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|Salbutamol Oral/Injection

BRONCHODILATORS, ADRENERGIC (Oral/Injection)

Some commonly used brand names are:

In the U.S.—

• Adrenalin ³
• Alupent ⁵
• Ana-Guard ³
• Brethine ⁶
• Bricanyl ⁶
• EpiPen Auto-Injector ³
• EpiPen Jr. Auto-Injector ³
• Isuprel ⁴
• Proventil ¹
• Proventil Repetabs ¹
• Ventolin ¹
• Volmax ¹

In Canada—

• Adrenalin ³
• Alupent ⁵
• Bricanyl ⁶
• EpiPen Auto-Injector ³
• EpiPen Jr. Auto-Injector ³
• Isuprel ⁴
• Ventolin ¹

Other commonly used names are:

• Adrenaline
• Salbutamol
• Orciprenaline

Category

• Anesthetic adjunct (local and regional)
• antiallergic, systemic
• antihemorrhagic, dental
• bronchodilator
• priapism reversal agent
• tocolytic agent

Description

Adrenergic bronchodilators are medicines that stimulate the nerves in many parts of the body, causing different effects.

Because these medicines open up the bronchial tubes (air passages) of the lungs, they are used to treat the symptoms of asthma, bronchitis, emphysema, and other lung diseases. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

Epinephrine injection (including the auto-injector but not the sterile suspension) is used in the emergency treatment of allergic reactions to insect stings, medicines, foods, or other substances. It relieves skin rash, hives, and itching; wheezing; and swelling of the lips, eyelids, tongue, and inside of the nose.

These medicines may be also used for other conditions as determined by your doctor.

Ephedrine capsules are available without a prescription. However, check with your doctor before taking ephedrine.

All of the other adrenergic bronchodilators are available only with your doctor"s prescription.

These medicines are available in the following dosage forms:

• Oral
• Albuterol
  • Oral solution (Canada)
  • Syrup (U.S.)
  • Tablets (U.S.)
  • Extended-release tablets (U.S.)
• Ephedrine
  • Capsules (U.S.)
• Metaproterenol
  • Syrup (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Terbutaline
  • Tablets (U.S. and Canada)

• Parenteral
• Albuterol
  • Injection (Canada)
• Ephedrine
  • Injection (U.S. and Canada)
• Epinephrine
  • Injection (U.S. and Canada)
• Isoproterenol
  • Injection (U.S. and Canada)
• Terbutaline
  • Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For adrenergic bronchodilators taken by mouth or given by injection, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to albuterol, ephedrine, epinephrine, isoproterenol, metaproterenol, or terbutaline. Also, tell your doctor if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Some of these medicines can increase blood sugar, blood pressure, and heart rate in the mother, and may increase the heart rate and decrease blood sugar in the infant. Before taking any of these medicines, make sure your doctor knows if you are pregnant or may become pregnant.

Some of these medicines also relax the muscles of the uterus and may delay labor.

• For albuterol : Albuterol has not been studied in pregnant women. Studies in animals have shown that albuterol causes birth defects when given in doses many times the usual human dose.
• For ephedrine : Ephedrine has not been studied in pregnant women or in animals.
• For epinephrine : Epinephrine has been shown to cause birth defects in humans. However, this medicine may be needed during allergic reactions that threaten the mother"s life.
• For isoproterenol : Studies on birth defects with isoproterenol have not been done in humans. However, there is some evidence that it causes birth defects in animals.
• For metaproterenol : Metaproterenol has not been studied in pregnant women. However, studies in animals have shown that metaproterenol causes birth defects and death of the animal fetus when given in doses many times the usual human dose.
• For terbutaline : Terbutaline has not been shown to cause birth defects in humans using recommended doses or in animal studies when given in doses many times the usual human dose.

Breast-feeding—

• For albuterol, isoproterenol, and metaproterenol : It is not known whether albuterol, isoproterenol, or metaproterenol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.
• For ephedrine : Ephedrine passes into breast milk and may cause unwanted side effects in babies of mothers using ephedrine.
• For epinephrine : Epinephrine passes into breast milk and may cause unwanted side effects in babies of mothers using epinephrine.
• For terbutaline : Terbutaline passes into breast milk but has not been shown to cause harmful effects in the infant. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—There is no specific information comparing use of isoproterenol, metaproterenol, or terbutaline in children with use in other age groups.

Excitement and nervousness may be more common in children 2 to 6 years of age who take albuterol than in adults and older children.

Infants and children may be especially sensitive to the effects of epinephrine.

Older adults—Older adults may be more sensitive to the side effects of these medicines, such as trembling, high blood pressure, or fast or irregular heartbeats.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking adrenergic bronchodilators, it is especially important that your health care professional know if you are taking any of the following:

• For all adrenergic bronchodilators
• Amphetamines or
• Appetite suppressants (diet pills) or
• Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Other medicines for asthma or other breathing problems—The chance for side effects may be increased

• Beta-adrenergic blocking agents taken orally or by injection (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor, Toprol XL], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren])—These medicines may prevent the adrenergic bronchodilators from working properly

• Beta-adrenergic blocking agents used in the eye (betaxolol [e.g., Betoptic], levobunolol [e.g., Betagan], metipranolol [e.g., OptiPranolol], timolol [e.g., Timoptic]—Enough of these medicines may be absorbed from the eye into the blood stream to prevent the adrenergic bronchodilators from working properly

• Cocaine—Unwanted effects of both medicines on the heart may be increased

• Digitalis medicines (e.g., Lanoxin) or
• Quinidine (e.g., Quinaglute Dura-Tabs, Quinidex)—The risk of heart rhythm problems may be increased

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking adrenergic bronchodilators while you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitors may dramatically increase the effects of MAO inhibitors

• Thyroid hormones—The effect of this medicine may be increased

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl, Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—The effects of these medicines on the heart and blood vessels may be increased

Other medical problems—The presence of other medical problems may affect the use of these medicines. Make sure you tell your doctor if you have any other medical problems, especially:

• Convulsions (seizures)—These medicines may make this condition worse

• Type 2 diabetes mellitus—These medicines may increase blood sugar, which could change the amount of insulin or other diabetes medicine you need

• Enlarged prostate—Ephedrine may make the condition worse

• Gastrointestinal narrowing—Use of the extended-release dosage form of albuterol may result in a blockage in the intestines.

• Glaucoma—Ephedrine or epinephrine may make the condition worse

• High blood pressure or
• Overactive thyroid—Use of ephedrine or epinephrine may cause severe high blood pressure and other side effects may also be increased

• Parkinson"s disease—Epinephrine may make stiffness and trembling worse

• Psychiatric problems—Epinephrine may make problems worse

• Reduced blood flow to the brain—Epinephrine further decreases blood flow, which could make the problem worse

• Reduced blood flow to the heart or
• Heart rhythm problems—These medicines may make these conditions worse

Proper Use of This Medicine

Use this medicine only as directed . Do not use more of it and do not use it more often than your doctor ordered, do not use more than recommended on the label unless otherwise directed by your doctor. To do so may increase the chance of side effects.

If you are using this medicine for asthma, you should use another medicine that works faster than this one for an asthma attack that has already started. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

For patients taking albuterol extended-release tablets :

• Swallow the tablet whole.
• Do not crush, break, or chew before swallowing.

For patients using epinephrine injection :

• This medicine is for injection only. If you will be giving yourself the injections, make sure you understand exactly how to give them. If you have any questions about this, check with your health care professional.
• When injected into the muscle (intramuscular) this medicine should be injected into the thigh. It should not be injected into the buttocks.
• Do not use the epinephrine solution or suspension if it turns pinkish to brownish in color or if the solution becomes cloudy.
• Keep this medicine ready for use at all times. Also, keep the telephone numbers for your doctor and the nearest hospital emergency room readily available.
• Check the expiration date on the injection regularly. Replace the medicine before that date.

For patients using epinephrine injection for an allergic reaction emergency :

• If a severe allergic reaction occurs, use the epinephrine injection immediately .
• After using the epinephrine injection, notify your doctor immediately or go to the nearest hospital emergency room. Be sure to tell your doctor that you have used the epinephrine injection.
• If you have been stung by an insect, remove the insect"s stinger with your fingernails, if possible. Be careful not to squeeze, pinch, or push it deeper into the skin. Ice packs or sodium bicarbonate (baking soda) soaks, if available, may then be applied to the area stung.
• If you are using the epinephrine auto-injector (automatic injection device):
  • The epinephrine auto-injector comes with patient directions. Read them carefully before you actually need to use this medicine. Then, when an emergency arises, you will know how to inject the epinephrine.
  • It is important that you do not remove the safety cap on the auto-injector until you are ready to use it. This prevents accidental activation of the device during storage and handling.
  • To use the epinephrine auto-injector:
    • Remove the gray safety cap.
    • Place the black tip on the thigh, at a right angle (90-degree angle) to the leg.
    • Press hard into the thigh until the auto-injector functions. Hold in place for several seconds. Then remove the auto-injector and discard.
    • Massage the injection area for 10 seconds.

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of solution or syrup that you take, or the amount of injection that you use, depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking it .

• For albuterol
• For symptoms of asthma, chronic bronchitis, emphysema, or other lung disease:
  • For oral dosage form (solution):
    • Adults and children 12 years of age and older—2 to 4 milligrams (mg) (1 to 2 teaspoonfuls) three or four times a day.
    • Children 6 to 12 years of age—2 mg (1 teaspoonful) three or four times a day.
    • Children 2 to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.1 mg per kg (0.045 mg per pound) of body weight up to a maximum dose of 2 mg (1 teaspoonful) three or four times a day..
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (syrup):
    • Adults and children 14 years of age and older—2 to 4 mg (1 to 2 teaspoonfuls) three or four times a day. Then your doctor may increase your dose, if needed.
    • Children 6 to 14 years of age—At first, 2 mg (1 teaspoonful) of albuterol three or four times a day. Then your doctor may increase your dose, if needed.
    • Children 2 to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.1 mg per kg (0.045 mg per pound) of body weight up to a maximum dose of 2 mg (1 teaspoonful) three or four times a day.
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and children 12 years of age and older—At first, 2 to 4 mg three or four times a day. Then your doctor may increase your dose, if needed.
    • Children 6 to 12 years of age—2 mg three or four times a day.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • Adults and children 12 years of age and older—4 to 8 mg every twelve hours.
    • Children 6 to 12 years of age—4 mg every twelve hours.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
  • For injection dosage form:
    • Dose is usually based on body weight and must be determined by your doctor. Depending on your condition, this medicine is injected into either a muscle or vein or injected slowly into a vein over a period of time.

