Promethazine Hydrochloride and Codeine Phosphate

Promethazine Hydrochloride and Codeine Phosphate is an FDA-registered drug product whose active ingredient is PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE. It is labelled by QUAGEN PHARMACEUTICALS LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 70752-139, application ANDA214238, label effective 20230215. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE are most often described in connection with: years age, promethazine hcl, codeine phosphate, oral solution, pediatric patients, specific populations, temporary relief, upper respiratory. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

2 DOSAGE AND ADMINISTRATION Adults 18 years of age and older : 5 mL every 4 to 6 hours as needed, not to exceed 6 doses (30 mL) in 24 hours. ( 2.2 ) Measure Promethazine HCl and Codeine Phosphate Oral Solution with an accurate milliliter measuring device. ( 2.1 , 5.7 ) Do not increase the dose or dosing frequency. ( 2.1 ) Prescribe for the shortest duration consistent with treatment goals. ( 2.3 ) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. ( 2.3 ) Reevaluate patient prior to refilling. (2.3) 2.1 Important Dosage and Administration Instructions Administer Promethazine HCl and Codeine Phosphate Oral Solution by the oral route only. Always use an accurate milliliter measuring device when administering Promethazine HCl and Codeine Phosphate Oral Solution to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [see Warnings and Precautions (5.7) ] . For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use. Advise patients not to increase the dose or dosing frequency of Promethazine 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) ] . The dosage of Promethazine 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) ]. 2.2 Recommended Dosage Adults 18 years of age and older : 5 mL every 4 to 6 hours as needed, not to exceed 6 doses (30 mL) in 24 hours. 2.3 Monitoring, Maintenance, and Discontinuation of Therapy Prescribe Promethazine HCl and Codeine Phosphate Oral Solution for the shortest duration that is consistent with individual patient treatment goals [see Warnings and Precautions (5.1) ]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [see Warnings and Precautions (5.2) ]. Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Warnings and Precautions (5.6) ]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with Promethazine HCl and Codeine Phosphate Oral Solution, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1) ]. Do not abruptly discontinue Promethazine HCl and Codeine Phosphate Oral Solution in a physically-dependent patient [see Drug Abuse and Dependence (9.3) ]. When a patient who has been taking Promethazine HCl and Codeine Phosphate Oral Solution regularly and may be physically dependent no longer requires therapy with Promethazine HCl and Codeine Phosphate Oral Solution, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. 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.

4 CONTRAINDICATIONS Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for: All children younger than 12 years of age [see Warnings and Precautions (5.2 , 5.3 , 5.5 ), Use in Specific Populations (8.4) ]. Postoperative pain management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.2 , 5.3 ) ]. Promethazine HCl and Codeine Phosphate Oral Solution is also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6) ] . Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.11) ]. A history of an idiosyncratic reaction to promethazine or to other phenothiazines [see Warnings and Precautions (5.14) ]. Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within 14 days [see Warnings and Precautions (5.16) , Drug Interactions (7.6) ]. Hypersensitivity to codeine, promethazine, or any of the inactive ingredients in Promethazine HCl and Codeine Phosphate Oral Solution [see Adverse Reactions (6) ]. Persons known to be hypersensitive to certain other opioids may exhibit cross-reactivity to codeine. Children younger than 12 years of age. ( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) Concurrent use of monoamine oxidase inhibitor (MAOI) therapy or within the last 14 days. ( 4 ) History of an idiosyncratic reaction to promethazine or to other phenothiazines. ( 4 ) Hypersensitivity to codeine or other opiates, promethazine, or any of the inactive ingredients in Promethazine HCl and Codeine Phosphate Oral Solution. ( 4 )

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 .

What is Promethazine Hydrochloride and Codeine Phosphate used for?
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 …

Who makes Promethazine Hydrochloride and Codeine Phosphate?
QUAGEN PHARMACEUTICALS LLC is the labeler of record for Promethazine Hydrochloride and Codeine Phosphate.

What form does Promethazine Hydrochloride and Codeine Phosphate come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Promethazine Hydrochloride and Codeine Phosphate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Promethazine Hydrochloride and Codeine Phosphate been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.