Possible side effects
Blood clots can develop in the veins of the lower extremities (symptoms include swelling, pain and redness in the legs), which can travel through the blood vessels into the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
Like all medicines, Triftazine can cause side effects, although not everyone gets them.
Stop taking Triftazine immediately and call your doctor if you develop symptoms of an allergic reaction. These symptoms include a rash, trouble swallowing or breathing, and swelling of the lips, face, throat, or tongue.
If any of the following side effects occur after taking this medicine, call your doctor immediately:
- Rarely, patients may develop neuroleptic malignant syndrome, which results in fever, muscle stiffness, drowsiness, temporary loss of consciousness and requires emergency hospitalization for treatment.
- If you have chest pain (angina) and it gradually gets worse.
- If you suffer from a sore throat, high fever, feel very tired, turn pale, have bruises and nosebleeds. This may indicate that you have blood problems resulting from taking Triftazin.
- Very rarely, drugs such as Triftazin can cause involuntary muscle contractions. Symptoms that may occur include slurred speech, strange movements of the face, especially the tongue, eyes, head, or neck (for example, a twisting of the neck that causes an unnatural position of the head, muscle rigidity, tremors or restlessness, and difficulty sitting). In some patients (especially those taking Triftazine in large doses) it can cause involuntary muscle contractions that can last for years. These patients may experience persistent chewing or tongue movements or other slight movements of the neck, head, or trunk. These patients also experienced uncontrolled movements of the arms and legs.
- Very rarely, patients may also experience fast or irregular heartbeat, constipation, difficulty or inability to urinate, or fever.
- Sometimes some patients complain that they feel lethargic, while others complain that they feel agitated.
- If you have angina and the pain gradually gets worse.
- There have been very rare reports of jaundice (yellowing of the skin and eyes), vision problems, pigmentation changes and blood problems.
- In older people with dementia, there is a small increase in the number of deaths in patients taking antipsychotics compared with patients not taking antipsychotics.
- Very rarely, at high doses of Triftazin, hyperprolactinemia may develop, accompanied by galactorrhea, amenorrhea or gynecomastia; may affect some hormone-dependent breast neoplasms. Phenothiazines may cause ECG changes such as QT prolongation and T wave changes; data were obtained on the development of ventricular arrhythmias (VF, VT (rare)), sudden death; heart attack and drug-induced torsade de pointes (Torsades de pointes).
Some patients may also experience weakness, drowsiness, dizziness, restlessness, insomnia, dry mouth, blurred vision or eye problems, muscle weakness, loss of appetite, weakness when standing, weight gain, fluid retention causing swelling or confusion.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Reporting Adverse Events
If you notice any side effects, tell your doctor, pharmacist or pharmacist, including any side effects not listed in this leaflet. You can also report side effects by going to the website www.arpimed.com and filling out the appropriate form “Report a side effect or ineffectiveness of a drug” and to the Scientific Center for Expertise of Medicines and Medical Technologies named after. Academician E. Gabrielyan by going to the website www.pharm.am to the “Report a side effect of a drug” section and fill out the form “Card of reporting a side effect of a drug.” Scientific center hotline phone number: +37410200505; +37496220505 By reporting side effects, you help gather more information about the safety of this drug.
How to store Triftazin
- The drug should be stored out of the reach of children, protected from moisture and light at a temperature of 150C -250C.
- Shelf life – 3 years. Do not take Triftazin after the expiration date indicated on the drug package. When indicating the expiration date, we mean the last day of the specified month.
- If the tablets change color or show other signs of deterioration, do not take the drug.
- Medicines should not be disposed of in wastewater or sewer systems. Ask your pharmacist how to dispose of any medicine you no longer need. These measures are aimed at protecting the environment.
Package contents and additional information
Triftazin contains
One film-coated tablet contains:
active substance: trifluoperazine – 5 mg (trifluoperazine hydrochloride – 6 mg);
excipients: microcrystalline cellulose, lactose monohydrate, povidone, corn starch, magnesium stearate, sodium starch glycolate, purified talc, hypromellose, propylene glycol, titanium dioxide, blue dye (brilliant blue).
