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This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
In the United States, the Food and Drug Administration (FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car.
(Reuters) -The U.S. Food and Drug Administration (FDA) declined to approve Merck's drug for chronic cough, the company said on Wednesday, marking the second rejection in less than two years.
Pentoxyverine or carbetapentane is an antitussive (cough suppressant) commonly used for cough associated with illnesses like common cold. It is sold over-the-counter as Solotuss, [1] or in combination with other medications, especially decongestants. One such product is Certuss, a combination of guaifenesin and pentoxyverine. [2]
Women should speak to their doctor or healthcare professional before starting or stopping any medications while pregnant. [1] Drugs taken in pregnancy including over-the counter-medications, prescription medications, nutritional supplements, recreational drugs, and illicit drugs may cause harm to the mother or the unborn child.
In animal and human studies, it has shown similar efficacy to theophylline but with significantly fewer side effects. [5] In February 2014, the US FDA granted an orphan drug designation to doxofylline for the treatment of bronchiectasis following the submission of an application by Alitair Pharmaceuticals, in May 2013.
Use in pregnancy appears to be safe. [6] Montelukast is in the leukotriene receptor antagonist family of medications. [6] It works by blocking the action of leukotriene D4 in the lungs resulting in decreased inflammation and relaxation of smooth muscle. [6] Montelukast was approved for medical use in the United States in 1998. [6]