"The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary di"...
- Patient Information:
General: Administration of Provocholine® (methacholine chloride powder for inhalation) to patients with epilepsy, cardiovascular disease accompanied by bradycardia, vagotonia, peptic ulcer disease, thyroid disease, urinary tract obstruction or other condition that could be adversely affected by a cholinergic agent should be undertaken only if the physician feels benefit to the individual outweighs the potential risks.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There have been no studies with methacholine chloride that would permit an evaluation of its carcinogenic or mutagenic potential or of its effect on fertilty.
Pregnancy Category C. Animal reproduction studies have not been conducted with methacholine chloride. It is not known whether methacholine chloride can cause fetal harm when administered to a pregnant patient or affect reproductive capacity. Methacholine chloride should be given to a pregnant woman only if clearly needed.
IN FEMALES OF CHILDBEARING POTENTIAL, PROVOCHOLlNE® INHALATION CHALLENGE SHOULD BE PERFORMED EITHER WITHIN TEN DAYS FOLLOWING THE ONSET OF MENSES OR WITHIN 2 WEEKS OF A NEGATIVE PREGNANCY TEST.
Provocholine® (methacholine chloride) inhalation challenge should not be administered to a nursing mother since it is not known whether methacholine chloride when inhaled is excreted in breast milk.
The safety and efficacy of Provo choline® inhalation challenge have not been established in children below the age of 5 years.
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
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.
Find out what women really need.