What Triftazin looks like and contents of the pack:
Blue film-coated tablets.
Description of packaging
Cardboard packaging containing 48 tablets (2 blisters of 24 tablets each) along with a leaflet.
Vacation conditions
Dispensed by prescription.
Triftazin 5 mg 50 pcs. film-coated tablets
pharmachologic effect
Antipsychotic (neuroleptic).
Composition and release form Triftazin 5 mg 50 pcs. film-coated tablets
Tablets - 1 tablet:
- Active substance: Trifluoperazine dihydrochloride (triftazine hydrochloride) in terms of triftazine base - 0.0050 g / 0.0100 g;
- Excipients: sucrose (sugar) - 0.115088 g / 0.257976 g, potato starch - 0.035000 g / 0.070000 g, colloidal silicon dioxide (aerosil) - 0.002748 g / 0.005496 g, calcium stearate - 0.001000 g / 0.002000 g, gelatin - 0.000065 g / 0.000130 g, povidone (low molecular weight medical polyvinylpyrrolidone 12600 ± 2700) - 0.002666 g / 0.005332 g, magnesium hydroxycarbonate (magnesium carbonate main) - 0.017102 g / 0.034204 g, titanium dioxide (titanium dioxide pigment) - 0.000350 g / 0.000700 g, talc - 0.000499 g / 0.000998 g, indigo carmine - 0.000308 g / 0.000616 g, beeswax - 0.000174 g/0.000348 g.
10 coated tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil.
50 or 100 film-coated tablets in a glass jar, sealed with a plastic lid or in a polymer jar.
Each jar or 5 blister packs along with instructions for use are placed in a cardboard pack.
Description of the dosage form
Blue-coated tablets with marbling, biconvex, round, with a smooth surface. The cross-section of the tablets is white with a creamy tint.
Directions for use and doses
Take orally after meals. Doses are selected individually according to the severity of the condition. When the maximum therapeutic effect is achieved, the dose is gradually reduced to a maintenance dose.
For psychotic diseases, 5 mg is usually prescribed 2 times a day, then over 2-3 weeks the dose is gradually increased to 15-20 mg per day, divided into 2-3 doses. To obtain the desired therapeutic effect and improve the patient's condition, it usually takes 2-3 weeks. The maximum daily dose is 40 mg.
At the first stage of dose selection in elderly, depleted, weakened patients and children, it is advisable to use dosage forms with a lower dosage of trifluoperazine. Elderly, as well as depleted and weakened patients require a lower initial dose, which, if necessary, is gradually increased, taking into account tolerability.
Pharmacodynamics
Antipsychotic drug (neuroleptic), piperazine derivative of phenothiazine. It also has a sedative, anti-hiccup, cataleptic, hypotensive, hypothermic and weak m-anticholinergic effect.
The antipsychotic effect is due to the blockade of D2-dopamine receptors of the mesolimbic and mesocortical systems, has a blocking effect on alpha-adrenergic receptors and suppresses the release of hormones of the hypothalamus and pituitary gland (with blockade of dopamine receptors, the release of prolactin by the pituitary gland increases). Blockade of vascular alpha-adrenergic receptors determines its hypotensive effect. Antiemetic effect - blockade of peripheral and central (chemoreceptor trigger zone of the cerebellar vomiting center) D2-dopamine receptors, as well as blockade of the endings of the vagus nerve in the gastrointestinal tract.
The sedative effect is due to the blockade of adrenergic receptors in the reticular formation of the brain stem.
Hypothermic effect - blockade of dopamine receptors in the hypothalamus.
Structurally similar to chlorpromazine, has higher activity, and is better tolerated. The sedative effect and effect on the autonomic nervous system is less pronounced than that of other phenothiazine derivatives, while the extrapyramidal and antiemetic effects are stronger.
Pharmacokinetics
Absorption is high. Bioavailability after oral administration is 35% (has a “first pass” effect through the liver). Communication with plasma proteins is 95%. The time required to achieve maximum concentration is 2-4 hours. Penetrates through the blood-brain barrier, the placenta and into breast milk. Intensively metabolized in the liver, the metabolites are pharmacologically inactive. The half-life is 15 - 30 hours. It is excreted mainly by the kidneys (in the form of metabolites) and with bile. During hemodialysis, it is dialyzed weakly (high binding to plasma proteins).
