TRAMADOL
Drugs in Pregnancy and Lactation.|
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Name: TRAMADOL
Class: Central Analgesic
Risk Factor: CM
Fetal Risk Summary
Tramadol is a synthetic, centrally acting, analgesic analogue of codeine that has the potential to cause physical dependence similar to, but much less, than that produced by opiates. Because of its low addiction potential, tramadol is not classified as a controlled substance. The drug is available only as an oral tablet in the United States but has been used both parenterally and rectally in other countries.
Oral doses up to 50 mg/kg in male rats and 75 mg/kg in female rats had no effects on fertility (1). Reproductive studies, conducted with tramadol in mice (120 mg/kg), rats (25 mg/kg or higher), and rabbits (75 mg/kg or higher), showed embryotoxic and fetotoxic effects at maternally toxic doses, 3–15 times the maximum human dose or higher, but no fetal toxicity was observed with lower doses that were not maternally toxic (1). No teratogenic effects were observed with any of the doses. The observed toxicity consisted of decreased fetal weights, skeletal ossification, and increased supernumerary ribs. Transient delays in developmental or behavioral parameters were seen in rat pups.
Shepard described a reproductive study using oral and SC tramadol in mice, at doses up to 120 mg/kg, and in rats, at doses up to 60 mg/kg, that observed no teratogenic effects (2). Schardein also cited the same study (3).
Tramadol has a molecular weight of approximately 300 and crosses the placenta to the fetus. In 40 women given 100 mg of tramadol during labor, the mean ratio of drug concentrations in the umbilical cord and maternal serum was 0.83 (4).
Several studies outside of the United States, some of which were reviewed in 1993 (5) and 1997 publications (4), have compared the use of tramadol with meperidine or morphine for labor analgesia (6,7,8,9,10,11 and 12). In five of these studies (6,7,8,9 and 10), the use of tramadol was associated with less neonatal respiratory depression than meperidine, but no difference was observed in two studies in comparison with meperidine or morphine (11,12). In one of these latter studies, no differences in maternal response, adverse effects, or newborn condition were observed between tramadol, meperidine, and morphine (11). In the other study, tramadol and meperidine were combined with triflupromazine, a phenothiazine tranquilizer added in an attempt to reduce the emetic effects of the analgesics, and compared with tramadol alone (12). No decrease or difference between the three groups in the incidence and severity of the side effects was observed.
The effects of tramadol and meperidine, 100 mg IV for each drug, were compared in laboring patients in a study conducted in Thailand (9). A second or third dose of 50 mg IV was given at 30-minute intervals if requested. A significant increase in the incidence of neonatal respiratory depression was observed in the offspring of the meperidine group, if delivery occurred 2–4 hours after the last dose. The respiratory depressant effects of meperidine are known to be time- and dose-related, increasing markedly after 60 minutes (see Meperidine).
A study from Singapore found that 100 mg IM of tramadol was equivalent in analgesic effect to 75 mg IM of meperidine for the control of labor pain (10). Meperidine was associated with a significantly higher frequency of adverse effects (nausea, vomiting, fatigue, drowsiness, and dizziness) in the mothers and a significantly lower respiratory rate in the newborns. However, the injection-delivery interval in the patients was 7–8 hours.
In a 1997 case report, a male infant developed withdrawal symptoms between 24 and 48 hours after birth (13). Symptoms consisted of trembling, tachypnea, tachycardia, hypertonic muscle tone, signs of tetany when touched, and a single mild convulsion. The mother admitted to taking tramadol 300 mg/day for 4 years. The infant was treated with diazepam and/or phenobarbital for 13 days until the symptoms had fully resolved. No long-term follow-up of the infant was reported. The authors concluded that the estimated elimination half-life of 36 hours was consistent with the course of the withdrawal syndrome (13).
Only the one report above has described the use of tramadol early in human gestation and an assessment of the risk, if any, that the drug presents to the embryo and fetus cannot be determined. Based on that case, neonatal withdrawal is a potential complication after continuous use in the mother. Because dose-related embryo and fetal toxicity have been observed in animals, use of tramadol during early human gestation should probably be avoided until additional data are available. Moreover, the delays in development and behavior observed in newborn rats appear to lessen any clinically significant advantage the drug may have over traditional narcotic analgesics.
