bitolterol mesylate, Tornalate

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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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

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