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Generic Name
Multivitamin (9)
Trade Name
Essentiale
Risk Category
C*
  • Studies on animals show adverse effect and toxicity on fetus.
  • No adequate and well controlled studies done on pregnant women.
  • Drugs should be given only if the potential benefit outweighs the potential risk to the fetus.
The risk category is A for vitamin E and nicotinamide.
FDA Pregnancy Risk Categories

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Indication
Indication Composition: Essential phospholipids (diglyceride esters of choline phosphoric acid) + Vit B1 + B2 + B6 + B12 + E + nicotinamide.
  • Treatment of chronic hepatitis.
  • Treatment of Cirrhosis.
  • Fetal Risk
    Fetal Risk
  • No adequate data for phospholipids in pregnancy but reported that if used in solutions for parenteral hyperalimentation, they can cause placental insufficiency with fat deposits resulting in abortions and preterm labor.
  • The dose of Vit E and nicotinamide is within the recommended dietary allowance (rda) in pregnancy.
  • The doses of other Vitamins are above the rda in pregnancy.
  • No fetal harm has been reported with high doses of Vit B12.
  • No well – controlled data for Vit B1 and B6 in pregnancy but suggested possible association between high doses of Vit B1 and anencephaly and of Vit B6 and phocomelia and infantile convulsions.
  • Breast Feeding
    Breast Feeding
  • No data for phospholipids.
  • Unknown excretion of nicotinamide into milk, other vitamins are excreted.
  • The doses of Vit B1,B2,B6 and B12 are above the rda in lactation but they can be used safely although high doses of Vit B6 may inhibit lactation.
  • Other Trade Names
     
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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