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)]. Save my name, email, and website in this browser for the next time I comment. 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. are pregnant. Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. It is generally taken by mouth Buy Actavis Promethazine with Codeine Purple cough syrup online with secured and express global delivery. It has the potential for excitatory side effects. The respiratory depressant effects of promethazine are not reversed by opioid antagonists, such as naloxone. Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a prescription medicine used, to temporarily treat cough and upper respiratory symptoms, including a stuffy nose (nasal, congestion) that you can have with allergies or a common cold. Signs and symptoms of overdosage with phenylephrine include headache, vomiting, hypertension, reflex bradycardia, cardiac arrhythmias including ventricular premature beats and ventricular tachycardia, convulsions, and cerebral hemorrhage. Monitor these patients for signs of hypotension after initiating Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. 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. Phenylephrine increases the work of the heart by increasing peripheral arterial resistance. Serious, life-threatening, or fatal respiratory depression may occur with use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. Respiratory depression is the chief risk for elderly patients treated with opioids, including Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution. Fertility studies with promethazine have not been conducted. 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)]. 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 (5.3, 5.5, 5.10)]. Before you take Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The molecular weight is 203.67. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution can cause you to be drowsy, slow your thinking and motor skills, and affect your vision. can cause serious side effects, including: Life-threatening breathing problems (respiratory depression). Use caution when considering the use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution in patients 65 years of age or older. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Temporary relief of stuffy nose. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is contraindicated in patients who are taking MAOIs (i.e., certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease) or have taken MAOIs within 14 days [see Contraindications (4)]. Acute overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, circulatory collapse, cardiac arrest, and death. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.1)]. Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution together with institution of appropriate therapy. Do not use a household teaspoon to measure your medicine. 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)]. Selling or giving away Promethazine Hydrochloride and Codeine Phosphate Oral You can also follow your state or local guidelines on how to safely throw away Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, the risk is greatest during the initiation of therapy, when Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is used concomitantly with other drugs that may cause respiratory depression [see Warnings and Precautions (5.10)], in patients with chronic pulmonary disease or decreased respiratory reserve, and in patients with altered pharmacokinetics or altered clearance (e.g., elderly, cachectic, or debilitated patients) [see Warnings and Precautions (5.6)]. The concomitant use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is achieved [see Warnings and Precautions (5.9)]. NDC 12634-909-06 178mL Bottle. Accidental use of even 1 dose of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. Healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose, Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children, Accidental overdose and death due to medication errors, Decreased mental alertness with impaired mental and/or physical abilities, Interactions with benzodiazepines and other CNS depressants, Paralytic ileus, gastrointestinal adverse reactions, Obscured clinical course in patients with head injuries, Paradoxical reactions, including dystonias, Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is contraindicated for all children younger than 12 years of age, 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 unless the benefits outweigh the risks. Instruct patients not to share Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with others and to take steps to protect Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution from theft or misuse. This rapid conversion results in higher than expected serum morphine levels. The concomitant use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with ergot alkaloids (e.g., methylergonovine maleate); atropine sulfate; steroids (e.g., hydrocortisone); angiotensin; aldosterone; norepinephrine transporter inhibitors (e.g., atomoxetine); and tricyclic antidepressants may enhance the pressor response and increase the risk of hypertension. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. The concurrent use of anticholinergics with Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution may produce paralytic ileus [see Drug Interactions (7.9)]. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Following oral administration or topical application of phenylephrine to the mucosa, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. The risk is increased with concurrent use of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution with alcohol and other central nervous system depressants [see Warnings and Precautions (5.10)]. Read Reviews (54) Find Lowest Prices. Furthermore, children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to its respiratory depressant effect. Bradycardia may be seen early in phenylephrine overdosage through stimulation of baroreceptors. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution contains promethazine, a phenothiazine. Codeine produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls respiratory rhythm and may produce irregular and periodic breathing. Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology (12.2)]. Patients should not start MAOIs while taking Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution [see Contraindications (4), Warnings and Precautions (5.17), Drug Interactions (7.6)]. An antagonist should not be administered in the absence of clinically significant respiratory depression. Do not give Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution to other people, even if they have the same symptoms that you have. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2)]. Opioids may cause increases in serum amylase [see Warnings and Precautions (5.22)]. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. Tell your healthcare provider if your cough does not get better within 5 days of treatment with Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. Phenylephrine and metabolites are excreted mainly in the urine within 48 hours. If a child accidentally takes Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, get emergency help right away. The most common side effects of Promethazine. Wockhardt followed not long after with Promethazine Hydrochloride and Codeine Phosphate. Promethazine possesses antihistamine (H1 receptor antagonist), antiemetic, sedative, and anticholinergic effects. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is not recommended for use in pregnant women [see Use in Specific Populations (8.1)]. “Who should not take Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?”. 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, who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor, 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, Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is not recommended for use in pregnant women. As an opioid, Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)], which can lead to overdose and death [see Overdosage (10)]. Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions (5.2)]. Published data from case-control and observational studies on codeine use during pregnancy are inconsistent in their findings. Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention. Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from, children. Paradoxical reactions, including dystonia, torticollis, tongue protrusion, hyperexcitability, and abnormal movements have been reported in patients following a single administration of promethazine. Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries. Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause breathing problems (respiratory depression) and drowsiness. 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. See. 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. The NDC Code 57664-185-34 is assigned to “Promethazine Hydrochloride And Codeine Phosphate ” (also known as: “Promethazine Hydrochloride And Codeine Phosphate”), a human prescription drug labeled by “Sun Pharmaceutical Industries, Inc.”. 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)]. Promethazine competitively antagonizes H1 receptors located in most of the smooth muscle including the gastrointestinal tract, uterus, large blood vessels and bronchial muscle.

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