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Last updated on Ephedrine-Xinhua Pharme tablets are indicated for the treatment or prevention of attacks of bronchospasm in asthma. Ephedrine-Xinhua Pharme has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic heart disease. Ephedrine-Xinhua Pharme increases blood pressure in man. Over the counter acquisition of sympathomimetics should always be considered in hypertensive patients whose blood pressure control has suddenly deteriorated. Patients with hyperthyroidism may be susceptible to the effects of Ephedrine-Xinhua Pharme. Ephedrine-Xinhua Pharme may precipitate acute urinary retention in patients with prostatic hypertrophy. Ephedrine-Xinhua Pharme should be given with care to patients with hyperthyroidism, diabetes mellitus, angle-closure glaucoma and renal impairment. Ephedrine-Xinhua Pharme has potentially life threatening effects in its acute cardiovascular and central stimulant effects. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The most common side-effects of Ephedrine-Xinhua Pharme are tachycardia, anxiety, nausea, restlessness and insomnia. Tremor, dry mouth, impaired circulation to the extremities, hypertension, headache and cardiac arrhythmias may occur. Tolerance with dependence has been reported with prolonged administration. Myocardial infarction has occurred very rarely in patients taking Ephedrine-Xinhua Pharme or pseudoEphedrine-Xinhua Pharme. Ephedrine-Xinhua Pharme may act as stimulant in children with nocturnal enuresis and cause sleeplessness. It may have sedative effects in some children. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www. The symptoms of overdose are normally seen as nausea, vomiting, hypertension, fever, palpitations, tachycardia, restlessness, respiratory depression and convulsions. Paranoid psychosis, delusions and hallucinations may also follow Ephedrine-Xinhua Pharme overdosage. In severe overdosage, the stomach should be emptied by emesis and lavage. Management is by supportive symptomatic therapy. Ephedrine-Xinhua Pharme is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. When given by mouth in therapeutic doses, Ephedrine-Xinhua Pharme constricts the peripheral vessels, thus increasing blood pressure. It also relaxes bronchioles. Ephedrine-Xinhua Pharme is rapidly and completely absorbed after oral administration and extensively distributed throughout the body with accumulation in the liver, lungs, kidneys, spleen and brain. Studies in mice have shown that the lethal toxicity of Ephedrine-Xinhua Pharme is increased by elevation of body temperature. Ephedrine-Xinhua Pharme induces acute locomotor stimulatory activity in rats and mice. The estimated lethal dose in children up to 2 years of age is mg and for adults 2g. Fatalities are rare and single doses up to mg have been given without serious toxic effects. Email Successfully Sent. Ephedrine-Xinhua Pharm Print. Name of the medicinal product. Special precautions for disposal and other handling. Components: Ephedrine. Available in countries. Qualitative and quantitative composition. Therapeutic indications. Dosage Posology and method of administration. Adults 15 - 60mg three times daily Children under 1 year 1 - 5 years 6 - 12 years not recommended 15mg three times daily 30mg three times daily Elderly Dosage should be substantially reduced. Ischaemic heart disease Hypertension Thyrotoxicosis Prostatic hypertrophy Ephedrine-Xinhua Pharme has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic heart disease. Special warnings and precautions for use. Effects on ability to drive and use machines. Undesirable effects. The elderly are more sensitive to the cardiovascular effects of Ephedrine-Xinhua Pharme. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. Pharmacodynamic properties. Pharmacokinetic properties. Preclinical safety data. Find in a country: A. Dosage should be substantially reduced.
