promethazine suppository stability at room temperature promethazine suppository stability at room temperature

The release of indomethacin from fatty-base suppositories, which had been stored at a low (4 degrees C) and a high (25-30 degrees C) temperature for about one month, was examined in vitro and in vivo. It works by blocking histamine, a substance released by the body during an Amelioration of allergic reactions to blood or plasma. Patients should be told to report any involuntary muscle movements. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Events, Store refrigerated between 2-8C (36-46F). Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. 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. Medically reviewed by Drugs.com. H -Phenothiazine, 10-ethanamine, Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. (See Hallucinations have also been reported. Oral or Rectal: 6.25 to 12.5 mg orally or rectally before meals and at bedtime, as necessary OR 25 mg orally or rectally once a day at bedtime Preoperative, postoperative, or obstetric sedation, Relief of apprehension and production of light sleep from which the patient can be easily aroused. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. tablet. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Diazepam may be used to control convulsions. Maximum dose: 25 Generic alternatives may be available. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Allergic conjunctivitis due to inhalant allergens and foods. Protect the medication from light. It is also important information to carry with you in case of emergencies. A very bad and sometimes deadly health problem called. Before Comments: 2 years and older: Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 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. MeSH Phenergan, Promethegan, Antinaus 50, Phenadoz. Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Stability Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 To determine the activation energy necessary by constructing an Arrhenius plot. You may get sunburned more easily. 2 years and older: Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. 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. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. National Library of Medicine 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. Nausea and Vomiting Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. Distributedby: Cosette Pharmaceuticals, Inc. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. You must check WARNINGSCNS Depression and Careers. 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. Administered IV as an adjunct to anesthesia or analgesia with reduced amounts of meperidine of other narcotic analgesics in special surgical situations (e.g., repeated bronchoscopy, ophthalmic surgery, poor-risk patients), Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Promethazine is an H On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. Talk with the doctor. Pregnancy Tests Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. sharing sensitive information, make sure youre on a federal The site is secure. Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Patients should be advised to report any involuntary muscle movements. WebThe NDC Packaged Code 0713-0526-12 is assigned to a package of 12 suppository in 1 box of Promethegan, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. The in vitro and in vivo results show that the release of indomethacin from fatty-base suppositories stored at a high temperature is less than the release from those stored at a low temperature. Patients should Promethazine HCl Suppositories, USP are for rectal administration only. Prophylaxis: Parenteral: 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. Duplication for commercial use must be authorized by ASHP. Box of 1000 NDC 0713-0526-10 WebPromethazine Hydrochloride Sensitization Not applicable. WARNINGSRespiratory Depression). 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. 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 average adult dose is 25 mg taken twice daily. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. Files, Presentations Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. It works by blocking the action of a certain natural substance in the body. 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 Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 , 4500 East-West Highway, Suite 900, Bethesda, Maryland. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. :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 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. tablet. Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen. Talk to your doctor about the risks of giving promethazine to your child. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. PROMETHAZINE HYDROCHLORIDE Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. How long does promethazine stay in your system? Use with care in children 2 years of age and older. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. Do not let anyone else take your medication. 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. Central Nervous System Report Adverse 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. (see Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). If your symptoms or health problems do not get better or if they become worse, call your doctor. Accessibility Dermatologic Dermatitis, photosensitivity, urticaria. 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). prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com Do not try to test for pregnancy at home. Keep from freezing. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse Information is also available online at ), More about getting RSS News & Updates from DailyMed, 12 in 1 BOX; Type 0: Not a Combination Product, 1000 in 1 BOX; Type 0: Not a Combination Product, Cosette Pharmaceuticals NC Laboratories, LLC, analysis(0713-0526, 0713-0536) , label(0713-0526, 0713-0536) , manufacture(0713-0526, 0713-0536) , pack(0713-0526, 0713-0536), 6 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. 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. 8600 Rockville Pike If the suppository feels soft, hold it under cold, running water for 1 minute. The American Society of Health-System Pharmacists 2. HAZARDS IDENTIFICATION PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Unauthorized use of these marks is strictly prohibited. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. J Pharm Sci. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Available for Android and iOS devices. ). Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. 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 How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. Avoid sun, sunlamps, and tanning beds. Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. Brand name: Phenergan 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 This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Updated 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 Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine.