PRAMIPEXOLE DIHYDROCHLORIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)

Доступна з:

Alembic Pharmaceuticals Limited

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Pramipexole dihydrochloride tablets are indicated for the treatment of  Parkinson’s disease. None.    Pregnancy Category C   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 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, and 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. 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 tablets and any potential adverse effects on the breastfed infant from pramipexole dihydrochloride tablets 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. Safety and effectiveness of pramipexole dihydrochloride tablets in pediatric patients has not been established. 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. 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 (5.6), and Clinical Pharmacology (12.3) ].

Огляд продуктів:

Pramipexole dihydrochloride tablets are available as follows:   0.125 mg: White to off white, circular tablet debossed with “E” on one side and “33” on the other side. Bottles of 90                                       NDC 46708-611-90   0.25 mg: White to off white, oval shaped tablet with break line on both side and debossed with “E E” on one side and “34 34” on other side. Bottles of 90                                       NDC 46708-612-90   0.5 mg: White to off white, oval shaped tablet with break line on both side and debossed with “E E” on one side and “35 35” on other side. Bottles of 90                                       NDC 46708-613-90   1 mg: White to off white, circular tablet with break line on both side and debossed with “E E” on one side and “36 36” on other side. Bottles of 90                                       NDC 46708-614-90 1.5 mg: White to off white, circular tablet with break line on both side and debossed with “E E” on one side and “37 37” on other side. Bottles of 90                                       NDC 46708-615-90 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

PRAMIPEXOLE DIHYDROCHLORIDE - PRAMIPEXOLE DIHYDROCHLORIDE TABLET
ALEMBIC PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAMIPEXOLE
DIHYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS.
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are non-ergot dopamine agonist
indicated for the treatment of: (1)
· Parkinson’s disease (PD) (1.1) (1)
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
DOSAGE FORMS AND STRENGTHS
Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg (3). (3)
CONTRAINDICATIONS
None (4) (4)
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) (5)
· Symptomatic orthostatic hypotension: Monitor during dose escalation
(5.2) (5)
· Impulse control/Compulsive behaviors: Patients may experience
compulsive behaviors and other
intense urges (5.3) (5)
· Hallucinations and Pschyotic-like Behaviour: May occur; risk
increases with age. (5.4) (5)
· Dyskinesia: May be caused or exacerbated by pramipexole
dihydrochloride tablets (5.5) (5)
· Events reported with dopaminergic therapy: Include hyperpyrexia and
confusion, fibrotic
complications, and melanoma (5.9) (5)
ADVERSE REA