United States - English - NLM (National Library of Medicine)
ORPHENADRINE CITRATE- orphenadrine citrate tablet, extended release
Orphenadrine Citrate Extended-Release Tablets
Gavis Pharmaceuticals, LLC.
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- -
phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C
H NOC H O and 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.
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.
INDICATIONS AND USAGE
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
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 Category C
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 anticholinergic 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
DRUG ABUSE AND DEPENDENCE
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.
DOSAGE AND ADMINISTRATION
Two tablets per day; one in the morning and one in the evening.
Orphenadrine citrate extended-release tablets 100 mg are round, white to off-white tablets, debossed
NL4 on one side and plain on the other 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
Storage and Handling
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-
Novel Laboratories, Inc.
Somerset, NJ 08873
for GAVIS Pharmaceuticals, LLC
400 Campus Drive
Somerset, NJ 08873
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
orphenadrine citrate tablet, extended release
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:33358 -274(NDC:4338 6 -48 0 )
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
O RPHENADRINE CITRATE (UNII: X0 A40 N8 I4S) (ORPHENADRINE - UNII:AL8 0 5O9 OG9 )
10 0 mg
Stre ng th
HYPRO MELLO SES (UNII: 3NXW29 V3WO)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)
no sco re
S hap e
S iz e
Marketing Start Date
Marketing End Date
NDC:33358 -274-6 0
6 0 in 1 BOTTLE
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 40 28 4
RxChange Co. (781126805)
Ad d re s s
Busine ss Ope rations
RxChange Co .
78 1126 8 0 5
ma nufa c ture (33358 -274)