pramipexole dihydrochloride
Tablet · Oral
Uses
Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: Parkinson's disease (PD) ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson’s Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Dosage and administration
Parkinson's Disease-Normal Renal Function* ( 2.2 ) Week Dosage (mg) Total Daily Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.5 4 0.75 TID 2.25 5 1 TID 3 6 1.25 TID 3.75 7 1.5 TID 4.5 * Doses should not be increased more frequently than every 5 to 7 days. Titrate to effective dose. If used with levodopa, may need to reduce levodopa dose. Parkinson's Disease-Impaired Renal Function ( 2.2 ) Creatinine Clearance Starting Dose (mg) Maximum Dose (mg) > 50 mL/min 0.125 TID 1.5 TID 30 to 50 mL/min 0.125 BID 0.75 TID 15 to 30 mL/min 0.125 QD 1.5 QD < 15 mL/min and hemodialysis patients Data not available Restless Legs Syndrome* ( 2.3 ) Titration Step Dose (mg) 2 to 3 hours before bedtime 1 0.125 2 (if needed) 0.25 3 (if needed) 0.5 * Dosing interval is 4 to 7 days (14 days in patients with CrCl 20 to 60 mL/min) 2.1 General Dosing Considerations Pramipexole dihydrochloride tablets are taken orally, with or without food. If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted. 2.2 Dosing for Parkinson's Disease In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth. 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: Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 three times a day 0.375 2 0.25 three times a day 0.75 3 0.5 three times a day 1.50 4 0.75 three times a day 2.25 5 1 three times a day 3.0 6 1.25 three times a day 3.75 7 1.5 three times a day 4.50 Maintenance Treatment Pramipexole dihydrochloride tablets were 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 (approximately 800 mg/day). 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 dihydrochloride 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 dihydrochloride 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. Dosing in Patients with Renal Impairment The recommended dosing of pramipexole dihydrochloride tablets in Parkinson's disease patients with renal impairment is provided in Table 2. Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson's Disease Patients with Renal Impairment Renal Status Starting Dose (mg) Maximum Dose (mg) Normal to mild impairment (creatinine Cl > 50 mL/min) 0.125 three times a day 1.5 three times a day Moderate impairment (creatinine Cl = 30 to 50 mL/min) 0.125 twice a day 0.75 three times a day Severe impairment (creatinine Cl = 15 to <30 mL/min) 0.125 once a day 1.5 once a day Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients) The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients. Discontinuation of Treatment Pramipexole dihydrochloride tablets 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 [see Warnings and Precautions ( 5.10 , 5.11 )] . 2.3 Dosing for Restless Legs Syndrome The recommended starting dose of pramipexole dihydrochloride tablets is 0.125 mg taken once daily 2 to 3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4 to 7 days (Table 3). Although the dose of pramipexole dihydrochloride tablets was increased to 0.75 mg in some patients during long-term open-label treatment, there is no evidence that the 0.75 mg dose provides additional benefit beyond the 0.5 mg dose. Table 3 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for RLS *if needed Titration Step Duration Dose (mg) to be taken once daily, 2 to 3 hours before bedtime 1 4 to 7 days 0.125 2* 4 to 7 days 0.25 3* 4 to 7 days 0.5 Dosing in Patients with Renal Impairment The duration between titration steps should be increased to 14 days in RLS patients with moderate and severe renal impairment (creatinine clearance 20 to 60 mL/min) [see Clinical Pharmacology ( 12.3 )] . Discontinuation of Treatment In clinical trials of patients being treated for RLS with doses up to 0.75 mg once daily, pramipexole dihydrochloride tablets were discontinued without a taper. In a 26 week placebo-controlled clinical trial, patients reported a worsening of RLS symptom severity as compared to their untreated baseline when pramipexole dihydrochloride tablets treatment was suddenly withdrawn [see Warnings and Precautions ( 5.10 )] .
Dosage forms and strengths
Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg ( 3 )
• 0.125 mg: White to off white, round, flat, bevel edged, uncoated tablets, debossed with “91” on one side and plain on other side. Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis).
• 0.25 mg: Peach colored, round, flat, bevel edged, uncoated tablets with “9/2” debossed on one side and breakline on other side. Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis).
• 0.5 mg: Reddish brown colored, round, biconvex, uncoated tablets with “9/3” debossed on one side and breakline on other side. Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis).
• 0.75 mg: Yellow colored, round, flat, bevel edged, uncoated tablets with “84” debossed on one side and plain on other side. Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis).
• 1 mg: Light pink colored, round, flat, bevel edged, uncoated tablets with “9/4” debossed on one side and breakline on other side. Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis).
• 1.5 mg: white to off white, round, flat, bevel edged, uncoated tablets with “9/5” debossed on one side and breakline on other side. Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis).
Contraindications
None None.
Warnings and precautions
Falling Asleep During Activities of Daily Living: Sudden onset of sleep may occur without warning; advise patients to report symptoms ( 5.1 ) Symptomatic Orthostatic Hypotension: Monitor during dose escalation ( 5.2 ) Impulse Control/Compulsive Behaviors: Patients may experience compulsive behaviors and other intense urges ( 5.3 ) Hallucinations and Psychotic-like Behavior: May occur; risk increases with age ( 5.4 ) Dyskinesia: May be caused or exacerbated by pramipexole dihydrochloride tablets ( 5.5 ) Postural Deformity: Consider reducing the dose or discontinuing pramipexole dihydrochloride tablets if postural deformity occurs ( 5.6 ) 5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients treated with pramipexole 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 dihydrochloride tablets, some perceived that they had no warning signs (sleep attack) 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 at doses above 1.5 mg/day (0.5 mg three times a day) for Parkinson's disease. In controlled clinical trials in RLS, patients treated with pramipexole dihydrochloride tablets at doses of 0.25 to 0.75 mg once a day, the incidence of somnolence was 6% compared to an incidence of 3% for placebo-treated patients [see Adverse Reactions ( 6.1 )] .It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should 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 dihydrochloride tablets, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with pramipexole dihydrochloride tablets such as the use of concomitant sedating medications or alcohol, the presence of sleep disorders, and concomitant medications that increase pramipexole plasma levels (e.g., cimetidine) [see Clinical Pharmacology ( 12.3 )] . If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.), pramipexole dihydrochloride tablets should ordinarily be discontinued. If a decision is made to continue pramipexole dihydrochloride tablets, advise patients not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent. While dose reduction 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. 5.2 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, both Parkinson's disease patients and RLS 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. 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. Also, clinical trials in patients with RLS did not incorporate orthostatic challenges with intensive blood pressure monitoring done in close temporal proximity to dosing. 5.3 Impulse Control/Compulsive Behaviors Case reports and the results of a cross-sectional study suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, binge eating, and/or other intense urges and the inability to control these urges while taking one or more of the medications, including pramipexole dihydrochloride tablets, that increase central dopaminergic tone. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with pramipexole dihydrochloride tablets for Parkinson's disease or RLS. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking pramipexole dihydrochloride tablets.
Side effects
Most common adverse reactions (incidence >5% and greater than placebo): Early PD without levodopa: nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations ( 6.1 ) Advanced PD with levodopa: postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia, and urinary frequency ( 6.1 ) RLS: nausea, somnolence, fatigue, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatc h. The following adverse reactions are discussed in greater detail in other sections of the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.1 )] . Symptomatic Orthostatic Hypotension [see Warnings and Precautions ( 5.2 )] . Impulse Control/Compulsive Behaviors [see Warnings and Precautions ( 5.3 )] . Hallucinations and Psychotic-like Behavior [see Warnings and Precautions ( 5.4 )] . Dyskinesia [see Warnings and Precautions ( 5.5 )] . Postural Deformity [see Warnings and Precautions ( 5.6 )] . Rhabdomyolysis [see Warnings and Precautions ( 5.8 )] . Retinal Pathology [see Warnings and Precautions ( 5.9 )] . Events Reported with Dopaminergic Therapy [see Warnings and Precautions ( 5.10 )]. Withdrawal Symptoms [see Warnings and Precautions ( 5.11 )]. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Parkinson's Disease During the premarketing development of pramipexole, patients with either early or advanced Parkinson's disease were enrolled in clinical trials. Apart from the severity and duration of their disease, the two populations differed in their use of concomitant levodopa therapy. Patients with early disease did not receive concomitant levodopa therapy during treatment with pramipexole; those with advanced Parkinson's disease all received concomitant levodopa treatment. Because these two populations may have differential risks for various adverse reactions, this section will, in general, present adverse-reaction data for these two populations separately. 