Label: ORPHENADRINE CITRATE tablet, extended release
- NDC Code(s): 0185-0022-01, 0185-0022-10
- Packager: Eon Labs, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated April 24, 2018
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- SPL UNCLASSIFIED SECTION
Orphenadrine citrate, USP is the citrate salt of orphenadrine (2-dimethyl-aminoethyl 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 and has a molecular weight of 461.51. The molecular formula C18H23NO • C6H8O7 is represented by the following structural formula:
Each orphenadrine citrate extended-release tablet, USP contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate extended-release tablets, USP also contain: calcium stearate, ethylcellulose and lactose monohydrate.
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
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.
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.
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 citrate has not been established. Therefore, if orphenadrine citrate is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.
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 a pregnant woman or can affect reproduction capacity. Orphenadrine citrate should be given to a pregnant woman only if clearly needed.
- PEDIATRIC USE
Adverse reactions of orphenadrine citrate are mainly due to the mild anti-cholinergic action of orphenadrine citrate 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.
- DRUG ABUSE AND DEPENDENCE
Orphenadrine citrate is toxic when overdosed and typically induces anti-cholinergic effects. In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable. Treatment for orphenadrine citrate overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring and appropriate supportive treatment of any emergent anti-cholinergic effects.
- DOSAGE AND ADMINISTRATION
Orphenadrine Citrate Extended-Release Tablets, USP, for oral administration, are available as
White, round-shaped tablets debossed “E” over “22” on one side and plain on the other side and supplied as:
NDC 0185-0022-01 bottles of 100
NDC 0185-0022-10 bottles of 1000
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
KEEP TIGHTLY CLOSED.
KEEP OUT OF THE REACH OF CHILDREN.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Princeton, NJ 08540
Rev. July 2017
- Orphenadrine Citrate Extended-Release Tablets, USP, 100 mg x 100 Tablets - Label
INGREDIENTS AND APPEARANCE
orphenadrine citrate tablet, extended release
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-0022 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9) ORPHENADRINE CITRATE 100 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color WHITE (WHITE) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code E;22 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0185-0022-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2000 03/31/2024 2 NDC:0185-0022-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040327 02/15/2000 Labeler - Eon Labs, Inc. (012656273)