PRAMIPEXOLE DIHYDROCHLORIDE 0.25
SUN PHARMA LTD
A to Z Drug Facts
|Lab Test Interferences|
|Patient Care Considerations|
|Class: Antiparkinson/Non-ergot dopamine receptor agonist|
Individualize by careful titration. ADULTS: PO Initial dose: 0.125 mg tid. Maintenance dose: Dosage may be increased every 5 to 7 days to maximum dose of 4.5 mg/day.
Drugs eliminated via cationic renal secretion (eg, cimetidine, ranitidine, diltiazem, triamterene, verapamil, quinidine, quinine): May reduce oral clearance of pramipexole. Pramipexole dosage adjustment may be needed if therapy with any of these agents is started or stopped during treatment with pramipexole. Dopamine antagonists (eg, butyrophenones, metoclopramide, phenothiazines, thioxanthenes): May reduce effectiveness of pramipexole.
CV: Orthostatic hypotension. CNS: Dizziness; somnolence; headache; confusion; hallucinations; abnormal dreams; tremor; insomnia; aggravated Parkinson's disease; dyskinesia; hypokinesia; hypesthesia; amnesia; extrapyramidal syndrome; abnormal thinking; hypertonia; akathisia; dystonia; delusions; paranoid reactions. EENT: Abnormal vision; rhinitis. GI: Nausea; dyspepsia; constipation; dry mouth; anorexia; dysphagia. GU: Urinary tract infection; urinary frequency; urinary incontinence; impotence; decreased libido. RESP: Dyspnea; pneumonia. OTHER: Asthenia; edema; malaise; injury; fever; weight decrease; myoclonus.
Pregnancy: Category C. Lactation: Inhibits prolactin secretion. Do not give to nursing mothers. Children: Safety and efficacy have not been established. Elderly: Incidence of hallucinations appears to be increased with age. Renal function impairment: Use with caution in presence of moderate-to-severe renal function impairment. Use lower initial and maintenance doses. Hypotension: Postural hypotension may occur, especially during dose escalation. Hallucinations: Can occur during pramipexole therapy. Frequency is greater when used in conjunction with L-dopa. Dyskinesia: Pramipexole may potentiate dopaminergic side effects of L-dopa and may cause or exacerbate pre-existing dyskinesias. Abrupt withdrawal: Rapid withdrawal or dose reduction of antiparkinsonism drugs may produce symptoms resembling the neuroleptic malignant syndrome. Retinal pathology: Pathological changes were observed in the retinas of albino rats receiving dopaminergic receptor agonists. The potential significance of this effect in humans has not been established but cannot be disregarded. CNS effects: Use concomitant CNS depressants with caution because of additive sedative effects. Concurrent L-dopa use: When pramipexole is used in combination with levodopa, the dose of levodopa may be reduced as tolerated.
|PATIENT CARE CONSIDERATIONS||
- Administer tid without regard to food.
- If nausea occurs, administer each dose with food.
- Store at controlled room temperature protected from light.
- Obtain patient history, including drug history and any known allergies.
- Note renal function impairment.
- Complete baseline assessment of parkinsonian symptoms before instituting therapy.
- Assess for therapeutic effects, adverse reactions, and drug interactions throughout course of therapy.
- Assess for orthostatic hypotension, dizziness, and mental status changes during initial phase of therapy or following dose escalation.
- Assist patient with position changes and ambulation during initial therapy to prevent falling.
- Monitor blood pressure and pulse routinely during therapy.
- Do not administer if significant changes in BP, pulse, or mental status occur. Notify physician.
- Instruct patient to take exactly as prescribed. Advise patient that dose may be taken without regard to meals but to take with food if nausea occurs.
- Inform patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
- Instruct patient to avoid sudden position changes to prevent orthostatic hypotension.
- Instruct patient to report the following symptoms to physician: Uncontrollable movements, dizziness, mood or mental changes, severe or persistent nausea, headache.
- Inform patient that hallucinations can occur and that elderly are more susceptible.
- Advise patient to use caution when taking other drugs with CNS depressant effects (eg, alcohol, sedatives).
- Advise patient not to take any other medications (including otc) without consulting physician.
- Advise patient to notify physician if becoming pregnant, planning to become pregnant, or are breastfeeding while taking this medication.
Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts
Substitutes not found for PRAMIPEX-0.25MG