Plizil
Plizil: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Plisil
ATX code: N06AB05
Active ingredient: paroxetine (paroxetine)
Manufacturer: Pliva Hrvatska d.o.o. (Republic of Croatia)
Description and photo update: 2018-21-11
Prices in pharmacies: from 279 rubles.
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Plizil is an antidepressant.
Release form and composition
Dosage form Plizila - film-coated tablets: round, from yellow to orange, with a line on both sides, engraved with "ROT 20" on one side (10 pcs. In blisters, in a cardboard box 3 blisters).
Composition of 1 tablet:
- active substance: paroxetine mesylate - 25.83 mg, which corresponds to the content of paroxetine - 20 mg;
- auxiliary components: sodium carboxymethyl starch, anhydrous calcium hydrogen phosphate, magnesium stearate;
- the composition of the film shell: hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E171), dyes of iron oxide red (E172) and iron oxide yellow (E172).
Pharmacological properties
Pharmacodynamics
Paroxetine - the active substance Plizil - is a selective inhibitor of the reuptake of 5-hydroxytryptamine (5-HT, serotonin) by neurons in the brain. This property determines its antidepressant effect and effectiveness in panic and obsessive-compulsive disorders.
The main metabolites of the drug are conjugated and polar products of methylation and oxidation, which are rapidly excreted from the body, have weak pharmacological activity and do not affect the therapeutic effect of paroxetine. Selective uptake of 5-HT by neurons caused by the action of paroxetine is not impaired during its metabolism.
The drug is characterized by low affinity for muscarinic cholinergic receptors.
Unlike tricyclic antidepressants, paroxetine, having a selective effect, also has low affinity for α 1 -, α 2 and β-adrenergic receptors, H 1 -histamine receptors, 5-HT 1 - and 5-HT 2 -serotonin and dopamine receptors …
In the course of studies of electroencephalography and behavior, it has been established that paroxetine has a weak activating effect when used in higher doses than is necessary to inhibit the uptake of 5-HT.
Unlike antidepressants that inhibit the reuptake of norepinephrine, paroxetine suppresses the antihypertensive effects of guanethidine much weaker.
In healthy volunteers, the drug did not cause significant changes in heart rate, blood pressure, and electroencephalography indicators.
Plizil does not have a negative effect on psychophysical functions, does not enhance the depressing effect of ethanol.
Pharmacokinetics
After oral administration, paroxetine is well absorbed. Metabolized during the first passage through the liver. In unchanged form, less than 2% of the taken dose of the drug is excreted in the urine, in the form of metabolites - about 64%. The intestine excretes approximately 36% of the dose, probably through bile, in which the concentration of unchanged paroxetine is less than 1% of the dose.
Paroxetine metabolites are excreted from the body in two phases: primary metabolism occurs during the first passage through the liver, then excretion is controlled by systemic elimination. Due to the stage of the first passage through the liver, the determined concentration of paroxetine in the systemic circulation is lower than the amount of the drug absorbed from the gastrointestinal tract.
With an increase in the dose of Plizil and with repeated dosing, when the load on the body increases, the effect of the first passage through the liver is partially absorbed, and the plasma clearance of paroxetine decreases.
The half-life can vary, averaging 16-21 hours. The maximum concentration is observed 7-14 days after the start of treatment. With prolonged use of Plizil, the pharmacokinetics does not change, as a result of which it is possible to increase the plasma concentration of the drug and fluctuate its pharmacokinetic parameters. This can only be seen in patients in whom low plasma levels of paroxetine are achieved with low doses.
The drug is extensively distributed in tissues. According to pharmacokinetic calculations, only 1% of the dose is present in plasma, while at therapeutic concentrations 95% is bound to plasma proteins.
The efficacy and side effects of paroxetine do not depend on its plasma concentration.
Indications for use
- social anxiety disorder, social phobia;
- panic disorder, including with agoraphobia;
- generalized anxiety disorder;
- obsessive compulsive disorder;
- depression of all types, including severe endogenous, reactive and depression, accompanied by anxiety;
- post-traumatic stress disorder.
Contraindications
Absolute:
- simultaneous use of monoamine oxidase inhibitors (MAO) and 14 days after their cancellation;
- age up to 18 years;
- period of pregnancy and lactation;
- hypersensitivity to any component of Plizil.
