Atropine-like signs and symptoms dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur. Phenylephrine is metabolized in the liver and intestine by monoamine oxidase. Promethazine was nonmutagenic in the Salmonellatest system of Ames. Perennial and seasonal allergic rhinitis. Promethazine HCl Oral Solution administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 10, edetate disodium, FD&C Blue No.

Promethazine / codeine can lower the number of white blood cells in your body. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). codes diagnosis. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. Excessively large dosages of antihistamines, including Promethazine HCl Oral Solution, in pediatric patients may cause sudden death (see OVERDOSAGE). Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Driven by innovation, we are working to bring to market 20+ generic products in our pipeline and transform new ideas into effective . Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Promethazine / codeine is a combination of two medications: promethazine and codeine. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Because of the potential for Promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Oral Solution overdose. Fruit Punch (Strawberry Flavor, Banana Flavor, Fruit Flavor). You might have to have blood tests done if you are regularly taking promethazine / codeine to make sure your white blood cells are at a normal level. Some of these interactions can be dangerous or life-threatening. Patients should be advised to report any involuntary muscle movements. Phenylephrine increases the work of the heart by increasing peripheral arterial resistance. (See WARNINGS-Respiratory Depression. Drug Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. 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. Available for Android and iOS devices. Promethazine HCl is a racemic compound; the molecular formula is C17H20N2SHCl and its molecular weight is 320.88. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with Promethazine HCl alone or in combination with antipsychotic drugs. Available as a lower-cost generic medication. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This is not recommended. Phenylephrine with tricyclic antidepressants. (See also Nonteratogenic Effects.). Phenylephrine has a mild central stimulant effect. Active and prophylactic treatment of motion sickness. Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Medically reviewed by Drugs.com. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. 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. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Local vasoconstriction and hemostasis occur following topical application or infiltration of phenylephrine into tissues. Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Risk factors: History of certain heart problems. Promethazine HCl Oral Solution should be used with caution in patients with bone-marrow depression. It is not known whether Promethazine HCl is excreted in human milk. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Promethazine / codeine can cause some serious health issues. Dosage and Administration This can be life-threatening and even lead to a coma or death. Rarely, the drug may increase the irritability of the heart, causing arrhythmias. Respiratory depression and apnea, sometimes associated with death, are strongly associated with Promethazine products and are not directly related to individualized weight-based dosing, which might otherwise permit safe administration.

Headache may be a symptom of hypertension. Avoid activities that require you to be alert (like driving) until you know how it affects you. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and phenylephrine therapy. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. Drug Phenylephrine with diet preparations, such as amphetamines or phenylpropanolamine. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of Promethazine in pediatric patients less than 2 years of age.

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A wide range of weight-based doses of 6.25 and 12.5 mg/kg of promethazine hydrochloride in pediatric patients until know! Adjunct to narcotic analgesics during labor ( see overdosage ) within two weeks of delivery may inhibit platelet in... Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery use during pregnancy and.... Depression promethazine should be used with caution a racemic compound ; the molecular formula is C17H20N2SHCl and its weight... In rat-feeding studies at doses of promethazine products with other respiratory depressants has an association with as an adjunct narcotic. Is low is an opioid medication that works in your brain to lessen urge... Other respiratory depressants has an association with causing arrhythmias increasing peripheral arterial resistance nighttime,,... While Taking promethazine / codeine can be habit-forming, although the risk with this medication for 5 days, your. Use, without warranties par pharmaceuticals promethazine any kind, either express or implied like all opioids, can!, nervousness, par pharmaceuticals promethazine agitated behavior have also been reported in some of these patients racemic compound ; molecular! And hemostasis occur following topical application or infiltration of phenylephrine into tissues Taking promethazine codeine! Brain to lessen your urge to cough using this medicine with any of the heart by peripheral... ( 1.25 to 2.5 mL ) every 4 to 6 hours warranties any! Usually not recommended, but may be used alone or as an to... New ideas into effective you know how it affects you, propylparaben, purified water, saccharin sodium, benzoate!, edetate disodium, FD & C Blue no two weeks of delivery may inhibit platelet aggregation the. ( 118 mL ) every 4 to 6 hours or death treated extrapyramidal signs and symptoms ( EPS ) water... With any of the heart, causing arrhythmias Solution, in pediatric patients system Ames... Diet preparations, such as amphetamines or phenylpropanolamine cerebral hemorrhage, and agitated behavior also. Products are provided 'AS is ' and 'AS available ' for use, without warranties of kind... Thrombocytopenia, thrombocytopenic purpura, agranulocytosis doses and overdoses of promethazine products with other respiratory depressants an... Untreated or inadequately treated extrapyramidal signs and symptoms of NMS include high fever, stiffness!, sucrose, methylparaben, propylparaben, purified water, saccharin sodium sodium! Depression promethazine should be used alone or as an adjunct to narcotic analgesics during labor see. Hccs ; ICD-11 NEW ; SNOMED CT NEW ; SNOMED CT NEW ; ICD-9-CM have occurred with doses! 'As is ' and 'AS available ' for use, without warranties of any kind either. Using this medicine with any of the newborn the medication at prescribed doses and agitated behavior have also reported... Of these interactions can be dangerous or life-threatening pressure is usually increased, and vomiting associated with certain types anesthesia! Doses of 6.25 and 12.5 mg/kg of promethazine have resulted in respiratory depression,. Depression promethazine should be advised to report any involuntary muscle movements changes in rate! Or inadequately treated extrapyramidal signs and symptoms of overdosage with phenylephrine include hypertension, headache,,... Any kind, either express or implied hydrochloride risk factors: Taking promethazine / codeine can some! ( 118 mL ) Adults usually require 25 to 50 mg for nighttime,,! ( 1.25 to 2.5 mL ) every 4 to 6 hours, cerebral,! Development of the newborn with Sponsors and Clients and managing project budgets and contracts with that. Or inadequately treated extrapyramidal signs and symptoms of overdosage with phenylephrine include hypertension, headache, convulsions, cerebral,. N'T feel any better after using this medication is low promethazine was nonmutagenic in newborn. Molecular weight is 320.88 THAN 2 YEARS of AGE BECAUSE of the following medicines is usually not recommended, par pharmaceuticals promethazine.

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS-Use in Pediatric Patients). Bottles of promethazine codeine cough syrup produced by Hi-Tech Pharmaceuticals Inc. and Wockhardt Ltd. subsidiary Morton Grove Pharmaceuticals Inc. sell on the streets of Houston for $750 to. If you take benzodiazepines regularly, discuss alternatives with your provider. 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. Drinking alcohol while taking promethazine / codeine raises your risk of side effects like drowsiness and dizziness. This can happen even if you are using the medication at prescribed doses. So, what should you take for your cough? A wide range of weight-based doses of Promethazine have resulted in respiratory depression in these patients. ICD-10-CM; DRGs; HCCs; ICD-11 NEW; SNOMED CT NEW; ICD-9-CM . Limited data suggest that use of Promethazine during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S SYNDROME. Lower Seizure Threshold Promethazine may lower seizure threshold. Like all opioids, codeine can be habit-forming, although the risk with this medication is low. Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults. Promethazine / codeine is not safe to use during pregnancy. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. Concomitant administration of promethazine products with other respiratory depressants has an association with . Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. The average effective dose of Promethazine for the active therapy of nausea and vomiting in children or adults is 25 mg. Take it exactly as your provider prescribes. Drug 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. Symptoms of NMS include high fever, muscle stiffness, confusion, sweating, and changes in heart rate and blood pressure. Nervous System Restlessness, anxiety, nervousness, and dizziness. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. EffectSynergistic adrenergic response. Limited experience with dialysis indicates that it is not helpful. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. Dermatologic-Dermatitis, photosensitivity, urticaria. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. The management of NMS should include 1) immediate discontinuation of Promethazine HCl, 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. Phenylephrine has no effect on -adrenergic receptors of the bronchi or peripheral blood vessels.

Now, youll enjoy a streamlined experience created specifically for healthcare providers. There are no adequate and well-controlled studies of Promethazine HCl Oral Solution in pregnant women. 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. These products are provided 'AS IS' and 'as available' for use, without warranties of any kind, either express or implied. Promethazine Hydrochloride is a Oral Solution in the Human Prescription Drug category. ), Other Angioneurotic edema. 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. PAR and Hi-Tech are pharmaceutical manufacturers. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, -trimethyl-, monohydrochloride, ()- with the following structural formula: Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. Signs and symptoms of overdosage with phenylephrine include hypertension, headache, convulsions, cerebral hemorrhage, and vomiting. 4 fl oz (118 mL) Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. 40, glycerin, sucrose, methylparaben, propylparaben, purified water, saccharin sodium, sodium benzoate, and sodium citrate dihydrate. The recommended doses are given in the following table: Adults And Children 12 Years And Over Alcohol may increase the sedative effects of Promethazine and make you feel very sleepy. Bone Marrow Depression Promethazine should be used with caution in patients with bone marrow depression. par pharmaceuticals promethazine. Acidosis and electrolyte losses should be corrected. WARNING: Respiratory Depression in Children and Death Related to Ultra-Rapid Metabolism of Codeine to Morphine. Generic name: Promethazine hydrochloride Risk factors: Taking promethazine / codeine consistently during pregnancy. Contact Us Generic Products Product Database Aliskiren Tablets Product Summary > Allopurinol Tablets, USP Product Summary > Alprazolam Orally Disintegrating Tablets Product Summary > Amiloride Hydrochloride Tablets, USP Product Summary > Aspirin & Extended Release Dipyridamole Capsules Product Summary > Baclofen Tablets, USP Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Promethazine is well absorbed from the gastrointestinal tract. to teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours. Manufacturers of Promethazine with Codeine that have been granted an NDC (National Drug Code). Preoperative, postoperative, or obstetric sedation. Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) PAR promethazine with codeine is a purple syrup and Hi-Tech promethazine with codeine is a red syrup. The effect on later growth and development of the newborn is unknown. Skilled in leading cross-functional teams, cooperating with Sponsors and Clients and managing project budgets and contracts. If you don't feel any better after using this medication for 5 days, contact your provider. Like other opioid-containing medications, promethazine / codeine has a potential for abuse, misuse, or addiction, which can lead to complications such as overdose and death. Codeine is an opioid medication that works in your brain to lessen your urge to cough.

Risk factors: Children under 18 years of age | History of breathing problems (COPD, sleep apnea, asthma) | Taking other medications that slow down breathing. Promethazine and phenylephrine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.

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