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 in a flavored syrup base with a pH between 4.4 and 5.2. Alcohol 7%.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Promethazine with Codeine Oral Solution is contraindicated in pediatric patients less than 12 years of age. (See
WARNINGS – Ultra- Rapid Metabolism of Codeine and Respiratory Depression
Promethazine with Codeine Oral Solution is contraindicated for post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (See
WARNINGS – Ultra- Rapid Metabolism of Codeine and Respiratory Depression
Codeine is contraindicated in patients with a known hypersensitivity to the drug.
Promethazine hydrochloride 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.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Central 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.
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
– Promethazine; Respiratory Depression
Other: Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see
– Promethazine; Neuroleptic Malignant Syndrome
Paradoxical Reactions: Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. 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.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine.
It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.
Signs and symptoms of overdosage with promethazine range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis and extensor-plantar reflexes (Babinski reflex).
Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.
Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur.
Treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy.
Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure.
Limited experience with dialysis indicates that it is not helpful.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
It is important that Promethazine with Codeine Oral Solution 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 used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
Promethazine with Codeine Oral Solution is contraindicated in pediatric patients less than 12 years of age, because the combination may cause fatal respiratory depression in this age population. (See WARNINGS – Ultra-Rapid Metabolism of Codeine and Respiratory Depression).
The average effective dose is given in the following table:
Adults (12 years of age and over)
||5 mL (1 teaspoonful) every 4 to 6 hours, not to exceed 30.0 mL in 24 hours.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
NDC: 53002-3270-1 118 mL in a BOTTLE
Promethazine with Codeine Syrup C-V
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4