In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. Last updated on Apr 1, 2022. the unsubscribe link in the e-mail. Formulated with phenol, promethazine has a pH between 4 and 5.5. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration. 5705185. Draw back the plunger to fill the syringe with the correct amount of medication. Mayo Clinic does not endorse companies or products. Subcutaneous injection is contraindicated. F) [See USP Controlled Room Temperature]. Anymore can cause great pain and discomfort as well as injury to the injection site. We comply with the HONcode standard for trustworthy health information. Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Promethazine hydrochloride injection may cause marked drowsiness or impair the mental or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Created for people with ongoing healthcare needs but benefits everyone. Promethazine hydrochloride injection is contraindicated for use in pediatric patients less than 2 years of age (see, ). information submitted for this request. Common side effects of Phenergan may include: drowsiness, dizziness; ringing in your ears; double vision; feeling nervous; dry mouth; or. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Phenergan Injection should be used with caution in patients with bone-marrow depression. Clinical effects are generally apparent within 5 minutes of an intravenous injection and within 20 minutes of an intramuscular injection. We comply with the HONcode standard for trustworthy health information. Phenergan is a registered trademark of Wyeth and is used under license. Because of the potential for promethazine hydrochloride to reverse epinephrines vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Phenergan Injection overdose. Promethazine hydrochloride injection was nonmutagenic in the Salmonella test system of Ames. Do not use if solution has developed color or contains a precipitate. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see PRECAUTIONS - Pediatric Use). The management of NMS should include 1) immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. information highlighted below and resubmit the form. Phenergan may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. 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. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg (approximately 2.1 and 4.2 times the maximum recommended human daily dose) of Phenergan Injection. All rights reserved. Berkeley Heights, NJ 07922. Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or unintentional intra-arterial injection as pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. 1. Subcutaneous injection is contraindicated as it may result in tissue necrosis. Phenergan Injection (promethazine hydrochloride injection, USP) is available as follows: 1 mL vials packaged in 25s (NDC 0641-6084-25), 1 mL vials packaged in 25s (NDC 0641-6085-25). Drug information provided by: Merative, Micromedex. When given intravenously DBL Promethazine Hydrochloride Injection 25 mg/1 mL should be diluted 1 in 10 with water for injections or preferably given through the tubing of a freely flowing I.V. 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. Promethazine hydrochloride is contraindicated for use in pediatric patients less than two years of age. Protect from light. Portions of this document last updated: May 01, 2023. Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. 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. Sympathetic block and heparinization have been employed during the acute management of unintentional intra-arterial injection, because of the results of animal experiments with other known arteriolar irritants. Amelioration of allergic reactions to blood or plasma. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. The mean plasma half-life for promethazine after intramuscular administration in healthy volunteers has been reported to be 9.8 3.4 hours. Helps you get and maintain an erection when you need it. It should be injected slowly at a rate of administration not greater than 25 mg/minute (ie. Note that any depressant effects of promethazine hydrochloride injection are not reversed by naloxone. ). In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. When labor is definitely established, 25 to 75 mg (average dose, 50 mg) Phenergan Injection may be given with an appropriately reduced dose of any desired narcotic (see PRECAUTIONS Drug Interactions). Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. Phenergan Injection (promethazine hydrochloride injection, USP), is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Histamine can cause itching, sneezing, runny nose, and watery eyes. Promethazine 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. Promethazine is a competitive H1 receptor antagonist, but does not block the release of histamine. Phenergan Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Administration of promethazine has been associated with reported cholestatic jaundice. Patients should be advised to immediately report persistent or worsening pain or burning at the injection site. Patients should be advised of the risk of respiratory depression, including potentially fatal respiratory depression in children less than 2 years of age (see WARNINGS - Respiratory Depression). Promethazine Injection Prescribing Information, Promethazine hydrochloride injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. If necessary, Phenergan Injection with a reduced dose of analgesic may be repeated once or twice at four-hour intervals in the course of a normal labor. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Phenergan should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results. Dosage must be individualized. Under no circumstances should promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see. Following intravenous administration in healthy volunteers, the plasma half-life for promethazine has been reported to range from 9 to 16 hours. You may opt-out of email communications at any time by clicking on tiredness, sleep problems ( insomnia ). In the event that a patient complains of pain during intravenous injection of promethazine hydrochloride injection, the injection should be stopped immediately to evaluate for possible arterial injection or perivascular extravasation. include protected health information. Use of syringes with rigid plungers or of small-bore needles might obscure typical arterial backflow if this is relied upon alone. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Preoperative, postoperative, and obstetric (during labor) sedation. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,-trimethyl-, monohydrochloride, ()-) is a racemic compound and has the following structural formula: Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see PRECAUTIONS Pediatric Use). Promethazine is also used to prevent and control motion sickness, nausea, vomiting, and dizziness. See DOSAGE AND ADMINISTRATION for important notes on administration. Promethazine hydrochloride injection may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). As an adjunct to preoperative or postoperative medication, 25 to 50 mg of Phenergan Injection in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. ), Angioneurotic edema. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Copyright: Merative US L.P. 1973, 2023. A paradoxical-type reaction has been reported in pediatric patients receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Check with your doctor or nurse immediately if any of the following side effects occur: Get emergency help immediately if any of the following symptoms of overdose occur: Some side effects may occur that usually do not need medical attention. HCl Injection, USP and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Hallucinations have also been reported. This topic evoked considerable response from the media and readers who contacted us with comments about our recommendations along with troubling stories of . Was 21.99. The effect on later growth and development of the newborn is unknown. Phenergan Injection administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at This product is light sensitive and should be inspected before use and discarded if either color or particulate is observed. information and will only use or disclose that information as set forth in our notice of Because of the potential for promethazine hydrochloride to reverse epinephrines vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride injection overdose. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Protect from light. Phenergan Injection may lower seizure threshold and 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. Subcutaneous injection is contraindicated. Phenergan Injection (promethazine hydrochloride injection, USP) is a clear, colorless solution. Last updated on Apr 1, 2022. Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or unintentional intra-arterial injection as pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Excessively large dosages of antihistamines, including promethazine hydrochloride injection, in pediatric patients may cause sudden death (see OVERDOSAGE). Phenergan Injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. . Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Treatment of overdosage is essentially symptomatic and supportive. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: . other information we have about you. Promethazine injection is used to relieve or prevent some types of allergy or allergic reactions. ), Angioneurotic edema. Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Phenergan Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Other side effects not listed may also occur in some patients. Atropine-like signs and symptoms-dry mouth; fixed, dilated pupils; flushing; etc., as well as gastrointestinal symptoms, may occur. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine hydrochloride alone or in combination with antipsychotic drugs. Aug 26, 2008 Aniroc said: Okay, this response to the post is 10 years later, but should anyone else require this information .Deltoid injections should never exceed 1mL. Neuroleptic Malignant Syndrome (potentially fatal) has also been reported. other information we have about you. If we combine this information with your protected Drug information provided by: Merative, Micromedex. WARNINGS - Severe Tissue Injury, Including Gangrene, ADVERSE REACTIONS - Paradoxical Reactions, WARNINGS - Neuroleptic Malignant Syndrome. Keep covered in carton until time of use. Save 2.20. You may report side effects to the FDA at 1-800-FDA-1088. When used for control of postoperative nausea and vomiting, the dosage of analgesics and barbiturates should be reduced accordingly (see PRECAUTIONS - Drug Interactions). Note that any depressant effects of Phenergan Injection are not reversed by naloxone. Caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age or older. Problem: Promethazine (Phenergan, Wyeth) is a commonly used injectable product that possesses antihistamine, sedative, anti-motion sickness, and anti-emetic effects. Cialis Together 10mg Tablets - Tadalafil - 4 Tablets. Phenergan Injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Promethazine HCl Injection, USP The product is light sensitive. Mayo Clinic does not endorse companies or products. the unsubscribe link in the e-mail. Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, and their use should be limited to prolonged vomiting of known etiology. Long-term animal studies have not been performed to assess the carcinogenic potential of Phenergan Injection, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility. Great pain and discomfort as well as gastrointestinal symptoms, may occur bone-marrow... 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Important notes on administration this is relied upon alone injection and within 20 minutes an! Decreased blood pressure, tachycardia, bradycardia, faintness be used in vomiting of unknown etiology in children adolescents! May cause sudden death ( see OVERDOSAGE ) control of nausea and vomiting associated with certain types of anesthesia surgery... Or of small-bore needles might obscure typical arterial backflow if this is relied upon alone in tissue necrosis product! For other uncomplicated allergic conditions of the potential for fatal respiratory depression fatal respiratory depression symptoms have found! Considerable response from the media and readers who contacted us with comments about our along... Suggested adult dose and maintain an erection when you need it types of anesthesia and surgery ( )! Exercised when administering promethazine hydrochloride injection was nonmutagenic in the e-mail Room Temperature ] to hours... 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