Relative (the drug is used with extreme caution):
- convulsive conditions;
- stable epilepsy (if unstable, it is recommended to avoid taking paroxetine);
- the appointment of electrical impulse therapy;
- mania;
- heart pathology;
- angle-closure glaucoma;
- hepatic / renal failure;
- hyperplasia of the prostate;
- the presence of diseases or risk factors that increase the likelihood of bleeding;
- simultaneous use of drugs that increase the risk of bleeding;
- elderly age.
Instructions for use Plizil: method and dosage
Plizil should be taken orally once a day, with meals, in the morning: swallow the tablets whole and drink plenty of water.
The optimal dose is selected individually for 2-3 weeks, if necessary, it is further adjusted.
Recommended daily doses of Plizil:
- social anxiety disorders, social phobia: initial dose - 20 mg. Efficiency is assessed no earlier than 2 weeks later. If necessary, the dose is gradually increased (by 10 mg once a week), the maximum allowable dose is 50 mg;
- panic disorder: the initial dose is 10 mg, then the dose is increased by 10 mg once a week. The average therapeutic dose is usually 40 mg, the maximum allowable is 50 mg;
- generalized anxiety disorders: 20 mg each;
- obsessive-compulsive disorder: the initial dose is 20 mg, then the dose is increased by 10 mg once a week. The average therapeutic dose is usually 40 mg, the maximum allowable is 60 mg;
- depression: 20 mg, if necessary, the dose is gradually increased (by 10 mg per day), but not more than 50 mg (maximum);
- post-traumatic mental disorders: the initial dose in most cases is 20 mg, if necessary, it is gradually increased (by 10 mg once a week) to a maximum of 50 mg.
The recommended daily dose of Plizil for patients with renal and hepatic insufficiency is 20 mg.
For elderly patients, the dose should not exceed 40 mg per day.
In the course of therapy, the effectiveness of Plizil should be assessed and, if necessary, the dose should be adjusted: at the beginning of treatment, regularly for 2-3 weeks, then as needed.
The duration of taking the drug is determined individually. To consolidate the effect after the disappearance of symptoms, treatment should be continued for at least 4-6 months in case of depression and more in case of panic and obsessive-compulsive disorders.
In order to avoid the development of withdrawal syndrome, you should stop taking Plizil gradually.
Side effects
- from the nervous system: panic attacks, confusion, fatigue, insomnia / drowsiness, convulsions, asthenia, paresthesia, anxiety, hallucinations, dizziness, decreased ability to concentrate, agitation, nervousness, tremors, mania, extrapyramidal disorders, depersonalization, serotonin syndrome;
- from the digestive system: constipation or diarrhea, decreased appetite, dry mouth, nausea, vomiting; in very rare cases - hepatitis;
- from the genitourinary system: increased urination, urinary retention, anorgasmia, decreased libido, sexual dysfunction, including ejaculation disorder and impotence;
- on the part of the cardiovascular system: orthostatic hypotension;
- on the part of the musculoskeletal system: myopathy, arthralgia, myasthenia gravis, myalgia;
- from the senses: changes in taste, visual impairment;
- allergic reactions: rash, urticaria, itching, ecchymosis, angioedema;
- others: increased sweating, hyperprolactinemia, galactorrhea, impaired secretion of antidiuretic hormone, hyponatremia; in case of abrupt cessation of treatment - withdrawal syndrome.
Overdose
Symptoms: drowsiness, anxiety, agitation, headache, dilated pupils, nystagmus, tremors, dry mouth, nausea, vomiting, fever, involuntary muscle contractions, sweating, junctional rhythm, changes in blood pressure, bradycardia, sinus tachycardia. With the simultaneous use of other psychotropic drugs and / or alcohol, in rare cases, changes in the electrocardiogram may occur, and coma is possible.
After taking a dose of Plizil, which is significantly higher than the recommended one, gastric lavage and the intake of activated carbon are indicated. There is no specific antidote. Further treatment is symptomatic.
special instructions
During the entire period of treatment, it is necessary to closely monitor the patients in connection with the likelihood of suicidal attempts. Young people under the age of 25 are at increased risk of suicide, especially in the first weeks of treatment and the first weeks after it ends.
