Label: ORPHENADRINE CITRATE tablet, extended release
71335-0117-3, view more71335-0117-4, 71335-0117-5, 71335-0117-6, 71335-0117-7, 71335-0117-8, 71335-0117-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0185-0022
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 19, 2020
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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
NDC: 71335-0117-0 56 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-1 20 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-2 60 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-3 100 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-4 90 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-5 30 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-6 28 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-7 45 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-8 14 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-0117-9 120 TABLET, EXTENDED RELEASE in a BOTTLE
- Orphenadrine Citrate 100mg ER Tablet
INGREDIENTS AND APPEARANCE
orphenadrine citrate tablet, extended release
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0117(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:71335-0117-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 2 NDC:71335-0117-7 45 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 3 NDC:71335-0117-4 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 4 NDC:71335-0117-5 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 5 NDC:71335-0117-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 6 NDC:71335-0117-8 14 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 7 NDC:71335-0117-9 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 8 NDC:71335-0117-3 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 9 NDC:71335-0117-6 28 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 10 NDC:71335-0117-0 56 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040327 02/15/2000 Labeler - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0117) , RELABEL(71335-0117)