Promethazine Hydrochloride and Codeine Phosphate
Generic: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Basic Information
Manufacturer
QUAGEN PHARMACEUTICALS LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
9aca56ec-28f8-4679-9f90-ec3e82deb9ac
Indications & Usage
1 INDICATIONS AND USAGE Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important 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, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Promethazine 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.
Promethazine HCl and Codeine Phosphate Oral Solution is a combination of codeine, an opioid agonist; and promethazine, a phenothiazine, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
( 1 ) Important Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine 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.
Important 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, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Promethazine 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.
Promethazine HCl and Codeine Phosphate Oral Solution is a combination of codeine, an opioid agonist; and promethazine, a phenothiazine, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
( 1 ) Important Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine 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.
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) ] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.13) ] Paradoxical reactions, including dystonias [see Warnings and Precautions (5.14) ] Seizures [see Warnings and Precautions (5.15) ] Interactions with MAOI [see Warnings and Precautions (5.16) ] Bone marrow suppression [see Warnings and Precautions (5.17) ] Severe hypotension [see Warnings and Precautions (5.18) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.19) ] Adrenal insufficiency [see Warnings and Precautions (5.20) ] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of codeine and/or promethazine.
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 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.
Other reactions include: Anaphylaxis : Anaphylaxis has been reported with codeine, one of the ingredients in Promethazine HCl and Codeine Phosphate Oral Solution.
Body as a whole : Coma, death, fatigue, falling injuries, lethargy.
Cardiovascular : Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.
Central Nervous System : Ataxia, 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, 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), 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.
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, and sweating.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 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 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.
Other reactions include: Anaphylaxis : Anaphylaxis has been reported with codeine, one of the ingredients in Promethazine HCl and Codeine Phosphate Oral Solution.
Body as a whole : Coma, death, fatigue, falling injuries, lethargy.
Cardiovascular : Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.
Central Nervous System : Ataxia, 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, 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), 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.
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, and sweating.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .