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CONTRAINDICATIONS

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 16 years of age, because the combination may cause fatal respiratory depression in this age population.

Antihistamines and codeine are both contraindicated for use in the treatment of lower

respiratory tract symptoms, including asthma.

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Promethazine hydrochloride and codeine phosphate syrup is a Schedule V Controlled Substance.

Abuse

Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parental codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence.

Dependence

Psychological dependence, physical dependence, and tolerance are known to occur with codeine