Galantamine Hydrobromide

Galantamine hydrobromide tablets, USP is a reversible, competitive acetylcholinesterase inhibitor. It is known chemically as
(4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C17H21NO3 •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 hydrobromide tablets contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, pregelatinized starch, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and titanium dioxide. The 4 mg tablets contain PEG 400 and polysorbate 80. The 8 mg tablets contain D&C red #27, triacetin and FD&C blue #1. The 12 mg tablets contain triethyl citrate, FD&C yellow # 6 and iron oxide yellow.

Sources

Galantamine Hydrobromide Manufacturers

Yabao Pharmaceutical Co., Ltd. Beijing

Galantamine Hydrobromide | Yabao Pharmaceutical Co., Ltd. Beijing

2.1 Galantamine Hydrobromide Tablets, USP
The dosage of galantamine hydrobromide tablets shown to be effective in controlled clinical trials is 16-32 mg/day given as twice daily dosing. As the dosage of 32 mg/day is less well tolerated than lower dosages and does not provide increased effectiveness, the recommended dosage range is 16-24 mg/day given twice daily. The dosage of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dosage of 24 mg of galantamine might provide additional benefit for some patients.
The recommended starting dosage of galantamine hydrobromide tablets is 4 mg twice a day (8 mg/day). The dosage should be increased to the initial maintenance dosage of 8 mg twice a day (16 mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice a day (24 mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice a day (16 mg/day).
Dosage increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
Galantamine hydrobromide tablets should be administered twice a day, preferably with morning and evening meals.
Patients and caregivers should be advised to ensure adequate fluid intake during treatment.
If therapy has been interrupted for more than three days, the patient should be restarted at the lowest dosage and the dosage escalated to the current dose.
The abrupt withdrawal of galantamine hydrobromide tablets in those patients who had been receiving dosages in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same dosages of that drug. The beneficial effects of galantamine hydrobromide tablets are lost, however, when the drug is discontinued.
2.2 Dosage in Patients with Hepatic Impairment
In patients with moderate hepatic impairment (Child-Pugh score of 7-9), the dosage should generally not exceed 16 mg/day. The use of galantamine hydrobromide tablets in patients with severe hepatic impairment (Child-Pugh score of 10-15) is not recommended [see Clinical Pharmacology (12.3)].
2.3 Dosage in Patients with Renal Impairment
In patients with creatinine clearance of 9 to 59 mL/min, the dosage should generally not exceed 16 mg/day. In patients with creatinine clearance less than 9 mL/min, the use of galantamine hydrobromide tablets is not recommended [see Clinical Pharmacology (12.3)].

No Recall
Watson Laboratories, Inc.

Galantamine Hydrobromide | Watson Laboratories, Inc.

Galantamine Hydrobromide Extended-Release Capsules
The dosage of galantamine hydrobromide extended-release capsules shown to be effective in a controlled clinical trial is 16-24 mg/day.
The recommended starting dose of galantamine hydrobromide extended-release capsules is 8 mg/day. The dose 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. Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
Galantamine hydrobromide extended-release capsules should be administered once daily in the morning, preferably with food.
Patients currently being treated with galantamine hydrobromide immediate-release tablets can convert to galantamine hydrobromide extended-release capsules by taking their last dose of galantamine hydrobromide immediate-release tablets in the evening and starting galantamine hydrobromide extended-release capsules once daily treatment the next morning. Converting from galantamine hydrobromide immediate-release tablets to galantamine hydrobromide extended-release capsules should occur at the same total daily dose.
Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for several days or longer, the patient should be restarted at the lowest dose and the dose escalated to the current dose.
The abrupt withdrawal of galantamine hydrobromide extended-release capsules in those patients who had been receiving doses in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same doses of that drug. The beneficial effects of galantamine hydrobromide extended-release capsules are lost, however, when the drug is discontinued.
Doses in Special Populations
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment. In patients with moderately impaired hepatic function (Child-Pugh score of 7-9), the dose should generally not exceed 16 mg/day. The use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment (Child-Pugh score of 10-15) is not recommended.
For patients with moderate renal impairment the dose should generally not exceed 16 mg/day. In patients with severe renal impairment (creatinine clearance < 9 mL/min), the use of galantamine hydrobromide extendedrelease capsules are not recommended.

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Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Galantamine Hydrobromide | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

The dosage of galantamine hydrobromide extended-release capsules shown to be effective in a controlled clinical trial is 16-24mg/day.
The recommended starting dose of galantamine hydrobromide extended-release capsules is 8 mg/day. The dose 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. Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
The dosage of galantamine hydrobromide immediate-release tablets shown to be effective in controlled clinical trials is 16-32 mg/day given as twice daily dosing. As the dose of 32 mg/day is less well tolerated than lower doses and does not provide increased effectiveness, the recommended dose range is 16-24 mg/day given in a BID regimen. The dose of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dose of 24 mg of galantamine hydrobromide immediate-release tablets might provide additional benefit for some patients.
The recommended starting dose of galantamine hydrobromide immediate-release tablets and oral solution is 4 mg twice a day (8 mg/day). The dose should be increased to the initial maintenance dose of 8 mg twice a day (16 mg). Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
Galantamine hydrobromide extended-release capsules should be administered once daily in the morning, preferably with food.
Galantamine hydrobromide immediate-release tablets and oral solution should be administered twice a day, preferably with morning and evening meals.
Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for several days or longer, the patient should be restarted at the lowest dose and the dose escalated to the current dose.
Caregivers should be instructed in the correct procedure for administering galantamine hydrobromide oral solution. In addition, they should be informed of the existence of an Instruction Sheet (included with the product) describing how the solution is to be administered. They should be urged to read this sheet prior to administering galantamine hydrobromide oral solution. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist.
The abrupt withdrawal of galantamine hydrobromide in those patients who had been receiving doses in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same doses of that drug. The beneficial effects of galantamine hydrobromide are lost, however, when the drug is discontinued.
Doses in Special Populations
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment. In patients with moderately impaired hepatic function (Child-Pugh score of 7-9), the dose should generally not exceed 16 mg/day. The use of galantamine hydrobromide in patients with severe hepatic impairment (Child-Pugh score of 10-15) is not recommended.
For patients with moderate renal impairment the dose should generally not exceed 16 mg/day. In patients with severe renal impairment (creatinine clearance < 9 mL/min), the use of galantamine hydrobromide is not recommended.

No Recall
Barr Laboratories Inc.

Galantamine Hydrobromide | La Prairie Group Ag

Directions
• apply daily after cleansing and toning
• smooth over face & throat
• apply liberally 15 minutes before sun exposure
• children under 6 months of age: Ask a doctor
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer
and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum
SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
Water (Aqua), C12-15 Alkyl Ethylhexanoate, Glycerin, Dimethicone/Vinyl DimethiconeCrosspolymer, Polyglyceryl-3 Methylglucose Distearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Steareth-21, Behenyl Alcohol, Butylene Glycol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyaluronate, Caprooyl Tetrapeptide-3, Salicornia Herbacea Extract, Sodium PCA, Tocopheryl Acetate, Resveratrol, Acetyl Decapeptide-3, Trehalose, Urea, Larix Sibirica Wood Extract, Palmitoyl Tripeptide-8, Carnosine, Potato Starch Modified, Disodium EDTA, Myrothamnus Flabellifolia Leaf/Stem Extract, Kefiran, Sodium Hydroxide, Glyceryl Stearate, Chlorella Vulgaris Extract, Silica, Panthenol, Polyquaternium-51, Glycine Soja (Soybean) Oil, PEG-100 Stearate, Hydrogenated Lecithin, Allantoin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, C13-14 Isoparaffin, Dextran, Caprylic/Capric Triglyceride, Polysorbate 80, Sodium Oleate, Laureth-7, Cetyl Dimethicone, Caprylyl Glycol, Polyquaternium-67, Steareth-2, Polyacrylamide, Carbomer, Synthetic Wax, Alcohol, Fragrance (Parfum), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Geraniol, Citronellol, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Sorbic Acid, Chlorphenesin, Methylparaben, Benzoic Acid, Yellow 5 (CI 19140), Red 4 (CI 14700)

No Recall
Sun Pharma Global Fze

Galantamine Hydrobromide | Jubilant Cadista Pharmaceuticals, Inc.

Hypertension
Dosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as Losartan potassium and Hydrochlorothiazide Tablets.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
The side effects (see WARNINGS) of losartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
Replacement Therapy: The combination may be substituted for the titrated components.
Dose Titration by Clinical Effect: A patient whose blood pressure is not adequately controlled with losartan monotherapy (see above) or hydrochlorothiazide alone may be switched to Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 (losartan 50 mg/ hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 once daily or one tablet of Losartan potassium and Hydrochlorothiazide Tablets 100/25 (losartan 100 mg/ hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to Losartan potassium and Hydrochlorothiazide Tablets 100/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 once daily or one tablet of Losartan potassium and Hydrochlorothiazide Tablets 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 (losartan 50 mg/ hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 once daily or one tablet of Losartan potassium and Hydrochlorothiazide Tablets 100/25 (losartan 100 mg/ hydrochlorothiazide 25 mg) once daily.
The usual dose of Losartan potassium and Hydrochlorothiazide Tablet is one tablet of Losartan potassium and Hydrochlorothiazide 50/12.5 once daily. More than two tablets of Losartan potassium and Hydrochlorothiazide 50/12.5 once daily or more than one tablet of Losartan potassium and Hydrochlorothiazide 100/25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.
Use in Patients with Renal Impairment: The usual regimens of therapy with Losartan potassium and Hydrochlorothiazide Tablets may be followed as long as the patient's creatinine clearance is greater than 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Losartan potassium and Hydrochlorothiazide Tablet is not recommended.
Patients with Hepatic Impairment: Losartan potassium and Hydrochlorothiazide Tablets is not recommended for titration in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given.
Severe Hypertension
The starting dose of Losartan potassium and Hydrochlorothiazide Tablets for initial treatment of severe hypertension is one tablet of Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of Losartan potassium-Hydrochlorothiazide Tablets 100/25 once daily. The maximum dose is one tablet of Losartan potassium and Hydrochlorothiazide Tablets 100/25 once daily. Losartan potassium and Hydrochlorothiazide Tablet is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, (see WARNINGS, Hypotension — Volume-Depleted Patients).
Hypertensive Patients with Left Ventricular Hypertrophy
Treatment should be initiated with Losartan potassium 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or Losartan potassium and Hydrochlorothiazide Tablets 50/12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, Losartan potassium 100 mg and hydrochlorothiazide 12.5 mg or Losartan potassium and Hydrochlorothiazide Tablets 100/12.5 may be substituted, followed by Losartan potassium 100 mg and hydrochlorothiazide 25 mg or Losartan potassium and Hydrochlorothiazide Tablets 100/25. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).
Losartan potassium and Hydrochlorothiazide Tablets may be administered with other antihypertensive agents.
Losartan potassium and Hydrochlorothiazide Tablets may be administered with or without food.

