Adepress pills coated 20mg N30
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Active ingredients
Paroxetine
Release form
Pills
Composition
Paroxetine hydrochloride hemihydrate 22.2 mg, which corresponds to a paroxetine content of 20 mg.
Pharmacological effect
Antidepressant. It is a selective serotonin reuptake inhibitor (5-hydroxytryptamine, 5-HT) brain neurons, which determines its antidepressant effect and effectiveness in the treatment of obsessive-compulsive (OCD) and panic disorder. In the metabolism of paroxetine, the selective capture caused by its action 5- NT neurons. Paroxetine has a low affinity for m-cholinergic receptors. Having a selective effect, unlike tricyclic antidepressants, paroxetine showed a low affinity for α1, α2-, β -adrenoreceptors, as well as to dopamine, 5HT1-like, 5HT2-like and histamine H1 receptors. Paroxetine does not violate the psychomotor functions and does not potentiate the inhibitory effect on them of ethanol. According to a study of the behavior and EEG of paroxetine, weak activating properties are detected, and when, appointed in doses higher than those necessary for inhibiting the capture of 5-HT. In healthy volunteers, it does not cause a significant change in the level of blood pressure, heart rate and EEG.
Pharmacokinetics
AbsorptionParoxetine is well absorbed after oral administration and undergoes metabolism of the first passage through the liver. Distribution The equilibrium state is reached in 7-14 days after the start of therapy, and the pharmacokinetics are not changed during long-term therapy. The clinical effects of paroxetine (side effects and efficacy) do not correlate with its concentration in plasma. Since paroxetine is exposed to the effect of first passage through the liver, its amount determined in the systemic circulation is less than that absorbed from the gastrointestinal tract. With an increase in the dose of paroxetine or with repeated dosing, partial absorption of the effect of the first passage through the liver and a decrease in the plasma clearance of paroxetine occur. As a result, it is possible to increase the concentration of paroxetine in plasma and fluctuations in pharmacokinetic parameters, which can be observed only in those patients who receive low levels of paroxetine in plasma when taking the drug in low doses. Paroxetine is extensively distributed in the tissues, and pharmacokinetic calculations show that only 1% of it is present in the plasma,and at therapeutic concentrations of 95% is associated with plasma proteins. Metabolism Paroxetine's main metabolites are polar and conjugated oxidation and methylation products, which are rapidly excreted from the body, have weak pharmacological activity and do not affect its therapeutic action. Paroxetine excretion of paroxetine metabolites biphasic, first as a result of the first passage through the liver, and then it is controlled by systemic elimination. T1 / 2 of paroxetine varies, but is usually about 1 day. The secretion of unchanged paroxetine in the urine is usually less than 2% of the dose, with metabolites making up about 64% of the dose. The intestine excretes about 36% of the dose, probably through bile, in which unchanged paroxetine is less than 1% of the dose. Thus, paroxetine is displayed mainly in the form of metabolites. Pharmacokinetics in special clinical situations Concentration of paroxetine in the blood plasma increases with impaired liver and kidney function, as well as in elderly people, while the range of plasma concentrations almost coincides with the range of concentrations in healthy adult volunteers.
Indications
Depression of all types, including reactive, severe endogenous depression and depression, accompanied by anxiety; Obsessive-compulsive disorder (OCD); Panic disorder, incl. with fear of being in a crowd (agoraphobia); Social anxiety disorder / social phobia; Generalized anxiety disorder; Post-traumatic stress disorder.
Contraindications
Simultaneous intake of MAO inhibitors and a period of 14 days after their cancellation; Unstable epilepsy; Pregnancy and lactation period (breastfeeding); Children's age; Increased sensitivity to the components of the drug. With caution: in liver failure, renal failure, angle-closure glaucoma, prostatic hyperplasia, mania, heart disease, epilepsy, convulsive states, simultaneous prescription of electropulse therapy, simultaneous use of drugs that increase the risk of bleeding, the presence of Ktorov risk of increased bleeding, and diseases that increase the risk of bleeding, as well as elderly patients.
Precautionary measures
Do not exceed the recommended dose. With caution, you should prescribe the drug for liver failure, renal failure, angle-closure glaucoma, prostate hyperplasia, mania, heart disease, epilepsy, convulsive states, simultaneous appointment of electropulse therapy, simultaneous administration of drugs that increase the risk of bleeding, the presence of risk factors increased bleeding and diseases that increase the risk of bleeding, as well as elderly patients.
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation.
