pharmacopeia
GET
/api/v1/drug/pramipexole
2D structure
(6S)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
SMILES CCCN[C@H]1CCC2=C(C1)SC(=N2)N
InChIKey FASDKYOPVNHBLU-ZETCQYMHSA-N

Mechanism of action

Sourced from openFDA

Pramipexole is a non-ergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D2 subfamily of dopamine receptors, binding with higher affinity to D3 than to D2 or D4 receptor subtypes. Parkinson's Disease 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.

Dopamine

Indications

Sourced from openFDA
  • & USAGE PRAMIPEXOLE DIHYDROCHLORIDE tablets is a non-ergot dopamine agonist indicated for the treatment of • the signs and symptoms of idiopathic Parkinson's disease (PD) ( 1.1 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.ICD-10: G20

Contraindications

Sourced from openFDA
  • None.contraindicated

Dosage & administration

Sourced from openFDA

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 5-7 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 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 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.

Warnings & precautions

Sourced from openFDA

• Falling asleep during activities of daily living: Sudden onset of sleep may occur without warning. Advise patients to report symptoms to the prescriber. ( 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: May occur. Risk increases with age. ( 5.4 ) • Dyskinesia: May be caused or exacerbated by PRAMIPEXOLE DIHYDROCHLORIDE tablets ( 5.5 ) • Renal Impairment: Requires dose reduction ( 2.2 , 12.3 ) • Events reported with dopaminergic therapy: Include withdrawal-emergent hyperpyrexia and confusion, fibrotic complications, and melanoma ( 5.9 ) 5.1 Falling Asleep During Activities of Daily Living 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 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 at doses above 1.5 mg/day (0.5 mg TID) for Parkinson's disease.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in other sections of the labeling: •Falling Asleep During Activities of Daily Living [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 [see Warnings and Precautions ( 5.4 )]. •Dyskinesia [see Warnings and Precautions ( 5.5)]. •Renal Impairment [see Warnings and Precautions (5.6)]. •Rhabdomyolysis [see Warnings and Precautions (5.7)]. •Retinal Pathology [see Warnings and Precautions ( 5.8)]. •Events Reported with Dopaminergic Therapy [see Warnings and Precautions (5.9)]. Most common adverse events (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 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ). Pediatric use: Safety and effectiveness in pediatric patients have not been established ( 8.4 ) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole 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 2-4% and 15-20%, 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 rabbits or humans.

Pharmacokinetics

Sourced from openFDA
Metabolism
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.

Overdosage

Sourced from openFDA

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 events 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.

Approval history

Sourced from openFDA
  • Oct 8, 2010ANDAANDA090781Glenmark Pharms Ltd
  • Oct 8, 2010ANDAANDA078894Alembic
  • Oct 8, 2010ANDAANDA090865Torrent Pharms
  • Sep 20, 2012ANDAANDA202164Macleods Pharms Ltd
  • Oct 26, 2012ANDAANDA202633Aurobindo Pharma Ltd
  • Jun 3, 2014ANDAANDA202702Strides Pharma
  • Oct 28, 2014ANDAANDA203855Sciegen Pharms
  • Aug 7, 2015ANDAANDA203354Dr Reddys

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
19,167 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective1,8229.5%
  2. 2Fatigue1,3907.3%
  3. 3Fall1,3557.1%
  4. 4Nausea1,1095.8%
  5. 5Pain1,0595.5%
  6. 6Condition Aggravated1,0275.4%
  7. 7Off Label Use1,0095.3%
  8. 8Hallucination9695.1%
  9. 9Dizziness9685.1%
  10. 10Dyspnoea9314.9%
  11. 11Headache8634.5%
  12. 12Gait Disturbance7994.2%
  13. 13Insomnia7954.1%
  14. 14Dyskinesia7894.1%
  15. 15Tremor7523.9%

Literature

View JSON

Recent PubMed references pinned to Pramipexole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 177 ClinicalTrials.gov registrations naming Pramipexole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pramipexole work?
Pramipexole is a non-ergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D2 subfamily of dopamine receptors, binding with higher affinity to D3 than to D2 or D4 receptor subtypes. Parkinson's Disease 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.
What is Pramipexole used for?
According to FDA labeling, Pramipexole carries indications including: & USAGE PRAMIPEXOLE DIHYDROCHLORIDE tablets is a non-ergot dopamine agonist indicated for the treatment of • the signs and symptoms of idiopathic Parkinson's disease (PD) ( 1.1 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pramipexole?
Pramipexole is classified as Dopamine agonists, Nonergot Dopamine Agonist, Dopamine Agonists, Increased Central Nervous System Dopamine Activity.
What are the brand names for Pramipexole?
Pramipexole is marketed under brand names including Mirapex.
What are the contraindications for Pramipexole?
Pramipexole labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
Note. Data for pramipexole is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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