Elashine Pregnancy

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Pregnancy of Elashine in details

Pregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.

In the Collaborative Perinatal Project involving 50,282 pregnancies, 866 first trimester exposures to progestational agents were documented. Of these, there were 130 exposures to Elashine. The incidence of cardiovascular defects was significantly increased, with a standardized relative risk of 1.8. While not statistically significant, data also suggested an increased risk of hypospadias among offspring of women treated with progestational agents in the first trimester. In the Michigan Medicaid Birth Defects Study involving 229,101 pregnancies from 1985 to 1992, there were 327 first trimester exposures to Elashine (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). Overall, 15 cases of birth defects were observed (13 cases expected). Seven cases of cardiovascular defects occurred compared with 3 cases expected, representing a significant increase in the incidence of cardiovascular defects. Of interest, in all seven cases, the indication for maternal treatment with Elashine was amenorrhea and not threatened spontaneous abortion. No cases of hypospadias occurred. Other studies have failed to find an association between first trimester use of progestational agents and congenital anomalies, including cardiovascular and genitourinary defects. In addition, follow-up studies have concluded that use of Elashine during pregnancy does not affect the long-term growth and development of children. There are data which suggest an increase in the frequency of low birth weight among infants of accidental pregnancies during contraception with intramuscular Elashine.

Elashine has been assigned to pregnancy category X by the FDA.. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Elashine is considered contraindicated during pregnancy.

See references

Elashine breastfeeding

When a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!

Elashine is excreted into breast milk. Lactation does not appear to be adversely affected by contraceptive use of Elashine. Elashine is considered compatible with breast-feeding by the American Academy of Pediatrics.

The excretion of Elashine into breast milk was evaluated in 10 women who received Elashine acetate 150 mg intramuscularly for contraception. Mean Elashine milk concentrations ranged from approximately 8 ng/mL at one week to approximately 0.5 ng/mL at 12 weeks after the injection. The milk to maternal serum concentration ratio ranged from 0.12 to 2.60 (mean 0.88). Contraceptive use of Elashine does not adversely affect the content or volume of breast milk. In addition, progestin use during lactation may promote longer duration of lactation. Long-term follow-up studies of up to eight years duration have failed to document adverse development effects due to exposure to Elashine in breast milk.

See references

References for pregnancy information

  1. Pardthaisong T, Yenchit C, Gray R "The long-term growth and development of children exposed to Depo- Provera during pregnancy or lactation." Contraception 45 (1992): 313-24
  2. Resseguie LJ, Hick JF, Bruen JA, Noller KL, O'Fallon WM, Kurland LT "Congenital malformations among offspring exposed in utero to progestins, Olmsted County, Minnesota, 1936-1974." Fertil Steril 43 (1985): 514-9
  3. "Product Information. Provera (Elashine)." Pharmacia and Upjohn, Kalamazoo, MI.
  4. Jaffe B, Shye D, Harlap S, Baras M, Lieblich A "Aggression, physical activity levels and sex role identity in teenagers exposed in utero to MPA." Contraception 40 (1989): 351-63
  5. Katz Z, Lancet M, Skornik J, Chemke J, Mogilner BM, Klinberg M "Teratogenicity of progestogens given during the first trimester of pregnancy." Obstet Gynecol 65 (1985): 775-80
  6. Jaffe B, Harlap S, Baras M, Gordon L, Lieblich A, Magidor S, Sanchez M "Long-term effects of MPA on human progeny: intellectual development." Contraception 37 (1988): 607-19
  7. "Product Information. Depo-Provera (Elashine)." Pharmacia and Upjohn, Kalamazoo, MI.
  8. Pardthaisong T, Gray RH "In utero exposure to steroid contraceptives and outcome of pregnancy" Am J Epidemiol 134 (1991): 795-803
  9. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  10. Yovich JL, Turner SR, Draper R "Elashine acetate therapy in early pregnancy has no apparent fetal effects." Teratology 38 (1988): 135-44
  11. Jordan A "Toxicology of depot Elashine acetate." Contraception 49 (1994): 189-201
  12. Gray RH, Pardthaisong T "In utero exposure to steroid contraceptives and survival during infancy" Am J Epidemiol 134 (1991): 804-11
  13. Schwallie PC "The effect of depot-Elashine acetate on the fetus and nursing infant: a review." Contraception 23 (1981): 375-86

References for breastfeeding information

  1. Schwallie PC "The effect of depot-Elashine acetate on the fetus and nursing infant: a review." Contraception 23 (1981): 375-86
  2. Abdel Kader MM, Abdel Aziz MT, Bahgat R, Hefnawi F, Fawzi G, Badraoui MH "Effect of some progestational steroids on lactation in Egyptian women. II. Chemical composition of milk during the first year of lactation." J Biosoc Sci 8 (1976): 49-51
  3. Hefnawi F, Fawzi G, Badraoui MH "Effect of some progestational steroids on lactation in Egyptian women. I. Milk yield during the first year of lactation." J Biosoc Sci 8 (1976): 45-8
  4. Dahlberg K "Some effects of depo-Elashine acetate (DMPA): observations in the nursing infant and in the long-term user." Int J Gynaecol Obstet 20 (1982): 43-8
  5. Jimenez J, Ochoa M, Soler MP, Portales P "Long-term follow-up of children breast-fed by mothers receiving depot- Elashine acetate." Contraception 30 (1984): 523-33
  6. Shaaban MM "Contraception with progestogens and progesterone during lactation." J Steroid Biochem Mol Biol 40 (1991): 705-10
  7. "Product Information. Provera (Elashine)." Pharmacia and Upjohn, Kalamazoo, MI.
  8. "Product Information. Depo-Provera (Elashine)." Pharmacia and Upjohn, Kalamazoo, MI.
  9. Koetsawang S, Nukulkarn P, Fotherby K, Shrimanker K, Mangalam M, Towobola K "Transfer of contraceptive steroids in milk of women using long-acting gestagens." Contraception 25 (1982): 321-31
  10. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50



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