PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Opioid Analgesic

Brand names: Promethazine Hydrochloride and Codeine Phosphate

Oral

Mechanism of Action

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 properties of codeine have been speculated to come from its conversion to morphine. The precise mechanism of action of codeine and other opiates is not known; however, codeine is believed to act centrally on the cough center. In excessive doses, codeine will depress respiration. Promethazine Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Promethazine possesses antihistamine (H 1 receptor antagonist), antiemetic, sedative, and anticholinergic effects. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

Indications

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

Contraindications

• 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
• Drug Interactions (7.6) ]. Hypersensitivity to codeine

FDA Warnings

5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy
8 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use
As an opioid, Promethazine 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) ]
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

Known Side Effects

11 documented side effects by frequency

Nausea

>10%

Vomiting

1-10%

Fatigue

1-10%

Diarrhea

1-10%

Headache

1-10%

Shortness of Breath

1-10%

Back Pain

0.1-1%

Anxiety

0.1-1%

Drug Not Working

0.1-1%

Weakness

0.1-1%

Joint Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral