Nativa - instructions for use, reviews, analogs and forms of release (100 μg and 200 μg tablets) of the drug for the treatment of diabetes insipidus, nocturnal enuresis and polyuria in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Nativa. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Nativ in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of the Native, in the presence of existing structural analogues. Use for the treatment of diabetes insipidus of central genesis, nocturnal enuresis and polyuria in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Nativa - contains a structural analogue of the natural hormone arginine-vasopressin, with a pronounced antidiuretic effect - desmopressin.

Desmopressin was obtained as a result of changes in the structure of the vasopressin molecule - deamination of L-cysteine ​​and replacement of 8-L-arginine with 8-D-arginine. Desmopressin increases the permeability of the epithelium of the distal sections of the convoluted tubules of the nephron for water and increases its reabsorption. Structural changes in combination with significantly enhanced antidiuretic ability lead to less pronounced effect of desmopressin on the smooth muscles of blood 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.

The use of desmopressin in diabetes insipidus of central origin 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. The maximum antidiuretic effect with oral administration comes in 4-7 hours.Antidiuretic effect with oral administration in a dose of 0.1-0.2 mg - up to 8 hours, at a dose of 0.4 mg - up to 12 hours.

Composition

Desmopressin acetate + excipients.

Pharmacokinetics

When administered orally, Cmax in plasma is achieved within 0.9 h. Simultaneous intake of food can reduce the degree of absorption from the gastrointestinal tract by 40%. Absorption on intake - 5%. Desmopressin does not penetrate the blood-brain barrier. It is excreted by the kidneys.

Indications

• diabetes insipidus of central genesis;
• primary nocturnal enuresis in children older than 5 years;
• polydipsia after surgery in the pituitary;
• nocturnal polyuria in adults (as symptomatic therapy).

Forms of release

Tablets are 100 μg and 200 μg.

Instructions for use and dosing regimen

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

Central diabetes insipidus: the recommended initial dose for children over 4 years and adults is 0.1 mg 1-3 times a day. In the subsequent dose is selected depending on the response to treatment.Usually the daily dose is from 0.2 to 1.2 mg. For most patients, the optimal maintenance dose is 0.1-0.2 mg 1-3 times per day.

Primary nighttime enuresis: The recommended initial dose for children over 5 years and adults is 0.2 mg per night. In the absence of effect, the dose may be increased to 0.4 mg. 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. It is necessary to monitor compliance with the restriction of fluid intake in the evening.

Nocturnal polyuria in adults: the recommended initial dose is 0.1 mg per night. In the absence of effect within 7 days, the dose is increased to 0.2 mg and then to 0.4 mg with increasing dose at a frequency of no more than 1 time per 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 to use the drug is not recommended.

Side effect

• fluid retention and / or hyponatremia;
• headache;
• dizziness;
• convulsions;
• nausea, vomiting;
• dry mouth;
• peripheral edema;
• increase in body weight;
• transient tachyarrhythmia;
• redness of the eyes;
• hyponatremic convulsions.

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 insufficiency of moderate and severe degree (creatinine clearance below 50 ml / min);
• Children under 4 years old (for treatment of diabetes insipidus) and up to 5 years (for treatment of primary nocturnal enuresis);
• syndrome of inappropriate production of antidiuretic hormone;
• deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Application in pregnancy and lactation

According to the known data, when using Nativa's drug 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.

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.

Use in children

Contraindicated in children under 4 years (for treatment of diabetes insipidus) and up to 5 years (for treatment of primary nocturnal enuresis).

Application in elderly patients

With extreme caution apply the drug in elderly patients (over 65 years) due to the high risk of side effects (fluid retention, hyponatremia).

special instructions

Most often, hyponatremia occurs in elderly patients (over 65 years of age). It is necessary to control the treatment of children, adolescents, patients at risk of increased intracranial pressure. To avoid the development of side effects, it is mandatory to minimize the intake of liquid 1 h before and during 8 hours after taking the drug in patients with primary nocturnal enuresis.

The product of Nativa should not be used when there are other additional reasons for fluid retention and electrolyte disorders.High risk of side effects is for elderly patients with initially low concentration of sodium in blood plasma and polyuria from 2.8 to 3 liters.

Prevention of the development of hyponatremia consists in increasing the frequency of determination of sodium in the blood plasma, especially when used with drugs that cause the syndrome of inadequate secretion of antidiuretic hormone (tricyclic antidepressants, selective serotonin reuptake inhibitors, narcotic analgesics, lamotrigine, chlorpromazine and carbamazepine) and nonsteroidal anti-inflammatory drugs NSAIDs). In the event of acute urinary incontinence, dysuria and / or nocturia, urinary tract infection, suspected bladder or prostate tumor, the presence of polydipsia and decompensated diabetes mellitus, the diagnosis and treatment of these conditions and diseases should be carried out before starting treatment with Nativa.

When prescribing Nativa therapy 3 days after the start of the dose and at each dose increase, the concentration of sodium in the blood plasma should be determined and the patient's condition monitored.

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

Impact on the ability to drive vehicles and manage mechanisms

Currently, there is no data on the possible impact of Nativ's drug on the ability to drive a car and to control mechanisms. Nevertheless, the use of the drug may lead to the development of side effects such as dizziness, headache, which can adversely affect the ability to drive and carry out potentially dangerous activities that require increased concentration and speed of psychomotor reactions. It is recommended to use caution when driving a car or working with machinery.

Drug Interactions

With the simultaneous use of Nativa enhances the action of hypertensive drugs.

With simultaneous application of buformin, tetracycline, lithium preparations, norepinephrine weaken the antidiuretic effect of desmopressin. With the simultaneous use of desmopressin with NSAIDs, an increased risk of side effects may occur.With simultaneous use of Indomethacin increases, but does not increase the duration of action of desmopressin. With simultaneous use of tricyclic antidepressants, selective serotonin reuptake inhibitors, narcotic analgesics, NSAIDs, lamotrigine, chlorpromazine and carbamazepine, which can cause the 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.

With the use of the Napoli with loperamide, a threefold increase in the concentration of desmopressin in plasma is possible, 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.

Analogues of Nativ's drug

Structural analogs for the active substance:

• Adiuretin;
• Vasomyrin;
• Desmopressin;
• Desmopressin acetate;
• Mininin;
• Nurem;
• Presinex;
• Emosint.

Analogues on the curative effect (means to combat diabetes insipidus of a central genesis):

• Adiuretin;
• Hypothiazide;
• Carbamazepine;
• Carbapine;
• Carbasan retard;
• Mininin;
• Oxodoline;
• Tegretol CR;
• Chlorpropamide.

Similar medicines:

Other medicines: