Promethazine and Phenylephrine HCl, and Codeine Phosphate
Generic: PROMETHAZINE, PHENYLEPHRINE, CODEINE
Basic Information
Manufacturer
Amneal Pharmaceuticals LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
5f23b254-872b-4e88-91be-710c3ea7687b
Indications & Usage
1 INDICATIONS AND USAGE Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older.
Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ] .
Contraindicated in pediatric patients under 12 years of age [see Contraindications (4) , Use in Specific Populations (8.4) ] .
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) , Use in Specific Populations (8.4) ] .
Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ], reserve Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
Promethazine and 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.
( 1 ) Limitations of Use Not indicated for pediatric patients under 18 years of age.
(1) Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy, reserve Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
(1 , 5.1)
Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ] .
Contraindicated in pediatric patients under 12 years of age [see Contraindications (4) , Use in Specific Populations (8.4) ] .
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) , Use in Specific Populations (8.4) ] .
Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ], reserve Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
Promethazine and 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.
( 1 ) Limitations of Use Not indicated for pediatric patients under 18 years of age.
(1) Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy, reserve Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
(1 , 5.1)
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.3) ] Life-threatening respiratory depression [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 , 5.6 ), Overdosage (10) ] Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children [see Warnings and Precautions (5.3) ] Accidental overdose and death due to medication errors [see Warnings and Precautions (5.7) ] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.8) ] Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.10) ] Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions (5.11) ] Increased intracranial pressure [see Warnings and Precautions (5.12) ] Obscured clinical course in patients with head injuries [see Warnings and Precautions (5.12) ] Cardiovascular effects [see Warnings and Precautions (5.13) ] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.14) ] Paradoxical reactions, including dystonias [see Warnings and Precautions (5.15) ] Seizures [see Warnings and Precautions (5.16) ] Interactions with MAOI [see Warnings and Precautions (5.17) ] Bone marrow suppression [see Warnings and Precautions (5.18) ] Severe hypotension [see Warnings and Precautions (5.19) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.20) ] Adrenal insufficiency [see Warnings and Precautions (5.21) ] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of codeine, promethazine, and/or phenylephrine.
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.
The most common adverse reactions to Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, sweating, tachycardia, arrhythmias including premature ventricular contractions, CNS stimulation including anxiety, restlessness, nervousness, tremor, and irritability.
Other reactions include: Anaphylaxis : Anaphylaxis has been reported with codeine, one of the ingredients in Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution.
Body as a whole : Coma, death, fatigue, falling injuries, hyperactivity, hyperthermia, lethargy, weakness.
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.
Central Nervous System : Ataxia, confusion, diplopia, facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tinnitus, tremor, vertigo.
Dermatologic : Flushing, hyperhidrosis, photosensitivity, pruritus, rash, urticaria.
Endocrine/Metabolic : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology (12.2) ] .
Gastrointestinal : Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, dysguesia, ischemic colitis, jaundice, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi).
Genitourinary : Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.
Hematologic : Bone marrow suppression, agranulocytosis, aplastic anemia, and thrombocytopenia have been reported.
Laboratory : Increases in serum amylase.
Musculoskeletal : Arthralgia, backache, muscle spasm.
Ophthalmic : Blurred vision, miosis (constricted pupils), mydriasis (dilated pupils), visual disturbances.
Paradoxical Reactions : Dystonias, torticollis, tongue protrusion, hyperexcitability, and abnormal movements have been reported following a single administration of promethazine.
Psychiatric : Agitation, anxiety, confusion, fear, dysphoria, depression, hallucinations.
Reproductive : Hypogonadism, infertility.
Respiratory : Apnea, bronchitis, cough, dry nose, dry throat, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, thickening of bronchial secretions, tightness of chest and wheezing, upper respiratory tract infection.
Other : Drug abuse, drug dependence, Neuroleptic Malignant Syndrome, opioid withdrawal syndrome.
Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids.
Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).
Opioid-induced esophageal dysfunction (OIED) : Cases of OIED have been reported in patients taking opioids, and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term.
Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, sweating, tachycardia, arrhythmias including premature ventricular contractions, CNS stimulation including anxiety, restlessness, nervousness, tremor, and irritability.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
The most common adverse reactions to Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, sweating, tachycardia, arrhythmias including premature ventricular contractions, CNS stimulation including anxiety, restlessness, nervousness, tremor, and irritability.
Other reactions include: Anaphylaxis : Anaphylaxis has been reported with codeine, one of the ingredients in Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution.
Body as a whole : Coma, death, fatigue, falling injuries, hyperactivity, hyperthermia, lethargy, weakness.
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.
Central Nervous System : Ataxia, confusion, diplopia, facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tinnitus, tremor, vertigo.
Dermatologic : Flushing, hyperhidrosis, photosensitivity, pruritus, rash, urticaria.
Endocrine/Metabolic : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology (12.2) ] .
Gastrointestinal : Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, dysguesia, ischemic colitis, jaundice, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi).
Genitourinary : Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.
Hematologic : Bone marrow suppression, agranulocytosis, aplastic anemia, and thrombocytopenia have been reported.
Laboratory : Increases in serum amylase.
Musculoskeletal : Arthralgia, backache, muscle spasm.
Ophthalmic : Blurred vision, miosis (constricted pupils), mydriasis (dilated pupils), visual disturbances.
Paradoxical Reactions : Dystonias, torticollis, tongue protrusion, hyperexcitability, and abnormal movements have been reported following a single administration of promethazine.
Psychiatric : Agitation, anxiety, confusion, fear, dysphoria, depression, hallucinations.
Reproductive : Hypogonadism, infertility.
Respiratory : Apnea, bronchitis, cough, dry nose, dry throat, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, thickening of bronchial secretions, tightness of chest and wheezing, upper respiratory tract infection.
Other : Drug abuse, drug dependence, Neuroleptic Malignant Syndrome, opioid withdrawal syndrome.
Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids.
Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).
Opioid-induced esophageal dysfunction (OIED) : Cases of OIED have been reported in patients taking opioids, and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term.
Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, sweating, tachycardia, arrhythmias including premature ventricular contractions, CNS stimulation including anxiety, restlessness, nervousness, tremor, and irritability.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.