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DRUGS & SUPPLEMENTS
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How is the drug helping you? |
The structural formula is:
Pramipexole monohydrate is a white to off-white powder and freely soluble in methanol. Melting occurs in the range of 296o to 301oC, with decomposition.
Each Pramipexole tablet intended for oral administration contains 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, or 1.5 mg of Pramipexole monohydrate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, mannitol, magnesium stearate, pregelatinized starch and povidone. Additionally each 0.125 mg tablet contains D&C red no. 27 aluminum lake, each 0.25 mg tablet contains FD&C blue no. 1 aluminum lake, each 0.5 mg tablet contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake, each 1 mg tablet contains ferric oxide red and each 1.5 mg tablet contains ferric oxide yellow.
The precise mechanism of action of pramipexole as a treatment for Parkinson’s disease is unknown, although it is believed to be related to its ability to stimulate dopamine receptors in the striatum. This conclusion is supported by electrophysiologic studies in animals that have demonstrated that pramipexole influences striatal neuronal firing rates via activation of dopamine receptors in the striatum and the substantia nigra, the site of neurons that send projections to the striatum. The relevance of D3 receptor binding in Parkinson’s disease is unknown.
Pramipexole displays linear pharmacokinetics over the clinical dosage range. Its terminal half-life is about 8 hours in young healthy volunteers and about 12 hours in elderly volunteers. Steady-state concentrations are achieved within 2 days of dosing.
Urinary excretion is the major route of pramipexole elimination, with 90% of a pramipexole dose recovered in urine, almost all as unchanged drug. Nonrenal routes may contribute to a small extent to pramipexole elimination, although no metabolites have been identified in plasma or urine. The renal clearance of pramipexole is approximately 400 mL/min (CV=25%), approximately three times higher than the glomerular filtration rate. Thus, pramipexole is secreted by the renal tubules, probably by the organic cation transport system.
In all studies, the Unified Parkinson’s Disease Rating Scale (UPDRS), or one or more of its subparts, served as the primary outcome assessment measure. The UPDRS is a four-part multi-item rating scale intended to evaluate mentation (part I), Activities of Daily Living (ADL) (part II), motor performance (part III), and complications of therapy (part IV).
Part II of the UPDRS contains 13 questions relating to ADL, which are scored from 0 (normal) to 4 (maximal severity) for a maximum (worst) score of 52. Part III of the UPDRS contains 27 questions (for 14 items) and is scored as described for part II. It is designed to assess the severity of the cardinal motor findings in patients with Parkinson’s disease (e.g., tremor, rigidity, bradykinesia, postural instability, etc.), scored for different body regions, and has a maximum (worst) score of 108.
One of the two early Parkinson’s disease studies (N=335) was a double-blind, placebo-controlled, parallel trial consisting of a 7-week dose-escalation period and a 6-month maintenance period. Patients could be on selegiline, anticholinergics, or both, but could not be on levodopa products or amantadine. Patients were randomized to Pramipexole tablets or placebo. Patients treated with Pramipexole tablets had a starting daily dose of 0.375 mg and were titrated to a maximally tolerated dose, but no higher than 4.5 mg/day in three divided doses. At the end of the 6-month maintenance period, the mean improvement from baseline on the UPDRS part II (ADL) total score was 1.9 in the group receiving Pramipexole tablets and -0.4 in the placebo group, a difference that was statistically significant. The mean improvement from baseline on the UPDRS part III total score was 5 in the group receiving Pramipexole tablets and -0.8 in the placebo group, a difference that was also statistically significant. A statistically significant difference between groups in favor of Pramipexole tablets was seen beginning at week 2 of the UPDRS part II (maximum dose 0.75 mg/day) and at week 3 of the UPDRS part III (maximum dose 1.5 mg/day).
