPTION SECTION.

DESCRIPTION. Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as white, crystalline powder having bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.It has the following structural formula:The empirical formula is C18H23NO.C6H8O7, representing 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 mL.. Orphenadrine citrate structural formula.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. INJECTION: Adults One mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.

DRUG ABUSE AND DEPENDENCE SECTION.

DRUG ABUSE AND DEPENDENCE. Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Orphenadrine Citrate Injection, USP is supplied as follows:NDCOrphenadrine Citrate Injection, USP (30 mg per mL)Package Factor25021-651-0260 mg per mL Single-Dose Vial10 vials per cartonOrphenadrine Citrate Injection, USP is an aqueous solution.. Storage Conditions. Store at 20 to 25C (68 to 77F); excursions permitted between 15 and 30C (59 and 86F). [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(R) Mfd. for SAGENT PharmaceuticalsSchaumburg, IL 60195 (USA)Made in India(C)2021 Sagent Pharmaceuticals, Inc.Revised: May 2021SAGENT Pharmaceuticals(R).

INDICATIONS & USAGE SECTION.

INDICATIONS AND 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.

OVERDOSAGE SECTION.

OVERDOSAGE. Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. In review of orphenadrine toxicity, the minimum lethal dose was found to be to 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial LabelNDC 25021-651-02Rx onlyOrphenadrine Citrate Injection, USP60 mg per mL(30 mg per mL)For Intravenous or Intramuscular Use2 mL Single-Dose Vial. PACKAGE LABEL PRINCIPAL DISPLAY PANEL VIAL LABEL.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

PRECAUTIONS SECTION.

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 citrate It is also not known whether orphenadrine citrate can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Orphenadrine citrate should be given to pregnant woman only if clearly needed.. Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

PREGNANCY SECTION.

Pregnancy. Pregnancy Category C. Animal reproduction studies have not been conducted with orphenadrine citrate It is also not known whether orphenadrine citrate can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Orphenadrine citrate should be given to pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

SAGENT(R) Rx only.

STORAGE AND HANDLING SECTION.

Storage Conditions. Store at 20 to 25C (68 to 77F); excursions permitted between 15 and 30C (59 and 86F). [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(R) Mfd. for SAGENT PharmaceuticalsSchaumburg, IL 60195 (USA)Made in India(C)2021 Sagent Pharmaceuticals, Inc.Revised: May 2021SAGENT Pharmaceuticals(R).

WARNINGS SECTION.

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 motor vehicle; ambulatory patients should therefore be cautioned accordingly.Orphenadrine citrate contains sodium metabisulfite, 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.