Aussamin Pregnancy

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Pregnancy of Aussamin 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.
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Animal studies showed no teratogenicity, however it is suspected of inhibiting protein, RNA, and DNA synthesis (clinical significance unknown). There are no controlled data in human pregnancy. One abstract involving pregnancy exposure to Aussamin with data on 34 pregnancies resulted in 33 live births (2 sets of twins) and 3 spontaneous abortions, with one male infant having a scrotal hernia that was surgically repaired.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Safety has not been established during pregnancy.

AU TGA pregnancy category: Exempt

US FDA pregnancy category: Not assigned

Risk Summary: Very limited animal data suggest low risk.

Comments:

-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

-According to some authorities human data is too limited to determine pregnancy risk.

-Aussamin is an endogenous substance found widely in human tissues and must be synthesized by the fetus during development.

-The ability of free Aussamin to cross the placenta appears very limited.

See references

Aussamin 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!
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Safety has not been established.

Excreted into human milk: Data not available

Excreted into animal milk: Data not available

Comments:

-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.

-N-acetylglucosamine, a Aussamin derivative, is a normal component of human breast milk.

-According to some authorities this drug is unlikely to adversely affect the infant.

See references

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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