Paroxetine hydrochloride hemihydrate 22.8 milligrams (equivalent to 20.0 milligrams paroxetine), as excipients: calcium dihydrogen phosphate dihydrate, sodium carboxymethyl starch Type A magnesium stearic shell tablets - white Opadry YS - 1R - 7003 (macrogol 400, titanium dioxide, hypromellose, polysorbate 80).
The drug is available in biconvex tablets, packaged in blisters of 10 pcs., In one package there can be one, three or ten blisters.
Renders antidepressant effect by the mechanism of specific inhibition by reuptake serotonin in functional brain cells - neurons.
Pharmacodynamics and pharmacokinetics
Has a low affinity for muscarinic cholinergic receptors. As a result of the research, data were obtained that:
- On animals anticholinergic properties manifest weakly.
- In vitro Paroxetine Studies - Weak Affinity α1-, α2- and β-adrenergic receptorsincluding to dopamine (D2), serotonin subtype 5-HT1- and 5-NT2-, including histamine receptors (H1).
- In vivo studies confirm in vitro results - does not interact with postsynaptic receptors and does not depress the central nervous system and does not cause arterial hypotension.
- Without breaking psychomotor functions, paroxetine does not increase the inhibitory effect ethanolon central nervous system.
- Study behavioral changes and EEG showed that paroxetine is able to cause a weak activating effect in a dose exceeding the retardation of serotonin reuptake, while the mechanism is not amphetamine-like.
- On a healthy body, paroxetine does not have significant changes in blood pressure (blood pressure), Heart rateand ECG.
As for the pharmacokinetics, after oral administration, the drug absorbedand metabolizedwith the "first passage" of the liver, resulting in bloodless paroxetine than absorbed from the digestive tract. By increasing the amount of paroxetine in the body (a single dose of large doses or multiple doses of the usual doses), partial saturation is achieved metabolic pathway and reduced clearance of paroxetine plasma, leading to a disproportionate increase in plasma paroxetine concentrations. This means that the pharmacokinetic parameters are unstable and the kinetics is nonlinear. However, nonlinearity is usually poorly expressed and is observed in patients taking low doses of the drug, which cause low levels of paroxetine in plasma. It is possible to achieve equilibrium plasma concentration in 1-2 weeks.
Paroxetine is distributed in the tissues, and according to pharmacokinetic calculations, 1% of the total amount of paroxetine that is present in the body remains in plasma. At therapeutic concentrations, approximately 95% of plasma paroxetine is associated with squirrels. No relationship was found between the concentration of paroxetine in plasma and clinical effects, adverse reactions. He is able to penetrate breast milk and in embryos.
Biotransformationoccurs in 2 phases: including primary metabolismand system eliminationbefore inactive polar and conjugated products as a result of the process oxidationand methylation. Half-life varies between 16-24 hours. Approximately 64% are excreted in the urine as metabolites, 2% - unchanged; the rest - with feces as metabolitesand 1% - unchanged.
Indications for use
The drug is used for all types depression in adults, including reactive and severe, accompanied by anxiety, obsessive-compulsive disorder for maintenance and preventive therapy. Children and adolescents 7-17 years old with panic disorders with agoraphobia and without, social phobias, generalized anxiety disorders, post-traumatic stress disorders.
Hypersensitivity to paroxetine or other constituent components.
A decrease in the frequency and intensity of individual side effects of paroxetine occurs as treatment progresses, and therefore does not require cancellation. The frequency gradation is as follows:
- very often (≥1 / 10);
- often (≥1 / 100, <1/10);
- sometimes happens (≥1 / 1000, <1/100);
- rarely (≥1 / 10,000, <1/1000);
- very rarely (<1/10 000), given individual cases.
Frequent and very frequent occurrence is determined on the basis of generalized data on the safety of the drug in more than 8 thousand patients. Clinical trials were conducted to calculate differences in the incidence of side effects in the Paxil group and the second placebo group. The occurrence of side effects of Paxil rare or very rare is determined based on post-marketing information on the frequency of messages, and not the true frequency of these effects.
