Composition
1 coated tablet contains:
Active ingredient:
trifluoperazine hydrochloride 5 mg
excipients:
refined sugar,
potato starch,
aerosil,
calcium stearate,
gelatin,
magnesium carbonate
, indigo carmine,
polyvinylpyrrolidone,
wax,
titanium dioxide,
talc.
Pharmacological action
Triftazine is a neuroleptic drug from the group of piperazine derivatives of phenothiazine. It has a pronounced antipsychotic and antiemetic effect, has a-adrenolytic and weak anticholinergic and sedative effects.
The neuroleptic effect is combined with a moderate stimulating effect (in small doses). Triftazine has a pronounced and long-lasting effect on productive psychotic symptoms (hallucinations, delusions). Causes extrapyramidal disorders.
Pharmacokinetics:
It is well absorbed from the gastrointestinal tract and from the sites of parenteral use.
The time to reach the maximum concentration with intramuscular use is 1-2 hours.
Binding to plasma proteins is 95% (therefore, it is poorly dialyzed).
It is metabolized in the liver, with a half-life of 15-30 hours, and most metabolites are pharmacologically inactive.
It is excreted by the kidneys and bile. Triphthazine passes through the placenta.
Indications
- schizophrenia and other mental illnesses that occur with delusions, hallucinations and psychomotor agitation;
- vomiting of central origin.
Contraindications
- individual hypersensitivity;
- inhibition of the function of the Central nervous system (CNS) and coma of any etiology;
- brain injury;
- liver, kidney and blood-forming organs disorders;
- progressive systemic disease of brain and spinal cord;
- gastric ulcer and 12 duodenal ulcer in the period of exacerbation;
- heart failure in the stage of decompensation; severe hypotension; diseases accompanied by the risk of thromboembolic complications;
- angle-closure glaucoma (risk of elevated intraocular pressure);
- prostatic hyperplasia;
- myxedema;
- pregnancy the period of breastfeeding;
- children’s age up to 3 years.
With caution: Elderly age, vomiting (the antiemetic effect of phenothiazines can mask vomiting associated with an overdose of other drugs).
Triftazine is used after comparing the risk and benefit of treatment in patients with alcohol intoxication, Reye’s syndrome, cachexia, as well as in breast cancer, Parkinson’s disease, gastric and duodenal ulcers, urinary retention, chronic respiratory diseases (especially in children), epileptic seizures.
Side effects
From the nervous system: drowsiness, dizziness, insomnia, phenomena of mental indifference (with prolonged use), delayed reactions to external stimuli. The use of Triftazine is often accompanied by extrapyramidal disorders (dyskinesia, akinetorigid phenomena, akathisia, hyperkinesis, tremor, vegetative disorders), in isolated cases convulsions. As correctors, antiparkinsonian agents are used – tropacin, trihexyphenidyl (cyclodol), etc. Dyskinesia (paroxysmal convulsions of the neck, tongue, and bottom of the oral cavity muscles, oculogyric crises) is stopped by caffeine-sodium benzoate (2 ml of a 20% solution subcutaneously) and atropine (1 ml of a 0.1% solution subcutaneously).
With prolonged use, tardive dyskinesia may develop, less often-neuroleptic malignant syndrome.
From the sensory organs: paresis of accommodation, with prolonged use – retinopathy, opacity of the lens and cornea.
From the genitourinary system: urinary retention, decreased potency, frigidity, decreased libido, ejaculation disorders, priapism, oliguria.
From the endocrine system: hypo – or hyperglycemia, glucosuria, amenorrhea, hyperprolactinemia, dysmenorrhea, galactorrhea, swelling or pain in the mammary glands, gynecomastia, weight gain.
From the digestive system: dry mouth, decreased appetite, constipation, bulimia, nausea, vomiting, diarrhea, gastralgia, cholestatic jaundice.
From the sensory organs: visual impairment – paresis of accommodation (at the beginning of treatment), retinopathy, opacity of the lens and cornea.
Laboratory parameters: thrombocytopenia, lympho-and leukopenia, increased blood clotting, anemia, agranulocytosis (more often at 4-10 weeks of treatment), pancytopenia, eosinophilia-less often than in other phenothiazines, false positive pregnancy tests.
From the cardiovascular system: tachycardia, decreased blood pressure (including orthostatic hypotension), especially in elderly patients and people suffering from alcoholism, cardiac arrhythmias, prolongation of the QT interval, decrease or inversion of the T wave. Allergic reactions: skin rash, urticaria, angioedema (less often than in other phenothiazines).
Other: pigmentation of the skin and conjunctiva, discoloration of the sclera and cornea, reduced tolerance to high temperatures (up to the development of heat stroke), melanosis.
