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. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. J Pharm Pharmacol. Do not take 2 doses at the same time or extra doses. Store promethazine suppositories in the refrigerator. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. National Library of Medicine Refrigerator settings should be mid-range at +5C (41F) to allow the highest 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. Insert the suppository & Articles, All Nausea and Vomiting Generic name: Promethazine Suppositories [proe-METH-a-zeen] 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. 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. Talk to your doctor about the risks of giving promethazine to your child. It 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. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 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. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. Dermatologic Dermatitis, photosensitivity, urticaria. Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). endobj PMC Amylin Pharmaceuticals. 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). Would you like email updates of new search results? breathing. :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 Ask the doctor or pharmacist if you are not sure. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Box of 12 NDC 0713-0536-12 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. 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. J Pharmacobiodyn. Follow all instructions closely. Pre- and Postoperative Use - Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg It is soluble in water and freely soluble in alcohol. Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. Other Angioneurotic edema. WebPromethazine is well absorbed from the gastrointestinal tract. Nonteratogenic Effects.). Promethazine HCl Rectal Suppositories, USP are available in boxes of 12 and 1000 as follows: 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 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. Promethazine may cause other side effects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Federal government websites often end in .gov or .mil. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Off-label information indicates unopened bottle stable when maintained at continuous room PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Careers. 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.. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Generic alternatives may be available. WARNINGSNeuroleptic Malignant Syndrome). 800-349-8919 Events, (What Central Nervous System Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. http://www.fda.gov/Safety/MedWatch WARNINGSRespiratory Depression). All Rights Reserved. Monoamine Oxidase Inhibitors (MAOI) If you are 65 or older, use this medicine (promethazine suppositories) with care. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 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. Presence in Breast Milk, Medline Plus, 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. Biochemical Data Summary. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Tell your doctor about the allergy and Be ready to tell or show what was Store them away from light, heat, and moisture. 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. DOSAGE AND ADMINISTRATION Get Label RSS Feed, Hold it in place for a few moments. This drug should be administered at a rate no greater than 25 mg/min. 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. You may report side effects to the FDA at 1-800-332-1088. Promethazine comes as a tablet and syrup (liquid) to take by mouth and as a suppository to use rectally.When promethazine is used to treat allergies, it is usually taken one to four times daily, before meals and/or at bedtime. Oxygen may also be administered. An increase in blood glucose has been reported in patients receiving promethazine HCl. Bethesda, MD 20894, Web Policies Comments: Oral or Rectal: 25 to 50 mg orally or rectally once Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see Patients should be advised to report any involuntary muscle movements. Paradoxical Reactions If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. 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. These results suggest that in conscious rats many factors such as a locomotor hyperactivity and enhancement of gastrointestinal motility caused by the rectal administration mask the real character of suppositories. Do not start, stop, or change the dose of To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. Use in Pediatric Patients). 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. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. Chem Pharm Bull (Tokyo). On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Available for Android and iOS devices. Subcutaneous administration is contraindicated. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Promethazine should not be given to babies or children who are younger than 2 years old and should be given with caution to children who are 2 years of age or older. Is NDC 0713-0526 included in the NDC Directory? The effect on later growth and development of the newborn is unknown. 0713-0536-12, Teratogenic Effects - Pregnancy Category C. 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). Disclaimer. Preoperative, postoperative, or obstetric sedation, Relief of apprehension and production of light sleep from which the patient can be easily aroused. Instead, the best way to dispose of your medication is through a medicine take-back program. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Please enable it to take advantage of the complete set of features! Hallucinations (seeing or hearing things that are not there). 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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. MeSH Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. Drug classes: Antihistamines, Phenothiazine antiemetics. 0713-0526-12, Promethazine suppositories are for rectal use only. If you are taking promethazine liquid, do not use a household spoon to measure your dose. (see Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Manufacturer Contact. Do not handle too much. RxNorm, Check with your pharmacist. official website and that any information you provide is encrypted Do not drive a car or operate machinery until you know how this medication affects you. government site. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). sharing sensitive information, make sure youre on a federal Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. PubMed, Subcutaneous administration is contraindicated. Alcohol can make the side effects of promethazine worse. Remove the wrapper. WebPromethazine HCL Suppository, Rectal - Uses, Side Effects, and More Common Brand(S): Phenergan, Promethegan Generic Name(S): promethazine View Free Coupon 8600 Rockville Pike 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. Call your doctor for medical Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). The American Society of Health-System Pharmacists Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. 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. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. Files, All Mapping In vivo and in vitro release of indomethacin from water-soluble and fatty base suppositories. Oral or Rectal: 6.25 to 12.5 mg orally or rectally before meals and at bedtime, if necessary, OR 25 mg orally or rectally once a day at bedtime Promethazine HCl 50mg. An official website of the United States government. Before Ask your pharmacist any questions you have about refilling your prescription. This site complies with the HONcode standard for trustworthy health information: verify here. Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. can do this. PRECAUTIONS- Information for Patients and Drug Interactions). Promethazine is an H is this? Promethazine may cause breathing to slow or stop, and may cause death in children. 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 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. The site is secure. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Promethazine is in a class of medications called phenothiazines. 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. If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. 20N Promethazine HCl Suppositories may lower seizure threshold. remington 1100 performance parts, vanderbilt biggest donors, derry nh fire department roster,