Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/858
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Promethazine Hydrochloride (Syrup)
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Promethazine products are contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients).<br/>ALLERGY: The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Children tolerate this product well. 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. Promethazine hydrochloride rectal suppositories may be used if the oral route is not feasible, but oral therapy should be resumed as soon as possible if continued therapy is indicated. The administration of promethazine hydrochloride in 25 mg doses will control minor transfusion reactions of an allergic nature.<br/>MOTION SICKNESS:<br/>NAUSEA AND VOMITING: The average effective dose of promethazine for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (cf. promethazine hydrochloride injection) or by rectal suppository. 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 by the oral route or 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 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 equal dose of meperidine and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg promethazine with an equal amount of meperidine 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 Syrup Plain is contraindicated for children under 2 years of age.
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Each 5 mL (teaspoonful) contains: Promethazine Hydrochloride, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.25 mg (In a flavored syrup base with a pH between 4.7 and 5.2) Alcohol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.0% In addition, the following inactive ingredients are present: artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, USP, citric acid anhydrous, USP, D&C Yellow No. 10, edetate disodium, USP, FD&C Blue No. 1, FD&C Red No. 40, glycerin, USP, liquid sugar, methylparaben, NF, purified water, USP, saccharin sodium, USP, sodium benzoate, NF, sodium citrate dihydrate, USP, and sodium propionate, NF. Promethazine hydrochloride is a racemic compound; the molecular formula is CHNS���HCl and its molecular weight is 320.89. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Its structural formula is: Promethazine hydrochloride 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.
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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 dopaminergic Central Nervous System (CNS) action. Promethazine is an Hreceptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. In therapeutic dosage, promethazine produces no significant effects on the cardiovascular system. 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.
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Promethazine products are contraindicated for use in pediatric patients less than two years of age. Promethazine is contraindicated 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.
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Promethazine Hydrochloride Syrup, USP 6.25 mg/5 mL is supplied as a clear, green syrup. Available in 4 fl oz (118 mL), 8 fl oz (237 mL) and pint (473 mL) bottles.<br/>RECOMMENDED STORAGE: Store at 20��to 25��C (68��to 77��F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP.
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PROMETHAZINE 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 IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANTEFFECTS BE AVOIDED.
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dailymed-ingredient:D&C_Yellow_No._10,
dailymed-ingredient:FD&C_Blue_No._1,
dailymed-ingredient:FD&C_Red_No._40,
dailymed-ingredient:artificial_banana_flavor,
dailymed-ingredient:artificial_fruit_flavor,
dailymed-ingredient:artificial_strawberry_flavor,
dailymed-ingredient:ascorbic_acid,
dailymed-ingredient:citric_acid_anhydrous,
dailymed-ingredient:edetate_disodium,
dailymed-ingredient:glycerin,
dailymed-ingredient:liquid_sugar,
dailymed-ingredient:methylparaben,
dailymed-ingredient:saccharin_sodium,
dailymed-ingredient:sodium_benzoate,
dailymed-ingredient:sodium_citrate_dihydrate,
dailymed-ingredient:sodium_propionate,
dailymed-ingredient:water
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| dailymed-instance:precautio... |
General: Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function.<br/>Information for Patients: Promethazine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine therapy. Children should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other CNS depressants, including narcotic analgesics, sedatives, hypnotics and tranquilizers, may have an additive effect and should be avoided or their dosage reduced. Patients should be advised to report any involuntary muscle movements or unusual sensitivity to sunlight.<br/>Drug Interactions: The sedative action of promethazine is additive to the sedative effects of other CNS depressants, including alcohol, narcotic analgesics, sedatives, hypnotics, tricyclic antidepressants and tranquilizers; therefore, these agents should be avoided or administered in reduced dosage to patients receiving promethazine.<br/>Drug/Laboratory Test Interactions: The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride:<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.<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 and 12.5 mg/kg of promethazine. 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. 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, including promethazine, 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 in pregnant women. Promethazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.<br/>Nonteratogenic Effects: Promethazine taken within two weeks of delivery may inhibit platelet aggregation in the newborn.<br/>Labor and Delivery: Promethazine, in appropriate dosage form, may be used alone or as an adjunct to narcotic analgesics during labor and delivery . See also "Nonteratogenic Effects".<br/>Nursing Mothers: It is not known whether promethazine is excreted in human milk. Caution should be exercised when promethazine is administered to a nursing woman.<br/>Pediatric Use: PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black Box Warning and Use in Pediatric Patients). Promethazine products should be used with caution in pediatric patients 2 years of age and older .<br/>Geriatric Use: Clinical studies of Promethazine formulations 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 products and observed closely.
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Promethazine Hydrochloride
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Promethazine Hydrochloride (Syrup)
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| dailymed-instance:adverseRe... |
CNS���Sedation, sleepiness, occasional blurred vision, dryness of mouth, dizziness; rarely confusion, disorientation and extrapyramidal symptoms such as oculogyric crisis, torticollis and tongue protrusion (usually in association with parenteral injection or excessive dosage). Cardiovascular���Increased or decreased blood pressure. Dermatologic���Rash, rarely photosensitivity. Hematologic���Rarely leukopenia, thrombocytopenia; agranulocytosis (1 case). Gastrointestinal���Nausea and vomiting.
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Promethazine is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.
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| dailymed-instance:name |
Promethazine Hydrochloride
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