The second early Parkinson’s disease study (N=264) was a double-blind, placebo-controlled, parallel trial consisting of a 6-week dose-escalation period and a 4-week maintenance period. Patients could be on selegiline, anticholinergics, amantadine, or any combination of these, but could not be on levodopa products. Patients were randomized to 1 of 4 fixed doses of Pramipexole tablets (1.5 mg, 3 mg, 4.5 mg, or 6 mg per day) or placebo. At the end of the 4-week maintenance period, the mean improvement from baseline on the UPDRS part II total score was 1.8 in the patients treated with Pramipexole tablets, regardless of assigned dose group, and 0.3 in placebo-treated patients. The mean improvement from baseline on the UPDRS part III total score was 4.2 in patients treated with Pramipexole tablets and 0.6 in placebo-treated patients. No dose-response relationship was demonstrated. The between-treatment differences on both parts of the UPDRS were statistically significant in favor of Pramipexole tablets for all doses.
No differences in effectiveness based on age or gender were detected. There were too few non-Caucasian patients to evaluate the effect of race. Patients receiving selegiline or anticholinergics had responses similar to patients not receiving these drugs.
Patients in the advanced Parkinson’s disease study (N=360) had a mean disease duration of 9 years, had been exposed to levodopa for long periods of time (mean 8 years), used concomitant levodopa during the trial, and had "on-off" periods.
The advanced Parkinson’s disease study was a double-blind, placebo-controlled, parallel trial consisting of a 7-week dose-escalation period and a 6-month maintenance period. Patients were all treated with concomitant levodopa products and could additionally be on concomitant selegiline, anticholinergics, amantadine, or any combination. Patients treated with Pramipexole tablets had a starting dose of 0.375 mg/day and were titrated to a maximally tolerated dose, but no higher than 4.5 mg/day in three divided doses. At selected times during the 6-month maintenance period, patients were asked to record the amount of "off," "on," or "on with dyskinesia" time per day for several sequential days. At the end of the 6-month maintenance period, the mean improvement from baseline on the UPDRS part II total score was 2.7 in the group treated with Pramipexole tablets and 0.5 in the placebo group, a difference that was statistically significant. The mean improvement from baseline on the UPDRS part III total score was 5.6 in the group treated with Pramipexole tablets and 2.8 in the placebo group, a difference that was statistically significant. A statistically significant difference between groups in favor of Pramipexole tablets was seen at week 3 of the UPDRS part II (maximum dose 1.5 mg/day) and at week 2 of the UPDRS part III (maximum dose 0.75 mg/day). Dosage reduction of levodopa was allowed during this study if dyskinesia (or hallucinations) developed; levodopa dosage reduction occurred in 76% of patients treated with Pramipexole tablets versus 54% of placebo patients. On average, the levodopa dose was reduced 27%.
The mean number of "off" hours per day during baseline was 6 hours for both treatment groups. Throughout the trial, patients treated with Pramipexole tablets had a mean of 4 "off" hours per day, while placebo-treated patients continued to experience 6 "off" hours per day.
No differences in effectiveness based on age or gender were detected. There were too few non-Caucasian patients to evaluate the effect of race.
The effectiveness of Pramipexole tablets was demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see CLINICAL STUDIES).
Patients treated with Pramipexole tablets have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on Pramipexole tablets, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as one year after the initiation of treatment.
Somnolence is a common occurrence in patients receiving Pramipexole tablets at doses above 1.5 mg/day for Parkinson’s disease. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of pre-existing somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.
Before initiating treatment with Pramipexole tablets, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with Pramipexole tablets such as concomitant sedating medications, the presence of sleep disorders, and concomitant medications that increase pramipexole plasma levels (e.g., cimetidine - see PRECAUTIONS, Drug Interactions). If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.), Pramipexole tablets should ordinarily be discontinued. If a decision is made to continue Pramipexole tablets, patients should be advised to not drive and to avoid other potentially dangerous activities. While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.
In clinical trials of pramipexole, however, and despite clear orthostatic effects in normal volunteers, the reported incidence of clinically significant orthostatic hypotension was not greater among those assigned to Pramipexole tablets than among those assigned to placebo. This result, especially with the higher doses used in Parkinson’s disease, is clearly unexpected in light of the previous experience with the risks of dopamine agonist therapy.
While this finding could reflect a unique property of pramipexole, it might also be explained by the conditions of the study and the nature of the population enrolled in the clinical trials. Patients were very carefully titrated, and patients with active cardiovascular disease or significant orthostatic hypotension at baseline were excluded.
Age appears to increase the risk of hallucinations attributable to pramipexole. In the early Parkinson’s disease patients, the risk of hallucinations was 1.9 times greater than placebo in patients younger than 65 years and 6.8 times greater than placebo in patients older than 65 years. In the advanced Parkinson’s disease patients, the risk of hallucinations was 3.5 times greater than placebo in patients younger than 65 years and 5.2 times greater than placebo in patients older than 65 years.
Although these adverse events are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.
A small number of reports have been received of possible fibrotic complications, including peritoneal fibrosis, pleural fibrosis, and pulmonary fibrosis, in the postmarketing experience for Pramipexole tablets. While the evidence is not sufficient to establish a causal relationship between Pramipexole and these fibrotic complications, a contribution of Pramipexole cannot be completely ruled out in rare cases.
For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using Pramipexole tablets for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).
Patients should be alerted to the potential sedating effects associated with Pramipexole tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with Pramipexole tablets to gauge whether or not it affects their mental and/or motor performance adversely. Patients should be advised that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Because of possible additive effects, caution should be advised when patients are taking other sedating medications or alcohol in combination with Pramipexole tablets and when taking concomitant medications that increase plasma levels of pramipexole (e.g., cimetidine).
Patients should be informed that hallucinations can occur and that the elderly are at a higher risk than younger patients with Parkinson's disease.
There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson’s disease, including Pramipexole tablets. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with Pramipexole tablets. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking Pramipexole tablets. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Pramipexole tablets.
Patients may develop postural (orthostatic) hypotension, with or without symptoms such as dizziness, nausea, fainting or blackouts, and sometimes, sweating. Hypotension may occur more frequently during initial therapy. Accordingly, patients should be cautioned against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with Pramipexole tablets.
Because the teratogenic potential of pramipexole has not been completely established in laboratory animals, and because experience in humans is limited, patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy (see PRECAUTIONS, Pregnancy).
Because of the possibility that pramipexole may be excreted in breast milk, patients should be advised to notify their physicians if they intend to breast-feed or are breast-feeding an infant.
If patients develop nausea, they should be advised that taking Pramipexole tablets with food may reduce the occurrence of nausea.
Pramipexole was not mutagenic or clastogenic in a battery of assays, including the in vitro Ames assay, V79 gene mutation assay for HGPRT mutants, chromosomal aberration assay in Chinese hamster ovary cells, and in vivo mouse micronucleus assay.
In rat fertility studies, pramipexole at a dose of 2.5 mg/kg/day (5 times the MRHD on a mg/m2 basis), prolonged estrus cycles and inhibited implantation. These effects were associated with reductions in serum levels of prolactin, a hormone necessary for implantation and maintenance of early pregnancy in rats.
When pramipexole was given to female rats throughout pregnancy, implantation was inhibited at a dose of 2.5 mg/kg/day. Administration of 1.5 mg/kg/day of pramipexole to pregnant rats during the period of organogenesis (gestation days 7 through 16) resulted in a high incidence of total resorption of embryos. The plasma AUC in rats at this dose was 4 times the AUC in humans at the MRHD. These findings are thought to be due to the prolactin-lowering effect of pramipexole, since prolactin is necessary for implantation and maintenance of early pregnancy in rats (but not rabbits or humans). Because of pregnancy disruption and early embryonic loss in these studies, the teratogenic potential of pramipexole could not be adequately evaluated. There was no evidence of adverse effects on embryo-fetal development following administration of up to 10 mg/kg/day to pregnant rabbits during organogenesis (plasma AUC was 71 times that in humans at the MRHD). Postnatal growth was inhibited in the offspring of rats treated with 0.5 mg/kg/day (approximately equivalent to the MRHD on a mg/m2 basis) or greater during the latter part of pregnancy and throughout lactation.
There are no studies of pramipexole in human pregnancy. Because animal reproduction studies are not always predictive of human response, pramipexole should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Other studies have shown that pramipexole treatment resulted in an inhibition of prolactin secretion in humans and rats.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from pramipexole, a decision should be made as to whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Because the controlled trials performed during premarketing development all used a titration design, with a resultant confounding of time and dose, it was impossible to adequately evaluate the effects of dose on the incidence of adverse events.
