Hedonin - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrophosphate anhydrous 12,568 / 50,270 / 100,54 mg, lactose monohydrate 1,0 / 4,0 / 8,0 mg, cellulose microcrystalline 12,0 / 48,0 / 96,0 mg, sodium carboxymethyl starch 2,750 / 11,0 / 22.0 mg, povidone 2.0 / 8.0 / 16.0 mg, magnesium stearate 0.90 / 3.60 / 7.20 mg;

film sheath:

for tablets 25 mg: opadray® 03B84929 pink 2.0 mg: hypromellose 1.250 mg, titanium dioxide 0.567 mg, macrogol 400 0.125 mg, iron oxide dye oxide yellow 0.03 mg, ferric oxide red oxide 0.028 mg;

for tablets 100 mg: opadrai®03B82923 yellow 6.0 mg: hypromellose 3.750 mg, titanium dioxide 1.695 mg, macrogol 400 0.375 mg, iron oxide dye yellow 0.180 mg;

for tablets 200 mg: opadray® U-1-7000 white 12.0 mg: hypromellose 7.5 mg, titanium dioxide 3.75 mg, macrogol 400 0.75 mg.

Description:

Round biconvex, film-coated tablets; for tablets 25 mg: yellow-pink color, for tablets 100 mg: yellow with risk, dFor tablets at a dosage of 200 mg: white or almost white. On the cross-section - the core is white or almost white.

Pharmacotherapeutic group:Antipsychotic agent (antipsychotic)

ATX: & nbsp

N.05.A.H.04 Quetiapine

Pharmacodynamics:

Antipsychotic agent (antipsychotic). Has a higher affinity for serotonin receptors (5-HT₂) than to dopamine receptors D₁ and D₂ in the brain. Has tropism for histamine and alpha₁adrenoreceptors, is less active with respect to alpha₂adrenoreceptors. Does not show selective affinity for m-cholino- and benzodiazepine receptors. Reduces activity of mesolimbic A₁₀-dophaminergic neurons, in comparison with A9-nigrostriate neurons involved in motor functions. Does not cause a prolonged increase in the concentration of prolactin. Duration of communication with 5NT₂-serotonin and D₂dopamine receptors is less 12 hours

Pharmacokinetics:

Absorption of the drug is high. Eating does not affect bioavailability. The connection with plasma proteins is about 83%. The drug is metabolized in the liver with the formation of an active metabolite of N-desalkylkvetiapine and a number of pharmacologically inactive metabolites under the influence of cytochrome P450 mediated isoenzyme CYP3A4. Quetiapine and some of its metabolites have a weak inhibitory effect on cytochrome isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4, but only in concentrations 10-50 times higher than those that occur at commonly used doses - 300-450 mg / day.

The drug is excreted mainly by the kidneys - 73%, through the intestines - 21%. Less than 5% of quetiapine is not metabolized and is excreted unchanged by the kidneys or through the intestine. Half-life is about 7 hours. The average clearance in elderly patients is 30-50% less than that observed in patients under the age of 65 years. With renal and hepatic insufficiency, the clearance decreases by 25%.

Indications:

Acute and chronic psychoses (including schizophrenia).

Manic episodes in the structure of bipolar disorder

Contraindications:

Hypersensitivity to any of the components of the drug, pregnancy, lactation, lactose intolerance (the drug contains lactose), simultaneous use of cytochrome P450 inhibitors, children under 18 years of age.

Carefully:

Patients with arterial hypotension, epilepsy and epileptic seizures (in the anamnesis).

Pregnancy and lactation:

The use of the drug during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

Inside, 2 times a day, regardless of food intake.

Acute and chronic psychosis, schizophrenia

The daily dose for the first 4 days is 50 mg (1 day), 100 mg (2 day), 200 mg (3 day),

300 mg (4 days). Starting from the 4th day, the dose should be titrated to an effective dose, ranging from 300 to 450 mg / day, if necessary - up to 750 mg / day.

In renal and / or liver failure and in elderly patients, the initial dose is 25 mg / day, followed by a daily increase of 25-50 mg to achieve an effective dose.

Manic episodes in the structure of bipolar disorder

The drug is used as a monotherapy or as an adjuvant therapy for mood stabilization.

The daily dose for the first 4 days is 100 mg (1 day), 200 mg (day 2), 300 mg (day 3), 400 mg (day 4). By the sixth day of treatment, the dose can be increased to 800 mg. The increase in the daily dose should not exceed 200 mg / day. Usually the effective dose is from 400 to 800 mg / day.

Side effects:

Co the sides of the nervous system: drowsiness, dizziness, headache, anxiety, asthenia, hostility, agitation, insomnia, akathisia, tremor, convulsions, depression, paresthesia, malignant neuroleptic syndrome (hyperthermia, muscle rigidity, altered mental status, lability in the autonomic nervous system, increased activity of CK).

From the side of the cardiovascular system: orthostatic hypotension, tachycardia, lengthening interval Q-T.

Co the sides of the digestive system: dryness of the oral mucosa, nausea, vomiting, abdominal pain, diarrhea or constipation, increased activity of "liver" transaminases.

From the respiratory system: pharyngitis, rhinitis.

Allergic reactions: skin rash, eosinophilia.

Laboratory indicators: leukopenia, hypercholesterolemia, hypertriglyceridemia, decreased concentration T4 (the first 4 weeks).

Other: back pain, chest pain, subfebrile condition, weight gain (mainly in the first weeks of treatment), myalgia, dry skin, decreased vision.

Overdose:

Cases of overdose are not established. Symptoms are associated with side effects of the drug, such as drowsiness, tachycardia, lowering blood pressure.

There is no specific antidote. Symptomatic treatment is recommended.

Interaction:

Does not induce the induction of enzyme systems of the liver involved in the metabolism of phenazone.

Inducers of microsomal liver systems (phenytoin and etc.), thioridazine increase the clearance of quetiapine,inhibitors of microsomal liver systems - reduce; at the same time simultaneous appointment of quetiapine and antidepressants - imipramine (inhibitor CYP2D6) or fluoxetine (inhibitor CYP3A4 and CYP2D6) does not have a significant effect on its pharmacokinetics.

Drugs that oppress the central nervous system, and ethanol increase the risk of side effects.

Effect on the ability to drive transp. cf. and fur:

Since taking the drug can cause drowsiness, lower blood pressure, then during the treatment should be careful when driving vehicles and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 25 mg, 100 mg, 200 mg.

Packaging:

For 10 tablets in PVC / PE / PVDC / AL blister.

By 3, 6 or 9 blisters together with instructions for use in a cardboard box.

Storage conditions:

Does not require special storage conditions.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000342

Date of registration:22.02.2011 / 12.11.2013

Expiration Date:22.02.2016

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

G.L.PHARMA, GmbH Austria

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp17.03.2017

Illustrated instructions

Instructions

Hedonin (Gedonin)