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Generic Name
Paracetamol (Acetaminophen), caffeine, chlorpheniramine maleate and phenylephrine hydrochloride
Trade Name
Coldex
Manufacturer
APM
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 catgory for paracetamol, caffeine and chlorpheniramine is B.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Analgesic.
  • Antihistamine.
  • Fetal Risk
    Fetal Risk
  • No adequate data for paracetamol reported that maternal toxic doses can cause fetal liver toxicity, kidney abnormalities and intrauterine death.
  • Suggested possible association with congenital dislocation of the hip and club foot if paracetamol used anytime in pregnancy.
  • Caffeine is teratogenic in animals at maternal toxic doses.
  • No adequate human data but suggested association between high maternal intake and decreased fertility, increased abortion rate, low birth weight, growth retardation and preterm delivery.
  • maternal ingestion of more than 500 mg/day of caffeine may cause cardiac arrythmias as a feature of drug withdrawal and change in fetal behavior (frequent body movement, irregular heart rate and breathing activity).
  • No well controlled human data for chlorpheniramine, suggested possible association with congenital malformations including : Poly-dactyly, ear, eye, gastrointestinal, genital defects, inguinal hernia and dislocation of the hip.
  • Use of antihistamines in the last two weeks of pregnancy, reported to cause retrolental fibroplasia in premature infants.
  • Phenylephrine is teratogenic in some animals.
  • No well-controlled human data but suggested possible association with eye, ear, digital defects, clubfoot during 1st trimester exposure and with musculoskeletal defects and umbilical hernia during exposure anytime in pregnancy.
  • It may cause uterine vessel spasm resulting in fetal hypoxia and bradycardia.
  • Breast Feeding
    Breast Feeding
  • Paracetamol is excreted into milk in small amounts.
  • Safe in breast feeding but reported single case of maculopapular rash in nursing infant.
  • Heavy amounts of caffeine cause irritability and poor sleeping in nursing infants, usual amounts are safe.
  • No data for chlorpheniramine and phenylephrine in breast feeding.
  • 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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