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:

Zydus Lifesciences Limited

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE

Composition:

PRAMIPEXOLE 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 2-4% and 15-20%, 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 r

Product summary:

Pramipexole Dihydrochloride Tablets, 0.125 mg are pink color, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P1'on one side and plain on other side and are supplied are as follows: NDC 65841-734-16 in bottle of 90 tablets NDC 65841-734-05 in bottle of 500 tablets NDC 65841-734-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 0.25 mg are pale blue color, round, flat, beveled-edged, uncoated tablets debossed with 'P2'on one side and break line on other side and are supplied as follows: NDC 65841-735-16 in bottle of 90 tablets NDC 65841-735-05 in bottle of 500 tablets NDC 65841-735-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 0.5 mg are lavender, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P' breakline '3' on one side and plain on other side and are supplied as follows: NDC 65841-736-16 in bottle of 90 tablets NDC 65841-736-05 in bottle of 500 tablets NDC 65841-736-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 1 mg are light peach to peach, round, flat, beveled-edged, uncoated tablets debossed with 'P4'on one side and break line on other side and are supplied as follows: NDC 65841-737-16 in bottle of 90 tablets NDC 65841-737-05 in bottle of 500 tablets NDC 65841-737-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 1.5 mg are yellow color, round, flat, beveled- edged, uncoated tablets debossed with 'P5'on one side and break line on other side and are supplied as follows: NDC 65841-738-16 in bottle of 90 tablets NDC 65841-738-05 in bottle of 500 tablets NDC 65841-738-10 in bottle of 1000 tablets Storage:                      Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container. Store in a safe place out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Cadila Healthcare Limited
----------
PATIENT INFORMATION
Pramipexole Dihydrochloride (PRAM-i-PEX-ole dye-HYE-droe-KLOR-ide)
Tablets
Read this Patient Information before you start taking pramipexole
dihydrochloride and each time you get a
refill. There may be new information. This information does not take
the place of talking with your doctor
about your medical condition or your treatment.
What is pramipexole dihydrochloride?
Pramipexole dihydrochloride is a prescription medicine used to treat:
•
signs and symptoms of Parkinson's disease (PD)
•
moderate to severe primary Restless Legs Syndrome (RLS)
It is not known if pramipexole dihydrochloride is safe and effective
in children.
What should I tell my doctor before taking pramipexole
dihydrochloride?
•
Before taking pramipexole dihydrochloride, tell your doctor if you:
•
feel sleepy during the day from a sleep problem other than Restless
Legs Syndrome
•
have low blood pressure, or if you feel dizzy or faint, especially
when getting up from sitting
or lying down
•
have trouble controlling your muscles (dyskinesia)
•
have kidney problems
•
drink alcohol. Alcohol can increase the chance that pramipexole
dihydrochloride will make
you feel sleepy or fall asleep when you should be awake.
•
have any other medical conditions
•
are pregnant or plan to become pregnant. It is not known if
pramipexole dihydrochloride will
harm your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if
pramipexole dihydrochloride passes
into your breast milk. You and your doctor should decide if you will
take pramipexole
dihydrochloride or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines,
vitamins, and herbal supplements.
The combination of pramipexole dihydrochloride and other medicines may
affect each other and may cause
side effects. Pramipexole dihydrochloride may affect the way other
medicines work, and other medicines
may affect how pramipexole dihydroch

Summary of Product characteristics

PRAMIPEXOLE DIHYDROCHLORIDE - PRAMIPEXOLE DIHYDROCHLORIDE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-734-10 in bottle of 1000 tablets
Pramipexole Dihydrochloride Tablets, 0.125 mg
Rx only
1000 tablets
NDC 65841-735-10 in bottle of 1000 tablets
Pramipexole Dihydrochloride Tablets, 0.25 mg
Rx only
1000 tablets
NDC 65841-736-10 in bottle of 1000 tablets
Pramipexole Dihydrochloride Tablets, 0.5 mg
Rx only
1000 tablets
NDC 65841-737-10 in bottle of 1000 tablets
Pramipexole Dihydrochloride Tablets, 1 mg
Rx only
1000 tablets
NDC 65841-738-16 in bottle of 90 tablets
Pramipexole Dihydrochloride Tablets, 1.5 mg
Rx only
90 tablets
NDC 65841-844-16 in bottle of 90 tablets
Pramipexole Dihydrochloride Tablets, 0.75 mg
Rx only
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-734
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE -
UNII:83619PEU5T)
PRAMIPEXOLE
DIHYDROCHLORIDE
0.125 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PRODUCT CHARACTERISTICS
COLOR
PINK (PINK)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
7mm
FLAVOR
IMPRINT CODE
P1
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-734-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
07/10/2010
2
NDC:65841-734-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
07/10/2010
3
NDC:65841-734-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
07/10/2010
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA078920
07/10/2010
PRAMIPEXOLE DIHYDROCHLORIDE