Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine.Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). ).Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring.There are no studies in humans, and the significance of these findings to humans, if any, is not known.Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine hydrochloride. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride has been used in association with other known marrow-toxic agents.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. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered.Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). 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 codeine therapy. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. As a result, codeine is contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Even at labeled dosage regiments, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Resuscitation may be required (see ).Limited data suggest that use of promethazine hydrochloride 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 effect of promethazine and/or codeine on later growth and development of the newborn is unknown.It is not known whether promethazine is excreted in human milk.Codeine is secreted into human milk. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. The average effective dose for children 6 years to under 12 years of age is ½ to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.Set id: 5eafbdbe-58f1-4f2c-a12f-7a5d924e5fff,THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE AND,CODEINE PHOSPHATE IS CONTRAINDICATED IN PEDIATRIC,PATIENTS LESS THAN 6 YEARS OF AGE. CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause … THE,ASSOCIATION DOES NOT DIRECTLY RELATE TO INDIVIDUALIZED,WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE,HYDROCHLORIDE AND CODEINE PHOSPHATE IS CONTRAINDICATED IN,PEDIATRIC PATIENTS LESS THAN 6 YEARS OF AGE, BECAUSE THE,COMBINATION MAY CAUSE FATAL RESPIRATORY DEPRESSION IN THIS,promethazine hydrochloride and codeine phosphate syrup,PRECAUTIONS - General - Ultra-rapid Metabolizers of Codeine,WARNINGS - Promethazine; Respiratory Depression,WARNINGS- Promethazine; Neuroleptic Malignant Syndrome. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.Codeine is contraindicated in patients with a known hypersensitivity to the drug.Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease.Codeine may cause or aggravate constipation.Respiraory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed.Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children.The respiratory depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. However, some women are ultra-rapid metabolizers of codeine. Codeine Phosphate-Promethazine HCl is a combination medicine used to treat cold or allergy symptoms such as runny nose, sneezing, and cough. 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. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine.Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system.Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. (See . Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).The diagnostic evaluation of patients with this syndrome is complicated. Codeine is contraindicated for post-operative pain management in these patients,Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death.Administration of promethazine has been associated with reported cholestatic jaundice.Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. Avoid analeptics, which may cause convulsions. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported.Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics).Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema.Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness.Drowsiness is the most prominent CNS effect of this drug. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure.Limited experience with dialysis indicates that it is not helpful.It is important that promethazine hydrochloride and codeine phosphate syrup is measured with an accurate measuring device (see ). Files,All Mapping pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Patients should be cautioned accordingly.Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol. Nausea is minimal after usual oral doses of codeine.Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.The concomitant 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 and should be avoided or their dosage reduced.Patients should be advised to report any involuntary muscle movements.Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Negligible amounts of codeine and its metabolites are found in the feces.Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours.The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed.Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients.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 should be used cautiously in persons with cardiovascular disease or with impairment of liver function.Patients should be advised to measure promethazine hydrochloride and codeine phosphate syrup with an accurate measuring device. Negligible amounts of codeine and its metabolites are found in the feces.Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours.The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.Atropine-like signs and symptoms - dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur.The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Codeine Phosphate-Promethazine HCl (codeine/promethazine) is a member of the upper respiratory combinations drug class and is commonly used for Cough.This Codeine Phosphate-Promethazine HCl price guide is based on using the.The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.Please note: This is a drug discount program, not an insurance plan. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life.Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.Narcotic analgesics cross the placental barrier. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.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. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. Convulsions may rarely occur. 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 codeine therapy. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. When given concomitantly with promethazine, 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. Acidosis and electrolyte losses should be corrected. It has a molecular weight of 406.37, a molecular formula of C H NO H PO • ½ H 0, and the following structural formula:Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients.Codeine may produce orthostatic hypotension in ambulatory patients.Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.Promethazine and codeine 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. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes 0-demethylation, N-demethylation, and partial conjugation with glucuronic acid. There are no adequate and well-controlled studies of promethazine in pregnant women.Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Codeine is less constipating than morphine.Codeine has good antitussive activity, although less than that of morphine at equal doses. 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 should be used with caution in patients with bone-marrow depression. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Codeine phosphate may be chemically designated as 7,8-Didehydro-4, 5α-epoxy- 3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate.The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see ). Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration.The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population,promethazine hydrochloride and codeine phosphate syrup,All Drug is this? Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the.A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. It has a molecular weight of 406.37, a molecular formula of C.Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.Promethazine hydrochloride and codeine phosphate syrup is a Schedule V Controlled Substance.Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Codeine is less constipating than morphine. Updated Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).The diagnostic evaluation of patients with this syndrome is complicated. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Diazepam may be used to control convulsions. 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 hydrochloride.Promethazine may lead to potentially fatal respiratory depression.Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.Promethazine may lower seizure threshold. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.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.
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