promethazine suppository stability at room temperature

This branded product is no longer on the market. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. 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. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. HHS Vulnerability Disclosure, Help Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: solution. The product's dosage form is suppository and is administered via rectal form. Bookshelf official website and that any information you provide is encrypted Be sure to mention any of the following: antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; azathioprine (Imuran);barbiturates such as phenobarbital (Luminal); cancer chemotherapy; epinephrine (Epipen); ipratropium (Atrovent)medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and selegiline (Eldepryl, Emsam, Zelapar); narcotics and other pain medication; sedatives; sleeping pills;and tranquilizers. ask your doctor about the safe use of alcohol while you are taking this medication. endobj 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%. Promethazine can interfere with the results of home pregnancy tests. stream It may cause very bad and sometimes deadly breathing problems. , 4500 East-West Highway, Suite 900, Bethesda, Maryland. with your doctor, nurse, pharmacist, or other health care provider. Stay informed and get access to the latest news, 4500 East-West Highway, However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 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. endobj For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary. Accessibility Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see Careers. If you are taking promethazine liquid, do not use a household spoon to measure your dose. The site is secure. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Presence in Breast Milk, Medline Plus, It is not known whether promethazine HCl is excreted in human milk. pharmacist if you have questions about the best way to throw out drugs. 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. The activation energies at pH 2.98, 3.94, and 5.12 were obtained from linear Arrhenius plots and were found to be 6601, 5888, 5570 cal/mole, respectively. Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 Promethazine HCl Suppositories, USP are for rectal administration only. 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. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Stand up after about 15 minutes. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Protect the medication from light. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. All Rights Reserved. Do not take a double dose to make up for a missed one. We comply with the HONcode standard for trustworthy health information. Hallucinations (seeing or hearing things that are not there). Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. It is also important information to carry with you in case of emergencies. Active and prophylactic treatment of motion sickness. A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. If suppository is soft, chill in a refrigerator or run cold water over it. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Patient should remain supine for Phenergan, Promethegan, Antinaus 50, Phenadoz. Events, (What 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 03/2020 VC7409, Boxed Warnings, Box of 12 NDC 0713-0536-12 PRECAUTIONSDrug Interactions). PRECAUTIONSDrug Interactions). Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. WARNINGSRespiratory Depression). Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of sharing sensitive information, make sure youre on a federal This site needs JavaScript to work properly. It may be given to you for other reasons. 1 0 obj Promethazine HCl 50mg. It works by blocking the action of a certain natural substance in the body. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. Call your doctor if you experience any unusual problems while you are taking this medication. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. WARNING: Nonteratogenic Effects Promethazine HCl Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine is in a class of medications called phenothiazines. Talk with the doctor. tablet. When promethazine is used to treat motion sickness, it is taken 30 to 60 Shakiness, trouble moving around, or stiffness. Older adults should not usually take promethazine because it is not as safe as other medications that can be used to treat the same conditions. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. 17 H If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Get Label RSS Feed, Generic alternatives may be available. Nonteratogenic Effects.). Promethazine can cause side effects. (See Promethazine is an H If you are 65 or older, use this medicine (promethazine suppositories) with care. Bookshelf Vasomotor rhinitis. Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Medically reviewed by Drugs.com. Store promethazine suppositories in the refrigerator. Convulsions may rarely occur. Chem Pharm Bull (Tokyo). www.fda.gov/medwatch. Uses of Promethazine Suppositories: It is used to ease allergy signs. 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. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. Combination products containing promethazine and codeine should not be given to children younger than 16 years old. Refrigerate at 36 to 46F (2 to 8C). If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. It works by blocking histamine, a substance released by the body during an Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. Store suppositories in a refrigerator. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Refrigerator settings should be mid-range at +5C (41F) to allow the highest Distributedby: Cosette Pharmaceuticals, Inc. (See The https:// ensures that you are connecting to the Last updated on Apr 10, 2023. Careers. H -Phenothiazine, 10-ethanamine, If you become pregnant while taking promethazine, call your doctor. MeSH WARNINGSNeuroleptic Malignant Syndrome). Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. 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. Pre- and Postoperative Use - Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg

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