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Orphenadrine Citrate Extended-Release Tablets | Orphenadrine Citrate

04:36 EDT 27th August 2014 | BioPortfolio

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Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula CHNO•CHOand molecular weight of 461.51. It has the following structural formula:

Each tablet for oral administration contains 100 mg orphenadrine citrate.

Each Orphenadrine citrate extended-release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate.

IMAGE 7728231a-1d1b-44b5-9f46-92cda8d87f62-01.jpg

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.

Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis.

Orphenadrine citrate tablets are 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 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 has not been established. Therefore, if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

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

Safety and effectiveness in pediatric patients have not been established.

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.

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

Orphenadrine is toxic when overdosed and typically induces anticholinergic 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 overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.

Two tablets per day; one in the morning and one in the evening.

Orphenadrine citrate extended-release tablets 100 mg are round, white tablets, debossed GG 931 on one side and plain on the reverse side and are supplied as:

NDC 43386-480-24 in bottles of 100 tablets

NDC 43386-480-26 in bottles of 500 tablets

NDC 43386-480-28 in bottles of 1000 tablets

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

01-2010M

8100

GIN-480-00

Manufactured by

Sandoz Inc.

Princeton, NJ 08540

for GAVIS Pharmaceuticals, LLC

400 Campus Drive

Somerset, NJ 08873

NDC 43386-480-24

Orphenadrine

Citrate

Extended-Release

Tablets

100 mg

Rx only

100 Tablets

IMAGE 55289877.jpg

Manufacturer

PD-Rx Pharmaceuticals, Inc.

Active Ingredients

Source

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Orphenadrine and Methocarbamol for LBP

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To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain.

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Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half will r...

The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients

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PubMed Articles [256 Associated PubMed Articles listed on BioPortfolio]

Influence of citrate concentration on the activation of blood cells in an in vitro dialysis setup.

Regional citrate anticoagulation has been associated with enhanced biocompatibility in hemodialysis, but the optimal dose of citrate remains to be established. Here, we compared parameters related to ...

Bone and plasma citrate is reduced in osteoporosis.

High concentration of citrate exists in bone of humans and all osteo-vertebrates, and citrate incorporation imparts important biomechanical and other functional properties to bone. However, which cell...

Citrate analysis using capillary electrophoresis and complexation with Eu-tetracycline.

A sensitive assay for citrate was developed. Citrate was incubated with 50 μM Eu-tetracycline and the complex separated using capillary electrophoresis utilizing post-column laser-induced luminescen...

Identification of a new high-molecular-weight Fe-citrate species at low citrate-to-Fe molar ratios: Impact on arsenic removal with ferric hydroxide.

Ferric hydroxide precipitation and flocculation is the most commonly used method for the removal of arsenic in water treatment. However, citrate often interrupts the precipitation of ferric hydroxides...

Photodegradation of amitriptyline in Fe(III)-citrate-oxalate binary system: Synergistic effect and mechanism.

Fe(III) and carboxylic acids are ubiquitous in surface water and atmospheric water droplets. Numerous documents have reported the photochemistry of Fe(III)-carboxylate complexes, typically including F...

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