Prozac Capsules 20 mg 14 pcs
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Active ingredients
Fluoxetine
Release form
Capsules
Composition
Active ingredient: Fluoxetine (Fluoxetinum). Concentration of active ingredient (mg): 20
Pharmacological effect
Prozac is an antidepressant, a selective serotonin reuptake inhibitor that determines its mechanism of action. Fluoxetine has virtually no affinity for other receptors, such as αl, α2, and β adrenergic, serotonergic, dopaminergic, histaminergic, muscarinic, and GABA receptors.
Pharmacokinetics
Absorption and distribution. When taken internally, fluoxetine is well absorbed. Peak plasma concentrations are reached after 6-8 hours. Fluoxetine is largely bound to plasma proteins and has a high volume of distribution (20-40 L / kg). The Cmax value is 15-55 ng / ml. Equilibrium plasma concentrations are achieved after taking the drug for several weeks. Equilibrium concentrations after prolonged use of the drug are similar to those observed at 4-5 weeks of taking the drug. Metabolism and excretion. Fluoxetine is largely metabolized in the liver to norfluoxetine and a number of other unidentified metabolites that are excreted in the urine. The half-life of fluoxetine is 4 to 6 days, and its active metabolite is 4 to 16 days.
Indications
Depression of various etiologies, Nervous bulimia, Obsessive-compulsive disorder, Premenstrual dysphoric disorder.
Contraindications
Hypersensitivity to the drug. Children and adolescents up to 18 years. Simultaneous reception of MAO inhibitors and the period up to 14 days after their cancellation. Simultaneous administration of pimozide. Simultaneous administration of thioridazine and a period of up to 5 weeks after its cancellation
Precautionary measures
Suicidal risk: in case of depression there is a possibility of suicidal attempts, which may persist until the onset of persistent remission. Selected cases of suicidal thoughts and suicidal behavior were described against the background of therapy with fluoxetine or shortly after its completion, similar to the action of other drugs of similar pharmacological action (antidepressants). Careful observation of patients at risk is needed.Doctors should convince patients to immediately report any thoughts or feelings that are disturbing; Although the effect of fluoxetine on the occurrence of such cases has not been established, data from combined studies of the use of antidepressants for mental disorders revealed an increased risk of suicidal thoughts and / or suicidal behavior in younger patients (under 25) compared with placebo. Drug therapy of patients with high risk should be accompanied by monitoring by the attending physician. Physicians should encourage patients of different ages to report any unpleasant thoughts and feelings that arise at any time during therapy. The following risk factors for suicide were identified in studies in adult patients with major depressive disorder in both groups taking placebo and fluoxetine.
Use during pregnancy and lactation
Pregnancy: 2072 cases of pregnancy occurring while receiving fluoxetine in the first trimester are known. Available data indicate the absence of undesirable effects on the course of pregnancy or on the development of the fetus or newborn. However, caution should be exercised, especially in late pregnancy, as there are rare reports of the development of withdrawal syndrome in the newborn (short-term motor anxiety, difficulty in feeding, rapid breathing and irritability) if the mother took the drug shortly before delivery. Fluoxetine can be used during pregnancy, provided that the intended benefit outweighs the potential risk. Breastfeeding: Fluoxetine is excreted in breast milk, therefore, caution should be exercised in the appointment of fluoxetine to nursing mothers. Childbirth: the effect of fluoxetine on the process of childbirth in humans is not known.
Dosage and administration
Depression. The initial recommended dose is 20 mg per day. Bulimia. The recommended dose is 60 mg per day. Obsessive compulsive disorder. The recommended dose is 20-60 mg per day. Premenstrual dysphoric disorders. The recommended dose is 20 mg per day. All indications. The recommended dose may be reduced or increased. Doses of more than 80 mg days have not been systematically studied. Age.There is no data on the need to change doses depending only on age. Reception write. Fluoxetine can be taken at any time, regardless of the meal. Concomitant diseases or concomitant treatment. In patients with impaired liver function, concomitant diseases or taking other medications, reduce the dose and reduce the frequency of intake.
