Pramipexole Dihydrochloride

PRAMIPEXOLE DIHYDROCHLORIDE

Manufacturer: Alembic Pharmaceuticals Inc.

Score: 141.0

Quick Summary

Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease. The drug is a non-ergot dopamine agonist that stimulates dopamine receptors in the striatum, with the precise mechanism of action unknown. Clinical trials have shown the drug to be effective in treating Parkinson's disease, with common adverse reactions including somnolence, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and peripheral edema. The recommended dosage is 0.375 mg given once daily, with gradual increases in dosage as needed and tolerated. Special population considerations include use in pregnancy, nursing mothers, pediatric patients, and geriatric patients, with caution advised in patients with renal impairment.

Key Clinical Findings and Indications

Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease
The drug is a non-ergot dopamine agonist that stimulates dopamine receptors in the striatum
Clinical trials have shown the drug to be effective in treating Parkinson's disease

Important Safety Information

Warning

Falling Asleep During Activities of Daily Living and Somnolence, Symptomatic Orthostatic Hypotension, Impulse Control/Compulsive Behaviors, Hallucinations and Psychotic-like Behavior, Dyskinesia, Postural Deformity, Rhabdomyolysis, Retinal Pathology, Events Reported with Dopaminergic Therapy, Withdrawal Symptoms

Contraindications

None

Adverse Reactions

Somnolence
Nausea
Constipation
Dizziness
Fatigue
Hallucinations
Dry mouth
Muscle spasms
Peripheral edema

Dosing Recommendations

General Guidance

Dose adjustment may be needed in patients with renal impairment

Parkinson's disease

Adult Dose

0.375 mg given once daily, with gradual increases in dosage as needed and tolerated

Pediatric Dose

Not applicable

Special Population Considerations

Pregnancy

There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride extended-release in pregnant women
No adverse developmental effects were observed in animal studies

Nursing Mothers

There are no data on the presence of pramipexole in human milk
Inhibition of lactation is expected because pramipexole inhibits secretion of prolactin in humans

Pediatric Use

Safety and effectiveness of pramipexole dihydrochloride extended-release tablets in pediatric patients have not been evaluated

Geriatric Use

Pramipexole total oral clearance is approximately 30% lower in subjects older than 65 years compared with younger subjects
Hallucinations were more common in the elderly, occurring in 13% of the patients ≥ 65 years of age compared to 2% of the patients <65 years of age

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