FDA Safety Recalls, We comply with the HONcode standard for trustworthy health information. If you are taking promethazine liquid, do not use a household spoon to measure your dose. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Call your doctor right away if you have slow, shallow, or trouble Uses of Promethazine Suppositories: It is used to ease allergy signs. Bethesda, MD 20894, Web Policies MeSH 1992 Aug;46(4):223-31. doi: 10.18926/AMO/32623. Promethazine HCl 50mg. Paradoxical Reactions 30 days. Keep out of the reach of children. It Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. SEVERE TISSUE INJURY, INCLUDING GANGRENE: Parenteral formulations can cause severe chemical irritation and damage to tissues regardless of the route of administration. We comply with the HONcode standard for trustworthy health information. It is also important information to carry with you in case of emergencies. Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see 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%. Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 Do not try to swallow the suppositories or insert in any other part of your body. 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. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. WebRefrigerated medications should be stored at temperatures between 2oC and 8oC (35oF to 46oF). Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. You must check There may be drug take-back programs in your area. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. If you think there has been an overdose, call your poison control center or get medical care right away. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. 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. 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. WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Chem Pharm Bull (Tokyo). Diazepam may be used to control convulsions. Promethazine suppositories are for rectal use only. This site complies with the HONcode standard for trustworthy health information: verify here. This report on medications is for your information only, and is not considered individual patient advice. sharing sensitive information, make sure youre on a federal xlI=ZMju! @ jzkZ$q{)w/_?FUV2Eg5nnf?eo w#T[)rUmp2ly!`w13?G]_LhFPpCsQH7ir_&C'57:/ Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. Subcutaneous administration is contraindicated. Monoamine Oxidase Inhibitors (MAOI) Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Last updated on Jan 28, 2022. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. suppository. Do not freeze the oral liquid. Low white blood cell counts have happened with this medicine (promethazine suppositories). Drowsiness is the most prominent CNS effect of this drug. 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. RxNorm, 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. Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Careers. The information is not a substitute for medical care. 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 Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Household teaspoons may not be an accurate measuring device. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. 1 receptor blocking agent. Would you like email updates of new search results? 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. 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. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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 ( 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. Select one or more newsletters to continue. IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. WebPromethazine is an H1 receptor blocking agent. PMC Comments: 2 years and older: However, you should not flush this medication down the toilet. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. 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 Store refrigerated between 2-8C (36-46F). (See Federal government websites often end in .gov or .mil. 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. MeSH Par promethazine with codeine vs Hi-Tech promethazine with codeine? 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. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Preoperative, postoperative, or obstetric sedation. 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. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Rectal suppositories Never take suppositories by mouth. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. Promethazine HCl 25mg. government site. How long does promethazine stay in your system? solution. Disclaimer. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. 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. 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. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. breathing. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. advice about side effects. 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. with your doctor, nurse, pharmacist, or other health care provider. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. The site is secure. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. Avoid prolonged exposure to the sun. 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. 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. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Stimulation may be evident, especially in children and geriatric patients. Dosage must be individualized. WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Glucose Tolerance Test J Pharmacobiodyn. Use this medicine (promethazine suppositories) as ordered by your doctor. This medicine may cause very bad and sometimes deadly breathing problems. FOIA 1 receptor blocking agent. 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 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&. Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed WARNINGSCNS Depression and ask your doctor about the safe use of alcohol while you are taking this medication. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. HHS Vulnerability Disclosure, Help 25 mg, white, bullet-shaped suppository wrapped in silver foil. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Distributedby: Cosette Pharmaceuticals, Inc. It works by blocking histamine, a substance released by the body during an Convulsions may rarely occur. 25 mg, white, bullet-shaped suppository wrapped in silver foil. Stored in a warmer box to prevent crystallization Take promethazine exactly as directed. Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. FOIA WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Promethazine FDA Warning Usual adult dosage is 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. The average adult dose is 25 mg taken twice daily. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. 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. 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. Avoid analeptics, which may cause convulsions. Pre- and Postoperative Use http://www.fda.gov/Safety/MedWatch Promethazine HCl Suppositories may lower seizure threshold. Promethazine HCl Suppositories, USP are useful for: Read all information given to you. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. Put suppository into the rectum with gentle pressure, pointed end first. :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 Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. It may cause very bad and sometimes deadly breathing problems. Available for Android and iOS devices. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. <> Promethazine HCl Suppositories, USPare useful for: Drug classes: Antihistamines, Phenothiazine antiemetics. Store suppositories in a refrigerator. Call your doctor if you experience any unusual problems while you are taking this medication. 2 years and older: to you and the baby. Information (Quality. 03/2020 VC7409, Boxed Warnings, Talk with the doctor. Allergic conjunctivitis due to inhalant allergens and foods. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. 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. All Rights Reserved. Stand up after about 15 minutes. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. Tell your doctor about the allergy and what signs you had. 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. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. WebStore the tablets and syrup at room temperature. WARNINGSRespiratory Depression). This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. There are many drugs that Unable to load your collection due to an error, Unable to load your delegates due to an error. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. It is soluble in water and freely soluble in alcohol. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. 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. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. is this? Monoamine Oxidase Inhibitors (MAOI) CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. This includes your doctors, nurses, pharmacists, and dentists. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. http://goo.gl/c4Rm4p WebPromethazine HCl 25mg. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, The https:// ensures that you are connecting to the For all patients taking this medicine (promethazine suppositories): This is not a list of all drugs or health problems that interact with this medicine (promethazine suppositories). Disclaimer. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Indomethacin sustained-release suppositories containing sugar ester. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Deep IM injection is the preferred route of administration. Promethazine HCl Suppositories may lower seizure threshold. A very bad and sometimes deadly health problem called. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Careers. Furuno K, Gomita Y, Yoshida T, Oishi R, Saeki K, Araki Y. Acta Med Okayama. Use in Pediatric Patients). In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. Box of 1000 NDC 0713-0526-10 Additionally, one of each type of IVPB solution will be stored under white light and one of ), 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
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