Naproxen/diphenhydramine
| Combination of | |
|---|---|
| Naproxen | NSAID |
| Diphenhydramine | Antihistamine |
| Clinical data | |
| Trade names | Aleve PM |
| AHFS/Drugs.com | aleve-pm |
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status |
|
Naproxen/diphenhydramine(trade nameAleve PM) is a formulation ofnaproxenwithdiphenhydraminemarketed byBayer Healthcare.[1]It is made as anover-the-counter drug.The intended use of the drug is relieve pain specifically when going to sleep.[2]
Adverse effects[edit]
Women in thethird trimester of pregnancyshould avoid this drug because there is a risk that naproxen, like otherNSAIDs,may cause premature closure of theductus arteriosus.[2]
In October 2020, the U.S.Food and Drug Administration(FDA) required thedrug labelto be updated for all nonsteroidal anti-inflammatory medications to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.[3][4]They recommend avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy.[3][4]
References[edit]
- ^"Aleve PM (Naproxen Sodium and Diphenhydramine Hydrochloride) Tablets".U.S. Food and Drug Administration. 13 May 2015.Retrieved19 July2015.
- ^abMichele, T. M. (2014, January 16). Center for Drug Evaluation and Research: Summary Review. Retrieved April 21, 2016, fromhttp://www.accessdata.fda.gov
- ^ab"FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications".U.S.Food and Drug Administration(FDA)(Press release). 15 October 2020.Retrieved15 October2020.
This article incorporates text from this source, which is in thepublic domain.
- ^ab"NSAIDs may cause rare kidney problems in unborn babies".U.S. Food and Drug Administration.21 July 2017.Retrieved15 October2020.This article incorporates text from this source, which is in thepublic domain.
| pyrazolones/ pyrazolidines | |
|---|---|
| salicylates | |
| acetic acidderivatives and related substances | |
| oxicams | |
| propionic acid derivatives (profens) |
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| n-arylanthranilic acids (fenamates) | |
| COX-2 inhibitors (coxibs) | |
| other | |
| NSAID combinations | |
Key:underlineindicates initially developed first-in-class compound of specific group;#WHO-Essential Medicines;†withdrawn drugs;‡veterinary use. | |
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