Medication info
Tamsulosin Hydrochloride Extended-Release Tablets 24mg (Galantamine Hydrobromide)

Tamsulosin Hydrochloride Extended-Release Tablets 24mg (Galantamine Hydrobromide)

Prescription medicationTabletOral
Ingredient · strength
Galantamine Hydrobromide›30.76mg / 1 tablet
Manufacturer / importer
Hyundai Pharmaceutical Co., Ltd.
Appearance
Light brown round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200710849 · Approved 2007.09.27 · Insurance code 642001120

Summary

Main use
Treatment of symptoms of mild to moderate Alzheimer's disease dementia
Who takes it
Adults · Children
Adult dose
Administer once daily in the morning. Administration immediately after breakfast is preferred. Swallow this medicine whole with an adequate amount of water; do not chew or crush it. Maintain adequate fluid intake while taking this medicine. Initial dose: A dose of 8mg once daily is recommended for the first 4 weeks. Maintenance dose: - After the initial dose, administer 16mg once daily for at least 4 weeks. - Thereafter, based on assessment of clinical benefit and tolerability, the dose may be increased to a maximum of 24mg once daily. - For patients who do not tolerate 24mg once daily well or who show no improvement in response, consider reducing the dose to 16mg once daily. - This medicine may be continued as long as the patient derives benefit. Assess its clinical benefit regularly, and consider discontinuing treatment if it is ineffective. - No rebound effect occurs after treatment interruption (e.g., in preparation for surgery). Galantamine blood concentrations may increase in patients with moderate to severe renal or hepatic impairment. Based on pharmacokinetic modeling, patients with moderate hepatic impairment should receive 8mg every other day for at least 1 week; morning administration is preferred. Then administer 8mg once daily for at least 4 weeks. Do not administer more than 16mg daily. This medicine is contraindicated in patients with severe hepatic impairment (Child-Pugh score >9). No dose adjustment is necessary in patients with mild hepatic impairment. No dose adjustment is necessary in patients with a creatinine clearance of 9mL/min or higher. This medicine is contraindicated in patients with severe renal impairment (creatinine clearance < 9mL/min). Consider reducing the dose of this medicine in patients receiving CYP 2D6 or CYP 3A4 inhibitors (e.g., ketoconazole).
Child dose
Use in children is not recommended.

Ingredients

Manufacturer
Hyundai Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of mild to moderate Alzheimer's disease dementia

  • Symptoms of mild Alzheimer's dementia
  • moderate dementia symptoms
View approved original text

This medication is used to treat symptoms of mild to moderate Alzheimer's type dementia. It helps improve memory impairment and cognitive decline due to dementia, enhancing the quality of life for daily activities. As a result, it aids patients in living more independently. It is also expected to slow the progression of symptoms. It is used with the goal of improving overall cognitive function and quality of life.

How to take

Adult dose

Administer once daily in the morning. Administration immediately after breakfast is preferred. Swallow this medicine whole with an adequate amount of water; do not chew or crush it. Maintain adequate fluid intake while taking this medicine. Initial dose: A dose of 8mg once daily is recommended for the first 4 weeks. Maintenance dose: - After the initial dose, administer 16mg once daily for at least 4 weeks. - Thereafter, based on assessment of clinical benefit and tolerability, the dose may be increased to a maximum of 24mg once daily. - For patients who do not tolerate 24mg once daily well or who show no improvement in response, consider reducing the dose to 16mg once daily. - This medicine may be continued as long as the patient derives benefit. Assess its clinical benefit regularly, and consider discontinuing treatment if it is ineffective. - No rebound effect occurs after treatment interruption (e.g., in preparation for surgery). Galantamine blood concentrations may increase in patients with moderate to severe renal or hepatic impairment. Based on pharmacokinetic modeling, patients with moderate hepatic impairment should receive 8mg every other day for at least 1 week; morning administration is preferred. Then administer 8mg once daily for at least 4 weeks. Do not administer more than 16mg daily. This medicine is contraindicated in patients with severe hepatic impairment (Child-Pugh score >9). No dose adjustment is necessary in patients with mild hepatic impairment. No dose adjustment is necessary in patients with a creatinine clearance of 9mL/min or higher. This medicine is contraindicated in patients with severe renal impairment (creatinine clearance < 9mL/min). Consider reducing the dose of this medicine in patients receiving CYP 2D6 or CYP 3A4 inhibitors (e.g., ketoconazole).

