Dotbal Pregnancy

• Pregnancy of Ethambutol (Dotbal) in details
• Ethambutol (Dotbal) breastfeeding
• Pregnancy of Isoniazid (Dotbal) in details
• Isoniazid (Dotbal) breastfeeding
• Pregnancy of Pyrazinamide (Dotbal) in details
• Pyrazinamide (Dotbal) breastfeeding
• Pregnancy of Rifampicin (Dotbal) in details
• Dotbal reviews

Consists of Ethambutol, Isoniazid, Pyrazinamide, Rifampicin

Pregnancy of Ethambutol (Dotbal) in details

Ethambutol (Dotbal) has been assigned to a pregnancy category C by the FDA. There are no controlled data in human pregnancy. There are reports of ophthalmic abnormalities occurring in infants born to women on antituberculous therapy that included Ethambutol (Dotbal). Ethambutol (Dotbal) should only be given during pregnancy when benefit outweighs risk.

Ethambutol (Dotbal) crosses the placenta. In one patient, maternal blood, placental blood and cord blood concentrations were 5.5, 5.0, and 4.1, respectively, immediately following delivery. No adverse effects were reported in the infant who had been exposed since 23 weeks gestation. Bobrowitz and colleagues studied 42 pregnancies which involved Ethambutol (Dotbal) exposure in addition to other antituberculous agents. The majority of these pregnancies were treated throughout gestation. No consistent pattern was noted in the reported fetal adverse effects, which included supernumerary nipple, small umbilical hernia, mild right tibial torsion, congenital dislocation of hips, left hydrocele, minimal metatarsus adductus, and skin tag on finger. Other reports also have not associated Ethambutol (Dotbal) with teratogenic effects. The initial therapy of active tuberculosis in pregnant patients recommended by the Centers for Disease Control and Prevention includes Ethambutol (Dotbal). Ethambutol (Dotbal) is also recommended by the American Thoracic Society in cases of suspected drug-resistant tuberculosis.

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Ethambutol (Dotbal) breastfeeding

Ethambutol (Dotbal) is excreted into human milk. Ethambutol (Dotbal) is considered compatible with breast-feeding by the American Academy of Pediatrics.

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References for pregnancy information

1. Bobrowitz ID "Ethambutol (Dotbal) in pregnancy." Chest 66 (1974): 20-4
2. "Product Information. Myambutol (Ethambutol (Dotbal))." Lederle Laboratories, Wayne, NJ.
3. Lewit T, Nebel L, Terracina S, Karman S "Ethambutol (Dotbal) in pregnancy: observations on embryogenesis." Chest 66 (1974): 25-6
4. CDC "Initial therapy for tuberculosis in the era of multidrug resistance. Recommendations of the advisory council for the elimintion of tuberculosis." MMWR Morb Mortal Wkly Rep 42 (1993): 1-8
5. American Thoracic Society, Centers for Disease Control "Treatment of tuberculosis and tuberculosis infection in adults and children." Am Rev Respir Dis 134 (1986): 355-63
6. Shneerson JM, Francis RS "Ethambutol (Dotbal) in pregnancy--foetal exposure." Tubercle 60 (1979): 167-9
7. Holdiness MR "Transplacental pharmacokinetics of the antituberculosis drugs." Clin Pharmacokinet 13 (1987): 125-9
8. Medchill MT, Gillum M "Diagnosis and management of tuberculosis during pregnancy." Obstet Gynecol Surv 44 (1989): 81-4
9. Snider DE Jr, Layde PM, Johnson MW, Lyle MA "Treatment of tuberculosis during pregnancy." Am Rev Respir Dis 122 (1980): 65-79

References for breastfeeding information

1. Snider DE, Powell KE "Should women taking antituberculosis drugs breast-feed?" Arch Intern Med 144 (1984): 589-90
2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
3. "Product Information. Myambutol (Ethambutol (Dotbal))." Lederle Laboratories, Wayne, NJ.

Pregnancy of Isoniazid (Dotbal) in details

Isoniazid (Dotbal) has been assigned to a pregnancy category C by the FDA. There are no controlled data in human pregnancies. Embryocidal effects were noted in both rats and rabbits after administration of Isoniazid (Dotbal) orally during pregnancy. While cases of suspected Isoniazid (Dotbal) induced anomalies have been reported, causality is unknown and retrospective analyses have failed to document significant teratogenic risk. Isoniazid (Dotbal) should only be given during pregnancy when need has been clearly established. The initial therapy of active tuberculosis in pregnant patients recommended by the Centers for Disease Control includes Isoniazid (Dotbal). Isoniazid (Dotbal) is also recommended by the American Thoracic Society. For HIV-infected women, the USPHS/IDSA (U.S. Public Health Service/Infectious Diseases Society of America) Prevention of Opportunistic Infections Working Group recommends that chemoprophylaxis be given during pregnancy to those with a positive tuberculin skin test or a history of exposure to active tuberculosis, after active disease has been ruled out. Isoniazid (Dotbal) is the prophylactic agent of choice unless exposure to drug-resistant tuberculosis is suspected. However, the Working Group also states that "because of theoretical concerns regarding possible teratogenicity associated with drug exposures during the first trimester, providers may choose to initiate prophylaxis after the first trimester."

