promethazine suppository stability at room temperature

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Do not A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Promethazine - St. Jude Childrens Research Hospital Call your doctor or get medical Promethazine Rectal: Uses, Side Effects Promethazine can cause side effects. PROMETHEGAN- promethazine hydrochloride suppositoryCosette Pharmaceuticals, Inc. Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, hard fat, and glyceryl monostearate. Promethazine: MedlinePlus Drug Information Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Promethazine may cause breathing to slow or stop, and may cause death in children. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. 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 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. See the FDA's Safe Disposal of Medicines website ( Monoamine Oxidase Inhibitors (MAOI) WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Do not take more or less of it or take it more often than prescribed by your doctor. Accessibility Do not let anyone else take your medication. (See also 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 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. Applies to the following strengths: 12.5 mg; 25 mg; 25 mg/mL; 50 mg; 25 mg/5 mL; 50 mg/mL; 6.25 mg/5 mL; 25 mg/25 mL-NaCl 0.9%. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Par promethazine with codeine vs Hi-Tech promethazine with codeine? In case of overdose, call the poison control helpline at 1-800-222-1222. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCL BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. Report Adverse Promethazine PDR Do not share your drugs with others and do not take anyone else's drugs. Promethazine is well absorbed from the gastrointestinal tract. Drowsiness is the most prominent CNS effect of this drug. WARNINGS Use in Pediatric Patients). breathing. 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. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. Distributedby: Cosette Pharmaceuticals, Inc. Check with your Store promethazine suppositories in the refrigerator. Duplication for commercial use must be authorized by ASHP. this version. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. ) or by phone (1-800-332-1088). You must check Promethazine Suppositories Description Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Promethazine Hydrochloride Suppositories are for rectal administration only. National Library of Medicine Adjunctive therapy to epinephrine and other standard measures for anaphylactic reactions, after acute manifestations have been controlled, Parenteral: 6.25 to 12.5 mg IM or IV every 4 hours a day, Oral and Rectal: 12.5 to 25 mg orally or rectally 2 times a day. 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. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. 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. Patients should be told to report any involuntary muscle movements. Dermographism. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. You may also report side effects at https://www.fda.gov/medwatch. J Pharm Pharmacol. Promethazine HCl Suppositories are useful for: Perennial and seasonal allergic rhinitis. A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. FROZEN Drugs Remove the wrapper. Promethazine HCl Suppositories may lower seizure threshold. 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. Call your doctor right away if you have slow, shallow, or trouble to you and the baby. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. There are many drugs that Federal government websites often end in .gov or .mil. Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Pregnancy Tests endobj official website and that any information you provide is encrypted You may report side effects to the FDA at 1-800-332-1088. The effect on later growth and development of the newborn is unknown. WARNINGSCNS Depression and 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. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse what signs you had. Motion Sickness Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 0713-0526-12 Promethegan Suppository PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, Patients should be advised to report any involuntary muscle movements. Do not take a double dose to make up for a missed one. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. A wide range of weight-based doses have resulted in respiratory depression in these patients. Instead, the best way to dispose of your medication is through a medicine take-back program. 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 Rectal Suppositories are contraindicated for children under 2 years of age (see Dosage must be individualized. & Articles, All There may be drug take-back programs in your area. Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Comments: 2 years and older: 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. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. WARNINGSCNS Depression and Antiemetic therapy in postoperative patients. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-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. PubMed, 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. You could have more side effects. WebPromethazine HCl Suppositories are for rectal administration only. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Take promethazine exactly as directed. Promethazine HCl Suppositories are for rectal administration only. Central Nervous System 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. It is soluble in water and freely soluble in alcohol. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. Stavchansky S, Wallace JE, Geary R, Hecht G, Robb CA, Wu P. J Pharm Sci. Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: Sedation Promethazine is an H is this? (See advice about side effects. https://medlibrary.org/lib/rx/meds/promethegan-5/. Before PMC Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary 0713-0536-10, Oral formulations are preferred; however, rectal or parenteral formulations may be given if oral formulations are not tolerated. Manufacturer Contact. Treatment Usual Pediatric Dose for Nausea/Vomiting. Promethazine HCl 12.5mg. 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. WARNINGSRespiratory Depression). Allergic conjunctivitis due to inhalant allergens and foods. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Use with care in children 2 years of age and older. Read all information given to you. Par promethazine with codeine vs Hi-Tech promethazine with codeine? WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. 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. Perennial and seasonal allergic rhinitis. 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. tablet. To determine the activation energy necessary by constructing an Arrhenius plot. 8600 Rockville Pike Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. WebPromethazine HCl 25mg. Amelioration of allergic reactions to blood or plasma. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused, Preoperative, postoperative, and obstetric (during labor) sedation, Oral and Rectal: 25 mg orally, or rectally once, then 12.5 to 25 mg every 4 to 6 hours as needed, Parenteral: 12.5 to 25 mg IM or IV every 4 hours as needed, Initial day: 25 mg orally or rectally 30 to 60 minutes before traveling, then 8 to 12 hours as needed, Succeeding days of travel: 25 mg orally or rectally upon rising, with the dose repeated before the evening meal. Keep containers out of reach of children and pets. All Rights Reserved. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. (See To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine HCl suppositories and observed closely. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. promethazine Promethazine HCl Suppositories,USPare for rectal administration only. Allergic conjunctivitis due to inhalant allergens and foods. It works by blocking the action of a certain natural substance in the body. 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. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. This report on medications is for your information only, and is not considered individual patient advice. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Preparation and In vitro Evaluation of Naproxen Suppositories. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Clinical Trials, Methods: During a 12-month period ending in June 2021, the prescribing information and published The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. Box of 1000 NDC 0713-0536-10 If suppository is soft, chill in a refrigerator or run cold water over it. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. Promethazine is also used to prevent and treat motion sickness. View Labeling Archives, The product's dosage form is suppository and is administered via rectal form. It works by blocking histamine, a substance released by the body during an WebStore the tablets and syrup at room temperature. It is not known whether promethazine HCl is excreted in human milk. Do not drive a car or operate machinery until you know how this medication affects you. Please enable it to take advantage of the complete set of features! Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air.

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