Indications for use Triftazin 5 mg 50 pcs. film-coated tablets
Schizophrenia (with productive and negative symptoms) and other psychotic diseases occurring with psychomotor agitation, hallucinatory and delusional disorders.
Contraindications
Hypersensitivity to the components of the drug (including other phenothiazine derivatives), severe cardiovascular diseases (decompensated chronic heart failure, arterial hypotension), severe depression of the function of the central nervous system (including against the background of drugs) and comatose states any etiology, traumatic brain injury, progressive diseases of the brain and spinal cord, suppression of bone marrow hematopoiesis, impaired hematopoiesis, severe liver failure, childhood.
Carefully:
Alcoholism (increased susceptibility to hepatotoxic reactions), angina pectoris, valvular heart lesions that limit the minute blood circulation (severe arterial hypotension may develop), breast cancer (as a result of phenothiazine-induced prolactin secretion, the potential risk of disease progression and resistance to treatment with endocrine and cytotoxic drugs increases). - static drugs), angle-closure glaucoma, prostatic hyperplasia with clinical manifestations, mild to moderate liver failure, renal failure, gastric and duodenal ulcers during exacerbation; diseases accompanied by an increased risk of thromboembolic complications; Parkinson's disease (extrapyramidal effects increase); epilepsy; myxedema; chronic diseases accompanied by breathing problems (especially in children); Reye's syndrome (increased risk of developing manifestations of hepatotoxicity in children and adolescents); cachexia, vomiting (the antiemetic effect of phenothiazines may mask vomiting associated with overdose of other drugs), old age. While taking the drug, exposure to high temperatures should be avoided (possible disruption of thermoregulation).
Neuroleptic malignant syndrome can occur at any time during treatment with antipsychotic drugs and can be fatal.
Application of Triftazin 5 mg 50 pcs. film-coated tablets during pregnancy and breastfeeding
The drug is contraindicated during pregnancy and breastfeeding.
special instructions
To correct extrapyramidal disorders, antiparkinsonian drugs are used - trihexyphenidyl and others; dyskinesias are relieved subcutaneously by administering 2 ml of a 20% caffeine solution and 1 ml of a 0.1% atropine solution).
The drug, having a cardiotoxic effect, can cause arterial hypotension, deterioration of cardiac hemodynamics (pulmonary edema, ventricular fibrillation and, as a result, sudden death) in elderly patients with psychosis.
In elderly patients, irreversible dyskinesias may develop. If signs of tardive dyskinesia or neuroleptic malignant syndrome appear, treatment should be discontinued.
During therapy with phenothiazines, it is possible to obtain false-positive tests for phenylketonuria.
Prescription of phenothiazines should be discontinued at least 48 hours before the proposed myelography (resumption is possible after 24 hours).
Impact on the ability to drive vehicles and operate machinery
During treatment, it is not recommended to drive vehicles, as well as engage in activities that require psychomotor speed and precise movements.
Overdose
Symptoms: areflexia or hyperreflexia, blurred vision, cardiotoxic (arrhythmia, heart failure, low blood pressure, shock, tachycardia, QRS changes, ventricular fibrillation, cardiac arrest), neurotoxic effects including agitation, confusion, seizures, disorientation, drowsiness , stupor or coma; mydriasis, dry mouth, hyperpyrexia or hypothermia, muscle rigidity, vomiting, pulmonary edema or respiratory depression.
Treatment: symptomatic: to eliminate extrapyramidal disorders, antiparkinsonian drugs from the group of central m-anticholinergics, barbiturates or diphenhydramine are used. If stimulants are needed, it is better to use amphetamine, dextroamphetamine or caffeine. Avoid stimulants that can cause seizures (picrotoxin, pentylenetetrazole). With the development of arterial hypotension, norepinephrine and phenylephrine are indicated. The use of other vasopressor agents (including adrenaline) is not recommended, because triphthazine metabolites can alter their action, leading to an even greater decrease in blood pressure. Monitoring the function of the cardiovascular system for at least 5 days, the function of the central nervous system, breathing, measuring body temperature, consulting a psychiatrist. Dialysis is ineffective. It is not allowed to induce vomiting to empty the stomach.
