CLONAZEPAM
Drugs in Pregnancy and Lactation.
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Name: CLONAZEPAM
Class: Anticonvulsant
Risk Factor: DM
Fetal Risk Summary
Clonazepam is a benzodiazepine anticonvulsant that is chemically and structurally similar to diazepam (1). The drug is used either alone or in combination with other anticonvulsants.
Reproduction studies in mice and rats during organogensis at doses up to 4 and 20 times, respectively, the maximum recommended human dose of 20 mg/day for seizures [MRHD-S], and 20 and 100 times, respectively, the maximum recommended human dose of 4 mg/day for panic disorders [MRHD-P], on a mg/m2 basis, revealed no evidence of embryo or fetal effects (2). In rabbits administered doses that were 0.2 to 10 times the MRHD-S and 1 to 50 times the MRHD-P, a low, non-dose-related incidence of a similar pattern of malformations (cleft palate, open eyelid, fused sternebrae, and limb defects) was observed in all dosage groups (2). At the highest dose (twice the dose that produced reductions in maternal weight gain), intrauterine growth retardation was also observed.
In a small series of patients (N = 150) matched with nonepileptic controls, anticonvulsant therapy, including five women using clonazepam, had no effect on the incidence of pregnancy-induced hypertension, albuminuria, premature contractions, premature labor, bleeding in pregnancy, duration of labor, blood loss at delivery, cesarean sections, and vacuum extractions (3).
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 19 newborns had been exposed to clonazepam during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Three (15.8%) major birth defects were observed (one expected), two of which were cardiovascular defects (0.2 expected). No anomalies were observed in five other categories of defects (oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias) for which specific data were available.
A prospective study published in 1999 described the outcomes of 517 pregnancies of epileptic mothers identified at one Italian center from 1977 (4). Excluding genetic and chromosomal defects, malformations were classified as severe structural defects, mild structural defects, and deformations. Minor anomalies were not considered. Spontaneous (N=38) and early (N=20) voluntary abortions were excluded from the analysis, as were 7 pregnancies that delivered at other hospitals. Of the remaining 452 outcomes, 427 were exposed to anticonvulsants of which 313 involved monotherapy: clonazepam (N=6), carbamazepine (N=113), phenobarbital (N=83), valproate (N=44), primidone (N=35), phenytoin (N=31), and other (N=1). There were no defects in the 25 pregnancies not exposed to anticonvulsants. Of the 42 (9.3%) outcomes with malformations, 24 (5.3%) were severe, 10 (2.2%) were mild, and 8 (1.8%) were deformities. There were no malformations with clonazepam monotherapy. The investigators concluded that the anticonvulsants were the primary risk factor for an increased incidence of congenital malformations (see also Carbamazepine, Phenobarbital, Phenytoin, Primidone, and Valproic Acid) (4).
Toxicity in the newborn, apparently related to clonazepam, has been reported. Apnea, cyanosis, lethargy, and hypotonia developed at 6 hours of age in an infant of 36 weeks' gestational age exposed throughout pregnancy to an unspecified amount of clonazepam (5). There was no evidence of congenital defects in the 2750 g newborn. Cord and maternal serum levels of clonazepam were 19 and 32 ng/mL, respectively, a ratio of 0.59. Both levels were within the therapeutic range (5–70 ng/mL). At 18 hours of age, the clonazepam level in the infant's serum measured 4.4 ng/mL. Five episodes of prolonged apnea (16–43 seconds/occurrence) were measured by pneumogram over the next 12 hours. Hypotonia and lethargy resolved within 5 days, but overt clinical apnea persisted for 10 days. Follow-up pneumograms demonstrated apnea spells until 10 weeks of age, but the presence of the drug in breast milk may have contributed to the condition (see Breast Feeding Summary). The authors concluded that apnea due to prematurity was not a significant factor. Neurologic development was normal at 5 months (5).
Breast Feeding Summary
Clonazepam is excreted into breast milk. In a woman treated with an unspecified amount of the anticonvulsant, milk concentrations remained constant between 11 and 13 ng/mL (5). The milk:maternal serum ratio was approximately 0.33. After 7 days of nursing, the infant, described above, had a serum concentration of 2.9 ng/mL. A major portion of this probably resulted from in utero exposure because the elimination half-life of clonazepam in neonates is thought to be prolonged. No evidence of drug accumulation after breast feeding was found. Persistent apneic spells, lasting until 10 weeks of age, were observed, but it was not known whether breast feeding contributed to the condition. Based on this case, the authors recommended that infants exposed in utero or during breast feeding to clonazepam should have serum levels of the drug determined and be closely monitored for central nervous system depression or apnea (5).
