Nourem, tablets 0,1 mg 30 pcs

Nourem® contains desmopressin, a structural analogue of the natural hormone arginine-vasopressin. Desmopressin is obtained as a result of changes in the structure of the vasopressin molecule – deamination of I-cysteine and substitution of 8-L-arginine for 8-D-arginine.

These structural changes lead in combination with a significantly enhanced antidiuretic ability to a less pronounced effect on vascular smooth muscle and internal organs compared to vasopressin, resulting in no unwanted spastic side effects.

Unlike vasopressin it has a more sustained effect and does not cause increase in BP. The drug increases permeability of epithelium of distal tubules of nephron for water and increases its reabsorption. Administration of Nourem® leads to decrease of urine volume and simultaneous increase of urine osmolarity and decrease of blood plasma osmolarity.

This results in decreased frequency of urination and decreased nocturnal polyuria. After oral administration the antidiuretic effect occurs within 15 minutes.

The maximum antidiuretic effect occurs after 4-7 hours after oral administration. Antidiuretic effect when administered orally in dose 0.1-0.2 mg – up to 8 hours, in dose 0.4 mg – up to 12 hours.

Indications

Active ingredient

Composition

1 tablet contains:

the active ingredient:

desmopressin acetate 0.1 mg (as trihydrate 0.105 mg), in terms of desmopressin 0.089 mg;

auxiliary substances:

corn starch pregelatinized 35.3 mg,

sodium carboxymethyl starch 3 mg,

How to take, the dosage

Ingestion.

The optimal dose of desmopressin is chosen individually.

The drug should be taken some time after meals because eating may affect absorption of the drug and its effectiveness.

Non-sugar diabetes of central genesis

The recommended starting dose for children over 4 years of age and adults is 0.1 mg 1-3 times daily. Subsequently, the dose is changed 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 nocturnal enuresis

The recommended starting dose is 0.2 mg at night. If there is no effect, the dose may be increased to 0.4 mg. It is necessary to monitor the observance of liquid intake restriction in the evening. The recommended course of continuous treatment is 3 months. The decision about continuation of treatment should be made on the basis of clinical data, which will be observed after discontinuation of the drug for 1 week.

Nighttime polyuria in adults

The recommended initial dose is 0.1 mg at night. If there is no effect within 1 week, the dose is increased to 0.2 mg and thereafter to 0.4 mg with increasing doses no more than once a week. It should be remembered about the danger of fluid retention in the body. If after 4 weeks of treatment and dose adjustment adequate clinical effect is not observed, it is not recommended to continue taking the drug.

Interaction

In concomitant use desmopressin increases the effect of hypertensive agents. When concomitant use, buformin, tetracycline, lithium preparations, norepinephrine weaken the antidiuretic effect of desmopressin.

Concomitant use of desmopressin with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of side effects. When concomitant use, indomethacin increases, but does not increase the duration of action of desmopressin.

When used concomitantly, tricyclic antidepressants, selective serotonin reuptake inhibitors, narcotic analgesics, NSAIDs, lamotrigine, chlorpromazine, and carbamazepine, which may cause inadequate antidiuretic hormone secretion syndrome, may increase antidiuretic effect of desmopressin and lead to increased risk of fluid retention and hyponatremia.

When using desmopressin with loperamide, a threefold increase in plasma concentration of desmopressin is possible, which significantly increases the risk of fluid retention and the occurrence of hyponatremia. It is possible that other drugs that slow down peristalsis may cause a similar effect.

Concomitant use of desmopressin with dimethicone may decrease the absorption of desmopressin.

Special Instructions

In order to avoid the development of side effects, it is mandatory to limit fluid intake to a minimum 1 hour before and within 8 hours after taking the drug in patients with primary nocturnal enuresis. Failure to follow this rule leads to the development of side effects.

Clinical studies have shown that hyponatremia most often occurs in elderly patients (65 years and older). Elderly patients with a baseline low plasma sodium concentration and polyuria of 2.8 to 3.0 liters have a high risk of side effects.

Desmopressin should not be used when there are other additional causes for fluid retention and electrolyte disturbances.

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

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

If against the background of treatment systemic infections, fever, gastroenteritis the drug should be discontinued.

Influence on driving and operating ability

There are currently no data on the possible effect of desmopressin on driving and operating ability.

Noem® use may, however, lead to side effects such as dizziness, headache which may adversely affect the ability to drive vehicles and perform potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

We recommend caution when driving vehicles and operating machinery.

Contraindications

Hypersensitivity to desmopressin or other drug components;

habitual or psychogenic polydipsia;

heart failure and other conditions requiring the prescription of diuretics;

Hyponatremia, including a history of hyponatremia (plasma sodium ion concentrations below 135 mmol/L);

moderate to severe renal impairment (creatinine clearance (CK) below 50 ml/min);

deficient antidiuretic hormone production syndrome.

Children under 4 years of age (for treatment of nonspecific diabetes) and 5 years of age (for treatment of primary nocturnal enuresis).

With caution

The drug should be used with caution in chronic renal failure (CK more than 50 ml/min), bladder fibrosis, water-electrolyte balance disorders, potential risk of increased intracranial pressure, during pregnancy, and in patients with cardiovascular disease, with bronchial asthma, epilepsy and migraine history (if necessary, the drug dose should be reduced).

Particular caution is exercised when prescribing the drug in elderly patients (65 years and older) due to the high risk of side effects (including fluid retention, hyponatremia). If the decision to treat with desmopressin is made, the plasma sodium concentration should be determined before prescription, 3 days after the start of administration, and with each increase in the dose, and the patient’s condition should be monitored.

Side effects

Central nervous system disorders: headache, dizziness.

Digestive system disorders: nausea, vomiting, dry mouth.

Others: sclera hyperemia, “hot flashes”, transient tachyarrhythmia, convulsions.

The administration of desmopressin without simultaneous fluid restriction may lead to fluid retention in the body accompanied by hyponatremia, weight gain, peripheral edema, and, in severe cases, seizures.

Concomitant use with imipramine or oxybutynin may cause hyponatremic seizures.

Overdose

Overdose leads to increased duration of action of desmopressin and increased risk of fluid retention and hyponatremia. Treatment of hyponatremia should be individualized, discontinuation of the drug and cancellation of fluid restriction are mandatory.

In the presence of symptoms of overdose infusion of 0.9% or hypertonic sodium chloride solution is possible. In case of marked fluid retention (seizures and loss of consciousness) furosemide should be added to therapy.

In case of overdose it is necessary to consult a physician.

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