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galantamine hydrobromide

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Overview

What is galantamine hydrobromide?

GALANTAMINE HBr ER capsules and GALANTAMINE HBr tablets contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4a,6,8a)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6-benzofuro[3a,3,2-][2]benzazepin-6-ol hydrobromide. It has an empirical formula of CHNO ∙HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:

GALANTAMINE HBr ER extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, respectively. Inactive ingredients include diethyl phthalate, ethylcellulose, gelatin, hypromellose, polyethylene glycol, sugar spheres (sucrose and starch), and titanium dioxide. The 16 mg capsule also contains red ferric oxide. The 24 mg capsule also contains red ferric oxide and yellow ferric oxide.

GALANTAMINE HBr tablets contain 4 mg, 8 mg, and 12 mg galantamine as 5.126 mg, 10.253 mg, and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, talc, and titanium dioxide. The 4 mg tablets contain yellow ferric oxide. The 8 mg tablets contain red ferric oxide. The 12 mg tablets contain red ferric oxide and FD&C yellow #6 aluminum lake.



What does galantamine hydrobromide look like?



What are the available doses of galantamine hydrobromide?

GALANTAMINE HBr ER extended-release capsules contain white to off-white pellets and are available in the following strengths:

8 mg white opaque, size 4 hard gelatin capsule with the inscription "GAL 8"

16 mg pink opaque, size 2 hard gelatin capsule with the inscription "GAL 16"

24 mg caramel opaque, size 1 hard gelatin capsule with the inscription "GAL 24"

GALANTAMINE HBr tablets are available in the following strengths:

4 mg circular biconvex, off-white tablet imprinted with "JANSSEN" on one side and "G 4" on the other side

8 mg circular biconvex, pink tablet imprinted with "JANSSEN" on one side and "G 8" on the other side

12 mg circular biconvex, orange-brown tablet imprinted with "JANSSEN" on one side and "G 12" on the other side

What should I talk to my health care provider before I take galantamine hydrobromide?

Pregnancy: Based on animal data may cause fetal harm. ()

How should I use galantamine hydrobromide?

GALANTAMINE HBr ER and GALANTAMINE HBr are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

GALANTAMINE HBr ER extended-release capsules should be administered once daily in the morning, preferably with food.

The recommended starting dosage of GALANTAMINE HBr ER is 8 mg/day. The dosage should be increased to the initial maintenance dose of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day should be attempted after a minimum of 4 weeks at 16 mg/day. Dosage increases should be based upon assessment of clinical benefit and tolerability of the previous dose.

The dosage of GALANTAMINE HBr ER shown to be effective in a controlled clinical trial is 16–24 mg/day.

Patients currently being treated with GALANTAMINE HBr tablets can convert to GALANTAMINE HBr ER (extended-release capsules) by taking their last dose of GALANTAMINE HBr tablets in the evening and starting GALANTAMINE HBr ER once daily treatment the next morning. Converting from GALANTAMINE HBr tablets to GALANTAMINE HBr ER should occur at the same total daily dosage.


What interacts with galantamine hydrobromide?

Sorry No Records found


What are the warnings of galantamine hydrobromide?

Sorry No Records found


What are the precautions of galantamine hydrobromide?

Sorry No Records found


What are the side effects of galantamine hydrobromide?

Sorry No records found


What should I look out for while using galantamine hydrobromide?

GALANTAMINE HBr ER and GALANTAMINE HBr are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.


What might happen if I take too much galantamine hydrobromide?

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 GALANTAMINE HBr ER and GALANTAMINE HBr (galantamine hydrobromide) overdosage. Intravenous atropine sulfate titrated to effect is recommended at an initial dose of 0.5 to 1.0 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.


How should I store and handle galantamine hydrobromide?

GALANTAMINE HBr ER extended-release capsules should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].GALANTAMINE HBr tablets should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].Keep out of reach of children.GALANTAMINE HBr ER extended-release capsules should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].GALANTAMINE HBr tablets should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].Keep out of reach of children.GALANTAMINE HBr ER extended-release capsules should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].GALANTAMINE HBr tablets should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. 25 mcg - Round, white to off-white color tablets debossed “Σ 19” on one side and bisected on the other side. They are available in bottles of 100’s (NDC 42794-019-02) and 1000’s (NDC 42794-019-06).NDC single dose pack with 1 tablet as Store between 15° and 30°C (59° and 86°F).Manufactured by:Sigmapharm Laboratories, LLCBensalem, PA 19020OS020-02 Rev. 0211Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. 25 mcg - Round, white to off-white color tablets debossed “Σ 19” on one side and bisected on the other side. They are available in bottles of 100’s (NDC 42794-019-02) and 1000’s (NDC 42794-019-06).NDC single dose pack with 1 tablet as Store between 15° and 30°C (59° and 86°F).Manufactured by:Sigmapharm Laboratories, LLCBensalem, PA 19020OS020-02 Rev. 0211Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. 25 mcg - Round, white to off-white color tablets debossed “Σ 19” on one side and bisected on the other side. They are available in bottles of 100’s (NDC 42794-019-02) and 1000’s (NDC 42794-019-06).NDC single dose pack with 1 tablet as Store between 15° and 30°C (59° and 86°F).Manufactured by:Sigmapharm Laboratories, LLCBensalem, PA 19020OS020-02 Rev. 0211Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. 25 mcg - Round, white to off-white color tablets debossed “Σ 19” on one side and bisected on the other side. They are available in bottles of 100’s (NDC 42794-019-02) and 1000’s (NDC 42794-019-06).NDC single dose pack with 1 tablet as Store between 15° and 30°C (59° and 86°F).Manufactured by:Sigmapharm Laboratories, LLCBensalem, PA 19020OS020-02 Rev. 0211Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. 25 mcg - Round, white to off-white color tablets debossed “Σ 19” on one side and bisected on the other side. They are available in bottles of 100’s (NDC 42794-019-02) and 1000’s (NDC 42794-019-06).NDC single dose pack with 1 tablet as Store between 15° and 30°C (59° and 86°F).Manufactured by:Sigmapharm Laboratories, LLCBensalem, PA 19020OS020-02 Rev. 0211Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. 25 mcg - Round, white to off-white color tablets debossed “Σ 19” on one side and bisected on the other side. They are available in bottles of 100’s (NDC 42794-019-02) and 1000’s (NDC 42794-019-06).NDC single dose pack with 1 tablet as Store between 15° and 30°C (59° and 86°F).Manufactured by:Sigmapharm Laboratories, LLCBensalem, PA 19020OS020-02 Rev. 0211Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. 25 mcg - Round, white to off-white color tablets debossed “Σ 19” on one side and bisected on the other side. They are available in bottles of 100’s (NDC 42794-019-02) and 1000’s (NDC 42794-019-06).NDC single dose pack with 1 tablet as Store between 15° and 30°C (59° and 86°F).Manufactured by:Sigmapharm Laboratories, LLCBensalem, PA 19020OS020-02 Rev. 0211Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. 25 mcg - Round, white to off-white color tablets debossed “Σ 19” on one side and bisected on the other side. They are available in bottles of 100’s (NDC 42794-019-02) and 1000’s (NDC 42794-019-06).NDC single dose pack with 1 tablet as Store between 15° and 30°C (59° and 86°F).Manufactured by:Sigmapharm Laboratories, LLCBensalem, PA 19020OS020-02 Rev. 0211


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Although the etiology of cognitive impairment in Alzheimer's disease (AD) is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimer's disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimer's disease).

Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase. While the precise mechanism of galantamine's action is unknown, it is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. If this mechanism is correct, galantamine's effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that galantamine alters the course of the underlying dementing process.

Non-Clinical Toxicology
GALANTAMINE HBr ER and GALANTAMINE HBr are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.

Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.

Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving GALANTAMINE HBr ER and GALANTAMINE HBr. Inform patients and caregivers that the use of GALANTAMINE HBr ER or GALANTAMINE HBr should be discontinued at the first appearance of a skin rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed and alternative therapy should be considered.

Serious adverse reactions are discussed in more detail in the following sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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