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galantamine hydrobromide

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galantamine hydrobromide

Razadyne, Razadyne ER, Reminyl (UK)

Pharmacologic class: Cholinesterase inhibitor

Therapeutic class: Anti-Alzheimer's agent

Pregnancy risk category B

Action

Unclear. May reversibly inhibit acetylcholinesterase, increasing concentration of acetylcholine (necessary for nerve impulse transmission) in brain synapses.

Availability

Oral solution: 4 mg/ml

Tablets: 4 mg, 8 mg, 12 mg

Indications and dosages

Mild to moderate dementia of Alzheimer's disease

Adults: Initially, 4 mg P.O. b.i.d. If patient tolerates dosage well after at least 4 weeks of therapy, increase to 8 mg P.O. b.i.d. May increase to 12 mg P.O. b.i.d. after at least 4 weeks at previous dosage. Recommended range is 16 to 24 mg daily in two divided doses.

Dosage adjustment

• Moderate hepatic or renal impairment

Off-label uses

• Vascular dementia

Contraindications

• Hypersensitivity to drug
• Severe hepatic or renal impairment
• Pregnancy or breastfeeding
• Children

Precautions

Use cautiously in:
• asthma, chronic obstructive pulmonary disease, GI bleeding, moderate hepatic or renal impairment, Parkinson's disease, seizures.

Administration

• Before giving, make sure patient is well hydrated, to minimize GI upset.
• Give with morning and evening meals.
• Give with antiemetics as needed.
• Use pipette to add oral solution to beverage; have patient drink it right away.

RouteOnsetPeakDuration
P.O.Unknown1 hrUnknown

Adverse reactions

CNS: depression, dizziness, headache, tremor, insomnia, drowsiness, fatigue, syncope

CV: bradycardia

EENT: rhinitis

GI: nausea, vomiting, diarrhea, abdominal pain, dyspepsia, anorexia

GU: urinary tract infection, hematuria

Hematologic: anemia

Other: weight loss

Interactions

Drug-drug Anticholinergics: antagonism of anticholinergic activity

Cholinergics: synergistic effects

Cimetidine, erythromycin, ketoconazole, paroxetine: increased galantamine bioavailability

Patient monitoring

• Assess fluid intake and output to ensure adequate hydration, which helps reduce GI upset.
• Monitor cognitive status.
• Evaluate patient for cardiac conduction abnormalities. Assess pulse regularly for bradycardia.
• Observe for bleeding tendencies.
Assess for depression and suicidal ideation.

Patient teaching

• Instruct caregiver in proper technique for using oral pipette.
• Teach caregiver how to measure patient's pulse. Tell him to report slow pulse right away.
• Recommend frequent, small servings of healthy food and adequate fluids to minimize GI upset.
Tell patient or caregiver to watch for and report signs and symptoms of depression.
• Advise patient or caregiver to establish effective bedtime routine.
• Caution caregiver to prevent patient from performing hazardous activities until adverse reactions are known.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.



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Canadian health authorities have issued a public advisory concerning the safety of galantamine hydrobromide as a treatment for mild cognitive impairment--an off-label use.
FDA stated the firm could not market it GalantaMind product as a dietary supplement because it did not consider the product's active ingredient, Galantamine hydrobromide extract 8 mg, to be eligible for the designation as it had been the subject of an approved NDA by Janssen Pharmaceutica Products.
 
 
 
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