A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Last updated on Jan 28, 2022. % 17H Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. (current), promethazine HCl 12.5 MG Rectal Suppository, promethazine hydrochloride 12.5 MG Rectal Suppository, promethazine hydrochloride 12.5 MG Rectal Suppository [Promethegan], promethazine HCl 25 MG Rectal Suppository, promethazine hydrochloride 25 MG Rectal Suppository, promethazine hydrochloride 25 MG Rectal Suppository [Promethegan]. Alcohol can make the side effects of promethazine worse. 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. PRECAUTIONS- Information for Patients and Drug Interactions). CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Keep all drugs in a safe place. All Rights Reserved. Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. AHFS 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. Copy the URL below and paste it into your RSS Reader application. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. This method is capable of distinguishing Treatment: Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. WebPromethazine HCL Suppository, Rectal - Uses, Side Effects, and More Common Brand(S): Phenergan, Promethegan Generic Name(S): promethazine View Free Coupon to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. 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. 20 N Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. Promethazine was nonmutagenic in the In conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than those after the animals were given suppositories stored at a low temperature, but the difference was significant only 30 min after administration. The product's dosage form is suppository and is administered via rectal form. Preoperative, postoperative, or obstetric sedation. You may report side effects to the FDA at 1-800-332-1088. Monoamine Oxidase Inhibitors (MAOI) Avoid sun, sunlamps, and tanning beds. Do not try to swallow the suppositories or insert in any other part of your body. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. To determine the activation energy necessary by constructing an Arrhenius plot. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. If you experience any of the following symptoms, call your doctor immediately: If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Deep IM injection is the preferred route of administration. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. Promethazine HCl Suppositories,USPare for rectal administration only. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. PMC Talk with the doctor. IV formulations should be diluted to a concentration of 25 mg/mL or less. WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. These results suggest that in conscious rats many factors such as a locomotor hyperactivity and enhancement of gastrointestinal motility caused by the rectal administration mask the real character of suppositories. Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary When promethazine is used to treat motion sickness, it is taken 30 to 60 minutes before travel and again after 8 to 12 hours if needed. Unauthorized use of these marks is strictly prohibited. taken, how much, and when it happened. It is used to treat sleep problems. It works by blocking the action of a certain natural substance in the body. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Promethazine HCl Suppositories, USP are for rectal administration only. is this? Combination products containing promethazine and codeine should not be given to children younger than 16 years old. Talk with the doctor. Labels, All Index Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, and unconsciousness, and sudden death. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. what signs you had. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. 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. 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. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. Use in Pediatric Patients). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. It may be given to you for other reasons. It is used to ease pain . 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. Take promethazine exactly as directed. Patient Medication Information. Paradoxical Reactions Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. 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. 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. Active and prophylactic treatment of motion sickness. WARNINGSCNS Depression and Promethazine HCl Suppositories, USP are useful for: 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. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. It works by blocking histamine, a substance released by the body during an Avoid prolonged exposure to the sun. There are many View NDC Code(s)NEW! Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Shakiness, trouble moving around, or stiffness. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. (See Promethazine HCl 50mg. 1 receptor blocking agent. 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. 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. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Promethazine suppositories are for rectal use only. 4 0 obj Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor and delivery. (see The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. Salmonella test system of Ames. Store them away from light, heat, and moisture. 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? The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. any drug without checking with your doctor. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Household teaspoons may not be an accurate measuring device. (see Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. (A left-handed person should lie on the right side and raise the left knee.). Ask the doctor or pharmacist if you are not sure. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see Limited experience with dialysis indicates that it is not helpful. Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: Pre- and Postoperative Use The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. It is not known whether promethazine HCl is excreted in human milk. How long does promethazine stay in your system? and transmitted securely. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Manufacturer Contact. If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. WebPromethazine Hydrochloride Sensitization Not applicable. If you think there has been an overdose, call your poison control center or get medical care right away. FDA Safety Recalls, Duplication for commercial use must be authorized by ASHP. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. Preparation and In vitro Evaluation of Naproxen Suppositories. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. 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 Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. Do not handle too much. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. Hold it in place for a few moments. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Promethazine is an H Use this medicine (promethazine suppositories) as ordered by your doctor. Bethesda, MD 20894, Web Policies Central Nervous System Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see Box of 1000 NDC 0713-0526-10 advice about side effects. 301-657-3000. tell your doctor and pharmacist if you are allergic to promethazine, other phenothiazines (certain medications used to treat mental illness, nausea, vomiting, severe hiccups, and other conditions) or any other medications. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. The concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced. sharing sensitive information, make sure youre on a federal 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. 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. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. Store refrigerated between 2-8C (36-46F). WebPhenadoz Suppositories are for rectal administration only. RxNorm, Use. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. WARNINGSNeuroleptic Malignant Syndrome). Is NDC 0713-0526 included in the NDC Directory? 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 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