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 reactions. Early Parkinson's Disease In the three double-blind , placebo-controlled trials of patients with early Parkinson's disease, the most common adverse reactions (>5%) that were numerically more frequent in the group treated with pramipexole dihydrochloride tablets were nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations. Approximately 12% of 388 patients with early Parkinson's disease and treated with pramipexole dihydrochloride tablets who participated in the double-blind, placebo-controlled trials discontinued treatment due to adverse reactions compared with 11% of 235 patients who received placebo. The adverse reactions most commonly causing discontinuation of treatment were related to the nervous system (hallucinations [3.1% on pramipexole dihydrochloride tablets vs 0.4% on placebo]; dizziness [2.1% on pramipexole dihydrochloride tablets vs 1% on placebo]; somnolence [1.6% on pramipexole dihydrochloride tablets vs 0% on placebo]; headache and confusion [1.3% and 1.0%, respectively, on pramipexole dihydrochloride tablets vs 0% on placebo]) and gastrointestinal system (nausea [2.1% on pramipexole dihydrochloride tablets vs 0.4% on placebo]). Adverse- reaction Incidence in Controlled Clinical Studies in Early Parkinson's Disease: Table 4 lists adverse reactions that occurred in the double-blind, placebo-controlled studies in early Parkinson's disease that were reported by ≥1% of patients treated with pramipexole dihydrochloride tablets and were numerically more frequent than in the placebo group. In these studies, patients did not receive concomitant levodopa. Table 4 Adverse-Reactions in Pooled Double-Blind, Placebo-Controlled Trials with Pramipexole Dihydrochloride Tablets in Early Parkinson's Disease Body System/ Adverse Reaction Pramipexole Dihydrochloride Tablets (N=388) % Placebo (N=235) % 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 Digestive System Nausea 28 18 Constipation 14 6 Anorexia 4 2 Dysphagia 2 0 Body as a Whole Asthenia 14 12 General edema 5 3 Malaise 2 1 Reaction unevaluable 2 1 Fever 1 0 Metabolic & Nutritional System Peripheral edema 5 4 Decreased weight 2 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 reactions 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 reactions 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.
Drug interactions
Dopamine antagonists: May diminish the effectiveness of pramipexole ( 7.1 ) 7.1 Dopamine Antagonists Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of pramipexole dihydrochloride tablets.
Use in specific populations
Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ) 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride tablets in pregnant women. No adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. Effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see Data]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. This increase in embryolethality is thought to result from the prolactin-lowering effect of pramipexole; prolactin is necessary for implantation and maintenance of early pregnancy in rats but not in rabbits or humans. Because of pregnancy disruption and early embryonic loss in this study, the teratogenic potential of pramipexole could not be adequately assessed in rats. The highest no-effect dose for embryolethality in rats was associated with maternal plasma drug exposures (AUC) approximately equal to those in humans receiving the maximum recommended human dose (MRHD) of 4.5 mg/day. There were no adverse effects on embryo-fetal development following oral administration of pramipexole (0.1, 1, or 10 mg/kg/day) to pregnant rabbits during organogenesis (plasma AUC up to approximately 70 times that in humans at the MRHD). Postnatal growth was inhibited in the offspring of rats treated with pramipexole (0.1, 0.5, or 1.5 mg/kg/day) during the latter part of pregnancy and throughout lactation. The no-effect dose for adverse effects on offspring growth (0.1 mg/kg/day) was associated with maternal plasma drug exposures lower than that in humans at the MRHD. 8.2 Lactation Risk Summary There are no data on the presence of pramipexole in human milk, the effects of pramipexole on the breastfed infant, or the effects of pramipexole on milk production. However, inhibition of lactation is expected because pramipexole inhibits secretion of prolactin in humans. Pramipexole or metabolites, or both, are present in rat milk [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pramipexole dihydrochloride and any potential adverse effects on the breastfed infant from pramipexole dihydrochloride or from the underlying maternal condition. Data In a study of radio-labeled pramipexole, pramipexole or metabolites, or both, were present in rat milk at concentrations three to six times higher than those in maternal plasma. 8.4 Pediatric Use Safety and effectiveness of pramipexole dihydrochloride tablets in pediatric patients has not been established. 8.5 Geriatric Use Pramipexole total oral clearance is approximately 30% lower in subjects older than 65 years compared with younger subjects, because of a decline in pramipexole renal clearance due to an age-related reduction in renal function. This resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. In clinical studies with Parkinson's disease patients, 38.7% of patients were older than 65 years. There were no apparent differences in efficacy or safety between older and younger patients, except that the relative risk of hallucination associated with the use of pramipexole dihydrochloride tablets was increased in the elderly. In clinical studies with RLS patients, 22% of patients were at least 65 years old. There were no apparent differences in efficacy or safety between older and younger patients. 8.6 Renal Impairment The elimination of pramipexole is dependent on renal function. Pramipexole clearance is extremely low in dialysis patients, as a negligible amount of pramipexole is removed by dialysis. Caution should be exercised when administering pramipexole dihydrochloride tablets to patients with renal disease [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.7 ), and Clinical Pharmacology ( 12.3 )] .
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride tablets in pregnant women. No adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. Effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see Data]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. This increase in embryolethality is thought to result from the prolactin-lowering effect of pramipexole; prolactin is necessary for implantation and maintenance of early pregnancy in rats but not in rabbits or humans. Because of pregnancy disruption and early embryonic loss in this study, the teratogenic potential of pramipexole could not be adequately assessed in rats. The highest no-effect dose for embryolethality in rats was associated with maternal plasma drug exposures (AUC) approximately equal to those in humans receiving the maximum recommended human dose (MRHD) of 4.5 mg/day. There were no adverse effects on embryo-fetal development following oral administration of pramipexole (0.1, 1, or 10 mg/kg/day) to pregnant rabbits during organogenesis (plasma AUC up to approximately 70 times that in humans at the MRHD). Postnatal growth was inhibited in the offspring of rats treated with pramipexole (0.1, 0.5, or 1.5 mg/kg/day) during the latter part of pregnancy and throughout lactation. The no-effect dose for adverse effects on offspring growth (0.1 mg/kg/day) was associated with maternal plasma drug exposures lower than that in humans at the MRHD.
Overdosage
There is no clinical experience with significant overdosage. One patient took 11 mg/day of pramipexole for 2 days in a clinical trial for an investigational use. Blood pressure remained stable although pulse rate increased to between 100 and 120 beats/minute. No other adverse reactions were reported related to the increased dose. 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.
Description
Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S )-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg : Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg : Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg : Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg : Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg : Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg : Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis). 3
How supplied
16.1 How Supplied Pramipexole Dihydrochloride Tablets are available as follows: Pramipexole Dihydrochloride Tablets 0.125 mg are white to off white, round, flat, bevel edged, uncoated tablets with "91" debossed on one side and plain on other side. Bottles of 30 NDC 13668-091-30 Bottles of 90 NDC 13668-091-90 Bottles of 500 NDC 13668-091-05 Bottles of 6,000 NDC 13668-091-42 Pramipexole Dihydrochloride Tablets 0.25 mg are peach colored, round, flat, bevel edged, uncoated tablets with "9/2" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-092-30 Bottles of 90 NDC 13668-092-90 Bottles of 500 NDC 13668-092-05 Bottles of 5,500 NDC 13668-092-41 Pramipexole Dihydrochloride Tablets 0.5 mg are reddish brown colored, round, biconvex, uncoated tablets with "9/3" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-093-30 Bottles of 90 NDC 13668-093-90 Bottles of 500 NDC 13668-093-05 Bottles of 4,000 NDC 13668-093-40 Pramipexole Dihydrochloride Tablets 0.75 mg are yellow colored, round, flat, bevel edged, uncoated tablets with "84" debossed on one side and plain on other side. Bottles of 30 NDC 13668-184-30 Bottles of 90 NDC 13668-184-90 Bottles of 500 NDC 13668-184-05 Bottles of 2,500 NDC 13668-184-31 Pramipexole Dihydrochloride Tablets 1 mg are light pink colored, round, flat, bevel edged, uncoated tablets with "9/4" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-094-30 Bottles of 90 NDC 13668-094-90 Bottles of 500 NDC 13668-094-05 Bottles of 2,500 NDC 13668-094-31 Pramipexole Dihydrochloride Tablets 1.5 mg are white to off white, round, flat, bevel edged, uncoated tablets with "9/5" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-095-30 Bottles of 90 NDC 13668-095-90 Bottles of 500 NDC 13668-095-05 Bottles of 1,500 NDC 13668-095-15 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children. 16.1 How Supplied Pramipexole Dihydrochloride Tablets are available as follows: Pramipexole Dihydrochloride Tablets 0.125 mg are white to off white, round, flat, bevel edged, uncoated tablets with "91" debossed on one side and plain on other side. Bottles of 30 NDC 13668-091-30 Bottles of 90 NDC 13668-091-90 Bottles of 500 NDC 13668-091-05 Bottles of 6,000 NDC 13668-091-42 Pramipexole Dihydrochloride Tablets 0.25 mg are peach colored, round, flat, bevel edged, uncoated tablets with "9/2" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-092-30 Bottles of 90 NDC 13668-092-90 Bottles of 500 NDC 13668-092-05 Bottles of 5,500 NDC 13668-092-41 Pramipexole Dihydrochloride Tablets 0.5 mg are reddish brown colored, round, biconvex, uncoated tablets with "9/3" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-093-30 Bottles of 90 NDC 13668-093-90 Bottles of 500 NDC 13668-093-05 Bottles of 4,000 NDC 13668-093-40 Pramipexole Dihydrochloride Tablets 0.75 mg are yellow colored, round, flat, bevel edged, uncoated tablets with "84" debossed on one side and plain on other side. Bottles of 30 NDC 13668-184-30 Bottles of 90 NDC 13668-184-90 Bottles of 500 NDC 13668-184-05 Bottles of 2,500 NDC 13668-184-31 Pramipexole Dihydrochloride Tablets 1 mg are light pink colored, round, flat, bevel edged, uncoated tablets with "9/4" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-094-30 Bottles of 90 NDC 13668-094-90 Bottles of 500 NDC 13668-094-05 Bottles of 2,500 NDC 13668-094-31 Pramipexole Dihydrochloride Tablets 1.5 mg are white to off white, round, flat, bevel edged, uncoated tablets with "9/5" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-095-30 Bottles of 90 NDC 13668-095-90 Bottles of 500 NDC 13668-095-05 Bottles of 1,500 NDC 13668-095-15
