Ephedrine

What is Ephedrine and how is it used?

Ephedrine is a prescription medicine used to treat the symptoms oflow blood pressureduring anesthesia (Hypotension). Ephedrine may be used alone or with other medications.

Ephedrine belongs to a class of drugs called Alpha/Beta Adrenergic Agonists.

It is not known if Ephedrine is safe and effective in children.

What are the possible side effects of Ephedrine?

Ephedrine may cause serious side effects including:

• chest pain, and
• irregular heartbeats

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Ephedrine include:

• nervousness,
• anxiety,
• dizziness,
• spinning sensation (vertigo),
• headache,
• nausea,
• loss of appetite,
• trouble sleeping,
• fast heart rate,
• pounding heartbeats,
• sweating,
• vomiting,
• weight loss, and
• difficult or painful urination

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ephedrine. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For IM, IV or SC Use 50 mg/mL pH 4.5 - 7.0

DESCRIPTION

Ephedrine Sulfate Injection, USP is a sterile solution of 50 mg ephedrine sulfate in water for injection.

Ephedrine occurs as fine, white, odorless crystals or powder and darkens on exposure to light. It is freely soluble in water and sparingly soluble in alcohol.

The chemical name for ephedrine sulfate is (C₁₀H₁₅NO)₂•H₂SO₄benzenemethanol α - [1 - (methylamino) ethyl] - sulfate (2:1) (salt). Its molecular weight is 428.54.

The structural formula is:

INDICATIONS

Ephedrine Sulfate Injection, USP is indicated in the treatment of allergic disorders, such as bronchialasthma. The drug has long been used as apressoragent, particularly during spinalanesthesiawhenhypotensionfrequently occurs. In Stokes-Adamssyndromewith completeheart block, ephedrine has a value similar to that ofepinephrine. It is indicated as acentral nervous systemstimulant innarcolepsyand depressive states. It is also used inmyasthenia gravis.

DOSAGE AND ADMINISTRATION

Adults

The usualparenteraldose is 25 to 50 mg given subcutaneously or intramuscularly. Intravenously, 5 to 25 mg may be administered slowly, repeated in 5 to 10 minutes, if necessary.

Children

The usualsubcutaneousorintramusculardose is 0.5 mg/kg of body weight or 16.7 mg/square meter of body surface every 4 to 6 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL per vial,NDC55390-875-01

Packed 25 vials per carton.Protect from light.

制造:贝德福德实验室™贝德福德,OH 44146. Manufactured by: Ben Venue Laboratories Inc. Bedford, OH 44146. Revised 10/01.

SIDE EFFECTS

With large doses of ephedrine sulfate most patients will experience nervousness,insomnia,vertigo, headache,tachycardia, palpitation andsweating. Some patients havenausea, vomiting andanorexia.Vesicalsphincterspasmmay occur and result in difficult andpainful urination.Urinaryretention may develop in males with prostatism.

Precordialpainandcardiacarrhythmias may occur following administration of Ephedrine Sulfate Injection, USP.

Drug Abuse And Dependence

Prolonged abuse of Ephedrine Sulfate Injection, USP can lead to symptoms of paranoidschizophrenia. When this occurs, patients exhibit such physical signs as tachycardia, poornutritionandhygiene,fever, coldsweatand dilated pupils.

Some measure of tolerance may develop with prolonged or excessive use butaddictiondoes not occur. Temporary cessation of medication and subsequent readministration restores its effectiveness.

DRUG INTERACTIONS

Concurrent use of ephedrine sulfate with general anesthetics, especially cyclopropane or halogenated hydrocarbons or digitalis glycosides may cause cardiac arrhythmias, since these medications may sensitize themyocardiumto the effects of ephedrine sulfate.

Therapeuticdoses of ephedrine sulfate can inhibit thehypotensiveeffect of guanethidine, bethanidine, and debrisoquin by displacing the adrenergic blockers from their site of action in the sympathetic neurons. The effect in man is seen as a relative or a complete blockade of theantihypertensivedrug by a sudden rise inblood pressure. Concomitant use of Ephedrine Sulfate Injection, USP and oxytocics may cause severehypotension.

