Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/734
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Promethazine Hydrochloride (Suppository)
|
| dailymed-instance:dosage |
Promethazine HCl Suppositories, USP are contraindicated for children under 2 years of age . Promethazine HCl Suppositories are for rectal administration only.<br/>Allergy: The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administrationof promethazine HCl in 25-mg doses will control minor transfusion reactions of an allergic nature.<br/>Motion Sickness: The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, Promethazine HCl Suppositories, 12.5 mg to 25 mg, twice daily, may be administered.<br/>Nausea and Vomiting: Antiemetics should not be used in vomiting of unknown etiology in children and adolescents . The average effective dose of Promethazine HCl Suppositories for the active therapy of nausea and vomiting in children or adults is 25 mg. 12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg, repeated at 4- to 6-hour intervals, as necessary.<br/>Sedation: This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg promethazine hydrochloride by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.<br/>Pre- and Postoperative Use: Promethazine HCl Suppositories in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg promethazine hydrochloride with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults. Promethazine HCl Suppositories are contraindicated for children under 2 years of age.
|
| dailymed-instance:descripti... |
Each rectal suppository of promethazine hydrochloride contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Promethazine Hydrochloride Suppositories are for rectal administration only. Promethazine HCl is a racemic compound; the empirical formula is CHNS���HCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as a 10H-Phenothiazine 10-ethanamine, N,N,��-trimethyl-, monohydrochloride, (��)- with the following structural formula: Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.
|
| dailymed-instance:clinicalP... |
Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an Hreceptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Promethazine HCl suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine HCl suppositories are 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 are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.
|
| dailymed-instance:supply |
Promethazine HCl Suppositories are available as follows: 12.5 mg, white bullet shaped suppositories sealed in white PVC/PE shells, 12 in a box (NDC 51672-1319-1).25 mg, white bullet shaped suppositories sealed in white PVC/PE shells, 12 in a box (NDC 51672-1320-1). Store refrigerated between 2��-8��C (36��-46��F).Dispense in well-closed container. Use carton to protect contents from light.
|
| dailymed-instance:boxedWarn... |
PROMETHAZINE HCL SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCL SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCL SUPPOSITORIES HAS RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTEREING PROMETHAZINE HCL SUPPOSITORIES TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCL SUPPOSITORY BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function.<br/>Information for Patients: Promethazine HCl Suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment . Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun.<br/>Drug Interactions:<br/>CNS Depressants: Promethazine HCl Suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with Promethazine HCl Suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.<br/>Epinephrine: Because of the potential for Promethazine HCl Suppositories to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Suppositories overdose.<br/>Anticholinergics: Concomitant use of other agents with anticholinergic properties should be undertaken with caution.<br/>Monoamine Oxidase Inhibitors (MAOI): Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with Promethazine HCl Suppositories.<br/>Drug/Laboratory Test Interactions: The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl:<br/>Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.<br/>Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine HCl.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning the carcinogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.<br/>Pregnancy:<br/>Teratogenic Effects - Pregnancy Category C: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 mg and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50 kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.<br/>Nonteratogenic Effects: Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.<br/>Labor and Delivery: Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor . Limited data suggest that use of Promethazine HCl Suppositories during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (see also Nonteratogenic Effects).<br/>Nursing Mothers: It is not known whether promethazine HCl is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Promethazine HCl Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.<br/>Pediatric Use: PROMETHAZINE HCL SUPPOSTORIES, USP ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black Box Warning and Use in Pediatric Patients). Promethazine HCl Suppositories, USP should be used with caution in pediatric patients 2 years of age and older .<br/>Geriatric Use: Clinical studies of Promethazine HCl Suppositories did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Promethazine HCl Suppositories and observed closely.
|
| dailymed-instance:genericMe... |
Promethazine Hydrochloride
|
| dailymed-instance:fullName |
Promethazine Hydrochloride (Suppository)
|
| dailymed-instance:adverseRe... |
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). Other - Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported.<br/>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.
|
| dailymed-instance:indicatio... |
Promethazine is useful for:
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Promethazine Hydrochloride
|