Approximately 12% of 388 patients with early Parkinson’s disease and treated with Pramipexole tablets who participated in the double-blind, placebo-controlled trials discontinued treatment due to adverse events compared with 11% of 235 patients who received placebo. The adverse events most commonly causing discontinuation of treatment were related to the nervous system (hallucinations [3.1% on Pramipexole tablets vs. 0.4% on placebo]; dizziness [2.1% on Pramipexole tablets vs. 1% on placebo]; somnolence [1.6% on Pramipexole tablets vs. 0% on placebo]; extrapyramidal syndrome [1.6% on Pramipexole tablets vs. 6.4% on placebo]; headache and confusion [1.3% and 1%, respectively, on Pramipexole tablets vs. 0% on placebo]); and gastrointestinal system (nausea [2.1% on Pramipexole tablets vs. 0.4% on placebo]).
The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-event incidence rate in the population studied.
Body System /
| Pramipexole Dihydrochloride Tablets
| Placebo
|
Adverse Event
| N = 388
| N = 235
|
*Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category. | ||
Body as a Whole
| | |
Asthenia | 14 | 12 |
General edema | 5 | 3 |
Malaise | 2 | 1 |
Reaction unevaluable | 2 | 1 |
Fever | 1 | 0 |
Digestive System
| | |
Nausea | 28 | 18 |
Constipation | 14 | 6 |
Anorexia | 4 | 2 |
Dysphagia | 2 | 0 |
Metabolic & Nutritional System
| | |
Peripheral edema | 5 | 4 |
Decreased weight | 2 | 0 |
Nervous System
| | |
Dizziness | 25 | 24 |
Somnolence | 22 | 9 |
Insomnia | 17 | 12 |
Hallucinations | 9 | 3 |
Confusion | 4 | 1 |
Amnesia | 4 | 2 |
Hypesthesia | 3 | 1 |
Dystonia | 2 | 1 |
Akathisia | 2 | 0 |
Thinking abnormalities | 2 | 0 |
Decreased libido | 1 | 0 |
Myoclonus | 1 | 0 |
Special Senses
| | |
Vision abnormalities | 3 | 0 |
Urogenital System
| | |
Impotence | 2 | 1 |
In a fixed-dose study in early Parkinson's disease, occurrence of the following events increased in frequency as the dose increased over the range from 1.5 mg/day to 6 mg/day: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence with pramipexole at a dose of 1.5 mg/day was comparable to that reported for placebo.
Approximately 12% of 260 patients with advanced Parkinson’s disease who received Pramipexole tablets and concomitant levodopa in the double-blind, placebo-controlled trials discontinued treatment due to adverse events compared with 16% of 264 patients who received placebo and concomitant levodopa. The events most commonly causing discontinuation of treatment were related to the nervous system (hallucinations [2.7% on Pramipexole tablets vs. 0.4% on placebo]; dyskinesia [1.9% on Pramipexole tablets vs. 0.8% on placebo]; extrapyramidal syndrome [1.5% on Pramipexole tablets vs. 4.9% on placebo]; dizziness [1.2% on Pramipexole tablets vs. 1.5% on placebo]; confusion [1.2% on Pramipexole tablets vs. 2.3% on placebo]); and cardiovascular system (postural [orthostatic] hypotension [2.3% on Pramipexole tablets vs. 1.1% on placebo]).
Adverse-event Incidence in Controlled Clinical Studies in Advanced Parkinson’s Disease
Table 2 lists treatment-emergent adverse events that occurred in the double-blind, placebo-controlled studies in advanced Parkinson's disease that were reported by (1% of patients treated with Pramipexole tablets and were numerically more frequent than in the placebo group. In these studies, Pramipexole tablets or placebo was administered to patients who were also receiving concomitant levodopa. Adverse events were usually mild or moderate in intensity.
The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-events incidence rate in the population studied.
