PRECAUTIONS - Information for patients, Set id: 5eafbdbe-58f1-4f2c-a12f-7a5d924e5fff, CODEINE PHOSPHATE IS CONTRAINDICATED IN PEDIATRIC PATIENTS, LESS THAN 6 YEARS OF AGE. Use of Promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Instruct nursing mothers to talk to the baby’s doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Atlantic Biologicals Corps. It is supplied in a clear green, pineapple flavored syrup and is available as follows: NDC 63187-595-04 4 fl. Close. Pharmacology refers to the chemical makeup and behavior of PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (syrup). Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. 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. /Font << Codeine is about 2/3 as effective orally as parenterally. Promethazine should be used with caution in patients with bone-marrow depression. oz. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Type: Rx. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, … 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. Principio activo: CODEINE PHOSPHATE+PROMETHAZINE HCL Marca: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE. Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. Codeine and promethazine puede también usarse para fines no mencionados en esta guía del medicamento. PRECAUTIONS - General - Ultra-rapid Metabolizers of Codeine. Codeine and promethazine is a combination medicine used to treat cold or allergy symptoms such as runny nose, sneezing, and cough.. Codeine and promethazine contains an opioid cough medicine, and may be habit-forming.Codeine and promethazine may also be used for purposes not listed in this medication guide. OVERDOSAGE. What is Codeine Phosphate-Promethazine HCl? Consulta si este medicamento se indica para tu condición médica: Diagnósticos del Paciente. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. >> 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. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. Codeine phosphate may be chemically designated as 7,8-Didehydro-4, 5α-epoxy- 3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. Promethazine is well absorbed from the gastrointestinal tract. endobj endobj Promethazine: Stimulation may be evident, especially in children and geriatric patients. 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. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine may lead to potentially fatal respiratory depression. >> The effect of promethazine and/or codeine on later growth and development of the newborn is unknown. 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. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl. 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. PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- promethazine hydrochloride and codeine phosphate syrup  Inactive Ingredients: Boysenberry flavor, citric acid, D&C Red 33, FD&C Blue 1, FD&C Yellow 6, glycerin, saccharin sodium, sodium benzoate, sodium citrate, sodium propionate, sucrose and purified water. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Information for Patients: Patients should be advised to measure Promethazine Hydrochloride and Codeine Phosphate Syrup with an accurate measuring device. It is important that promethazine hydrochloride and codeine phosphate syrup is measured with an accurate measuring device (see PRECAUTIONS - Information for patients). Promethazine Hydrochloride and Codeine Phosphate Syrup contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent. << Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Promethazine se usa para el tratamiento de los síntomas de alergia, como picazón, nariz mocosa, estornudos, ojos llorosos o con escozor, ronchas, y sarpullidos que pican. Consulta si este medicamento se indica para tu condición médica: Diagnósticos del Paciente. 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 Salmonella assay. Drowsiness is the most prominent CNS effect of this drug. Clinical studies of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. << Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered. Caution should be exercised when promethazine hydrochloride and codeine phosphate syrup is administered to a nursing woman. It is important that promethazine hydrochloride and codeine phosphate syrup is measured with an accurate measuring device (see ). The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. NDC 12634-909-04 120mL Bottle. /F6 6 0 R Codeine: It is difficult to determine what constitutes a standard toxic or lethal dose. información acerca de promethazine hydrochloride and codeine phosphate promethazine hcl+codeine phosphate syrup 10/6.25 mg/5ml promethazine hcl and codeine phosphate syrup … 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. Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. (see and ). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. A WIDE RANGE OF WEIGHT-BASED DOSES, OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN. THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE AND, CODEINE PHOSPHATE IS CONTRAINDICATED IN PEDIATRIC, PATIENTS LESS THAN 6 YEARS OF AGE. 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. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. %PDF-1.4 Promethazine Hydrochloride and Codeine Phosphate Syrup contains promethazine hydrochloride, USP 6.25 mg/5 mL, codeine phosphate, USP 10 mg/5 mL and alcohol 7 percent. 