See Supplemental Patient Information
- Promethazine component of this drug is associated with fatal respiratory depression; avoid use of this combination drug in pediatric patients <2 yrs of age. Respiratory depression, including fatalities, have been reported during post-marketing surveillance in pediatrics <2 yrs of age. Wide range of weight-based doses has resulted in such events. Use the lowest effective dose in pediatric patients
2 yrs and avoid concomitant use with other respiratory depressant drugs - Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Concomitant use with other CNS depressants such as alcohol, sedatives/hypnotics, narcotics, general anesthetics, tranquilizers, and tricyclic antidepressants may amplify such impairment; eliminate the use of such agents or administer in reduced dosage in the presence of this combination drug
- Potentially fatal respiratory depression may occur with promethazine use. Avoid usage in patients with compromised respiratory function (e.g. COPD, sleep apnea)
- Promethazine may lower seizure threshold
- Potential for occurrence of leukopenia and agranulocytosis exists usually when promethazine hydrochloride is used in association with other known marrow-toxic agents
- A potentially fatal symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) has been reported in association with promethazine alone or in combination with antipsychotic drugs. Manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability
- Immediately discontinue antipsychotic drugs and other drugs not essential for concomitant therapy, provide intensive symptomatic treatment, carefully monitor patients and provide treatment for concomitant serious medical problems for management of NMS
- Carefully consider reintroduction of drug therapy in patients recovered from NMS as recurrences of NMS may occur
- Antiemetic agents are not recommended for therapy of uncomplicated vomiting in pediatric patients; limit their use for prolonged vomiting of known etiology
- Avoid the use of this combination drug in pediatric patients having signs and symptoms suggesting Reye’s syndrome or other hepatic diseases
- Promethazine-containing products are contraindicated in pediatric patients <2 yrs of age
- Excessively high doses of promethazine in pediatric patients may lead to sudden death. Hallucinations and convulsions may occur 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 for occurrence of dystonias with the use of promethazine
- Cholestatic jaundice may occur with the usage of this drug
- Administer this combination drug to a pregnant woman only if clearly needed
- Pharmacist should recommend an appropriate measuring device and provide instructions for measuring the correct dose. A household teaspoon is not an accurate measuring device and could lead to overdosage
Cautions: Use cautiously in
- Hepatic impairment
- Cardiovascular disease
- Seizure disorders
- Bone-marrow depression
- Narrow-angle glaucoma
- Prostatic hypertrophy
- Stenosing peptic ulcer
- Pyloroduodenal obstruction
- Bladder-neck obstruction
- Concomitant use of CNS depressants
- Sedated patients
- Concomitant use with narcotics or local anesthetics
- Debilitated patients
- Patients confined to the supine position
- Pediatric patients 2 yrs of age and older
- Atopic children
- Geriatric patients
Supplemental Patient Information
- Advise patients to measure the combination oral solution using an accurate measuring device
- Instruct patients to avoid engaging in activities requiring mental alertness such as operating hazardous machinery or driving an automobile
- Inform patients to promptly report their physician if any involuntary muscle movements occur
- Advise patients to avoid prolonged exposure to the sun
