Myungin Galantamine Extended Release Capsule 16 mg (Galantamine Hydrobromide)

Adult dose

Administer once daily in the morning. It is preferable to administer immediately after breakfast. Swallow this medicine whole with an appropriate amount of water; do not chew or crush it. Maintain adequate fluid intake during treatment with this medicine. Initial dose: 8mg once daily is recommended for the first 4 weeks. Maintenance dose: - After administration of 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 daily. - For patients who do not tolerate 24mg daily well or whose response does not improve, consider reducing the dose to 16mg daily. - This medicine may be continued for as long as the patient benefits from treatment. Regularly assess the clinical benefit of this medicine, and consider discontinuing treatment if it is ineffective. - No rebound phenomenon occurs after discontinuation of treatment (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, preferably in the morning. Thereafter, administer 8mg once daily for at least 4 weeks. Do not exceed 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 pediatric patients is not recommended.

This medication should not be administered to patients with hypersensitivity to its components or those with severe liver or kidney dysfunction. When taking this medication, care is needed as abnormal reactions such as nausea, vomiting, diarrhea, dizziness, headache, and fatigue may occur. In particular, nausea and vomiting frequently occur during dose adjustment and usually subside within a week. This medication is used for patients with mild to moderate Alzheimer's type dementia, and its efficacy has not been proven for other types of dementia or memory disorders. If skin rashes or serious skin reactions occur, immediate discontinuation of the medication and consultation with a physician are required. Weight loss may occur during treatment, so it's important to regularly monitor the patient's weight. Patients with heart-related diseases, slow heart rates, heart conduction disorders, or those taking medications that lower heart rates should be cautious while taking this medication. Patients with a history of gastrointestinal ulcers or those recovering from gastrointestinal surgery should be closely monitored for symptoms while taking this medication, and in some cases, administration should be avoided. This medication may induce seizures, so patients with neurological conditions should be careful, as well as patients with severe asthma or chronic obstructive pulmonary disease. Patients recovering from bladder surgery or those with urinary disorders are not recommended to take this medication. This medication may interact with certain muscle relaxants during anesthesia to enhance muscle relaxation effects; thus, it's important to inform medical personnel if surgery is planned. Patients with lactose intolerance should not take preparations containing lactose. Pregnant women should be administered with caution, considering the risks and benefits to the fetus, and breastfeeding women are advised to avoid taking this medication. This medication may cause dizziness and drowsiness in the first week of use, so caution is required when driving or operating machinery. In the case of overdose, symptoms of poisoning such as nausea, vomiting, bradycardia, hypotension, and seizures may occur, necessitating an immediate visit to a medical institution; cholinergic treatment may be administered if necessary. This medication should be kept out of reach of children and should not be transferred to another container as it may be detrimental to quality maintenance. This medication may cause interactions if taken with other cholinergic medications, so co-administration should be avoided, and dosage adjustment may be needed if taken with drugs that inhibit specific liver metabolic enzymes.

Reduced appetite, depression, dizziness, headache, tremors, fainting, somnolence, drowsiness, bradycardia, nausea, vomiting, diarrhea, abdominal pain, upper abdominal pain, indigestion, abdominal discomfort, muscle cramps, fatigue, weakness, lethargy, weight loss, falls, lacerations, dehydration, taste disturbances, hypersomnia, sensory disturbances, blurred vision, I degree atrioventricular block, palpitations, tachycardia, ventricular premature contractions, flushing, hypotension, nausea, hyperhidrosis, muscle weakness, hypersensitivity, hallucinations, visual hallucinations, auditory hallucinations, seizures, tinnitus, complete atrioventricular block, hypertension, hepatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, increased liver enzymes, rash, pruritus, extrapyramidal syndrome, Parkinson's syndrome, worsening of Parkinson's syndrome, hand paralysis, bradykinesia, Pisa syndrome, delirium, sweating, edema, constipation, thirst, gastritis, belching, jaundice, elevated γ-GT, elevated ALT/AST, exacerbation of chronic kidney failure, urinary incontinence, vertigo, sweating, gastrointestinal cramps, drooling, tearing, defecation, urination, exhaustion, bronchial hypersecretion, bronchospasm, torsades de pointes, ventricular tachycardia, brief loss of consciousness

This medication should be stored in a tightly sealed container to avoid contact with air and is best stored at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the efficacy of the medication.

Appearance

Opaque pink hard capsule containing white to off-white extended release pellets.

Package unit

100 capsules/box [(10 capsules/PTP x 10)], 30 capsules/bottle, 100 capsules/bottle