Antiemetic therapy in postoperative patients. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Box of 1000 NDC 0713-0526-10 Stability 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. Stay Cool: Storing Meds in the Fridge or Freezer Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. Medically reviewed by Drugs.com. Promethazine Suppositories Information - Drugs.com Drowsiness is the most prominent CNS effect of this drug. Take the missed dose as soon as you remember it. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. J Pharmacobiodyn. Before CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Bethesda, MD 20894, Web Policies 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.. Use in Pediatric Patients). National Library of Medicine Furuno K, Gomita Y, Yoshida T, Oishi R, Saeki K, Araki Y. Acta Med Okayama. Do not freeze the oral liquid. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Report Adverse 65 years and older: Elderly patients should be given lower initial doses and should be closely monitored for adverse events. Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). Tell all of your health care providers that you take this medicine (promethazine suppositories). Promethazine HCl is a racemic compound; the empirical formula is C Other Angioneurotic edema. This possibility should be considered with Promethazine HCl Suppositories. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. Dosage must be individualized. Active and prophylactic treatment of motion sickness. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Respiratory rate, especially in pediatric patients. 03/2020 VC7409, Boxed Warnings, help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. 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. R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Usual Pediatric Dose for Nausea/Vomiting. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Talk to your doctor if you think you might be pregnant while you are taking promethazine. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. In the in vitro release test using a dialysis cell method, much lower amounts of indomethacin were released from the suppositories stored at a high temperature than from those stored at a low temperature. It is soluble in water and freely soluble in alcohol. Box of 12 NDC 0713-0526-12 Promethazine can interfere with the results of home pregnancy tests. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). http://goo.gl/c4Rm4p N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Where do I get this medication? Generic name: Promethazine Suppositories [proe-METH-a-zeen] hUV?Rr$F/~H>d'K[U[\6 n=>r,+wk2rP#hqB8&\,d `S6XGfRFLm1b%Ux/w4 *uU=pk6M;]-I%d.@TdzJ]C//RbU=8q]W0,75ni. 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. advice about side effects. Medication Storage Flashcards | Quizlet 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. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. Call your doctor right away if you have slow, shallow, or trouble Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. This medicine may cause the results of some pregnancy tests to be wrong. Keep out of the reach of children. Combination products containing promethazine and codeine should not be given to children younger than 16 years old. 8600 Rockville Pike PRECAUTIONSDrug Interactions). If you are a consumer or patient please visit 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. Before Promethazine Nonteratogenic Effects Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. The product's dosage form is suppository and is administered via rectal form. It may be given to you for other reasons. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Amylin Pharmaceuticals. ), 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 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. tablet. <> Call your doctor or get medical HHS Vulnerability Disclosure, Help Shakiness, trouble moving around, or stiffness. Promethazine is an H Treatment of overdosage is essentially symptomatic and supportive. Teratogenic Effects - Pregnancy Category C Presence in Breast Milk, Medline Plus, Avoid sun, sunlamps, and tanning beds. Accessibility 25 mg, white, bullet-shaped suppository wrapped in silver foil. 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. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Acidosis and electrolyte losses should be corrected. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Off-label information indicates unopened bottle stable when maintained at continuous room On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. The site is secure. 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. 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. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. Avoid driving and doing other tasks or actions that call for you to be. Stability Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. 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&. If suppository is soft, chill in a refrigerator or run cold water over it. Promethazine 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. Stability of Refrigerated and Frozen Drugs - Care Plus Pharmacy Federal government websites often end in .gov or .mil. Allergic conjunctivitis due to inhalant allergens and foods. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Distributedby: Cosette Pharmaceuticals, Inc. Promethazine HCl Suppositories, USP are useful for: PRECAUTIONS- Information for Patients and Drug Interactions, Cosette Pharmaceuticals, Inc. product information by RSS, Additional medications in the Prescription Medications section by. ). We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Updated 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. Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. This includes your doctors, nurses, pharmacists, and dentists. Chem Pharm Bull (Tokyo). <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Diazepam may be used to control convulsions. to you and the baby. Additionally, one of each type of IVPB solution will be stored under white light and one of How long does promethazine stay in your system? 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. Treatment It is not known whether promethazine HCl is excreted in human milk. WARNING: PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Drug classes: Antihistamines, Phenothiazine antiemetics. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. Promethazine HCl Suppositories,USPare for rectal administration only. 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 WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Deep IM injection is the preferred route of administration. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Promethazine HCl Suppositories may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. 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. 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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. This report on medications is for your information only, and is not considered individual patient advice. Monoamine Oxidase Inhibitors (MAOI) The .gov means its official. 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. Do not try to test for pregnancy at home. Promethazine HCl 50mg. promethazine Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. WARNINGS Use in Pediatric Patients). 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 Avoid analeptics, which may cause convulsions. The https:// ensures that you are connecting to the FOIA PRECAUTIONS- Information for Patients and Drug Interactions). FROZEN Drugs Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com endobj ) for more information if you do not have access to a take-back program. 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). 25 mg, white, bullet-shaped suppository wrapped in silver foil. If the suppository feels soft, hold it under cold, running water for 1 minute. Copy the URL below and paste it into your RSS Reader application. If you have questions about side effects, call your doctor. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. PDR Uses of Promethazine Suppositories: It is used to ease allergy signs. In vivo and in vitro release of indomethacin from water-soluble and fatty base suppositories. MeSH Store suppositories in a refrigerator. Use with care in children 2 years of age and older. All Rights Reserved. Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. what signs you had. 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 ) or by phone (1-800-332-1088). Store promethazine suppositories in the refrigerator. PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV 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. Dinoprostone See the FDA's Safe Disposal of Medicines website (
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