Central Nervous System: Ataxia, confusion, diplopia, facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tinnitus, tremor, vertigo. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is not recommended for use in pregnant women, including during or immediately prior to labor. Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death [see Overdosage (10)]. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation. including severe constipation or stomach pain. Phenylephrine is known to be poorly absorbed orally. Advise patients to throw the drug in the household trash following these steps. Use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in children also exposes them to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)], which can lead to overdose and death [see Warnings and Precautions (5.1), Overdosage (10)]. If Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is prescribed, monitor such patients closely, particularly when initiating Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution and when Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.10)]. children between 12 to 18 years of age who have certain risk factors for breathing problems. Store Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C). It also contains quite a bit of sorbitol too which is very bad for u too. breathing (respiratory depression) and cause death. You may report side effects to FDA at 1-800-FDA-1088. Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution can cause serious side effects, including: Call your healthcare provider or get emergency medical help right away if anyone taking Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, or your breastfeeding baby, has any of the symptoms below: Keep Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from children. Dermatologic: Flushing, hyperhidrosis, photosensitivity, pruritus, rash, urticaria. Increased pressure in your head (increased intracranial pressure). An increased risk of specific malformations with codeine exposure such as respiratory malformations, spina bifida and congenital heart defects were reported in some studies. Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children. Use Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with caution in patients who are taking antihypertensive drugs. Fertility studies with codeine have not been conducted. Small amounts of codeine and its metabolite, morphine, are transferred to human breast milk. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. See “What is the most important information I should know about Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?”. Life-threatening respiratory depression and death have occurred in children who received codeine. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Phenylephrine hydrochloride was equivocal in the in vitro mouse lymphoma assay without metabolic activation; however, a test with metabolic activation was not performed. The codeine and promethazine in Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. You may have an increased risk of an allergic reaction to Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution if you are allergic to certain other opioid medicines. The following serious adverse reactions are described, or described in greater detail, in other sections: The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of codeine, promethazine, and/or phenylephrine. certain medicines to treat a fungal infection, certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C. Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution is a prescription medicine used in adults to temporarily treat cough and upper respiratory symptoms, including a stuffy nose (nasal congestion), that you can have with allergies or a common cold. Morphine and its M6 glucuronide conjugate are pharmacologically active. If a child accidentally takes Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, get emergency help right away. Rarely, the drug may increase the irritability of the heart, causing arrhythmias. What is the most important information I should know about Hitech Promethazine Syrup and, Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause children to stop. The cardiac pressor response may be potentiated and acute hypertensive crisis may occur when phenylephrine containing preparations are used with prior administration of MAOIs [see Warnings and Precautions (5.17)]. Because elderly patients are more likely to have decreased renal function, monitor these patients closely for respiratory depression, sedation, and hypotension. Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP contains Alcohol 7.15% v/v. Codeine may cause miosis, even in total darkness. Hitech Promethazine Syrup and Codeine Phosphate Oral Solution in a safe place to prevent misuse, and abuse. The concomitant use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with all cytochrome P450 3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir) or discontinuation of a cytochrome P450 3A4 inducer such as rifampin, carbamazepine, and phenytoin, may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome P450 2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of codeine in pediatric patients, Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is not indicated for use in patients younger than 18 years of age [see Indications (1), Use in Specific Populations (8.4)]. Dosing errors can result in accidental overdose and death. have a type of glaucoma called “narrow angle glaucoma”. It is not known if these fertility problems will be reversible, even after you stop taking Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. Taking Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution with certain other medicines can cause side effects or affect how well Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution or the other medicines work. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME, Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes and sweating and/or orthostatic hypotension. Because opioid agonists may increase biliary tract pressure, with resultant increase in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after administration of a dose of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. For example, many reported cases of death occurred in the post-operative period following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine. The mean elimination half-life of phenylephrine is around 2.5 hours. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Adverse Reactions (6)]. Avoid the use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in patients taking benzodiazepines, other CNS depressants, or alcohol. No evidence of tumorigenicity was observed in male and female mice at codeine dietary doses up to 400 mg/kg/day (approximately equivalent to 45 times the MRHD on a mg/m2 basis). Promethazine HCl and Codeine Phosphate Oral Solution is a Schedule V Controlled Substance. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Discontinuation of a concomitantly used cytochrome P450 2D6 inhibitor may result in a decrease in codeine plasma concentration and an increase in active metabolite morphine plasma concentration which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. Because of the risk of life-threatening respiratory depression and death: Clinical studies have not been conducted with Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in geriatric populations. Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Avoid driving a car or operating machinery during treatment with Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. Hematologic: Bone marrow suppression, agranulocytosis, aplastic anemia, and thrombocytopenia have been reported. In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Phenylephrine has a mild central stimulant effect [see Adverse Reactions (6)].