Zeldox Capsule 40 mg (Ziprasidone Hydrochloride Monohydrate)

Adult dose

Take this medicine with food. Swallow the dosage form whole; do not chew or crush it, or open the capsule. 1. Schizophrenia The recommended dosage regimen for acute treatment is 40 mg per dose twice daily with food. Thereafter, the daily dose may 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, the dose 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. Ziprasidone is effective for treating patients with acute exacerbations and for maintaining clinical improvement during continued treatment. For maintenance therapy, patients should take the minimum effective dose; 20 mg per dose twice daily is sufficient in many cases. Long-term administration of ziprasidone is effective in preventing recurrent exacerbations of the disease and is also associated with improvement in negative symptoms. 2. Treatment of bipolar I disorder - Acute treatment of manic or mixed episodes associated with bipolar I disorder Initial treatment: The initial total daily dose is 40 mg per dose twice daily with food. Then, on day 2, increase the dose to 60 or 80 mg per dose twice daily; thereafter, adjust the dose within the range of 40 ~ 80 mg per dose twice daily according to tolerability and efficacy. In clinical trials using flexible dosing, the mean daily dose was approximately 120 mg. Maintenance therapy: There are no data from controlled clinical trials to guide physicians in the long-term treatment of patients whose symptoms improved during acute treatment of mania with ziprasidone alone. - Adjunctive therapy with a mood stabilizer (lithium or valproate) for maintenance treatment of bipolar I disorder Continue treatment with 40-80mg twice daily with food, at the same dose at which the patient was stabilized during initial treatment. Patients should be reassessed regularly to determine the need for this maintenance therapy. Older patients No dose adjustment is required in patients aged 65 years or older. Administration in patients with renal impairment No dose adjustment is required in patients with renal impairment. Administration in patients with hepatic 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. In toxicity studies in dogs, intrahepatic cholestasis and elevations in serum ALT and alkaline phosphatase occurred at doses associated with exposure approximately 2 times the maximum clinical exposure (plasma AUC). Therefore, caution should be exercised when administering ziprasidone to patients with hepatic impairment. Effect of smoking No dose adjustment is required in smokers.

Child dose

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

This medication may prolong the QT interval related to heart rhythm, which can increase the risk of arrhythmia or sudden death. Particularly, caution is required when used with bradycardia, hypokalemia, hypomagnesemia, or other drugs that prolong the QT interval or in patients with congenital long QT syndrome. Before administration, potassium and magnesium levels should be checked in the blood, and if deficient, should be supplemented. This drug should be avoided in patients with a history of cardiovascular disease, and administration should be stopped if the QTc interval exceeds 500 msec. Additionally, a severe side effect known as neuroleptic malignant syndrome may occur, and if symptoms such as high fever, muscle rigidity, altered mental state, or irregular pulse appear, the drug should be immediately discontinued. Severe skin adverse reactions have also been reported; if rash, urticaria, eosinophilia or systemic symptoms appear, administration should be stopped. Long-term use may result in tardive dyskinesia, so dose adjustment or discontinuation should be considered if symptoms occur. This drug may cause drowsiness, orthostatic hypotension, and motor and sensory instability, increasing the risk of falls; caution is required. It is not recommended for use in the elderly with dementia-related psychosis due to increased mortality and risk of cerebrovascular adverse reactions. There is also a risk of venous thromboembolism, thus patients with risk factors should be carefully monitored before and after administration. This drug should not be used in cases of hypersensitivity, acute myocardial infarction, decompensated heart failure, long QT syndrome, or certain genetically predisposed lactose intolerant patients. Pregnant or breastfeeding women should exercise caution while using this medication, and women of childbearing potential should use appropriate contraceptive methods. Safety and efficacy have not been established in pediatric and adolescent populations. Overdose may lead to severe side effects, so patients should take it exactly as prescribed by their doctor. This drug may increase central nervous system depressant effects when taken with alcohol, so caution is required. Additionally, there may be interaction potential when combined with other central nervous system medications, so consultation with a physician is necessary. Patients may experience drowsiness or dizziness during treatment, so caution is required when driving or operating machinery.

QTc interval prolongation, torsades de pointes, sudden death, high fever, muscle rigidity, altered mental state, irregular pulse and blood pressure, tachycardia, cardiac arrhythmia, sweating, increased creatine phosphokinase, rhabdomyolysis, acute renal failure, drug reaction (DRESS), skin reaction (rash, exfoliative dermatitis), eosinophilia, fever, lymphadenopathy, hepatitis, nephritis, pneumonia, myocarditis, pericarditis, Stevens-Johnson syndrome, delayed movement disorders, drowsiness, orthostatic hypotension, motor and sensory instability, headache, weakness, constipation, thirst, increased salivation, nausea, vomiting, weight loss, anxiety, restlessness, nervousness, dizziness, movement disorders, dyskinesia, extrapyramidal syndrome, hypertonicity, insomnia, tremors, laboratory test abnormalities, pain, allergic reactions, fever, suicidal ideation, hypotension, tachycardia, bradycardia, congestive heart failure, migraine, dyspepsia, abdominal distension, tongue swelling, gastritis, fatty liver, eosinophilia, ALT increase, thirst, alkaline phosphatase increase, dehydration, LDH increase, joint disease, leg cramps, arthralgia, myalgia, myasthenia, chorea-athentosis, osteoporosis, depression, speech disorder, grand mal seizure, hallucinations, hostility, reduced motor function, muscle weakness, ocular movement seizure, sensory distortion, language impairment, dream disturbances, abnormal gait, asthenia, ataxia, confusion, neuropathy, paralysis, stupor, affective flattening, rhinitis, morbilliform rash, rash, urticaria, psoriasis, skin diseases, visual disturbances, amblyopia, conjunctivitis, dry eyes, optic neuritis, urinary incontinence, dysuria, gynecomastia, erectile dysfunction, suicide attempts, arrhythmias, tooth discoloration, myalgia, abnormal gait, stuttering, hallucinations, psychosis, respiratory infections, pruritus, enuresis, frequency, leukopenia, palpitations, drug toxicity, memory impairment, sleep disorders, excessive sedation, delusions, open wound of the thorax, priapism, facial drooping, serotonin syndrome, insomnia, mania, sedation, fatigue, appetite loss, dysphagia, pharyngitis, dyspnea, fungal dermatitis, rash, angioedema, oral-facial edema, urinary incontinence

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is best stored at room temperature, between 1 to 30 degrees Celsius. This will help maintain the drug’s efficacy over time.

Appearance

Blue capsule containing a white to pale gray powder

Package unit

30 capsules (10 capsules/blister x 3)