No Recall
Mylan Pharmaceuticals Inc.

Galantamine Hydrobromide | Mylan Pharmaceuticals Inc.

2.1 Galantamine Hydrobromide Extended-release Capsules
Galantamine hydrobromide extended-release capsules should be administered once daily in the morning, preferably with food.
The recommended starting dosage of galantamine hydrobromide extended-release capsules 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 hydrobromide extended-release capsules shown to be effective in a controlled clinical trial is 16 to 24 mg/day.
Patients currently being treated with galantamine hydrobromide tablets or oral solution can convert to galantamine hydrobromide extended-release capsules by taking their last dose of galantamine hydrobromide tablets or oral solution in the evening and starting galantamine hydrobromide extended-release capsules once daily treatment the next morning. Converting from galantamine hydrobromide tablets to galantamine hydrobromide extended-release capsules should occur at the same total daily dosage.
Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for more than three days, the patient should be restarted at the lowest dosage and the dosage escalated to the current dose.
The abrupt withdrawal of galantamine hydrobromide extended-release capsules and galantamine hydrobromide tablets in those patients who had been receiving dosages in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same dosages of that drug. The beneficial effects of galantamine hydrobromide extended-release capsules and galantamine hydrobromide tablets are lost, however, when the drug is discontinued.
2.3 Dosage in Patients with Hepatic Impairment
In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9), the dosage should generally not exceed 16 mg/day. The use of galantamine tablets in patients with severe hepatic impairment (Child-Pugh score of 10 to 15) is not recommended [see Clinical Pharmacology (12.3)].
2.4 Dosage in Patients with Renal Impairment
In patients with creatinine clearance of 9 to 59 mL/min, the dosage should generally not exceed 16 mg/day. In patients with creatinine clearance < 9 mL/min, the use of galantamine tablets is not recommended [see Clinical Pharmacology (12.3)].

No Recall
Patriot Pharmaceuticals, Llc

Galantamine Hydrobromide | Patriot Pharmaceuticals, Llc

2.1 GALANTAMINE HBr ER Extended-Release Capsules
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.
2.2 GALANTAMINE HBr Immediate-Release Tablets
The dosage of GALANTAMINE HBr tablets shown to be effective in controlled clinical trials is 16–32 mg/day given as twice daily dosing. As the dosage of 32 mg/day is less well tolerated than lower dosages and does not provide increased effectiveness, the recommended dosage range is 16–24 mg/day given twice daily. The dosage of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dosage of 24 mg of GALANTAMINE HBr might provide additional benefit for some patients.
The recommended starting dosage of GALANTAMINE HBr tablets is 4 mg twice a day (8 mg/day). The dosage should be increased to the initial maintenance dosage of 8 mg twice a day (16 mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice a day (24 mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice a day (16 mg/day).
Dosage increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
GALANTAMINE HBr tablets should be administered twice a day, preferably with morning and evening meals.
Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for more than three days, the patient should be restarted at the lowest dosage and the dosage escalated to the current dose.
The abrupt withdrawal of GALANTAMINE HBr ER and GALANTAMINE HBr in those patients who had been receiving dosages in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same dosages of that drug. The beneficial effects of GALANTAMINE HBr ER and GALANTAMINE HBr are lost, however, when the drug is discontinued.
2.3 Dosage in Patients with Hepatic Impairment
In patients with moderate hepatic impairment (Child-Pugh score of 7–9), the dosage should generally not exceed 16 mg/day. The use of GALANTAMINE HBr ER and GALANTAMINE HBr in patients with severe hepatic impairment (Child-Pugh score of 10–15) is not recommended [see Clinical Pharmacology (12.3)].
2.4 Dosage in Patients with Renal Impairment
In patients with creatinine clearance of 9 to 59 mL/min, the dosage should generally not exceed 16 mg/day. In patients with creatinine clearance less than 9 mL/min, the use of GALANTAMINE HBr ER and GALANTAMINE HBr is not recommended [see Clinical Pharmacology (12.3)].

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