Local reactions: when administered intramuscularly, infiltrates may occur, and contact dermatitis may occur if liquid forms get on the skin.
Interaction
With simultaneous use Triftazine with other drugs, providing a depressing effect on the Central nervous system (funds for General anesthesia, narcotic analgesics, ethanol (alcohol) – containing drugs, barbiturates, tranquilizers, etc. ) may increase CNS depression and respiratory depression;
prolonged undesirable combination with analgesics and antipyretics – may develop hyperthermia;
with tricyclic antidepressants, maprotiline or inhibitors of monoamine oxidase (MAO) – increase the risk of developing neuroleptic malignant syndrome; with anticonvulsant drugs may decrease the convulsive threshold; drugs for the treatment of hyperthyroidism increases the risk of developing agranulocytosis; with other drugs cause extrapyramidal reactions may increase the frequency and severity of extrapyramidal disorders;
hypotensive drugs – possible severe orthostatic hypotension; with ephedrine – a possible attenuation of the vasoconstrictor effect of ephedrine. Epinephrine (epinephrine) use should be avoided during treatment with Triphtazine, as it is possible to pervert the effect of epinephrine, which can lead to a drop in blood pressure. The antiparkinsonian effect of levodopa is reduced by blocking dopamine receptors. Triphthazine can inhibit the action of amphetamines, clonidine, and guanethidine. Triftazine enhances the anticholinergic effects of other drugs, while the antipsychotic effect of a neuroleptic may decrease.
When Triftazine is co-administered with prochlorperazine, prolonged loss of consciousness may occur.
Combination with lithium supplements increases the risk of extrapyramidal complications. Triftazine can mask some manifestations of ototoxicity (tinnitus, dizziness), drugs that have an ototoxic effect (for example, the use of drugs that have an ototoxic effect). antibiotics). Other hepatotoxic drugs increase the risk of hepatotoxicity. Antacids containing Al3+ and Mg2+ reduce the absorption of triphthazine.
How to take, course of use and dosage
Triftazine is taken orally, after meals.
Doses are selected individually in accordance with the severity of the condition, and it is advisable to use dosage forms with an appropriate (lower) dosage to titrate the dose. When the maximum therapeutic effect is achieved, the dose is gradually reduced to maintenance. Usually, for the treatment of anxiety states, adults are prescribed 1 mg 2 times a day. For patients with psychotic disorders, start 2-5 mg 2 times a day. To obtain an optimal therapeutic effect, the dose is gradually increased to 15-20 mg / day, divided into 2-3 doses, the maximum daily dose is 40 mg.
To obtain the desired therapeutic effect and improve the patient’s condition, it usually takes 2-3 weeks.
Children 6-12 years of age with psychotic disorders are prescribed 1 mg 1-2 times a day, if necessary, this dose can be increased to 4%^%mg/day. The dose for children over 12 years of age is 5-6 mg per day, divided into several doses.
Adults with vomiting – 1-2%^%mg 2 times a day. For elderly patients, the initial dose of the drug should be reduced by 2 times.
Overdose
Symptoms: areflexia or hyperreflexia, blurred vision, cardiotoxic effects (arrhythmia, heart failure, decreased blood pressure, shock, tachycardia, QRS complex changes, ventricular fibrillation, cardiac arrest), neurotoxic effects, including agitation, confusion, convulsions, disorientation, drowsiness, stupor or coma; mydriasis, dry mouth, hyperpyrexia or hypothermia, muscle stiffness, vomiting, pulmonary edema, or respiratory depression.
Treatment – symptomatic: for arrhythmia – intravenous (iv) phenytoin 9-11 mg/kg, for heart failure – cardiac glycosides, with a pronounced decrease in blood pressure – intravenous fluid or vasopressors, such as norepinephrine, phenylephrine (avoid prescribing alpha – and beta-adrenomimetics, such as epinephrine, since a paradoxical decrease in blood pressure is possible due to alpha-adrenergic blockade with trifluoperazine), for convulsions – diazepam (avoid barbiturates, due to possible subsequent depression of the central nervous system and respiration), for Parkinsonism – diphenyltropine, diphenhydramine.Monitoring of the cardiovascular system function for at least 5 days, CNS function, respiration, body temperature measurement, psychiatric consultation. Dialysis is ineffective.
Special instructions
During treatment, it is necessary to regularly monitor blood pressure, pulse, and liver, kidney, and blood function.
Do not use alcohol during treatment!
During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Storage conditions
Store in a dry place, protected from light and out of reach of children.
Shelf life
3 years
Active ingredient
Trifluoperazine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Purpose
For adults as directed by your doctor
Indications
Schizophrenia, Mental disorders
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Side effects of Triphtazine, pills 5mg, 50pcs.
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