Paroxetine
Paroxetine: 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: Paroxetine
ATX code: N06AB05
Active ingredient: paroxetine (paroxetine)
Producer: Replek Farm Skopje, LLC (Republic of Macedonia), Ozon, LLC (Russia)
Description and photo update: 2018-21-11
Prices in pharmacies: from 288 rubles.
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Paroxetine is an antidepressant.
Release form and composition
Paroxetine is available in the form of film-coated tablets: round, biconvex, white, with a dividing line, with a rough shell (7, 10, 14, 20, 25 or 30 pieces in a blister strip, in a cardboard box 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 packs; 10, 20, 30, 40, 50 or 100 pcs. In a jar, in a cardboard box 1 jar).
1 tablet contains:
- active substance: paroxetine hydrochloride hemihydrate - 22.76 mg or 34.14 mg, which is equivalent to the content of 20 mg or 30 mg of paroxetine, respectively;
- auxiliary components: colloidal silicon dioxide, copovidone, crospovidone, microcrystalline cellulose, magnesium stearate, calcium hydrogen phosphate, talc;
- shell: macrogol 6000, hypromellose, titanium dioxide, talc.
Pharmacological properties
Pharmacodynamics
Paroxetine is a drug for the treatment of depressive conditions. The antidepressant effect, effectiveness in the treatment of panic and obsessive-compulsive disorder (OCD) is due to its selective inhibition of the reuptake of serotonin (5-HT, 5-hydroxytryptamine) by neurons in the brain.
The weak anticholinergic effect of paroxetine contributes to its slight affinity for alpha 1 -, alpha 2 - and beta-adrenergic receptors, m-cholinergic receptors, dopamine (D 2), histamine H 1 -receptors, 5HT 1 -like, 5HT 2 -like receptors. The activity of paroxetine does not cause disturbances in psychomotor functions, does not enhance the inhibitory effect of ethanol on them.
When the doses of Paroxetine, necessary to inhibit serotonin uptake, are exceeded, according to the results of behavioral studies and EEG (electroencephalography), weak activating properties of the drug are revealed. There may be a slight change in the EEG, blood pressure (BP) and heart rate (HR).
Pharmacokinetics
After the drug enters the gastrointestinal tract, it is absorbed, followed by a metabolic process by first passing through the liver.
The equilibrium concentration of the drug is achieved after 7-14 days of therapy. The drug is characterized by a nonlinear dependence of pharmacokinetic parameters on the dose and / or treatment period.
Paroxetine is extensively distributed in tissues; only 1% of the dose taken is present in plasma.
Linking blood proteins - 95%.
Inhibits the isoenzyme CYP2D6. The drug metabolism occurs in the liver with the formation of inactive metabolites. The main metabolites include conjugated and polar oxidation and methylation products with insignificant pharmacological activity. Without participating in the therapeutic effect of the drug, they are quickly excreted from the body. The selective uptake of serotonin by neurons due to the action of paroxetine during metabolism is not impaired.
The half-life is approximately 24 hours.
64% of paroxetine is excreted through the kidneys in the form of metabolites and 2% - unchanged.
Less than 1% is excreted through the intestines unchanged, the rest of the drug is in the form of metabolites.
The first phase of excretion of metabolites occurs as a result of the first passage of paroxetine through the liver, in the second phase the excretion process is controlled by systemic elimination.
In case of impaired liver and / or kidney function and in elderly people, the level of paroxetine concentration in blood plasma increases.
Indications for use
- reactive depression, severe endogenous depression, depression accompanied by anxiety, and other types of depression;
- generalized anxiety disorder;
- obsessive compulsive disorder;
- social phobia (social anxiety disorder);
- panic disorder with and without agoraphobia.
Contraindications
- unstable epilepsy;
- concomitant therapy with monoamine oxidase (MAO) inhibitors and within 14 days after their withdrawal;
- period of pregnancy;
- breast-feeding;
- childhood;
- hypersensitivity to the components of the drug.
According to the instructions, Paroxetine should be prescribed with caution in case of mania, convulsive conditions, epilepsy, angle-closure glaucoma, hepatic and / or renal failure, heart pathology, prostatic hyperplasia, simultaneous electrical pulse therapy, in combination with drugs that increase the risk of bleeding, patients with factors the risk of increased bleeding; and diseases that increase the risk of bleeding.
Instructions for the use of Paroxetine: method and dosage
The tablets are taken orally, in the morning, once a day, during meals, swallowing whole and drinking plenty of water.
The dose should be selected individually during the first 14–21 days of therapy. If necessary, it can be corrected later.
Recommended daily dosage:
- depression: the initial dose is 20 mg, to achieve the desired therapeutic effect, it can be gradually increased by 10 mg. The maximum daily dose is 50 mg;
- generalized anxiety disorders: 20 mg;
- obsessive-compulsive disorder: the initial dose is 20 mg, it should be increased by 10 mg every 7 days. The average therapeutic dose is 40 mg. The maximum daily dose is 60 mg;
- social anxiety disorders (social phobia): initial dose - 20 mg. In the absence of a therapeutic effect after 14 days of using the drug, it should be increased by 10 mg at intervals of at least 7 days, taking into account the clinical condition of the patient. The maximum daily dose is 50 mg;
- panic disorder: the initial dose is 10 mg (to reduce the risk of developing a possible exacerbation of panic symptoms), every 7 days it is increased by 10 mg. The average therapeutic daily dose is 40 mg, the maximum dose is 50 mg.
In elderly patients, the daily dose should not exceed 40 mg.
