Minirin

Minirin

desmopressin

Manufacturer:

Ferring

Distributor:

Metro Drug
Full Prescribing Info
Contents
Desmopressin acetate.
Indications/Uses
Central diabetes insipidus. The use of Minirin (desmopressin acetate) in patients with an established diagnosis will result in a reduction in urinary output with concomitant increase in urine osmolality and decrease in plasma osmolality. This will result in decreased urinary frequency and decreased nocturia.
Primary nocturnal enuresis in patients ≥5 years who have normal ability to concentrate urine.
Symptomatic treatment of nocturia in adults associated with nocturnal polyuria, ie nocturnal urine production exceeding bladder capacity.
Dosage/Direction for Use
Optimal dose of Minirin tablets is individually adjusted.
Central Diabetes Insipidus: Adults and Children: Initially, 100 mcg 3 times daily. The dose is then adjusted according to the response of the patient. According to clinical experience gained so far, the daily dose varies between 0.2 and 1.2 mg. For most patients, 100-200 mcg 3 times daily is the optimal dosage regimen.
Primary Nocturnal Enuresis: Initial Dose: 200 mcg at bedtime. The dose may be increased up to 400 mcg if the lower dose is not sufficiently effective. The need for continued treatment should be reassessed after 3 months by means of a period of at least 1 week without Minirin treatment. A restricted water intake must be observed.
Nocturia: The recommended initial dose is 100 mcg at bedtime. If this dose is not sufficiently effective after 1 week, it can be increased to 200 mcg and then to 400 mcg by means of weekly increases. Fluid restriction is to be enforced.
Overdosage
Overdosage increases the risk of fluid retention and hyponatremia. Although the treatment of hyponatremia should be individualized, the following general recommendations can be given:
Asymptomatic hyponatremia is treated with discontinuation of desmopressin treatment and fluid restriction. Infusion of isotonic or hypertonic sodium chloride may be added in cases with symptoms. When the fluid retention is severe (convulsions and unconsciousness), treatment with furosemide should be added.
Contraindications
Habitual and psychogenic polydipsia. Cardiac insufficiency and other conditions requiring treatment with diuretic agents. Moderate to severe renal insufficiency; syndrome of inappropriate antidiuretic hormone secretion; known hyponatremia.
Special Precautions
In the treatment of primary nocturnal enuresis and nocturia fluid intake shall be limited to the least possible during the period of 1 hr before and 8 hrs after administration. Treatment without concomitant reduction in fluid intake can lead to water retention and/or hyponatremia (headache, nausea/vomiting, weight gain and in serious cases, convulsions). In patients with urgency/urge incontinence, organic causes for increased micturition, frequency or nocturia [eg, benign prostate hyperplasia (BPH), urinary tract infection, bladder stones/tumors], polydipsia and poorly adjusted diabetes mellitus, the specific cause should be treated. In clinical trials, higher occurrence of hyponatremia was found in patients >65 years. Therefore, initiation of treatment in the elderly is not recommended, especially not in those patients suffering from other conditions that may increase the likelihood of fluid or electrolyte imbalance. Elderly patients with low serum sodium levels and patients with high 24-hr urine volume (above 2.8-3 L) may have an increased risk for hyponatremia. Although not investigated, other drugs slowing intestinal transport might have the same effect.
Precautions to avoid hyponatremia including careful attention to fluid restriction and more frequent monitoring of serum sodium must be taken in case of concomitant treatment with drugs, which are known to induce SIADH eg, tricyclic antidepressant, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine; case of concomitant treatment with NSAIDs.
Treatment with desmopressin should be interrupted during acute intercurrent illnesses, characterized by fluid and/or electrolyte imbalance eg, systemic infections, fever and gastroenteritis.
Avoid fluid overload in the very young and elderly and conditions characterized by fluid or electrolyte imbalance.
Use in pregnancy: Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate no adverse effects of desmopressin on pregnancy or on the health of the fetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
Use in lactation: Results from analyses of milk from nursing mothers receiving high-dose desmopressin (300 mcg intranasally), indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
Adverse Reactions
A few percent of treated patients can be expected to experience side effects eg, headache, nausea and stomach pain. Epistaxis also occurred.
Treatment without concomitant restriction of water intake may lead to water retention with accompanying signs and symptoms (reduced serum sodium, weight gain, and in serious cases, convulsions).
Drug Interactions
Indomethacin may augment the magnitude but not the duration of the response to desmopressin.
Tricyclic antidepressant, selective serotonin re-uptake inhibitors, chlorpromazine, carbamazepine, loperamide, medicines that slow down intestinal passage, pain reliever and anti-inflammatory medicines.
Storage
Store at room temperature (maximum 25°C) and in a dry place (maximum 60% relative humidity).
MIMS Class
ATC Classification
H01BA02 - desmopressin ; Belongs to the class of vasopressin and analogues. Used in posterior pituitary lobe hormone preparations.
Presentation/Packing
Tab 100 mcg x 30's. 200 mcg x 30's.
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