Side effects
As in the case of the use of other drugs in the group of selective serotonin reuptake inhibitors, the following undesirable effects are noted against the use of fluoxetine. Cardiovascular system: Often (≥1% - less than 10%): atrial flutter, hot flashes (hot flushes). Infrequently (≥0. 1% - less than 1%): hypotension. Rarely (less than 0. 1%): vasculitis, vasodilation. Digestive System: Very common (≥10%): diarrhea, nausea. Often (≥1% - less than 10%): dry mouth, dyspepsia, vomiting, anorexia (including weight loss). Infrequently (≥0. 1% - less than 1%): dysphagia, taste perversion. Rarely (less than 0. 1%): pain along the esophagus. General effect on the body: Very often (≥10%): weakness (including asthenia). Often (≥1% - less than 10%): chills, anxiety attacks, anxiety, yawning. Rarely (≥0. 1% - less than 1%): feeling of heat, feeling of cold, indisposition, discomfort. Immune system: Very rare (less than 0. 1%): anaphylactic reactions, serum sickness. Metabolic and nutritional disorders: Often (≥1% - less than 10%): anorexia (including weight loss). Musculoskeletal System: Infrequently (≥0. 1% - less than 1%): muscle twitching. Nervous system: Very often (≥10%): headache. Often (≥1% - less than 10%): impaired attention, dizziness, lethargy, drowsiness (including hyper drowsiness, sedation), tremor. Infrequently (≥0, 1% - less than 1%): psychomotor hyperactivity, ataxia, impaired coordination, bruxism, dyskinesia, myoclonus. Rarely (less than 0. 1%): bukko-globalny syndrome, convulsions. Mental disorders: Very often (≥10%): insomnia (including early morning awakening, primary and secondary insomnia). Often (≥1% - less than 10%): unusual dreams (including nightmares), nervousness, tension, decreased libido (including lack of libido), euphoria, sleep disorder. Infrequently (≥0. 1% - less than 1%): depersonalization, hyperthymia, impaired orgasm (including anorgasmia), impaired thinking. Rarely (less than 0. 1%): mania, hypomania.Skin: frequently (≥1% - menshe10%): rash, itching, rash (including Exfoliative, hyperthermic, erythematous, follicular, generalized, makuleznaya, makuleznopapuleznaya, morbilliform, maculopapular, pruritic, vesicular, erythema with umbilicated in the center erythema), urticaria. Infrequently (≥0. 1% - less than 1%): ecchymosis, tendency to bruise, alopecia, cold sweat. Rarely (less than 0. 1%): angioedema, photosensitivity reactions. Sense organs: Often (≥1% - less than 10%): blurred vision. Infrequently (≥0. 1% - less than 1%): mydriasis. Urogenital system: Often (≥1% - less than 10%): frequent urination (including pollakiuria), ejaculation disorders (including lack of ejaculation, dysfunctional ejaculation, early ejaculation, delayed ejaculation, retrograde ejaculation), erectile dysfunction, gynecological bleeding, erectile dysfunction, gynecological bleeding, erectile dysfunction, gynecological bleeding the number of bleeding from the cervix, dysfunctional uterine bleeding, bleeding from the genital tract, menometer, menorrhagia, metrorrhagia, polymenorrhea, post-menopause bleeding, uterine bleeding, vaginal bleeding ). Infrequently (≥0. 1% - less than 1%): dysuria. Rarely (less than 0. 1%): sexual dysfunction. Spontaneous (post-marketing) messages Endocrine system: Insufficient secretion of antidiuretic hormone. Hepatobiliary system: Rarely (less than 0. 1%): Idiosyncratic hepatitis. Nervous system: Serotonin syndrome. Genitourinary system: priapism.
Overdose
There are 633 cases of fluoxetine overdose in adult patients, of which 378 have fully recovered; 15 symptoms of disturbance of accommodation, gait, confusion, inaccessibility to contact, nervousness, dysfunction of the respiratory system, vertigo, tremor, increased blood pressure, impaired potency in men, movement disorders and hypomania persisted; 34 were fatal; data on the remaining 206 patients are not known. The maximum known dose of fluoxetine, which was taken by man inside, is 8 g; This overdose case resulted in a complete recovery. The minimum known dose of fluoxetine, which was accompanied by death, but without a well-established causal connection, is 520 mg.The main manifestations of overdose included seizures, drowsiness, nausea, tachycardia and vomiting. Other serious manifestations reported in fluoxetine overdose (both isolated and in combination with other drugs) included coma, delirium, prolongation of the QT interval and ventricular tachyarrhythmia, including ventricular fibrillation-flutter and cardiac arrest, decreased blood pressure, syncope, mania, pyrexia, stupor and a condition similar to malignant neuroleptic syndrome. Treatment. It is recommended to monitor the general condition and heart activity, along with the conduct of general symptomatic and supportive measures / The specific antidote is unknown. Enhanced diuresis, dialysis, hemoperfusion and cross-transfusion are unlikely to benefit. In the treatment of overdose should consider the possibility of using multiple drugs.
