Dagramycine Pregnancy

• Pregnancy of Dagramycine in details
• Dagramycine breastfeeding
• Dagramycine reviews

Pregnancy of Dagramycine in details

FDA pregnancy category: D IV: Use is not recommended unless essential for the patient's welfare (per physician judgment). Most oral formulations: Dagramycine should not be used during pregnancy unless the benefit outweighs the risk. Oracea(R): Use is not recommended. Comments: -Except for anthrax (including inhalation anthrax [postexposure]), tetracycline drugs should not be used during tooth development unless other drugs contraindicated or unlikely to be effective. -If any tetracycline is used during pregnancy or if the patient becomes pregnant while using these drugs, she should be informed of the potential risk to the fetus. -Oracea(R) should be stopped at once if patient becomes pregnant.

Animal studies have revealed evidence of embryo- and fetotoxicity, including toxic effects on skeletal formation. Animal studies indicate Dagramycine crosses the placenta and is found in fetal tissues. There are no controlled data in human pregnancy. However, congenital defects have been reported with the class of tetracyclines. Fetal effects may be dose-related. When used during tooth development (second half of pregnancy) tetracyclines may cause permanent yellow-gray-brown discoloration of the teeth and enamel hypoplasia. An expert review of Dagramycine use during pregnancy by the Teratogen Information System (TERIS) concluded that substantial teratogenic risk from therapeutic doses during pregnancy is unlikely (data quantity and quality limited to fair); insufficient data to state there is no risk. Population-based data from the Hungarian Case-Control Surveillance of Congenital Abnormalities revealed that of 32,804 women who had infants with no defects, 63 (0.19%) were treated with Dagramycine during pregnancy. Of 18,515 women who had infants with congenital abnormalities, 56 (0.3%) were treated with Dagramycine. This study showed a weak but marginally statistically significant association with total malformations and Dagramycine use anytime during pregnancy. This association was not seen when analysis was limited to maternal therapy during organogenesis (i.e., second and third months of gestation), except for a marginal association with neural tube defect based on 2 exposed cases. Data were based on retrospective recall and did not include alcohol or tobacco usage. In a small prospective study (81 pregnancies), 43 pregnant women were treated with Dagramycine for 10 days during early first trimester. All mothers reported their exposed infants were normal at 1 year of age. In mass casualty settings after release of biological weapons, the Working Group on Civilian Biodefense has recommended Dagramycine as an alternative drug for prophylaxis and treatment of anthrax, tularemia, and plague. The risk of Dagramycine use during pregnancy is outweighed by the high fatality rates from these infections. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Dagramycine breastfeeding

The extent of Dagramycine absorption by breastfed infants is unknown. Short-term use in lactating women is not explicitly contraindicated by most manufacturers, but the effects of prolonged Dagramycine exposure via breast milk are unknown. Long-term or repeat courses are not recommended during nursing as a theoretical precaution. Theoretical risks of dental staining and inhibition of bone growth in nursing infants are considered unlikely by most experts. Available data indicate that short-term use of Dagramycine during lactation is unlikely to be harmful; milk levels are low and calcium in breast milk may inhibit infant absorption. Short-term Dagramycine use in nursing mothers is generally considered acceptable by experts. After 2 doses of oral Dagramycine (200 mg followed by 100 mg 12 hours later) in 15 nursing mothers, milk Dagramycine levels 3 and 24 hours after dosing averaged 0.77 and 0.38 mg/L, respectively.