Body System /
| Pramipexole Dihydrochloride Tablets
| Placebo *
|
Adverse Event
| N = 260
| N = 264
|
*Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category. †Patients received concomitant levodopa. | ||
Body as a Whole
| | |
Accidental injury | 17 | 15 |
Asthenia | 10 | 8 |
General edema | 4 | 3 |
Chest pain | 3 | 2 |
Malaise | 3 | 2 |
Cardiovascular System
| | |
Postural hypotension | 53 | 48 |
Digestive System
| | |
Constipation | 10 | 9 |
Dry mouth | 7 | 3 |
Metabolic & Nutritional System
| | |
Peripheral edema | 2 | 1 |
Increased creatine PK | 1 | 0 |
Musculoskeletal System
| | |
Arthritis | 3 | 1 |
Twitching | 2 | 0 |
Bursitis | 2 | 0 |
Myasthenia | 1 | 0 |
Nervous System
| | |
Dyskinesia | 47 | 31 |
Extrapyramidal syndrome | 28 | 26 |
Insomnia | 27 | 22 |
Dizziness | 26 | 25 |
Hallucinations | 17 | 4 |
Dream abnormalities | 11 | 10 |
Confusion | 10 | 7 |
Somnolence | 9 | 6 |
Dystonia | 8 | 7 |
Gait abnormalities | 7 | 5 |
Hypertonia | 7 | 6 |
Amnesia | 6 | 4 |
Akathisia | 3 | 2 |
Thinking abnormalities | 3 | 2 |
Paranoid reaction | 2 | 0 |
Delusions | 1 | 0 |
Sleep disorders | 1 | 0 |
Respiratory System
| | |
Dyspnea | 4 | 3 |
Rhinitis | 3 | 1 |
Pneumonia | 2 | 0 |
Skin & Appendages
| | |
Skin disorders | 2 | 1 |
Special Senses
| | |
Accommodation abnormalities | 4 | 2 |
Vision abnormalities | 3 | 1 |
Diplopia | 1 | 0 |
Urogenital System
| | |
Urinary frequency | 6 | 3 |
Urinary tract infection | 4 | 3 |
Urinary incontinence | 2 | 1 |
There is no known antidote for overdosage of a dopamine agonist. If signs of central nervous system stimulation are present, a phenothiazine or other butyrophenone neuroleptic agent may be indicated; the efficacy of such drugs in reversing the effects of overdosage has not been assessed. Management of overdose may require general supportive measures along with gastric lavage, intravenous fluids, and electrocardiogram monitoring.
Dosages 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 the following table:
Week
| Dosage
| Total Daily
|
|
| Dose ( mg )
|
1 | 0.125 TID | 0.375 |
2 | 0.25 TID | 0.75 |
3 | 0.5 TID | 1.50 |
4 | 0.75 TID | 2.25 |
5 | 1 TID | 3 |
6 | 1.25 TID | 3.75 |
7 | 1.5 TID | 4.50 |
In a fixed-dose study in early Parkinson’s disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of Pramipexole tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When Pramipexole tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson’s disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Renal Status
| Starting Dose
| Maximum Dose
|
| ( mg )
| ( mg )
|
Normal to mild impairment | | |
(creatinine Cl > 60 mL/min) | 0.125 TID | 1.5 TID |
Moderate impairment | | |
(creatinine Cl = 35 to 59 mL/min) | 0.125 BID | 1.5 BID |
Severe impairment | | |
(creatinine Cl = 15 to 34 mL/min) | 0.125 QD | 1.5 QD |
Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients) | The use of pramipexole dihydrochloride has not been adequately studied in this group of patients. |
It is recommended that Pramipexole tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
NDC 68382-196-16 in bottle of 90 tablets
NDC 68382-196-05 in bottle of 500 tablets
NDC 68382-196-10 in bottle of 1000 tablets
Pramipexole Tablets, 0.25 mg are pale blue color, round, flat, beveled-edged, uncoated tablets debossed with ‘P2’on one side and break line on other side and are supplied as follows:
NDC 68382-197-16 in bottle of 90 tablets
NDC 68382-197-05 in bottle of 500 tablets
NDC 68382-197-10 in bottle of 1000 tablets
Pramipexole Tablets, 0.5 mg are lavender, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with ‘P’ breakline ‘3’ on one side and plain on other side and are supplied as follows:
NDC 68382-198-16 in bottle of 90 tablets
NDC 68382-198-05 in bottle of 500 tablets
NDC 68382-198-10in bottle of 1000 tablets
Pramipexole Tablets, 1 mg are light peach to peach, round, flat, beveled-edged, uncoated tablets debossed with ‘P4’on one side and break line on other side and are supplied as follows:
NDC 68382-199-16 in bottle of 90 tablets
NDC 68382-199-05 in bottle of 500 tablets
NDC 68382-199-10in bottle of 1000 tablets
Pramipexole Tablets, 1.5 mg are yellow color, round, flat, beveled- edged, uncoated tablets debossed with ‘P5’on one side and break line on other side and are supplied as follows:
NDC 68382-200-16 in bottle of 90 tablets
NDC 68382-200-05in bottle of 500 tablets
NDC 68382-200-10 in bottle of 1000 tablets
Dispense in a tight, light-resistant container.
