صيدلية اونلاين

Minirin Nasal Spray 5ml

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1. Name of the medicinal product

Desmopressin Intranasal Solution

2. Qualitative and quantitative composition

Desmopressin acetate 0.01% w/v

3. Pharmaceutical form

Aqueous solution for intranasal administration

4. Clinical particulars
4.1 Therapeutic indications

Desmopressin Intranasal Solution is indicated for:

1) The diagnosis and treatment of vasopressin-sensitive cranial diabetes insipidus.

2) The treatment of nocturia associated with multiple sclerosis where other treatments have failed.

3) Establishing renal concentration capacity.

4.2 Posology and method of administration

Treatment of Diabetes Insipidus:

Dosage is individual but clinical experience has shown that the average maintenance doses are as follows:

Adults: 10 to 20 micrograms once or twice daily.

Elderly: 10 to 20 micrograms once or twice daily.

Children: 5 to 20 micrograms daily, (a lower dose may be required for infants).

Diagnosis of Diabetes Insipidus:

The diagnostic dose in adults and children is 20 micrograms. Failure to elaborate a concentrated urine after water deprivation, followed by the ability to do so after the administration of Desmopressin confirms the diagnosis of cranial diabetes insipidus. Failure to concentrate after the administration suggests nephrogenic diabetes insipidus.

Treatment of nocturia:

For multiple sclerosis patients up to 65 years of age with normal renal function suffering from nocturia the dose is 10 to 20 micrograms at bed time. Not more than one dose should be used in any 24 hour period.

Renal Function Testing:

To establish renal concentration capacity, the following single doses are recommended:

Adults: 40 micrograms

Elderly: 40 micrograms

Children (1 - 15 years): 20 micrograms

Infants (to 1 year): 10 micrograms

Adults and children with normal renal function can be expected to achieve concentrations above 700mOsm/kg in the period of 5-9 hours following administration of Desmopressin Intranasal Solution. It is recommended that the bladder should be emptied at the time of administration.

In normal infants a urine concentration of 600mOsm/kg should be achieved in the 5 hour period following the administration of /Desmopressin Intranasal Solution. The fluid intake at the two meals following the administration should be restricted to 50% of the ordinary intake in order to avoid water overload.

4.3 Contraindications

Desmopressin Intranasal Solution is contraindicated in cases of:

- cardiac insufficiency and other conditions requiring treatment with diuretic agents.

- hypersensitivity to the preservative.

Before prescribing Desmopressin Intranasal the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.

When used to control nocturia in patients with multiple sclerosis, Desmopressin should not be used in patients with hypertension or cardiovascular disease.

Desmopressin should not be prescribed to patients over the age of 65 for the treatment of nocturia associated with multiple sclerosis.

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