1992 Aug;46(4):223-31. doi: 10.18926/AMO/32623. PDR Stand up after about 15 minutes. If you are 65 or older, use this medicine (promethazine suppositories) with care. 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. This may lead to a higher chance of getting an. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Take the missed dose as soon as you remember it. This possibility should be considered with Promethazine HCl Suppositories. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). Call your child's doctor immediately and get emergency medical treatment if your child has difficulty breathing, wheezes, slows or pauses in breathing, or stops breathing. official website and that any information you provide is encrypted Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. Information (Quality. HHS Vulnerability Disclosure, Help 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. 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. You may get sunburned more easily. 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. Thermal and photolytic degradation studies of promethazine sharing sensitive information, make sure youre on a federal <> Information is also available online at It works by blocking the action of a certain natural substance in the body. It may be given to you for other reasons. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Salmonella test system of Ames. Promethazine suppositories are for rectal use only. Vasomotor rhinitis. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Teratogenic Effects - Pregnancy Category C Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. (see 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. Manufacturer Contact. 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. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. 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. Call your doctor for medical The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. 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. Federal government websites often end in .gov or .mil. The https:// ensures that you are connecting to the The American Society of Health-System Pharmacists Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Dermographism. Bethesda, MD 20894, Web Policies If it is close to the time for your next dose, skip the missed dose and go back to your normal time. The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. Use this medicine (promethazine suppositories) as ordered by your doctor. There are many drugs that photolytic degradation studies of promethazine Promethazine may cause other side effects. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Vials stored at room temperature should not be returned to the refrigerator. Stored in a warmer box to prevent crystallization tablet. . Monoamine Oxidase Inhibitors (MAOI) All Rights Reserved. Phenergan Suppositories Dosage 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. Maximum dose: 25 You will need to talk about the benefits and risks Pre- and Postoperative Use Oral formulations are preferred; however, rectal or parenteral formulations may be given if oral formulations are not tolerated. Pregnancy Tests Monoamine Oxidase Inhibitors (MAOI) Updated (See PRECAUTIONS- Information for Patients and Drug Interactions). Vasomotor rhinitis. Perennial and seasonal allergic rhinitis. The product's dosage form is suppository and is administered via rectal form. J Pharm Pharmacol. 1989 Nov;37(11):3145-7. doi: 10.1248/cpb.37.3145. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. WebPromethazine Hydrochloride Sensitization Not applicable. Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: View NDC Code(s)NEW! PRECAUTIONSDrug Interactions). 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. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. ), 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 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. It is soluble in water and freely soluble in alcohol. Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Acidosis and electrolyte losses should be corrected. ) or by phone (1-800-332-1088). Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, and unconsciousness, and sudden death. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Glucose Tolerance Test PROMETHAZINE 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. with your doctor, nurse, pharmacist, or other health care provider. 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. 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. PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package Generic alternatives may be available. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. 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. 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. Accessibility It is not known whether promethazine HCl is excreted in human milk. Oxygen may also be administered. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. 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. 20N You may also report side effects at https://www.fda.gov/medwatch. Box of 12 NDC 0713-0526-12 Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. Files, All Mapping 301-657-3000. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. sharing sensitive information, make sure youre on a federal 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). Be ready to tell or show what was Diazepam may be used to control convulsions. WebPromethazine HCl 25mg. Promethazine Suppositories Information - Drugs.com Other Angioneurotic edema. Store refrigerated between 2-8C (36-46F). These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Insert the suppository WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. official website and that any information you provide is encrypted Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. ). Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. The average effective dose of promethazine HCl for the active therapy of nausea and vomiting in children or adults is 25 mg. 12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals. Promethazine is an H Use. 2SHCl and its molecular weight is 320.88. 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. FROZEN Drugs Influence of storage temperature on indomethacin release from Keep containers out of reach of children and pets. can do this. Allergic conjunctivitis due to inhalant allergens and foods. Remove the wrapper. On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. 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. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). WebPromethazine is an H1 receptor blocking agent. Please enable it to take advantage of the complete set of features! If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Promethazine is in a class of medications called phenothiazines. Accessibility Promethazine HCl Suppositories are for rectal administration only. Off-label information indicates unopened bottle stable when maintained at continuous room Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. Keep all drugs in a safe place. Sedative doses may be given the night before surgery. Get Label RSS Feed, If you become pregnant while taking promethazine, call your doctor. Careers. Presence in Breast Milk, Medline Plus, Dosage must be individualized. Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Amelioration of allergic reactions to blood or plasma. Par promethazine with codeine vs Hi-Tech promethazine with codeine? http://www.fda.gov/Safety/MedWatch Limited experience with dialysis indicates that it is not helpful. Copyright, 2023. June 14, 2022. The first-order rate constant increased with increasing pH. Methods: During a 12-month period ending in June 2021, the prescribing information and published Promethazine HCl 12.5mg. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. solution. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. Use with care in children 2 years of age and older. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: WebStability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER Unopened vial should not be left at room temperature for a total time exceeding 12 hours prior to use. Do not freeze the oral liquid. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Brand name: Phenergan Clipboard, Search History, and several other advanced features are temporarily unavailable. 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. Please enable it to take advantage of the complete set of features! When promethazine is used to treat motion sickness, it is taken 30 to 60 (See also This report on medications is for your information only, and is not considered individual patient advice. Protect the medication from light. 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. J Pharm Pharmacol. 20 N An official website of the United States government. If your symptoms or health problems do not get better or if they become worse, call your doctor. Promethazine can cause side effects. 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 WebPhenadoz Suppositories are for rectal administration only. Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. Talk with the doctor. FOIA Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Talk with the doctor. WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. https://www.poisonhelp.org/help PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV this version. Bookshelf Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. 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. 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. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. Clinical Trials, Drowsiness is the most prominent CNS effect of this drug. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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 When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Patients should be advised to avoid prolonged sun exposure during treatment. 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.. drugs that can do this. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Promethazine is also used to prevent and treat motion sickness. Paradoxical Reactions Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH. :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 Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. We comply with the HONcode standard for trustworthy health information. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 0713-0526-12, IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious.
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