BOXED WARNING
id: 06964377-2f6a-4a10-84a4-ba8b2a8319a9
displayName: Boxed Warning section
FDA Article Code: 34066-1
WARNING: Respiratory Depression in Children and Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory Depression in Children
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.
Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
DESCRIPTION
id: c4cad044-a506-4592-9497-1e440266d188
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%.
Inactive Ingredients: ascorbic acid, citric acid, D & C yellow #10, edetate disodium, ethyl alcohol, FD&C Blue #1, FD&C Red #40, glycerin, methylparaben, pineapple flavor, purified water, sodium benzoate, sodium citrate, sucralose, and sucrose.
Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8- Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan- 6α-ol phosphate (1:1) (salt) hemihydrate.
The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C18H21NO3 • H3PO4 • 1/2H2O, and the following structural formula:
Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±) -10-[2-(Dimethylamino) propyl] phenothiazine monohydrochloride.
Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S • HCl, and the following structural formula:
INDICATIONS AND USAGE
id: a6a8de2f-12fe-4c6c-97cf-d12ae0261572
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
CONTRAINDICATIONS
id: ee598bc9-5547-4a81-b66d-0f6436fe6d7d
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
Codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
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.
Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.
WARNINGS
id: a0362aa8-0b7c-4d33-bf36-29f7f5291263
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Respiratory Depression in Children
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.
Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.
Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed.
PRECAUTIONS
id: 02c7bd0c-051d-4df4-ab28-fc9f10d3cf60
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed.
DOSAGE AND ADMINISTRATION
id: 195a5c49-9bd9-4baf-aabd-527c0c166931
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
It is important that promethazine hydrochloride and codeine phosphate syrup is measured with an accurate measuring device (see
PRECAUTIONS-Information for Patients
). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be use. A pharmacist can provide an appropriate device and can provide instruction for measuring the correct dose.
The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
The average effective dose for children 6 years and under 12 years of age is ½ to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
HOW SUPPLIED
id: 77365b70-00e1-4f60-a897-4be73053c30b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Promethazine Hydrochloride and Codeine Phosphate Syrup contains promethazine hydrochloride, USP 6.25 mg/5 mL, codeine phosphate, USP 10 mg/5 mL and alcohol 7 percent. It is supplied in a clear green, pineapple flavored syrup and is available as follows:
NDC 63187-595-04 4 fl. oz. (118 mL)
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP.
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Manufactured by:
Sun Pharmaceutical Industries, Inc.
Bryan, OH 43506
Relabeled By:
Proficient Rx LP
Thousand Oaks, CA 91320
5981T05 Iss: 03/15
