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for cloth Naproxen Pregnancy and Breastfeeding Warnings Naproxen is also known as: Aflaxen , Aleve , All Day Pain Relief, All Day Relief, Anaprox , Anaprox-DS , Comfort Pac with Naproxen, EC-Naprosyn , Flanax Pain Reliever , Leader Naproxen Sodium, Midol Extended Relief , Naprelan , Naprosyn , Naproxen Sodium DS, Pamprin All Day Relief Overview Side Effects Dosage Professional Tips More Interactions Pregnancy Warnings Breastfeeding Warnings User Reviews Drug Images Support Group Q & A Compare Alternatives Pricing & Coupons Naproxen Pregnancy Warnings Animal studies have revealed evidence of an increased risk of miscarriage, pre- and post-implantation loss, gastroschisis, embryo-fetal lethality, and cardiac malformation following use of prostaglandin synthesis inhibitors in early pregnancy. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, pulmonary hypertension, fetal renal impairment, oligohydramnios, and inhibition of platelet aggregation. There are no controlled data in human pregnancy. Administration during labor and delivery is not recommended; onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child. NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out. Avoid use during last trimester of pregnancy. Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: Not assigned. Risk Summary: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Comments: -Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. -Not recommended in women attempting to conceive as may impair female fertility. See references Naproxen Breastfeeding Warnings Use should be avoided. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown. This drug has been found in the milk of lactating women at concentrations of approximately 1% of that found in plasma. Due to the long half-life and potential for serious adverse events in breastfed infants, other agents may be preferred. See references References for pregnancy information "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate." "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA. Cerner Multum, Inc. "Australian Product Information." O 0 "Product Information. Naprelan 375 (naproxen)." Shionogi USA Inc, Florham Park, NJ. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 References for breastfeeding information Cerner Multum, Inc. "Australian Product Information." O 0 "Product Information. Naprelan 375 (naproxen)." Shionogi USA Inc, Florham Park, NJ. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA. "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate." United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]): Print this page See Also... Naproxen use while Breastfeeding (in more detail) Naproxen Consumer Information Pregnancy Support Group FDA Pregnancy Categories Medicine use during Pregnancy Medicine use while Breastfeeding Safe Medications during Breastfeeding Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist. Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Naproxen Rating 423 User Reviews 6.9 /10 423 User Reviews 6.9 Rate it! Drug Class Nonsteroidal anti-inflammatory agents Related Questions & Answers Does naproxen contain aspirin? Can I take naproxen for batricial phnemonia? What is Naproxen 500 mg used for? Can I take naproxen with an antibiotic? Naproxen vs Ibuprofen: What's the difference? Can i use naproxen for cluster headaches? Read more questions try and


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