DESCRIPTION
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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%.
INDICATIONS AND USAGE
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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
CONTRAINDICATIONS
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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.
Use In Pediatric Patients
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displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0
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. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration.
Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in these patients (see and ).
WARNINGS – Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
CONTRAINDICATIONS
Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.
OVERDOSAGE
Other Considerations
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displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Administration of promethazine has been associated with reported cholestatic jaundice.
PRECAUTIONS
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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.
ADVERSE REACTIONS
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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Codeine:
Nervous System – CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions.
Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics).
Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported.
Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics).
Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema.
Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness.
Promethazine:
Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.
Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness.
Dermatologic – Dermatitis, photosensitivity, urticaria.
Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
Gastrointestinal – Dry mouth, nausea, vomiting, jaundice.
Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See .)
WARNINGS – Promethazine;
Respiratory Depression
Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See .)
WARNINGS – Promethazine;
Neuroleptic Malignant Syndrome
Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.
DOSAGE AND ADMINISTRATION
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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 with codeine syrup is measured with an accurate measuring device (see ). 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 used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
PRECAUTIONS-Information For Patients
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 to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP
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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
