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RAMIPEX 1 Pramipexole Hydrochloride 1mg Tablet 1's

RXDRUG-DRP-5802-1pc
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Description

Indications/Uses

Used in the 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

General Dosing Considerations: Pramipexole tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole tablets have occurred, retitration of therapy may be warranted.
Dosing in Patients with Normal Renal Function: Initial Treatment: Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1 (see Table 1):




Maintenance Treatment: Pramipexole is 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.
When pramipexole tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered.
Dosing in Patients with Renal Impairment: The recommended dosing of pramipexole in Parkinson's disease patients with renal impairment is provided in Table 2. (See Table 2.)




Discontinuation of Treatment: Pramipexole may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day.
Or as prescribed by the physician.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity to Pramipexole or to any of the excipients of the drug product.
 

Special Precautions

Falling Asleep During Activities of Daily Living and Somnolence: 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. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Pramipexole. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of the dose or termination of therapy may be considered. Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Symptomatic Orthostatic Hypotension: Dopamine agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension, especially during dose escalation.
Parkinson's disease patients, in addition, appear to have an impaired capacity to respond to an orthostatic challenge. For these reasons, Parkinson's disease patients being treated with dopaminergic agonists ordinarily require careful monitoring for signs and symptoms of orthostatic hypotension, especially during dose escalation, and should be informed of this risk. Impulse Control/Compulsive Behaviors Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson's disease, including pramipexole dihydrochloride. Furthermore, patients and caregivers should be aware of the fact that other behavioral symptoms of impulse control disorders and compulsions such as binge eating and compulsive shopping can occur. Dose reduction/tapered discontinuation should be considered.
Hallucinations and Psychotic-like Behavior: Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa. Patients should be informed that (mostly visual) hallucinations can occur.
Patients with a major psychotic disorder should ordinarily not be treated with dopamine agonists, including pramipexole, because of the risk of exacerbating the psychosis. In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of pramipexole.
Dyskinesia: Pramipexole may potentiate the dopaminergic side effects of levodopa and may cause or exacerbate preexisting dyskinesia.
Renal Impairment: Since pramipexole is eliminated through the kidneys, caution should be exercised when prescribing pramipexole to patients with renal impairment.
Ophthalmologic monitoring: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Neuroleptic malignant syndrome: Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
Melanoma: Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population.
Hence, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using pramipexole dihydrochloride tablets for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g.,dermatologists).

Adverse Reactions

The following adverse reactions are expected under the use of Pramipexole: abnormal dreams, amnesia, behavioral symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, dyspnea, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral edema, pneumonia, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Parkinson's disease, most common adverse reactions: The most commonly (≥5%) reported adverse drug reactions in patients with Parkinson's disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue. The incidence of somnolence is increased at doses higher than 1.5 mg pramipexole salt per day. A more frequent adverse drug reaction in combination with levodopa was dyskinesia. Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.




Patient to seek medical attention immediately at the first sight of any adverse drug reaction shall appear.

Drug Interactions

Carbidopa/Levodopa and Selegiline: Both products did not influence the pharmacokinetics of Pramipexole.
Cimetidine: Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules. Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, and mexiletine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products. Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Other drugs eliminated via renal secretion: Population pharmacokinetic analysis suggests that co-administration of drugs that are secreted by the cationic transport system (e.g., ranitidine, diltiazem, triamterene, verapamil, quinidine, and quinine) decreases the oral clearance of pramipexole by about 20%, while those secreted by the anionic transport system (e.g., cephalosporins, penicillins, indomethacin, hydrochlorothiazide, and chlorpropamide) are likely to have little effect on the oral clearance of pramipexole. Other known organic cation transport substrates and/or inhibitors (e.g., cisplatin and procainamide) may also decrease the clearance of pramipexole.
Amantadine: Amantadine may slightly decrease the oral clearance of pramipexole.
Probenecid: Probenecid, a known inhibitor of renal tubular secretion of organic acids via the anionic transporter, did not noticeably influence pramipexole pharmacokinetics.
CYP interactions: Inhibitors of cytochrome P450 enzymes would not be expected to affect pramipexole elimination because pramipexole is not appreciably metabolized by these enzymes in vivo or in vitro. Pramipexole does not inhibit CYP enzymes CYP1A2, CYP2C9, CYP2C19, CYP2E1, and CYP3A4.
Caution is advised when other sedating drugs or alcohol are used with pramipexole because of possible additive effects and the risk of precipitating sudden onset of sleep.
 
 

Features

Brand
RAMIPEX 1
Full Details
Dosage Strength
1 mg
Drug Ingredients
  • Pramipexole
Drug Packaging
Tablet 1's
Generic Name
Pramipexole Hydrochloride
Dosage Form
Tablet
Registration Number
DRP-5802
Drug Classification
Prescription Drug (RX)
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