promethazine suppository stability at room temperature

0713-0536-10, Promethazine HCl 50mg. Active and prophylactic treatment of motion sickness. 25 mg, white, bullet-shaped suppository wrapped in silver foil. Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. The average parenteral dose given during established labor is 50 mg. Tell your doctor about the allergy and 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 initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. The American Society of Health-System Pharmacists Talk to your doctor if you think you might be pregnant while you are taking promethazine. (A left-handed person should lie on the right side and raise the left knee.). If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). 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. PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package We comply with the HONcode standard for trustworthy health information. Dermographism. Call your doctor if you experience any unusual problems while you are taking this medication. 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. Duplication for commercial use must be authorized by ASHP. Hallucinations (seeing or hearing things that are not there). Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 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 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. Please enable it to take advantage of the complete set of features! Box of 12 NDC 0713-0536-12 Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. 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. 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. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. government site. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. Talk with the doctor. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. 20N 2 0 obj On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. PMC plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. 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. breathing. Some drugs may have another patient information leaflet. Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. taken, how much, and when it happened. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. 25 mg, white, bullet-shaped suppository wrapped in silver foil. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 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. 0713-0526-12 Promethegan Suppository PRECAUTIONSDrug Interactions). Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. 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. PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV Use in Pediatric Patients). Doses should be adjusted to the age and severity of the patient. MeSH Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. 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. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. 0713-0536-12, Teratogenic Effects - Pregnancy Category C. PROMETHAZINE HCL SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black Box Warning and Use in Pediatric Patients). suppository. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. If you are a consumer or patient please visit The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. Preoperative, postoperative, or obstetric sedation. It If the suppository feels soft, hold it under cold, running water for 1 minute. Promethazine HCl 25mg. Keep from freezing. If you become pregnant while taking promethazine, call your doctor. Check with your pharmacist. Updated Active and prophylactic treatment of motion sickness. Stavchansky S, Wallace JE, Geary R, Hecht G, Robb CA, Wu P. J Pharm Sci. what signs you had. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. PRECAUTIONS- Information for Patients and Drug Interactions). The product's dosage form is suppository and is administered via rectal form. FROZEN Drugs If your symptoms or health problems do not get better or if they become worse, call your doctor. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. National Library of Medicine Take the missed dose as soon as you remember it. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH. Vasomotor rhinitis. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. 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. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. Read all information given to you. Put suppository into the rectum with gentle pressure, pointed end first. PMC :u Qt/OYFTU^Jir+*;M&+X!u N1FTVpWcHxTYYM~g;|W=7 _WCB>>n>tn@Zt|f.l1Ax{x`K-n;sPVF5e.7_+Vn7b71/=Arsdnp %6y'-KhYsoK6}^tW3VJWw^TYI.JJ The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. 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&. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of 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. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Indomethacin (Rectal Route) Proper Use - Mayo Clinic Promethazine suppositories are for rectal use only. (see tablet. Would you like email updates of new search results? 8600 Rockville Pike This site complies with the HONcode standard for trustworthy health information: verify here. It works by blocking histamine, a substance released by the body during an Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Information (Quality. Hallucinations have also been reported. 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. Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch (1.25 to 2.5 centimeters) in children who are 2 years of age older and 1 inch (2.5 centimeters) in adults. Indomethacin sustained-release suppositories containing sugar ester. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Bethesda MD 20814 Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Preoperative, postoperative, or obstetric sedation. Promethegan (promethazine hydrochloride) dose, indications, Ask the doctor or pharmacist if you are not sure. Instead, the best way to dispose of your medication is through a medicine take-back program. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Unauthorized use of these marks is strictly prohibited. WebRefrigerated medications should be stored at temperatures between 2oC and 8oC (35oF to 46oF). It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Stay informed and get access to the latest news, 4500 East-West Highway,

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