Depratal is an antidepressant used to treat major depressive disorder, diabetic peripheral neuropathic pain, and generalized anxiety disorder.
Composition
active ingredient: duloxetine hydrochloride; 1 enteric-coated tablet contains duloxetine hydrochloride, equivalent to duloxetine 60 mg; 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.
Method of application
For major depressive disorder. The initial and recommended maintenance dose is 60 mg once daily, regardless of food intake.
For generalized anxiety disorder, the recommended starting dose is 30 mg once daily without regard to meals. In patients with inadequate response, the dose should be increased to 60 mg daily, which is the usual maintenance dose in most patients. In patients with comorbid major depressive disorder, the recommended starting 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, without regard to meals. In some patients, dose escalation may be recommended up to a maximum of 120 mg daily, given in 2 divided doses. This dosage has been evaluated for safety in clinical trials. Plasma concentrations of duloxetine show wide interindividual variability. Therefore, some patients who do not respond adequately to the 60 mg dose may receive a higher dose.
The therapeutic effect of treatment appears within 2 months.
Application features
Use during pregnancy or breastfeeding
Pregnancy
Adequate controlled studies in pregnant women have not been conducted, therefore the use of the drug during pregnancy is not recommended.
Breast-feeding
Duloxetine is poorly excreted in breast milk. The established dose for the infant 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 infants is unknown, therefore breastfeeding while taking duloxetine is not recommended.
Fertility
In animal studies, duloxetine did not affect male fertility, and effects in women occurred only at doses that caused maternal toxicity.
Children
The drug is not used in pediatric practice.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effect of duloxetine on the speed of reactions when driving vehicles or using other mechanisms have not been conducted. The use of duloxetine may be associated with sedation and dizziness. During treatment, patients may experience a sedation reaction or dizziness. If this occurs, you should refrain from potentially hazardous activities that require increased attention and speed of psychomotor reactions.
Overdose
Symptoms: Overdoses of duloxetine 5400 mg have been reported, either alone or in combination with other medicinal products. Several fatalities have occurred, primarily with mixed overdoses, but there have also been fatalities following duloxetine alone at doses of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) have included somnolence, coma, serotonin syndrome, convulsions, vomiting and tachycardia. Symptoms of overdose (predominantly with other medicinal products) have included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Specific antidotes are not known, and specific treatment (cyproheptadine and/or temperature control) is necessary if serotonin syndrome occurs. A clear airway should be checked. Cardiac monitoring and vital signs should be monitored, along with appropriate symptomatic and supportive measures. Gastric lavage may be appropriate if performed immediately after ingestion or for symptomatic purposes. Activated charcoal reduces absorption. Duloxetine has a large volume of distribution, so forced diuresis, hemoperfusion, and exchange perfusion are unlikely to be useful.
Contraindication
A contraindication for the use of the drug is hypersensitivity to duloxetine or to any of the drug's excipients.
Duloxetine should not be administered with non-selective, irreversible monoamine oxidase inhibitors (MAOIs).
Duloxetine should not be prescribed to patients with unstable hypertension, as it may trigger a hypertensive crisis.
Duloxetine should not be prescribed to patients with end-stage renal disease (creatinine clearance <30 mL/min).
Duloxetine should not be prescribed to patients with liver disease, as it may cause liver failure.
Duloxetine should not be administered in combination with fluvoxamine, ciprofloxacin or enoxacin (strong CYP1A2 inhibitors) due to increased plasma concentrations of duloxetine.
Storage conditions
Store at a temperature not exceeding 25°C in the original packaging.
Keep out of reach of children.
