"The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension.
Pulmonary hypertension is caused by abnormally high blood pressure in the arteries of the lungs. It make"...
POWDER FOR INHALATION
NOT FOR INJECTION
PROVOCHOLINE® (METHACHOLINE CHLORIDE POWDER FOR INHALATION) IS A BRONCHOCONSTRICTOR AGENT FOR DIAGNOSTIC PURPOSES ONLY AND SHOULD NOT BE USED AS A THERAPEUTIC AGENT. PROVOCHOLINE® (methacholine chloride) INHALATION CHALLENGE SHOULD BE PERFORMED ONLY UNDER THE SUPERVISION OF APHYSICIANTRAINED INAND THOROUGHLY FAMILIAR WITH ALL ASPECTS OF THE TECHNIQUE OF METHACHOLINE CHALLENGE, ALL CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE MANAGEMENT OF RESPIRATORY DISTRESS. EMERGENCY EQUIPMENT AND MEDICATION SHOULD BE IMMEDIATELY AVAILABLE TO TREAT ACUTE RESPIRATORY DISTRESS.
PROVOCHOLINE® (methacholine chloride) SHOULD BE ADMINISTERED ONLY BY INHALATION. SEVERE BRONCHOCONSTRICTION AND REDUCTION IN RESPIRATORY FUNCTION CAN RESULT FROM THE ADMINISTRATION OF PROVOCHOLlNE® . PATIENTS WITH SEVERE HYPERREACTIVITY OF THE AIRWAYS CAN EXPERIENCE BRONCHOCONSTRICTION AT A DOSAGE AS LOW AS 0.025 MG/ML (0.125 CUMULATIVE UNITS). IF SEVERE BRONCHOCONSTRICTION OCCURS, IT SHOULD BE REVERSED IMMEDIATELY BY THE ADMINISTRATION OF A RAPID ACTING INHALED BRONCHODILATOR AGENT (BETAAGONIST). BECAUSE OF THE POTENTIAL
FOR SEVERE BRONCHOCONSTRICTION, PROVOCHOLINE® (methacholine chloride) CHALLENGE SHOULD NOT BE PERFORMED IN ANY PATIENT WITH CLINICALLY APPARENT ASTHMA, WHEEZING, OR VERY LOW BASELINE PULMONARY FUNCTION TESTS (e.g., FEV1 LESS THAN 1 TO 1.5 LITER OR LESS THAN 70% OF THE PREDICTED VALUES). PLEASE CONSULT STANDARD NOMOGRAMS FOR PREDICTED VALUES.1
Provocholine® (methacholine chloride powder for inhalation) is a parasympathomimetic (cholinergic) bronchoconstrictor agent to be administered in solutiOn only, by inhalation, for diagnostic purposes. Each 20 mL vial contains 100 mg of methacholine chloride powder which is to be reconstituted with 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). See DOSAGE AND ADMINISTRATION for dilution procedures, concentrations and schedule of administration.
Chemically, methacholine chloride (the active ingredient) is 1-propanaminium, 2-(acetyloxy)N,N,N, - trimethyl,-chloride. It is a white to practically white deliquescent compound, soluble in water. Methacholine chloride has an empirical formula of C8H18CINO2, a calculated molecular weight of 195.69, and the following structural formula:
1. Morris JF, Koski WA, Johnson LC. Spirometric standards for healthy non-smoking adults. Am Rev Resp Dis. Jan 1971; 103: 57-67.
Last reviewed on RxList: 9/25/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Provocholine Information
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