Do not try to swallow the suppositories or insert in any other part of your body. Tell all of your health care providers that you take this medicine (promethazine suppositories). FOIA 25 mg, white, bullet-shaped suppository wrapped in silver foil. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. AHFS (See Medically reviewed by Drugs.com. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. solution. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The effect on later growth and development of the newborn is unknown. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. Promethazine may cause breathing to slow or stop, and may cause death in children. :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 Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. South Plainfield, NJ 07080 J Pharmacobiodyn. Use. Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. 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. Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Last updated on Jan 28, 2022. Clinical studies of promethazine formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. (See also Methods: During a 12-month period ending in June 2021, the prescribing information and published Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. The American Society of Health-System Pharmacists Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. Treatment Do not freeze. Dosage must be individualized. Please enable it to take advantage of the complete set of features! A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The stability of aqueous solutions of promethazine hydrochloride as a function of pH. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Promethazine is in a class of medications called phenothiazines. % Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. 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. 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. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. 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. Stand up after about 15 minutes. Careers. Box of 12 NDC 0713-0536-12 Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. 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 Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Store refrigerated between 2-8C (36-46F). 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&. The site is secure. J Pharm Pharmacol. 4 0 obj To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or There may be drug take-back programs in your area. In case of overdose, call the poison control helpline at 1-800-222-1222. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Nonteratogenic Effects Promethazine HCl 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. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). 25 mg, white, bullet-shaped suppository wrapped in silver foil. 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. Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. The https:// ensures that you are connecting to the Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Central Nervous System An official website of the United States government. 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. This medicine may cause very bad and sometimes deadly breathing problems. Bethesda, MD 20894, Web Policies Box of 12 NDC 0713-0526-12 Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). Patient Medication Information. The injection solution should be inspected for particulate matter and discoloration before administration. Dermographism. Respiratory rate, especially in pediatric patients. If you are taking promethazine liquid, do not use a household spoon to measure your dose. Unable to load your collection due to an error, Unable to load your delegates due to an error. Do not take a double dose to make up for a missed one. WebPromethazine is well absorbed from the gastrointestinal tract. Deep IM injection is the preferred route of administration. A wide range of weight-based doses have resulted in respiratory depression in these patients. Hallucinations have also been reported. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Salmonella test system of Ames. If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. This site complies with the HONcode standard for trustworthy health information: verify here. Additionally, one of each type of IVPB solution will be stored under white light and one of It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. 8600 Rockville Pike 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. 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. Promethazine HCl is a racemic compound; the empirical formula is C WARNINGSBlack Box Warning and Store promethazine suppositories in the refrigerator. Report Adverse Information is also available online at to you and the baby. If you are a consumer or patient please visit 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. Files, Presentations Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. The information is not a substitute for medical care. J Pharm Sci. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. PubMed, All Rights Reserved. Prophylaxis: Parenteral: 2013 Mar;75(2):143-8. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Bookshelf Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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. IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. This report on medications is for your information only, and is not considered individual patient advice. Usual Pediatric Dose for Nausea/Vomiting. Keep containers out of reach of children and pets. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. WebPromethazine HCl Suppositories are for rectal administration only. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Avoid prolonged exposure to the sun. DOSAGE AND ADMINISTRATION Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. Promethazine FDA Warning Keep from freezing. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. 2SHCl and its molecular weight is 320.88. Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> When promethazine is used to treat motion sickness, it is taken 30 to 60 minutes before travel and again after 8 to 12 hours if needed. Patients should be told to report any involuntary muscle movements. 2 SHCl and its molecular weight is 320.88. In the in vitro release test using a dialysis cell method, much lower amounts of indomethacin were released from the suppositories stored at a high temperature than from those stored at a low temperature. Promethazine HCl 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. Events, (What Allergic conjunctivitis due to inhalant allergens and foods. Federal government websites often end in .gov or .mil. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. WebPromethazine is an H1 receptor blocking agent. The .gov means its official. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. 800-349-8919 government site. 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. 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. Before You may also report side effects at https://www.fda.gov/medwatch. Monoamine Oxidase Inhibitors (MAOI) 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 Pre- or postoperative use: 25 to 50 mg IM or IV once 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. 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.
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