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  • Deprivox 100mg 20 tablets — Made in Germany — Free Delivery

Deprivox 100mg 20 tablets — Made in Germany — Free Delivery

(Deprivox 100mg)
Deprivox 100mg 20 tablets — Made in Germany — Free Delivery
Deprivox 100mg 20 tablets — Made in Germany — Free Delivery
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Description Deprivox 100mg 20 tablets — Made in Germany — Free Delivery

Indications

Depression. obsessive-compulsive states.

Application

Depression. The initial daily dose for adults is 50 mg for a week, which must be taken once a day, preferably at bedtime. the dose is gradually increased until effective. the effective daily dose is usually 100 mg and may in some cases be increased to 300 mg / day (selected individually, depending on the patient's response).
Daily dose exceeding 100 mg should be divided into 2 or 3 doses.
Improvement should be expected after 2-4 weeks of therapy with an adequate dose of the preparation. It is recommended to continue treatment if the patient has no symptoms of the disease for 6 months (according to WHO recommendations). The recommended dose to prevent the recurrence of depression is 100 mg 1 time per day.
Tablets should be swallowed without chewing and washed down with water.
Obsessive Compulsive Disorders (adults and children over 8 years of age). The recommended initial daily dose during the 1st week of treatment is 50 mg. Further, the dose is gradually increased until an effective one is reached. In adults, the usual daily dose of Deprivox is 100–200 mg, with a maximum dose of 300 mg/day. If improvement in the patient's condition is not noted within 10 weeks of therapy, treatment with Deprivox should be reviewed. No studies have been conducted on the recommended duration of therapy with Deprivox.
Due to the chronic nature of the disease, it is recommended to continue treatment for at least 10 weeks after the appearance of a satisfactory therapeutic response to the use of the preparation.
The dose for each patient should be selected individually, therapy is carried out with the minimum effective dose; the duration of the course of treatment must be periodically adjusted. For patients who respond well to therapy, a combination of medication and behavioral therapy is recommended.
Liver and kidney failure, heart disease. In patients with hepatic and renal insufficiency or severe heart failure, therapy with Deprivox should be initiated at low doses and under constant medical supervision.

Contraindications

Deprivox should not be co-administered with tizanidine and MAO inhibitors. the preparation is prescribed 2 weeks after the completion of therapy with MAO inhibitors.
Fluvoxamine maleate should not be administered to patients with a known hypersensitivity to fluvoxamine maleate or any of its constituents.

Side effects

Nausea, sometimes accompanied by vomiting, is a symptom that occurs most frequently during treatment with fluvoxamine. the severity of this side effect, as a rule, decreases during the first 2 weeks from the start of treatment. other side effects are often associated with the disease and do not need appropriate therapy.
The frequency of side effects is determined as follows:
very often (≥1/10); often (≥1/100, 1/10); infrequently (≥1/1000, 1/100); rarely (≥1/10,000, 1/1000); very rarely (≥1/10,000); unknown (cannot be determined from the data of the studies).
From the side of the cardiovascular system: often - palpitation (increased sensation of heart beats) / tachycardia; infrequently - (orthostatic arterial) hypotension; rarely - hemorrhages, ecchymosis, purpura.
Disturbances from the lymphatic system and the blood system: unknown - hemorrhage (see SPECIAL INSTRUCTIONS).
Nervous system disorders: often - headache, dizziness, drowsiness, tremor, agitation, anxiety, insomnia, nervousness; infrequently - ataxia, extrapyramidal symptoms; rarely - convulsions, akathisia (see SPECIAL INSTRUCTIONS), serotonin syndrome or neuroleptic malignant syndrome (see SPECIAL INSTRUCTIONS); very rarely - paresthesia, change in taste perception.
Gastrointestinal disorders: often - pain in the abdominal cavity, constipation, diarrhea, dry mouth, dyspepsia; unknown - nausea, which is sometimes accompanied by vomiting; gastrointestinal bleeding.
Skin disorders: often - increased sweating; infrequently - skin reactions of hypersensitivity (rash, itching, Quincke's edema); rarely - photosensitivity.
Musculoskeletal and connective tissue disorders: infrequently - arthralgia, myalgia.
Endocrine system disorders: rarely - syndrome of inappropriate secretion of antidiuretic hormone (see SPECIAL INSTRUCTIONS).
Metabolic and digestive disorders: unknown - change in body weight; often - anorexia (loss of appetite); rarely - hyponatremia (see SPECIAL INSTRUCTIONS).
General disorders: often - asthenia, malaise.
Hepatobiliary disorders: rarely - impaired liver function.
Reproductive system disorders: infrequently - a violation (delay) of ejaculation; rarely - galactorrhea.
Mental disorders: often - agitation, anxiety, insomnia, nervousness; infrequently - excitement, hallucinations; rarely - mania; very rarely - anorgasmia, paresthesia, changes in taste sensations; unknown - suicidal thoughts and mood.
Cases of the appearance of suicidal thoughts and moods are observed during treatment and during the cessation of fluvoxamine therapy (see SPECIAL INSTRUCTIONS).
After discontinuation of therapy, a withdrawal reaction may occur, although the available preclinical and clinical data do not indicate that this treatment is addictive. In connection with the withdrawal of the preparation, the following symptoms were observed: dizziness, paresthesia, headache, nausea and anxiety. They were usually mild and disappeared on their own. Before stopping treatment, it is desirable to consider the need for a gradual reduction in the dose of the preparation.
During placebo-controlled studies of the preparation for 10 weeks in children and adolescents with obsessive-compulsive disorders, the following side effects were often noted: insomnia, asthenia, excitement, hyperkinesia, drowsiness and dyspepsia. Serious side effects in this study included agitation and hypomania. Seizures have been reported during treatment in children and adolescents.

