1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. 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. In 1987, Sterchele5 described the Glucose Tolerance Test WebPromethazine HCL Suppository, Rectal - Uses, Side Effects, and More Common Brand(S): Phenergan, Promethegan Generic Name(S): promethazine View Free Coupon Avoid analeptics, which may cause convulsions. It is used to treat sleep problems. Keep out of the reach of children. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. 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. MeSH <> PMC Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Dermographism. 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 WebPhenadoz Suppositories are for rectal administration only. government site. Promethazine FDA Warning Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. Doses should be adjusted to the age and severity of the patient. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. Bethesda, MD 20894, Web Policies How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. If you are taking promethazine liquid, do not use a household spoon to measure your dose. Caution should be exercised when administering parenteral formulations in pediatric patients 2 years of age and older; it is recommended that the lowest effective dose of oral formulations be used in and concomitant administration of other drugs with respiratory depressant effects be avoided in this patient population. Promethazine HCl in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. Disclaimer. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Promethazine HCl 12.5mg. You will need to talk about the benefits and risks Treatment: WARNINGSCNS Depression and Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. WebPromethazine HCl 25mg. :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 It is also important information to carry with you in case of emergencies. Pre- and Postoperative Use WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. WARNINGSNeuroleptic Malignant Syndrome). Promethazine may make your skin sensitive to sunlight. 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. Promethazine Suppositories Description Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Promethazine Hydrochloride Suppositories are for rectal administration only. 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. PROMETHAZINE Furuno K, Gomita Y, Yoshida T, Oishi R, Saeki K, Araki Y. Acta Med Okayama. Throw away unused or expired drugs. Last updated on Apr 10, 2023. If your child is throwing up for an unknown reason. 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. Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Would you like email updates of new search results? Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. WebPromethazine is well absorbed from the gastrointestinal tract. Brand name: Phenergan This medicine may cause very bad and sometimes deadly breathing problems. 2 0 obj Comments: 2 years and older: If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. Limited experience with dialysis indicates that it is not helpful. Would you like email updates of new search results? Promethazine Suppositories Information - Drugs.com This method is capable of distinguishing the intact drug from its thermal and photodegradation products. solution. Unable to load your collection due to an error, Unable to load your delegates due to an error. This possibility should be considered with Promethazine HCl Suppositories. Salmonella test system of Ames. Medically reviewed by Drugs.com. Call your doctor or get medical PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Manufacturer Contact. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Keep from freezing. 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. Antiemetic therapy in postoperative patients. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. Low white blood cell counts have happened with this medicine (promethazine suppositories). View NDC Code(s)NEW! Alcohol can make the side effects of promethazine worse. If you experience any of the following symptoms, call your doctor immediately: If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. <> On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Follow all instructions closely. photolytic degradation studies of promethazine Diazepam may be used to control convulsions. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Do not let anyone else take your medication. ) for more information if you do not have access to a take-back program. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. Patients should be told to report any involuntary muscle movements. 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. Lie down on your left side and raise your right knee to your chest. https://www.poisonhelp.org/help tablet. Put suppository into the rectum with gentle pressure, pointed end first. Stay Cool: Storing Meds in the Fridge or Freezer Household teaspoons may not be an accurate measuring device. Promethazine HCl Suppositories,USPare for rectal administration only. Promethazine is an H 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.. Take promethazine exactly as directed. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Uses of Promethazine Suppositories: It is used to ease allergy signs. 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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. PROMETHAZINE HYDROCHLORIDE 17H Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. Phenergan, Promethegan, Antinaus 50, Phenadoz. IV formulations should be diluted to a concentration of 25 mg/mL or less. Do not take more often than told by the doctor. Privacy Policy | Copyright 2023. Stability Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. Perennial and seasonal allergic rhinitis. Do not try to test for pregnancy at home. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although Tell all of your health care providers that you take this medicine (promethazine suppositories). Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. Unauthorized use of these marks is strictly prohibited. this version. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 800-349-8919 Box of 12 NDC 0713-0536-12 Copy the URL below and paste it into your RSS Reader application. 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 Promethazine HCl Suppositories, USPare useful for: Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Promethazine HCl Suppositories, USP are for rectal administration only. We comply with the HONcode standard for trustworthy health information. 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. Paradoxical Reactions Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. This drug should be administered at a rate no greater than 25 mg/min. Federal government websites often end in .gov or .mil. http://www.upandaway.org. Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. 1972 Dec;24:Suppl:133P-134. 0713-0536-10, It is not known whether promethazine HCl is excreted in human milk. Other Angioneurotic edema. In vivo and in vitro release of indomethacin from water-soluble and fatty base suppositories. Phenergan, Promethegan, Antinaus 50, Phenadoz. It is used to help motion sickness . Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. 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 FDA Safety Recalls, www.fda.gov/medwatch. HHS Vulnerability Disclosure, Help Keep all drugs out of the reach of children and pets. WebRefrigerated medications should be stored at temperatures between 2oC and 8oC (35oF to 46oF). H-Phenothiazine, 10-ethanamine, 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. The .gov means its official. (see Amelioration of allergic reactions to blood or plasma. Dinoprostone 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. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Biochemical Data Summary. Remove the wrapper. Promethazine 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. Talk to your doctor about the risks of giving promethazine to your child. room temperature Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. All Rights Reserved. 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. J Pharmacobiodyn. Allergic conjunctivitis due to inhalant allergens and foods. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. hUV?Rr$F/~H>d'K[U[\6 n=>r,+wk2rP#hqB8&\,d `S6XGfRFLm1b%Ux/w4 *uU=pk6M;]-I%d.@TdzJ]C//RbU=8q]W0,75ni. Nausea and Vomiting Phenergan - Food and Drug Administration Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.
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