PRAMIPEXOLE DIHYDROCHLORIDE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Glenmark Pharmaceuticals Inc., USA

INN (International namn):

PRAMIPEXOLE DIHYDROCHLORIDE

Sammansättning:

PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). None. Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride 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. 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. Safety and effectiveness of pramipexole dihydrochloride 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. 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. 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) ].

Produktsammanfattning:

Pramipexole Dihydrochloride Tablets are available as follows: 0.125 mg: circular, white, flat beveled tablets engraved with ‘PX’ on one side and plain on the other side. Bottles of 63 with child-resistant closure NDC 68462-330-63 Bottles of 90 with child-resistant closure NDC 68462-330-90 Bottles of 500 with child-resistant closure NDC 68462-330-05 Unit-dose pack of 100 (10 x 10) NDC 68462-330-11 0.25 mg: oval, white, flat beveled tablets engraved with ‘PX’ and ‘1’ on either side of a break line on one side and a break line on the other side. Bottles of 90 with child-resistant closure NDC 68462-331-90 Bottles of 500 with child-resistant closure NDC 68462-331-05 Unit-dose pack of 100 (10 x 10) NDC 68462-331-11 0.5 mg: oval, white, flat beveled tablets engraved with ‘PX’ and ‘2’ on either side of a break line on one side and a break line on the other side. Bottles of 90 with child-resistant closure NDC 68462-332-90 Bottles of 500 with child-resistant closure NDC 68462-332-05 Unit-dose pack of 100 (10 x 10) NDC 68462-332-11 0.75 mg: oval, white, flat beveled uncoated tablets engraved with ‘PX’ and ‘5’ on one side and plain on the other side. 1 mg: oval, white, flat beveled tablets engraved with ‘PX’ and ‘3’ on either side of a break line on one side and a break line on the other side. Bottles of 90 with child-resistant closure NDC 68462-333-90 Bottles of 500 with child-resistant closure NDC 68462-333-05 Unit-dose pack of 100 (10 x 10) NDC 68462-333-11 1.5 mg: oval, white, flat beveled tablets engraved with ‘PX’ and ‘4’ on either side of a break line on one side and a break line on the other side. Bottles of 90 with child-resistant closure NDC 68462-334-90 Bottles of 500 with child-resistant closure NDC 68462-334-05 Unit-dose pack of 100 (10 x 10) NDC 68462-334-11 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

PRAMIPEXOLE DIHYDROCHLORIDE- PRAMIPEXOLE DIHYDROCHLORIDE TABLET
GLENMARK PHARMACEUTICALS INC., USA
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions, Withdrawal Symptoms (5.11) 7/2021
INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist
indicated for the treatment of:
•
•
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence >5% and greater than
placebo):
•
•
Parkinson’s disease (PD) (1.1)
Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2)
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 es