Storage
16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosing Instructions Instruct patients to take pramipexole dihydrochloride tablets only as prescribed. If a dose is missed, advise patients not to double their next dose. Pramipexole dihydrochloride tablets can be taken with or without food. If patients develop nausea, advise that taking pramipexole dihydrochloride tablets with food may reduce the occurrence of nausea. Pramipexole is the active ingredient that is in both pramipexole dihydrochloride tablets and extended-release pramipexole tablets. Ensure that patients do not take both extended-release pramipexole and pramipexole dihydrochloride tablets. Sedating Effects Alert patients to the potential sedating effects associated with pramipexole dihydrochloride tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse reaction 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 dihydrochloride tablets to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., conversations or eating) 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, advise caution when patients are taking other sedating medications or alcohol in combination with pramipexole dihydrochloride tablets and when taking concomitant medications that increase plasma levels of pramipexole (e.g., cimetidine) [see Warnings and Precautions ( 5.1 )] . Postural (Orthostatic) Hypotension Advise patients that they 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, caution patients 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 dihydrochloride tablets [see Warnings and Precautions ( 5.2 )] . Impulse Control Symptoms Including Compulsive Behaviors Alert patients and their caregivers to the possibility that they may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, binge eating and/or other intense urges and the inability to control these urges while taking pramipexole dihydrochloride tablets. [see Warnings and Precautions ( 5.3 )] . Hallucinations and Psychotic-like Behavior Inform patients that hallucinations and other psychotic-like behavior can occur. In patients with Parkinson's disease, the elderly are at a higher risk than younger patients [see Warnings and Precautions ( 5.4 )] . Withdrawal-Emergent Hyperpyrexia and Confusion Advise patients who have been prescribed a lower dose or who have been withdrawn from the drug to notify their healthcare provider if they have symptoms such as fever, muscular rigidity, or altered consciousness [see Warnings and Precautions ( 5.10 )] . Withdrawal Symptoms Advise patients that withdrawal symptoms may occur during or after discontinuation or dose reduction of pramipexole dihydrochloride. Advise patients who have been prescribed a lower dose or who have been withdrawn from the drug to notify their healthcare provider if they have withdrawal symptoms such as apathy, anxiety, depression, fatigue, insomnia, sweating, or pain. Notify patients that in case of severe withdrawal symptoms, a trial re- administration of a dopamine agonist at the lowest effective dose may be considered [see Warnings and Precautions ( 5.11 )] . Pregnancy Because the teratogenic potential of pramipexole has not been completely established in laboratory animals, and because experience in humans is limited, advise women to notify their physicians if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations ( 8.1 )] . Lactation Because of the possibility that pramipexole may be excreted in breast milk, advise women to notify their physicians if they intend to breast-feed or are breast-feeding an infant [see Use in Specific Populations ( 8.2 )] . Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. pi-logo
Label text from the FDA structured product label by Torrent Pharmaceuticals Limited (revised Mar 31, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Pramipexole Dihydrochloride in 131 products
pramipexole dihydrochloride NDC products (131)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7816 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5036 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-3280 | Pramipexole Dihydrochloride .25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-2455 | Pramipexole Dihydrochloride .5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 62332-005 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-006 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-007 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-154 | Pramipexole Dihydrochloride .375 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-155 | Pramipexole Dihydrochloride .75 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-156 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-160 | Pramipexole Dihydrochloride 3.75 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-004 