Название документа

Kvetiapin-Darnitsa – the means operating on nervous system. Antipsychotic means. Tsvetiapin.

Indications

Treatment of schizophrenia.

Treatment of bipolar disorders, including:

  • for treatment of moderate and heavy maniacal episodes in bipolar disorder;
  • for treatment of big depressive episodes in bipolar disorder.

For prevention of a recurrence of a disease at patients with bipolar disorder at which maniacal or depressive episodes were exposed to treatment kvetiapiny.

Structure

  • active ingredient: quetiapine; tablets on 200 mg: 1 tablet, film coated, contains 230.27 mg of a kvetiapin of the fumarat that is equivalent to 200 mg of a kvetiapin;
  • other components: a gipromeloza, calcium hydrophosphate a dihydrate, lactose monohydrate, starch corn, sodium stearate, cellulose microcrystalline, talc, silicon dioxide colloidal anhydrous krakhmalglikolit (type A), magnesium;
  • film covering: tablets on 200 mg: hydroxypropyl cellulose (E 463), GPMC 2910/gipromelloza 6sr (E 464), titan dioxide (E 171), talc.

Contraindication

Increased individual sensitivity to medicine components.

Contraindicated simultaneous use of inhibitors of P450 3A4 cytochrome, such as HIV protease inhibitors, azolny antifungal drugs, erythromycin, klaritromitsin and nefazodon.

Side reactions

most often can be observed by

At reception of a kvetiapin drowsiness, dizziness, dryness in a mouth, a headache, a withdrawal, high level of triglycerides in blood serum, increase in the general cholesterol in blood serum, increase in body weight, reduction of level of hemoglobin and extrapyramidal symptoms.

As well as concerning other antipsychotic means, use of a kvetiapin was followed by increase in body weight, a syncope, a malignant antipsychotic syndrome, a leukopenia and peripheral hypostases.

Route of administration

Medicine can be applied irrespective of food.

Kvetiapin-Darnitsa should apply Medicine two times a day To treatment of schizophrenia. The general daily dose for the first four days of treatment makes 50 mg in the first day, 100 mg in the second day, 200 mg – the third day and 300 mg – the fourth day. Since fourth day, the dose should be adjusted within the range of effective doses – from 300 mg/days to 450 mg/days. Depending on the clinical answer and shipping of the patient the dose can be corrected in the range from 150 to 750 mg/days

in bipolar disorder

Kvetiapin-Darnitsa should apply Medicine two times a day To treatment of moderate and heavy maniacal episodes. The general daily dose for the first four days of treatment makes 100 mg in the first day, 200 mg in the second day, 300 mg – the third day and 400 mg – the fourth day. Correction of a dose to 800 mg/days till sixth day it is necessary to carry out with a step no more than 200 mg/days

Drug dose can adjust within the range of doses from 200 to 800 mg/days, depending on the clinical answer and shipping of each certain patient. Range of effective doses is from 400 to 800 mg/days

in bipolar disorder

Medicine Kvetiapin-Darnitsa should be applied To treatment of big depressive episodes once a day before going to bed. The general daily dosage for the first four days of treatment makes 50 mg (in the 1st day), 100 mg (for the 2nd day), 200 mg (for the 3rd day) and 300 mg (for the 4th day). The recommended daily dosage – 300 mg. In clinical trials there was no additional benefit in group of use of 600 mg in comparison with group of 300 mg. The dose of 600 mg can be effective for certain patients. The doctor with experience of treatment of bipolar disorder has to appoint doses over 300 mg. According to clinical trials, for certain patients in case of the problems connected with intolerance of medicine it is necessary to consider a question of a dose decline to minimum – 200 mg.

Feature of use

Use during pregnancy or feeding by a breast

can only appoint medicine by

during pregnancy if the expected advantage justifies potential risk.

that kvetiapin gets into breast milk of the person, however this information is contradictory. Due to the lack of reliable data the decision on the feeding termination by a breast or the therapy termination kvetiapiny should be accepted taking into account advantage of chest feeding for the child and advantage of therapy for the woman.

Children

Data on safety and effektivnost which would demonstrate in favor of medicament use to children and teenagers aged up to 18 years therefore kvetiapin it is not necessary to apply in pediatric practice.

Ability to influence speed of response at control of motor transport or other mechanisms

Considering

what kvetiapin preferably affects central nervous system, medicine can have adverse impact on the types of activity demanding concentration of attention. Therefore, patients should recommend to avoid driving or other mechanisms, the individual sensitivity to this influence will not be defined yet.

Overdose

Signs and symptoms of overdose about which it was reported were a consequence of strengthening of the known pharmacological effects of active ingredient, such as drowsiness and sedation, tachycardia, arterial hypotension and anticholinergic effects. The overdose can lead to lengthening of an interval to QT, spasms, the epileptic status, a rhabdomyolysis, respiratory depression, a delay of urination, a disorientation, nonsense and/or excitement, a coma and to a lethal outcome. Patients with earlier available serious cardiovascular illness can be in group of the increased risk of emergence of effects of overdose.

Treatment.

is not present

Specific antidote.

Interaction with other medicines and other types of interactions

Considering priority influence of a kvetiapin on central nervous system, kvetiapin it is necessary to apply with care in combination with other medicines of the central action and alcohol.

needs to show care at treatment of the patients using other medicaments with anticholinergic (muskarinovy) effects.

Storage conditions

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Characteristics
Active ingredients Kvetiapin
Amount of active ingredient 200 mg
Applicant Darnitsa
Code of automatic telephone exchange N05AH04 Kvetiapin
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status The branded generic
Origin Chemical
Prescription status According to the prescription
Primary packing blister
Producer DZHENEFARM S.A.
Quantity in packing 30 tablets (3 blisters on 10 pieces)
Release form tablets for internal use
Route of administration Oral
Sign Import
Storage temperature from 5 °C to 30 °C
Trade name Kvetiapin

Reviews Kvetiapin-Darnitsa of the tab. of p/o of 200 mg No. 30

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Kvetiapin-Darnitsa of the tab. of p/o of 200 mg No. 30

  • Product Code: 183991
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