promethazine suppository stability at room temperature

Oral or Rectal: 6.25 to 12.5 mg orally or rectally before meals and at bedtime, if necessary, OR 25 mg orally or rectally once a day at bedtime (see . prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. Promethazine is well absorbed from the gastrointestinal tract. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCL SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. WebPromethazine Hydrochloride Sensitization Not applicable. Generic name: Promethazine Suppositories [proe-METH-a-zeen] Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. 800-349-8919 Chem Pharm Bull (Tokyo). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. IV formulations should be diluted to a concentration of 25 mg/mL or less. Report Adverse Patient Medication Information. WARNINGSCNS Depression and Household teaspoons may not be an accurate measuring device. If you think there has been an overdose, call your poison control center or get medical care right away. Sedation Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. 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 AHFS <> Manufacturer Contact. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Prophylaxis: Parenteral: The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: 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. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Promethazine HCl 25mg. Monoamine Oxidase Inhibitors (MAOI) 2 years and older: You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. We comply with the HONcode standard for trustworthy health information. 2 SHCl and its molecular weight is 320.88. %PDF-1.5 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%. Central Nervous System Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Store promethazine suppositories in the refrigerator. Limited experience with dialysis indicates that it is not helpful. Promethazine HCl 12.5mg. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Federal government websites often end in .gov or .mil. Clipboard, Search History, and several other advanced features are temporarily unavailable. You could have more side effects. Promethazine comes as a tablet and syrup (liquid) to take by mouth and as a suppository to use rectally.When promethazine is used to treat allergies, it is usually taken one to four times daily, before meals and/or at bedtime. You must check Careers. R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O Promethazine Suppositories | Cleveland Clinic You may also report side effects at https://www.fda.gov/medwatch. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. Stability Take the missed dose as soon as you remember it. tablet. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. government site. The site is secure. Promethazine HCl Suppositories may lower seizure threshold. ) or by phone (1-800-332-1088). 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 works by blocking the action of a certain natural substance in the body. Tell your Respiratory rate, especially in pediatric patients. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. This drug should be administered at a rate no greater than 25 mg/min. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 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. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. PMC % Do not handle too much. 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. PRECAUTIONSDrug Interactions). Many times this medicine (promethazine suppositories) is taken on an as needed basis. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. Copy the URL below and paste it into your RSS Reader application. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. 1 0 obj Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. 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. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. How long does promethazine stay in your system? tablet. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). <> Do not drive a car or operate machinery until you know how this medication affects you. (see to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. The effect on later growth and development of the newborn is unknown. 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 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. You will need to talk about the benefits and risks Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. It is used to help motion sickness . Indocin Suppositories (indomethacin) dose, indications 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. Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient 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. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. 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. Drug classes: Antihistamines, Phenothiazine antiemetics. Copyright, 2023. Methods: During a 12-month period ending in June 2021, the prescribing information and published J Pharm Sci. The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. 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. Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. 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. Drowsiness is the most prominent CNS effect of this drug. Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. taken, how much, and when it happened. Perennial and seasonal allergic rhinitis. photolytic degradation studies of promethazine Tell all of your health care providers that you take this medicine (promethazine suppositories). Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 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. Select one or more newsletters to continue. National Library of Medicine Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. Store suppositories in a refrigerator. It may cause very bad and sometimes deadly breathing problems. Patients receiving parenteral formulations should report persistent/worsening pain or burning at the injection site. This site needs JavaScript to work properly. This medicine may cause the results of some pregnancy tests to be wrong. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV Medically reviewed by Drugs.com. drugs that can do this. Avoid prolonged exposure to the sun. It is used to ease pain . Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. Refrigerator settings should be mid-range at +5C (41F) to allow the highest The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Do not freeze. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 25 mg, white, bullet-shaped suppository wrapped in silver foil. Do not try to swallow the suppositories or insert in any other part of your body. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. Promethazine is also used to prevent and treat motion sickness. Use with care in children 2 years of age and older. ask your doctor about the safe use of alcohol while you are taking this medication. www.fda.gov/medwatch. , 4500 East-West Highway, Suite 900, Bethesda, Maryland. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Box of 1000 NDC 0713-0536-10 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. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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