Overall, the effects of opioids appear to be modestly immunosuppressive. The concurrent use of anticholinergics with Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution may produce paralytic ileus [see Drug Interactions (7.9)]. Use Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with caution in patients who are taking antihypertensive drugs. If you take too much Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. Hematologic: Bone marrow suppression, agranulocytosis, aplastic anemia, and thrombocytopenia have been reported. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants, Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Inform patients and caregivers that potentially fatal additive effects may occur if Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [see Drug Interactions (7.4)]. Before you take Promethazine Hydrochloride and Codeine Phosphate Oral Solution, tell your. To reduce the risk of overdose and respiratory depression, ensure that the dose of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is communicated clearly and dispensed accurately [see Dosage and Administration (2.1)]. Promethazine HCl and Codeine Phosphate Oral Solution is a Schedule V Controlled Substance. take cold or allergy medicines that contain antihistamines or cough suppressants. There is no information on the effects of the codeine on milk production. Phenylephrine increases the work of the heart by increasing peripheral arterial resistance. Because of the risk of respiratory depression, avoid the use of opioid antitussives, including Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients. Rarely, the drug may increase the irritability of the heart, causing arrhythmias. Codeine has low plasma protein binding with about 7 to 25% of codeine bound to plasma proteins. Buy Codeine Phosphate (30mg) tablets Online , It is typically used to treat mild to moderate degrees of pain . Two-year studies in F344/N rats and B6C3F1 mice were conducted to assess the carcinogenic potential of codeine. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. If you take the wrong dose of Promethazine Hydrochloride and Codeine Phosphate Oral Solution you could overdose and die. Codeine and its active metabolite, morphine, are present in human milk. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Selling or giving away Promethazine Hydrochloride and Codeine Phosphate Oral Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology (12.2)]. It also contains quite a bit of sorbitol too which is very bad for u too. Are you suffering from Severe Cough or any oral problems? Maternal use of phenylephrine can cause fetal tachycardia. Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including codeine, one of the active ingredients in Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution contains 3 medicines, promethazine, phenylephrine, and codeine. Other: Drug abuse, drug dependence, Neuroleptic Malignant Syndrome, opioid withdrawal syndrome. Promethazine passes the blood brain barrier and the placental barrier. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications. breathing (respiratory depression) and cause death. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. Codeine can be thought of as the “star of the show” it provides the pleasurable effects often sought out by the user. There are no available data with Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Avoid the use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in patients taking muscle relaxants. Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. Do not abruptly discontinue Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in a physically-dependent patient [see Drug Abuse and Dependence (9.3)]. Due to synergistic adrenergic effects of phenylephrine, one of the active ingredients in Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, the concomitant use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with sympathomimetic amines such as epinephrine, amphetamine, phenylpropanolamine, and bronchodilator beta2-adrenoreceptor agonists may result in tachycardia, arrhythmias, serious hypertensive response and possible stroke. Wockhardt followed not long after with Promethazine Hydrochloride and Codeine Phosphate. Order Actavis Promethazine With Codeine purple Cough Syrup, Hi-tech Promethazine Codeine, Wockhardt Prometh With codeine cough syrup, Qualitest Prometh w/ codeine cough syrup and various brands, All 100% Sealed Pints / Bottles of Cough Syrups / Lean and other related products from Licensed and Original Manufacturers. is not for children under 18 years of age. changes in pulse, heart rate, or blood pressure, decrease in mental and physical performance. Phenylephrine is irregularly absorbed from and readily metabolized in the gastrointestinal tract. Carcinogenicity, mutagenicity, and fertility studies have not been conducted with Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution; however, published information is available for the individual active ingredients. Dosage Form: oral syrup. The dosage of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [see Dosage and Administration (2.3), Warnings and Precautions (5.6)]. Avoid the use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in patients who are taking inhibitors of CYP2D6. It works by preventing the effects of a substance called histamine, which is produced by the body. Postmarketing cases of respiratory depression, including fatalities have been reported with use of promethazine in pediatric patients. Children may be particularly sensitive to the additive respiratory depressant effects when promethazine is combined with other respiratory depressants, including codeine [see Warnings and Precautions (5.4)]. Always use an accurate milliliter measuring device when administering Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution to ensure that the dose is measured and administered accurately. Codeine causes miosis, even in total darkness. Fertility studies with promethazine have not been conducted. Respiratory depression is the chief risk for elderly patients treated with opioids, including Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Assess each patient’s risk prior to prescribing Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, prescribe Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution for the shortest duration that is consistent with individual patient treatment goals. Breathing problems (respiratory depression), Severe drowsiness, breathing problems (respiratory depression), coma, and death, Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution is a federal controlled substance (C. V) because it contains codeine that can be abused or lead to dependence. Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions (6)]. The codeine in Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution may result in constipation or obstructive bowel disease, especially in patients with underlying intestinal motility disorders. Reserve Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Additive adverse effects resulting from cholinergic blockade (e.g., xerostomia, blurred vision, or constipation) may occur when anticholinergic drugs are administered with promethazine. If concomitant use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with inhibitors and inducers of CYP3A4 is necessary, monitor patients for signs and symptoms that may reflect opioid toxicity and opioid withdrawal [see Drug Interactions (7.1, 7.2)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. Keep Promethazine Hydrochloride and Codeine Phosphate Syrup in a safe place to prevent misuse and abuse. They both manufacture promethazine with codeine syrup so the only real significant difference is the taste and colour.PAR promethazine with codeine is a purple syrup and Hi-Tech promethazine with codeine is a red syrup.They both contain the same dose of active ingredients promethazine hydrochloride/codeine phosphate 6.25mg-10mg/5mL syrup. Whether C6G has pharmacological activity is unknown. The sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine. take certain medicines used to treat mood, anxiety, psychotic or thought disorders, or depression, including monoamine oxidase inhibitors (MAOIs), tricyclics, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), or antipsychotics. 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. The mean elimination half-life of phenylephrine is around 2.5 hours. Take Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution using an accurate milliliter (mL) measuring device. Reproductive toxicity studies have not been conducted with Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution; however, studies are available with individual active ingredients. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)]. Avoid the use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. Promethazine has an elimination half-life of 10-14 hours, with excretion of metabolites appearing in the urine and feces. It is soluble in water and freely soluble in alcohol. Children are particularly sensitive to the respiratory depressant effects of codeine [see Warnings and Precautions (5.2, 5.3)] and promethazine [see Warnings and Precautions (5.4)]. The product's dosage form is syrup… Concomitant use of opioids, including Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation. [see Adverse Reactions (6), Drug Interactions (7.5)]. Phenothiazines are associated with dystonic reactions, particularly in pediatric patients who have an acute illness associated with dehydration. Because elderly patients are more likely to have decreased renal function, monitor these patients closely for respiratory depression, sedation, and hypotension. OTHER NAME(S): Promethazine-Codeine Syrup. Promethazine has high protein binding with about 80 to 93% of promethazine bound to plasma proteins. See “What is the most important information I should know about Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?”. Temporary relief of stuffy nose. Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Fertility studies with phenylephrine have not been conducted. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)]. “Drug-seeking” behavior is very common in persons with substance use disorders. Rinse the measuring device with water after each use. Add any text here or remove it. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Body as a whole: Coma, death, fatigue, falling injuries, hyperactivity, hyperthermia, lethargy, weakness. Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. Cardiovascular: Peripheral edema, atrial fibrillation, myocardial infarction, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush. Cytochrome P450 2D6 is the major enzyme responsible for conversion of codeine to morphine and P450 3A4 is the major enzyme mediating conversion of codeine to norcodeine. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Increased pressure in your head (increased intracranial pressure). an antihistamine. 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. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.20), Clinical Considerations]. Buy Promethazine Codeine Cough Syrup Online. Actions of histamine on H1 receptors increases capillary permeability and edema formation, flare and pruritus. What should I avoid while taking Promethazine, What are the possible side effects of Promethazine. 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. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution contains codeine, a substance with a high potential for abuse similar to other opioids including morphine and codeine. Donot give Hitech Promethazine Syrup with Codeine Phosphate Oral Solution to children, younger than 12 years of age because it is dangerous, You should not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to. The use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [see Contraindications (4)]. Avoid use of promethazine in patients at risk for respiratory depression. If you do not have one, ask your pharmacist to give you a measuring device to measure the correct amount of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. Instruct patients how to measure and take the correct dose of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia. This rapid conversion results in higher than expected serum morphine levels. The chemical name for phenylephrine hydrochloride, a sympathomimetic amine salt, is (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. Other drugs that have the same active ingredients (e.g. Take Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution by mouth only. Do not start or stop taking other medicines without talking to your healthcare provider. Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is not indicated for use in patients younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of codeine in these patients [see Indications (1), Warnings and Precautions (5.5)]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [see Warnings and Precautions (5.2)]. It is based on codeine phosphate; promethazine hydrochloride and acetaminophen; hydrocodone bitartrate (the active ingredients of Promethazine with codeine and Norco, respectively), and Promethazine with codeine and Norco (the brand names). Because the duration of opioid reversal is expected to be less than the duration of action of codeine in Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, carefully monitor the patient until spontaneous respiration is reliably reestablished. Always use an accurate milliliter measuring device when measuring and administering Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution [see Dosage and Administration (2.1), Warnings and Precautions (5.7)]. Accidental ingestion of even one dose of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, especially by children, can result in respiratory depression and death. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Hitech Promethazine Syrup and Codeine Phosphate Oral Solution in a safe place to prevent misuse and abuse. Histamine can cause itching, sneezing, runny nose, and watery eyes. Penetration into the blood brain barrier is minimal. [see Use in Specific Populations (8.1), Patient Counseling Information (17)]. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism, Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. General information about the safe and effective use of Promethazine. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution should be used with caution in patients with bone-marrow depression. Advise patients not to increase the dose or dosing frequency of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.1), Overdosage (10)]. Codeine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Codeine Phosphate . An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. If concomitant use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with inhibitors of CYP2D6 is necessary, monitor patients for signs and symptoms that may reflect opioid toxicity and opioid withdrawal [see Drug Interactions (7.3)]. Phenylephrine is metabolized primarily by monoamine oxidase and sulfotransferase in the intestinal wall and liver. Codeine is an opiate painkiller which can induce a pleasurable state in those who consume it. Addiction can occur at recommended dosages and if the drug is misused or abused. Promethazine is widely distributed in body tissues. If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy. Management of respiratory depression includes discontinuation of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, close observation, supportive measures, and use of opioid antagonists (e.g., naloxone), depending on the patient’s clinical status [see Overdosage (10)]. Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2)]. plan to have children. Increased risk of seizures in people with seizure disorders. Therefore, individuals who are ultra-rapid metabolizers should not use Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. Hitech Promethazine Syrup and Codeine Phosphate Oral Solution in a safe place to prevent misuse, and abuse. NDC 12634-909-06 178mL Bottle. How should I dispose of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution? Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Codeine has been reported to have an apparent volume of distribution of approximately 3 to 6 L/kg, indicating extensive distribution of the drug into tissues. The majority of studies examining the use of phenylephrine and promethazine in pregnancy did not find an association with an increased risk of congenital anomalies. The molecular weight is 320.88. The cardiac pressor response may be potentiated and acute hypertensive crisis may occur when phenylephrine containing preparations are used with prior administration of MAOIs. Serious, life-threatening, or fatal respiratory depression may occur with use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. 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. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes and sweating and/or orthostatic hypotension. No evidence of tumorigenicity was observed in male and female rats at phenylephrine hydrochloride dietary doses up to 50 mg/kg/day (approximately equivalent to 20 times the MRHD on a mg/m2 basis). 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. Phenylephrine hydrochloride tested negative in the in vitro bacterial reverse mutation assay, in vitro Chinese hamster ovary (CHO) cell chromosomal aberrations assay, and in vivo rat micronucleus assay. Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP also contains the following inactive ingredients: anhydrous citric acid, ascorbic acid, edetate disodium, glycerin, methylparaben, natural & artificial citrus flavor FN-7176, purified water, saccharin sodium, sodium benzoate, sodium metabisulfite, sodium citrate, and sucrose. Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution include: Keep Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution and all medicines out of the reach of children. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. What is the most important information I should know about, “What is the most important information I should know about Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?”. Tell your healthcare provider right away if you are pregnant or think you may be pregnant. What is the most important information I should know about Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution? 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.

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