ONADRINE TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ORPHENADRINE CITRATE

Available from:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (International Name):

ORPHENADRINE CITRATE

Units in package:

500 Tablet Tablets; 1000 Tablets; 100 Tablet Tablets; 1000 Tablet Tablets

Manufactured by:

SUNWARD PHARMACEUTICAL SDN. BHD.

Patient Information leaflet

NOT APPLICABLE

Summary of Product characteristics

ONADRINE TABLET
Each tablet contains:
Orphenadrine Citrate 50mg
PHARMACOLOGY:
Orphenadrine Citrate is a centrally acting (brain stem) compound,
which in animals
selectively blocks facilitatory functions of the reticular formation.
Orphenadrine does not
produce myoneural block, nor does it affect crossed extensor reflexes.
Orphenadrine
prevents nicotine-induced convulsions but not those produced by
strychnine.
The mode of therapeutic action of Orphenadrine has not been clearly
identified, but may be
related to its analgesic properties. Orphenadrine citrate also
possesses anticholinergic
actions.
Orphenadrine is readily absorbed from the gastrointestinal tract and
is almost completely
metabolised to at least 8 metabolites. It is mainly excreted in the
urine as metabolites and
unchanged drug. A half life of 14 hours has been reported.
INDICATIONS:
Orphenadrine Citrate is indicated as an adjunct to rest, physical
therapy, and other
measures for the relief of discomfort associated with acute painful
musculo-skeletal
conditions.
DOSAGE:
Oral administration.
Two tablets daily; one in the morning and one in the evening.
CONTRAINDICATIONS:
Orphenadrine Citrate is 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.
SIDE EFFECTS/ADVERSE EFFECTS:
Adverse effects 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 includes; tachycardia, palpitation, urinary hesitancy
or retention, blurred
vision,
dilatation
of
pupils,
increased
ocular
tension,
weakness,
nausea,
vomiting,
headache,
dizziness,
constipation,
drowsiness,
hypersensitive
reactions,
pruritus,
hallucinations,
agitation,
tremor,
gastric
irritation,
and
rarely
urticaria
and
other
dermatoses.
PRECAUTIONS/WARNING