Zeldox® [Ziprasidone]

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Dosage and Administration

Adverse reactions

From the side of the central nervous system and peripheral nervous system: asthenia, headache, extrapyramidal syndrome, insomnia or drowsiness, tremor, blurred vision, psychomotor agitation, akathisia, dizziness, dystonic reactions. Seizures were extremely rare (less than 1% of patients receiving ziprasidone). The index of movement disorders (Movement Disorder Burden Score), reflecting the severity of extrapyramidal symptoms when using ziprasidone, is much lower (p

Malignant neuroleptic syndrome (NNS): when using antipsychotics, cases of NNS have been observed, which is a rare but potentially fatal complication. Clinical manifestations of ZNS are an increase in body temperature (hyperpyrexia), muscle rigidity, a change in mental status and instability of the autonomic nervous system (arrhythmia, change in blood pressure, tachycardia, profuse sweating, and heart rhythm disturbance). Additional signs may include increased levels of CPK, myoglobinuria (rhabdomyolysis) and acute renal failure. If symptoms appear that can be attributed to signs of NNS, or an unexpectedly high body temperature, not accompanied by the appearance of the remaining symptoms of NNS, all antipsychotics, including ziprasidone, should be immediately discontinued.

Cases of NNS are noted in the post-marketing application of Zeldoks.

Slow dyskinesia: With long-term use of ziprasidone, as well as other antipsychotics, there is a risk of developing slow dyskinesias and other remote extrapyramidal syndromes. If there are signs of dyskinesia, it is advisable to reduce the dose of ziprasidone or cancel it.

From the digestive system: constipation, dry mouth, dyspepsia, excessive salivation, nausea, vomiting.

Other: against the background of maintenance therapy with ziprasidone, an increase in prolactin level was sometimes observed (in most cases, it normalized without stopping treatment), arterial hypertension. Weight gain fluctuations have been reported upwards by an average of 0.5 kg with short-term use (within 4-6 weeks) and downward by 1-3 kg with long-term use (over a year) compared with patients who did not take the drug.

Contraindications

- Hypersensitivity to ziprasidone or any inactive component of the drug.
- A prolonged history of the QT interval, including congenital long QT syndrome.
- Recently suffered acute myocardial infarction.
- Decompensated heart failure.
- Arrhythmias requiring anti-arrhythmic agent IA and Class III.
- Pregnancy.
- The period of breastfeeding.
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- Joint medication, extending the QT interval, in particular the antiarrhythmic agents of classes IA and III, arsenic trioxide, halofantrin, methadone, mezoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron, mefloquine, a heart pattern, a heart pattern, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart pattern, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage, a heart bandage.
- Age up to 18 years. The efficacy and safety of ziprasidone in patients under the age of 18 years has not been studied.

Carefully:

- Use in violation of the liver. In patients with mild or moderate hepatic insufficiency, it is advisable to reduce the dose of the drug.There is no experience of using ziprasidone in patients with severe hepatic insufficiency; therefore, in this group, the drug should be used with caution.
- QT interval. Ziprasidone causes a slight or moderate prolongation of the QT interval. It is believed that there is a relationship in the occurrence of prolongation of the QT interval by more than 500 ms and paroxysmal ventricular arrhythmia (torsade des pointes). which is potentially life-threatening (some drugs, including anti-arrhythmic agents of class IA and III, cause a similar effect). There were rare cases of such arrhythmias in patients with multiple mixed risk factors taking ziprasidone (post-marketing use), although a causal relationship with taking the drug has not been established. Ziprasidone should be administered with caution to patients with the following risk factors that may exacerbate the possibility of such arrhythmias:
- Bradycardia.
- Electrolyte imbalance.
- Use with other drugs that extend the QT interval.

If the QT interval exceeds 500 ms, it is recommended to stop treatment.

When treating patients with a history of seizures, caution should be exercised.

