galantamine hydrobromide

(redirected from Reminyl XL)

galantamine hydrobromide

Razadyne, Razadyne ER, Reminyl (UK), Reminyl XL (CA) (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

Capsules (extended-release): 8 mg, 16 mg, 24 mg

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. Or initially, 8 mg P.O. daily (Razadyne ER). If patient tolerates dosage after at least 4 weeks, increase to 16 mg P.O. daily. Further increase to 24 mg P.O. daily should be attempted after minimum of 4 weeks at 16 mg/day.

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.

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-drugAnticholinergics: 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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References in periodicals archive ?
Other royalties are primarily in respect of REMINYL and REMINYL XL (known as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide (excluding the UK and the Republic of Ireland) by Janssen Pharmaceutical N.
Litigation proceedings relating to 3TC, COMBIVIR, EPIVIR, EPZICOM, RAZADYNE, RAZADYNE ER, REMINYL, REMINYL XL and ZEFFIX are ongoing.
affected sales of REMINYL and of REMINYL XL in England and Wales.
and REMINYL XL, together with other drugs in the same class, be reimbursed on
REMINYL XL (trademark of Johnson & Johnson, excluding UK and Republic of Ireland)
REMINYL XL (galantamine hydrobromide) (trademark of Johnson & Johnson, excluding UK
Shire plc "Shire is encouraged that the new NICE appraisal consultation document for AD[1] acknowledges that the acetylcholinesterase inhibitor class of drugs are both clinically effective and cost-effective for the treatment of moderate AD and that they will remain available on the NHS," says John Freeman, Managing Director of Shire Pharmaceuticals' UK operation, which markets Reminyl(R) and Reminyl XL (galantamine)[2] in the UK.
Other royalties are primarily in respect of REMINYL and REMINYL XL (now marketed as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide by Janssen, with the exception of the United Kingdom and the Republic of Ireland where Shire acquired the exclusive marketing rights from May 2004.
With Reminyl and Reminyl XL having been proven as clinically effective for mild and moderate AD, and licensed for these conditions, it is hard to reconcile this recommendation from NICE with the recently issued Scottish Intercollegiate Guidelines Network (SIGN's) report.
The recommendation potentially affected sales of REMINYL and of REMINYL XL in England and Wales.
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) "Shire is encouraged that the new NICE appraisal consultation document for AD[1] acknowledges that the acetylcholinesterase inhibitor class of drugs are both clinically effective and cost-effective for the treatment of moderate AD and that they will remain available on the NHS," says John Freeman, Managing Director of Shire Pharmaceuticals' UK operation, which markets Reminyl(R) and Reminyl XL (galantamine)[2] in the UK.