Isoniazid (Dotbal) crosses the placenta. At delivery, serum cord concentrations have been reported to range from 0% to 66% of that found in maternal serum. Reports of the use of Isoniazid (Dotbal) during pregnancy generally involve multiple drug therapy. Malformations reported which have involved Isoniazid (Dotbal) use include one case each of myelomeningocele and hypospadias. The Collaborative Perinatal Project reported 85 fetal exposures to Isoniazid (Dotbal) during the first trimester. Ten malformations were reported, which was nearly twice the normal rate. However, due to the small number of exposures, no conclusion could be drawn. Hemorrhagic complications resulting from vitamin K deficiency have been reported in two infants whose mothers received antituberculous drugs. One mother had been treated with Isoniazid (Dotbal) and rifampin, and the other with Isoniazid (Dotbal), rifampin, and Isoniazid (Dotbal). A third infant with hemorrhagic disease had only been exposed to Isoniazid (Dotbal) and rifampin. Pleural mesothelioma was reported in a nine-year-old child whose mother received Isoniazid (Dotbal) during the second and third trimesters of pregnancy. The carcinogenicity of Isoniazid (Dotbal) has not been documented.

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Isoniazid (Dotbal) breastfeeding

Isoniazid (Dotbal) and acetylisoniazid, a metabolite, are excreted into human milk. Following oral administration of 300 mg, approximately 7 mg was excreted in breast milk over 24 hours. While adverse effects in the nursing infant are not reported, it may be prudent to monitor the infant for signs of peripheral neuritis and hepatotoxicity. Isoniazid (Dotbal) is considered compatible with breast-feeding by the American Academy of Pediatrics.

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References for pregnancy information

1. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
2. Miceli JN, Olson WA, Cohen SN "Elimination kinetics of Isoniazid (Dotbal) in the newborn infant." Dev Pharmacol Ther 2 (1981): 235-9
3. Albino JA, Reichman LB "The treatment of tuberculosis." Respiration 65 (1998): 237-55
4. Holdiness MR "Transplacental pharmacokinetics of the antituberculosis drugs." Clin Pharmacokinet 13 (1987): 125-9
5. Bromberg YM, Salzberger M, Bruderman I "Placental transmission of isonicotinic acid hydrazide." Gynaecologia 140 (1955): 141-4
6. CDC "Initial therapy for tuberculosis in the era of multidrug resistance. Recommendations of the advisory council for the elimintion of tuberculosis." MMWR Morb Mortal Wkly Rep 42 (1993): 1-8
7. Eggermont E, Logghe N, Van De CAsseye M, et al. "Haemorrhagic disease of the newborn in the offspring of rifampicin and Isoniazid (Dotbal) treated mothers." Acta Paediatr Belg 29 (1976): 87-90
8. "Product Information. INH (Isoniazid (Dotbal))." Ciba Pharmaceuticals, Summit, NJ.
9. American Thoracic Society and the Centers for Disease Control and Prevention. "Treatment of tuberculosis and tuberculosis infection in adults and children." Am J Respir Crit Care Med 149 (1994): 1359-74
10. Lowe CR "Congenital defects among children born to women under supervision or treatment for pulmonary tuberculosis." Br J Prev Soc Med 18 (1964): 14-6
11. Tuman KJ, Chilcote RR, Berkow RI, Moohr JW "Mesothelioma in child with prenatal exposure to Isoniazid (Dotbal)." Lancet 2 (1980): 362
12. Snider DE Jr, Layde PM, Johnson MW, Lyle MA "Treatment of tuberculosis during pregnancy." Am Rev Respir Dis 122 (1980): 65-79
13. Medchill MT, Gillum M "Diagnosis and management of tuberculosis during pregnancy." Obstet Gynecol Surv 44 (1989): 81-4
14. CDC. Centers for Disease Control and Prevention. "1999 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus." MMWR Morb Mortal Wkly Rep 48(RR-10) (1999): 1-66

References for breastfeeding information

1. Berlin CM, Lee C "Isoniazid (Dotbal) and acetylisoniazid disposition in human milk, saliva and plasma." Fed Proc 38 (1979): 426
2. Snider DE, Powell KE "Should women taking antituberculosis drugs breast-feed?" Arch Intern Med 144 (1984): 589-90
3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
4. "Product Information. INH (Isoniazid (Dotbal))." Ciba Pharmaceuticals, Summit, NJ.

Pregnancy of Pyrazinamide (Dotbal) in details

Pyrazinamide (Dotbal) has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Pyrazinamide (Dotbal) is only recommended during pregnancy when benefit outweighs risk.

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Pyrazinamide (Dotbal) breastfeeding

Pyrazinamide (Dotbal) is excreted into human milk in small amounts. The manufacturer recommends that caution be used when administering Pyrazinamide (Dotbal) to nursing women.

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References for pregnancy information

1. "Product Information. Pyrazinamide (Dotbal)." VersaPharm Inc, Marietta, GA.
2. American Thoracic Society, CDC, Infectious Diseases Society of America "Treatment of tuberculosis." MMWR Morb Mortal Wkly Rep 52(RR-11) (2003): 1-77

References for breastfeeding information

1. Holdiness MR "Antituberculosis drugs and breast-feeding." Arch Intern Med 144 (1984): 1888
2. "Product Information. Pyrazinamide (Dotbal)." VersaPharm Inc, Marietta, GA.

Pregnancy of Rifampicin (Dotbal) in details

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

References

1. DailyMed. "ISONIAZID; RIFAMPIN: 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).
2. DailyMed. "PYRAZINAMIDE: 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).
3. DailyMed. "ETHAMBUTOL HYDROCHLORIDE: 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).

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Information checked by Dr. Sachin Kumar, MD Pharmacology