Galantamine (Galantamine)

Trade Name

Galantamine

Active Ingredient

Power

4 mg/1

Type / form

Tablets

Status

Manufacturer

West-Ward Pharmaceuticals Corp.

Storage and handling for Galantamine

GALANTAMINE HYDROBROMIDE Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Galantamine (Galantamine) which is also known as Galantamine and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 4 mg/1 per ml. Read more

Galantamine (Galantamine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • u00a0
  • 5.1
  • Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimeru2019s type.
  • Galantamine is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimeru2019s type. ()
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  • Galantamine tablets USP are available as 4 mg, 8 mg or 12 mg film coated tablets for oral administration.
  • u2022
  • 3
  • Galantamine is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.
  • Known hypersensitivity to galantamine or any excipients. ()
  • No data
  • Serious adverse reactions are discussed in more detail in the following sections of the labeling:
  • The most common adverse reactions (u22655%) were nausea, vomiting, diarrhea, dizziness, headache and decreased appetite. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or n
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  • 8.1
  • Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug.
  • As in any case of overdose, general supportive measures should be utilized. Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or fasciculations, some or all of the following signs of cholinergic crisis may develop: severe nausea, vomiting, gastrointestinal cramping, salivation, lacrimation, urination, defecation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.
  • Tertiary anticholinergics such as atropine may be used as an antidote for galantamineoverdosage. Intravenous atropine sulfate titrated to effect is recommended at an initial dose of 0.5 mg to 1 mg i.v. with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics. It is not known whether galantamine and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration). Dose-related signs of toxicity in animals included hypoactivity, tremors, clonic convulsions, salivation, lacrimation, chromodacryorrhea, mucoid feces, and dyspnea.
  • In one postmarketing report, one patient who had been taking 4 mg of galantamine daily for a week inadvertently ingested eight 4 mg tablets (32 mg total) on a single day. Subsequently, she developed bradycardia, QT prolongation, ventricular tachycardia and torsades de pointes accompanied by a brief loss of consciousness for which she required hospital treatment. Two additional cases of accidental ingestion of 32 mg (nausea, vomiting, and dry mouth; nausea, vomiting, and substernal chest pain) and one of 40 mg (vomiting), resulted in brief hospitalizations for observation with full recovery. One patient, who was prescribed 24 mg/day and had a history of hallucinations over the previous two years, mistakenly received 24 mg twice daily for 34 days and developed hallucinations requiring hospitalization. Another patient, who was prescribed 16 mg/day of oral solution, inadvertently ingested 160 mg (40 mL) and experienced sweating, vomiting, bradycardia, and near-syncope one hour later, which necessitated hospital treatment. His symptoms resolved within 24 hours.
  • Galantamine tablets contain galantamine hydrobromide, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4a,,8a)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6-benzofuro[3a,3,2-][2]benzazepin-6-ol hydrobromide. It has a molecular formula of CHNO u2022HBr and a molecular weight of 368.27. Galantamine hydrobromide USP is a white to off-white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:
  • Galantamine Tablets USP, are available for oral administration containing galantamine hydrobromide equivalent to 4 mg, 8 mg or 12 mg galantamine (base). Inactive ingredients include: colloidal silicon dioxide, crospovidone, lactose (anhydrous), magnesium stearate, microcrystalline cellulose and Opadry II (light green). Opadry II (light green) contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Red #40, hypromellose, macrogol, polydextrose, titanium dioxide and triacetin.
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  • Carcinogenesis
  • In a 24-month oral carcinogenicity study in rats, an increase in endometrial adenocarcinomas was observed at 10 mg/kg/day (4 times the MRHD of 24 mg/day on a mg/mbasis or 6 times on a plasma exposure [AUC] basis) and 30 mg/kg/day (12 times MRHD on a mg/mbasis or 19 times on an AUC basis). No increase in neoplastic changes was observed in females at 2.5 mg/kg/day (equivalent to the MRHD on a mg/m basis or 2 times on an AUC basis) or in males up to the highest dose tested of 30 mg/kg/day (12 times the MRHD on a mg/m and AUC basis).
  • Galantamine was not carcinogenic in a 6-month carcinogenicity study in transgenic (P 53-deficient) mice at oral doses up to 20 mg/kg/day, or in a 24-month carcinogenicity study in mice at oral doses up to 10 mg/kg/day (equivalent to the MRHD on a plasma AUC basis).
  • Mutagenesis
  • Galantamine was negative in a battery of (bacterial reverse mutation, mouse lymphoma , and chromosomal aberration in mammalian cells) and (mouse micronucleus) genotoxicity assays.
  • Impairment of Fertility
  • No impairment of fertility was seen in rats given up to 16 mg/kg/day (7 times the MRHD on a mg/m basis) for 14 days prior to mating in females and for 60 days prior to mating in males.
  • The effectiveness of galantamine as a treatment for Alzheimeru2019s disease is demonstrated by the results of 5 randomized, double-blind, placebo-controlled clinical investigations in patients with probable Alzheimeru2019s disease, 4 with the immediate-release tablet and 1 with the extended-release capsule [diagnosed by NINCDS-ADRDA criteria, with Mini-Mental State Examination scores that were u226510 and u226424]. Doses studied with the tablet formulation were 8 mg to 32 mg/day given as twice daily doses. In 3 of the 4 studies with the tablet, patients were started on a low dose of 8 mg, then titrated weekly by 8 mg/day to 24 mg or 32 mg as assigned. In the fourth study (USA 4-week Dose Escalation Fixed-Dose Study) dose escalation of 8 mg/day occurred over 4-week intervals. The mean age of patients participating in these 4 galantamine trials was 75 years with a range of 41 to 100. Approximately 62% of patients were women and 38% were men. The racial distribution was White 94%, Black 3% and other races 3%. Two other studies examined a three times daily dosing regimen; these also showed or suggested benefit but did not suggest an advantage over twice daily dosing.
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  • Serious Skin Reactions
  • Advise patients and caregivers to discontinue galantamine and seek immediate medical attention at the first appearance of skin rash.
  • General Dosing Guidance
  • Instruct caregivers about the recommended dosage and administration of galantamine. Galantamine tablets should be administered twice per day, preferably with the morning and evening meals. Dose escalation (dose increases) should follow a minimum of four weeks at prior dose. If therapy has been interrupted for more than three days, the patient should be restarted with the lowest dose and then re-titrated to an appropriate dosage .
  • Advise patients and caregivers to ensure adequate fluid intake during treatment .
  • Advise patients and caregivers that the most frequent adverse events associated with use of the drug can be minimized by following the recommended dosage and administration.
  • Distr. by: Eatontown, NJ 07724
  • 10004050/01
  • Revised April 2016
  • Galantamine Tablets USP 4 mg
  • 0054-0090-21
  • Rx only
  • Galantamine Tablets USP 8 mg
  • 0054-0091-21
  • Rx only
  • Galantamine Tablets USP 12 mg
  • 0054-0092-21
  • Rx only

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