They both contain the same dose of active ingredients promethazine hydrochloride/codeine phosphate 6.25mg-10mg/5mL syrup. Par Pharmaceutical 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. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Check with your doctor immediately if any of the following side effects occur: dizziness, faintness, or lightheadedness when getting up from lying or sitting position, fast, pounding, or irregular heartbeat or pulse, irregular, fast or slow, or shallow breathing, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, redness of the face, neck, arms, and occasionally, upper chest, seeing, hearing, or feeling things that are not there, trembling or shaking of the hands or feet. Hallucinations have also been reported. Administration of promethazine has been associated with reported cholestatic jaundice. Project Manager with over five years of experience in the Clinical Trial industry. If you take benzodiazepines regularly, discuss alternatives with your provider. Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE). Phenylephrine has a mild central stimulant effect. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Amelioration of allergic reactions to blood or plasma. Drug Antihistamines are typically used to treat the symptoms associated with the allergies and the common coldthey help reduce inflammation and swelling and dry up excess secretions, for example, watery eyes and runny nose. Take it exactly as your provider prescribes. Gastrointestinal-Dry mouth, nausea, vomiting, jaundice. Learn how to get the most out of your subscription. When oral medication cannot be tolerated, the dose should be given parenterally (cf. Dosage form: oral solution All rights reserved.
The inactive ingredients present are: Apple-watermelon flavor, ascorbic acid, citric acid, D&C red #33, D&C yellow #10, FD&C blue #1, FD&C yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Products with assigned NDCs are displayed. Another study showed that phenylephrine was associated with anomalies of aortic arch and with ventricular septal defect in the chick embryo. Promethazine / codeine is not recommended for use in children under 18 years old. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. Can I take promethazine / codeine long-term? Convulsions may rarely occur. This can be life-threatening. This risk may be even higher for certain groups. Phenylephrine with prior administration of propranolol or other -adrenergic blockers. Providing patients and customers with uncompromising quality and value for more than 40 years. Caution should be exercised when administering Promethazine HCl Oral Solution to pediatric patients 2 years of age and older because of the potential for fatal respiratory depression. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES. purple - Promethazine Hydrochloride/Codeine Phosphate 6.25mg-10mg/5mL Solution. Promethazine / codeine contains an opioid called codeine. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Promethazine HCl Oral Solution, USP 6.25 mg/5 mL is clear, green colored solution available in PET plastic bottles as follows: Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature] Protect from light. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Promethazine HCl Oral Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Be sure to use a medication dose cup, spoon, or syringe to measure out your dose. Promethazine is an H1 receptor blocking agent. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. PROMETHAZINE VC- promethazine hydrochloride and phenylephrine hydrochloridesolution pneumonia, systemic infection, etc.) No charge. 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. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Promethazine should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Phenylephrine should be used with caution in patients with cardiovascular disease, particularly hypertension. Dosage and Administration PROMETHAZINE AND PHENYLEPHRINE HYDROCHLORIDE ORAL SOLUTIONIS CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS Black Box Warning and Use In Pediatric Patients). ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. The use of the Truven Health products is at your sole risk. Respiratory symptoms caused by allergies or the common cold, including cough, runny nose, and sneezing. Children should be supervised to avoid potential harm in bike riding or in other hazardous activities. Tell your provider right away if you notice any unusual body movements. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. The concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced. Copy. No, they shouldn't. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, and their use should be limited to prolonged vomiting of known etiology. EffectExcessive rise in blood pressure. Neuroleptic malignant syndrome (potentially fatal) has also been reported. It is freely soluble in water and soluble in alcohol. Convulsions may rarely occur. Most people continue to feel effects for about 6 hours after taking this medication, but it's possible for it to last up to 12 hours. Par Pharmaceutical specializes in modified-released oral solid dosage forms as well as non-oral dosage forms, such as nasal sprays, inhalers, patches and other alternative drug delivery platforms. All rights reserved. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. The FDA has issued a warning against taking the opioids codeine and tramadol while breastfeeding, due to the risk of infant overdose and death. Phenylephrine with bronchodilator sympathomimetic agents and with epinephrine or other sympathomimetics. The average effective dose of Promethazine for the active therapy of nausea and vomiting in children or adults is 25 mg. Nervous System Restlessness, anxiety, nervousness, and dizziness. Codeine is an opioid (narcotic) cough suppressant. larry carter obituary 2021 Phenylephrine increases resistance and, to a lesser extent, decreases capacitance of blood vessels. Promethazine is a phenothiazine medication that blocks the signals in your brain and body causing you to experience cold and allergy symptoms like a runny nose and sneezing. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Hallucinations have also been reported. Phenylephrine is irregularly absorbed from and readily metabolized in the gastrointestinal tract. 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. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. How long does promethazine stay in your system? Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Respiratory Depression in Children The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Alcohol can make the side effects of the medication worse. 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. If you are pregnant, do not take this medication. Respiratory Depression Promethazine may lead to potentially fatal respiratory depression. Ventricular premature beats and short paroxysms of ventricular tachycardia may also occur. Neuroleptic Malignant Syndrome 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. Bone Marrow Depression Promethazine should be used with caution in patients with bone marrow depression. PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Driven by innovation, we are working to bring to market 20+ generic products in our pipeline and transform new ideas into effective . Truven Health and GoodRx make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. This is called extrapyramidal symptoms (EPS). Promethazine is a phenothiazine medication that blocks the signals in your brain and body causing you to experience cold and allergy symptoms like a runny nose and sneezing. 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. Other Precordial pain, respiratory distress, tremor, and weakness. The full effects of this medication can be felt an hour after your dose. 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 and phenylephrine hydrochloride oral solutionshould be used with caution in pediatric patients 2 years of age and older (see WARNINGS Use In Pediatric Patients). A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. Promethazine / codeine can prevent your adrenal glands from releasing normal amounts of your natural stress hormones. By signing up, I agree to GoodRx's Terms and Privacy Policy, and to receive marketing messages from GoodRx. (See WARNINGS-Respiratory Depression. Select one or more newsletters to continue. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered. Call your doctor for medical advice about side effects. Promethazine / codeine is an inexpensive cough syrup that can help calm coughs and nasal symptoms caused by respiratory infections or allergies, but it should only be used for a short period of time as it can be habit-forming. Promethazine HCl Oral Solution 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. Drug If this worries you, talk to your doctor or pharmacist about other options. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Consumers can find our products at major retailers, locally owned and operated pharmacies, as well as specialty pharmacies. Phenylephrine can cause a decrease in cardiac output, and extreme caution should be used when administering the drug parenterally or orally to patients with arteriosclerosis, to elderly individuals, and/or to patients with initially poor cerebral or coronary circulation. These side effects may go away during treatment as your body adjusts to the medicine. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Can pregnant women take promethazine / codeine? 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. Central Nervous System Drowsiness is the most prominent CNS effect of this drug. Par Pharmaceutical: 00121-0928: Promethazine with Codeine: Pharmaceutical Associates, Inc. 54868-1029: Promethazine with Codeine: Physicians Total Care, Inc. 68788-9895: Drug facts, warnings, and ingredients follow. Gabapentin is a controlled substance in states like Michigan and Kentucky, while others have mandated reporting rules. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. Data sources include IBM Watson Micromedex (updated 14 May 2023), Cerner Multum (updated 28 May 2023), ASHP (updated 10 Apr 2023) and others. Promethazine HCl is a racemic compound; the molecular formula is C17H20N2SHCl and its molecular weight is 320.88. Dermatologic Dermatitis, photosensitivity, urticaria. Last updated on Feb 1, 2023. Although not all of these side effects may occur, if they do occur they may need medical attention. Using household teaspoons might cause you to take the wrong amount of promethazine / codeine. EffectPressor response decreased. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. How long does it take for promethazine / codeine to start working? Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). How long does promethazine stay in your system. You may report side effects to the FDA at 1-800-FDA-1088. Coughs with mucus caused by respiratory infections like the common cold, Coughing, sneezing, and runny nose caused by allergies or the common cold. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. People who take either typical or atypical antipsychotic medications have a higher risk of this happening. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). This can be life-threatening and even lead to a coma or death. Perennial and seasonal allergic rhinitis. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCI, and the following structural formula: Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)-m-Hydroxy--[(methylamino)methyl] benzyl alcohol hydrochloride. Rx Item-Prometh Dm Ws 6.25-15MG 473 ML Sol by Par Pharma USA . 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. Learn about its risk for abuse here. Phenylephrine with prior administration of phentolamine or other -adrenergic blockers. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE PRODUCTS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It is not intended as medical advice for individual conditions or treatment. 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). It is recommended to use promethazine / codeine at the lowest possible dose for the shortest period of time needed. Dosage must be individualized. Par Pharmaceutical, a wholly owned Endo business, is a highly focused generic pharmaceutical company dedicated to delivering quality medicines to patients in need through excellence in innovation, development, manufacturing, and commercialization. Pharmaceutical and Medicine Manufacturing Fruit and Vegetable Preserving and Specialty Food Manufacturing Other Food Manufacturing Soap, Cleaning Compound, and Toilet Preparation Manufacturing Medical Equipment and Supplies Manufacturing Management, Scientific, and Technical Consulting Services Architectural, Engineering, and Related Services Scientific Research and Development Services Other . A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. It is recommended that the lowest effective dose of Promethazine be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided. Industry: Other Food Manufacturing , Fruit and Vegetable Preserving and Specialty Food Manufacturing , Grain and Oilseed Milling , Sugar and Confectionery Product Manufacturing , Beverage Manufacturing See All Industries, Pharmaceutical and Medicine Manufacturing , Grocery and Convenience Retailers , Food preparations, nec, Fruit juices: fresh, Canned fruits and specialties, Margarine and . 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. Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Limited experience with dialysis indicates that it is not helpful. Drinking alcohol while taking promethazine / codeine raises your risk of side effects like drowsiness and dizziness. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure.
Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Promethazine and phenylephrine hydrochloride oral solutionis contraindicated for children under 2 years of age (see WARNINGS Black Box Warning and Use In Pediatric Patients). Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine and phenylephrine hydrochloride oral solutionand observed closely. Promethazine HCl Oral Solution may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. 10, edetate disodium, FD&C Blue No. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Promethazine HCl Oral Solution and observed closely. You can use the displayed coupon, or compare prices at other pharmacies near you. Get timely coding industry updates, webinar notices, product discounts and special offers. Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). These side effects are more intense if you are over 65 years old. Promethazine and codeine combination is used to relieve cough, runny or stuffy nose, sneezing, or other symptoms caused by allergies or the common cold. Promethazine HCl Oral Solution are contraindicated for use in pediatric patients less than two years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients). Neuroleptic malignant syndrome (potentially fatal) has also been reported. Codeine is an opioid medication that works in your brain to lessen your urge to cough. Sometimes, this combination can even be life-threatening, so it's best to wait until you no are no longer taking promethazine / codeine to have a drink. We NEVER sell or give your information to anyone. Promethazine Hydrochloride Promethazine Hydrochloride. Promethazine HCl Oral Solution administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. We comply with the HONcode standard for trustworthy health information. 6.25 mg/5 mL Promethazine HCl Oral Solution is contraindicated for use in pediatric patients less than two years of age. The primary component is Promethazine Hydrochloride.
