Pramipexole
Generic Name: pramipexole
Brand Names:
Pramipexole
11 DESCRIPTION Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride 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•H2O, and its molecular weight is 302.27. The structural formula is: Pramipexole dihydrochloride is a white to almost white crystalline powder.
Overview
11 DESCRIPTION Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride 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•H2O, and its molecular weight is 302.27. The structural formula is: Pramipexole dihydrochloride is a white to almost white crystalline powder.
Uses
1 INDICATIONS & 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.
Dosage
2 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 5-7 days. Titrate to effective dose. If used with levodopa, may need to reduce levodopa dose.
Side Effects
6 ADVERSE REACTIONS 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)].
Interactions
7 DRUG INTERACTIONS See also Dosage and Administration (2.2) and Clinical Pharmacology ( 12.3 ) 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. 7.2 Drug/Laboratory Test Interactions There are no known interactions between pramipexole and laboratory tests.
Warnings
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS None. None (4)
Pregnancy
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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Pramipexole dihydrochloride tablets are available as follows: 0.125 mg, white to off-white, round, flat, beveled edge uncoated tablets, debossed with 'SG' on one side '126' on other side.
Frequently Asked Questions
What is Pramipexole used for?▼
1 INDICATIONS & 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.
What are the side effects of Pramipexole?▼
6 ADVERSE REACTIONS 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)].
Can I take Pramipexole during pregnancy?▼
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.
What are the important warnings for Pramipexole?▼
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS None. None (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.