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Medically reviewed by Drugs. Last updated on Mar 1, Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Ephedrine sulfate injection must be diluted before administration as an intravenous bolus to achieve the desired concentration. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion. The recommended dosage for the treatment of clinically important hypotension in the setting of anesthesia is an initial dose of 5 mg to 10 mg administered by intravenous bolus. Administer additional boluses as needed, not to exceed a total dosage of 50 mg. Serious postpartum hypertension has been described in patients who received both a vasopressor i. Some of these patients experienced a stroke. Carefully monitor the blood pressure of individuals who have received both ephedrine and an oxytocic. Data indicate that repeated administration of ephedrine can result in tachyphylaxis. Clinicians treating anesthesia-induced hypotension with ephedrine sulfate injection should be aware of the possibility of tachyphylaxis and should be prepared with an alternative pressor to mitigate unacceptable responsiveness. When used to prevent hypotension, ephedrine has been associated with an increased incidence of hypertension compared with when ephedrine is used to treat hypotension. The following adverse reactions associated with the use of ephedrine sulfate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiac disorders: Tachycardia, palpitations thumping heart , reactive hypertension, bradycardia, ventricular ectopics, R-R variability. Clonidine, propofol, monoamine oxidase inhibitors MAOIs , atropine. Carefully monitor the blood pressure of individuals who have received both ephedrine and any of these drugs. Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Clinician should monitor patient for blood pressor response and adjust the dosage or choice of pressor accordingly. Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Be aware of this potential interaction. No treatment or other interventions are needed. Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine. Limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. However, there are clinical considerations \\\\\\\\\\[see Clinical Considerations\\\\\\\\\\]. Animal reproduction studies have not been conducted with ephedrine sulfate. In the U. Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. Monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. Limited published literature reports that ephedrine is present in human milk. However, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Ephedrine and its metabolite are excreted in urine. In patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. Monitor patients with renal impairment carefully after the initial bolus dose for adverse events. Overdose of ephedrine can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician. Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is 1R,2S - - methylaminephenylpropanol sulfate, and the molecular weight is Its molecular formula is C 10 H 15 NO 2. H 2 SO 4 and structural formula is depicted below:. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg equivalent to 38 mg ephedrine base in water for injection. The pH range is 4. Pressor effects by direct alpha- and beta-adrenergic receptor activation are mediated by increases in arterial pressures, cardiac output, and peripheral resistance. Indirect adrenergic stimulation is caused by norepinephrine release from sympathetic nerves. Ephedrine stimulates heart rate and cardiac output and variably increases peripheral resistance; as a result, ephedrine usually increases blood pressure. Tachyphylaxis to the pressor effects of ephedrine may occur with repeated administration \\\\\\\\\\[see Warnings and Precautions 5. Publications studying pharmacokinetics of oral administration of - -ephedrine support that - -ephedrine is metabolized into norephedrine. However, the metabolism pathway is unknown. Both the parent drug and the metabolite are excreted in urine. Limited data after intravenous administration of ephedrine support similar observations of urinary excretion of drug and metabolite. The plasma elimination half-life of ephedrine following oral administration was about 6 hours. Ephedrine crosses the placental barrier \\\\\\\\\\[see Use in Specific Populations 8. Ephedrine sulfate tested negative in the in vitro bacterial reverse mutation assay, the in vitro mouse lymphoma assay, the in vitro sister chromatid exchange, the in vitro chromosomal aberration assay, and the in vivo rat bone marrow micronucleus assay. The evidence for the efficacy of ephedrine injection is derived from the published literature. Increases in blood pressure following administration of ephedrine were observed in 14 studies, including 9 where ephedrine was used in pregnant women undergoing neuraxial anesthesia during Cesarean delivery, 1 study in non-obstetric surgery under neuraxial anesthesia, and 4 studies in patients undergoing surgery under general anesthesia. Ephedrine has been shown to raise systolic and mean blood pressure when administered as a bolus dose following the development of hypotension during anesthesia. Each mL contains 50 mg of ephedrine sulfate USP, equivalent to 38 mg ephedrine base. Store in carton until time of use. Manufactured by: Amneal Pharmaceuticals Pvt. Other brands: Akovaz , Corphedra. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Subscribe to Drugs. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. We comply with the HONcode standard for trustworthy health information - verify here. Skip to Content. Ephedrine Sulphate Injection. View All. Interactions that Augment the Pressor Effect Oxytocin and oxytocic drugs Clinical Impact: Serious postpartum hypertension has been described in patients who received both a vasopressor i. Intervention: Carefully monitor the blood pressure of individuals who have received both ephedrine and an oxytocic. Clonidine, propofol, monoamine oxidase inhibitors MAOIs , atropine Clinical Impact: These drugs augment the pressor effect of ephedrine. Intervention: Carefully monitor the blood pressure of individuals who have received both ephedrine and any of these drugs. Interactions that Antagonize the Pressor Effect Clinical Impact: These drugs antagonize the pressor effect of ephedrine. Intervention: Clinician should monitor patient for blood pressor response and adjust the dosage or choice of pressor accordingly. Rocuronium Clinical Impact: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Intervention: Be aware of this potential interaction. Epidural anesthesia Clinical Impact: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Intervention: Monitor and treat the patient according to clinical practice. Theophylline Clinical Impact: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. Intervention: Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides Clinical Impact: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Intervention: Carefully monitor patients on cardiac glycosides who are also administered ephedrine. Drug Status Rx. Availability Prescription only. Akorn, Inc. Pfizer Inc. Sandoz Inc. Drug Class. Decongestants Vasopressors. Related Drugs. Ephedrine Images. Subscribe to our newsletters. FDA alerts for all medications. Daily news summary. Weekly news roundup. Monthly newsletter. I accept the Terms and Privacy Policy. Email Address. Explore Apps. About About Drugs. All rights reserved. Interactions that Augment the Pressor Effect. Oxytocin and oxytocic drugs. Clinical Impact:. These drugs augment the pressor effect of ephedrine. Interactions that Antagonize the Pressor Effect. These drugs antagonize the pressor effect of ephedrine. Other Drug Interactions. Epidural anesthesia. Monitor and treat the patient according to clinical practice. Cardiac glycosides. Product Information. Inactive Ingredients. Marketing Information.
Ephedrine-Xinhua Pharm
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