Ephedrin 1 ml of 5%. 10 ampules
Ephedrin 1 ml of 5%. 10 ampules
It is used to control the hypotension accompanying spinal anesthesia; as a pressor agent in hypotensive states following sympathectomy or after overdose ganglioblokerii antiadrenergic agents used in hypertension arteritis.
Route of administration and dosage:
The product can be administered subcutaneously, intramuscularly and intravenously. It is to be understood that even at the lowest therapeutic dose in normotensive patients and lead to increased blood pressure of 15-20mm Hg.
In patients with severe hypotension ephedrine should be used with caution and to maximize the highest therapeutic doses and for a short period of time during which it is necessary to take additional measures to correct blood pressure infusion volume replacement solutions.
As a pressor agent ephedrine typically administered subcutaneously or intramuscularly at a dose of 25-50 mg dose range of 10-50 mg. If necessary, it can be applied more intramuscular dose of 50 mg or 25 mg i.v.. Intravenosnoto application always proceed slowly, it is even recommended that it be implemented as a drip infusion over approximately 5010 min parenteral maximum daily dose for adults should not exceed 150mg.
In children, a daily dose 3mg/kg or 100mg/m2 skin surface either subcutaneously or intravenously, in 4-6 divided doses.
Svrahchuvstvitelnnost to sympathomimetic amines, atherosclerosis, heavy organic heart diseases, hypertension, glaucoma, patients who have previously received or halothane anesthesia with cyclopropane (increased sensitivity to a myocardium to the arrhythmogenic effect of sympathomimetics), thyrotoxicosis, diabetes.
Special precautions and warnings:
Be applied very cautiously in elderly patients. Be used with caution in patients with renal impairment because of the risk of real vasoconstriction and decreased urine output.
Ephedrine can cause hypertension and subsequent intracranial haemorrhage. Ephedrine can cause angina pain in patients with coronary insufficiency and ischemic heart disease.
Repeated dose and high doses can be observed tahofilaksiya.
Injection under the skin can cause local ischemia of tissue necrosis.
Antagonist is a ganglionic blocking and antiadrenergic drugs. Ephedrine reduces the antihypertensive effect of gvanetedin. Alpha adrenergic blockers reduce the vasopressor activity of ephedrine, causing vazodilatotsiya. In combination therapy of reserpine or methyldopa ephedrine may be reduced pressor effect of the latter. A similar effect can be observed with the combination of a drug with diuretic agents.
When a combination of ephedrine with MAO inhibitors as possible sharp increase in blood pressure, and in combination with beta-blockers reduces the bronchodilator effect. Ephedrine is an antagonist of non-narcotic analgesics and drugs that inhibit the central nervous system.
Ephedrine should be used with caution in combination with drugs that increase the sensitivity of myocardial sympathomimetics - e.g. patients anesthetized with halothane or cyclopropyl or receiving digitalis glycosides. Ephedrine is not combined with other sympathomimetic agents due to the potential for additive effects and increased toxicity.
Pregnancy and lactation:
According to the FDA classification belongs to category C. There are no data how ephedra can cause harm to the fetus and cause adverse effects on reproduction. It is known, however, that crosses the placenta and is excreted in breast milk. Can lead to a significant increase in heart rate of the fetus when administered to pregnant women. Use of the product during pregnancy and lactation should be done only in cases where the expected benefit to the mother outweighs the significant risk to the fetus and newborn.
Impact on alertness, ability to drive and use machines:
Should not be used when driving or operating machinery.
Acute toxic effects are usually a result of prolonged therapeutic drug action or even more frequently due to overdose.
The most serious adverse reaction caused by excessive doses of ephedrine with extreme hypertension, vasoconstriction associated with excitation of ?-adrenoceptors. It may lead to cerebral hemorrhage. In other cases it may be observed vasodilation with hypotension.
At usual doses some patients react with short pallor, shortness of breath, tremor, feelings of anxiety and restlessness, confusion and tension, fatigue, palpitations, dizziness, headache, sweating. There may be nausea, vomiting, hallucinations.
For repeated injections can cause contraction of the sphincter of the bladder and inability to voluntary urination.
The danger of dysuria must be considered, particularly in the case of adult males.
Continuous introduction of ephedrine can cause much more serious hypotension compared with before treatment. On the other hand, high doses of parenteral drug causing extreme elevations in blood pressure, tachycardia and subsequent brain hemorrhage. CNS symptoms of overdose are nausea, vomiting, loss of appetite, nervous agitation, insomnia, mydriasis, vertigo. In severe cases - seizures and coma, respiratory arrest. Apply symptomatic therapy and forced diuresis.
Ephedrine is an alkaloid isolated from the stems of plants of the family Ephedraceae, and is more active than obtained synthetically efetonin.
Belongs to a group of sympathomimetic agents, but acts less and longer than adrenaline. Inhibits the activity of monoamine oxidase, the incentive alpha-and beta-adrenoceptors. Cause spasm of the peripheral vessels, increases the heart rate, increases blood pressure, expands the bronchi, inhibits intestinal peristalsis and widens. Increases metabolism, in therapeutic doses slightly increase blood sugar levels. At therapeutic doses showed little stimulant effect on the central nervous system (mental and motor restlessness, insomnia) and increases the excitability and respiratory center.
Ephedrine hydrochloride is rapidly absorbed and full of tissues after parenteral subcutaneous administration. Parenteral administration of the product ensures high systemic bioavailability and rapid onset of effect. The duration of action is short 30-60min. Wherein a half-life 3-6 hours. Bronchodilation occurs on average 15-60 minutes after oral administration and lasts 2-4 hours. The duration of the pressor effects and cardiac response is an average of 1 hour after iv administration of a dose of the order of 10 25 mg. or after i.m. or s.c. administration of 25-50mg. and up to 4 hours after oral administration of the product at doses of 15-50mg .. The plasma concentrations associated with the induction of bronchodilation show considerable variation - in the same study, the above concentration range of more than 20ng/mL 80ng/mL.
Small part ephedrine slowly metabolized in the liver and the metabolites were identified as p-hydroxyephedrin, p-hydroxynorephedrine, norephedrine, and conjugates thereof. Eliminated from the body primarily through urinary excretion largely unchanged. Also its metabolites are excreted through the urine. The rate of excretion into urine is affected by its pH, such as at low speed of the process is increased. Crosses the placenta and is excreted in breast milk.
Preclinical safety data:
In experiments with rats in vivo brain microdialysis l-ephedrine administered at a high dose (40mg/kg, i.p.) caused a marked hyperthermia and a 20-fold increase in the level of extracellular dopamine released in brain microdialysis of Structure caudate / putamen. 25mg/kg dose caused a weaker degree of hyperthermia and 10-fold increase in the level of dopamine levels.
Controlled studies in animals for a possible embryotoxic, teratogenic and carcinogenic effects of the product have not been conducted.
3. Pharmaceutical particulars
List of excipients and their amounts:
Composition of one vial 50mg/ml - 1ml:
Water for injections to 1ml.
Five years from the date of manufacture.
In original packaging in a dry and dark place at a temperature below 25 ° C. Do not freeze.
The product was filled into 1 ml ampoules. Ten vials were placed in a blister pack of rigid PVC foil.