MeSH Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse <> Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. http://www.upandaway.org. Follow all instructions closely. Treatment Combination products containing promethazine and codeine should not be given to children younger than 16 years old. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. 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. Promethazine can interfere with the results of home pregnancy tests. Vasomotor rhinitis. Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). We comply with the HONcode standard for trustworthy health information. 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. You may report side effects to the FDA at 1-800-332-1088. The site is secure. Promethazine HCl 50mg. Acidosis and electrolyte losses should be corrected. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Alcohol can make the side effects of promethazine worse. 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. 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. PRECAUTIONSDrug Interactions). 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. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. 03/2020 VC7409, Boxed Warnings, WARNINGSCNS Depression and 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 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. Avoid sun, sunlamps, and tanning beds. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. 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. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. 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. 800-349-8919 PRECAUTIONS- Information for Patients and Drug Interactions, Cosette Pharmaceuticals, Inc. product information by RSS, Additional medications in the Prescription Medications section by. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. Patient should remain supine for 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). There are many drugs that 1987 Jun;76(6):441-5. doi: 10.1002/jps.2600760606. (See also Patients should PRECAUTIONS- Information for Patients and Drug Interactions). HHS Vulnerability Disclosure, Help If your child is throwing up for an unknown reason. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. If suppository is soft, chill in a refrigerator or run cold water over it. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. You could have more side effects. Please enable it to take advantage of the complete set of features! Amelioration of allergic reactions to blood or plasma. It is soluble in water and freely soluble in alcohol. Promethazine HCl is a racemic compound; the empirical formula is C WARNINGSRespiratory Depression). Other Angioneurotic edema. Call your doctor for medical 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. Ask your doctor or pharmacist if you are not sure. WARNINGSNeuroleptic Malignant Syndrome). WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. Stimulation may be evident, especially in children and geriatric patients. 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. Patients should be advised to avoid prolonged sun exposure during treatment. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. www.fda.gov/medwatch. is this? Oral formulations are preferred; however, rectal or parenteral formulations may be given if oral formulations are not tolerated. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. 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. FDA Safety Recalls, A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. breathing. Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see Promethazine may make your skin sensitive to sunlight. PRECAUTIONS- Information for Patients and Drug Interactions). Call your doctor or get medical An official website of the United States government. https://medlibrary.org/lib/rx/meds/promethegan-5/. Preoperative, postoperative, or obstetric sedation. Take promethazine exactly as directed. WebPhenadoz Suppositories are for rectal administration only. 17 H 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. If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Store promethazine suppositories in the refrigerator. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. This method is capable of distinguishing WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. This may lead to a higher chance of getting an. J Pharmacobiodyn. You may also report side effects at https://www.fda.gov/medwatch. 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. ask your doctor about the safe use of alcohol while you are taking this medication. This drug should not be used to treat nausea and vomiting of unknown etiology. 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. Use with care in children 2 years of age and older. Bethesda, MD 20894, Web Policies 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. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Promethazine can cause side effects. Monoamine Oxidase Inhibitors (MAOI) Subcutaneous administration is contraindicated. Get Label RSS Feed, If you become pregnant while taking promethazine, call your doctor. 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 (see 20N Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Perennial and seasonal allergic rhinitis. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. 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. Doses should be adjusted to the age and severity of the patient. 1978 Feb;30(2):75-80. doi: 10.1111/j.2042-7158.1978.tb13165.x. WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than 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 first-order rate constant increased with increasing pH. This report on medications is for your information only, and is not considered individual patient advice. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. This includes your doctors, nurses, pharmacists, and dentists. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. Dosage must be individualized. PMC 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. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. Clipboard, Search History, and several other advanced features are temporarily unavailable. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Promethazine HCl Suppositories may lower seizure threshold. The average parenteral dose given during established labor is 50 mg. Nonteratogenic Effects The syrup version of promethazine should be in a light-protected bottle with the lid tightly closed at all times. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Respiratory rate, especially in pediatric patients. Purpose: The aim of this review was to build upon previous literature describing the maximum duration for which refrigerated medications can tolerate room temperature excursions while maintaining stability and potency. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine HCl suppositories and observed closely. Dispense in well-closed container. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Tell your doctor or pharmacist about all the medications your child is taking, especially barbiturates such as phenobarbital (Luminal), medications for anxiety, narcotic medications for pain, sedatives, sleeping pills, and tranquilizers. Preoperative, postoperative, or obstetric sedation. Bethesda MD 20814 If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Chem Pharm Bull (Tokyo). Store promethazine suppositories in the refrigerator. 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. National Library of Medicine 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. 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. %PDF-1.5 Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. can do this. 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. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Hallucinations have also been reported. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS).
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