Post-marketing cases of respiratory depression, including fatalities, have been reported with use of this drug in pediatric patients less than 2 years of age. Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: 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. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. It is used to treat sleep problems. Unable to load your collection due to an error, Unable to load your delegates due to an error. Diazepam may be used to control convulsions. . You may also report side effects at https://www.fda.gov/medwatch. Web- Store at controlled room temperature (between 68 and 77 degrees F) - Store in a cool, well ventilated, dry place - Store in carton until time of use Pentazine : - Discard product if it WebPromethazine is an H1 receptor blocking agent. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Federal government websites often end in .gov or .mil. In the in vitro release test using a dialysis cell method, much lower amounts of indomethacin were released from the suppositories stored at a high temperature than from those stored at a low temperature. WebStore the tablets and syrup at room temperature. Maximum dose: 25 Treatment On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. Perennial and seasonal allergic rhinitis. Call your doctor right away if you have slow, shallow, or trouble ) for more information if you do not have access to a take-back program. If you are 65 or older, use this medicine (promethazine suppositories) with care. Webexplain the stability of the product at room temperature. The in vitro and in vivo results show that the release of indomethacin from fatty-base suppositories stored at a high temperature is less than the release from those stored at a low temperature. PubMed, Avoid analeptics, which may cause convulsions. 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. Allergic conjunctivitis due to inhalant allergens and foods. Caution should be exercised when administering parenteral formulations in pediatric patients 2 years of age and older; it is recommended that the lowest effective dose of oral formulations be used in and concomitant administration of other drugs with respiratory depressant effects be avoided in this patient population. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. 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. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See Amelioration of allergic reactions to blood or plasma. 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. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. Promethazine can interfere with the results of home pregnancy tests. Check with your pharmacist. Store promethazine rectal suppositories in a refrigerator between 36 - 46F. endobj Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> ). J Pharm Pharmacol. 30 days. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Hallucinations (seeing or hearing things that are not there). 1 receptor blocking agent. Keep containers out of reach of children and pets. If you have any of these health problems: If you have any of these health problems: Low blood cell count or poor bone marrow function. Parenteral formulations: Store ampoules in the carton until ready to use. Other Angioneurotic edema. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. Promethazine HCl Suppositories may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. <> advice about side effects. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. Do not take more or less of it or take it more often than prescribed by your doctor. You could have more side effects. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. RESPIRATORY DEPRESSION (PEDIATRIC PATIENTS): This drug should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. RxNorm, Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. suppository. Stimulation may be evident, especially in children and geriatric patients. xlI=ZMju! @ jzkZ$q{)w/_?FUV2Eg5nnf?eo w#T[)rUmp2ly!`w13?G]_LhFPpCsQH7ir_&C'57:/ WARNINGS Use in Pediatric Patients). WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. Promethazine can cause side effects. 2 SHCl and its molecular weight is 320.88. Keep out of the reach of children. Brand name: Phenergan Promethazine HCl 12.5mg. Once warmed, remove from wrapper and insert high into the posterior vaginal fornix. Promethazine is also used to prevent and treat motion sickness. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. WARNINGSRespiratory Depression). The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. It works by blocking the action of a certain natural substance in the body. Pregnancy Tests For all patients taking this medicine (promethazine suppositories): This is not a list of all drugs or health problems that interact with this medicine (promethazine suppositories). Subcutaneous administration is contraindicated. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). 8600 Rockville Pike 8600 Rockville Pike Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). Is NDC 0713-0526 included in the NDC Directory? Before Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. ask your doctor about the safe use of alcohol while you are taking this medication. Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. Promethazine is an H A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. This possibility should be considered with Promethazine HCl Suppositories. WebStability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER Unopened vial should not be left at room temperature for a total time exceeding 12 hours prior to use. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Some drugs may have another patient information leaflet. This site needs JavaScript to work properly. PMC Monoamine Oxidase Inhibitors (MAOI) Amylin Pharmaceuticals. 1978 Feb;30(2):75-80. doi: 10.1111/j.2042-7158.1978.tb13165.x. Vasomotor rhinitis. Low white blood cell counts have happened with this medicine (promethazine suppositories). The .gov means its official. Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor and delivery. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Preparation and In vitro Evaluation of Naproxen Suppositories. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. All Rights Reserved. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. % 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 Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. This medicine may cause very bad and sometimes deadly breathing problems. Pre- and Postoperative Use Please enable it to take advantage of the complete set of features! Nonteratogenic Effects 3 0 obj 20 N 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. Keep all drugs in a safe place. MeSH Talk to your doctor about the risks of giving promethazine to your child. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. WARNING: PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Call your doctor for medical 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. Do not let anyone else take your medication. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. We comply with the HONcode standard for trustworthy health information. How long does promethazine stay in your system? 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. Off-label information indicates unopened bottle stable when maintained at continuous room A&k]h/+ulm.d!*/XHvPr]SjTHc%t ?($uL Db~4;22bt`gE[6Pi*8G:#k:V`BQS=X9R2N$ARz ]x~#RVY2ZdVX lr+baz|To+-$`>*>c 7o&. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. Use in Pediatric Patients). A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Use this medicine (promethazine suppositories) as ordered by your doctor. Usual adult dosage is 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. tablet. WARNINGS Use in Pediatric Patients). It works by blocking histamine, a substance released by the body during an In 1987, Sterchele5 described the hUV?Rr$F/~H>d'K[U[\6 n=>r,+wk2rP#hqB8&\,d `S6XGfRFLm1b%Ux/w4 *uU=pk6M;]-I%d.@TdzJ]C//RbU=8q]W0,75ni. WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. Promethazine should not routinely be used to treat vomiting in children; it should only be used in specific cases when a doctor decides that it is needed. The impairment may be amplified by concomitant use 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 either be eliminated or given in reduced dosage in the presence of promethazine HCl (see If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. It is used to help motion sickness . If you think there has been an overdose, call your poison control center or get medical care right away. Glucose Tolerance Test and transmitted securely. Promethazine suppositories are for rectal use only. endobj %PDF-1.5 Refrigerate at 36 to 46F (2 to 8C). Take promethazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Promethazine suppositories are for rectal use only. Do not try to swallow the suppositories or insert in any other part of your body. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Comments: 2 years and older: Salmonella test system of Ames. 17 H 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. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. 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. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. The average parenteral dose given during established labor is 50 mg. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. 301-657-3000. Promethazine HCl Suppositories, USPare useful for: Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Monoamine Oxidase Inhibitors (MAOI) Unable to load your collection due to an error, Unable to load your delegates due to an error. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Be sure to mention any of the following: antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; azathioprine (Imuran);barbiturates such as phenobarbital (Luminal); cancer chemotherapy; epinephrine (Epipen); ipratropium (Atrovent)medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and selegiline (Eldepryl, Emsam, Zelapar); narcotics and other pain medication; sedatives; sleeping pills;and tranquilizers. tablet. 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. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Remove the wrapper. Stavchansky S, Wallace JE, Geary R, Hecht G, Robb CA, Wu P. J Pharm Sci. 0713-0536-10, Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: Mild, uncomplicated CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. 1 0 obj 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. Combination products containing promethazine and codeine should not be given to children younger than 16 years old. 0713-0526-12, Tell your doctor about the allergy and (A left-handed person should lie on the right side and raise the left knee.). Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient