NAPROXEN

Drugs in Pregnancy and Lactation.

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Name: NAPROXEN
Class: Nonsteroidal Anti-inflammatory
Risk Factor:    BM*

Fetal Risk Summary

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used in the management of the signs and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and juvenile arthritis. It is in same subclass (propionic acids) as five other NSAIDs (fenoprofen, flurbiprofen, ibuprofen, ketoprofen, and oxaprozin). Drugs in this class have been shown to inhibit labor and to prolong the length of pregnancy (1).

At 0.23–0.28 times the human systemic exposure at the recommended dose, no evidence of impaired fertility or fetal harm was seen in mice, rats, and rabbits (2). A 1990 report described an investigation on the effects of several nonsteroidal antiinflammatory agents on mouse palatal fusion both in vivo and in vitro (3). The compounds, including naproxen, were found to induce cleft palate.

Consistent with the relatively low molecular weight (about 230), naproxen readily crosses the placenta to the fetal circulation. In a mother treated with 250 mg of naproxen every 8 hours for four doses, cord blood levels in twins 5 hours after the last dose were 59.5 and 68 ΅g/mL (4).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 1,448 newborns had been exposed to naproxen during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 70 (4.8%) major birth defects were observed (62 expected). Specific data were available for six defect categories, including (observed/expected) 14/14 cardiovascular defects, 2/2 oral clefts, 0/1 spina bifida, 3/4 polydactyly, 2/2 limb reduction defects, and 3/3 hypospadias. These data do not support an association between the drug and congenital defects.

A combined 2001 population-based observational cohort study and a case-control study estimated the risk of adverse pregnancy outcome from the use of NSAIDs (5). The use of NSAIDs during pregnancy was not associated with congenital malformations, preterm delivery, or low birth weight, but a positive association was discovered with spontaneous abortions (SABs) (see Ibuprofen for details).

Prostaglandin synthesis inhibitors may cause constriction of the ductus arteriosus in utero, which may result in primary pulmonary hypertension of the newborn (6,7). The dose, duration, and period of gestation are important determinants of these effects. Most studies of NSAIDs used as tocolytics have indicated that the fetus is relatively resistant to premature closure of the ductus before the 34th or 35th week of gestation (see Indomethacin). However, three fetuses (one set of twins) exposed to naproxen at 30 weeks for 2–6 days in an unsuccessful attempt to halt premature labor had markedly decreased plasma concentrations of prostaglandin E (5,8). Primary pulmonary hypertension of the newborn with severe hypoxemia, increased blood clotting times, hyperbilirubinemia, and impaired renal function were observed in the newborns. One infant died 4 days after birth, probably because of subarachnoid hemorrhage. Autopsy revealed a short and constricted ductus arteriosus. Use in other patients for premature labor at 34 weeks or earlier has not result in neonatal problems (9,10).

In a case report published in 2000, a mother took an over-the-counter preparation of naproxen 220 mg twice a day over the 4 days immediately preceding birth of a term 3790-g male infant (11). Within 2 hours of birth the infant developed typical signs and symptoms of primary pulmonary hypertension with a closed ductus arteriosus. Conservative management was initiated and the infant was improving by the sixth postnatal day. At 6 weeks of age, the infant was doing well clinically without cyanosis.

Because of the potential newborn toxicity, naproxen should not be used late in the 3rd trimester (2,5,12). Moreover, women attempting to conceive should not use any prostaglandin synthesis inhibitor, including naproxen, because of the findings in a variety of animal models that indicate these agents block blastocyst implantation (13,14). In addition, as noted above, NSAIDs have been associated with SABs.

[*Risk Factor D if used in 3rd trimester or near delivery.]

Breast Feeding Summary

Naproxen passes into breast milk in very small quantities. The milk:plasma ratio is approximately 0.01 (2). Following 250 or 375 mg twice daily, maximum milk levels were found 4 hours after a dose and ranged from 0.7 to 1.25 ΅g/mL and 1.76 to 2.37 ΅g/mL, respectively (15,16). The total amount of naproxen excreted in the infant's urine was 0.26% of the mother's dose. The effect on the infant from these amounts is unknown. The American Academy of Pediatrics considers naproxen to be compatible with breast feeding (17).