Breast Feeding Summary
Both tramadol and its pharmacologic active metabolite are excreted into human milk (1). After a single 100-mg IV dose, the cumulative amounts of the parent drug and metabolite excreted into milk within 16 hours were 100 and 27 µg, respectively (1). The recommended dose of tramadol is 50–100 mg every 4–6 hours up to a maximum of 400 mg/day. Moreover, the mean absolute bioavailability of a 100-mg oral dose is 75%. Thus, ingestion of the recommended dose may produce drug amounts in breast milk that could exceed those reported above. The effects of this exposure on a nursing infant are unknown.
References
- Product information. Ultram. McNeil Pharmaceutical, 1997.
- Yamamoto H, Kuchii M, Hayano T, Nishino H. A study on teratogenicity of both CG-315 and morphine in mice and rats. Oyo Yakuri 1972;6:1055–69. As cited in Shepard TH. Catalog of Teratogenic Agents. 8th ed. Baltimore, MD: Johns Hopkins University Press, 1995:420.
- Yamamoto H, Kuchii M, Hayano T, Nishino H. Teratogenicity of the new central analgesic 1-(m-methoxyphenyl)-2-(dimethylaminomethyl)cyclohexanol hydrochloride (Cg-315) in mice and rats. Oyo Yakuri 1972;6:1055–69. As cited in Schardein JL. Chemically Induced Birth Defects. 2nd ed. New York: Marcel Dekker, 1993:133.
- Lewis KS, Han NH. Tramadol: a new centrally acting analgesic. Am J Health-Syst Pharm 1997;54:643–52.
- Lee CR, McTavish D, Sorkin EM. Tramadol. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in acute and chronic pain states. Drugs 1993;46:313–40.
- Husslein P, Kubista E, Egarter C. Obstetrical analgesia with tramadol—results of a prospective randomized comparative study with pethidine. Z Geburtshilfe Perinatol 1987;191:234–7.
- Bitsch M, Emmrich J, Hary J, Lippach G, Rindt W. Obstetrical analgesia with tramadol. Fortschr Med 1980;98:632–4.
- Bredow V. Use of tramadol versus pethidine versus denaverine suppositories in labor—a contribution to noninvasive therapy of labor pain. Zentralbl Gynakol 1992;114:551–4.
- Suvonnakote T, Thitadilok W, Atisook R. Pain relief during labour. J Med Assoc Thailand 1986;69:575–80.
- Viegas OAC, Khaw B, Ratnam SS. Tramadol in labour pain in primiparous patients. A prospective comparative clinical trial. Eur J Obstet Gynecol Reprod Biol 1993;49:131–5.
- Prasertsawat PO, Herabutya Y, Chaturachinda K. Obstetric analgesia: comparison between tramadol, morphine, and pethidine. Curr Ther Res Clin Exp 1986;40:1022–8.
- Kainz C, Joura E, Obwegeser R, Plockinger B, Gruber W. Effectiveness and tolerance of tramadol with or without an antiemetic and pethidine in obstetric analgesia. Z Geburtshilfe Perinatol 1992;196:78–82.
- Meyer FP, Rimasch H, Blaha B, Banditt P. Tramadol withdrawal in a neonate. Eur J Clin Pharmacol 1997;53:159–60.
Q&A about Tramadol
I've had this terrible back-pain for the past year...but being 19yrs old at the moment, my mother doesn't believe i should talk to a doctor, and that i just need to start working out again. i can see her point, however, the pain, at its worst, will inhibit me from doing everyday-things like walking around or even sitting up comfortably in a chair. it comes and goes, and is mostly obvious when i do alot of physical activity (this case causes the pain for the next few days) or even when i'm sitting in my desk in one of my classes for over twenty minutes... is there a way i can get a doctor to prescribe me tramadol? i say tramadol because it's a non-narcotic/non-opiate but i hear it works better than aspirin and ibuprofen...which isn't cutting it for me right now. AND, if yes, is there a way to get it prescribed without my mom or our insurance know? (Mother's income has nearly ceased, i don't want any monetary stress on her right now...) please help out....it hurts... =-/
Tramadol is only available by prescription, and it doesn't work that well from my experience. Try taking some Aleve, and use heat for the pain til you can get to the doc. ThermaCare heat wraps work well for providing continuous heat for several hours and can be worn under your clothes.
I understand that opiates such as Hydrocodone, Morphine, and Oxycodone can have their effects increased by using certain chemicals such as the ones I named in my question. Would this method still apply to Tramadol, it being a synthetic analouge of codeine? This isn't for abuse purposes, but for the desire to take less medication on a daily basis, due to the overall effects being increased. Thank you very much my friends.
