COMPOSITION :
Epinephrine Bitartrate Injection 1 mg/ml, each ml contains : Epinephrine bitartrate equivalent to Epinephrine 1 mg.
DESCRIPTIONS :
Epinephrine Bitartrate with active ingredient Epinephrine bitartrate (equivalent to Epinephrine) available in injection 1 mg/ml.
INDICATIONS :
Emergency treatment in severe acute anaphylactic reactions that caused by insect bites, drugs and other allergens. Epinephrine can also be used for the treatment of sympathomimetic respiratory disorders due to bronchial spasm.
DOSAGE AND ADMINISTRATIONS :
Dose
- Adults : 0.3 – 0.5 mg through intramuscular or subcutaneous injection, the dose can be repeated every 5 – 15 minutes as needed based on the patient’s condition and reaction.
- Children : 10 mcg (0.01 ml/kgBW) by intramuscular or subcutaneous injection, if necessary, the dose can be repeated at intervals of 20 minutes to 4 hours based on the patient’s condition and reaction.
- Single dose should not exceed 500 mcg.
Administrations
- Epinephrine is generally administered by intramuscular injection or subcutaneous.
- Injection should not be used if the color change into pink or darker than bright yellow or sediment formed.
CONTRAINDICATIONS :
- Hypersensitivity to sympathomimetic amine drugs.
- Epinephrine should not be used in the second stage of labor. Epinephrine generally inhibits spontaneous contractions or is induced by oxytocin and can slow down the second stage of labor.
- Epinephrine should not be injected into the fingers, toes, nose, ears or genital area.
WARNINGS AND PRECAUTIONS :
- Epinephrine injection can be given by intramuscular (more widely used) or subcutaneous injection, but intramuscular in the buttocks should be avoided. In an emergency situation, diluted Epinephrine solution (1:10000) can be given by slow intravenous injection or as a continuous IV infusion.
- Epinephrine must be used cautiously in patients with cardiovascular disease, cerebrovascular insufficiency, diabetes mellitus, hypertension, chronic lung disease, angina pectoris or hyperthyroidism.
- Epinephrine must be used cautiously in elderly patients.
- Epinephrine is used during pregnancy only if the benefits outweigh the possible risks to the fetus.
- Epinephrine is distributed to breast milk. Breastfeeding should be avoided in women who receive epinephrine injections.
DRUG INTERACTIONS :
- Epinephrine should not be given together with other sympathomimetic drugs because of the possibility of additive effects and increased toxicity.
- Tricyclic antidepressants, some antihistamines and thyroid hormones can increase the effect of Epinephrine, especially on heart rate and rhythm.
- Administration of Epinephrine in patients receiving halogenated hydrocarbon anesthetics (e.g., Halothane), cycloprane or trichlorethylene which increases cardiac irritability and causes myocardium to be more sensitive to Epinephrine, resulting in arrhythmias including premature ventricular contractions, tachycardia or fibrillation.
- Concomitant use with Propanolol can cause severe hypotension, followed by reflex bradycardia, which is caused by stimulation of adrenergic receptors.
- Epinephrine should not be used in patients who receive excessive doses of other drugs (e.g., Digoxin or Quinidine) that can increase the risk of cardiac arrhythmias.
ADVERSE REACTIONS :
-
- Feelings of worry, anxiety, dizziness, headache, tremors and palpitations.
- Cerebrovascular bleeding or other bleeding and hemiplegia, especially in elderly patients.
- Re-injection can cause necrosis caused by vascular constriction at the site of injection.
- Long-term use/overdose can cause severe metabolic acidosis.
- High doses can result in cardiac arrhythmias.
PRESENTATION :
Epinephrine Bitartrate Injection 1 mg/ml Box, 10 ampoules @ 1 ml
Reg. No. GKL1902360643A1
STORAGE :
KEEP IN REFRIGERATOR (2 – 8)ºC, PROTECT FROM LIGHT AND DO NOT FREEZING
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
