Eudaxen Tablet
Diazoxide
50mg
Everest Pharmaceuticals Ltd.
| Pack size | 100s in HDPE container |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 150.00 AED |
Indications
Eudaxen Tablet is used for:
Intractable hypoglycemia
Adult Dose
Oral
Chronic intractable hypoglycaemia
Adult:
Initially, 3-5 mg/kg daily in 2 or 3 divided doses.
Maintenance: 3-8 mg/kg daily
The dosage may be titrated to a maximum of 8 mg/kg/day.
Patients with refractory hypoglycemia may require higher dosages such as 10-15 mg/kg daily.
Child Dose
Oral
Chronic intractable hypoglycaemia
Child:
Initially, 3-5 mg/kg daily in 2 or 3 divided doses.
Maintenance: 3-8 mg/kg daily
The dosage may be titrated to a maximum of 8 mg/kg/day.
Neonates:
Initially, 5 mg/kg bid.
Maintenance: 1.5-3 mg/kg bid or tid up to 8 mg/kg tid may be required in some cases.
>1 mth
Initially, 1.7 mg/kg tid.
Maintenance: 1.5-3 mg/kg bid or tid up to 5 mg/kg tid may be required in some cases.
The dosage may be titrated to a maximum of 15 mg/kg/day.
Renal Dose
Renal Impairment
Dose reductions may be necessary.
Administration
Contra Indications
Hypersensitivity to diazoxide, thiazides, or sulfonamide derivatives
Use for functional hypoglycemia
Precautions
Use caution in coronary or cerebral insufficiency, DM, extravasation, heart failure (may increase fluid retention), cardiovascular insufficiency, gout, hypotension, hypokalemia, liver disease, renal dysfunction
Development of abnormal facial features in four children treated chronically (>4 years) with this drug for hypoglycemia hyperinsulinism reported
Treatment with this drug should be initiated under close clinical supervision, with careful monitoring of blood glucose and clinical response until patient’s condition has stabilized; this usually requires several days; if not effective in two to three weeks, the drug should be discontinued
Since the plasma half-life of diazoxide is prolonged in patients with impaired renal function, a reduced dosage should be considered. Serum electrolyte levels should also be evaluated for such patients.
Compensatory HTN (aortic coarctation, arteriovenous shunt)
Ineffective in pheochromocytoma
Nonketotic hyperosmolar coma may occur during treatment; transient cataracts reported
May displace bilirubin from albumin; use caution in newborns with hyperbilirubinemia
The antidiuretic property of diazoxide may lead to significant fluid retention, which in patients with compromised cardiac reserve, may precipitate congestive heart failure; the fluid retention will respond to conventional therapy with diuretics
Concomitantly administered thiazides may potentiate the hyperglycemic and hyperuricemic actions of diazoxide
Diabetic ketoacidosis and hyperosmolar nonketotic coma may develop very rapidly; monitor patients for up to 7 days due to long half-life of the drug
Ketoacidosis and nonketotic hyperosmolar coma reported in patients treated with recommended doses usually during intercurrent illness; prompt recognition and treatment essential and prolonged surveillance following the acute episode necessary because of long drug half-life of approximately 30 hours; occurrence of these serious events may be reduced by careful education of patients regarding monitoring urine for sugar and ketones and for prompt reporting of abnormal findings and unusual symptoms to healthcare provider
MONITORING REQUIREMENTS
Monitor blood pressure.
Monitor white cell and platelet count during prolonged use.
Pregnancy-Lactation
Pregnancy
Safety in pregnancy has not been established; there are no adequate data on fetal effects of this drug when given to pregnant women
When use of this drug is considered, the indications should be limited to those approved for this drug, and the potential benefits to the mother must be weighed against possible harmful effects to the fetus
This drug crosses the placental barrier and appears in cord blood; when given to mother prior to delivery of infant, the drug may produce fetal or neonatal hyperbilirubinemia, thrombocytopenia, altered carbohydrate metabolism, and possibly other side effects have occurred in adults
Alopecia and hypertrichosis lanuginosa reported in infants whose mothers received oral diazoxide during last 19 to 60 days of pregnancy
Labor and delivery
Since intravenous administration of the drug during labor may cause cessation of uterine contractions, and administration of oxytocic agents may be required to reinstate labor, caution is advised in administering therapy at that time.
Animal data
Reproduction studies using oral preparation in rats have revealed increased fetal resorptions and delayed parturition, as well as fetal skeletal anomalies; evidence of skeletal and cardiac teratogenic effects in rabbits has been noted with intravenous administration
The drug has also been demonstrated to cross the placental barrier in animals and to cause degeneration of fetal pancreatic beta cells
Lactation
Information is not available concerning passage of diazoxide in breast milk; because many drugs are excreted in human milk and because of the potential for adverse reactions from diazoxide in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Interactions
Enhanced hyperglycaemic, hyperuricemic or hypotensive effects w/ diuretics.
Increased risk of hypotension w/ other antihypertensive drugs or vasodilators.
Increased risk of hyperglycaemia w/ concomitant phenytoin, corticosteroids or oestrogen-progestogen combinations.
May displace other highly protein-bound drugs (e.g. coumarin and its derivatives) resulting in higher blood levels of these substances.
Adverse Effects
Side effects of Diazoxide :
Frequency Not Defined
Angina
Cardiac arrest
Anxiety
Fever
Polyneuritis
CHF
Hypotension
Palpitation
Tachycardia
Dizziness
Anorexia
Abdominal pain
Constipation
Diarrhea
Loss of taste
Nausea
Vomiting
Diabetic ketoacidosis
Hirsutism
Scalp hair loss
Hyperglycemia
Sodium and fluid retention
Mechanism of Action
Diazoxide increases the concentration of glucose in the plasma and inhibits the secretion of insulin by the β-cells of the pancreas, and may increase the hepatic output of glucose. When given IV, it produces a fall in BP by causing vasodilation of the arterioles, thus a reduction in peripheral resistance. It has an antidiuretic action and produces fluid and electrolyte retention.
Note
Eudaxen 50mg Tablet manufactured by Everest Pharmaceuticals Ltd.. Its generic name is Diazoxide. Eudaxen is availble in Bangladesh.
Farmaco BD drug index information on Eudaxen Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.