GALANTAMINE capsule, extended release

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Aurobindo Pharma Limited

INN (Isem Internazzjonali):

GALANTAMINE HYDROBROMIDE

Kompożizzjoni:

GALANTAMINE 8 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Galantamine extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine extended-release capsules 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 extended-release capsules or galantamine tablets  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 extended-release capsules on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine extended-release capsules and any potential adverse effects on the breastfed infant from galantamine extended-release capsules 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 extended-release capsules  and galantamine tablets 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 extended-release capsules in patients with severe hepatic impairment is not recommended [see Dosage and Administration (2.2) 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 extended-release capsules in patients with creatinine clearance less than 9 mL/min is not recommended [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] .

Sommarju tal-prodott:

How Supplied Galantamine extended-release capsules USP are supplied as follows: Galantamine Extended-Release Capsules USP, 8 mg are white opaque size “1” hard gelatin capsule with inscription “A” over the cap & “8” over the body containing white to off-white, round, biconvex, single mini tablet.                             Bottles of 30                                         NDC 65862-744-30                             Bottles of 90                                         NDC 65862-744-90                             Bottles of 100                                       NDC 65862-744-01                             Bottles of 500                                       NDC 65862-744-05                             Bottles of 1,000                                    NDC 65862-744-99 Galantamine Extended-Release Capsules USP, 16 mg are pink opaque size “1” hard gelatin capsule with inscription “A” over the cap & “16” over the body containing white to off-white, round, biconvex, two mini tablets.                             Bottles of 30                                         NDC 65862-745-30                             Bottles of 90                                         NDC 65862-745-90                             Bottles of 100                                       NDC 65862-745-01                             Bottles of 500                                       NDC 65862-745-05                             Bottles of 1,000                                    NDC 65862-745-99 Galantamine Extended-Release Capsules USP, 24 mg are caramel opaque size “1” hard gelatin capsule with inscription “A” over the cap & “24” over the body containing white to off-white, round, biconvex, three mini tablets.                             Bottles of 30                                         NDC 65862-746-30                             Bottles of 90                                         NDC 65862-746-90                             Bottles of 100                                       NDC 65862-746-01                             Bottles of 500                                       NDC 65862-746-05                             Bottles of 1,000                                    NDC 65862-746-99 Storage and Handling Galantamine extended-release capsules USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

GALANTAMINE - GALANTAMINE CAPSULE, EXTENDED RELEASE
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
GALANTAMINE EXTENDED-RELEASE CAPSULES.
GALANTAMINE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Galantamine extended-release capsules are a cholinesterase inhibitor
indicated for the treatment of mild
to moderate dementia of the Alzheimer’s type (1)
DOSAGE AND ADMINISTRATION
Recommended starting dosage is 8 mg/day in morning; increase to
initial maintenance dose of 16
mg/day after a minimum of 4 weeks. Based on clinical benefit and
tolerability, dosage may be
increased to 24 mg/day after a minimum of 4 weeks at 16 mg/day. (2.1)
Take with food; ensure adequate fluid intake during treatment (2.1)
Hepatic impairment: should not exceed 16 mg/day for moderate hepatic
impairment; do not use in
patients with severe hepatic impairment (2.2)
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. (2.3)
Conversion from galantamine tablets to galantamine extended-release
capsules should occur at the
same daily dosage with the last dose of galantamine tablets taken in
evening and starting galantamine
extended-release capsules once daily treatment the next morning. (2.5)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 8 mg, 16 mg, 24 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