Alcohol should not be consumed during therapy.
Patients undergoing therapy with MAO inhibitors can be prescribed Plizil no earlier than 2 weeks after their cancellation.
In some cases, paroxetine interferes with the action of insulin and / or oral hypoglycemic agents, which requires their correction.
The drug is discontinued if seizures develop. It is necessary to stop taking Plizil when the first signs of mania appear.
In connection with the risk of neuroleptic malignant syndrome, special care should be taken with the simultaneous use of antipsychotics.
Elderly patients may develop hyponatremia.
Influence on the ability to drive vehicles and complex mechanisms
Paroxetine does not impair psychomotor and cognitive function. Nevertheless, during the period of therapy with Plizil, like other psychotropic drugs, it is recommended to refrain from engaging in potentially hazardous activities that require speed of reactions and increased attention.
Application during pregnancy and lactation
The drug is not used to treat pregnant and breastfeeding women.
Pediatric use
According to the instructions, Plizil is not recommended for use in pediatrics, since the safety and efficacy of paroxetine in children and adolescents under 18 have not been established.
With impaired renal function
In case of impaired renal function, Plizil is used with caution. The recommended daily dose is 20 mg.
For violations of liver function
For violations of liver function, Plizil is used with caution. The recommended daily dose is 20 mg.
Use in the elderly
In old age, Plizil is used with caution. The daily dose should not exceed 40 mg.
Drug interactions
Food and antacids do not affect the absorption and effectiveness of Plizil.
Due to incompatibility, paroxetine is contraindicated to be used simultaneously with thioridazine and MAO inhibitors.
Antipsychotics increase the risk of developing neuroleptic malignant syndrome.
Inducers and inhibitors of liver enzymes can affect the metabolism and pharmacokinetics of the drug, which may require dose adjustment.
With the simultaneous use of tryptophan and lithium preparations, a mutual strengthening of the action is noted. Tryptophan is not recommended during Plizil therapy. If it is necessary to take lithium preparations, their concentration in the blood should be monitored.
Paroxetine can increase the concentration of procyclidine, as well as increase the bleeding time in patients receiving warfarin (with constant prothrombin time).
During therapy, the toxic effect of ethanol may increase, so you should refrain from drinking alcohol.
Serotonergic drugs (such as tramadol or sumatriptan) can increase the serotonergic effect.
Phenytoin and other anticonvulsants may decrease the concentration of paroxetine and increase the incidence of side effects.
Due to the inhibition of cytochrome P 450 by paroxetine, it is possible to increase the action and increase the risk of side effects with the simultaneous use of the following drugs: metoprolol, phenothiazine antipsychotics (for example, thioridazine), indirect anticoagulants, phenytoin, barbiturates, class 1C antiarrhythmics (including propafenone), tricyclic antidepressants (imipramine, amitriptyline, fluoxetine, desipramine, nortriptyline).
Due to possible blood clotting disorders, it is recommended to be careful with the simultaneous use of aspirin, nonsteroidal anti-inflammatory drugs, tricyclic antidepressants, phenothiazines, atypical antipsychotics.
Analogs
Plizil's analogs are Adepress, Aktaparoxetine, Apo-Paroxetine, Paroxetine, Paxil, Plizil N, Sirestill, Reksetin.
Terms and conditions of storage
The shelf life is 3 years.
Keep out of reach of children at temperatures up to 30 ° C.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Plizil
According to reviews, Plizil is an effective antidepressant agent that is well tolerated and has few contraindications. Many people notice a noticeable improvement in their condition after taking the first pill. However, it is not recommended to change the dose on your own, as this is fraught with the development of undesirable effects, and you should not abruptly stop treatment, otherwise there is a likelihood of a withdrawal syndrome (including nausea and lethargy).
In some reviews, side effects from the gastrointestinal tract are described, due to which the drug had to be canceled.
Plizil price in pharmacies
The approximate price for Plizil is 410 rubles per pack of 30 tablets.
Plizil: prices in online pharmacies
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Drug name Price Pharmacy |
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Plizil N 20 mg film-coated tablets 30 pcs. 279 r Buy |
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Plizil 20 mg film-coated tablets 30 pcs. 353 r Buy |
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Plizil N tablets p.p. 20mg 30 pcs. 439 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
