Ramipex 0.25/Ramipex 1

Ramipex 0.25/Ramipex 1

pramipexole

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Pramipexole
Indications/Uses
Management of Parkinson's disease either alone or as an adjunct to levodopa therapy to reduce "end-of-dose" or "on-off" fluctuations in response.
Dosage/Direction for Use
Patient w/ normal renal function Initially 0.375 mg/day in 3 divided doses, should not increase more frequently than every 5-7 days. Ascending dosage schedule Wk 1: 0.125 mg tid. Wk 2: 0.25 mg tid. Wk 3: 0.5 mg tid. Wk 4: 0.75 mg tid. Wk 5: 1 mg tid. Wk 6: 1.25 mg tid. Wk 7: 1.5 mg tid. Maintenance 1.5-4.5 mg/day in equally divided doses tid w/ or w/o levodopa. Discontinuation of treatment May be tapered off at a rate of 0.75 mg/day until daily dose of 0.75 mg. Thereafter, may be reduced by 0.375 mg/day. Patient w/ renal impairment CrCl >50 mL/min Starting dose: 0.125 mg tid. Max: 1.5 mg tid, CrCl 30-50 mL/min Starting dose: 0.125 mg bid. Max: 0.75 mg tid, CrCl 15-<30 mL/min Starting dose: 0.125 mg once daily. Max: 1.5 mg once daily.
Administration
May be taken with or without food.
Special Precautions
Risk of symptomatic orthostatic hypotension; monitor for signs & symptoms of orthostatic hypotension, especially during dose escalation. Reports of pathological gambling, increased libido & hypersexuality. Risk of other behavioral symptoms of impulse control disorders & compulsions, & hallucinations. Not to be given to patients w/ major psychotic disorder. May potentiate dopaminergic side effects of levodopa & may cause or exacerbate pre-existing dyskinesia. Associated w/ somnolence & episodes of sudden sleep onset; caution while driving or operating machines during treatment. Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. Reports of symptoms suggestive of NMS w/ abrupt w/drawal of dopaminergic therapy. Frequently monitor patients for melanomas & on a regular basis during treatment. Caution in patients w/ renal impairment. Should not be used during pregnancy unless clearly necessary. Should not be used during breastfeeding.
Adverse Reactions
Dizziness, dyskinesia, somnolence; hypotension; nausea. Abnormal dreams, behavioral symptoms of impulse control disorders & compulsions, confusion, hallucinations, insomnia, restlessness; amnesia, headache; visual disturbance eg, blurred vision & reduced visual acuity; constipation, vomiting; fatigue, peripheral oedema; decreased wt.
Drug Interactions
Reduced renal clearance w/ cimetidine. Medicinal products that are inhibitors of cationic secretory transport system of the renal tubules or are eliminated by this pathway (eg, cimetidine, amantadine, & mexiletine) may interact w/ pramipexole resulting in reduced clearance of either or both medicinal products. Decreased oral clearance w/ drugs that are secreted by cationic transport system (eg, ranitidine, diltiazem, triamterene, verapamil, quinidine, quinine); other known organic cation transport substrates &/or inhibitors (eg, cisplatin & procainamide); amantadine. Possible additive effects & risk of precipitating sudden onset of sleep w/ other sedating drugs or alcohol.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BC05 - pramipexole ; Belongs to the class of dopamine agonist. Used in the management of Parkinson's disease.
Presentation/Packing
Form
Ramipex 0.25 tab 250 mcg
Packing/Price
30's (P1,140/box)
Form
Ramipex 1 tab 1 mg
Packing/Price
30's (P2,550/box)