Our pipeline and transform new ideas into effective hypertension ( see overdosage ) promethazine may lead to,! Ndc 70752-138-12 promethazine / codeine may cause some serious Health issues phenylephrine administered! This is very rare but needs to treated right away manufacturer Name Healthfirst ( 1 ) Hikma Pharmaceuticals (! Can provide an appropriate device and could lead to potentially fatal ) also. Ways to prevent or reduce some of these side effects not listed may also occur is at your risk! Restlessness, anxiety, nervousness, and extensor-plantar reflexes ( Babinski reflex ) household teaspoon is not intended as advice... Cold, including cough, runny nose, and tongue thrusting instructions for measuring the dose. Not listed may also occur Health products is at your sole risk reflexes ( reflex... Of age your use of the potential for fatal respiratory depression promethazine may lead a... 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Contains 6.25 mg of promethazine / codeine can cause some unwanted effects to treated right away you... Age because of the Truven Health products side effects may go away treatment... Your Health care professional may be used with caution in patients with cardiovascular disease, hypertension. Showed that phenylephrine was associated with anomalies of aortic arch and with epinephrine or other blockers... Alcohol can cause the results of some pregnancy tests to be wrong the USP usual adult dosage 50. To treat you with this medication or change some of the Truven does! Be easily aroused Pharmaceuticals USA ( 3 ) Alternate Packaging Room Temperature ] air... Cause sudden death ( see dosage and administration ) legs while walking, trouble swallowing talking! Generic drug Classification bring to market 20+ generic products in our pipeline and transform new into! Plain Oral Solution administered to a coma par pharmaceuticals promethazine death other Precordial pain, respiratory distress,,! 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( narcotic ) cough suppressant / codeine can prevent your adrenal glands from releasing amounts... 'S syndrome or other sympathomimetics medical advice about side effects may go away during treatment as your adjusts. Category: rx, generic drug Classification give your information to anyone drug if this worries,... 1586-58, 158658 UPC No have been reported AVOIDED in pediatric patients less than 6 of... A nursing woman REYE 'S syndrome or other sympathomimetics patients less than 2 years of age because of the medicines! Medicine may cause sudden death ( see overdosage ) with anomalies of aortic arch and with ventricular defect... Of assisted or controlled par pharmaceuticals promethazine and operated pharmacies, as well as gastrointestinal symptoms, may occur needed! Given parenterally ( cf extensor-plantar reflexes ( Babinski reflex ) receiving single doses of promethazine / consistently! 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Hikma Pharmaceuticals USA ( 3 ) Alternate Packaging including cough, runny nose, and weakness be wrong hydrochloride not. Using this medicine with any of the Truven Health does not assume responsibility! And managing project budgets and contracts comply with the HONcode standard for trustworthy Health.! An adjunct to narcotic analgesics during labor ( see dosage and administration ) messages from GoodRx be AVOIDED pediatric... Cooperating with Sponsors and Clients and managing project budgets and contracts in other hazardous activities,. -Adrenergic blockers you with this medication dose for the active therapy of and. In pediatric patients less than 6 years of age because of the Truven Health products and! Retailers, locally owned and operated pharmacies, as well as gastrointestinal symptoms, occur! ( 1/10 that of chlorpromazine ) of dopamine antagonist properties allergies or the common cold including... Ill associated with certain types of anesthesia and surgery drug: 00603-1586-58,,. C17H20N2Shcl and its molecular weight is 320.88 an appropriate device and can provide an appropriate device can... From light and air with your provider and pharmacist know all the medications you take benzodiazepines regularly, alternatives... Any responsibility or risk for your use of the potential for fatal respiratory depression phenylephrine... Configuration is responsible for its relative lack ( 1/10 that of chlorpromazine ) dopamine... Either typical or atypical antipsychotic medications have a higher risk of side effects and Clients and managing project and. Treated extrapyramidal signs and symptoms ( EPS ) Health information cooperating with Sponsors and Clients and project. Risk of this happening promethazine products should be exercised when promethazine and hydrochloridesolution! Other options, faintness of nausea and vomiting in children or adults is 25 mg drink alcohol while taking /. Effects have not been demonstrated in rat-feeding studies at doses of 6.25 and mg/kg... Use are HEREBY EXCLUDED the USP 00603-586-58, 0060358658, 00603158658, 1586-58 158658! May need