GALANTAMINE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA)

Inapatikana kutoka:

Aurobindo Pharma Limited

INN (Jina la Kimataifa):

GALANTAMINE HYDROBROMIDE

Tungo:

GALANTAMINE 4 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Risk Summary There are no adequate data on the developmental risk associated with the use of galantamine hydrobromide in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see Data). In the U.S. general population, the estimated background risk of major birth defects and 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 In rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. The no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (MRHD) of 24 mg/day on a body surface area (mg/m2 ) basis. When galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. The no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the MRHD on a mg/m2 basis. In a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. The no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the MRHD on a mg/m2 basis. Risk Summary There are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide and any potential adverse effects on the breastfed infant from galantamine hydrobromide or from the underlying maternal condition. The safety and effectiveness in pediatric patients have not been established. Eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6519 patients have investigated galantamine hydrobromide in the treatment of mild to moderate dementia of the Alzheimer’s type [see Adverse Reactions (6.1) and Clinical Studies (14)] . The mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. In patients with moderate hepatic impairment, a dosage adjustment is recommended. The use of galantamine hydrobromide in patients with severe hepatic impairment is not recommended [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] . In patients with a creatinine clearance of 9 to 59 mL/min, a dosage adjustment is recommended. The use of galantamine hydrobromide in patients with creatinine clearance less than 9 mL/min is not recommended [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)] .

Bidhaa muhtasari:

How Supplied Galantamine tablets USP are supplied as follows:  Galantamine Tablets USP, 4 mg  are off-white, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘49’ on the other side.         Bottles of 60                           NDC 65862-458-60         Bottles of 1,000                      NDC 65862-458-99         Bottles of 10,000                    NDC 65862-458-19 Galantamine Tablets USP, 8 mg are pink, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘50’ on the other side.         Bottles of 60                           NDC 65862-459-60         Bottles of 1,000                      NDC 65862-459-99         Bottles of 7,000                      NDC 65862-459-71 Galantamine Tablets USP, 12 mg are orange-brown, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘51’ on the other side.         Bottles of 60                           NDC 65862-460-60         Bottles of 1,000                      NDC 65862-460-99         Bottles of 4,000                      NDC 65862-460-49 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

GALANTAMINE - GALANTAMINE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GALANTAMINE TABLETS.
GALANTAMINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 8/2021
INDICATIONS AND USAGE
Galantamine tablets are a cholinesterase inhibitor indicated for the
treatment of mild to moderate
dementia of the Alzheimer’s type (1)
DOSAGE AND ADMINISTRATION
Galantamine tablets: recommended starting dosage is 4 mg twice daily;
increase to initial maintenance
dosage of 8 mg twice daily after a minimum of 4 weeks. Based on
clinical benefit and tolerability,
dosage may be increased to 12 mg twice daily after a minimum of 4
weeks at 8 mg twice daily. (2.2)
Take with food; ensure adequate fluid intake during treatment (2.2)
Hepatic impairment: should not exceed 16 mg/day for moderate hepatic
impairment; do not use in
patients with severe hepatic impairment (2.3)
Renal impairment: should not exceed 16 mg/day for creatinine clearance
9 to 59 mL/min; do not use in
patients with creatinine clearance less than 9 mL/min (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets – 4 mg, 8 mg, 12 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to galantamine hydrobromide or any excipients
(4)
WARNINGS AND PRECAUTIONS
Serious skin reactions: discontinue at first appearance of skin rash
(5.1)
All patients should be considered at risk for adverse effects on
cardiac conduction, including
bradycardia and AV block, due to vagotonic effects on sinoatrial and
atrioventricular nodes (5.3)
Active or occult gastrointestinal bleeding: monitor, especially those
with an increased risk for developing
ulcers (5.4)
Cholinomimetics may cause bladder outflow obstruction (5.5)
Monitor for respiratory adverse events in patients with a history of
severe asthma or obstructive
pulmonary disease (5.7)
ADVERSE REACTIONS
The most common a