Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Lie down on your left side and raise your right knee to your chest. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. 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. View Labeling Archives, The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Amelioration of allergic reactions to blood or plasma. Do not freeze. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Paradoxical Reactions 20 N Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Glucose Tolerance Test 30 days. Promethazine HCl is a racemic compound; the empirical formula is C 2 SHCl and its molecular weight is 320.88. 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. Unauthorized use of these marks is strictly prohibited. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. 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. It works by blocking the action of a certain natural substance in the body. Additionally, one of each type of IVPB solution will be stored under white light and one of Medically reviewed by Drugs.com. 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 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. Keep all drugs in a safe place. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see Be ready to tell or show what was Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 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. Sedation Promethazine HCl is a racemic compound; the empirical formula is C Nonteratogenic Effects Promethazine HCl Talk with the doctor. 25 mg, white, bullet-shaped suppository wrapped in silver foil. If you are a consumer or patient please visit WARNINGSRespiratory Depression). AHFS 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 Nonteratogenic Effects Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Files, Presentations Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. WARNINGS Use in Pediatric Patients). PMC Promethazine HCl 50mg. 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. Clinical Trials, Talk with the doctor. 1987 Jun;76(6):441-5. doi: 10.1002/jps.2600760606. ). It is not known whether promethazine HCl is excreted in human milk. Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient HHS Vulnerability Disclosure, Help Copy the URL below and paste it into your RSS Reader application. National Library of Medicine 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. IV formulations should be diluted to a concentration of 25 mg/mL or less. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. If you have any questions about this medicine (promethazine suppositories), please talk ask your doctor about the safe use of alcohol while you are taking this medication. Vasomotor rhinitis. tablet. Would you like email updates of new search results? South Plainfield, NJ 07080 Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). Federal government websites often end in .gov or .mil. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. 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. 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. It is used to ease pain . Bethesda, MD 20894, Web Policies If you have questions about side effects, call your doctor. 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&. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. 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. endobj Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Careers. 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. Respiratory rate, especially in pediatric patients. 2 0 obj Do not handle too much. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. FOIA Par promethazine with codeine vs Hi-Tech promethazine with codeine? Files, All Mapping The American Society of Health-System Pharmacists Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. Do not 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. When given concomitantly with Promethazine HCl Suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. If you become pregnant while taking promethazine, call your doctor. 25 mg, white, bullet-shaped suppository wrapped in silver foil. In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. View NDC Code(s)NEW! Promethazine suppositories are for rectal use only. Take promethazine exactly as directed. H-Phenothiazine, 10-ethanamine, Stand up after about 15 minutes. The effect on later growth and development of the newborn is unknown. Call your doctor right away if you have slow, shallow, or trouble It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. To determine the activation energy necessary by constructing an Arrhenius plot. An increase in blood glucose has been reported in patients receiving promethazine HCl. PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, Manufacturer Contact. WebStore the tablets and syrup at room temperature. If you think there has been an overdose, call your poison control center or get medical care right away. Wash your hands thoroughly and resume your normal activities. Last updated on Jan 28, 2022. Would you like email updates of new search results? PRECAUTIONS- Information for Patients and Drug Interactions). 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. When given concomitantly with Promethazine HCl Suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. WebPromethazine HCl 25mg. Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). All Rights Reserved. PRECAUTIONS- Information for Patients and Drug Interactions). Promethazine HCl 12.5mg. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 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. http://www.upandaway.org. Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed Acidosis and electrolyte losses should be corrected. WARNINGSCNS Depression and Dermatologic Dermatitis, photosensitivity, urticaria. Store promethazine suppositories in the refrigerator. If you are 65 or older, use this medicine (promethazine suppositories) with care. 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. Take promethazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Promethazine suppositories are for rectal use only. Do not try to swallow the suppositories or insert in any other part of your body. Distributedby: Cosette Pharmaceuticals, Inc. 8600 Rockville Pike To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. The stability of aqueous solutions of promethazine hydrochloride as a function of pH. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Dosage must be individualized. (see % Prophylaxis: Parenteral: and transmitted securely. 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. Store them away from light, heat, and moisture. This drug should be administered at a rate no greater than 25 mg/min. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.

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