special instructions

When switching from therapy with MAO inhibitors to taking deprivox (fluvoxamine), the course of treatment should be started at least 2 weeks after the completion of therapy with reversible or irreversible MAO inhibitors.
Therapy with MAO inhibitors should be started at least 1 week after completion of therapy with Deprivox. In patients with hepatic or renal insufficiency, severe heart failure, an increase in the level of liver enzymes with severe symptoms is occasionally noted. In such cases, the preparation should be discontinued.
Special care should be taken in patients with epilepsy. In the event of seizures, therapy with Deprivox should be discontinued.
As with any treatment for depression, there is a risk of suicidal ideation at the start of therapy between the start of treatment and clinical improvement. As with the use of other antidepressants, the therapeutic effect may not be clinically manifested during the first ≥2 weeks.
As with other antidepressants, Deprivox should be discontinued if a manic phase develops.
It is recommended to adjust the dose in elderly patients, who are usually much more sensitive to the side effects of the preparation.
Rare cases of bleeding (usually ecchymosis and purpura) have been reported. Deprivox should be used with caution in patients taking preparations that adversely affect platelet function (antipsychotics, phenothiazine antipsychotics, tricyclic antidepressants, NSAIDs, acetylsalicylic acid), or with a previously established high risk of bleeding.
To avoid the development of a withdrawal syndrome during the end of the course of therapy, doses should be reduced gradually.
Clinical experience with the simultaneous use of Deprivox and electroshock therapy is insufficient.
When using Deprivox, blood glucose levels may increase, especially at the initial stages of treatment. Therefore, patients may need to adjust the dose of antidiabetic agents.
When combined with Deprivox, plasma concentrations of terfenadine, astemizole or cisapride may increase, which increases the risk of prolongation of the QT interval and the appearance of torsade de pointes arrhythmias. Therefore, the preparation should not be administered in combination with these preparations.
Data in elderly patients do not indicate clinically significant differences in usual daily doses compared with young people. However, increasing doses in elderly patients should be slower and always with caution.
In rare cases, treatment with fluvoxamine has been associated with serotonin syndrome or neuroleptic malignant syndrome, especially when fluvoxamine is combined with other serotonergic and/or neuroleptic agents (including triptans, tramadol, selective serotonin reuptake inhibitors and St. John's wort). Since these syndromes can lead to life-threatening conditions, treatment with fluvoxamine should be discontinued when symptoms (groups of symptoms) such as hyperthermia, muscle rigidity, myoclonus, instability of the autonomic nervous system with possible rapid changes in blood pressure, heart rate and respiratory rate, changes mental status, including agitation, irritability, excessive agitation with progression of delirium and coma) and symptomatic treatment.
As with other serotonin reuptake inhibitors, hyponatremia is rare with fluvoxamine and resolves upon discontinuation. In some cases, the appearance of hyponatremia is associated with a syndrome of inappropriate secretion of antidiuretic hormone. Most cases have been reported in elderly patients.
Deprivox can cause a slight decrease in heart rate (by 2-6 bpm).
During pregnancy and breastfeeding. There are no clinical data on the use of the preparation during pregnancy. Preclinical studies have not revealed any negative effect of the preparation at therapeutic doses on the course of pregnancy, fetal development, childbirth or postnatal development. But some caution should be observed when prescribing Deprivox during pregnancy.
Fluvoxamine is excreted in breast milk (the milk/plasma ratio is about 0.3). Thus, Deprivox should not be used during breastfeeding; while taking the preparation, breastfeeding should be abandoned.
Children and adolescents (under the age of 18). There are currently insufficient data on the use of Deprivox in the treatment of depression in adolescents and children under 18 years of age. For obsessive-compulsive disorders, the preparation is used in children over the age of 8 years according to the dosages indicated in the APPLICATION section.
Influence on the ability to drive vehicles and precise mechanisms. The effect of the preparation at a dose of 150 mg / day on psychomotor function and response was studied experimentally in healthy volunteers: no negative effects were noted. However, in some cases, the ability to drive vehicles and work with precise mechanisms was reduced. High doses of the preparation or its use in combination with alcohol or preparations that affect the central nervous system (benzodiazepines) significantly changed the ability to adequately respond.
It should be borne in mind at the beginning of treatment that a side effect of the preparation is drowsiness.