Interaction with other drugs
Fluoxetine and its main metabolite, norfluoxetine, have long half-life, which must be considered when combining fluoxetine with other drugs, as well as when replacing it with another antidepressant. Phenytoin. Changes in the concentration of phenytoin in the blood were detected when it was combined with fluoxetine. In some cases, there were manifestations of intoxication. Increasing the dose of phenytoin or fluoxetine with their simultaneous appointment should be carried out with caution and under the control of the clinical dynamics of the condition. Serotonergic drugs. The simultaneous intake of serotonergic drugs (for example, tramadol and triptans) contributes to the increased likelihood of developing serotonin syndrome. The simultaneous administration of triptans also contributes to an increase in the likelihood of the development of narrowing of the coronary vessels and arterial hypertension. Benzodiazepines. With simultaneous use of fluoxetine and benzodiazepines may increase the half-life of the latter. When alprazolam and fluoxetine were taken together, an increase in the concentration of alprazolam in the blood and an increase in its sedative effect were observed. Lithium and tryptophan. It is known about the development of serotonin syndrome with taking SSRIs and lithium, or tryptophan, and therefore the simultaneous appointment of fluoxetine with these drugs should be carried out with caution.When fluoxetine and lithium are taken simultaneously, more frequent and careful monitoring of the clinical condition is necessary. The drugs metabolized with participation of an isoenzyme of CYP2D6 (propafenone, carbamazepine, trshlichesky antidepressants). It should be noted that the metabolism of fluoxetine (as well as tricyclic antidepressants, as well as selective serotonergic antidepressants) is carried out with the participation of the cytochrome of the liver cytochrome system CYP2D6. Simultaneous administration of drugs, the main route of biotransformation of which is metabolism with the participation of the CYP2D6 isoenzyme, and having a small therapeutic dose range (such as propafenone, carbamazepine, tricyclic antidepressants) should be carried out using minimal therapeutic doses. The above is also applicable if less than 5 weeks have passed since the discontinuation of fluoxetine. Anticoagulants for oral administration and other drugs that affect the blood coagulation system (NSAIDs, acetylsalicylic acid). It is known to change the anticoagulant action (by laboratory parameters and / or clinical manifestations) without any general characteristic tendency, but with the probability of increased bleeding while taking fluoxetine and oral anticoagulants. The functional state of the blood coagulation system in patients receiving warfarin should be carefully monitored when prescribing and withdrawing fluoxetine. Electroconvulsive therapy (ECT). There are rare reports of prolonged seizures in patients taking fluoxetine and receiving ECT, therefore caution is advised. Alcohol. In experimental studies, fluoxetine did not contribute to an increase in alcohol concentration in the blood, as well as enhancing the effects of alcohol. However, simultaneous administration of SSRIs and alcohol is not recommended. Means based on the plant Hypericum perforatum. As with other SSRIs, a pharmacodynamic interaction is possible between fluoxetine and plant-based products Hypericum perforatum, which can lead to an increase in undesirable effects.
special instructions
There are reports of the occurrence of skin rash, anaphylactic reactions and progressive systemic disorders involving the skin, lungs, liver, and kidneys in the pathological process in patients taking fluoxetine. If a skin rash or other possible allergic reactions appear, the etiology of which cannot be determined, Prozac should be discontinued.As with the use of other antidepressants, Prozac should be used with caution in patients who have had epileptic seizures in history. When fluoxetine was used, there were cases of hyponatremia (in some cases, the sodium level in the blood was less than 110 mmol / l). Mostly similar cases were observed in elderly patients and in patients treated with diuretics, due to a decrease in BCC. In patients with diabetes mellitus, hypoglycemia was observed during treatment with Prozac, and after discontinuation of the drug - hyperglycemia. At the beginning and after treatment with fluoxetine, it may be necessary to adjust the doses of insulin and / or hypoglycemic drugs for oral administration. Results of experimental studies: No evidence of carcinogenicity has been obtained in in vitro or animal studies. Use in Pediatrics: Safety and efficacy of Prozac in children have not been established. Impact on ability to drive vehicles and control mechanisms: Drugs that affect mental activity can affect decision-making ability and driving skills. Patients should be advised to avoid driving a car or controlling dangerous machinery until it is determined that the drug does not affect the ability of these activities.