Enurex Oral Solution
Desmopressin
360 mcg/ml
UniMed UniHealth Pharmaceuticals Ltd.
| Pack size | 15ml pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1000.00 AED |
Available as:
Indications
Enurex Oral Solution is used for:
Diabetes Insipidus, Nocturnal Enuresis, Nocturia
Adult Dose
Diabetes Insipidus
Oral
Initial: 0.05 mg 12 hourly
Effective range: 0.1-1.2 mg divided by 8-12 hourly
Observe fluid restriction
Nocturnal Enuresis
Primary nocturnal enuresis
0.2 mg daily at bedtime. (up to 0.6 mg/day)
Nocturia
Nocturnal polyuria was defined in clinical trials as nighttime urine production exceeding one-third of 24-hour urine production
Sublingual tablets
Indicated for nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void
Before starting or resuming, assess the sodium concentration and only start or resume in patients with a normal serum sodium concentration
Women: 27.7 mcg SL once daily, 1 hr before bedtime, administered SL without water
Men: 55.3 mcg SL once daily, 1 hr before bedtime, administered SL without water
Child Dose
Oral
Nocturnal Enuresis
>6 years: 0.2 mg PO daily at bedtime. (up to 0.6 mg/day)
Renal Dose
Renal impairment
CrCl <50 mL/min: Contraindicated; has been used unlabeled in acute and chronic renal failure patients experiencing uremic bleeding or prevention of surgical bleeding
CrCl >50 mL/min: No adjustments necessary
Administration
Oral Administration
Sublingual tablets
Place 1 tablet under the tongue 1 hr before bedtime and to empty their bladder immediately prior to bedtime
Tablet should remain under the tongue until it dissolves
Advise patients to limit fluid intake to a minimum starting 1 hr prior to administration and for 8 hr following administration
Avoid caffeine and alcohol before bedtime
May be taken with or without food.
Contra Indications
Cardiac insufficiency w/ ongoing diuretic treatment.
Patient w/ habitual and psychogenic polydipsia, hyponatraemia or history of hyponatraemia.
Moderate to severe renal impairment (CrCl <50 mL/min).
Precautions
Hyponatremia: Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported. Unless properly diagnosed and treated, hyponatremia can be fatal. Instruct patients about proper fluid restriction and monitor serum sodium as needed
MONITORING PARAMETERS
In nocturia, periodic blood pressure and weight checks are needed to monitor for fluid overload.
Pregnancy-Lactation
Pregnancy
Prolonged experience with desmopressin in pregnant women over several decades, based on available published data and case reports, did not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; in addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin; no adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m²)
Not recommended for treatment of nocturia in pregnant women; nocturia is usually related to normal, physiologic changes during pregnancy that do not require treatment
Lactation
Desmopressin is present in small amounts in human milk and is poorly absorbed orally by infant
There is no information on effects of desmopressin on breastfed infant or on milk production; development and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed infant from therapy or from the underlying maternal condition
Interactions
May enhance antidiuretic effect w/ NSAIDs (e.g. ibuprofen), indometacin, TCAs, chlorpromazine, carbamazepine, SSRIs, opiates, lamotrigine.
May reduce antidiuretic effect w/ lithium, epinephrine (large dose), heparin, demeclocycline.
Contraindicated (1)
mometasone, intranasal
Serious (1)
mometasone inhaled
Adverse Effects
Side effects of Desmopressin :
>10%
Dry mouth, men (14%)
Dry mouth, women (12%)
1-10%
Headache (2-5%)
Hyponatremia, men (4%)
Headache, men (4%)
Hyponatremia, women (3%)
Dizziness, men (3%)
Dizziness (3%)
Epistaxis (2-3%)
Headache, women (2%)
Dizziness, women (2%)
Nasal spray
Rhinitis (3-8%)
Abdominal pain (2%)
Asthenia (2%)
Chills (2%)
Nostril pain (2%)
Gastrointestinal disorder (2%)
Nausea (2%)
Conjunctivitis (2%)
Eye edema (2%)
Lachrymation disorder (2%)
Frequency Not Defined
Abnormal blood pressure (infrequent)
Increased heart rate
Increased blood pressure
Flushing
Seizure (rare)
Hyponatremia
Hyposmolality (rare)
Water intoxication syndrome
Thromboembolic disorder
Allergic reaction (acute)
Anaphylaxis (rare)
Mechanism of Action
Desmopressin increases cyclic adenosine monophosphate (cAMP) in renal tubular cells which increases water permeability resulting in reduced urine volume and enhanced urine osmolality. It also stimulates factor VII and plasminogen activator activity in the blood, but w/ minimal pressor activity.
Onset: Antidiuretic: Approx 60 min (oral); 15-30 min (intranasal).
Note
Enurex 360 mcg/ml Oral Solution manufactured by UniMed UniHealth Pharmaceuticals Ltd.. Its generic name is Desmopressin. Enurex is availble in Bangladesh.
Farmaco BD drug index information on Enurex Oral Solution is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
Some other brands of Desmopressin :
Oral Lyophilisate Tablets
Minirin Melt
120mcg
Radiant Pharmaceutical Ltd.
Oral Lyophilisate Tablets
Minirin Melt
60mcg
Radiant Pharmaceutical Ltd.
Tablet
Nocpres
0.1 mg
Healthcare Pharmaceuticals Ltd.
Tablet
Nocpres
0.2 mg
Healthcare Pharmaceuticals Ltd.
Tablet
Enurex
200 mcg
UniMed UniHealth Pharmaceuticals Ltd.