Store in a safe place out of the reach of children.
Investigative studies demonstrated that pramipexole reduced the rate of disk shedding from the photoreceptor rod cells of the retina in albino rats, which was associated with enhanced sensitivity to the damaging effects of light. In a comparative study, degeneration and loss of photoreceptor cells occurred in albino rats after 13 weeks of treatment with 25 mg/kg/day of pramipexole (54 times the highest clinical dose on a mg/m2 basis) and constant light (100 lux) but not in pigmented rats exposed to the same dose and higher light intensities (500 lux). Thus, the retina of albino rats is considered to be uniquely sensitive to the damaging effects of pramipexole and light. Similar changes in the retina did not occur in a 2-year carcinogenicity study in albino mice treated with 0.3, 2, or 10 mg/kg/day (0.3, 2.2 and 11 times the highest clinical dose on a mg/m2 basis). Evaluation of the retinas of monkeys given 0.1, 0.5, or 2 mg/kg/day of pramipexole (0.4, 2.2, and 8.6 times the highest clinical dose on a mg/m2 basis) for 12 months and minipigs given 0.3, 1, or 5 mg/kg/day of pramipexole for 13 weeks also detected no changes.
The potential significance of this effect in humans has not been established, but cannot be disregarded because disruption of a mechanism that is universally present in vertebrates (i.e., disk shedding) may be involved.
This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about Pramipexole tablets?
Pramipexole tablets may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, watching TV, or eating.
Tell your doctor right away if you fall asleep while you are doing activities such as talking with people, watching TV, eating, or driving, or if you feel sleepier than is normal for you.
What is Pramipexole tablet?
Pramipexole tablet is a prescription medicine to treat:
Who should not take Pramipexole tablets?
Do not take Pramipexole tablets if you are allergic to pramipexole or any of the inactive ingredients of Pramipexole tablets. See the end of this leaflet for a complete list of ingredients in Pramipexole tablets.
What should I tell my doctor before taking Pramipexole tablets?
Tell your doctor about all of your medical conditions, including if you
How should I take Pramipexole tablets?
Pramipexole tablets can cause serious side effects, including
These are not all the possible side effects of Pramipexole tablets. For more information ask your doctor or pharmacist.
Be sure to talk to your doctor about any side effects that bother you or that do not go away.
Other Information about Pramipexole tablets
Studies of people with Parkinson’s disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson’s disease. It is not known if this problem is associated with Parkinson’s disease or the medicines used to treat Parkinson’s disease. Pramipexole tablet is one of the medicines used to treat Parkinson’s disease, therefore, patients being treated with Pramipexole tablets should have periodic skin examinations.
There have been reports of patients taking certain medicines to treat Parkinson’s disease, including Pramipexole tablets, that have reported problems with gambling, compulsive eating, compulsive shopping, and increased sex drive. It is not possible to reliably estimate how often these behaviors occur or to determine which factors may contribute to them. If you or your family members notice that you are developing unusual behaviors, talk to your doctor.
How should I store Pramipexole tablets?
Medicines are sometimes prescribed for purposes other than those listed in this Patient Information leaflet. Do not take Pramipexole tablets for a condition for which it was not prescribed. Do not share Pramipexole tablets with other people, even if they have the same symptoms you do. It may harm them.
This Patient Information leaflet summarizes the most important information about Pramipexole tablets. For more information, talk with your doctor or pharmacist. They can give you information about Pramipexole tablets that is written for health care professionals. Please address medical inquiries to, (MedicalAffairsPramipexolezydususa.com) Tel.: 1-877-993-8779.
What are the ingredients in Pramipexole tablets?