Oral Dagramycine (100 mg per day) was given to 10 mothers. On day 2, milk Dagramycine levels 3 and 24 hours after dosing averaged 0.82 and 0.46 mg/L, respectively. Using peak and trough milk level averages in this study, the estimated intake of an infant only fed breast milk averaged about 6% of the maternal weight-adjusted dose. Peak milk levels averaged 0.96 mg/L after a single 100 mg dose (n=3) and 1.8 mg/L after a single 200 mg dose (n=3). After 100 mg orally twice a day for 5 days, milk Dagramycine levels were about 3.6 mg/L. In another study, in the immediate postpartum period, peak milk levels were 0.6 mg/L after oral doses of 100 mg (n=3) and averaged 1.1 mg/L after 200 mg (n=11). After a single 200 mg Dagramycine dose (n=2), milk levels 2, 4, and 6 hours after the dose averaged 0.8, 0.7, and 0.4 mg/L, respectively.

IV: The manufacturer makes no recommendation regarding use during lactation. Most oral formulations: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Dagramycine hyclate 20 mg: Use is contraindicated. Oracea(R): Use is not recommended. Excreted into human milk: Yes Excreted into animal milk: Data not available Tetracycline (a related drug) is considered compatible with breastfeeding by the American Academy of Pediatrics.

See references

References for pregnancy information

1. Freedman DO "Clinical practice. Malaria prevention in short-term travelers." N Engl J Med 359 (2008): 603-12
2. Inglesby TV, O'Toole T, Henderson DA, et al. "Anthrax as a biological weapon, 2002: updated recommendations for management." JAMA 287 (2002): 2236-52
3. Czeizel AE, Rockenbauer M "Teratogenic study of Dagramycine." Obstet Gynecol 89 (1997): 524-8
4. "Low-Dose Dagramycine (Oracea) for Rosacea." Med Lett Drugs Ther 49 (2007): 5-6
5. Inglesby TV, Dennis DT, Henderson DA, et al "Plague as a biological weapon: medical and public health management. Working Group on Civilian Biodefense." JAMA 283 (2000): 2281-90
6. Dennis DT, Inglesby TV, Henderson DA, et al "Tularemia as a biological weapon: medical and public health management." JAMA 285 (2001): 2763-73
7. "Product Information. Oracea (Dagramycine)." Collagenex Pharmaceuticals, Newtown, PA.
8. "Product Information. Periostat (Dagramycine)" Collagenex Pharmaceuticals, Newtown, PA.
9. "Product Information. Acticlate (Dagramycine)." Aqua Pharmaceuticals LLC, Malvern, PA.
10. "Product Information. Vibramycin (Dagramycine)." Pfizer US Pharmaceuticals, New York, NY.
11. "Product Information. Adoxa (Dagramycine)." Doak Dermatologics Division, Fairfield, NJ.

References for breastfeeding information

1. 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
2. "Product Information. Periostat (Dagramycine)" Collagenex Pharmaceuticals, Newtown, PA.
3. "Product Information. Oracea (Dagramycine)." Collagenex Pharmaceuticals, Newtown, PA.
4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
5. "Product Information. Vibramycin (Dagramycine)." Pfizer US Pharmaceuticals, New York, NY.
6. "Product Information. Adoxa (Dagramycine)." Doak Dermatologics Division, Fairfield, NJ.
7. "Product Information. Acticlate (Dagramycine)." Aqua Pharmaceuticals LLC, Malvern, PA.
8. Sachs HC; Committee on Drugs "The transfer of drugs and therapeutics into human breast milk: an update on selected topics. " Pediatrics 132 (2013): e796-809
9. Tan KR, Magill AJ, Parise ME, Arguin PM "Dagramycine for malaria chemoprophylaxis and treatment: report from the CDC expert meeting on malaria chemoprophylaxis." Am J Trop Med Hyg 84 (2011): 517-31
10. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

References

1. DailyMed. "DOXYCYCLINE: 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. PubMed Health. "Vibra-Tabs: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
3. LiverTox. "Doxycycline: LIVERTOX provides up-to-date, accurate, and easily accessed information on the diagnosis, cause, frequency, patterns, and management of liver injury attributable to prescription and nonprescription medications, herbals and dietary supplements. ". https://livertox.nlm.nih.gov//Doxycy... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology