Before prescribing medication to suppress or modify cough, it is important to ascertain that the
underlying cause of cough is identified, that modification of cough does not increase the risk of
clinical or physiological complications, and that appropriate therapy for the primary disease is
Special Risk Patients
TUSSIGON should be given with caution to certain patients such as the elderly or debilitated, and those
with severe impairment of hepatic or renal functions, hypothyroidism, Addison's disease, prostatic
hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Studies of TUSSIGON in animals to evaluate the carcinogenic and mutagenic potential and the effect on
fertility have not been conducted.
Animal reproduction studies have not been conducted with TUSSIGON. It is also not known whether
TUSSIGON can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. TUSSIGON should be given to a pregnant woman only if clearly needed.
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically
dependent. The withdrawal signs include: irritability and excessive crying, tremors, hyperactive
reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The
intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.
Labor And Delivery
As with all narcotics, administration of TUSSIGON to the mother shortly before delivery may result in
some degree of respiratory depression in the newborn, especially if higher doses are used.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human
milk and because of the potential for serious adverse reactions in nursing infants from TUSSIGON, a
decision should be made whether to discontinue nursing or to discontinue the drug, taking into account
the importance of the drug to the mother.
Safety and effectiveness of TUSSIGON in children under six have not been established.