• NDC Code(s): 70752-139-06, 70752-139-12
  • Packager: QUAGEN PHARMACEUTICALS LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: Abbreviated New Drug Application

DRUG LABEL INFORMATION

Updated October 30, 2020

If you are a consumer or patient please visit this version.

    • HIGHLIGHTS OF PRESCRIBING INFORMATION
      These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL …
    • TABLE OF CONTENTS
      Table of Contents
    • BOXED WARNING (WHAT IS THIS?)

      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

      Addiction, Abuse, and Misuse
      Promethazine 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. 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. Assess each patient’s risk prior to prescribing Promethazine HCl and Codeine Phosphate Oral Solution, prescribe Promethazine HCl and Codeine Phosphate Oral Solution for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment. [see WARNINGS AND PRECAUTIONS (5.1)].

      Life-Threatening Respiratory Depression
      Serious, life-threatening, or fatal respiratory depression may occur with use of Promethazine HCl and Codeine Phosphate Oral Solution. Monitor for respiratory depression, especially during initiation of Promethazine HCl and Codeine Phosphate Oral Solution therapy or when used in patients at higher risk [see WARNINGS AND PRECAUTIONS (5.2)].

      Accidental Ingestion
      Accidental ingestion of even one dose of Promethazine HCl and Codeine Phosphate Oral Solution, especially by children, can result in a fatal overdose of codeine [see WARNINGS AND PRECAUTIONS (5.2)].

      Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children

      Life-threatening respiratory depression and death have occurred in children who received codeine. 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 [see WARNINGS AND PRECAUTIONS (5.3)]. Promethazine 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 [see CONTRAINDICATIONS (4)].

      Avoid the use of Promethazine 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. quagen

      Promethazine and Respiratory Depression in Children
      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)].

      Risk of Medication Errors
      Ensure accuracy when prescribing, dispensing, and administering Promethazine HCl and Codeine Phosphate Oral Solution. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering Promethazine HCl and Codeine Phosphate Oral Solution [see DOSAGE AND ADMINISTRATION (2.1)WARNINGS AND PRECAUTIONS (5.7)].

      Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
      The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of Promethazine HCl and Codeine Phosphate Oral Solution in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor [see WARNINGS AND PRECAUTIONS (5.9)DRUG INTERACTIONS (7.17.27.3)].

      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. Avoid the use of Promethazine HCl and Codeine Phosphate Oral Solution in patients taking benzodiazepines, other CNS depressants, or alcohol. [see WARNINGS AND PRECAUTIONS (5.10)DRUG INTERACTIONS (7.4)]

      Neonatal Opioid Withdrawal Syndrome 
      Promethazine HCl and Codeine Phosphate Oral Solution is not recommended for use in pregnant women [see USE IN SPECIFIC POPULATIONS (8.1)]. Prolonged use of Promethazine HCl and Codeine quagen Phosphate Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If Promethazine HCl and Codeine Phosphate Oral Solution is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS (5.20)].

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    • 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 …
    • 2 DOSAGE AND ADMINISTRATION
      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 …
    • 3 DOSAGE FORMS AND STRENGTHS
      Oral solution: Each 5 mL contains codeine phosphate, 10 mg and promethazine hydrochloride 6.25 mg, in a flavored syrup base [see – Description (11)].
    • 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 …
    • 5 WARNINGS AND PRECAUTIONS
      5.1 Addiction, Abuse, and Misuse – Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, a Schedule V controlled substance. As an opioid, Promethazine HCl and Codeine Phosphate …
    • 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 …
    • 7 DRUG INTERACTIONS
      No specific drug interaction studies have been conducted with Promethazine HCl and Codeine Phosphate Oral Solution. 7.1 Inhibitors of CYP3A4 – The concomitant use of Promethazine HCl and Codeine …
    • 8 USE IN SPECIFIC POPULATIONS
      8.1 Pregnancy – Risk Summary – Promethazine HCl and Codeine Phosphate Oral Solution is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of …
    • 9 DRUG ABUSE AND DEPENDENCE
      9.1 Controlled Substance – Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, a Schedule V controlled substance. 9.2 Abuse – Codeine – Promethazine HCl and Codeine Phosphate …
    • 10 OVERDOSAGE
      Clinical Presentation – Codeine – Acute overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis) …
    • 11 DESCRIPTION
      Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine. Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution …
    • 12 CLINICAL PHARMACOLOGY
      12.1 Mechanism of Action – Codeine – Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic and antitussive …
    • 13 NONCLINICAL TOXICOLOGY
      13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility – Carcinogenicity, mutagenicity, and fertility studies have not been conducted with Promethazine HCl and Codeine Phosphate Oral Solution …
    • 16 HOW SUPPLIED/STORAGE AND HANDLING
      Promethazine HCl and Codeine Phosphate Oral Solution, 6.25 mg and 10 mg per 5 mL, is a clear, purple solution, supplied as: NDC Number                    Size – 70752-139-06                   4 … quagen
    • 17 PATIENT COUNSELING INFORMATION
      Advise the patient to read the FDA-approved patient labeling (Medication Guide). Addiction, Abuse, and Misuse – Inform patients that the use of Promethazine HCl and Codeine Phosphate Oral …
    • MEDICATION GUIDE
      MEDICATION GUIDE – Promethazine (proe METH a zeen) Hydrochloride and Codeine (KOE deen) Phosphate Oral Solution, C-V – What is the most important information I should know about …
    • PRINCIPAL DISPLAY PANEL
      PRINCIPAL DISPLAY PANEL – NDC 70752-139-06 – Promethazine Hydrochloride – and Codeine Phosphate Oral – Solution CV – 6.25 mg and 10 mg per 5 mL – 4 fl … quagen