Depratal 60mg 28 tablets — Made in Poland by Adamed — Free Delivery
(Depratal )
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Description Depratal 60mg 28 tablets — Made in Poland by Adamed — Free Delivery
Product description
Depratal is an antidepressant used to treat major depressive disorder, diabetic peripheral neuropathic pain, and generalized anxiety disorder.
Compound
active ingredient: duloxetine hydrochloride;
1 enteric tablet contains duloxetine hydrochloride, which is equivalent to 60 mg duloxetine;
excipients: pressed sugar, corn starch, magnesium stearate;
shell composition: methacrylic acid-ethyl acrylate copolymer (1:1), dispersion 30% triethyl citrate; talc titanium dioxide (E 171) simethicone emulsion.
Mode of application
With major depressive disorder. The initial and recommended maintenance dose is 60 mg once a day, regardless of food intake.
For generalized anxiety disorder, the recommended starting dose is 30 mg once daily with or without food. In patients with insufficient treatment effect, the dose should be increased to 60 mg per day, which is the usual maintenance dose in most patients. In patients with comorbid major depressive disorder, the recommended initial and maintenance dose is 60 mg once daily (see also dosage recommendations above).
For diabetic peripheral neuropathic pain. The recommended starting dose is 60 mg once daily with or without food. Some patients may be advised to increase the dose to a maximum of 120 mg per day, divided into 2 doses. This dosing has been evaluated for safety in clinical trials. The plasma concentration of duloxetine shows great individual variability. So, some patients who do not respond well to the 60 mg dose may receive a high dose.
The therapeutic effect of the treatment is manifested within 2 months.
Application features
Use during pregnancy or lactation
Pregnancy
Adequate controlled studies with the participation of pregnant women have not been conducted, therefore, the use of the preparation during pregnancy is not recommended.
Lactation
Duloxetine is poorly excreted in breast milk. The established dose for a child at the rate of 1 mg per 1 kg of body weight is approximately 0.14% of the maternal dose. The safety of duloxetine in children is unknown, so breast-feeding while taking duloxetine is not recommended.
Fertility
In animal studies, duloxetine did not affect male fertility, and effects in women appeared only at doses that caused maternal toxicity.
Children
The preparation is used in pediatric practice.
The ability to influence the reaction rate when driving vehicles or operating other mechanisms
A study of the effect of duloxetine on the reaction rate when driving motor transport or operating other mechanisms was not conducted. The use of duloxetine may be associated with sedation and dizziness. During treatment, patients may experience a sedative reaction or dizziness. If this occurs, one should refrain from potentially hazardous activities that require increased attention and speed of psychomotor reactions.
Overdose
Symptoms. There have been cases of overdose when using duloxetine 5400 mg as monotherapy or in combination with other preparations. A few deaths have been reported primarily in mixed overdose, but there have also been deaths following duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other preparations) included drowsiness, coma, serotonin syndrome, convulsions, vomiting, and tachycardia. Overdose symptoms (mainly when taken in combination with other preparations) included drowsiness, coma, serotonin syndrome, epileptic seizures, vomiting and tachycardia.
Specific antidotes are not known; when serotonin syndrome occurs, specific treatment (cyproheptadine and/or temperature control) is necessary. Airway patency should be checked. Cardiac monitoring and monitoring of vital signs is recommended, along with appropriate symptomatic and supportive measures. Gastric lavage may be appropriate if it is performed immediately after taking the preparation or for symptomatic purposes. Activated charcoal reduces the absorption of the preparation. Duloxetine has a large volume of distribution in the body, and therefore forced diuresis, hemoperfusion and exchange perfusion are unlikely to be useful.
Contraindications
Contraindication for the use of the preparation is hypersensitivity to duloxetine or to any excipients of the preparation.
Duloxetine should not be administered together with non-selective irreversible MAOIs (MAOIs).
Duloxetine should not be given to patients with unstable hypertension as it may precipitate a hypertensive crisis.
Duloxetine should not be given to patients with end-stage renal disease (creatinine clearance <30 ml/min).
Duloxetine should not be given to patients with liver disease as it may lead to liver failure.
Duloxetine should not be given in combination with fluvoxamine, ciprofloxacin or enoxacin (strong inhibitors of CYP1A2) due to increased plasma concentrations of duloxetine.
Storage conditions
Store below 25°C in original packaging.
Keep out of the reach of children.
Tags: Depratal
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