Dosage and administration
Adepress pills should be taken 1 time / day, in the morning, during meals, without chewing, drinking water. The dose is adjusted individually for the first 2-3 weeks after the start of therapy and subsequently adjusted if necessary. The effect in most cases develops gradually. The dose should be increased by 10 mg every week to achieve a therapeutic effect. The maximum daily dose should not exceed 60 mg / day. In renal and / or liver failure, the recommended dose is 20 mg / day. For elderly patients, the daily dose should not exceed 40 mg. To prevent relapse, supportive therapy is necessary. After the disappearance of the symptoms of depression, this course may be 4-6 months, and for obsessive and panic disorders - more than 4-6 months. Avoid abrupt withdrawal of the drug. In order to prevent the development of withdrawal syndrome, discontinuation of the drug Adepress should be carried out gradually.
Side effects
From the side of the central nervous system and peripheral nervous system: often - drowsiness or insomnia, tremor, asthenia, dizziness, anxiety; sometimes - confusion, hallucinations, extrapyramidal disorders, paresthesias, reduced ability to concentrate; rarely - cramps, mania; very rarely - serotonin syndrome (agitation, hyperreflexia, diarrhea), panic disorders. From the sense organs: in some cases - visual impairment, mydriasis. From the musculoskeletal system: rarely - myasthenia, myoclonia, arthralgia, myalgia. From the urinary system: frequent urination; rarely - urinary retention. From the reproductive system: ejaculation disorders, libido disorders; rarely - hyperprolactinemia / galactorrhea, anorgasmia. On the part of the digestive system: loss of appetite, nausea, vomiting,dry mouth; sometimes constipation or diarrhea; in some cases - hepatitis. From the cardiovascular system: orthostatic hypotension. Allergic reactions: rarely - rash, urticaria, ecchimatosis, pruritus, angioedema. Other things: increased sweating; in rare cases - hyponatremia, a violation of the secretion of antidiuretic hormone.
Overdose
Symptoms: nausea, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contraction, agitation, anxiety, tachycardia. In very rare cases, while taking with other psychotropic drugs and / or ethanol (alcohol), changes on the ECG, coma are possible. Treatment: gastric lavage, taking activated charcoal. If necessary, conduct symptomatic therapy. There is no specific antidote.
Interaction with other drugs
Simultaneous ingestion of food and antacid agents does not affect the absorption and pharmacokinetic parameters of Adepress. Adepress should not be taken simultaneously with MAO inhibitors for 14 days after their withdrawal. During Adepress therapy, you should refrain from taking alcohol because of the increased toxic effect of ethanol. Due to the inhibition of paroxetine cytochrome P450, the effect of barbiturates, phenytoin, indirect anticoagulants, tricyclic antidepressants, phenothiazine neuroleptics and antiarrhythmics cells may be enhanced assa 1C, metoprolol and increased risk of side effects while prescribing these drugs. When administered concurrently with drugs that inhibit liver enzymes, a decrease in the dose of Adepress may be necessary. Paroxetine increases bleeding time while receiving warfarin at a constant prothrombin time. Adepressa with atypical neuroleptics, tricyclic antidepressants, phenothiazine preparations, acetylsalicylic acid, NSAIDs, possibly disturbed and the process of blood coagulation. Simultaneous administration of Adepress with serotonergic drugs (tramadol, sumatriptan) may lead to increased serotonergic effect. Mutual enhancement of tryptophan, lithium and paroxetine preparations has been noted. While administering Adepress with closures and other antipastomas and lithium and paroxetine, it is noted. and an increase in the frequency of side effects. Paroxetine suppresses the antihypertensive effects of guanethidine much less than with antidepressantsinhibiting the capture of norepinephrine.
special instructions
In order to avoid the development of a malignant neuroleptic syndrome, Adepress should be prescribed with caution to patients taking neuroleptics. Treatment with Adepress is prescribed 2 weeks after discontinuation of MAO inhibitors. oral hypoglycemic drugs. When convulsions develop, treatment with Adepress is stopped. Adepre therapy should be discontinued at the first signs of mania som. During the first few weeks of treatment with Adepress, the patient’s condition should be carefully monitored due to possible suicidal attempts. During therapy with Adepress, one should refrain from taking alcohol due to the increased toxic effect. Use in pediatrics safety and efficacy in this group of patients have not been established. The effect on the ability to drive vehicles and control mechanisms. Despite the fact that paroxetine does not worsen cognitive and psychomotor functions, patients should refrain or exercise extreme caution when driving and in other potentially hazardous activities that require increased concentration and psychomotor speed.