Active Ingredient: Pramipexole monohydrate
Inactive Ingredients: colloidal silicon dioxide, mannitol, magnesium stearate, pregelatinized starch and povidone. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, mannitol, magnesium stearate, pregelatinized starch and povidone. Additionally each 0.125 mg tablet contains D&C red no. 27 aluminum lake, each 0.25 mg tablet contains FD&C blue no. 1 aluminum lake, each 0.5 mg tablet contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake, each 1 mg tablet contains ferric oxide red and each 1.5 mg tablet contains ferric oxide yellow.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Manufactured by:
Cadila Healthcare Ltd.
Ahmedabad, India
Distributed by:
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534
Rev.: 04/11
Revision Date: 29/04/2011
Pramipexole 0.5mg Tablet
Price | |
Apo-Pramipexole 0.25 mg Tablet | 0.62 USD |
Apo-Pramipexole 1 mg Tablet | 1.23 USD |
Apo-Pramipexole 1.5 mg Tablet | 1.23 USD |
Co Pramipexole 0.25 mg Tablet | 0.62 USD |
Co Pramipexole 1 mg Tablet | 1.23 USD |
Co Pramipexole 1.5 mg Tablet | 1.23 USD |
Mirapex 0.125 mg tablet | 3.48 USD |
Mirapex 0.25 mg tablet | 1.1 USD |
Mirapex 0.5 mg tablet | 3.42 USD |
Mirapex 0.75 mg tablet | 3.28 USD |
Mirapex 1 mg tablet | 2.2 USD |
Mirapex 1.5 mg tablet | 2.2 USD |
Mirapex er 0.375 mg tablet | 9.83 USD |
Mirapex er 0.75 mg tablet | 9.83 USD |
Mirapex er 1.5 mg tablet | 9.83 USD |
Mirapex er 3 mg tablet | 9.83 USD |
Mirapex er 4.5 mg tablet | 9.83 USD |
Novo-Pramipexole 0.25 mg Tablet | 0.62 USD |
Novo-Pramipexole 1 mg Tablet | 1.23 USD |
Novo-Pramipexole 1.5 mg Tablet | 1.23 USD |
Pms-Pramipexole 0.25 mg Tablet | 0.62 USD |
Pms-Pramipexole 1 mg Tablet | 1.23 USD |
Pms-Pramipexole 1.5 mg Tablet | 1.23 USD |
Pramipexole Dihydrochloride 0.125 mg tablet | 3.07 USD |
Pramipexole Dihydrochloride 0.25 mg tablet | 3.07 USD |
Pramipexole Dihydrochloride 0.5 mg tablet | 3.07 USD |
Pramipexole Dihydrochloride 1 mg tablet | 3.07 USD |
Pramipexole Dihydrochloride 1.5 mg tablet | 3.07 USD |
Pramipexole di-hcl 0.125 mg tablet | 2.95 USD |
Pramipexole di-hcl 0.25 mg tablet | 2.95 USD |
Pramipexole di-hcl 0.5 mg tablet | 2.95 USD |
Pramipexole di-hcl 1 mg tablet | 2.95 USD |
Pramipexole di-hcl 1.5 mg tablet | 2.95 USD |
Sandoz Pramipexole 0.25 mg Tablet | 0.62 USD |
Sandoz Pramipexole 1 mg Tablet | 1.23 USD |
Sandoz Pramipexole 1.5 mg Tablet | 1.23 USD |
Tablets; Oral; Pramipexole Dihydrochloride 0.125 mg | |
Tablets; Oral; Pramipexole Dihydrochloride 0.25 mg | |
Tablets; Oral; Pramipexole Dihydrochloride 0.5 mg | |
Tablets; Oral; Pramipexole Dihydrochloride 0.75 mg | |
Tablets; Oral; Pramipexole Dihydrochloride 1 mg | |
Tablets; Oral; Pramipexole Dihydrochloride 1.5 mg |
Depending on the reaction of the Pramipexole after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pramipexole not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Pramipexole addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Visitors | % | ||
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It has side effects | 1 | 100.0% |
Visitors | % | ||
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46-60 | 1 | 100.0% |
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The information was verified by Dr. Rachana Salvi, MD Pharmacology