If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. Prophylaxis: Parenteral: Would you like email updates of new search results? 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. https://medlibrary.org/lib/rx/meds/promethegan-5/. (see PRECAUTIONS- Information for Patients and Drug Interactions). If you think there has been an overdose, call your poison control center or get medical care right away. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Check with your Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Preoperative, postoperative, or obstetric sedation. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. endobj 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. The effect on later growth and development of the newborn is unknown. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. 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. Refrigerator settings should be mid-range at +5C (41F) to allow the highest Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. 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. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. Vasomotor rhinitis. Deep IM injection is the preferred route of administration. Patients should Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. It is used to help motion sickness . Use in Pediatric Patients). Avoid sun, sunlamps, and tanning beds. Files, Presentations Patient should remain supine for In the event that vasopressors are considered for the management of severe hypotension that does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Talk with the doctor. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Pre- and Postoperative Use - Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg Promethazine HCl 50mg. Use with care in children 2 years of age and older. If you are 65 or older, use this medicine (promethazine suppositories) with care. tablet. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. H-Phenothiazine, 10-ethanamine, suppository. Call your doctor right away if you have slow, shallow, or trouble WebPhenadoz Suppositories are for rectal administration only. Patients should be advised to report any involuntary muscle movements. Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. (See <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Avoid prolonged exposure to the sun. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Read all information given to you. Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. A wide range of weight-based doses have resulted in respiratory depression in these patients. 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. If your child is throwing up for an unknown reason. Bethesda MD 20814 Diazepam may be used to control convulsions. Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. 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. 3 0 obj Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Generic name: Promethazine Suppositories [proe-METH-a-zeen] Promethazine was nonmutagenic in the 4 0 obj Drug classes: Antihistamines, Phenothiazine antiemetics. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. The American Society of Health-System Pharmacists Before WARNINGSRespiratory Depression). Tell your doctor or pharmacist about all the medications your child is taking, especially barbiturates such as phenobarbital (Luminal), medications for anxiety, narcotic medications for pain, sedatives, sleeping pills, and tranquilizers. 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. and transmitted securely. Ask your pharmacist any questions you have about refilling your prescription. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. 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 Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient Do not freeze. 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 Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. breathing. Promethazine HCl Rectal Suppositories USP, are available as follows: Promethazine HCl Suppositories USP, 12.5 mg carton of 12 suppositories Promethazine HCl Suppositories USP, 25 mg carton of 12 suppositories Store refrigerated between 2-8C (36-46F). Dispense in well-closed container. Do not start, stop, or change the dose of Last updated on Jan 28, 2022. Par promethazine with codeine vs Hi-Tech promethazine with codeine? 2 SHCl and its molecular weight is 320.88. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. Epinephrine Because of the potential for promethazine HCl to reverse epinephrines vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Suppositories overdose. Promethazine HCl Suppositories, USPare useful for: Hallucinations have also been reported. 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. Disclaimer. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. FDA Safety Recalls, Monoamine Oxidase Inhibitors (MAOI) 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). Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. 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. H -Phenothiazine, 10-ethanamine, It is not known whether promethazine HCl is excreted in human milk. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. to you and the baby. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. HHS Vulnerability Disclosure, Help Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Dermographism. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Bethesda, MD 20894, Web Policies Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. If suppository is soft, chill in a refrigerator or run cold water over it. tell your doctor if you have or have ever had an enlarged prostate (a male reproductive gland); glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); seizures; ulcers; blockage in the passage between the stomach and intestine; blockage in the bladder; asthma or other lung disease; sleep apnea; cancer;any condition that affects the production of blood cells in your bone marrow; or heart or liver disease.
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