Zeldox Capsule 60 mg (Ziprasidone Hydrochloride Monohydrate)

Adult dose

Take this medicine with food. Swallow the dosage form whole; do not chew, crush, or open the capsule. 1. Schizophrenia The recommended dosage regimen for acute treatment is 40 mg per dose twice daily with food. The daily dose may then be adjusted, based on the individual's clinical condition, up to a maximum of 80 mg per dose twice daily. If dose adjustment is needed based on signs of illness, doses should generally be adjusted at intervals of at least 2 days. The maximum recommended dose (80 mg twice daily) may be reached as early as the third day of treatment. For maintenance therapy, patients should take the minimum effective dose; 20 mg per dose twice daily is often sufficient. 2. Treatment of bipolar I disorder - Acute treatment of manic or mixed episodes associated with bipolar I disorder Initial treatment: The initial daily dose is 40 mg per dose twice daily with food. The dose per administration is then increased to 60 mg or 80 mg on day 2, taken twice daily; thereafter, adjust the dose per administration within the range of 40 ~ 80 mg twice daily according to tolerability and efficacy. In clinical trials using flexible dosing, the mean daily dose was approximately 120 mg. Maintenance treatment: There are no data from controlled clinical trials to guide physicians in long-term treatment of patients whose symptoms improved during acute treatment of mania with ziprasidone alone. - Adjunctive treatment with a mood stabilizer (lithium or valproate) for maintenance treatment of bipolar I disorder Continue treatment at the same dose at which the patient was stabilized during initial treatment, within the range of 40-80mg twice daily with food. Patients should be reassessed regularly to determine the need for this maintenance treatment. No dose adjustment is required in older adults aged 65 years or older. No dose adjustment is required in patients with renal impairment. In patients with mild to moderate hepatic impairment due to cirrhosis (Child-Pugh A or B), serum drug concentrations after oral administration were 30% higher and the terminal half-life was approximately 2 hours longer than in patients with normal hepatic function. Therefore, ziprasidone should be used with caution in patients with hepatic impairment. No dose adjustment is required for smokers.

Child dose

The safety and efficacy of ziprasidone in pediatric patients under 18 years of age have not been established.

This medication may affect the electrical activity of the heart and prolong the QT interval. This can rarely increase the risk of cardiac arrhythmias or sudden death, so patients with heart disease or electrolyte imbalances should be particularly cautious. If hypokalemia or hypomagnesemia is suspected, it is advisable to check electrolyte levels with a blood test before administration. Moreover, if other medications that prolong the QT interval are taken simultaneously, the risk may increase, so consult a physician. This medication can cause severe side effects such as serious skin reactions or neuroleptic malignant syndrome, so if rash, high fever, muscle rigidity, or changes in consciousness occur, notify healthcare professionals immediately. Long-term use may lead to tardive dyskinesia, a movement disorder, so if abnormal symptoms occur, consult a physician. During the initial dosage, there is a risk of dizziness or falls due to orthostatic hypotension, so caution is needed. Women who are pregnant or may become pregnant should consult healthcare professionals before using this medication as it may affect the fetus. This medication may cause drowsiness or decreased concentration, so be cautious when driving or operating machinery. In case of overdose, serious side effects may occur, so be sure to adhere to the prescribed dose and seek medical attention immediately if abnormal symptoms arise. This medication can interact with other drugs, so if other medications are being taken, be sure to inform your healthcare provider, especially if taking heart-related medications or CYP3A4 inhibitors. Store this medication in a tightly sealed container at room temperature out of children's reach, and keep it in the original container.

• QTc interval prolongation
• torsade de pointes
• sudden death
• high fever
• muscle rigidity
• altered mental state
• irregular pulse and blood pressure
• tachycardia
• cardiac arrhythmia
• sweating

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at room temperature between 1 to 30 degrees Celsius. If packed in blisters, it can be used for 48 months from the date of manufacture, and if in a bottle, it can be safely used for 36 months from the date of manufacture.

Appearance

White or light gray powder in white hard gelatin capsules (upper and lower parts)

Package unit

30 capsules (10 capsules/blister x 3)