Child dose

Use in children is not recommended.

Precautions

This medication should not be used in patients who are hypersensitive to its ingredients or in patients with severe liver or kidney impairment. It contains lactose; therefore, it should not be given to patients with genetic conditions such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. It contains coloring agent Yellow No. 5, and should be used cautiously in patients with allergy or hypersensitivity to this component. Various adverse reactions may occur, including nausea, vomiting, dizziness, headache, bradycardia, diarrhea, abdominal pain, fatigue, etc., especially during the initial treatment phase where nausea and vomiting may commonly occur, requiring close attention. Serious skin reactions may occur. If any skin rash or unusual symptoms appear, discontinue use immediately and consult a physician. Weight loss may happen, thus patients should be closely monitored for weight changes. Patients with heart disease or slow heart rates, patients with heart conduction disorders, and those on digoxin or beta-blockers should be cautious of heart-related adverse reactions such as bradycardia. Patients with a history of gastrointestinal ulcers or risk factors should be carefully monitored for gastrointestinal symptoms, and it is not recommended for patients with gastrointestinal obstruction or recovering from surgery. Patients with a history of seizures, severe asthma, or obstructive lung disease should exercise caution when administering this medication. It is advisable not to use in patients recovering from bladder surgery or with urinary disorders. During anesthesia, this medication can enhance the effects of muscle relaxants, so it is essential to inform the physician of this during the anesthesia planning. During pregnancy, it should be used cautiously considering the risks to the fetus and the benefits of the drug, and it is recommended not to be administered to nursing mothers. Dizziness and drowsiness may occur when driving or operating machinery, so caution is advised. In the case of overdose, serious symptoms such as nausea, vomiting, bradycardia, seizures may occur, requiring immediate medical attention and appropriate treatment, potentially using antidotes like atropine if necessary. It should not be used in conjunction with other cholinergic medications, and there may be interactions with some drugs requiring dose adjustments. Keep out of reach of children, and do not transfer to other containers for safety.

Side effects

Decreased appetite, depression, dizziness, headache, tremor, fainting, somnolence, drowsiness, bradycardia, nausea, vomiting, diarrhea, abdominal pain, upper abdominal pain, indigestion, abdominal discomfort, muscle spasm, fatigue, asthenia, lethargy, weight loss, falls, laceration, dehydration, dysgeusia, hypersomnia, paresthesia, blurred vision, I-degree heart block, palpitations, sinus bradycardia, ventricular premature contractions, flushing, hypotension, nausea, sweating, muscle weakness, hypersensitivity, hallucinations, visual hallucinations, auditory hallucinations, convulsions, tinnitus, complete heart block, hypertension, hepatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, elevated liver enzymes, dizziness, loss of appetite, rash, pruritus, extrapyramidal syndrome, Parkinson's syndrome, worsening of Parkinson's syndrome, hand paralysis, bradykinesia, Pierre Robin syndrome, delirium, sweating, edema, constipation, thirst, gastritis, belching, jaundice, elevated γ-GT, elevated ALT/AST, exacerbation of chronic kidney failure, urinary incontinence, drowsiness, severe nausea, gastrointestinal cramping, drooling, tearing, defecation, urination, bradycardia, hypotension, collapse, convulsions, bronchial hypersecretion, bronchospasm, muscle weakness, Torsades de Pointes, QT prolongation, ventricular tachycardia, brief loss of consciousness

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Light brown round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.