PRAMIPEXOLE DIHYDROCHLORIDE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Rising Pharma Holdings, Inc.

SNN (starptautisko nepatentēto nosaukumu):

PRAMIPEXOLE DIHYDROCHLORIDE

Kompozīcija:

PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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) ].

Produktu pārskats:

Pramipexole Dihydrochloride tablets are available as follows: Pramipexole Dihydrochloride Tablets, 0.125 mg are white to off-white, round, flat, beveled edge uncoated tablets, debossed with ‘Y’ on one side ‘41’ on other side. Bottles of 90                                                   NDC 57237-180-90 Bottles of 1,000                                              NDC 57237-180-99 Pramipexole Dihydrochloride Tablets, 0.25 mg are white to off-white, oval, biconcave, beveled edge uncoated tablets, debossed with ‘Y’ and ‘42’ separated by score line on one side and plain with score line on other side. Bottles of 90                                                   NDC 57237-181-90 Bottles of 1,000                                              NDC 57237-181-99 Pramipexole Dihydrochloride Tablets, 0.5 mg are white to off-white, oval, biconcave, beveled edge uncoated tablets, debossed with ‘Y’ and ‘43’ separated by score line on one side and plain with score line on other side. Bottles of 90                                                   NDC 57237-182-90 Bottles of 1,000                                              NDC 57237-182-99 Pramipexole Dihydrochloride Tablets, 0.75 mg are white to off-white, oval, biconcave, beveled edge uncoated tablets, debossed with ‘Y’ on one side and ‘44’ on other side. Bottles of 90                                                   NDC 57237-183-90 Bottles of 1,000                                              NDC 57237-183-99 Pramipexole Dihydrochloride Tablets, 1 mg are white to off-white, round, flat, beveled edge uncoated tablets, debossed with ‘Y’ and ‘45’ separated by score line on one side and plain with score line on other side. Bottles of 90                                                   NDC 57237-184-90 Bottles of 1,000                                              NDC 57237-184-99 Pramipexole Dihydrochloride Tablets, 1.5 mg are white to off-white, round, flat, beveled edge uncoated tablets, debossed with ‘Y’ and ‘46’ separated by score line on one side and plain with score line on other side. Bottles of 90                                                   NDC 57237-185-90 Bottles of 1,000                                              NDC 57237-185-99 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

PRAMIPEXOLE DIHYDROCHLORIDE - PRAMIPEXOLE DIHYDROCHLORIDE TABLET
RISING PHARMA HOLDINGS, INC.
----------
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 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)
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)
<15 mL/min and hemodialysis patients
Data not available
>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
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
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
*
Impulse Control/Compulsive Behaviors: