If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Promethazine is well absorbed from the gastrointestinal tract. >> endobj We do not record any personal information entered above. The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Promethazine 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. Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Thank you. 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. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered. Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. 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. endobj Size: 473 mL. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. 353.759999 0] Codeine phosphate may be chemically designated as 7,8-Didehydro-4, 5α-epoxy- 3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. THEASSOCIATION DOES NOT DIRECTLY RELATE TO INDIVIDUALIZEDWEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFEADMINISTRATION. Promethazine hydrochloride and codeine phosphate syrup is a Schedule V Controlled Substance. 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. It is supplied in a clear green, pineapple flavored syrup and is available as follows: NDC 63187-595-04 4 fl. /Type /ExtGState and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). La combinación de codeine and promethazine se usa para el tratamiento de los síntomas del resfrío o alergias como nariz mocosa, estornudos, y tos. Your email has been sent. endobj 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. An increase in blood glucose has been reported in patients receiving promethazine. Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. endobj Your Name. Promethazine Hydrochloride and Codeine Phosphate Syrup contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent. OVERDOSAGE. 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 PHOSPHATE+PROMETHAZINE HCL In English Marca Contraindicaciones Efectos secundarios Advertencias Interacciones. Children: This medicine is not for use in children younger than 18 years of age. 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. Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. WARNINGS - Promethazine; Respiratory Depression, Angioneurotic edema. Codeine and promethazine puede también usarse para fines no mencionados en esta guía del medicamento. WARNINGS - CNS DepressionPRECAUTIONS - Drug interactions. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. Separate multiple email address with a comma . Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see ). 1722. >> información acerca de promethazine hydrochloride and phenylephrine hydrochloride and codeine phosphate The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Avoid analeptics, which may cause convulsions. << /Parent 2 0 R Promethazine Hydrochloride and Codeine Phosphate (Page 3 of 5) Proficient Rx LP 1 December 2018. 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. Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics). Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mL Rx Only CV BOXED WARNING WARNING: Respiratory Depression in Children and Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory Depression in Children The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less … ��C4��ҟ�_�U���: ���=� �'�D�K��wz 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 (see and ). Codeine is about 2/3 as effective orally as parenterally. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. 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. /F6 6 0 R However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence. 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. Promethazine with Codeine Drug Information / Drug Summary email print Close window. Accidental use by a child is a medical emergency and can cause death. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur. Neuroleptic malignant syndrome (potentially fatal) has also been reported. Advertisement. Acidosis and electrolyte losses should be corrected. Caution should be exercised when codeine is administered to a nursing woman. (see and ). When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose. Atlantic Biologicals Corps. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Promethazine should be used with caution in patients with bone-marrow depression. 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. PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- promethazine hydrochloride and codeine phosphate syrup  Clase terapéutica: DERIVADOS DEL OPIO Y EXPECTORANTES REPORTA UN EFECTO SECUNDARIO Códigos … 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. In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects of MAOI interaction. << /SA true endobj Get an overview of PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (syrup), including warnings and precautions, directions, and the names of other drugs and products that include the same medication. 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. /Creator (��) /SMask /None>> Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Email this page. Administration of promethazine has been associated with reported cholestatic jaundice. Send the page "" to a friend, relative, colleague or yourself. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Codeine: Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression, and gastrointestinal, urinary, and pupillary effects. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. �1��b}8��]B�e�c�f[ ���' THE COMBINATION OF PROMETHAZINEHYDROCHLORIDE AND CODEINE PHOSPHATE IS CONTRAINDICATED INPEDIATRIC PATIENTS LESS THAN 6 YEARS OF AGE, BECAUSE THECOMBINATION MAY CAUSE FATAL RESPIRATORY DEPRESSION IN THISAGE POPULATIONWARNINGS - Boxed WarningUse in Pediatric Patients, The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patient 6 years and older (see ). ¿Qué es PROMETHAZINE HCL AND CODEINE PHOSPHATE SYRUP ORAL 10 MG/5ML y para qué sirve? /ColorSpace << /MediaBox [0 0 612 792] If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Promethazine Hydrochloride and Codeine Phosphate Syrup and observed closely. Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. 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. 5 0 obj The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. 1 0 obj Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Resuscitation may be required (see ). It is important that promethazine hydrochloride and codeine phosphate syrup is measured with an accurate measuring device (see PRECAUTIONS - Information for patients). Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. NDC 12634-909-08 237 mL Bottle. 3 0 obj There are no adequate and well-controlled studies of promethazine in pregnant women. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Negligible amounts of codeine and its metabolites are found in the feces. /Annots 14 0 R Consulta si este medicamento se indica para tu condición médica: Diagnósticos del Paciente. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory
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