Valdoxan is a drug used in the treatment of major depressive disorders.
Release form and composition
Valdoxan is available in film-coated tablets, the main active ingredient of which is agomelatine.
Corn starch, lactose monohydrate, magnesium stearate, povidone-K30, stearic acid, colloidal silicon dioxide, sodium carboxymethyl starch are used as excipients in the preparation.
Valdoxan is available in blisters of 14, 28, 98 and 100 pieces per pack.
Indications for use
According to the instructions, Valdoxan is indicated for use in major depressive episodes in adulthood.
According to the instructions, Valdoksan contraindicated in:
- The use of fluvoxamine and ciprofloxacin;
- High patient sensitivity to any component of the drug;
- Hepatic insufficiency or elevated transaminase levels;
- Lactose intolerance;
as well as under the age of 18 and over 75 years old.
According to the instructions, Valdoksan carefully prescribed for:
- Moderate and severe renal failure;
- The history of manic or hypomania episodes;
- The use of grepafloxacin, propranolol, enoxacin;
- The patient has risk factors for the development of abnormal liver function (obesity, diabetes, non-alcoholic fatty hepatosis);
- The use of drugs that can cause abnormalities in the liver;
- The patient’s history of suicide events;
as well as to persons who have experienced suicidal intent or alcohol abuse prior to treatment.
Dosing and Administration
Tablets Valdoksan intended for oral administration. They are taken regardless of the meal once a day (in the evening).
The recommended daily dosage of Valdoxan is 25 mg.
If no clinical effect is observed after two weeks of drug therapy, the dosage is increased to 50 mg per day (after careful evaluation of the benefit-risk ratio for the patient and under strict medical supervision of the liver function).
The duration of drug therapy is at least 6 months.
When skipping the next drug intake, there is no need to take the missed dose.
When using Valdoxan, certain adverse reactions may develop:
- Central nervous system: dizziness, headache, insomnia, drowsiness, migraine, restless legs syndrome, paresthesia;
- Digestive tract: diarrhea, constipation, nausea, vomiting, abdominal pain;
- Mental disorders: anxiety, agitation (irritability, aggressiveness, anxiety, unusual and nightmarish dreams, mania / hypomania), hallucinations, suicidal thoughts or behavior;
- Body of vision: blurred vision;
- Hepatobiliary system: an increase in ALT, ACT, ALP, GGT, hepatitis, jaundice, liver failure;
- Organ hearing: tinnitus;
- Skin and subcutaneous tissue: sweating, eczema, urticaria, swelling of the face, angioedema, pruritus, erythematous rash;
- Musculoskeletal system: back pain;
- Other: fatigue, increase or decrease in body weight.
When using Valdoxan, it should be borne in mind that:
- At the beginning of treatment, after 3, 6, 12, and 24 weeks, follow-up liver function tests should be performed. In the future, they are held depending on the clinical situation;
- If symptoms of possible abnormalities in the liver (bleached stools, dark urine, yellow eyes and skin, unexplained fatigue, pain in the upper right abdomen) occur, Valdoxan is immediately stopped;
- With the development of symptoms of mania, Valdoxan is discontinued;
- Since major depression increases the risk of development of suicidal thoughts in patients, which persists until a distinct remission, patients should always be under medical supervision until a steady improvement in their condition, especially for patients who have had suicide events in the anamnesis and suicidal intent before starting therapy;
- An overdose of Valdoxan is manifested by drowsiness, weakness, pain in the epigastric region, anxiety, anxiety, agitation, dizziness, exertion, malaise, cyanosis. When you receive 2450 mg of the drug, the patient's condition normalizes independently. Overdose treatment is symptomatic, followed by monitoring in specialized departments;
- Rifampicin reduces Valdoxan's bioavailability;
- The drug is not recommended to take simultaneously with alcoholic beverages.
Valdoxan analogue is the drug Agomelatine.
Terms and conditions of storage
Valdoxan is stored at a temperature not exceeding 25 ° in places not accessible to children, not more than three years.