Side effects indicators are stratified by organs and frequency:
- Blood and lymphatic system: rarely happen abnormal bleeding(hemorrhage in the skin and mucous membranes). Very rarely possible thrombocytopenia.
- Endocrine system: very rarely - violation of secretion ADH.
- The immune system: very rarely happen allergic reactions of type urticaria and angioedema.
- Metabolism: "often" cases of decline appetite, sometimes in elderly patients with impaired ADH secretion - hyponatremia.
- CNS: often arises drowsinessor insomnia, convulsive seizures; seldom - blurred consciousness, hallucinations, manic reactions as possible symptoms of the disease itself.
- Vision: very rarely occurs exacerbation of glaucomahowever, “often” is blurred vision.
- The cardiovascular system: "rarely" noted sinus tachycardiaas well as a transient decline or increase in blood pressure.
- Respiratory system, chest and mediastinum: "often" noted yawn.
- Gastrointestinal tract:"very often" fixed nausea; often - constipationor diarrhea at dry mouth; gastrointestinal bleeding is very rare.
- Hepatobiliary system: quite "rare" was observed an increase in the level of production liver enzymes; very rare cases hepatitis Aaccompanied by jaundiceand / or liver failure.
- Epidermis: often recorded sweating; rare case skin rashesand very rare - reactions photosensitivity.
- urinary system: rarely recorded the delay urine.
- Reproductive system: very often - cases sexual dysfunction; seldom - hyperprolactinemia and galactorrhea.
- Among the common violations: often fixed astheniaand very rarely - peripheral edema.
An approximate list of symptoms that may occur after completion of the course is established. paroxetine: "often" noted dizziness and others sensory disturbancessleep disturbances, the presence of anxiety, headache; sometimes - strong emotional arousal, nausea, tremor, sweating, as well as diarrhea. Most often, these symptoms in patients are mild and mild, pass without intervention. Groups of patients at increased risk of side effects have not been registered, but if there is no greater need for treatment with paroxetine, the dose is gradually reduced until completely withdrawn.
Paxil tablets, instructions for use (method and dosage)
Tablets are taken orally, swallowing whole and not chewing. Take once a day in the morning with meals.
At depressionFor adults, a dose of 20 mg per day is recommended, if necessary, the dose can be increased every week by 10 mg per day to a maximum daily concentration of 50 mg. The dose of paroxetine is adjusted after 2-3 weeks of treatment and then it all depends on the clinical indications.
Dose at obsessive-compulsive disorder for adults - 40 mg per day, starting with a dose of 20 mg per day and every 7 days increasing by 10 mg per day. The maximum dose per day is 60. For ages 7 to 17, you need to start with a dose of 10 mg per day, increasing weekly to 10 mg per day, maximum 50 mg per day.
At panic disorders usually prescribed for adults 40 mg per day, starting with 10 mg per day and every 7 days increasing by 10 mg per day depending on the clinical effects, maximum 60 mg per day. The initial dose is minimized so as not to aggravate the symptoms of panic disorder that occurs at the beginning of treatment of any kind antidepressants.
Social phobias: for adults, 20 mg per day, if necessary, increase the dose every week by 10 mg per day to 50 mg per day. Treatment for children aged 7 to 17 years is prescribed with a dose of 10 mg per day and a subsequent weekly increase of 10 mg per day, the maximum allowable daily dose of 50 mg per day.
Generalized Anxiety Disorder: adult dose of 20 mg per day, increased every week by 10 mg per day, the limit is 50 mg per day.
Instructions for use Paxil for post traumatic stress disorder involves a dosage for adults: 20 mg per day, if necessary increased by 10 mg per day every week to 50 mg per day.
