Serocvel XR (quetiapine) tablets with prolonged release 50 mg. №60

Description

Serocvel XR (quetiapine) tablets with prolonged release 50 mg. №60

Composition

active substance:

• tablets of 50 mg: 1 tablet contains 57.56 mg of quetiapine fumarate, which corresponds to 50 mg of quetiapine;
• tablets of 200 mg: 1 tablet contains 230.26 mg of quetiapine fumarate, which corresponds to 200 mg of quetiapine;
• tablets of 300 mg: 1 tablet contains 345.38 mg of quetiapine fumarate, which corresponds to 300 mg of quetiapine;
• tablets of 400 mg: 1 tablet contains 460.50 mg of quetiapine fumarate, which corresponds to 400 mg of quetiapine;

excipients:

lactose, monohydrate; microcrystalline cellulose; sodium citrate; magnesium stearate; hypromellose 2208; hypromellose 2910; polyethylene glycol 400; titanium dioxide (E 171);

• for tablets of 50, 200 and 300 mg – iron oxide yellow (E 172);
• for tablets of 50 mg – iron oxide red (E 172).

Medicinal form

Tablets covered with a film shell, prolonged action.

The main physical and chemical properties:

• 50 mg: capsule-shaped, biconvex, peach-colored, film-coated tablet, engraved with “ХР 50” on one side and smooth on the other;
• 200 mg: capsule-shaped biconvex tablet of yellow color, covered with a film shell, with the engraving “ХР 200” on one side and smooth on the other;
• 300 mg: capsule-shaped biconvex tablet of light yellow color, covered with a film shell,
• engraved ‘XR 300’ on one side and smooth on the other;
• 400 mg: capsule-shaped biconvex tablet of white color, covered with a film shell, with the engraving “ХР 400” on one side and smooth on the other.

Pharmacotherapeutic group

Means acting on the nervous system. Antipsychotic drugs. Quetiapine.
ATX code N05A H04.

Pharmacological properties

It is an antipsychotic agent. The active substance interacts with various types of neurotransmitter receptors, since it has a greater affinity for serotonin receptors than dopamine receptors in the brain, as well as a high affinity for α1-adreno-, histamine receptors, but less affinity for α2-adrenergic receptors. It has no affinity for benzodiazepine and M-cholinergic receptors. Possesses antipsychotic activity.

Indications

Serocvel XR tablets is used:

• with schizophrenia;
• for manic episodes associated with bipolar disorder.

Contraindications

Serocvel XR tablets does not apply:

• if you are allergic to quetiapine;
• with intolerance to excipients;
• with the simultaneous use of inhibitors of cytochrome P450 ZA4 (azole antifungal agents, inhibitors of HIV protease, erythromycin, nefazodone, clarithromycin).

Application during pregnancy and lactation

Safety and efficacy have not been investigated, therefore quetiapine XR can only be prescribed in cases where the need for treatment for the mother outweighs the risk to the fetus.
Withdrawal symptoms have been reported in newborns whose mothers were treated with quetiapine during pregnancy.
The excretion of quetiapine in breast milk has not been investigated, therefore, it is necessary to stop feeding during the treatment period.

Method of administration and dosage

Serocvel XR tablets are taken orally once a day at least one hour before a meal.
The doctor prescribes the dosage and duration of treatment individually.
The standard dose for schizophrenia is 50 mg on the 1st day, 100 mg on the 2nd day, 200 mg on the 3rd day, 300 mg on the 4th day. Then the dose is increased until the desired effect is achieved (usually within the range of 300-450 mg / day), maximum – 750 mg.
The standard dose in the course of treatment of manic episodes in bipolar disorder is 100 mg on the 1st day, 200 mg on the 2nd day, 300 mg on the 3rd day, 400 mg on the 4th day. In the future, the dose is increased (no more than 200 mg per day) to 800 mg, starting from the 6th day. Depending on the clinical efficacy and tolerability of the drug, the dose may be 200–800 mg / day, with a maximum of 800 mg.

Overdose

Symptoms: lengthening of the Q – T interval, drowsiness, sedation, tachycardia, arterial hypotension.
In case of severe overdose, the possibility of using multidirectional measures, intensive care, incl. restoration / maintenance of airway patency, adequate oxygenation, lung ventilation, hemodynamic support.

Side effects:

• Hematological disorders: eosinophilia, neutropenia, thrombocytopenia.
• Immune disorders: hypersensitivity, incl. anaphylactic reaction.
• Mental disorders: nightmares, abnormal dreams, suicidal thoughts / behavior.
• Neurological disorders: dysarthria, seizures, headache, extrapyramidal disorders, loss of consciousness, restless legs syndrome, epilepsy, tardive dyskinesia.
• Cardiac disorders: prolongation of the Q – T interval on the electrocardiogram.
• Vascular disorders: venous thromboembolism.
• Ophthalmic disorders: blurred vision.
• Respiratory disorders: shortness of breath, rhinitis.
• Digestive disorders: dysphagia, vomiting, jaundice, hepatitis.
• Dermatological disorders: Quincke’s edema, Stevens-Johnson syndrome.
• Musculoskeletal disorders: rhabdomyolysis.
• Endocrine disorders: hyperprolactinemia, decreased secretion of vasopressin.
• Metabolic disorders: hyponatremia, hyperglycemia.
• Genitourinary disorders: priapism, galactorrhea, sexual dysfunction, breast swelling, dysmenorrhea.
• General: withdrawal symptoms, weight gain, increased appetite, irritability.
• Laboratory changes: increased levels of AlAT, AsAT, increased levels of γ-HT, TG, total cholesterol, decreased hemoglobin, CPK levels.