Non-ergot dopamine agonist, Antidyskinetic (dopamine agonist)

Parkinson's disease, idiopathic.

FDA Pregnancy Category C

Adequate and well-controlled studies have not been done in humans

Breast-feeding,

Because of the potential for serious adverse reactions in the nursing infant, discontinuation of nursing or discontinuation of pramipexole is recommended.

Pediatrics,

Safety and efficacy have not been established.

Geriatrics,

Pramipexole clearance was approximately 30% lower in subjects older than 65 years of age as compared with younger subjects because of an age-related reduction in renal function; this resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. There were no other apparent differences in efficacy and safety of pramipexole between older and younger patients.

Contraindications

Risk-benefit should be considered when the following medical problem exists:

Fibrotic complications from ergot-derived dopaminergic agents, history of.

Hallucinations, Hypotension, Orthostatic hypotension, Renal function impairment, Retinal degeneration, or retinal problem, Sensitivity to pramipexole.

Drug interactions

Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Carbidopa and levodopa combination, Levodopa, Cimetidine, Dopamine antagonists , including:

Haloperidol , Metoclopramide ,Phenothiazines Thioxanthenes , Medications excreted by renal secretion, including: Diltiazem ,Quinidine ,Quinine, Ranitidine ,Triamterene &Verapamil .

Parkinson's disease, idiopathic-

In patients with normal renal function:Oral, initially 0.375 mg a day, administered in three divided doses. Dosages should be increased gradually at intervals of 5 to 7 days

Safety and efficacy have not been established

Those indicating need for medical attention:

Incidence more frequent

Asthenia, drowsiness, confusion, drowsiness; dyskinesia, hallucinations, insomnia, nausea, orthostatic hypotension.

Incidence less frequent

Akathisia, amnesia, confusion, diplopia or other eye or vision changes, dysphagia, edema, falling asleep without warning;  fever, frequent urination, muscle or joint pain, myasthenia, paranoid reaction, pneumonia, Abnormal thinking,chest pain ,delusions ,dizziness, peripheral edema, urinary incontinence ,urinary tract.

 Those indicating need for medical attention only if they continue or are bothersome

Incidence more frequent

Constipation; Dryness of mouth.

Incidence less frequent

Abnormal dreams, Anorexia ,Decreased libido or impotence ,increased sweating ,malaise ,rhinitis  skin problems, such as rash, weight loss

Store below 30^oC.Keep the medicine in the box.Protect from light & moisture.

Boxes of 100  Scored Tablet 0.18, 0.35 & 0.7 mg