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

Mininin® contains desmopressin - structural analogue of the natural hormone arginine-vasopressin obtained as a result of changes in the structure of the molecule of vasopressin. These structural changes lead, in combination with a significantly enhanced antidiuretic ability, to a less pronounced effect on the smooth musculature 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. The use of the preparation Mininin® with central diabetes insipidus leads to a decrease in the volume of excreted urine and a simultaneous increase in the osmolarity of the urine and a decrease in the 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 occurs 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.

Pharmacokinetics:

Suction: when administered orally, the bioavailability of desmopressin from Mininin® tablets is 0.08-0.16%. Simultaneous food intake can reduce the degree of absorption from the gastrointestinal tract by 40%.

Distribution: the volume of distribution is 0.2-0.3 l / kg. The maximum concentration in plasma is reached within 2 hours. Desmopressin does not penetrate the blood-brain barrier.

Metabolism: desmopressin is metabolized in the kidneys.

Excretion: is excreted by the kidneys. The half-life at ingestion varies between 2 and 3 hours.

Indications:

- Non-diabetes mellitus of the central genesis;

- primary nocturnal enuresis in children older than 5 years;

- nocturnal polyuria in adults (as symptomatic therapy).

Contraindications:

- Hypersensitivity to the components of the drug;

- habitual or psychogenic polydipsia;

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

- hyponatremia, including in the anamnesis;

- renal insufficiency of moderate and severe degree (creatinine clearance (CK) less than 50 ml / min);

- syndrome of inadequate production of antidiuretic hormone;

- Children under 4 years old (for treatment of diabetes insipidus) and 5 years (for treatment of primary nocturnal enuresis);

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

If you have any of these diseases, consult a doctor before taking the drug.

Carefully:

Chronic renal failure (QC more than 50ml / min), fibrosis of the bladder, violation of water-electrolyte balance, a potential risk of increasing intracranial pressure, pregnancy, elderly (over 65 years).

Pregnancy and lactation:

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.

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 Mininin® 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 for children over 4 years and adults is 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 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 adjusting the dose of an adequate clinical effect is not observed continue to take the drug is not recommended.

Side effects:

Frequently (≥1% and <10%): headache, dizziness, nausea, vomiting, dry mouth, peripheral edema, weight gain.

Rarely (≥ 0.01% and <0.1%): redness of the eyes, "hot flashes", transient tachyarrhythmia, convulsions.

Attention! Taking Minirin® without the simultaneous restriction of fluid intake can lead to fluid retention in the body, accompanied by hyponatremia, weight gain, edema and in severe cases - seizures.

When used simultaneously with imipramine or oxybutynin, hypoglycemic convulsions.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Exceeding the recommended dosages increases the risk and can lead to fluid retention, plasma hypoosmolarity, hyponatremia, development of convulsive syndrome and other neurological and psychic symptoms.

Treatment: withdrawal of the drug, restriction of fluid intake, in severe cases - a slow intravenous infusion of a hypertonic solution of sodium chloride simultaneously with furosemide.

In hyponatremia, the following is recommended:

- with asymptomatic hyponatremia, discontinue Minirin® and restrict fluid intake;

- in the presence of symptoms of hyponatremia, an infusion of 0.9% or a hypertonic solution of sodium chloride is recommended;

- In severe cases of fluid retention in the body (seizures and / or loss of consciousness), therapy should be supplemented with diuretics (furosemide).

Interaction:

With simultaneous application desmopressin strengthens the action of hypertensive drugs.

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

With the simultaneous use of desmopressin with non-steroidal anti-inflammatory drugs (NSAIDs), an increased risk of side effects may occur.

With simultaneous application indomethacin strengthens, but does not increase 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, 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.

When using desmopressin with loperamide, a threefold increase in desmopressin concentration 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.

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.

In order to avoid the development of side effects, it is necessary to minimize the intake of liquid 1 hour prior to use and within 8 hours after application of the drug in patients with primary nocturnal enuresis.

Mininin® should not be used when there are other additional causes 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 blood plasma, especially when used simultaneously 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 NSAIDs.

When Acute urinary incontinence, dysuria and / or nocturia, urinary tract infections, suspected bladder or prostate cancer, the presence of polydipsia and decompensated diabetes mellitus. Diagnosis and treatment of these conditions and diseases should be performed prior to treatment with Mininin®.

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

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

Currently, there are no data on the possible impact of Mininin® on the ability to drive vehicles and work with 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 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 or working with machinery.

Form release / dosage:

Tablets, 0.1 and 0.2 mg.

Packaging:

For 15, 30 or 90 tablets at plastic bottle with a screw-on, opening by pressing (protection from children) cover, with a drying capsule inside the lid in a cardboard box with instructions for use inside.

On the cardboard pack, it is possible to apply a sticker (s) to control the first opening.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Do not remove the drying capsule from the lid.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N012314 / 01

Date of registration:18.08.2010 / 01.11.2012

The owner of the registration certificate:Fering International Center S.A.Fering International Center S.A. Switzerland

Manufacturer: & nbsp

FERRING INTERNATIONAL CENTER, S.A. Switzerland

Representation: & nbspFERRING PHARMACEUTICALS LLCFERRING PHARMACEUTICALS LLCRussia

Information update date: & nbsp15.01.2016

Illustrated instructions

Instructions

Mininin® (Minirin®)