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Promethazine Hydrochloride Oral Solution

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Promethazine Hydrochloride Oral Solution 5976T05_Prometh_Promethazine 2/11/16 8:11 AM Page 1 Part #: 5976T05 Flat Size: 11.25x10.125 Fold Size: 1.125x1.125 Titles: 12 pt, Heads/Subheads: 8 pt, Text: 6 pt, Med Guide: 10 pt. viduals known to be hypersensitive or to have had an idiosyncratic reaction to related to individualized weight-based dosing, which might otherwise permit safe PROMETHAZINE HYDROCHLORIDE promethazine or to other phenothiazines. administration. Concomitant administration of promethazine products with other ORAL SOLUTION, USP Antihistamines are contraindicated for use in the treatment of lower respiratory tract respiratory depressants has an association with respiratory depression, and some- symptoms, including asthma. times death, in pediatric patients. 6.25 mg/5 mL Antiemetics are not recommended for treatment of uncomplicated vomiting in pedi- (Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL) WARNINGS atric patients, and their use should be limited to prolonged vomiting of known Rx Only Promethazine HCl Oral Solution should not be used in pediatric patients less than 2 etiology. The extrapyramidal symptoms which can occur secondary to Promethazine years of age because of the potential for fatal respiratory depression. HCl Oral Solution administration may be confused with the CNS signs of undiag- DESCRIPTION nosed primary disease, e.g., encephalopathy or Reye’s syndrome. The use of Postmarketing cases of respiratory depression, including fatalities, have been Each teaspoonful (5 mL) of Promethazine HCl Oral Solution contains 6.25 mg promet- Promethazine HCl Oral Solution should be avoided in pediatric patients whose signs reported with use of promethazine in pediatric patients less than 2 years of age. hazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The and symptoms may suggest Reye’s syndrome or other hepatic diseases. inactive ingredients present are ascorbic acid, citric acid, D&C Yellow No. 10, edetate dis- A wide range of weight-based doses of promethazine have resulted in respiratory odium, ethyl alcohol, FD&C Blue No. 1, FD&C Red No. 40, glycerin, methylparaben, depression in these patients. Excessively large dosages of antihistamines, including Promethazine HCl Oral pineapple flavor, purified water, sodium benzoate, sodium citrate, sucralose, and sucrose. Caution should be exercised when administering promethazine to pediatric patients Solution, in pediatric patients may cause sudden death (see OVERDOSAGE). 2 years of age and older. It is recommended that the lowest effective dose of Hallucinations and convulsions have occurred with therapeutic doses and overdoses Promethazine HCl is a racemic compound; the molecular formula is C H N S•HCI 17 20 2 promethazine be used in pediatric patients 2 years of age and older and concomi- of Promethazine HCl Oral Solution in pediatric patients. In pediatric patients who are and its molecular weight is 320.89. Promethazine HCl, a phenothiazine derivative, is tant administration of other drugs with respiratory depressant effects be avoided. acutely ill associated with dehydration, there is an increased susceptibility to dysto- chemically designated as 10-[2-(Dimethylamino)propyl] phenothiazine monohy- nias with the use of promethazine HCl. drochloride. Its structural formula is: CNS Depression Promethazine HCl Oral Solution may impair the mental and/or physical abilities Other Considerations required for the performance of potentially hazardous tasks, such as driving a vehicle Administration of promethazine HCl has been associated with reported cholestatic or operating machinery. The impairment may be amplified by concomitant use of other jaundice. central-nervous-system depressants such as alcohol, sedatives/hypnotics (including PRECAUTIONS barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepres- sants, and tranquilizers; therefore such agents should either be eliminated or given in General reduced dosage in the presence of promethazine HCl (see PRECAUTIONS – Drugs having anticholinergic properties should be used with caution in patients with Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline Information for Patients and Drug Interactions). narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduode- powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely nal obstruction, and bladder-neck obstruction. Respiratory Depression soluble in water and soluble in alcohol. Promethazine HCl Oral Solution should be used cautiously in persons with cardiovas- Promethazine HCl Oral Solution may lead to potentially fatal respiratory depression. cular disease or with impairment of liver function. CLINICAL PHARMACOLOGY Use of Promethazine HCl Oral Solution in patients with compromised respiratory func- Promethazine is a phenothiazine derivative which differs structurally from the antipsy- tion (e.g. COPD, sleep apnea) should be avoided. Information for Patients chotic phenothiazines by the presence of a branched side chain and no ring Lower Seizure Threshold Patients should be advised to measure Promethazine HCl Oral Solution with an accu- substitution. It is thought that this configuration is responsible for its relative lack rate measuring device. A household teaspoon is not an accurate measuring device and Promethazine HCl Oral Solution may lower seizure threshold. It should be used with caution (1/10 that of chlorpromazine) of dopamine antagonist properties. could lead to overdosage, especially when a half a teaspoon is measured. A pharma- in persons with seizure disorders or in persons who are using concomitant medications, Promethazine is an H receptor blocking agent. In addition to its antihistaminic action, cist can recommend an appropriate measuring device and can provide instructions for 1 such as narcotics or local anesthetics, which may also affect seizure threshold. it provides clinically useful sedative and antiemetic effects. measuring the correct dose. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are Bone-Marrow Depression Promethazine HCl Oral Solution may cause marked drowsiness or impair the mental apparent within 20 minutes after oral administration and generally last four to six Promethazine HCl Oral Solution should be used with caution in patients with bone- and/or physical abilities required for the performance of potentially hazardous tasks, hours, although they may persist as long as 12 hours. Promethazine is metabo- marrow depression. Leukopenia and agranulocytosis have been reported, usually such as driving a vehicle or operating machinery. Ambulatory patients should be told lized by the liver to a variety of compounds; the sulfoxides of promethazine and when Promethazine HCl Oral Solution has been used in association with other known to avoid engaging in such activities until it is known that they do not become drowsy N-desmethylpromethazine are the predominant metabolites appearing in the urine. marrow-toxic agents. or dizzy from promethazine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. INDICATIONS AND USAGE Neuroleptic Malignant Syndrome Promethazine HCl Oral Solution is useful for: A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant The concomitant use of alcohol or other central-nervous-system depressants, such as Syndrome (NMS) has been reported in association with promethazine HCl alone or in sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general Perennial and seasonal allergic rhinitis. combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment (see Vasomotor rhinitis. muscle rigidity, altered mental status and evidence of autonomic instability (irregular WARNINGS-CNS Depression and PRECAUTIONS–Drug Interactions). pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). Allergic conjunctivitis due to inhalant allergens and foods. Patients should be advised to report any involuntary muscle movements. The diagnostic evaluation of patients with this syndrome is complicated. In arriving at Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Avoid prolonged exposure to the sun. a diagnosis, it is important to identify cases where the clinical presentation includes Amelioration of allergic reactions to blood or plasma. both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated A patient information leaflet is included and summarizes important information about promethazine. Dermographism. or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat Drug Interactions Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard meas- stroke, drug fever and primary central nervous system (CNS) pathology. ures, after the acute manifestations have been controlled. CNS Depressants – Promethazine HCl Oral Solution may increase, prolong, or inten- The management of NMS should include 1) immediate discontinuation of promet- sify the sedative action of other central-nervous-system depressants such as alcohol, Preoperative, postoperative, or obstetric sedation. hazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent sedatives/hypnotics
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