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-003 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-159 | Pramipexole Dihydrochloride 4.5 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-158 | Pramipexole Dihydrochloride 3 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-157 | Pramipexole Dihydrochloride 2.25 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-006 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-003 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-004 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-005 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-580 | Pramipexole Dihydrochloride 4.5 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-007 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-574 | Pramipexole Dihydrochloride .375 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-575 | Pramipexole Dihydrochloride .75 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-576 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-577 | Pramipexole Dihydrochloride 2.25 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-578 | Pramipexole Dihydrochloride 3 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-579 | Pramipexole Dihydrochloride 3.75 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-611 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-612 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-613 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-614 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-615 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 60687-592 | Pramipexole Dihydrochloride 1 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-581 | Pramipexole Dihydrochloride .5 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-570 | Pramipexole Dihydrochloride .25 mg/1 Tablet | American Health Packaging | ANDA |
| 65862-604 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-605 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-606 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-607 | Pramipexole Dihydrochloride .75 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-608 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-609 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 72162-2569 | Pramipexole Dihydrochloride .75 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-5042 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2167 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1877 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1808 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1537 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1504 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0584 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8289 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-5013 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 55111-613 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-612 | Pramipexole Dihydrochloride .75 mg/1 Tablet, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-611 | Pramipexole Dihydrochloride .375 mg/1 Tablet, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-614 | Pramipexole Dihydrochloride 3 mg/1 Tablet, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-615 | Pramipexole Dihydrochloride 4.5 mg/1 Tablet, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 68462-627 | Pramipexole Dihydrochloride .75 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-330 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-331 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-332 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-333 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-334 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 60429-090 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 60429-089 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 60429-088 | Pramipexole Dihydrochloride .75 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 60429-087 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 60429-086 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 60429-085 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 50742-336 | Pramipexole Dihydrochloride 3.75 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-337 | Pramipexole Dihydrochloride 4.5 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-331 | Pramipexole Dihydrochloride .375 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-332 | Pramipexole Dihydrochloride .75 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-333 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-334 | Pramipexole Dihydrochloride 2.25 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-335 | Pramipexole Dihydrochloride 3 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 33342-034 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-035 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-033 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-032 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-031 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-208 | Pramipexole Dihydrochloride .375 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-209 | Pramipexole Dihydrochloride .75 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-210 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-211 | Pramipexole Dihydrochloride 2.25 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-212 | Pramipexole Dihydrochloride 3 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-213 | Pramipexole Dihydrochloride 3.75 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-214 | Pramipexole Dihydrochloride 4.5 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 0904-6704 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0615-8552 | Pramipexole Dihydrochloride .5 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8551 | Pramipexole Dihydrochloride .25 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 16714-916 | Pramipexole Dihydrochloride .375 mg/1 Tablet, Extended Release | NorthStar RxLLC | ANDA |
