Valdoksan user's manual
- Valdoksan user's manual
- Form of formulation and composition of the preparation
- Pharmacological properties of the preparation
- Indications for use
- Dosing and Administration
- Use during pregnancy and lactation
- Adverse events
- Interaction with other medicinal products
- special instructions
- Conditions of dispensing and storage of the drug
- Valdoksan price
The drug Valdoxane is a drug from the group of psychoanaleptics (antidepressant), the therapeutic effect of which is aimed at normalizing the work of the nervous system, eliminating depressive states and feelings of depression in the patient.
Form of formulation and composition of the preparation
The drug Valdoxan is available in the form of tablets for oral use, coated with a protective film coating of orange color. The drug is packed in blisters of 14 pieces in cathornic boxes. In each box there are 1,2,7 blisters.
Each tablet contains active ingredient agomelatine in an amount of 25 mg, as well as a number of auxiliary components: magnesium stearate, silicon dioxide, cellulose, lactose, povidone.
Pharmacological properties of the preparation
Tablets are intended for oral administration. After entering the gastrointestinal tract, the active ingredients are rapidly absorbed through its mucous membranes into the common bloodstream. Under the influence of the drug in patients, a sense of fear, depression, depression disappears. Against the background of therapy with this drug, normalization of sleep in patients, suppression of aggression and irritability, improvement of mood and overall well-being are noted.
Against the background of taking the drug in patients there is no change in the indices of blood pressure and heart rate. After the termination of the course of therapy, patients do not have withdrawal syndrome, that is, there is no need to cancel the medicine gradually, reducing the dosage.
During the period of Valdoxan therapy, patients do not get addicted, and active active pill components do not suppress the sexual function, like many other drugs in this group.
Indications for use
This medication is prescribed for adult patients for the treatment of serious psychological disorders and protracted depressions.
The drug Valdoxane is not prescribed for the treatment of mental disorders in patients with such conditions:
- Severe liver or kidney damage in the active phase;
- Age of the patient under 18;
- Aggressiveness, hostility to others;
- Suicidal tendencies;
- Conflict or, conversely, alienation to others;
- Individual intolerance of the active components of the tablet;
- Lactase insufficiency, galactosemia;
- Renal failure;
- Affective insanity;
- Chronic alcoholism or treatment with other drugs that have a harmful effect on the liver.
Dosing and Administration
The dose of the drug and the duration of the course of therapy should be calculated only by the doctor strictly individually for each individual patient.
According to the instructions to the drug, tablets Valdoxane should be taken orally regardless of food intake, without chewing or grinding. Take the tablet with a sufficient amount of liquid.
The recommended dose of the drug is 25 mg per day 1 time. The drug is taken more often at night, since the components included in the tablet can cause drowsiness in the patient. If within 14 days from the beginning of the course of therapy the patient does not have a positive dynamics, then he should consult a doctor again, in some cases it is advisable to increase the recommended dose by half, dividing it into 2 doses.
With an increase in the dose of the drug and against the background of treatment with valdoxan, the patient should constantly monitor liver transaminases and general health, including drug tolerance.
According to the instructions, depending on the indications and severity of clinical symptoms of the disease, the duration of the course of therapy with the drug is about six months, after which it is necessary to take a break.
Older patients need a dose adjustment to prevent the development of side effects.
Use during pregnancy and lactation
In medicine, there is no reliable data on the safety of the active components of the drug on the development of the fetus and the course of pregnancy in women. Studies that have been conducted on animals have not revealed a teratogenic effect of agomelatine on intrauterine development of calves, and there were no abnormalities or developmental deficiencies in the born animals. Despite this, for the purpose of safety and precaution, this medication is not prescribed for the treatment of pregnant women.
Regarding the use of Valdoxan during breastfeeding, there is no evidence of the ability of the main active ingredient to penetrate breast milk, therefore, for the purpose of precaution, this medication is not prescribed for the treatment of nursing mothers. If, for any reason, treatment with Valdoxan is extremely necessary for a woman, it is recommended to stop breastfeeding and transfer it to a milk formula.
In most cases, many patients in the first 14 days after the start of the course of therapy observed the development of side effects on the drug, which are the norm and, as a rule, do not require discontinuation of treatment. Side effects were as follows:
- From the digestive tract - nausea, constipation, sometimes pain in the epigastric region;
- From the nervous system - dizziness, drowsiness or insomnia, headaches, in rare cases, paresthesia;
- Increased sweating, tinnitus;
- Pain in the lumbar region and general malaise;
- Changing the picture of blood - an increase in liver transaminases, in rare cases, icterus of the skin;
- In rare cases with hypersensitivity, patients developed urticaria, skin itching, and Quincke edema.
At first, the anxiety, anxiety, increased irritability, nightmares can disturb the patient when taking the medication.
Interaction with other medicinal products
With the simultaneous use of this drug with Rifampicin, patients may experience a decrease in the therapeutic effect of Valdoxan.
Patients who smoke or systematically consume alcoholic beverages can note a significant decrease in the therapeutic effect of the drug, in addition, simultaneous use of antidepressants with alcohol can lead to severe liver damage and severe inhibition of the CNS.
During the period of treatment with this drug, patients need to regularly check the blood test and monitor their overall health. With an increase in hepatic transmissions, it is recommended that the blood be re-examined after 3 days, if the level of transmandase continues to increase, then treatment with Valdoxan should be discontinued.
If the patient has symptoms that indicate a violation of liver function, such as jaundice, darkening of the urine and discoloration of stool, pain in the right hypochondrium, jaundice, sclera of the eyes, drug therapy should be stopped immediately and sent to the patient for a full examination.
With special care, tablets are prescribed for patients with diabetes mellitus, hypertension, obesity, impaired liver function.
Conditions of dispensing and storage of the drug
Tablets Valdoksan are released in pharmacies only on prescription of the attending physician. Shelf life of the drug is 3 years from the date of manufacture. It is recommended to keep the tablets away from children at a temperature of no higher than 25 degrees.
The average cost of the drug Valdoksan in pharmacies in Moscow is 1600-1750 rubles per package.