Interactions

The preparation is not prescribed in combination with MAO inhibitors.
Fluvoxamine is a potent inhibitor of CYP 1A2 and, to a lesser extent, CYP 2C and CYP 3A4. Preparations that are predominantly metabolized with the participation of these isoenzymes are excreted more slowly and may have high plasma concentrations when used simultaneously with Deprivox. This is especially true for preparations with a narrow therapeutic index. It is necessary to carefully monitor the condition of patients, and if necessary, change the dose of preparations.
Fluvoxamine has a borderline effect on CYP 2D6. It is not thought to affect non-oxidative metabolism or renal excretion.
CYP 1A2. When used together with Deprivox, an increase in the blood plasma of previously stable concentrations of such tricyclic antidepressants (for example, clomipramine, imipramine, amitriptyline) and neuroleptics (for example, clozepine, olanzapine) was observed, which are mainly metabolized by cytochrome CYP 1A2. It is required to consider the need to reduce the dose of these preparations before starting treatment with Deprivox.
It is necessary to carefully monitor the condition of patients who simultaneously take Deprivox and preparations with a narrow therapeutic index metabolized by CYP 1A2 (tacrine, theophylline, methadone, mexiletine), and if necessary, change the dosage of this preparation.
When used together with Deprivox, the concentration of warfarin in the blood plasma increases significantly and the prothrombin time increases.
Special cases of the cardiotoxic effect of the combination of fluvoxamine with thioridazine have been recorded.
Since the concentration of propranolol in the blood plasma increases when taken with Deprivox, it may be necessary to reduce its dose.
Plasma caffeine levels may increase when caffeinated beverages are used with Deprivox. Therefore, patients who consume a significant amount of drinks that contain caffeine should reduce them if they are prescribed Deprivox and the side effects of caffeine (tremor, palpitations, nausea, anxiety, insomnia) occur.
When taking ropinirole in combination with Deprivox, its plasma concentration may increase, which increases the risk of overdose. Therefore, it is necessary to monitor patients, and, if necessary, reduce the dose of ropinirole during treatment with Deprivox and after its withdrawal.
CYP2C. It is necessary to carefully monitor the condition of patients who simultaneously take fluvoxamine and preparations with a narrow therapeutic index that are metabolized by CYP 2C (such as phenytoin), and if necessary, change the dose of this preparation.
CYP 3A4. Terfenadine, astemizole, cisapride (see SPECIAL INSTRUCTIONS).
Careful monitoring of the condition of patients who are simultaneously taking fluvoxamine and preparations with a narrow therapeutic index metabolized by CYP 3A4 (such as carbamazepine, cyclosporine) is necessary, and if necessary, change the dose of this preparation.
When taken simultaneously with Deprivox, an increase in plasma concentrations of benzodiazepines metabolized by oxidation (for example, trizolam, midazolam, alprazolam and diazepam) is possible. The dose of these benzodiazepines should be reduced when co-administered with Deprivox.
Glucuronidation. The preparation does not affect the concentration of digoxin in plasma.
renal excretion. The preparation does not affect the concentration of atenolol in the blood plasma.
Pharmacodynamic interaction. Serotonergic effects may be enhanced when Deprivox is used in combination with other serotonergic preparations (including triptans, tramadol, selective serotonin reuptake inhibitors and St. John's wort) (see SPECIAL INSTRUCTIONS).
Deprivox is prescribed in combination with lithium to patients with severe forms of the disease resistant to preparationtreatment. However, lithium (and possibly tryptophan) may enhance the serotonergic effects of Deprivox. Therefore, the combination of these preparations should be used with caution in patients with severe, treatment-resistant depression.
In patients receiving oral anticoagulants and Deprivox, there may be an increased risk of bleeding. Therefore, careful monitoring of the condition of such patients is necessary.
During the use of the preparation Deprivox, as well as other psychotropic preparations, patients should avoid drinking alcohol.

Overdose

There have been reports of overdose with Deprivox alone or in combination with other preparations. most cases of overdose are characterized by gastrointestinal symptoms (nausea, vomiting and diarrhea), drowsiness, dizziness. in addition, there were reports of disorders of the cardiovascular system (tachycardia, bradycardia and hypotension), consciousness, as well as convulsions, the development of coma and impaired liver function.
In some cases, an overdose has been noted when using Deprivox in combination with other preparations.
There are reports of death in patients who have deliberately taken a very high dose of Deprivox in combination with other preparations or, in exceptional cases, Deprivox alone.
The maximum fixed dose of Deprivox taken by the patient is 12 g; it was possible to achieve a complete recovery of the patient's condition with the help of symptomatic treatment.
Treatment: There is no specific antidote. In case of an overdose, gastric lavage should be performed immediately after taking the tablets and symptomatic treatment should be initiated. The use of activated charcoal and laxatives is recommended (for diarrhea, laxatives should be discarded).

Storage conditions

At a temperature not exceeding 25 ° C in the original packaging.

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