Promethazine-Codeine (promethazine HCl/codeine)

Dosages of promethazine hydrochloride by the various routes of administration are identical.

Because of the risk of potentially fatal respiratory depression, promethazine hydrochloride should not be used in children younger than 2 years of age. The drug should be used cautiously and at the lowest effective dosage in older children (See Cautions: Pediatric Precautions.)

Promethazine hydrochloride may be administered orally, rectally, or by deep IM injection. Promethazine hydrochloride also is administered by IV injection. However, because IV administration of the drug has been associated with severe tissue injury, including gangrene requiring amputation, the US Food and Drug Administration (FDA) states that deep IM injection is the preferred method for administration of promethazine hydrochloride injections. (See Cautions: Precautions and Contraindications.) If IV administration of promethazine hydrochloride is required, FDA states that the drug should be administered through the tubing of an IV infusion set that is known to be correctly functioning; FDA also states that the maximum rate of IV administration is 25 mg/minute, and the maximum concentration of the injection is 25 mg/mL. If the patient complains of pain at the injection site during presumed IV injection of the drug, the injection should immediately be stopped, and the possibility of intra-arterial placement of the needle or perivascular extravasation should be evaluated. Promethazine hydrochloride injection is commercially available in 2 strengths: 25 mg/mL and 50 mg/mL. FDA states that the preparation containing 50 mg/mL is for IM injection only; the preparation containing 25 mg/mL may be administered by IM or IV injection.

Because of the risk of severe tissue injury and amputations if promethazine hydrochloride is inadvertently administered intra-arterially or if extravasation were to occur, some medication safety experts (e.g., the Institute for Safe Medication Practices (ISMP)) recommend that parenteral administration of the drug be avoided and replaced by safer alternative therapies.

Subcutaneous or intra-arterial injection of promethazine hydrochloride is contraindicated.

Promethazine hydrochloride injection should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The injection should be discarded if the solution is discolored or contains a precipitate.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Safe use of promethazine during pregnancy (except during labor) with respect to possible adverse effects on fetal development has not been established. Although there are no adequate and controlled studies to date in humans, promethazine has not been shown to be teratogenic in rats receiving oral dosages of 6.25-12.5 mg/kg daily (about 2.1-4.2 times the maximum recommended human dosage, depending on the use of the drug). The drug has been shown to produce fetal mortality in rats receiving intraperitoneal dosages of 25 mg/kg daily. Antihistamines, including promethazine, have been fetocidal in rodents, but the pharmacologic effects of histamine in rodents differ from those in humans. Promethazine has been reported to possibly ameliorate the effects of hemolytic disease of the newborn+ (erythroblastosis fetalis) when administered during pregnancy in Rh-sensitized women, but the safety and efficacy of the drug for this use have not been clearly established; other methods of management are preferred. Promethazine should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

It is not known whether promethazine is distributed into milk. Because many drugs are distributed in human milk and because of the potential for serious adverse reactions to promethazine in nursing infants if it were distributed, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced messaging available.