• For epinephrine
• For injection dosage form:
  • For allergic reactions:
    • Adults—At first, 300 to 500 micrograms (mcg) (0.3 to 0.5 mg) injected into a muscle or under the skin. Then the dose may be repeated, if needed, every ten to twenty minutes for up to three doses. In some cases, it may be necessary for 100 to 250 mcg to be injected slowly into a vein by your doctor instead of injecting the dose into a muscle or under the skin.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 mcg per kg (4.5 mcg per pound) of body weight, up to 300 mcg (0.3 mg) a dose, injected into a muscle or under the skin. The dose may be repeated, if needed, every fifteen minutes for up to three doses.
  • For symptoms of bronchial asthma, chronic bronchitis or other lung disease:
    • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 mcg per kg (4.5 mcg per pound) of body weight, up to 300 to 500 mcg (0.3 to 0.5 mg) a dose, injected under the skin. The dose may be repeated, if needed, every twenty minutes for up to three doses.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 mcg per kg (4.5 mcg per pound) of body weight, up to 300 mcg (0.3 mg) a dose, injected under the skin. The dose may be repeated, if needed, every fifteen minutes for three or four doses or every four hours.

• For isoproterenol
• For injection dosage form:
  • For symptoms of asthma, chronic bronchitis, emphysema, or other lung disease:
    • Isoproterenol is given by intravenous injection in a doctor"s office or hospital.

• For metaproterenol
• For oral dosage forms (syrup or tablets):
  • For symptoms of asthma, chronic bronchitis, emphysema, or other lung disease:
    • Adults and children 9 years of age and older or weighing 27 kilograms (kg) (59 pounds) or more—20 milligrams (mg) three or four times a day.
    • Children 6 to 9 years of age or weighing up to 27 kg (59 pounds)—10 mg three or four times a day.
    • Children up to 6 years of age—Dose must be determined by your doctor.

• For terbutaline
• For symptoms of asthma, chronic bronchitis, emphysema, or other lung disease:
  • For oral dosage form (tablets):
    • Adults and adolescents 15 years of age and older—5 milligrams (mg) three times a day. The medicine may be taken about every six hours while you are awake, until three doses have been taken.
    • Children 12 to 15 years of age—2.5 mg three times a day, taken about every six hours.
    • Children 6 to 11 years of age—Dose is based on body weight and must be determined by your doctor.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
  • For injection dosage form:
    • Adults and children 12 years of age or older—250 micrograms (mcg) injected under the skin. The dose may be repeated after fifteen to thirty minutes, if needed. However, not more than 500 mcg should be taken within a four-hour period.
    • Children 6 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 5 to 10 mcg per kg (2.3 to 4.5 mcg per pound) of body weight injected under the skin. The dose may be repeated after fifteen to twenty minutes for up to a total of three doses.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed dose—If you are using this medicine regularly and you miss a dose, use it as soon as possible. Then use any remaining doses for that day at regularly spaced intervals. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the injection or syrup form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they could increase the unwanted effects of this medicine.

For patients with diabetes:

• This medicine may cause your blood sugar levels to rise, which could change the amount of insulin or diabetes medicine that you need to take.

For patients taking this medicine for asthma:

• If you still have trouble breathing or if your condition becomes worse (for example, if you have to use an inhaler more frequently to relieve asthma attacks), check with your doctor right away.

For patients who are using epinephrine injection :

• Because epinephrine reduces blood flow to the area where it is injected, it is possible that it could cause damage to the tissues if it is injected in one spot too often. Check with your doctor right away if you notice severe pain at the place of injection.

For patients who are using the epinephrine auto-injector :

• Do not inject this medicine into your hands or feet. There is already less blood flow to the hands and feet, and epinephrine could make that worse and cause damage to these tissues. If you accidentally inject epinephrine into your hands or feet, check with your doctor or go to the hospital emergency room right away.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Although not all of the side effects listed above have been reported for each of these medicines, they have been reported for at least one of them. All of these medicines are similar, so many of the above side effects may occur with any of the medicines.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, some of the adrenergic bronchodilators are used in certain patients with the following medical conditions:

• Premature labor (terbutaline)
• Bleeding of gums and teeth during dental procedures (epinephrine)
• Priapism (prolonged abnormal erection of penis) (epinephrine)
• Hyperkalemia (too much potassium in the blood) in children (albuterol)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 06/17/2002

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