ORPHENADRINE CITRATE tablet, extended release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)

Inapatikana kutoka:

Amneal Pharmaceuticals of New York LLC

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 musculo skeletal conditions. 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. Orphenadrine has been chronically abused for its euphoric effects.[1] The mood elevating effects may occur at therapeutic doses of orphenadrine.[2]

Bidhaa muhtasari:

Orphenadrine Citrate Extended-release Tablets, 100 mg - Each round, white, convex tablet imprinted with “G” on one side and “2011” on the other side. They are available as follows: Bottles of 100:                                    NDC 0115-2011-01 Bottles of 500:                                    NDC 0115-2011-02 Store at controlled room temperature 15° to 30°C (59° to 86°F). Dispense in tightly-closed, light-resistant container (USP). Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 124-05 Rev. 01-2019-00

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS
(100 MG)
RX ONLY
DESCRIPTION
Orphenadrine citrate is the citrate salt of orphenadrine
(2-dimethylaminoethyl-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.
Each orphenadrine citrate extended-release tablet contains 100 mg
orphenadrine citrate, USP.
Orphenadrine citrate extended-release tablets also contain
ethylcellulose NF, povidone USP, lactose
monohydrate NF, and magnesium stearate NF.
CLINICAL PHARMACOLOGY
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
skeletal 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 musculo skeletal conditions.
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
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.
PRECAUTIONS
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
dosag