FDA
Orphenadrine Citrate
The FDA lists this product in 13 strengths and forms.
Indications
Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.
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 and precautions
Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine citrate extended-release tablets 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.
Pregnancy and breastfeeding
PREGNANCY Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine citrate extended-release tablets. It is also not known whether orphenadrine citrate extended-release tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine citrate extended-release tablets should be given to a pregnant woman only if clearly needed.
Adverse reactions
Adverse reactions of orphenadrine citrate extended-release tablets are mainly due to the mild anti-cholinergic action of orphenadrine citrate extended-release tablets 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.