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. /SM 0.02 Codeine has good antitussive activity, although less than that of morphine at equal doses. Treatment: Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. If a … 3 0 obj WARNINGS - Use in Pediatric Patients. [/Pattern /DeviceRGB] x��Mo#7���}^```����C�C0�dd�ur��ߖԲ�|���[�fd#��&���]E��?,~��x����s���q��YV��W��~7�͍��֕����*>YϋO�O���?��Y�s�������z�S��/�֖�M7�q��߆M���i*�t�K�����.�����ɥv�1���o���ԭ1ec6�y;��?j�ƶ��Y��|섫��;�²p�6˄uf�s�����i���ð*�~.����xڠ��㥧���������ׅ��n;b�#v?�#n?RnGV���v��G*�Sc�ϴ���f����%.~�)������1q-4�f��8��0 sҘ�Ę�h���l'ٖ����6nҏ� �����Q0��l�����'���l�m�[h��iZ��+�� @��ϱ]��I� 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. 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. 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. This rapid conversion results in higher than expected serum morphine levels. The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. 4 0 obj In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. 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. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. 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. Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Rx only. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. /CSpg /DeviceGray These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine, which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. 9 0 obj Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. WARNINGS - Promethazine; Respiratory Depression, Angioneurotic edema. 641.759999 0] We do not record any personal information entered above. There are no adequate and well-controlled studies of promethazine in pregnant women. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. stream información acerca de promethazine hydrochloride and codeine phosphate syrup oral 6.25 mg/5ml - estados unidos Codeine Phosphate-Promethazine HCl Prices This Codeine Phosphate-Promethazine HCl price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies. An increase in blood glucose has been reported in patients receiving promethazine. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. The duration of action, which is dose-dependent, usually did not exceed 3 hours. Negligible amounts of codeine and its metabolites are found in the feces. CONTRAINDICATIONS. Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. /Creator (��) Promethazine was nonmutagenic in the test system of Ames. Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. ¿Qué es PROMETHAZINE W/CODEINE y para qué sirve? ... PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE. (See ). Promethazine: 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. The diagnostic evaluation of patients with this syndrome is complicated. información acerca de promethazine hydrochloride and phenylephrine hydrochloride and codeine phosphate << Consulta si este medicamento se indica para tu condición médica: Diagnósticos del Paciente. Caution should be exercised when codeine is administered to a nursing woman. 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. Psychological dependence, physical dependence, and tolerance are known to occur with codeine. Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. 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. >> Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is … Codeine is less constipating than morphine. (118 mL) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Codeine may produce orthostatic hypotension in ambulatory patients. /Type /Page 353.759999 0] Resuscitation may be required (see ). 2 5 m g a n d 1 0 m g / 5 m L � R x O n l y � C V) Promethazine es un antihistamínico. Thank you. It is strongly recommended that an accurate measuring device be used. Data is not available for other ethnic groups. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Patients should be advised to measure Promethazine with Codeine Oral Solution with an accurate measuring device. Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. >> CONCOMITANT ADMINISTRATION OF, PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY, DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. Promethazine with Codeine Drug Information / Drug Summary email print Close window. WARNINGS - CNS DepressionPRECAUTIONS - Drug interactions. Avoid analeptics, which may cause convulsions. Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness. It is supplied as follows: NDC 12634-909-02 60 mL Bottle. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. If promethazine and codeine is taken by someone else or by accident, get medical help right away. Diazepam may be used to control convulsions. 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. /ExtGState << Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Compare To: Phenergan® with Codeine. /SMask /None>> OVERDOSAGE. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. 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. 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, unconsciousness, and sudden death. [ ] /Pattern << Animal reproduction studies have not been conducted with the drug combination – promethazine and codeine. /CreationDate (D:20190118163528-05'00')