Nurem - instructions for use, doses, side effects, contraindications

Excipients: starch corn pregelatinized 35.3 mg, sodium carboxymethyl starch 3 mg, mannitol 62 mg, magnesium stearate 0.6 mg, cellulose microcrystalline 19 mg.

Dosage of 0.2 mg

1 tablet contains:

active substance: desmopressin acetate 0.2 mg (as trihydrate 0.21 mg), calculated as desmopressin 0.178 mg;

Excipients: starch corn pregelatinized 35.2 mg, sodium carboxymethyl starch 3 mg, mannitol 62 mg, magnesium stearate 0.6 mg, microcrystalline cellulose 19 mg.

Description:

Dosage of 0.1 mg: tablets are round, flat-cylindrical, white or almost white in color.

Dosage of 0.2 mg: tablets are round, biconcave, white or almost white in color.

Pharmacotherapeutic group:diabetes insipid treatment medication

ATX: & nbsp

H.01.B.A.02 Desmopressin

Pharmacodynamics:

The drug Nourem® contains desmopressin - structural analogue of the natural hormone arginine-vasopressin. Desmopressin was obtained as a result of changes in the structure of the molecule vasopressin - deamination of 1-cysteine and substitution 8-L-arginine on the 8-D-arginine. These structural changes result in a combination with a significantly enhanced antidiuretic ability to have a less pronounced effect on the smooth muscles of the vessels and internal organs compared with vasopressin, which leads to the absence of undesirable spastic side effects.

In contrast, vasopressin acts longer and does not cause an increase in blood pressure (BP). The drug increases the permeability of the epithelium of the distal convoluted tubules of the nephron for water and increases its reabsorption.

Application of the drug Nourem^® leads to a decrease in the volume of excreted urine and a simultaneous increase in osmolarity of urine and a decrease in osmolarity of the blood plasma.This leads to a decrease in the frequency of urination and a decrease in nocturnal polyuria.

After ingestion, the antidiuretic effect occurs within 15 minutes. The maximum antidiuretic effect occurs when ingested after 4-7 hours. Antidiuretic effect when ingested at a dose of 0.1-0.2 mg - up to 8 hours, at a dose of 0.4 mg - up to 12 hours.

Pharmacokinetics:

Suction

Absolute bioavailability for oral administration varies from 0.08% to 0.16%. Simultaneous intake of food can reduce the degree of absorption by 40%. Desmopressin begins to be detected in the blood 15-30 minutes after admission, the time to reach the maximum concentration in the blood plasma (Tc_m_Oh) - 2 hours.

Distribution

The volume of distribution is 0.2-0.3 l / kg. Desmopressin does not penetrate the blood-brain barrier.

Metabolism

Metabolised in the kidneys.

Excretion

It is excreted by the kidneys in part unchanged, partially subjected to enzymatic cleavage. The half-life (T_1/2) with oral administration - 2-3 hours.

Indications:

- Non-diabetes mellitus of central origin;

- primary nocturnal enuresis in children older than 5 years;

- nocturnal polyuria in adults (as symptomatic therapy).

Contraindications:

- Hypersensitivity to desmopressin or other components of the drug;

- habitual or psychogenic polydipsia;

- heart failure and other conditions requiring the appointment of diuretics;

- hyponatremia, including in the anamnesis (concentration of sodium ions in the blood plasma below 135 mmol / l);

- renal failure of moderate and severe severity (creatinine clearance (CC) below 50 ml / min);

- syndrome of inappropriate production of antidiuretic hormone;

- children under 4 years (for treatment of diabetes insipidus) and 5 years (for treatment of primary nocturnal enuresis).

Carefully:

With caution should be used in chronic renal failure (QC more than 50 ml / min), fibrosis of the bladder, with violations of water-electrolyte balance, the potential risk of increased intracranial pressure, during pregnancy, as well as in patients with diseases of the cardiovascular system, with bronchial asthma, epilepsy and migraine in the anamnesis (if necessary, reduce the dose of the drug).

With special care appoint the drug to elderly patients (65 years and older) due to a high risk of side effects (including fluid retention, hyponatremia).If the decision to treat desmopressin is taken, it is necessary to determine the concentration of sodium in the blood plasma and monitor the patient's condition before the appointment, 3 days after the start of the dose and at each dose increase.

Pregnancy and lactation:

Pregnancy

According to known data, when using desmopressin in pregnant women with diabetes insipidus, there was no side effect on the course of pregnancy, on the state of health of the pregnant, fetus and newborn. However, the prospective benefit to the mother and the potential risk to the fetus should be correlated.

Breastfeeding period

Studies have shown that the amount of desmopressin entering the body of a newborn with breast milk from a woman taking high doses of desmopressin is significantly less than that which can affect diuresis.

Dosing and Administration:

Inside.

The optimal dose of desmopressin is selected individually. The drug should be taken some time after eating, as eating can affect the absorption of the drug and its effectiveness.

Non-diabetes mellitus of central origin

The recommended initial dose is dFor children over 4 years and adults - 0.1 mg 1-3 times a day. In the subsequent dose change depending on the response to treatment. Usually the daily dose is in the range of 0.2-1.2 mg. For most patients, the optimal maintenance dose is 0.1-0.2 mg 1-3 times a day.

Primary night enuresis

The recommended initial dose is 0.2 mg per night. In the absence of effect, the dose may be increased to 0.4 mg.

It is necessary to monitor compliance with the restriction of fluid intake in the evening.

The recommended course of continuous treatment is 3 months. The decision to continue treatment should be made on the basis of clinical data, which will be observed after the drug is discontinued within 1 week.

Nocturnal polyuria in adults

The recommended initial dose is 0.1 mg per night. In the absence of effect within 1 week, the dose is increased to 0.2 mg and subsequently to 0.4 mg with increasing dose with frequency Mr.e more than once a week.

Remember the danger of fluid retention in the body.

If after 4 weeks of treatment and dose adjustments adequate clinical effect is not observed, continue taking the drug is not recommended.

Side effects:

From the central nervous system: headache, dizziness.

From the digestive system: nausea, vomiting, dry mouth.

Other: hyperemia sclera, "hot flashes", transient tachyarrhythmia, convulsions.

Receiving desmopressin without simultaneous liquid receiving limitation can cause fluid retention in the body accompanied hyponatremia, weight gain, peripheral edema, and in severe cases - convulsions.

When used simultaneously with imipramine or oxybutynin, hyponatremic convulsions are possible.

Overdose:

Overdose leads to an increase in the duration of action of desmopressin and an increased risk of fluid retention and hyponatremia.

Treatment of hyponatremia should be individual, it is mandatory to stop taking the drug and to cancel the restriction on the intake of fluid. If there are symptoms of an overdose, an infusion of 0.9% or a hypertonic solution of sodium chloride is possible. In case of severe fluid retention (seizures and loss of consciousness), therapy should be added furosemide.

In case of overdose, see a doctor.

Interaction:

With simultaneous application desmopressin strengthens the action of hypertensive drugs.

With simultaneous application buformin, tetracycline, lithium preparations, norepinephrine weaken the antidiuretic effect of desmopressin.

With simultaneous use of desmopressin with notSteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of side effects.

With simultaneous application indomethacin strengthens, but does not increase the duration of action of desmopressin.

With the simultaneous use of tricyclic antidepressants, selective serotonin reuptake inhibitors, narcotic analgesics, NSAIDs, lamotrigine, chlorpromazine and carbamazepine, capable of causing a syndrome of inadequate secretion of antidiuretic hormone, can enhance the antidiuretic effect of desmopressin and lead to an increased risk of fluid retention and hyponatremia.

When using desmopressin with loperamide, a triple increase in the concentration of desmopressin in the plasma, which significantly increases the risk of fluid retention and the occurrence of hyponatremia. Perhaps other medications that slow down peristalsis can cause a similar effect.

With simultaneous use of desmopressin with dimethicone, a decrease in desmopressin absorption is possible.

Special instructions:

To avoid the development of side effects, it is mandatory to limit to a minimum the intake of fluid 1 hour before admission and within 8 hours after taking the drug in patients with a primary night enuresis. Non-compliance with this rule leads to the development of side effects.

Clinical studies have shown that most often hyponatremia occurs in elderly patients (65 years and older). High risk of side effects is in elderly patients with initially low concentration of sodium in blood plasma and polyuria from 2.8 to 3.0 liters.

Desmopressin should not be used in cases where there are other additional causes for fluid retention and electrolyte disorders.

Prevention of hyponatremia development consists in increasing the frequency of determination of sodium in blood plasma, especially in cases of simultaneous reception with drugs that cause the syndrome of inadequate secretion of antidiuretic hormone (tricyclic antidepressants, selective inhibitors of serotonin, chlorpromazine and carbamazepine) and NSAIDs.

In cases of acute incontinence, dysuria and / or nocturia, urinary tract infection, with a suspected bladder tumor or prostate, with polydipsia and decompensated diabetes mellitus, the diagnosis and treatment of these conditions and conditions should be performed before desmopressin treatment begins.

When developing against the background of treatment of systemic infections, fever, gastroenteritis, the drug should be stopped.

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

At present, there is no evidence of the possible effect of desmopressin on the ability to drive vehicles and mechanisms. However, the use of Nurem® can lead to the development of side effects such as dizziness, headache, which can adversely affect the ability to drive vehicles and carry out potentially dangerous activities that require increased concentration and speed of psychomotor reactions. It is recommended to use caution when driving vehicles and machinery.

Form release / dosage:

Tablets, 0.1 mg and 0.2 mg.

Packaging:

For 10 or 30 tablets in a contour mesh box made of PVC film or PVC / HDPE film or PVC / PCTFE foil and aluminum printed lacquer foil.

For 3, 6 out-of-round cell packs of 10 tablets or 1, 2, 3, 4 contour packs of 30 tablets together with the instructions for use are placed in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003031

Date of registration:11.06.2015

Date of cancellation:2020-06-11

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia

Representation: & nbspCANONFARMA PRODUCTION CJSC CANONFARMA PRODUCTION CJSC Russia

Information update date: & nbsp15.01.2016

Illustrated instructions

Instructions

Nurem® (Nourem®)