Side effects Triftazin 5 mg 50 pcs. film-coated tablets
From the nervous system: drowsiness, dizziness, insomnia (at the beginning of treatment), with prolonged use in high doses (0.5 -1.5 g / day) - akathisia, dystonic extrapyramidal reactions (spasms of the muscles of the face, neck and back, tic-like movements or jerking, twisting movements of the body, inability to move the eyes, weakness in the arms and legs), parkinsonism (difficulty speaking and swallowing, loss of balance control, mask-like face, shuffling gait, stiffness in the arms and legs, tremors of the hands and fingers), tardive dyskinesia (smacking and puckering of lips, puffing out of cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of arms and legs), neuroleptic malignant syndrome (seizures, difficulty or rapid breathing, rapid or irregular pulse, hyperthermia, unstable blood pressure, increased sweating, loss of urinary control, severe muscle rigidity, unusually pale skin, excessive fatigue and weakness), phenomena of mental indifference, delayed reaction to external irritations and other mental changes, convulsions.
From the genitourinary system: urinary retention, decreased potency, frigidity (at the beginning of treatment), decreased libido, ejaculation disorders, priapism, oliguria.
From the endocrine system: hypo- or hyperglycemia, hyperprolactinemia, galactorrhea, swelling or pain in the mammary glands, gynecomastia, amenorrhea, dysmenorrhea, weight gain.
From the digestive system: loss of appetite, dry mouth, constipation (at the beginning of treatment), bulimia or anorexia, nausea, vomiting, diarrhea, gastralgia, cholestatic jaundice, hepatitis, intestinal paresis.
From the senses: visual impairment - accommodation paresis (at the beginning of treatment), retinopathy, clouding of the lens and cornea, blurred visual perception.
From the hematopoietic organs: inhibition of bone marrow hematopoiesis (thrombocytopenia, leukopenia, agranulocytosis (4-10 weeks of treatment), pancytopenia, eosinophilia), hemolytic anemia.
Laboratory indicators: false-positive tests for pregnancy and phenylketonuria.
From the cardiovascular system: tachycardia, decreased blood pressure (including orthostatic hypotension) especially in elderly patients and persons with alcoholism (at the beginning of treatment), heart rhythm disturbances, prolongation of the QT interval, decrease or inversion of the T wave, increased frequency of attacks of angina pectoris (against the background of increased physical activity).
Allergic reactions: skin rash, urticaria, exfoliative dermatitis, angioedema.
Other: skin coloring from blue-violet to brown, photosensitivity, discoloration of the sclera and cornea, decreased tolerance to high temperatures (up to the development of heat stroke - hot dry skin, loss of the ability to sweat, confusion), myasthenia gravis.
Drug interactions
Weakens the effects of levodopa and phenamine derivatives, the latter reduce the antipsychotic activity of trifluoperazine. Enhances the effect of ethanol and other drugs that depress the central nervous system (general anesthesia, narcotic analgesics, opioids, barbiturates), as well as atropine.
When taken simultaneously with antiepileptic drugs (including barbiturates), trifluoperazine reduces their effect (lowers the epileptic threshold).
Reduces the effect of anorexigenic drugs (with the exception of fenfluramine).
Reduces the effectiveness of the emetic effect of apomorphine, enhances its inhibitory effect on the central nervous system.
Increases plasma concentrations of prolactin and interferes with the action of bromocriptine. When used together with tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors, it is possible to prolong and intensify the sedative and anticholinergic effects, with thiazide diuretics - the occurrence of electrolyte imbalance, with lithium preparations - a decrease in absorption in the gastrointestinal tract, an increase in the rate of excretion of lithium by the kidneys, increased severity extrapyramidal disorders, early signs of lithium intoxication (nausea and vomiting) may be masked by the antiemetic effect of trifluoperazine.
