par pharmaceuticals promethazinepar pharmaceuticals promethazine

The use of Promethazine HCl Oral Solution should be avoided in pediatric patients whose signs and symptoms may suggest Reye's syndrome or other hepatic diseases.

Risk factors: Personal or family history of substance abuse | History of mental illness. Distributed by: This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Skilled in leading cross-functional teams, cooperating with Sponsors and Clients and managing project budgets and contracts. Promethazine / codeine is not safe to use during pregnancy. 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. Another study showed that phenylephrine was associated with anomalies of aortic arch and with ventricular septal defect in the chick embryo. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY.

It is not known whether promethazine or phenylephrine are excreted in human milk. Quagen Pharmaceuticals LLC, NDC 70752-138-06 Hikma Pharmaceuticals USA #00641608325; Phenergan Promethazine HCl 50 mg / mL Injection Ampule 1 mL. larry carter obituary 2021 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.

par pharmaceuticals promethazine. Use of Promethazine HCl Oral Solution in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. 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.

2023 Par Pharmaceutical. For children, Promethazine HCl Oral Solution, 12.5 to 25 mg, twice daily, may be administered. Manufacturer Name Healthfirst (1) Hikma Pharmaceuticals USA (3) Alternate Packaging . Dermatologic Dermatitis, photosensitivity, urticaria. Last updated on Nov 14, 2022. Perennial and seasonal allergic rhinitis. This is called extrapyramidal symptoms (EPS). Which drugs cause opioid-induced constipation? Select the NDC to see product information. Phenylephrine is metabolized in the liver and intestine by monoamine oxidase. Drug and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Copy. Patients should be advised to report any involuntary muscle movements.

Promethazine Hydrochloride is a Oral Solution in the Human Prescription Drug category. to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours. Risk factors: History of certain heart problems. Select the NDC to see product information. 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. GoodRx works to make its website accessible to all, including those with disabilities. Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, and their use should be limited to prolonged vomiting of known etiology. 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. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is a combination of codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist, indicated for the temporary relief of cough and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate, Losartan Potassium and Hydrochlorothiazide, Oxycodone Hydrochloride and Acetaminophen, NPI Look-Up Tool (National Provider Identifier), Generics Bidco I, LLC dba Qualitest Pharmaceuticals. Promethazine Hydrochloride Oral Solution, USP Thank you for choosing Find-A-Code, please Sign In to remove ads. Promethazine in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. purple - Promethazine Hydrochloride/Codeine Phosphate 6.25mg-10mg/5mL Solution. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. 2023 Par Pharmaceutical. When oral medication cannot be tolerated, the dose should be given parenterally (cf. Promethazine should not be taken at least 3 days before the start of a skin test. Rx Item-Prometh Dm Ws 6.25-15MG 473 ML Sol by Par Pharma USA . In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of Promethazine HCl. demo request yours today subscribe start today free subscription Hallucinations and convulsions have occurred with therapeutic doses and overdoses of Promethazine in pediatric patients. Drowsiness is the most prominent CNS effect of this drug. Phenylephrine has no effect on -adrenergic receptors of the bronchi or peripheral blood vessels. Make sure your provider and pharmacist know all the medications you take before starting promethazine / codeine. 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. A study of the effects of adrenergic drugs on ovum transport in rabbits indicated that treatment with phenylephrine did not alter incidence of pregnancy; the number of implantations was significantly reduced when high doses of the drug were used. EffectCardiostimulating effects blocked.

