PRAMIPEXOLE DIHYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE

Composition:

PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 and any potential adverse effects on the breastfed infant from pramipexole 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. 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) ].

Product summary:

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. NDC 60429-085-90, bottle of 90 tablets 0.25 mg, white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘27’ on the right side of the bisect. NDC 60429-086-90, bottle of 90 tablets 0.5 mg, white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘28’ on the right side of the bisect. NDC 60429-087-90, bottle of 90 tablets 1.0 mg, white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘30’ on the right side of the bisect. NDC 60429-089-90, bottle of 90 tablets 1.5 mg, white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘31’ on the right side of the bisect. NDC 60429-090-90, bottle of 90 tablets Store at 20 ºC to 25ºC (68 ºF to 77ºF); (see USP controlled Room Temperature). Protect from light. Store in a safe place out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAMIPEXOLE DIHYDROCHLORIDE- PRAMIPEXOLE DIHYDROCHLORIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. 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:
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 5-7 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) 2-3 HOURS BEFORE
BEDTIME
1
0.125
2 (if needed)
0.25
3 (if needed)
0.5
*Dosing interval is 4-7 days (14 days in patients with CrCl 20-60
mL/min)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.125 mg, 0.25 mg (functional scored tablets), 0.5 mg
(functional scored tablets), 0.75 mg, 1 mg
(functional scored tablets), and 1.5 mg (functional scored tablets) (
3).
CONTRAINDICATIONS
*
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 H