My dog was perscribed tramadol HCL 50mg tablets for post op but he no longer needs them. Now one of my friends asked if she could have them. Both her and I have had tramadol pprscribed to us as people, will it be harmful if she takes the tramadol given to the dog????
I was on Lexapro, but had to stop taking it due to pain issues where I had to start taking tramadol. Was advised not to take these two together because of the risk of seizures. Now, I am severely depressed and I want to get back on SSRI's right away. Does anybody know how long I must wait once I stop taking the tramadol?
I stopped using tramadol cold turkey (after heavy use for about a month) about 3 and a half weeks ago and I have no more actual "withdrawals" but I still feel severly depressed. I was not nearly this depressed before I started using tramadol. The week after I stopped I had thoughts of suicide, the depression was so bad. So how much longer is this depression supposed to last?
Anyone have any insight on this?
The acute withdrawal usually lasts no more than a week, but mentally can last much longer. There is what is called PAW (post acute withdrawal) which for long-term users can last up to a year. Since you were only using a month, I would say you should start feeling better very soon.
Basically you are flooding your system with a drug that makes you feel good. Your body gets used to it and needs it to feel normal. When you remove that, things get thrown out of whack.
Congrats on quitting and good luck to you. It will get better, I promise.
I have been taking vicodin for a while for back pain/headaches. I am thinking about switching to tramadol because it is cheaper and easier to get. What is the difference between the two?
Tramodol is a centrally-acting opioid analgesic that exerts its effect through the inhibition of norepinephrine and serotonin reuptake .
Both are used for acute and chronic pain, and both have addiction potential. If your MD is prescibing these medications for you, either should be readily available at your pharmacy. Take precaution whe using Vicodin, because of the Tylenol content. Tylenol is toxic to the body if you take an excessive of 3000-4000mg per day.
Also, I would suggest you talk to your MD about non-narcotic medications that may prevent you fom getting headaches. Beta blockers, Tricyclic antidepressants, Valproic Acid, Calcium channel blockers and Topamax are all known to have some measure of effectiveness in preventing chronic daily headaches. As with any medication, please use with caution, and under the supervision of an MD.
For those of you that think tramadol is not addictive, thats BS! It is addictive and i am experienceing it first hand. I have been trying to wean myself off of it for the last 6 months with no improvement because when i lower my dose i have severe mood swings and become very angry and my energy levels are depleted, and i cant be a good mother to my 1 year old. When i PMS the bad symptoms get even worse so i increase my dose and im fine, but that puts me back right where i started. So now im looking into another way, medication. Will a doctor give me medication for this, what kind, and how can i take it without becoming addicted to it? Im determined to live a drug free life and the day im free of this addiction will be one of the best days of my life.
I would talk to your doctor, they will more than likely give you something else for the withdrawls.
In rehab they gave me klonopin to keep the withdrawls down...plus a blood pressure medicine.....you might want to check yours if you havent already.
I could talk about this subject all day, but I just really wish you luck for you and your baby!
Unfortunatley the statistics arent all that great for us first time quiters....hopefully it only takes you once, if not then you are NOT a failure.
When/if you do quite, please check out about going to an NA meeting. (Narcotics Annonymous)
My family has gone for years, they can really help!
I am sure they have a website, just dont know what it is, probably easy to google.
Is codeine a more potent painkiller than tramadol?
I am regularly prescribed Vicodin after a car accident last summer, but I plan on stopping because I've developed too big of a tolerance. I heard Tramadol can be very effective and somewhat safer. As someone who has taken Vicodin for over a year and needs three or four to feel effects, do you think Tramadol will work for me?
Incidentally, tramadol is not safer, and has addiction and withdrawal issues just like Vicodin (many patients are now complaining the withdrawals are worse than Vicodin).
If you are taking 3-4 Vicodin to feel relief, you have the increased issue of too much acetaminophen which can cause liver damage in the long term. You should probably discuss your pain issues with someone who works with long term pain patients. There are many methods for managing back pain without significant use of opiate pain medications, as well as safer opiate preparations for long term use.
I don't want to give bad news, but I don't think tramadol would be a good choice in your situation given the limited information you have provided.
I have seen an enormous amount of websites listing Tramadol as one of their medications. I am considering purchasing some, but want to make sure it's legal. I have seen Vicodin for sale online but know that is illegal to purchase over the internet. Does anyone know if I can safely purchase Tramadol?