Medications and Drugs
Pharmacy Author: Omudhome Ogbru, PharmD
Medical and Pharmacy Editor: Jay W. Marks, MD
GENERIC NAME: bitolterol mesylate
BRAND NAME: (Tornalate: This brand no longer is available in the U.S.)
DRUG CLASS AND MECHANISM: Bitolterol is a bronchodilator used in the
treatment of asthma. It is similar to albuterol (Ventolin). Asthma is a disorder
of breathing in which there is narrowing of the airways that carry air to the
lungs including the bronchi. This narrowing is caused by muscle spasm and
inflammation within the airways. Bitolterol relaxes the smooth muscles
surrounding these airways, increasing the diameter and easing the flow of air
through the airways. Bitolterol probably does not affect inflammation in the
lung either with asthma or other inflammatory lung disorders such as bronchitis.
Nevertheless, if spasm of the airways occurs because of bronchitis, bitolterol
may be useful therapy for the asthmatic component of the illness. Bitolterol is
unique in that it is a "prodrug;" It must first be converted by the body into
its active form. Bitolterol has a rapid onset of action (2-5 minutes), and its
effects may last up to 6-8 hours. The FDA approved bitolterol in December 1984.
PRESCRIPTION: Yes
GENERIC AVAILABLE: No
PREPARATIONS: Inhaler: 0.37 mg/Inhalation; Solution for Inhalation: 0.2%
STORAGE: Bitolterol should be stored at room temperature, 15 to 30 C (59
to 86 F).
PRESCRIBED FOR: Bitolterol is used for the relief of bronchospasm due to
asthma and other respiratory illnesses.
DOSING: The recommended adult dose for treating asthma is 2 inhalations every
8 hours. Maximum dose is 2 inhalations every 4 hours or 3 inhalations every 6
hours.
DRUG INTERACTIONS: Tricyclic antidepressants [for example, amitriptyline
(Elavil, Endep), monoamine oxidase inhibitors (for example, tranylcypromine)
should not be combined with bitolterol because of their additive effects on the
vascular system (increased blood pressure, heart rate, etc.). A period of two
weeks should elapse between treatment with bitolterol and tricyclic
antidepressants or monoamine oxidase inhibitors.
Use of bitolterol with other stimulant medications is discouraged because of
their combined effects on heart rate, blood pressure, and the potential for
causing chest pain in patients with underlying coronary heart disease.
Beta-blockers, for example, propranolol (Inderal, Inderal LA), block the
effect of bitolterol and may induce bronchospasm in asthmatics. Bitolterol may
cause hypokalemia (low potassium). Therefore, combining bitolterol with loop
diuretics, for example, furosemide (Lasix), which lowers potassium levels in the
blood, may increase the likelihood of hypokalemia.
PREGNANCY: There are no adequate studies in
pregnant women.
NURSING MOTHERS: It's not known if bitolterol is excreted in
breast milk.
SIDE EFFECTS: Side effects of bitolterol include nervousness, tremor,
headache, palpitations, fast heart rate,
elevated blood pressure, nausea,
dizziness, and
heartburn. Throat irritation and
nosebleeds can also occur.
Allergic reactions may occur rarely and may manifest as rash, hives,
swelling, anaphylaxis, or
shock. Worsening of diabetes and lowering of potassium have
also been reported. In rare patients, inhaled bitolterol can paradoxically
precipitate life-threatening bronchospasm.
Reference: FDA Prescribing Information
Last Editorial Review: 9/15/2009
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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