When combined with beta-blockers, it enhances the hypotensive effect, increasing the risk of developing irreversible retinopathy, arrhythmias and tardive dyskinesia. Reduces the effect of indirect anticoagulants.
The use of alpha and beta adrenergic agonists (epinephrine) and sympathomimetics (ephedrine) can lead to a paradoxical decrease in blood pressure. Amitriptyline, amantadine, H1-histamine receptor blockers and other drugs with an m-anticholinergic effect increase m-anticholinergic activity. Aluminum and magnesium-containing antacid drugs or antidiarrheal adsorbents reduce absorption.
Antithyroid drugs increase the risk of developing agranulocytosis. Probucol, astemizole, cisapride, disopyramide, erythromycin, pimozide, procainamide, quinidine further prolong the QT interval, which increases the risk of developing ventricular tachycardia.
With the simultaneous use of phenothiazides with propranolol, an increase in the concentration of both drugs is observed.
Triphtazinum
From the central nervous system:
drowsiness, dizziness, insomnia (at the beginning of treatment), dry mouth; with long-term use of high doses - akathisia, dystonic extrapyramidal disorders (spasms of the muscles of the face, neck and back, tic-like movements or twitching, twisting movements of the body, inability to move the eyes, weakness in the arms and legs), parkinsonism (difficulty speaking and swallowing, loss of control balance, mask-like face, shuffling gait, stiffness of arms and legs, trembling of hands and fingers), tardive dyskinesia (smacking and wrinkling of lips, puffing out of cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of arms and legs).
Dyskinesias are relieved by subcutaneous injection of 2 ml of 20% sodium caffeine solution and 1 ml of 0.1% atropine solution), neuroleptic malignant syndrome (convulsions, difficulty or rapid breathing, rapid heartbeat or irregular pulse, hyperthermia, unstable blood pressure, sweating, loss of control urination, pronounced muscle rigidity, unusually pale skin, unusual fatigue and weakness), phenomena of mental indifference, delayed reaction to external irritations and other mental changes, in isolated cases - convulsions (antiparkinsonian drugs are used as correctors - tropacin, cyclodol, etc.) ; paradoxical reactions - hallucinations, psychomotor agitation.
From the senses
: blurred visual perception, accommodation paresis (at the beginning of treatment); with long-term use - retinopathy, clouding of the lens and cornea.
From the digestive system
: loss of appetite, anorexia, constipation (at the beginning of treatment), bulimia, nausea, vomiting, diarrhea, gastralgia; rarely - cholestatic jaundice, hepatitis, intestinal paresis.
From the genitourinary system
: urinary retention, decreased potency and libido, frigidity (at the beginning of treatment), ejaculation disorders, priapism, oliguria.
From the endocrine system
: hypo- or hyperglycemia, glycosuria, amenorrhea, hyperprolactinemia, dysmenorrhea, galactorrhea, swelling or pain in the mammary glands, gynecomastia, weight gain.
From the cardiovascular system
: tachycardia, increased frequency of angina attacks (against the background of increased physical activity), at the beginning of treatment - a decrease in blood pressure (including orthostatic hypotension), especially in elderly patients and people suffering from alcoholism; heart rhythm disturbances, changes in the electrocardiogram (prolongation of the QT interval, decrease or inversion of the T wave).
Allergic reactions
: skin rash, urticaria, angioedema, exfoliative dermatitis.
Laboratory indicators
: leukopenia, thrombocytopenia, anemia, agranulocytosis (on days 4-10 of treatment), pancytopenia, eosinophilia (less common than other phenothiazines), hemolytic anemia, false-positive tests for phenylketonuria, false-positive pregnancy tests.
Others
: photosensitivity, staining of the skin and conjunctiva, discoloration of the sclera and cornea, decreased tolerance to high temperatures (up to the development of heat stroke - hot dry skin, loss of the ability to sweat, muscle weakness, confusion), myasthenia gravis.
Cases of sudden death (including those possibly caused by cardiac causes) have been reported when taking phenothiazine antipsychotics.