| 16714-917 | Pramipexole Dihydrochloride .75 mg/1 Tablet, Extended Release | NorthStar RxLLC | ANDA |
| 16714-918 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet, Extended Release | NorthStar RxLLC | ANDA |
| 16714-919 | Pramipexole Dihydrochloride 2.25 mg/1 Tablet, Extended Release | NorthStar RxLLC | ANDA |
| 16714-920 | Pramipexole Dihydrochloride 3 mg/1 Tablet, Extended Release | NorthStar RxLLC | ANDA |
| 16714-922 | Pramipexole Dihydrochloride 4.5 mg/1 Tablet, Extended Release | NorthStar RxLLC | ANDA |
| 57237-180 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 57237-185 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 57237-184 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 57237-183 | Pramipexole Dihydrochloride .75 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 57237-182 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 57237-181 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 50228-127 | Pramipexole Dihydrochloride .25 mg/1 Tablet | ScieGen Pharmaceuticals Inc | ANDA |
| 50228-130 | Pramipexole Dihydrochloride 1 mg/1 Tablet | ScieGen Pharmaceuticals Inc | ANDA |
| 50228-126 | Pramipexole Dihydrochloride .125 mg/1 Tablet | ScieGen Pharmaceuticals Inc | ANDA |
| 50228-128 | Pramipexole Dihydrochloride .5 mg/1 Tablet | ScieGen Pharmaceuticals Inc | ANDA |
| 50228-129 | Pramipexole Dihydrochloride .75 mg/1 Tablet | ScieGen Pharmaceuticals Inc | ANDA |
| 50228-131 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | ScieGen Pharmaceuticals Inc | ANDA |
| 64380-749 | Pramipexole Dihydrochloride .75 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-750 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-747 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-746 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-748 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-751 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 13668-091 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 13668-092 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 13668-093 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 13668-184 | Pramipexole Dihydrochloride .75 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 13668-094 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 13668-095 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 29300-209 | Pramipexole Dihydrochloride .5 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-211 | Pramipexole Dihydrochloride 1.5 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-270 | Pramipexole Dihydrochloride .75 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-207 | Pramipexole Dihydrochloride .125 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-208 | Pramipexole Dihydrochloride .25 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-210 | Pramipexole Dihydrochloride 1 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 69680-146 | Pramipexole Dihydrochloride .75 mg/1 Tablet, Extended Release | Vitruvias Therapeutics, Inc. | ANDA |
| 69680-145 | Pramipexole Dihydrochloride .375 mg/1 Tablet, Extended Release | Vitruvias Therapeutics, Inc. | ANDA |
| 71034-002 | Pramipexole Dihydrochloride .375 mg/1 Tablet, Extended Release | Xiamen LP Pharmaceutical Co., Ltd. | ANDA |
| 71034-003 | Pramipexole Dihydrochloride .75 mg/1 Tablet, Extended Release | Xiamen LP Pharmaceutical Co., Ltd. | ANDA |
pramipexole dihydrochloride recalls
- D-1851-2019 Sep 18, 2019 · Class III · Terminated
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg - D-0653-2016 Feb 17, 2016 · Class II · Terminated
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Frequently asked questions
What is pramipexole dihydrochloride used for?
Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: Parkinson's disease (PD) ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson’s Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment…
What are the side effects of pramipexole dihydrochloride?
Most common adverse reactions (incidence >5% and greater than placebo): Early PD without levodopa: nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations ( 6.1 ) Advanced PD with levodopa: postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation,… See the full label for the complete list.
Who makes pramipexole dihydrochloride?
pramipexole dihydrochloride is listed by 21 labelers in the FDA NDC directory, including A-S Medication Solutions, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, American Health Packaging.
Has pramipexole dihydrochloride been recalled?
The FDA enforcement database lists 2 recalls for pramipexole dihydrochloride, most recently D-1851-2019 (class iii): Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg