Universal reference book for medicines
Name of the preparation: NANTARID ® (NANTARID ® )

Active substance: quetiapine

Type: Antipsychotic drug (antipsychotic)

Manufacturer: GEDEON RICHTER (Hungary) manufactured by MATRIX Laboratories (India)
Composition, form of production and packaging
The tablets covered with a film cover of
yellow-pink color, round, biconcave.

1 tab.

quetiapine fumarate 28.783 mg,

which corresponds to the content of quetiapine 25 mg

Excipients: calcium hydrophosphate anhydrous - 12.567 mg, lactose monohydrate - 1 mg, microcrystalline cellulose - 12 mg, sodium carboxymethyl starch - 2.75 mg, povidone - 2 mg, magnesium stearate - 0.9 mg.

The composition of the film shell: opadrai ® pink 03В84929 - 2 mg (hypromellose - 1.25 mg, titanium dioxide - 0.567 mg, macrogol 400 - 0.125 mg, iron oxide, yellow oxide - 0.03 mg, iron oxide, red oxide - 0.028 mg).

10 pieces.
- blisters (3) - packs of cardboard.
The tablets covered with a film cover of yellow color, round, biconcave, with risk on one side.

1 tab.

quetiapine fumarate 115.13 mg,

which corresponds to the content of quetiapine 100 mg

Excipients: calcium hydrophosphate anhydrous - 50.27 mg, lactose monohydrate - 4 mg, microcrystalline cellulose - 48 mg, sodium carboxymethyl starch - 11 mg, povidone - 8 mg, magnesium stearate - 3.6 mg.

The composition of the film shell: opadray ® yellow 03В82923 - 6 mg (hypromellose - 3.75 mg, titanium dioxide - 1.695 mg, macrogol 400 - 0.375 mg, iron oxide oxide yellow - 0.18 mg).

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (6) - packs of cardboard.
Tablets covered with a film membrane from white to almost white, round, biconvex.

1 tab.

quetiapine fumarate 230.26 mg,

which corresponds to the content of quetiapine 200 mg

Excipients: calcium hydrophosphate anhydrous - 100.54 mg, lactose monohydrate - 8 mg, microcrystalline cellulose - 96 mg, sodium carboxymethyl starch - 22 mg, povidone - 16 mg, magnesium stearate - 7.2 mg.

The composition of the film shell: opadray ® white Y-1-7000 - 12 mg (hypromellose - 7.5 mg, titanium dioxide - 3.75 mg, macrogol 400 - 0.75 mg).

10 pieces.
- blisters (6) - packs of cardboard.
Tablets, coated with a film shell from white to almost white, in the form of capsules, with a risk on one side.

1 tab.

quetiapine fumarate 345.39 mg,

which corresponds to the content of quetiapine 300 mg

Excipients: calcium hydrophosphate anhydrous - 150.81 mg, lactose monohydrate - 12 mg, microcrystalline cellulose - 144 mg, sodium carboxymethyl starch - 33 mg, povidone - 24 mg, magnesium stearate - 10.8 mg.

The composition of the film shell: opadray ® white Y-1-7000 - 18 mg (hypromellose - 11.25 mg, titanium dioxide - 5.625 mg, macrogol 400 - 1.125 mg).

10 pieces.
- blisters (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Antipsychotic drug (antipsychotic).
Has a higher affinity for serotonin 5-HT 2 -receptors than for dopamine D 1 - and D 2 -receptors of the brain. Has an affinity for histamine and? 1- adrenoreceptors, is less active in relation to? 2- adrenoreceptors. There was no selective affinity for cholinergic muscarinic and benzodiazepine receptors. Reduces the activity of mesolimbic A10-dopaminergic neurons, in comparison with A9-nigrostriate neurons involved in motor functions. Does not cause a prolonged increase in the concentration of prolactin. The duration of communication with serotonin 5-HT 2 -receptors and dopamine D 2 -receptors is less than 12 hours after administration of the drug.
PHARMACOKINETICS

Suction

When oral administration is well absorbed from the digestive tract.
Absorption is high, eating does not affect bioavailability.
Distribution

Quetiapine approximately 83% binds to plasma proteins.
The pharmacokinetics of quetiapine is linear, and does not differ between men and women.
Metabolism

It is actively metabolized in the liver with the formation of pharmacologically inactive metabolites under the influence of the isoenzyme CYP3A4.
Quetiapine and some of its metabolites have a weak inhibitory effect on cytochrome isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, but only in concentrations 10-50 times higher than those that occur at the usual dose of 300-450 mg / day.
Excretion

It is excreted by the kidneys 73%, through the intestines - 21%.
T 1/2 - about 7 hours. Less than 5% of quetiapine is not metabolized and is excreted unchanged by the kidneys or through the intestine.
Pharmacokinetics in special clinical cases

The average clearance of quetiapine in elderly patients is 30-50% less than that observed in patients aged 18 to 65 years.

In patients with liver cirrhosis, T 1/2 is slightly increased, and the bioavailability of the drug is reduced (dosage adjustment may be required).

The mean plasma clearance of quetiapine was approximately 25% less in patients with severe renal dysfunction (CK less than 30 ml / min / 1.73 m 2 ) and in patients with liver damage (alcohol cirrhosis in the compensation stage), but individual clearance rates were within , corresponding to healthy people.

INDICATIONS

- Acute and chronic psychoses, including schizophrenia;

- manic episodes in bipolar disorder.

DOSING MODE

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

In the treatment of acute and chronic psychoses, including schizophrenia, the daily dose for the first 4 days of therapy is 50 mg (1 day), 100 mg (day 2), 200 mg (day 3), 300 mg (day 4).
Starting from 4 days, the dose should be selected up to an effective dose ranging from 300 to 450 mg / day. Depending on the clinical effect and tolerability of the drug, the dose may vary from 150 to 750 mg / day.
In the treatment of manic episodes with bipolar disorder, the daily dose for the first 4 days of therapy is 100 mg (1 day), 200 mg (day 2), 300 mg (day 3), 400 mg (day 4).
Further, within 6 days, the daily dose is increased to 800 mg, but not more than 200 mg / day. Depending on the clinical effect and the tolerability of the drug, the dose may vary from 200 to 800 mg / day. The effective dose is from 400 to 800 mg / day.
The plasma clearance of quetiapine in elderly people is reduced by 30-50% compared to young patients, so prescribing the drug should be done with caution, especially at the beginning of treatment.
The starting dose is 25 mg / day, followed by an increase of 25-50 mg / day until the effective dose is reached.
In renal and / or liver failure , quetiapine should be treated with 25 mg / day, followed by a daily increase of 25-50 mg to achieve an effective dose.

The safety and efficacy of the drug in children and adolescents have not been investigated.

SIDE EFFECT

Side effects observed with the use of the drug are classified into categories according to the frequency of their occurrence: very often (? 1/10);
often (? 1/100, <1/10);infrequently (? 1/1000, <1/100); rarely (? 1/10 000, <1/1000); very rarely (<1/10 000, including individual messages).
On the part of the hematopoiesis system: often - leukopenia;
infrequently - eosinophilia, thrombocytopenia; very rarely - neutropenia.
On the part of the endocrine system: often - weight gain (mainly in the first weeks of treatment), hyperglycemia or decompensation of diabetes mellitus;
very rarely - diabetes.
From the nervous system: very often - dizziness, drowsiness, headache;
often syncope, unusual and nightmarish dreams, fainting, extrapyramidal symptoms, anorexia;infrequently - anxiety, hostility, agitation, insomnia, akathisia, tremor, convulsions, depression, dysarthria, paresthesia; rarely - malignant neuroleptic syndrome (hyperthermia, muscle rigidity, altered mental status, lability in the autonomic nervous system, increased activity of creatine phosphokinase); very rarely - tardive dyskinesia.
From the cardiovascular system: often - orthostatic hypotension, palpitation, tachycardia, increased blood pressure, prolongation of the QT interval on the ECG;individual reports - the risk of venous thromboembolism.

From the side of the digestive system: very often - dry mouth;
often - nausea, vomiting, diarrhea or constipation, dyspepsia, infrequently - dysphagia; rarely - abdominal pain, jaundice; very rarely - hepatitis.
From the respiratory system: often - pharyngitis, rhinitis.

Allergic reactions: infrequent - skin rash, hypersensitivity reactions;
very rarely - angioedema, Stevens-Johnson syndrome.
On the part of the reproductive system: rarely - priapism (painful erection).

From the side of the organ of vision: often - blurred vision.

From the immune system: infrequently - hypersensitivity reactions;
very rarely - angioedema, Stevens-Johnson syndrome.
Laboratory indicators: very often - hypercholesterolemia, hypertriglyceridemia;
often - increased activity of liver transaminases; infrequently, increased GGT activity, decreased total and free T4 (the first 4 weeks), and general T3 and reversible T3 (only with high doses of quetiapine), increased creatine phosphokinase activity not associated with malignant neuroleptic syndrome.
Other: very often - withdrawal syndrome;
often - peripheral edema, asthenia, increased sweating; rarely - back pain, chest pain, subfebrile condition, myalgia, dry skin, weak eyesight.
CONTRAINDICATIONS

- the period of breastfeeding;

- children and adolescents under 18 years of age (effectiveness and safety not established);

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption (in the drug form of the drug contains lactose);

- Hypersensitivity to quetiapine or other components of the drug.

Caution should be given to the drug in cardiovascular and cerebrovascular diseases, arterial hypotension, congenital syndrome of QT interval prolongation, or the presence of conditions potentially capable of inducing prolongation of the QT interval (simultaneous administration of drugs prolonging the QT interval, congestive heart failure, hypokalemia, hypomagnesemia), hypothyroidism , diabetes mellitus, hepatic insufficiency, epilepsy, convulsive fits in the anamnesis, pregnancy, elderly patients, patients at risk
development of venous thromboembolism.
PREGNANCY AND LACTATION

Safety and effectiveness of use in pregnancy is not established.
Therefore, in pregnancy, Nantaride ® can only be used if the expected benefit to the mother exceeds the potential risk to the fetus. The degree of excretion of quetiapine with human milk is not known. If Nantaride ® is needed during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER

In renal failure , quetiapine should be treated with 25 mg / day, followed by a daily increase of 25-50 mg to achieve an effective dose.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

For hepatic insufficiency , quetiapine should be started with 25 mg / day, followed by a daily increase of 25-50 mg until an effective dose is reached.

APPLICATION FOR CHILDREN

The safety and efficacy of the drug in children and adolescents have not been investigated.

APPLICATION IN ELDERLY PATIENTS

The plasma clearance of quetiapine in elderly people is reduced by 30-50% compared to young patients, so prescribing the drug should be done with caution, especially at the beginning of treatment.
The starting dose is 25 mg / day, followed by an increase of 25-50 mg / day until the effective dose

SPECIAL INSTRUCTIONS

With a sharp cancellation of high doses of antipsychotic drugs, the following acute reactions (withdrawal syndrome) can occur: nausea, vomiting, and rarely insomnia.
Cases of exacerbation of psychotic symptoms and the appearance of involuntary motor disorders (akathisia, dystonia, dyskinesia) have been reported. In this regard, it is recommended to gradually phase out the drug.
Given that quetiapine mainly affects the central nervous system, Nantharid ® should be used with caution in combination with other drugs that have an inhibitory effect on the central nervous system.
It is recommended to refrain from drinking alcohol.
When symptoms of tardive dyskinesia appear, reduce the dose or stop using quetiapine.

Caution should be exercised while prescribing quetiapine concomitantly with drugs that extend the QT interval, especially in the elderly, in patients with congenital QT interval elongation, congestive heart failure, myocardial hypertrophy, hypokalemia, and hypomagnesemia.

Malignant neuroleptic syndrome can be associated with ongoing antipsychotic treatment.
Clinical manifestations of the syndrome include: hyperthermia, altered mental status, muscle rigidity, instability of the autonomic nervous system, increased activity of creatine phosphokinase. With the development of this syndrome, quetiapine should be withdrawn and treated accordingly.
In patients with prolonged use of quetiapine, cataracts were reported.
In this regard, an ophthalmological examination should be conducted before the start of therapy and once every 6 months with prolonged use of the drug.
As with other antipsychotics, caution should be exercised in the treatment of patients with a history of seizures.

There are some reports of the risk of venous thromboembolism in the use of antipsychotic drugs.
Before and during quetiapine treatment, all possible risk factors for venous thromboembolism should be identified and preventive measures taken.
Impact on the ability to drive vehicles and manage mechanisms

Nantaride ® can cause drowsiness, so patients are advised not to work with mechanisms that present a hazard, including.
it is not recommended to drive and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE

Data on drug overdose are limited.
The cases of taking quetiapine in a dose exceeding 20 g without fatal outcomes and the coping of side effects without consequences are described. Very rarely reported cases of overdose of quetiapine, which led to an elongation of the QT interval, coma or death.
Symptoms: excessive sedation, drowsiness, tachycardia, arterial hypotension.

Treatment: there are no specific antidotes to quetiapine.
In case of an accidental overdose within the first hour after taking it is necessary to consider the possibility of symptomatic therapy and it is recommended to carry out activities aimed at maintaining the function of respiration, cardiovascular system, ensuring adequate oxygenation and ventilation. Medical supervision and surveillance should be continued until the patient is fully recovered.
DRUG INTERACTION

When concurrently prescribing drugs with a strong inhibitory effect on the CYP3A4 isoenzyme (such as the azole antifungal agents and macrolide antibiotics), the concentration of quetiapine in the plasma may increase.
In such cases, lower doses should be used. Particular attention should be paid to elderly and weakened patients.It is necessary to individually evaluate the relationship between risk and benefit for each patient.
Simultaneous administration of Nantaride ® with carbamazepine and phenytoin inducing microsomal enzymes of the liver may reduce the concentration of the drug in the plasma, which may require an increase in its dose, depending on the clinical effect.
This should also be taken into account when removing phenytoin, carbamazepine or other inducer of microsomal liver enzymes or substituting for a drug that does not induce microsomal liver enzymes (eg, valproic acid).
Quetiapine does not induce the induction of microsomal liver enzymes involved in the metabolism of phenazone.

The pharmacokinetics of quetiapine does not change with simultaneous use of cimetidine (inhibitor P450), fluoxetine antidepressants (inhibitor CYP3A4 and CYP2D6) or imipramine (CYP2D6 inhibitor).

The pharmacokinetics of quetiapine did not change significantly when taken concomitantly with risperidone, haloperidol, lithium preparations, and valproic acid preparations.
However, simultaneous administration of quetiapine with thioridazine led to an increase in the clearance of quetiapine.
Drugs that depress the central nervous system, and ethanol increase the risk of side effects.

With concurrent administration of quetiapine 750 mg / day and lorazepam 2 mg once, the lorazepam clearance is reduced by 20%.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 4 years.
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