Monoamine oxidase inhibitors may potentiate thepressoreffect of ephedrine sulfate, possibly resulting in ahypertensive crisis. Ephedrine Sulfate Injection, USP should not be administered during or within 14 days following the administration of MAO inhibitors.

WARNINGS

No information provided.

PRECAUTIONS

General

Special care should be used when administering Ephedrine Sulfate Injection, USP to patients withheart disease,angina pectoris,diabetes, hyperthyroidism, prostatichypertrophyorhypertensionand to patients receiving digitalis. Prolonged use may produce a syndrome resembling an anxiety state. Tolerance to ephedrine sulfate may develop, but temporary discontinuance to the drug restores its original effectiveness.

Pregnancy Category C

动物繁殖研究尚未conducted with Ephedrine Sulfate Injection, USP. Also, it is not known whether the drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ephedrine Sulfate Injection, USP should be given to a pregnant woman only if clearly indicated.

It is not known what effect Ephedrine Sulfate Injection, USP may have on the newborn or on the child's later growth and development when the drug is administered to the mother just before or during labor.

Nursing Mothers

Ephedrine sulfate is excreted in breast milk. Use by nursing mothers is not recommended because of the higher than usual risk for infants.

OVERDOSE

Symptoms

The principal manifestation of ephedrine sulfatepoisoningis convulsions. Inacutepoisoning the following signs and symptoms may occur:nausea, vomiting,chills,cyanosis, irritability, nervousness,fever,suicidalbehavior,tachycardia, dilated pupils,blurred vision,opisthotonos, spasms, convulsions,pulmonaryedema, gasping respirations,comaandrespiratory failure. Initially, the patient may havehypertension, followed later byhypotensionaccompanied by anuria.

Treatment

If respirations are shallow or cyanosis is present, artificialrespirationshould be administered. Vasopressors are contraindicated. Incardiovascularcollapseblood pressureshould be maintained.

Antidote

For hypertension, 5 mg phentolamine mesylate diluted insalinemay be administered slowly intravenously, or 100 mg may be given orally. Convulsions may be controlled by diazepam or paraldehyde. Cool applications anddexamethasone1 mg/kg, administered slowly intravenously, may control pyrexia.

CONTRAINDICATIONS

Allergic reactions to ephedrine sulfate are rare. The hypersensitivity, if known, is a specificcontraindication. Patients hypersensitive to other sympathomimetics may also be hypersensitive to ephedrine sulfate.

CLINICAL PHARMACOLOGY

Ephedrine sulfate is a potent sympathomimetic that stimulates both α and β receptors and has clinical uses related to both actions. Itsperipheralactions, which it owes in part to the release of norepinephrine, simulate responses that are obtained when adrenergic nerves are stimulated. These include an increase inblood pressure, stimulation ofheart muscle, constriction of arterioles, relaxation of thesmooth muscleof thebronchiandgastrointestinal tract, anddilationof the pupils. In thebladder, relaxation of the detrusormuscleis not prominent, but the tone of the trigone andvesiclesphincter is increased.

Ephedrine sulfate also has a potent effect on theCNS. It stimulates thecerebral cortexand subcortical centers, which accounts for its use innarcolepsy.

Thecardiovascularresponses reported in man include moderatetachycardia, unchanged or augmentedstroke volume, enhancedcardiac output, variable alterations in peripheralresistanceand usually a rise in blood pressure. The action of ephedrine is more prominent on theheartthan on the blood vessels. Ephedrine sulfate increases the flow of coronary,cerebraland muscle blood.

In patients withmyasthenia gravis, administration of Ephedrine Sulfate Injection, USP produces a real but modest increase inmotorpower. The exact mechanism by which ephedrine sulfate affectsskeletal musclecontractions is unknown.

PATIENT INFORMATION

No information provided. Please refer to thePRECAUTIONSsection.