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References
- Reith H, Schafer H. Antiepileptic drugs during pregnancy and the lactation period. Pharmacokinetic data. Dtsch Med Wochenschr 1979;104:818–23.
- Product information. Klonopin. Roche Laboratories, 2000.
- Hiilesmaa VK, Bardy A, Teramo K. Obstetric outcome in women with epilepsy. Am J Obstet Gynecol 1985;152:499–504.
- Canger R, Battino D, Canevini MP, Fumarola C, Guidolin L, Vignoli A, Mamoli D, Palmieri C, Molteni F, Granata T, Hassibi P, Zamperini P, Pardi G, Avanzini G. Malformations in offspring of women with epilepsy: a prospective study. Epilepsia 1999;40:1231–6.
- Fisher JB, Edgren BE, Mammel MC, Coleman JM. Neonatal apnea associated with maternal clonazepam therapy: a case report. Obstet Gynecol 1985;66(Suppl):34S–5S.
Q&A about Clonazepam
My doctor prescribed me Clonazepam 1/2 a tablet every night for panic attacks... I don't like to take medicaton, and I am afraid to start taking this drug. My question is : can I take this medication only when I feel that I need it?
My wife has severe restless legs syndrome, making it very difficult for her to sleep. She had to get off Mirapex and other dopamine agonists due to severe leg/foot edema and just two days ago was switched to Clonazepam. It's supposed to make sleeping possible despite RLS but, at best, so far, it seems to take a long time to work -- if it is working at all.
I take klonopin for panic disorder and was recently given the generic version, clonazepam as a refill. Since then I feel like crap. Is there a difference in effectivness between the two?
Years ago, when I was taking generic Valium, and was then given a bottle of 'real' Valium, it did not work as well. So, maybe it's just a matter of the new version getting into your system for a long enough time.
I am in need of some information. I have been on a great deal of medication for my Bi-Polar and OCD. I have been having a terrible time with anxiety and was put on 1mg 2x's a day of Clonazepam. I am not clear on how long it takes this medication to start working. I do know all of the others I have taken in the past took up to 6 weeks before I saw even a little bit of relief. I hope this isn't the case with the Clonazepam. I know the answers I want to hear but break it to me. I can handle it. LOL
I am wondering if a urine test would show klonopin (clonazepam) in it, and if so, how long does it stay in your system? And would a blood test prove it more than a urine?
Many thanks!!
For those that have tried clonazepam and valium and/or xanax, can you please describe the differences between them?
Thanks.
The differences between them are negligible. Having taken all three, I would say xanax is the most effective, but also the most impairing. Klonopin is commonly given for panic attacks and works quickly and effectively. Valium isn't prescribed as frequently anymore, but I found to be the most manageable.
For benzos, it is all about dosage. If you take too much, you will be a wreck, so start off with the smallest dose possible before you know how it will affect you.
Also, the physical dependence is quick, and withdrawal is horrible, which is why they are so addictive and dangerous.
I live in Canada and have been prescribed Clonazepam for GAD and I am really interested in finding out how many people are prescribed Clonazepam. Would anyone know where I could find info on this or statistics on he number of people who take this medication?. I feel like I am the only one who needs this to function with the anxiety or the stresses of everyday life. I know im not really alone, but I think it would help to find out if this is more common that I think. Thanks for your help!
know that diazapam (the parent drug - Valium) is the most commonly used medicine in the world? More popular than aspirin and anti-biotics. Hope that puts things into perspective.
Only on occasion I take 0.5 mg or 1 mg of prescribed clonazepam for panic attacks, and it works well. For the past week my left eye has been twitching like crazy and I think it's due to stress as this is not the first time it's occurred. Sometimes the twitching is a signal for me that a cold sore is just around the corner. Sometimes it happens, sometimes not. At present I haven't got the usual syptoms of a panic attack i.e. fast heart beat, my world coming to an end, et cetera. I'm going through a minor cold now and I'm not taking anything for it except keeping myself hydrated and a few extra-strength Tylenol for the headaches. I thought that maybe taking a quarter of the 1 mg clonazepam pill might take away the twitching. Thank you.
I took a 2mg clonazepam rivotril, what is its average onset time? thanks.
