Consists of Bromhexine, Guaifenesin, Terbutaline
Pregnancy of Bromhexine (Ucdex SYRUP) in details
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Pregnancy of Guaifenesin (Ucdex SYRUP) in details
The Collaborative Perinatal Project reported 197 first-trimester exposures to Guaifenesin (Ucdex SYRUP). Fourteen malformations were reported for a relative risk not significantly different from 1.0. In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to Guaifenesin (Ucdex SYRUP) and 349 exposures anytime during pregnancy were recorded. A total of 9 birth defects were reported with first trimester exposure (6 expected) and included 2 cardiovascular defects. These data do not support an association between Guaifenesin (Ucdex SYRUP) and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)
Guaifenesin (Ucdex SYRUP) has been assigned to pregnancy category C. by the FDA. There are no controlled data in human pregnancy. Guaifenesin (Ucdex SYRUP) is only recommend for use during pregnancy when benefit outweighs risk.
See references
Guaifenesin (Ucdex SYRUP) breastfeeding
There are no data on the excretion of Guaifenesin (Ucdex SYRUP) into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
See references
References for pregnancy information
- "Product Information. Humabid (Guaifenesin (Ucdex SYRUP))." Medeva Pharmaceuticals, Rochester, NY.
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
References for breastfeeding information
- Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
Pregnancy of Terbutaline (Ucdex SYRUP) in details
Terbutaline (Ucdex SYRUP) has been shown to cross the placenta, and the fetus may experience the general adverse effects reported in the mother. Pulmonary edema has been associated with the intravenous use of Terbutaline (Ucdex SYRUP) in pregnant women. Myocardial necrosis in one infant was thought to be associated with Terbutaline (Ucdex SYRUP) given at a rate of 0.5 mg/hr for 12 weeks by subcutaneous infusion. In one retrospective review of 8,709 patients receiving continuous low-dose subcutaneous infusion of Terbutaline (Ucdex SYRUP) to arrest preterm labor, only 47 (0.54%) had one or more cardiopulmonary problems. Pulmonary edema was reported in 28 patients (0.32%), 17 of whom had been treated concurrently with large amounts of IV fluids or one to three tocolytic agents and four of whom had been diagnosed with pregnancy-induced hypertension and/or multiple gestation. Other cardiovascular effects occurred in 19 patients (0.22%), including electrocardiogram changes, irregular heart rate, chest pain, or shortness of breath. However, 7 of these patients had a history of cardiac problems. Use of Terbutaline (Ucdex SYRUP) in pregnant women for the relief of bronchospasm may interfere with uterine contractility. For the treatment of asthma, administration by metered dose inhaler results in lower plasma concentrations and consequently fewer adverse effects for the mother and fetus. Hepatitis has been reported in at least two patients receiving Terbutaline (Ucdex SYRUP) to control premature labor.
Terbutaline (Ucdex SYRUP) has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity. Terbutaline (Ucdex SYRUP) is only recommended for use during pregnancy when benefit outweighs risk.
See references
Terbutaline (Ucdex SYRUP) breastfeeding
Terbutaline (Ucdex SYRUP) is excreted in small amounts into human milk. In four mothers taking 2.5 to 5 mg per day of Terbutaline (Ucdex SYRUP), milk concentrations averaged 3 to 4 ng/mL. The calculated daily dose of Terbutaline (Ucdex SYRUP) taken in by a nursing infant ranges from 0.2% to 0.7% of the mother's dose. Terbutaline (Ucdex SYRUP) is not detectable in the plasma of nursing infants and clinical signs of beta-adrenergic stimulation have not been reported. Terbutaline (Ucdex SYRUP) is considered be compatible with breast-feeding by the American Academy of Pediatrics.
See references
References for pregnancy information
- Ingemarsson I, Bengtsson B "A five-year experience with Terbutaline (Ucdex SYRUP) for preterm labor: low rate of severe side effects." Obstet Gynecol 66 (1985): 176-80
- Ingemarsson I, Westgren M, Lindberg C, Ahren B, Lundquist I, Carlsson C "Single injection of Terbutaline (Ucdex SYRUP) in term labor: placental transfer and effects on maternal and fetal carbohydrate metabolism." Am J Obstet Gynecol 139 (1981): 697-701
- "Product Information. Brethaire (Terbutaline (Ucdex SYRUP))." Novartis Pharmaceuticals, East Hanover, NJ.
- Fletcher SE, Fyfe DA, Case CL, Wiles HB, Upshur JK, Newman RB "Myocardial necrosis in a newborn after long-term maternal subcutaneous Terbutaline (Ucdex SYRUP) infusion for suppression of preterm labor." Am J Obstet Gynecol 165 (1991): 1401-4
- Quinn PG, Sherman BW, Tavill AS, Gibas AL "Terbutaline (Ucdex SYRUP) hepatitis in pregnancy: report of two cases and literature review." Am J Gastroenterol 89 (1994): 781-4
- Benedetti TJ, Hargrove JC, Rosene KA "Maternal pulmonary edema during premature labor inhibition." Obstet Gynecol 59 (1982): s33-7
- Bergman B, Bokstrom H, Borga O, Enk L, Hedner T, Wangberg B "Transfer of Terbutaline (Ucdex SYRUP) across the human placenta in late pregnancy." Eur J Respir Dis Suppl 134 (1984): 81-6
- Roth AC, Milsom I, Forssman L, Ekman LG, Hedner T "Effects of intravenous Terbutaline (Ucdex SYRUP) on maternal circulation and fetal heart activity." Acta Obstet Gynecol Scand 69 (1990): 223-8
- Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8
- Guernsey BG, Villarreal Y, Snyder MD, Gabert HA "Pulmonary edema associated with the use of betamimetic agents in preterm labor." Am J Hosp Pharm 38 (1981): 1942-8
References for breastfeeding information
- Lonnerholm G, Lindstrom B "Terbutaline (Ucdex SYRUP) excretion into breast milk." Br J Clin Pharmacol 13 (1982): 729-30
- Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
- Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8
- Boreus LO, de Chateau PU "Terbutaline (Ucdex SYRUP) in breast milk." Br J Clin Pharmacol 13 (1982): 731-2
References
- DailyMed. "TERBUTALINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "GUAIFENESIN; HYDROCODONE BITARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Terbutaline (By injection): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