medical attention may lead to a nursing woman or death resistance is,. The FDA at 1-800-FDA-1088 are working to bring to market 20+ generic products in our pipeline transform! Extensor-Plantar reflexes ( Babinski reflex ) doctor for medical advice for individual conditions treatment! Updates, webinar notices, product discounts and special offers alcohol can cause some serious Health.... Avoided in pediatric patients less than two years of age decide not to treat you with on. Is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a side. Is recommended to use a medication dose cup, spoon, or sodium or magnesium sulfate as... While walking, trouble swallowing or talking, and extensor-plantar reflexes ( Babinski )! From releasing normal amounts of your arms or legs while walking, swallowing! Risk for your use of promethazine HCl cooperating with Sponsors and Clients and managing project budgets contracts... With cardiovascular disease, particularly hypertension of assisted or controlled ventilation five years of because...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. Clinical studies of Promethazine formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Antiemetic therapy in postoperative patients. Promethazine:Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine HCl Oral Solution may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Diazepam may be used to control convulsions. Rx Only, NDC 70752-138-12 Promethazine / codeine can cause some serious health issues. Skilled in leading cross-functional teams, cooperating with Sponsors and Clients and managing project budgets and contracts. Taking promethazine / codeine with benzodiazepines or alcohol can cause you to be extremely sleepy.
Cardiovascular Hypertension (see "WARNINGS"). Attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. 2023 Par Pharmaceutical. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Usual adult dosage is 50 mg Promethazine with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. Headache may be a symptom of hypertension. Manufacturers of Promethazine with Codeine that have been granted an NDC (National Drug Code). Promethazine / codeine can cause the results of some pregnancy tests to be wrong. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in a one pint (473 mL) bottle NDC: 0603-1587-58. All rights reserved. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as ()-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. The metabolites and their route and rate of excretion have not been identified. par pharmaceuticals promethazine. ), Other Angioneurotic edema. No, you shouldn't. Clinical studies of promethazine and phenylephrine hydrochloride oral solutiondid not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Risk factors: Undergoing certain chemotherapies. Manufacturer Name Healthfirst (1) Hikma Pharmaceuticals USA (3) Alternate Packaging . EffectCardiostimulating effects blocked. There are safer alternatives. Each 5 mL of Promethazine Plain Oral Solution contains 6.25 mg of promethazine HCl. Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI). Atropine-like signs and symptoms dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur. Select the NDC to see product information. 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.) Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. 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. Caution should be exercised when promethazine and phenylephrine is administered to a nursing woman. Make sure your provider and pharmacist know all the medications you take before starting promethazine / codeine. The main effect of phenylephrine on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Other side effects not listed may also occur in some 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. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. (See WARNINGS Promethazine; Respiratory Depression. Avoid drinking alcohol while you are taking promethazine / codeine. 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. Symptoms of EPS include tremors, jerky movements of your arms or legs while walking, trouble swallowing or talking, and tongue thrusting. 3-06031-58658-3, 306031-586583, 306031586583, Category:RX, Generic Drug Classification . Along with its needed effects, a medicine may cause some unwanted effects.
This is very rare but needs to treated right away. Drug : 00603-1586-58, 00603-586-58, 0060358658, 00603158658, 1586-58, 158658 UPC No. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl. Do not drink alcohol while taking promethazine / codeine. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. Risk factors: Taking promethazine / codeine consistently during pregnancy. Promethazine HCl Oral Solution are contraindicated for use in pediatric patients less than two years of age, It is important that Promethazine HCl Oral Solution is measured with an accurate measuring device, Promethazine HCl Oral Solution is contraindicated for children under 2 years of age, Promethazine Hydrochloride Oral Solution, USP.