Pramipex Tablets (Generic Pramipexole Dihydrochloride Tablets)

Pramipex Tablets (Generic Pramipexole Dihydrochloride Tablets)
© The Swiss Pharmacy

Pramipex (Generic Pramipexole Dihydrochloride Tablets) is used
in adults for treatment of the signs and symptoms of idiopathic
Parkinson's disease, alone (without Levodopa) or in combination
with Levodopa. It can improve your ability to move and decrease
shakiness (tremor), stiffness, slowed movement, and
unsteadiness. It may also decrease the number of episodes of
not being able to move ("on-off syndrome").
Pramipexole tablets are also used in adults for symptomatic
treatment of moderate to severe idiopathic Restless Legs
Syndrome that causes an unusual urge to move the legs.
Symptoms usually occur at night along with uncomfortable/
unpleasant feelings in the legs.

Pramipex Tablets are manufactured by Sun Pharmaceutical
Industries Limited, India in the strengths of 0.125 mg, 0.25 mg, 0.50
mg and 1 mg.

Chemical Structure

The active ingredient contained in Pramipex
tablets is Pramipexole Dihydrochloride.
Each Pramipex tablet contains 0.125 mg, 0.25 mg
0.50 mg or 1 mg of Pramipexole Dihydrochloride.

Uses of Pramipex 0.125 mg, 0.25 mg, 0.50 mg and 1 mg Tablets:
Pramipex tablets (Generic Pramipexole Dihydrochloride tablets) are
used to treat Parkinson disease. It may be used alone or in
combination with other medicines (eg, Levodopa). Pramipexole is a
dopamine agonist that works on the nervous system to help treat the
symptoms of Parkinson disease.
Pramipexole is also used to treat Restless Legs Syndrome (RLS). RLS
is a neurologic disorder that affects sensation and movement in the
legs and causes the legs to feel uncomfortable. This results in an
irresistible feeling of wanting to move your legs to make them
comfortable.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9574_Pramipexole-Dihydrochloride-Tablets.html

Recommended Adult Dosage
The starting dose of Pramipex tablets (Generic Pramipexole
tablets) in adults patients with normal renal function for the
treatment of Parkinson's Disease is 0.375 mg/day given in
three divided doses. Doses should be increased gradually and
should not be increased more frequently than every 5 to 7
days.
For maintenance treatment, Pramipexole tablets were
effective and well tolerated over a dosage range of 1.5 to 4.5
mg/day administered in equally divided doses three times per
day with or without concomitant Levodopa (approximately
800 mg/day).

Recommended Adult Dosage
Treatment of Restless Legs Syndrome in Adult patients:
Pramipex (Generic Pramipexole Dihydrochloride Tablets)
should be taken orally, swallowed with water, and can be taken
either with or without food.
The recommended starting dose of Pramipexole (Pramipex) is
0.125 mg taken once daily 2 to 3 hours before bedtime. For
patients requiring additional symptomatic relief, the dose may
be increased every 4 to 7 days to 0.50 mg per day.

Contraindications
➔
Pramipex tablets are contraindicated in patients with a
known hypersensitivity to Pramipexole Dihydrochloride
or any component of the tablet.

Storage Instructions
Pramipex tablets (Generic Pramipexole Dihydrochloride tablets) have
to be stored at controlled room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from children and pets.

Warnings
Falling asleep during activities of daily living: Sudden onset of sleep
may occur without warning. Pramipexole has been associated with
somnolence and episodes of sudden sleep onset, particularly in
patients with Parkinson's disease. Sudden onset of sleep during daily
activities, in some cases without awareness or warning signs, has been
reported uncommonly. Advise patients to report symptoms to the
prescribing doctor.
Symptomatic Orthostatic Hypotension: Monitor closely especially
during dose escalation.
Impulse Control/Compulsive Behaviors: Patients may experience
compulsive behaviors and other intense urges.
Hallucinations: May occur. Risk increases with age.

Warnings
Dyskinesia: May be caused or exacerbated by Pramipex. In advanced
Parkinson's disease, in combination treatment with Levodopa,
dyskinesia can occur during the initial titration of Pramipexole. If they
occur, the dose of levodopa should be decreased.
Renal Impairment: No data available in patients with moderate or
severe renal impairment.
Events Reported with Dopaminergic Therapy: Include withdrawal-
emergent hyperpyrexia and confusion, fibrotic complications, and
melanoma.
Postural Deformity: Consider reducing the dose or discontinuing
Pramipex tablets if postural deformity occurs.

Possible Side Effects
Most common Pramipexole Dihydrochloride (Pramipex tablets)
side effects with an incidence rate of greater than or equal to 5%
and more than placebo:
Early Parkinson's Disease (PD) without Levodopa: nausea, dizziness,
somnolence, insomnia, constipation, asthenia, and hallucinations:
Advanced PD with Levodopa: postural (orthostatic) hypotension,
dyskinesia, extrapyramidal syndrome, insomnia, dizziness,
hallucinations, accidental injury, dream abnormalities, confusion,
constipation, asthenia, somnolence, dystonia, gait abnormality,
hypertonia, dry mouth, amnesia, and urinary frequency.

Possible Side Effects
Most common Pramipexole Dihydrochloride (Pramipex
tablets) side effects with an incidence rate of greater
than or equal to 5% and more than placebo:
Restless Legs Syndrome (RLS): nausea, somnolence,
fatigue, and headache.

Pramipex Tablets Overdosage
There is no clinical experience with significant Pramipexole
Dihydrochloride (Pramipex tablets) overdosage. One patient took 11
mg/day of Pramipexole for 2 days in a clinical trial for an
investigational use.
Blood pressure remained stable although pulse rate increased to
between 100 and 120 beats/minute. No other adverse reactions were
reported related to the increased dose.

Treatment of Pramipex Tablets Overdosage
There is no known antidote for overdosage of a dopamine agonist. If
signs of central nervous system stimulation are present, a
phenothiazine or other butyrophenone neuroleptic agent may be
indicated; the efficacy of such drugs in reversing the effects of
overdosage has not been assessed.
Management of overdose may require general supportive measures
along with gastric lavage, intravenous fluids, and electrocardiogram
monitoring.

Pramipex Tablets During Pregnancy
Pramipexole Dihydrochloride (Pramipex tablets) has been classified by
the US FDA as Pregnancy Category C.
There are no adequate data on the developmental risk associated with
the use of Pramipexole Dihydrochloride in pregnant women. No
adverse developmental effects were observed in animal studies in
which Pramipexole was administered to rabbits during pregnancy.
Effects on embryofetal development could not be adequately
assessed in pregnant rats; however, postnatal growth was inhibited at
clinically relevant exposures.
Pramipex should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.

Pramipex Tablets (Generic Pramipexole
Dihydrochloride Tablets) are manufactured by Sun
Pharmaceutical Industries Limited, India.

Pramipex Tablets (Generic Pramipexole Dihydrochloride Tablets)

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