Expiration date: 04/2026
Structure and Composition:
Film-coated tablets. One tablet contains: Quetiapine (as fumarate) 25, 100 or 200 mg
excipients: Povidone MCC dihydrate dibasic calcium phosphate starch (sodium glycolate) lactose monohydrate, magnesium stearate
shell composition: iron oxide red (tablet 25 mg) of iron oxide yellow (tablets of 25 and 100 mg), titanium dioxide, polyethylene glycol, hydroxypropylmethylcellulose 400
in blister 10 pcs. a stack of cardboard 3 or 6 blister (tablet 25 mg) or a stack of cardboard 3, 6 or 9 blisters (tablets of 100 and 200 mg) or a stack of cardboard one blister (6 tablets of 25 mg of 3 tablets of 100 mg and 1 tablet 200 mg).
Description pharmaceutical form:
Tablets 25 mg: round, diameter 6 mm, peach, biconvex, coated tablets.
Tablet 100 mg: Round, 8.5 mm in diameter, yellow, biconvex, coated tablets.
200 mg Tablet: round, 11 mm diameter, white, biconvex covered sheath.
Pharmachologic effect:
It has higher affinity for serotonin 5HT2-receptors when compared to dopamine D1- and D2-receptors in the brain, as well as high affinity for histamine and alpha 1-adrenoceptors.
Pharmacokinetics:
The plasma protein binds to 83%. T1 / 2 -. About 7 hours is derived from the urine (73%) and the feces (21%) in the form of inactive metabolites. Biotransformiroetsa with the participation of cytochrome P450.
Indications:
Acute and chronic psychosis, including schizophrenia.
Contraindications:
Hypersensitivity.
Application of pregnancy and breastfeeding:
Perhaps if the expected effect of therapy outweighs the potential risk to the fetus. At the time of treatment should stop breastfeeding.
Side effect:
Cardio-vascular system and blood (blood, hemostasis): Orthostatic hypotension, hypertension, tachycardia, leukopenia.
From the nervous system and sensory organs: drowsiness, dizziness, anxiety, rarely - neuroleptic malignant syndrome.
On the part of metabolism: increased cholesterol, serum triglycerides, ALT and AST, changes in the level of liver enzymes.
On the part of the digestive tract: dry mouth, diarrhea or constipation, indigestion.
For the skin: rash, dry skin.
Other: pain (abdominal pain, headache, back pain, muscles, chest, ear), fatigue, rhinitis, urinary tract infection, fever, weight gain.
Drug Interactions:
Effect weaken inducers of microsomal liver enzymes (phenytoin, carbamazepine, barbiturates, rifampicin) and thioridazine (increases Cl).
Dosage and administration:
Inside, regardless of meals, 2 times a day.
Adults. The daily dose during the first 4 days of therapy: the first day - 50 mg, of the second day - 100 mg, and the third day - 200 mg, Day 4 - 300 mg. Since four of the day the dose should be titrated up to an effective dosage is typically in the range of 300 to 450 mg / day. Depending on the clinical response and tolerance of the individual patient, the dose can vary from 150 to 750 mg / day.
Elderly. Like other antipsychotics, Seroquel should be used with caution in the elderly, especially in the initial period of therapy. In elderly patients, an initial dose of Seroquel should be 25 mg per day. The dosage should be increased to 25-50 mg daily to achieve an effective dose which is likely to be less than in younger patients.
The safety and efficacy of Seroquel in children and adolescents has not been investigated.
In patients with impaired liver and kidney function quetiapine therapy should start with a dose of 25 mg / day. The dosage should be increased to 25-50 mg daily to achieve an effective dose.
Overdose:
Symptoms: drowsiness, sedation, tachycardia, hypotension.
Treatment: symptomatic recovery and control of upper airway, ensuring adequate oxygenation and ventilation, monitoring and maintenance of the cardiovascular system.
Precautionary measures:
Use caution when combined with other drugs having central activity, alcohol, as well as the combined administration with potent inhibitors of the biotransformation -. Ketoconazole, erythromycin, and others.
Special instructions:
Should not be used during the drivers of vehicles and people skills relate to the high concentration of attention.
