dimenhydrinate กับ dramamine นั้นคือตัวเดียวกันค่ะ
ข้างล่างนี้คือข้อมูลจาก Reprotox ค่ะ เอามาแปะให้ แต่เป็นภาษาอังกฤษ ต้องแปลนิดนึงค่ะ มี references ให้ด้านล่างค่ะ
Quick take: Use of dimenhydrinate in human pregnancy has been reported without an apparent increase in birth defects.
* * *
Dimenhydrinate is an antihistamine commonly sold as the over-the-counter (OTC) medicinal, Dramamine, for the prevention of motion sickness. Chemically, dimenhydrinate is the chlorotheophylline salt of diphenhydramine (Benadryl; #1073), another commonly encountered antihistamine.
In one study, rats were fed 75 mg/kg/d dimenhydrinate throughout pregnancy; this dose did not increase the incidence of congenital anomalies (1). One prospective study reported in 1964 (2) did not identify an association between dimenhydrinate exposures during pregnancy and birth defects. The Collaborative Perinatal Project studied 319 mothers with first trimester exposures to dimenhydrinate and 697 exposures anytime in pregnancy (3). Associations between drug use and an increased incidence of both cardiovascular defects and inguinal hernia were suggested in the findings, but the statistical significance of these associations could not be determined with the available data (3). A German cohort study identified the children of 628 women who took dimenhydrinate or one of three other antiemetic drugs (meclizine (#1125), triflupromazine (#2067), or chlorphenoxamine (#3841)) during the first three months of pregnancy (13). Analysis of outcomes in this population in comparison with 628 matched pairs did not uncover an increased risk of congenital anomalies in the drug exposed infants. The incidence of congenital defects was not elevated among infants prenatally exposed to dimenhydrinate in the data of the Hungarian Congenital Abnormality Registry (14).
If administered during labor, dimenhydrinate can increase uterine contractility (4). In the past, some clinicians have attempted to shorten labor with dimenhydrinate (5,6). The use of dimenhydrinate as an antiemetic during pregnancy and labor is not recommended by one source because of the availability of meclizine (#1125), which is believed to be a more effective antiemetic (7).
An investigation questioned women who used antihistamines, including dimenhydrinate, during nursing. Minor adverse reactions in the baby that did not require medical attention were reported by 9.4% of the mothers using antihistamines (8). The most commonly observed effect in 6 of 8 reports was irritability (8). In another study by the same group, among mothers who reported using antihistamines while breastfeeding, adverse effects such as irritability, drowsiness, or decreased sleep was noted in 22.6% of babies (9). No side effect was serious enough for a mother to seek medical attention for the infant.
Because of their anticholinergic effects, antihistamines may, in theory, reduce milk production. In spite of this theoretical concern, advice to women on the use of these agents can be based on the generally reassuring reports that have been published (8,9) and on the available reports indicating that low amounts of other antihistamines appear in milk (10-12). If anticholinergic effects of antihistamines result in a decrease in milk supply, we would assume that such an effect would resolve on discontinuation of the medication, but we are not aware of data on this question. If symptoms such as jitteriness or poor feeding develop in a nursing infant with maternal use of antihistamines, it would be reasonable to stop the medication or to switch to formula feeding and look for resolution of the infant's symptoms, but it seems unlikely that a causal relationship between these symptoms and lactational exposure to antihistamines will occur very often.
1. McColl JD et al: Effect of some therapeutic agents in the developing rat fetus. Toxicol Appl Pharmacol 7:409-417, 1965.
2. Mellin GW: Drugs in the first trimester of pregnancy and fetal life of Homo Sapiens. Am J Obstet Gynecol 90:1169- 1180, 1964.
3. Heinonen OP et al: Birth Defects and Drugs in Pregnancy, Littleton Publishing Sciences Group, 1977, pp 367-370.
4. Shephard B et al: The acute effects of Dramamine on uterine contractility during labor. J Reprod Med 16:27-8, 1976.
5. Watt LO: Oxytocic effects of dimenhydrinate in obstetrics. Can Med Assoc J 84:533-4, 1961.
6. Rotter CW et al: The use of intravenous Dramamine to shorten the time of labor and potentiate analgesia. Am J Obstet Gynecol 75:1101-4, 1958.
7. Berkowitz RL et al: Handbook for Prescribing Medications During Pregnancy 2nd ed. Little, Brown and Co. Boston/Toronto 1986 p 107.
8. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G: Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol 168:1393-9, 1993.
9. Moretti ME, Liau-Chu M, Taddio A, Ito S, Koren G: Adverse events in breastfed infants exposed to antihistamines in maternal milk. Reprod Toxicol 9: 588, 1995.
10. Findlay JWA, Butz RF, Sailstad JM, Warren JT, Welch RM: Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers. Br J Clin Pharmacol 18:901-6, 1984.
11. Lucas BD, Purdy CY, Scarim SK, Benjamin S, Abel SR, Hilleman DE: Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther 1995;57:398-402.
12. Hilbert J, Radwanski E, Affrime MB, Perentesis G, Symchowicz S, Zampaglione N: Excretion of loratadine in human breast milk. J Clin Pharmacol 1988;28:234-9.
13. Michaelis J, Michaelis H, Gluck E, Koller S: Prospective study of suspected associations between certain drugs administered during early pregnancy and congenital malformations. Teratology 27:57-64, 1983.
14. Czeizel AE, Vargha P: A case-control study of congenital abnormality and dimenhydrinate usage during pregnancy. Arch Gynecol Obstet 271:113-118, 2005.
8 มิ.ย. 51 22:08:32
A:188.8.131.52 X: TicketID:168800