Lanoxin (Paediatric) Syrup (Elixir)
Digoxin
0.05mg/ml
ASPEN BAD OLDESLOE GmbH
| Pack size | 60ml Glass Bottle with Dropper |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | AL BAKER TRADING EST. |
| Retail Price | 20.50 AED |
Available as:
Indications
Lanoxin (Paediatric) Syrup (Elixir) is used for:
Heart failure, Supraventricular arrhythmias, Atrial fibrillation and Atrial flutter
Adult Dose
Atrial Fibrillation
Rapid digitalizing (loading-dose) regimen
PO: 10-15 mcg/kg total loading dose; administer 50% initially; then may cautiously give 1/4 the loading dose q6-8hr twice; peform careful assessment of clinical response and toxicity before each dose
Maintenance
PO: 3.4-5.1 mcg/kg/day or 0.125-0.5 mg/day PO; may increase dose every 2 weeks based on clinical response, serum drug levels, and toxicity
Heart Failure
As per ACCF/AHA guidelines, a loading dose to initiate digoxin therapy in patients with heart failure is not necessary
0.125-0.25 mg PO/IV qDay; higher doses including 0.375-0.5 mg/day rarely needed
Use lower end of dosing (0.125 mg/day) in patients with low lean body mass
Child Dose
Heart Failure/Atrial Fibrillation
Use doses at the lower end of the spectrm when treating heart failure
Reduce dose by 20-25% when changing from oral formulation or IM to IV therapy
Premature neonate
PO: 1st loading dose, 10-15 mcg/kg; 2nd and 3rd loading doses, 5-7.5 mcg/kg q6-8hr for 2 doses; maintenance: 5-7.5 mcg/kg/day divided q12hr
Full-term neonate
PO: 1st loading dose, 12.5-17.5 mcg/kg; 2nd and 3rd loading doses, 6.25-8.75 mcg/kg q6-8hr for 2 doses; maintenance: 6-10 mcg/kg/day divided q12hr
Infants & children 1-24 months
PO: 1st loading dose, 17.5-30 mcg/kg; 2nd and 3rd loading doses, 8.75-15 mcg/kg q6-8hr for 2 doses; maintenance: 10-15 mcg/kg/day divided q12hr
2-5 years
PO: 1st loading dose, 15-20 mcg/kg; 2nd and 3rd loading doses, 8.75-10 mcg/kg q6-8hr for 2 doses; maintenance: 7.5-10 mcg/kg/day divided q12hr
5-10 years
PO: 1st loading dose, 10-17.5 mcg/kg; 2nd and 3rd loading doses, 5-8.75 mcg/kg q6-8hr for 2 doses; maintenance: 5-10 mcg/kg/day divided q12hr
>10 years & <100 kg
PO: 1st loading dose, 5-7.5 mcg/kg; 2nd and 3rd loading doses, 2.5-3.75 mcg/kg q6-8hr for 2 doses; maintenance: 2.5-5 mcg/kg/day
Renal Dose
Use lower end of dosing (0.125 mg/day) in patients with impaired renal function
Administration
May be taken with or without food.
Contra Indications
Digitalis toxicity, ventricular tachycardia/fibrillation, obstructive cardiomyopathy. Arrhythmias due to accessory pathways (e.g. Wolff-Parkinson-White syndrome).
Precautions
Cardiac dysrhythmias, hypokalaemia, hypertension, IHD, hypercalcaemia, hypomagnesaemia, electroconversion, chronic cor pulmonale, aortic valve disease, acute myocarditis, congestive cardiomyopathies, constrictive pericarditis, heart block, elderly, renal impairment, abnormalities in thyroid function; pregnancy. IV digoxin can only be given to patients who have not received cardiac glycosides in the preceding 2 wk.
Lactation: Drug enters breast milk; use with caution (American Academy of Pediatrics committee states, "compatible with nursing")
Pregnancy-Lactation
Pregnancy
Experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and fetal outcomes
Untreated underlying maternal conditions (eg, heart failure, atrial fibrillation) during pregnancy pose a risk to the mother and fetus
Clinical considerations
Pregnant women with heart failure are at increased risk for preterm birth; clinical classification of heart disease may worsen with pregnancy and lead to maternal or fetal death
Pregnant women with atrial fibrillation are at an increased risk of delivering a low birth weight infant; atrial fibrillation may worsen with pregnancy and can lead to maternal or fetal death
Fetal/neonatal adverse reactions
Digoxin has been shown to cross the placenta and is found in amniotic fluid
Monitor neonates for signs and symptoms of digoxin toxicity, including vomiting, and cardiac arrhythmias
Dose adjustments during pregnancy and the postpartum period
Digoxin requirements may increase during pregnancy and decrease in the postpartum period
Monitor serum digoxin levels during pregnancy and the postpartum period
Labor or delivery
Risk of arrhythmias may increase during labor and delivery
Monitor patients continuously during labor and delivery
Lactation
The digoxin dose received through breastfeeding is up to 4% of the neonatal maintenance dosage, which is unlikely to be clinically relevant
There are no data on the effects of digoxin on the breastfed infant or the effects on milk production
Interactions
Effectiveness reduced by phenytoin, neomycin, sulphasalazine, kaolin, pectin, antacids and in patients receiving radiotherapy. Metoclopramide may alter the absorption of solid dosage forms of digoxin. Blood levels increased by calcium channel blockers, spironolactone, quinidine and calcium salts.
Potentially Fatal: Electrolyte imbalances such as hypokalaemia and hypomagnesemia (e.g. admin of potassium-losing diuretics, corticosteroids) can increase the risk of cardiac toxicity.
Adverse Effects
Side effects of Digoxin :
1-10%
Dizziness (4.9%), Mental disturbances (4.1%), Diarrhea (3.2%), Headache (3.2%), Nausea (3.2%), Vomiting (1.6%), Maculopapular rash (1.6%)
<1%
Anorexia, Cardiac dysrhythmia, Arrhythmia in children (consider a toxicity)
Frequency Not Defined
Visual disturbance (blurred or yellow vision), Heart block (1°/2°/3°), Asystole, Tachycardia
Potentially Fatal: Cardiac arrhythmias in combination with heart block.
Mechanism of Action
Digoxin is a cardiac glycoside which has positive inotropic activity characterized by an increase in the force of myocardial contraction. It also reduces the conductivity of the heart through the atrioventricular (AV) node. Digoxin also exerts direct action on vascular smooth muscle and indirect effects mediated primarily by the autonomic nervous system and an increase in vagal activity.
Note
Lanoxin (Paediatric) 0.05mg/ml Syrup (Elixir) manufactured by ASPEN BAD OLDESLOE GmbH. Its generic name is Digoxin. Lanoxin (Paediatric) is availble in United Arab Emirates.
Farmaco UAE drug index information on Lanoxin (Paediatric) Syrup (Elixir) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.