Zeldox (ziprazidone) capsules 40 mg. №28

Description

Zeldox (ziprazidone) capsules 40 mg. №28

Composition 

active substance: ziprasidone;

• 1 capsule contains 22.65 mg of ziprasidone hydrochloride monohydrate, which is equivalent to 20 mg of ziprasidone;
• 1 capsule contains 45.30 mg of ziprasidone hydrochloride monohydrate, which is equivalent to 40 mg of ziprasidone;
• 1 capsule contains 90.60 mg of ziprasidone hydrochloride monohydrate, which is equivalent to 80 mg of ziprasidone.

excipients: lactose monohydrate; pregelatinized corn starch; magnesium stearate; gelatin shell: titanium dioxide (E 171), sodium dodecyl sulfate, indigotine (E 132), gelatin; black ink: shellac, ethanol anhydrous, isopropyl alcohol, n-butyl alcohol, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, iron oxide black (E 172).

Dosage form

Hard capsules.

Basic physical and chemical properties:

• 20 mg capsules: tightly closed hard gelatin capsules, size № 4, blue and white, marked with black ink “Pfizer” and “ZDX 20”;
• 40 mg capsules: tightly closed hard gelatin capsules, size № 4, blue, marked with black ink “Pfizer” and “ZDX 40”;
• 80 mg capsules: tightly closed hard gelatin capsules, size № 2, blue and white, marked with Pfizer and ZDX 80 black ink.

Pharmacotherapeutic group

Antipsychotics. Derivatives of indole. ATX code N05A E04.

Pharmacological properties

The active substance of the drug – ziprasidone, is similar to human serotonin and dopamine receptors. In the study of the effects of ziprasidone using positron emission tomography 12 hours after a single dose of 40 mg, a blockade of 2A serotonin receptors and D2 receptors was recorded. In addition, ziprasidone has been shown to act on serotonin receptors such as 5HT2C, 5HT1D and 5HT1A.

Indications

Zeldox is used to treat patients with schizophrenia. In addition, the drug is used in the treatment of patients with manic and mixed episodes occurring against the background of moderate bipolar disorder.

Contraindications

The drug is not used in the treatment of patients with ziprasidone intolerance, diagnosed with QT prolongation and congenital QT increase syndrome.
The drug is contraindicated in patients who have recently suffered an acute myocardial infarction or suffering from decompensated heart failure.
The capsules are not used in patients with arrhythmia treated with class IA and III drugs and in patients receiving drugs that potentially prolong the QT interval, such as arsenic trioxide, halofantrine, levometadil acetate, cisapride, pimozide and mefloquine.

Method of application and dose

The capsules are taken orally with a meal. The dose, frequency of administration and duration of the course of therapy are selected by the specialist individually.
Adult patients in the treatment of bipolar disorder and schizophrenia are prescribed 40 mg twice a day. With good tolerability, the dose of ziprasidone can be increased to 80 mg if necessary. Dosage increase is possible only on the third day of treatment. It is not recommended to take more than 160 mg of ziprasidone in a knock due to the lack of information on the safety and effectiveness of the drug in high doses.
After the main course of treatment, it is possible to take the drug twice a day in a maintenance dosage of 20 mg.

Overdose

There are very few reports of overdose with Zeldox, but it is known that patients receiving high doses of ziprasidone may develop extrapyramidal disorders, increased QT interval, increased drowsiness, anxiety, tremor, inhibition, convulsions and dystonic reactions.
In case of Zeldox poisoning, the patient is prescribed gastric lavage, monitoring of the cardiovascular system and symptomatic treatment.

Side effects

Rhinitis, loss of appetite, unexplained anxiety, chest tightness, depressive episodes, bradyphrenia, mania, hypomania, sleep disorders, extrapyramidal disorders, akathisia, dystonia, parkinsonism, headaches, tremor, generalized tonic-clonic convulsions paresthesias, hypertonia, restless legs and crooked neck syndrome, increased QT interval, orthostatic hypotension, hypertensive crisis, syncope, decreased visual acuity, dry eye mucosa, tinnitus, vertigo, dyspnea, dyspeptic disorders.