In patients with diabetes mellitus, after initiation of treatment with atypical antipsychotics, regular monitoring of glucose concentration in the blood is necessary. If there are risk factors for diabetes mellitus (in particular, obesity, the presence of diabetes mellitus in the family history), patients who started treatment with atypical neuroleptics should determine the fasting blood glucose concentration during the onset of such therapy and periodically during it. All patients receiving atypical antipsychotics should be monitored for signs of hyperglycemia, including polydipsia, polyuria, polyphagia and weakness. With the development of these manifestations in patients receiving atypical antipsychotics, it is necessary to determine the fasting blood glucose concentration.

In some cases, hyperglycemia is stopped after the abolition of an atypical neuroleptic; however, some patients require continued hypoglycemic therapy even after discontinuation of the intended drug that caused the disorder.

Ziprasidone can provoke hypotension, accompanied by dizziness, tachycardia and, in some patients, fainting, especially during the initial dose titration period, which is probably due to it? 1 -block-blocking activity. Cases of syncope were reported in 0.6% of patients receiving ziprasidone.

Aspiration pneumonia is a common condition that occurs in elderly patients, particularly those with severe dementia due to Alzheimer's disease. Ziprasidone and other antipsychotics should be used with caution in patients at risk of aspiration pneumonia.

Drug interactions

The combined use of ziprasidone and drugs that cause lengthening of the QT interval (including class IA and class III antiarrhythmic drugs) increases the risk of QT lengthening and paroxysmal ventricular tachycardia (this combination is contraindicated).
When ziprasidone is used together with drugs that have a depressant effect on the central nervous system, it is possible to mutually enhance this action (this combination requires caution).

Ziprasidone does not inhibit the cytochrome P system isoenzymes₄₅₀ 1A2, 2C9 or 2C19. Concentrations of ziprasidone causing inhibition of CYP2D6 and CYP3A4 in vitro no less than 1000 times the concentration of the drug that could be expected in vivo. This indicates a lack of likelihood of a clinically significant interaction between ziprasidone and drugs metabolized by these isoenzymes.
In accordance with the results of in vitro studies and clinical trial data in healthy volunteers, it was shown that ziprasidone did not have an effect through CYP2D6 on the metabolism of dextromethorphan and its main metabolite, dextrophan.
When used together with oral hormonal contraceptives, ziprasidone did not cause significant changes in the pharmacokinetics of estrogen, or ethinyl estradiol (which is a substrate of CYP3A4), or progester-containing components.

Ziprasidone does not affect the pharmacokinetics of lithium when used together.
Ziprasidone is largely bound to plasma proteins. In in vitro studies, warfarin and propranolol (drugs with a high degree of protein binding) did not affect the binding of ziprasidone to plasma proteins and ziprasidone did not affect the binding of these drugs to plasma proteins. Thus, the possibility of the interaction of drugs with ziprasidone due to the displacement of plasma from its association with proteins seems unlikely.
Ziprasidone is metabolized by aldehyde oxidase and, to a lesser extent, CYP3A4. Clinically significant aldehyde oxidase inhibitors or inducers are unknown.
Combined use with ketoconazole (400 mg / day) as a potential inhibitor of CYP3A4 resulted in an increase of approximately 35% AUC and C_max ziprasidone, which hardly has clinical significance.

Combined use with carbamazepine (200 mg 2 times / day) as an inducer of CYP3A4 led, in turn, to a decrease in AUC and C_max ziprasidone by 36%, which is hardly of clinical importance.
When combined, cimetidine, a non-specific inhibitor of isoenzymes, did not significantly affect ziprasidone pharmacokinetics.
The simultaneous use of antacids containing aluminum and magnesium did not affect the pharmacokinetics of ziprasidone.
In clinical studies, the clinically significant effect of simultaneous use of propranolol and lorazepam on pharmacokinetic parameters and serum ziprasidone concentration was not established.

Pregnancy and Lactation

Special instructions

Overdosage

• Brand name: Zeldox
• Active ingredient: Ziprasidone
• Dosage form: Capsules
• Manufacturer: Pfizer
• Country of Origin: USA