The https:// ensures that you are connecting to the 20N sharing sensitive information, make sure youre on a federal Store promethazine rectal suppositories in a refrigerator between 36 - 46F. Methods: During a 12-month period ending in June 2021, the prescribing information and published In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. However, many people have no side effects or only have minor side effects. Respiratory rate, especially in pediatric patients. Active and prophylactic treatment of motion sickness. Subcutaneous administration is contraindicated. Information is also available online at Amylin Pharmaceuticals. Bookshelf PMC (See also government site. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Promethazine HCl is a racemic compound; the empirical formula is C Stability Patients should be told to report any involuntary muscle movements. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP , 4500 East-West Highway, Suite 900, Bethesda, Maryland. Remove the wrapper. Comments: 2 years and older: Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. WebPromethazine HCL Suppository, Rectal - Uses, Side Effects, and More Common Brand(S): Phenergan, Promethegan Generic Name(S): promethazine View Free Coupon In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. Patients should Box of 12 NDC 0713-0526-12 PRECAUTIONS- Information for Patients and Drug Interactions). DailyMed help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. Do not flush down a toilet or pour down a drain unless you are told to do so. 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. 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. Prophylaxis: Parenteral: 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 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 Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see Pregnancy Tests IV formulations should be diluted to a concentration of 25 mg/mL or less. If you will be giving promethazine to a child, also tell the child's doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Promethazine HCl Suppositories are useful for: Perennial and seasonal allergic rhinitis. Promethazine All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. 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. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. Promethazine HCl 50mg. It is used to treat sleep problems. DOSAGE AND ADMINISTRATION This drug should be administered at a rate no greater than 25 mg/min. Unauthorized use of these marks is strictly prohibited. Medically reviewed by Drugs.com. Protect the medication from light. stream Diazepam may be used to control convulsions. 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). How long does promethazine stay in your system? Accessibility Unable to load your collection due to an error, Unable to load your delegates due to an error. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is (See Promethazine HCl Suppositories may lower seizure threshold. Once warmed, remove from wrapper and insert high into the posterior vaginal fornix. If you are taking promethazine liquid, do not use a household spoon to measure your dose. 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. Maximum dose: 25 Acidosis and electrolyte losses should be corrected. 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. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. 0713-0526-12 Promethegan Suppository Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, sharing sensitive information, make sure youre on a federal Remove the wrapper. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Careers. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. Furuno K, Gomita Y, Yoshida T, Oishi R, Saeki K, Araki Y. Acta Med Okayama. 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. FDA Safety Recalls, ), 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 Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. 0713-0536-10, The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. View NDC Code(s)NEW! Stability If you are a consumer or patient please visit Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. Antiemetic therapy in postoperative patients. It may cause very bad and sometimes deadly breathing problems. Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. 2013 Mar;75(2):143-8. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. 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 CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Limited experience with dialysis indicates that it is not helpful. official website and that any information you provide is encrypted The site is secure. Promethazine HCl 12.5mg. 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. FOIA This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Promethazine HCl Suppositories, USPare useful for: Tell your Distributedby: Cosette Pharmaceuticals, Inc. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. 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. You will need to talk about the benefits and risks Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. WebPromethazine HCl Suppositories are for rectal administration only. <> WARNINGSNeuroleptic Malignant Syndrome). Promethazine suppositories are for rectal use only. There are many drugs that Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. It works by blocking histamine, a substance released by the body during an DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Allergic conjunctivitis due to inhalant allergens and foods, Amelioration of allergic reactions to blood or plasma, In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, Mild, uncomplicated allergic skin manifestations of urticaria and angioedema, Other uncomplicated allergic condition of the immediate type when oral therapy is impossible or contraindicated, Early stages of labor: 50 mg IM or IV once, Nighttime sedation: 25 to 50 mg IM or IV once. Drowsiness is the most prominent CNS effect of this drug. Talk with the doctor. The site is secure. The .gov means its official. 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. room temperature It is not known whether promethazine HCl is excreted in human milk. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. PubMed, Combination products containing promethazine and codeine should not be given to children younger than 16 years old. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. 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. You must check 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. 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. Sedative doses may be given the night before surgery. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 25 mg, white, bullet-shaped suppository wrapped in silver foil. WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. 1992 Aug;46(4):223-31. doi: 10.18926/AMO/32623. Parenteral formulations: Store ampoules in the carton until ready to use. Indomethacin sustained-release suppositories containing sugar ester. 301-657-3000. Subcutaneous administration is contraindicated. The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Updated Indomethacin (Rectal Route) Proper Use - Mayo Clinic Tell your child's doctor if your child has any condition that affects his/her breathing such as lung disease, asthma, or sleep apnea (stops breathing for short periods of time during sleep). tell your doctor if you have or have ever had an enlarged prostate (a male reproductive gland); glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); seizures; ulcers; blockage in the passage between the stomach and intestine; blockage in the bladder; asthma or other lung disease; sleep apnea; cancer;any condition that affects the production of blood cells in your bone marrow; or heart or liver disease. Keep containers out of reach of children and pets. 8600 Rockville Pike An increase in blood glucose has been reported in patients receiving promethazine HCl. 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. 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. Hallucinations have also been reported. 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. Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. PMC Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. MeSH suppository. % 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. Treatment of overdosage is essentially symptomatic and supportive. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. WARNING: PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. 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&. This medicine may cause the results of some pregnancy tests to be wrong. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. Antiemetic therapy in postoperative patients. 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. Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. Promethazine HCl suppositories (promethazine hydrochloride suppositories) are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.
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