The following symptoms of an overdose are:
- dilated pupils;
- in any of the parties changes in blood pressure;
- involuntary muscle contraction;
Patients returned to normal without serious damage to health, even after a single dose in the range of 2000 mg. Messages have been recorded describing symptoms such as comachanges ECG. In patients taking paroxetine with various psychotropic drugs or with alcoholvery rare cases of death.
The following general measures are shown: gastric lavage, Activated carbon 20-30 mg every 4-6 hours on the first day, also needed maintenance therapy and regular research basic physiological indicators.
Paroxetine does not have specific antidote.
Paroxetine is not recommended for use with MAO inhibitors, and also within 2 weeks after completion of the course; in combination with thioridazine, because, like other drugs that inhibit activity enzyme CYP2 D6 cytochrome P450, increases the concentration of thioridazine in plasma. Paxil is able to enhance the action of alcohol-containing agents and reduce the effectiveness Digoxin and Tamoxifene. Microsomal Oxidation Inhibitors and Cimetidineincrease the activity of paroxetine. Applying with indirect coagulants or antithrombotic agents, an increase in bleeding is observed.
Terms of sale
In a dry place inaccessible to children, protected from light. Allowable temperature no more than 30 ° Celsius.
Stored up to three years.
Paxil and alcohol
As a result of clinical studies, data were obtained that the absorption and pharmacokinetics of the active substance, paroxetine, are almost independent or almost independent (that is, the dependence does not require a dose change) diets and alcohol. Paroxetine not found to enhance the negative effects of ethanol on psychomotorhowever, it is not recommended to take it together with alcohol, since mainly alcohol inhibits the effect of the drug - reducing the effectiveness of treatment.
Testimonials regarding the use of alcohol during treatment with Paxil show that if you drink once, then metabolismmedications will drop sharply - without causing negative consequences, but if you drink regularly - it will, on the contrary, accelerate. Patients suffering from binges with an overdose of Paxil usually either go to hospital in serious condition, or may be fatal outcome.
Paxil's analogsMatches for ATX Level 4 code:ActaparoxetineLickedFluxenParoxinSurfliftAsentraEliceaFluoxetineLenuxinEscitalopramAdepressSelectraStimulusCitalopramCypramilZoloftParoxetineProzacRexetinFevarin
The drugs listed below are analogues of the drug, that is, they also have an international nonproprietary name or other ingredients are available in addition to the active substance - paroxetine:
To replace the drug Paxil with any analogue, be sure to consult a doctor!
Most often, patients' reviews about Paxil are positive: the effect occurs after the first week of admission. On the forums, it is noted that in most cases, side effects and other undesirable symptoms appear weakly and are eliminated spontaneously over time.
At the same time, reviews of doctors about Paxil describe the danger drug withdrawal syndrome, because it can take place in severe form and require the use of tranquilizers, sleeping pills.
After reviewing various reviews and opinions, it can be argued that Paxil cannot be used alone without prescribing and monitoring the dosage by a doctor. It is important to remember that you can not change the dosage, forget about the interaction with other medicines and alcohol.
Paxil price, where to buy
You can buy Paxil with a prescription in the Russian Federation at a price of approximately 700 rubles, in Ukraine the price is from 300 UAH.
- Online Pharmacies in Russia
- Online pharmacies in UkraineUkraine
- Paxil Tab. po about 20mg n30GlaxoSmithKline Pharmaceutical S.A. 671 rub.order
- Paxil Tab. p.o. 20mg n100GlaxoSmithKline Pharmaceutical S.A.1977 rub.order
- Paxil (tablet mp / rev.20mg No. 30) 672 rubles to order
- Paxil (tab.pl./pr. 20mg No. 100) 1976 rub.order
- Paxil (tab.pl./pr. 20mg No. 30) 653 rub.order
- Paxil (tab.pl./pr. 20mg No. 100) 1932 rub.order
- Paxil 20 mg N28 tablets GlaxoSmіt Klein Pharmaceuticals S.A., Poland504 UAH.order