Patients with renal and / or hepatic insufficiency are shown to use the drug in a dose of not more than 20 mg per day.
Termination of therapy should be done by gradually reducing the dose of the drug, this will avoid the development of withdrawal syndrome.
Side effects
- from the nervous system: fatigue, drowsiness, anxiety, dizziness, insomnia, tremor, asthenia, nervousness, extrapyramidal disorders, hallucinations, confusion, serotonin syndrome, mania, agitation, panic attacks, depersonalization, amnesia, myoclonus, convulsions;
- on the part of the cardiovascular system: orthostatic hypotension;
- from the digestive system: dry mouth, change in taste, increase or decrease in appetite, nausea, vomiting, diarrhea, constipation; possibly hepatitis;
- from the senses: visual impairment;
- from the urinary system: frequent urination, urinary retention;
- from the musculoskeletal system: muscle weakness, myopathy, arthralgia, myalgia;
- from the reproductive system: impotence, ejaculation disorder, hyperprolactinemia, anorgasmia, other sexual dysfunctions;
- allergic reactions: itching, rash, ecchymosis, urticaria, angioedema;
- others: rhinitis, increased sweating, impaired secretion of antidiuretic hormone, hyponatremia.
Overdose
Symptoms: dry mouth, sweating, drowsiness, nausea, vomiting, irritability, tremor, nystagmus, mydriasis, agitation, convulsions, sinus tachycardia, increased blood pressure, bradycardia, junctional rhythm; in very rare cases (against the background of the simultaneous use of other psychotropic drugs and / or alcohol) - changes in electrocardiography, coma. When taking a significant dose, it is possible to develop serotonin syndrome, rarely - rhabdomyolysis.
Treatment: there is no specific antidote, so the patient should immediately rinse the stomach, take activated charcoal. After that, symptomatic therapy is carried out according to indications.
special instructions
Since there is a risk of suicidal attempts during the first weeks of using Paroxetine, careful monitoring of the patient's condition is required.
Elderly people may experience hyponatremia while taking paroxetine.
With the simultaneous use of insulin and / or oral hypoglycemic agents, their dose may need to be adjusted.
Treatment should be discontinued when seizures develop, the first signs of mania appear.
Care should be taken with concomitant neuroleptic therapy to prevent the development of neuroleptic malignant syndrome.
Alcohol consumption during treatment is contraindicated.
Influence on the ability to drive vehicles and complex mechanisms
It is recommended to refrain or take special care when driving vehicles and performing other potentially hazardous activities that require increased attention and high speed of psychomotor reactions.
Application during pregnancy and lactation
The use of Paroxetine is contraindicated during gestation and during breastfeeding.
Pediatric use
The drug should not be prescribed in childhood, since the safety and efficacy of Paroxetine in this category of patients have not been established.
With impaired renal function
Care should be taken when prescribing Paroxetine to patients with renal insufficiency.
In renal failure, treatment is indicated in a daily dose of 20 mg.
For violations of liver function
Care should be taken when prescribing Paroxetine to patients with hepatic insufficiency.
In case of liver failure, treatment is indicated in a daily dose of not more than 20 mg.
Use in the elderly
The daily dose for elderly patients should not exceed 40 mg.
Drug interactions
With the simultaneous use of Paroxetine:
- MAO inhibitors should not be used. In addition, you can start taking paroxetine no earlier than 14 days after their cancellation;
- medicines that inhibit liver enzymes may require a dose reduction of paroxetine;
- antacids do not affect the absorption of the drug and its pharmacokinetic parameters;
- procyclidine increases its concentration;
- phenothiazine antipsychotics, tricyclic antidepressants, barbiturates, phenytoin, metoprolol, indirect anticoagulants, class 1C antiarrhythmics can enhance their therapeutic effect and increase the risk of side effects;
- ethanol enhances its toxic effect;
- warfarin against the background of unchanged prothrombin time increases bleeding time;
- atypical antipsychotics, tricyclic antidepressants, phenothiazine drugs, nonsteroidal anti-inflammatory drugs, acetylsalicylic acid can contribute to disruption of the blood coagulation process;
- tramadol, sumatriptan (serotonergic drugs) may increase the serotonergic effect;
- tryptophan, lithium preparations contribute to the mutual enhancement of the action;
- phenytoin and other anticonvulsants may increase the incidence of unwanted effects;
- guanethidine somewhat weakens its antihypertensive effect, but to a much lesser extent than when combined with antidepressants that inhibit the uptake of norepinephrine.
Analogs
Paroxetine analogs are: Actaparoxetine, Apo-Paroxetine, Plizil, Serlift, Fluxen, Paroxin, Reksetin, Adepress, Paxil.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, protected from moisture and light.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Paroxetine
Reviews of Paroxetine are mostly positive. The effectiveness of the drug is confirmed by patients and doctors. The action of the drug helps to restore emotional and mental stability.
With prolonged use of tablets, the development of drug dependence, undesirable phenomena, including from the reproductive system, is possible. Patients are advised to be careful when driving, as the drug disrupts the coordination of movements.
The price of Paroxetine in pharmacies
The price of Paroxetine for a package containing 30 tablets can range from 304 to 356 rubles.
Paroxetine: prices in online pharmacies
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Drug name Price Pharmacy |
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Paroxetine 20 mg film-coated tablets 30 pcs. 288 r Buy |
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Paroxetine tablets p.p. 20mg 30 pcs. 368 RUB Buy |
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Paroxetine 20 mg film-coated tablets 30 pcs. 368 RUB 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!