References

  1. Fuchs F. Prevention of prematurity. Am J Obstet Gynecol 1976;126:809–20.
  2. Product information. Naprosyn. Roche Laboratories, 2000.
  3. Montenegro MA, Palomino H. Induction of cleft palate in mice by inhibitors of prostaglandin synthesis. J Craniofac Genet Del Biol 1990;10:83–94.
  4. Wilkinson AR. Naproxen levels in preterm infants after maternal treatment. Lancet 1980;2:591–2.
  5. Nielsen GL, Sorensen HT, Larsen H, Pedersen L. Risk of adverse birth outcome and miscarriage in pregnant users of non-steroidal anti-inflammatory drugs: population based observational study and case-control study. Br Med J 2001;322:266–70.
  6. Levin DL. Effects of inhibition of prostaglandin synthesis on fetal development, oxygenation, and the fetal circulation. Semin Perinatol 1980;4:35–44.
  7. Rudolph AM. The effects of nonsteroidal antiinflammatory compounds on fetal circulation and pulmonary function. Obstet Gynecol 1981;58(Suppl):63s–7s.
  8. Wilkinson AR, Aynsley-Green A, Mitchell MD. Persistent pulmonary hypertension and abnormal prostaglandin E levels in preterm infants after maternal treatment with naproxen. Arch Dis Child 1979;54:942–5.
  9. Gerris J, Jonckheer M, Sacre-Smits L. Acute hyperthyroidism during pregnancy: a case report and critical analysis. Eur J Obstet Gynecol Reprod Biol 1981;12:271–80.
  10. Wiqvist N, Kjellmer I, Thiringer K, Ivarsson E, Karlsson K. Treatment of premature labor by prostaglandin synthetase inhibitors. Acta Biol Med Germ 1978;37:923–30.
  11. Talati AJ, Salim MA, Korones SB. Persistent pulmonary hypertension after maternal naproxen ingestion in a term newborn: a case report. Am J Perinatol 2000;17:69–71.
  12. Anonymous. PG-synthetase inhibitors in obstetrics and after. Lancet 1980;2:185–6.
  13. Matt DW, Borzelleca JF. Toxic effects on the female reproductive system during pregnancy, parturition, and lactation. In Witorsch RJ, editor. Reproductive Toxicology. 2nd ed. New York, NY: Raven Press, 1995:175–93.
  14. Dawood MY. Nonsteroidal antiinflammatory drugs and reproduction. Am J Obstet Gynecol 1993;169:1255–65.
  15. Jamali F, Tam YK, Stevens RD. Naproxen excretion in breast milk and its uptake by suckling infant (abstract). Drug Intell Clin Pharm 1982;16:475.
  16. Jamali F, Stevens DRS. Naproxen excretion in milk and its uptake by the infant. Drug Intell Clin Pharm 1983;17:910–11.
  17. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.

Index

Q&A about Naproxen

Amanda
Naproxen????
I'm 13 and i take Naproxen a couple times a month for cramps.

I herd from a couple people that it can cause stomach bleeding.

Can it?
The mom
Yes, one of the effects of Naprosyn- naproxen sodium- is the possibility of stomach bleeding. However, that will be true of most of the pain relievers you would take, they are all known to be possible causes for stomach irritations. However, it is not a highly probably problem for you, given your age and the frequency of use. It's a problem much more associated with old age and constant high dose use, and when there are already stomach problems present- like ulcers. As long as you are careful to take it with food or milk, and aren't drinking alcohol, you won't likely have any problems like bleeding at all. When you are looking at the side effects and complications of taking medicines, you need to keep in mind that in drug studies, the pharmaceutical companies have to report EVERYTHING that was noted in the test population. Even if a problem only happened once in the test group of say a few thousand, it still has to be reported, even if it doesn't make sense at all- like somebody complaining they got a sore throat while taking a medicine to treat their knee pain. I also use Naprosyn a couple days a month, and have done so for years now. It works better for me than anything else, I only take a couple per day, for a max of 2-3 days. I suspect this is how you use it as well. Don't let your friends scare you. All medicines have some kind of side effects that must be listed on the inserts, it's the law. The trick is learning to read them and put the risks in some sense of proportion, and deciding how high the risk is versus what good it will do you. In this case, the risk of bleeding is low, and suffering is pretty much the only other choice. So take your naproxen with food or milk, and relax.
joyness1...
How long does it take Naproxen gastrointestinal effects to subside?
I took Naproxen 3 days ago at midnight. I woke up with horrible wrenching stomach pains. I do not take naproxen regularly. I did take it with a bowl of cereal. However, it is now 3 days later, and I'm still feeling horrible pains of gas and acid indigestion, which by the way is way worse starting at 4am in the morning. I went to urgent care and they said it was the Naproxen. How long does it take to get over this?
hsmommy0...
You need to get something to help coat your tummy like Mylanta or Peptobismal until it subsides. It could of been an allergic reaction too. Just give it a little time. Some people it only take s afew days to get over and others it can take up to a week. Try the Peptobismal when you feel the upset coming on and it should help. You have to be really careful with Naproxen. Taking it with milk or some bread helps to buffer it in the tummy.
hunnybun...
Is it safe to take both naproxen & tylenol? Naproxen at night and tylenol during the day?
I need the naproxen for an inflamed piriformis muscle. but tylenol does me better as far as pain goes. The 550 naproxen does't begin to do a thing for pain.
kiki
It is ok to take both. However, naproxen seems like a real weak med for inflamed muscle. In my opinion the best med for inflamed muscle is Ibuprofen, it helps so well. I , myself would take 400 to 600 mg of Ibuprofen, it really helps. Naproxwn never worked for me either. Hopes this helps.
edas s
How would you compare Naproxen to Hydrocodone for pain relief?
I recently had some Hydrocod-APAP 325mgs from my motor vehicle accident, but recently ran out. I found some Naproxen 500mg in my medicine cabinet and wanted to ask experienced people's opinions on how the pain relief feels different.

I understand that Hydrocodone is an opiate analegic and Naproxen is an anti-inflammatory, but I would still like to see how people compare the 2.
Charlie
You can't compare them,, they are different and they effect your body different. One is for pain and the other is for inflammation.

Here is a good link you should check out for Rx info.

http://pdrhealth.com

And the 325 you are talking about in the hydrocodone is the Tylenol in it not the narcotic. You probably meant 5/325 which is 5 mg. of hydrocodone. I take hydrocodone, just a different strength every day for a spine injury

And I agree with the RN. If the naproxen provides pain relief you will be far better off taking it. Good luck
makeup.g...
What is the maximum dosage a person should take of Naproxen in a 24/hr period?
I have menstrual cramps and they're absolutely killer right now. Ive tried a hot bath, Ive tried yoga, Ive tried laying in the fetal position, Ive tried tylenol with codine (2) and i've just now taken 1 & a half naproxen
SZO
The recommended starting dose is 550 mg of naproxen sodium as ANAPROX/ANAPROX DS followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium.
Michelle S
What do I do if I accidentally took Naproxen 36 hours prior to surgery?
I was having horrible back spasms last night and there was no Tylenol in the house. I found some Naproxen that was prescribed a while back and took it. I was looking over my pre-surgery paperwork this morning and realized that Naproxen is on the no list for 48 hours prior. Am I still safe for surgery tomorrow afternoon?
Sean
Tell your surgeon about it.

You'll probably be OK because Naproxen only disables your platelets temporarily, unlike aspirin, which permanently inactivates them.

But it depends on the surgery and the surgeon, so let them know.
carry_th...
What is the difference between Naprolen and Naproxen?
My previous doctor RX'd me naproxen and then I switched doctors and this new one RX'd me naprolen just now. I webmd'd this and it said that naprolen IS naproxen. He knows I'm on naproxen, so why'd he RX me what seems like the same thing?
ilse72
Your doctor was being kind to you! Naprolen is the generic form of naproxen meaning it will cost you far less money. That is the major difference; you are still getting the same medication but at a major savings.
Jade K
Can anyone tell me the difference between ibuprofen and naproxen?
was told to go off the ibuprofen for joint problems and was given naproxen.
sadie_oy...
Ibuprofen and naproxen sodium tame the pain caused by inflammation, such as arthritis, sprains, bruises, sunburns, and minor toothaches. There is a key difference between ibuprofen and naproxen: Naproxen sodium provides longer-lasting pain relief per dose than ibuprofen. A standard 220 mg tablet or caplet lasts eight to 12 hours, compared to the four-to-six-hour period for a 200 mg dose of ibuprofen.
ashley b
How long does it take Percocet or Naproxen to get out of your system?
My job took a random drug test (urinalysis) the other day and I had recently taken an old Percocet prescription for a headache (I have really bad ones). I have also taken Naproxen for my headaches...how long does it take these things to get out of my system?
[not on Yahoo any longer]
Hi there,

Don't worry about Naproxen. They don't test for that. Let me teach you how to calculate this value. Every drug has a value called a half-life. There are many different kinds of half-lives, but when we talk about half-life in general like this (removing the drug from the body), we are talking about "elimination" half-life. This is the value you see in data sheets on places like Wiki. The half-life means "The time taken for Half the drug to be eliminated".

Anyway, the half-life of Oxycodone (Percocet) is 3 - 4.5 hours. Now a lot of factors can increase this value (eg. if you suffer from renal failure, liver issues etc.) But assuming the worst, and let's say you have taken 20mg of Oxycodone. This means:

4.5 hours later - 10mg remaining

9 hrs later - 5mg remaining

13.5 hrs later - 2.5mg

18 hrs - 1.25mg

22.5 hrs - 0.625mg

27 hrs - 0.3125mg left

31.5 hours - 0.16mg left ----> by this point, you don't have to worry.

So all in all, to be on the safe side, keep this value at 36 hours but allow a buffer of upto 48 hours to be on the safe side since there are other factors to consider like your dosage and body-weight. Hope this helps.
TinyTeac...
How does the medicine Naproxen make you feel?
I just had a D&C surgery yesterday and was prescribed Lortab 5's. I took 2 for the pain and all it did was make me vomit.It never killed the pain. Today my doctor sent for Naproxen. I've never heard of this medicine before. Have any of you ever taken it and know how it makes you feel? I'm hoping for a medicine that will numb me to the pain. Loratabs just didn't work for me.
thedonut...
Naproxin sodium? as in Aleve? If that is what you mean it sucks. It has never helped me in the slightest but I have never had side effects when using it.