Valdoxan pills 25mg №28

Valdoxan

Film Coated Tablets

Composition

1 pill Valdoxan contains:
Active substance: active substance agomelatine 25 mg.
Excipients: lactose monohydrate, Magnesium stearate, corn starch, povidone, colloidal silicon dioxide, sodium carboxymethyl starch, stearic acid.
Film shell: glycerol, hypromellose, iron dye yellow oxide, macrogol 6000, magnesium stearate, titanium dioxide.

Packaging

28 pcs.

Mechanism of action

Valdoxan has antidepressant effects.

Treatment of major depressive disorder.

Contraindications

• hypersensitivity to the components of Valdoxan;
• severe liver failure.

Pregnancy and Breastfeeding

Little experience with Valdoxan in pregnant women did not show any adverse effects on the course of pregnancy, the health of the fetus or newborn. Currently, there is no other epidemiological information on this. In pregnancy, the drug Valdoxan should be used with caution and in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
It is not known whether agomelatine is excreted in human breast milk. If Valdoxan is required during lactation, breastfeeding should be discontinued.
In experimental animal studies, no direct or indirect adverse effects of Valdoxan on pregnancy, embryo or fetus development, labor or postnatal development were found. It is shown that agomelatine and its metabolites are excreted in breast milk from rats.

Dosage and administration

Valdoxan accept inside.
The recommended dose is 25 mg (1 tab.) 1 time per day in the evening. If necessary, after two weeks of treatment, the dose of Valdoxan can be increased to 50 mg (2 tab.) Once a day in the evening.

Adverse reactions

Clinical trials of Valdoxan included more than 4,600 patients. More than 2,400 patients with depression received the drug Valdoxan in doses of 25-50 mg / day. At these doses, in the short-term placebo-controlled trials, the number of side effects did not differ from those in the placebo group. Side effects were most often mild or moderate and were observed in the first 2 weeks of treatment. The most frequently observed were dizziness, nausea, diarrhea, dryness of the oral mucosa, abdominal pain and itching. The incidence of headache in most cases did not differ from that in the treatment of placebo. Side effects were transient and, in general, did not require cessation of treatment.
In short-term, placebo-controlled clinical trials, adverse reactions that were considered likely to be associated with treatment with agomelatine at a dose of 25–50 mg / day are presented below. In parentheses indicate the frequency of side effects in patients treated with Valdoxan, compared with the placebo group.
Determination of the frequency of adverse reactions: very often -> 1/10; often -> 1/100, <1/10; sometimes -> 1/1000, <1/100; rarely -> 1/10000, <1/1000; very rarely - <1/10000.
CNS and peripheral nervous system: often - dizziness (5.4% and 3.1%); sometimes - paresthesias (0.9% and 0.1%).
From the digestive system: often - nausea (7.7% and 7.1%), dry mouth (3.3% and 3%), diarrhea (2.9% and 2.2%), epigastric pain (2.3% and 1.3%); 0.5% - while receiving agomelatine in a dose of 25–50 mg / day (and 0.2% in the placebo group), a transient increase in AST was observed 3 times higher than the upper limit of normal. In most cases, these indicators returned to normal without withdrawing treatment.
Dermatological reactions: often - itching (1% and 0.5%); sometimes - dermatitis (0.5% and 0.4%), eczema (0.2% and 0.1%), erythematous rash (0.2% and no response).
From the organs of vision: sometimes - blurred vision (0.6% and no reaction).
In the framework of double-blind studies of the use of agomelatine for more than 6 months at doses of 25–50 mg / day, the frequency of newly identified side effects did not differ from that compared with placebo. With long-term use of the drug Valdoxan, no new side effects have been identified.
The type and frequency of adverse reactions did not depend on the sex and age of the patients.

Drug Interactions

Potential effects of other medicines.
Agomelatine is 90% metabolized in the liver with the participation of cytochrome P450 1A2 (CYP1A2) and 10% by CYP2C9 / 19. Therefore, any drugs whose metabolism depends on these isoenzymes may increase or decrease the bioavailability of agomelatine.
Fluvoxamine is a strong inhibitor of the isoenzyme CYP1A2 and a moderate inhibitor of the isoenzyme CYP2С9 and significantly slows down the metabolism of agomelatine, while the concentration of agomelatine increases approximately 60 (12-412) times. Therefore, the simultaneous use of agomelatine and strong inhibitors of the isoenzyme CYP1A2 (such as fluvoxamine, ciprofloxacin) is contraindicated. The simultaneous appointment of agomelatine and estrogen, which are mild inhibitors of the CYP1A2 isoenzyme, leads to an increase in the concentration of agomelatine several times. Although the combined use of agomelatine and estrogen was not accompanied by a deterioration in the safety profile of the therapy, caution should be exercised when co-administering agomelatine with other moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, grepafloxacin, enoxacin) until sufficient clinical experience has been accumulated (see “Special instructions”).
Potential effect of agomelatine on other drugs 
In vivo, agomelatine does not induce cytochrome P450 isoenzymes. Agomelatine does not inhibit the CYP1A2 isoenzyme in vivo and other cytochrome P450 isoenzymes in vitro. Therefore, agomelatine does not affect the concentration of drugs whose metabolism is associated with these isoenzymes.
Drugs, largely binding to plasma proteins  
Agomelatine did not change the free concentration of drugs that are largely associated with plasma proteins and, in turn, they did not affect the concentration of agomelatine.
Other medicines 
The absence of pharmacokinetic and pharmacodynamic interactions of agomelatine and drugs commonly used in the target patient population: benzodiazepines, lithium preparations, paroxetine, Fluconazole and theophylline was detected.
Alcohol 
The use of agomelatine in conjunction with alcohol is not recommended.
Electroconvulsive Therapy (ECT) 
There are no data on the use of agomelatine simultaneously with ECT. Since agomelatine did not contribute to seizures in animal studies, the undesirable effects of the combined use of agomelatine and ECT seem unlikely.

Overdosage

Data overdose Valdoxan limited.During clinical studies, several reports of overdose (up to 450 mg) of agomelatine, as well as an overdose (up to 525 mg) in combination with other psychotropic drugs have been received.
Symptoms of overdose: drowsiness and pain in the epigastrium.
Specific antidotes for Valdoxan are not known. Treatment should include symptomatic treatment and monitoring in specialized units with follow-up.

In the dark place at a temperature of no higher than 25 ° C.

3 years.