Phenergan, Promethegan, Antinaus 50, Phenadoz. 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 Allergic conjunctivitis due to inhalant allergens and foods. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. There are many Federal government websites often end in .gov or .mil. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. A very bad and sometimes deadly health problem called. Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. 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. All Rights Reserved. (See also Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. 4 0 obj Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. official website and that any information you provide is encrypted (See Allergic conjunctivitis due to inhalant allergens and foods. Presence in Breast Milk, Medline Plus, 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. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. 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 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. Promethazine HCl Suppositories may lower seizure threshold. We comply with the HONcode standard for trustworthy health information. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. Dosage must be individualized. 2SHCl and its molecular weight is 320.88. J Pharm Sci. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. 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 1 receptor blocking agent. Promethazine FDA Warning How long does promethazine stay in your system? The average parenteral dose given during established labor is 50 mg. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. Clinical Trials, Do not handle too much. 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. This includes your doctors, nurses, pharmacists, and dentists. Avoid analeptics, which may cause convulsions. 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 Promethazine HCl 50mg. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. Teratogenic Effects - Pregnancy Category C Put suppository into the rectum with gentle pressure, pointed end first. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. tablet. The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: Careers. Subcutaneous administration is contraindicated. MeSH Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. 2013 Mar;75(2):143-8. Talk to your doctor if you think you might be pregnant while you are taking promethazine. official website and that any information you provide is encrypted Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH. Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. Files, Presentations Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Avoid driving and doing other tasks or actions that call for you to be. This site needs JavaScript to work properly. How long does promethazine stay in your system? Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. It is used to ease pain . If your child is throwing up for an unknown reason. The product's dosage form is suppository and is administered via rectal form. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. A wide range of weight-based doses have resulted in respiratory depression in these patients. Promethazine HCl Suppositories, USP are for rectal administration only. Perennial and seasonal allergic rhinitis. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. WebPromethazine Suppositories Insulin Formulations Latanoprost Ophthalmic Drops Etonogestrel/Ethinyl Estradiol Vaginal Rings Name common medications stored at room temperature Antibiotic powders for reconstitution How is mannitol stored? If you are 65 or older, use this medicine (promethazine suppositories) with care. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. drugs that can do this. Promethazine HCl 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 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. Oxygen may also be administered. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. Do not take more or less of it or take it more often than prescribed by your doctor. 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. FOIA Tell all of your health care providers that you take this medicine (promethazine suppositories). FDA Safety Recalls, To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or, Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (, All Drug Limited data suggest that use of promethazine HCl 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. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. It is used to help motion sickness . Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor and delivery. WARNINGSCNS Depression and WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Please enable it to take advantage of the complete set of features! 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. 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. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Also tell your doctor and pharmacist if you have ever had an unusual or unexpected reaction when you took promethazine, another phenothiazine, or any other medication. You may get sunburned more easily. Brand name: Phenergan MeSH Events, you should know that this medication may make you drowsy. See the FDA's Safe Disposal of Medicines website ( 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. Follow all instructions closely. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). 30 days. Distributedby: Cosette Pharmaceuticals, Inc. Available for Android and iOS devices. Use with care in children 2 years of age and older. View Labeling Archives, Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. Refrigerator settings should be mid-range at +5C (41F) to allow the highest The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. If you have questions about side effects, call your doctor. Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 Do not try to swallow the suppositories or insert in any other part of your body. Manufacturer Contact. 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. Many times this medicine (promethazine suppositories) is taken on an as needed basis. Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. Oral formulations are preferred; however, rectal or parenteral formulations may be given if oral formulations are not tolerated. 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 average effective dose of promethazine HCl 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. The .gov means its official. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. The information is not a substitute for medical care. Tell your child's doctor if your child has any condition that affects his/her breathing such as lung disease, asthma, or sleep apnea (stops breathing for short periods of time during sleep). 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. Accessibility In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. Vasomotor rhinitis. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Promethazine is in a class of medications called phenothiazines. 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. Nonteratogenic Effects.). Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Mild, uncomplicated CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine HCl Rectal Suppositories, USP are available in boxes of 12 and 1000 as follows: 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. June 14, 2022. Files, All Mapping We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. There are many drugs that Store promethazine suppositories in the refrigerator. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. J Pharm Pharmacol. This possibility should be considered with Promethazine HCl Suppositories. You will need to talk about the benefits and risks 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. Drowsiness is the most prominent CNS effect of this drug. http://www.upandaway.org. Limited experience with dialysis indicates that it is not helpful. Labels, All Index Do not try to test for pregnancy at home. 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. Central Nervous System Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. breathing. Keep containers out of reach of children and pets. Promethazine is also used to prevent and treat motion sickness. Nausea and Vomiting An official website of the United States government. Convulsions may rarely occur. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. Promethazine HCl is a racemic compound; the empirical formula is C Monoamine Oxidase Inhibitors (MAOI) Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. Do not WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. National Library of Medicine endobj ask your doctor about the safe use of alcohol while you are taking this medication. Copyright, 2023. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. Usual Pediatric Dose for Nausea/Vomiting. Duplication for commercial use must be authorized by ASHP. http://www.fda.gov/Safety/MedWatch 0713-0526-12, It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. continuous twisting movements of the hands and feet, wide pupils (black circles in the middle of the eyes), difficulty falling asleep or staying asleep, hallucinations (seeing things or hearing voices that do not exist), overwhelming or unmanageable fear or emotion, uncontrollable shaking of a part of the body, sore throat, fever, chills, and other signs of infection, inability to respond to people around you, swelling of the face, eyes, lips, tongue, throat, arms, hands, feet, ankles, or lower legs. If suppository is soft, chill in a refrigerator or run cold water over it. Dosage must be individualized. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. this version. 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. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patient should remain supine for This method is capable of distinguishing the intact drug from its thermal and photodegradation products. Allergic conjunctivitis due to inhalant allergens and foods, Amelioration of allergic reactions to blood or plasma, In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, Mild, uncomplicated allergic skin manifestations of urticaria and angioedema, Other uncomplicated allergic condition of the immediate type when oral therapy is impossible or contraindicated, Early stages of labor: 50 mg IM or IV once, Nighttime sedation: 25 to 50 mg IM or IV once. Ask your doctor or pharmacist if you are not sure. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. 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. endobj Box of 12 NDC 0713-0526-12 In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine HCl Suppositories are useful for: Perennial and seasonal allergic rhinitis. Report Adverse Promethazine HCl Suppositories may lower seizure threshold. J Pharm Pharmacol. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. 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. Vasomotor rhinitis. Store promethazine rectal suppositories in a refrigerator between 36 - 46F. Bethesda, MD 20894, Web Policies It IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. Medically reviewed by Drugs.com. Protect the medication from light. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. 17 H WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Purpose: The aim of this review was to build upon previous literature describing the maximum duration for which refrigerated medications can tolerate room temperature excursions while maintaining stability and potency. This drug should be administered at a rate no greater than 25 mg/min. The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. Stored in a warmer box to prevent crystallization Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient WebWhen promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Additionally, one of each type of IVPB solution will be stored under white light and one of Bethesda, MD 20894, Web Policies Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. The site is secure. 1 receptor blocking agent. This medicine may cause the results of some pregnancy tests to be wrong.
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