Minirin 0.1mg Ferring tablets for central, night -time diabetes (30 tablets)

Desmopressin is a strong compound with EC50 value (concentration of 50%) 1.6pg/ml in anti -urinary effect. After drinking, the effect lasts from 6 - 14 hours or more may be expected.

Clinical trials with desmopressin tablets in the treatment of urinary nights are as follows:

Discount at least 50% in the average number of night urination has been achieved in 39% of patients when taking desmopressin compared to 5% of patients when using placebo (p

The average of the number of urination each night decreases by 44% when using desmopressin compared to 15% when placebo (p

The median time of the period of sleep is not initially disturbed by 64% when using desmopressin compared to 20% when using placebo (p

The average time of sleep is not initially disturbed by 2 hours when using desmopressin compared to 31 minutes when using placebo (p

Desmopressin

Parent

Stated significance compared to placebo

O

(ml/min)

0.87

(0.34)

1.55

(0.57)

152

(51)

178

(70)

Desmopressin's oral dosage effect in each patient from 0.1mg to 0.4mg in 3 weeks compared to placebo.

pharmacokinetic

absorption

Simultaneously used with food reduces the speed and level of 40%absorption.

Distribution

Desmopressin's distribution is best described by a 2 -compartment distribution model with an integral distribution in the excretion phase of 0.3 - 0.5l/kg.

Biological Change

The metabolism of desmopressin in vivo has not been studied. Desmopressin metabolism studies in Vitro liver mucous mucous mucous mucous mucous mucus have shown that there is no significant amount of metabolized in the liver by the Cytochrome P450 system. Therefore, the metabolism in Vivo's liver because the Cytochrome P450 system is not likely to occur. The effect of desmopressin on the pharmacokinetics of other drugs may be minimal because there is no inhibition of cytochrome P450.

Elimination

The total clearance of desmopressin has been calculated up to 7.6 liters/hour. Desmopressin's sale time is estimated at 2.8 hours. In healthy subjects, the unchanged excretory number is 52% (44% - 60%).

Linear/non -linear

There is no sign that non -linear in any pharmacokinetic parameters of desmopressin.

Characteristics in special patient groups

kidney failure

Depending on the degree of renal failure, the area under the curve (AUC) and the selling time increases with the severity of kidney failure in patients with medium renal impairment and severe renal failure (creatinine clearance below 50ml/min), contraindicated use of desmopressin.

Hepatic failure

No research has been conducted.

Children

The pharmacokinetics of the minirin tablet has been studied in children with bedwetting at night (PNE) and does not detect any significant differences compared to adults.

Precautions when using

Read the instructions carefully before use. If you need more information, please consult your doctor. This drug is only used by a doctor.

Special warning:

When used in the predominations of first night bedwetting and urine, the reception of fluid must be limited to the lowest level from 1 hour before taking the drug until the next morning (at least 8 hours) after taking the drug. The non -combination treatment of reduced fluid collection can lead to fluid fluid and/or hypoglycemia, with or without warning signs and symptoms (headache, nausea/vomiting, weight gain and seizures in severe cases).

All of their patients and guardians, if any, should be carefully guided to comply with fluid restrictions.

Patients with rare genetic problems in tolerance Galactose, Lapp Lactase deficiency or malposure - Galactose should not use this drug.

Caution:

Severe bladder dysfunction and congestion of the bladder should be considered before starting treatment.

Elderly patients and patients with serum sodium concentrations are lower than normal may have an increased risk of hypoglycemia. Desmopressin should be discontinued during the period of acute diseases characterized by an imbalance of fluid and/or electrolyte (such as systemic infection, fever, gastritis - bowel). Must be cautious in patients at risk of increased intracranial pressure.

Be careful when using desmopressin in patients with conditions characterized by epidemic imbalance and/or electrolyte. Need to avoid reducing sodium hematra includes careful attention to fluid restrictions, which must monitor serum sodium more often in case of treatment simultaneously with the known drugs that cause inappropriate anti -urinary secretion syndrome (SIADH), for example 3 -ring anti -depression drugs, selective Serotonin reabsorption drugs, chlorpromazine and carbamazepine, simultaneous treatment of non -steroid anti -non -steroid drug cases at the same time (NSAID).

The ability to drive and operate machines

The drug can cause drowsiness and dizziness and can affect the ability to drive and operate machinery.

Pregnancy

data on a limited amount (n = 53) Pregnant women with diabetes as well as data on a limited amount (n = 54) pregnant women with Von Willebrand shows no disadvantages of Desmopressin on pregnancy or health of pregnancy/babies. So far, there are no other relevant epidemiological data. Animal studies do not show direct or indirect effects on pregnancy, embryo/fetal development, birth or development after birth.

Be careful when prescribing pregnant women.

Studies on fertility have not been conducted. In vitro analysis of human models in humans has shown that there is no shipping of desmopressin through the placenta when used at the concentration of treatment corresponding to the recommended dose.

breastfeeding period

The results from the milk analysis of nursing mothers using high doses Desmopressin (300μg in the nose) shows that the amount of desmopressin can be transferred to the baby is significantly less than the amount needed to affect the card.

Drug interaction

The known substances cause inappropriate anti -urinary hormone syndrome, such as 3 -round antidepressants, selective Serotonin Rhemorror, Chlorpromazine and Carbamazepine as well as some drug diabetes in Sulfonylirea During/hypoglycemia (see the warning and prudent part when used).

Non -steroid anti -inflammatory drugs (NSAID) can cause fluid retention/sodium reduction (see the warning and caution especially when used). The simultaneous treatment with loopamide can lead to tripled increase in plasma desmopressin concentrations, which can lead to an increased risk of fluid fluid/sodium fluid. Although it has not been studied, other drugs slow down the intestinal transport may have the same effect.

Not sure that the desmopressin interacts with drugs that affect the metabolism of the liver, because the desmopressin has been shown not to undergo significant liver metabolism in in vitro studies with human microsomes. However, no official studies have been conducted in vivo.

Concentrated use with food reduces the speed and level of 40%minirin tablet absorption. Not observing significant effects on pharmacological resources (urine production or osmotic).

Food awareness can reduce the intensity and time of the anti -urinary effect at the low doses of 0.1mg minirin tablets for oral.