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Minirin

Minirin

desmopressin

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Desmopressin acetate
Indications/Uses
Central diabetes insipidus. Tab & oral lyophilisate: Primary nocturnal enuresis in childn ≥5 yr. Inj & nasal spray: Renal concentrating capacity test. Inj: Therapeutic control of bleeding & bleeding prophylaxis in connection w/ minor surgical procedures in patients w/ mild haemophilia A & von Willebrand's disease.
Dosage/Direction for Use
Central diabetes insipidus Tab Adult & childn Initially 0.1 mg tds then adjusted according to the response of the patient. Optimal dose regimen: 0.1-0.2 mg tds for most patients. Oral lyophilisate Individualized dosage. Total daily dose: 120-720 mcg. Adult & childn Initially 60 mcg SL tds. Maintenance: 60-120 mcg SL tds. IV Inj Adult 1-4 mcg (0.25-1 mL) once daily-bd. Childn >1 yr 0.4-1 mcg (0.1-0.25 mL) once daily-bd, <1 yr 0.2-0.4 mcg (0.05-0.1 mL) once daily-bd. Nasal spray Adult 10-20 mcg 1-2 times daily. Childn 5-10 mcg 1-2 times daily. Primary nocturnal enuresis Tab Initially 0.2 mg at bedtime, may be increased up to 0.4 mg if dose is not sufficiently effective. Oral lyophilisate Initially 120 mcg SL at bedtime, may be increased up to 240 mcg SL. Duration of treatment: Up to 3 mth. Renal concentrating capacity test IM/SC Inj Adult 4 mcg (1 mL) as single dose. Childn >1 yr 1-2 mcg (0.25-0.5 mL) as single dose, <1 yr 0.4 mcg (0.1 mL) as single dose. Nasal spray Adult 40 mcg. Childn >1 yr 20 mcg. Infant <1 yr 10 mcg. Therapeutic control of bleeding & bleeding prophylaxis in Haemophilia A & von Willebrand's disease IV Inj 0.3 mcg/kg infused slowly over 15-30 min. Adult & childn weighing ≥10 kg Use 50 mL of diluent, <10 kg Use 10 mL of diluent. If +ve effect is obtained, the initial dose may be repeated 1-2 times w/ interval of 6-12 hr.
Contraindications
Hypersensitivity. Habitual or psychogenic polydipsia. SIADH secretion. Hyponatraemia. History of known or suspected cardiac insufficiency & other conditions requiring treatment w/ diuretics. Tab, oral lyophilisate & nasal spray: Moderate & severe renal insufficiency (CrCl <50 mL/min). Inj: History of unstable angina. von Willebrand's disease type IIB.
Special Precautions
Treatment w/o concomitant fluid intake reduction may lead to fluid retention &/or hyponatremia w/ or w/o accompanying warning signs & symptoms. Consider severe bladder dysfunction & outlet obstruction before starting treatment. Patient at risk for increased ICP. Interrupt or carefully adjust treatment during acute intercurrent illnesses characterised by fluid &/or electrolyte imbalance (eg, systemic infections, fever, gastroenteritis) & in excessive bleeding (Inj). Monitor fluid & electrolyte balance. Pregnancy & lactation. Tab & oral lyophilisate: Limit fluid intake to a min from 1 hr before until 8 hr after administration when used for primary nocturnal enuresis. Tab: Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Increased risk of hyponatraemia w/ elderly & patient w/ serum Na levels in the lower range of normal. Frequently monitor serum Na in case of concomitant treatment w/ drugs known to induce SIADH (eg, TCAs, SSRIs, chlorpromazine & carbamazepine); NSAIDs. Inj: Hypersensitivity. Limit fluid intake to a max of 0.5 L from 1 hr before until 8 hr after administration when used for diagnostic purposes. Consider other haemostatic therapies in situations where long-term haemostasis is required (active bleeding >2-4 days) due to risk of tachyphylaxis development following repeated desmopressin dosing. Restrict fluid intake to the least possible & regularly check body wt during haemostatic use. Interrupt treatment & drastically reduce fluid intake if there is gradual increase of body wt, decrease of serum Na to <130 mmol/L or plasma osmolality to <270 mOsm/kg. Minirin does not reduce prolonged bleeding time in thrombocytopenia. Patient w/ risk factors & history of thrombosis, atherosclerotic CV or cerebrovascular disease or angioplasty. Co-administration w/ other drugs affecting water &/or Na homeostasis. Moderate & severe renal insufficiency (CrCl <50 mL/min). Infant. Elderly.
Adverse Reactions
Headache, abdominal pain & nausea. Tab & oral lyophilisate: Hyponatraemia; dizziness; HTN; diarrhoea, constipation, vomiting; bladder & urethral symptoms; oedema. Tab, oral lyophilisate & inj: Fatigue. Inj: Tachycardia; flushing, hypotension. Nasal spray: Epistaxis; nasal congestion, rhinitis. Insomnia, affect lability, nightmare, anxiety, aggression, URTI; gastroenteritis.
Drug Interactions
Increased risk of water retention/hyponatremia w/ substances known to induce SIADH (eg, TCAs, SSRIs chlorpromazine & carbamazepine); opioids, NSAIDs & some sulfonylurea antidiabetics (for Inj). Tab & oral lyophilisate: May increase plasma conc w/ loperamide. Tab: Food intake may reduce intensity & duration of the antidiuretic effect.
MIMS Class
Antidiuretics / Haemostatics
ATC Classification
H01BA02 - desmopressin ; Belongs to the class of vasopressin and analogues. Used in posterior pituitary lobe hormone preparations.
Presentation/Packing
Form
Minirin dDAVP inj 4 mcg/mL
Packing/Price
1 mL x 10 × 1's
Form
Minirin dDAVP oral lyophilisate 60 mcg
Packing/Price
10 × 10's;10 × 3's
Form
Minirin dDAVP nasal spray 0.1 mg/mL
Packing/Price
2.5 mL x 1's
Form
Minirin dDAVP tab 0.1 mg
Packing/Price
30's
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