Phenylephrine is irregularly absorbed from and readily metabolized in the gastrointestinal tract. 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). With a sterile manufacturing facility located in Rochester, Michigan, Par Sterile Products possesses an unparalleled reputation for high-quality products and an impeccable record of regulatory compliance. 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. Cardiovascular Hypertension (see "WARNINGS"). Because phenylephrine is an adrenergic agent, it should be given with caution to patients with thyroid diseases, diabetes mellitus, and heart disease or those receiving tricyclic antidepressants. No, they shouldn't. Consumers can find our products at major retailers, locally owned and operated pharmacies, as well as specialty pharmacies. Gastrointestinal-Dry mouth, nausea, vomiting, jaundice. 6.25 mg/5 mL Symptoms of EPS include tremors, jerky movements of your arms or legs while walking, trouble swallowing or talking, and tongue thrusting. 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. Hallucinations have also been reported. Drug Diazepam may be used to control convulsions. Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. Please discuss if promethazine / codeine is the safest option for you with your provider before starting it. Promethazine HCl Oral Solution should be used with caution in pediatric patients 2 years of age and older (see WARNINGS-Use in Pediatric Patients). Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. 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. We NEVER sell or give your information to anyone. 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. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. See our privacy policy. All rights reserved. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Symptoms of NMS include high fever, muscle stiffness, confusion, sweating, and changes in heart rate and blood pressure. These side effects are more intense if you are over 65 years old. Amelioration of allergic reactions to blood or plasma. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. 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. Administration of Promethazine HCl has been associated with reported cholestatic jaundice. We have already encountered some chemical formulas for simple ionic compounds. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. Phenylephrine should be used with caution in patients with cardiovascular disease, particularly hypertension.

Receive price alerts, news, and other messages from GoodRx about Promethazine / codeine and other healthcare topics and relevant savings offers. Promethazine / codeine contains an opioid called codeine. 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. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Drug Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE). It is freely soluble in water and soluble in alcohol. 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. Risk factors: Children under 18 years of age | History of breathing problems (COPD, sleep apnea, asthma) | Taking other medications that slow down breathing. Phenylephrine with diet preparations, such as amphetamines or phenylpropanolamine. Products with assigned NDCs are displayed. Drug Promethazine with Codeine Oral Solution is a federal controlled substance (C-V) because it contains codeine that can be abused or lead to dependence. 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. Be sure to use a medication dose cup, spoon, or syringe to measure out your dose. 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. Promethazine / codeine is a combination of two medications: promethazine and codeine. 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. 4. 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). Note that any depressant effects of promethazine are not reversed by naloxone. People who take either typical or atypical antipsychotic medications have a higher risk of this happening. 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. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. 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. Treatment of overdosage is essentially symptomatic and supportive. Taking promethazine / codeine with benzodiazepines or alcohol can cause you to be extremely sleepy. Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). PARPHARM.COM 2023 Par Pharmaceutical. This risk may be even higher for certain groups. Caution should be exercised when promethazine and phenylephrine is administered to a nursing woman. Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Acidosis and electrolyte losses should be corrected. Official answer by Drugs.com PAR and Hi-Tech are pharmaceutical manufacturers. 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. Do not drink alcohol while taking promethazine / codeine. Available for Android and iOS devices. Take it exactly as your provider prescribes. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Manufacturers of Promethazine Hydrochloride that have been granted an NDC (National Drug Code). 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. ICD-10-CM; DRGs; HCCs; ICD-11 NEW; SNOMED CT NEW; ICD-9-CM . 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. It's best to wait until you are done taking this medication to take a home pregnancy test. The inactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. By only using promethazine / codeine for a short period of time, you are taking the proper steps to prevent yourself from becoming dependent on this medication. 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. Coughs with mucus caused by respiratory infections like the common cold, Coughing, sneezing, and runny nose caused by allergies or the common cold. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as ()-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. CNS Depressants 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. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. (See WARNINGS-Neuroleptic Malignant Syndrome.). 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. Monoamine Oxidase Inhibitors (MAOI) Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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 with tricyclic antidepressants. Convulsions may rarely occur. You can use the displayed coupon, or compare prices at other pharmacies near you. Promethazine with Codeine Oral Solution contains 2 medicines, promethazine and codeine. 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). Concomitant administration of Promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. When given concomitantly with Promethazine HCl Oral Solution, 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. Promethazine was nonmutagenic in the Salmonella test system of Ames. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. It is labeled and distributed by Par Pharmaceutical. 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. If you notice any other effects, check with your healthcare professional. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g. Promethazine / codeine causes dizziness and drowsiness. Thumbnail; .