Minirin (desmopressin) tablets 0.1 mg. №30 vial

Description

Minirin composition
active substance: desmopressin;
1 tablet contains desmopressin acetate 0.1 mg, corresponding to desmopressin base 0.089 mg;
excipients: lactose monohydrate; potato starch; povidone; magnesium stearate.

Dosage form
Tablets.

Pharmacological properties
Minirin contains desmopressin – a structural analogue of the natural hormone of the pituitary gland – arginine vasopressin. The difference between them is the deamination of cysteine ​​and the replacement of L-arginine with D-arginine. This leads to a significant increase in the duration of action and the complete absence of pressor effect in clinically applicable doses. The EC50 (semi-maximum effective concentration) of desmopressin, which causes an antidiuretic effect, is 1.6 pg / ml. After oral administration, the effect lasts from 6 to 14 hours.

Indication:

• diabetes mellitus of central origin;
• primary nocturnal enuresis in children over 5 years of age with normal renal concentration;
• symptomatic treatment of nocturia associated with nocturnal polyuria in adults.

Contraindication:

• normal or psychogenic polydipsia (urine output exceeds 40 ml / kg / 24 h);
• heart failure or other conditions that require diuretics;
• renal failure from moderate to severe (creatinine clearance below 50 ml / min);
• hyponatremia;
• syndrome of inappropriate secretion of antidiuretic hormone;
• hypersensitivity to desmopressin or to other components of the drug;
• alcohol abuse;
• severe classical Willebrand-Jurgens syndrome (type IIb), in patients with 5% factor VIII activity, factor VIII antibodies.

Children
Use in children over 5 years of age with normal renal concentration function for the treatment of primary nocturnal enuresis.

Use during pregnancy or breastfeeding
The drug should be used with caution in pregnant women and blood pressure monitoring is recommended. Minirin should be prescribed to pregnant women only after careful consideration of the benefits and risks of treatment. The analysis of breast milk from mothers who took high doses of desmopressin (300 mcg intranasally) shows that the amount of desmopressin that can be transmitted to the baby is much less than that required to affect diuresis.

Method of application and dosage
The dosage of desmopressin tablets should be adjusted individually. Desmopressin should always be taken at the same time in relation to food, because food reduces its absorption.
If after 4 weeks of treatment and dose adjustment there is no adequate clinical effect, it is not recommended to continue taking the drug.
If symptoms of fluid retention and / or hyponatraemia (headache, edema, nausea / vomiting, weight gain and, in severe cases, convulsions) develop, treatment should be stopped immediately until the patient has fully recovered. When resuming treatment, patients should closely monitor fluid restriction.
The recommended doses for children are the same as for an adult.

Overdose
In case of acute drug overdose, side effects may be exacerbated.
Overdose of the drug leads to prolonged duration of action with an increased risk of fluid retention and hyponatremia. Although the treatment of hyponatremia depends on the individual patient, the following general recommendations should be tried:

• in case of asymptomatic hyponatremia, drug treatment should be discontinued and fluid intake limited;
• in the case of hyponatremia with severe symptoms, additional infusions of isotonic or hypertonic sodium chloride solution may be prescribed.
• in case of cerebral edema, the patient should be immediately transferred to the intensive care unit. Seizures in children also require intensive care.

Side effects:

• From the metabolism: hyponatremia.
• Mental disorders: insomnia.
• From the nervous system: headache; often – dizziness; drowsiness, paresthesia.
• From the eyes: visual impairment.
• From the heart: a feeling of palpitations.
• Vascular disorders: hypertension.
• From the gastrointestinal tract: nausea, abdominal pain, diarrhea, constipation, vomiting.
• From the skin and subcutaneous tissue: sweating, itching, rash, urticaria.
• From the kidneys and urinary system: symptoms from the bladder and urethral symptoms.
• General disorders: edema, fatigue.

Expiration date
3 years.

Storage conditions
Store Minirin in a dry place, out of reach of children at a temperature not exceeding 25 ° C.