promethazine/codeine (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

promethazine/codeine

oral liquid: Schedule V

  • (6.25mg/10mg)/5mL
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Cough

Temporary relief cough and upper respiratory tract symptoms associated with allergies or common cold

6.25 mg/10 mg (5 mL) PO q4-6hr; not to exceed 30 mL/24 hr

Renal Impairment

Caution; may need to initiate at a lower dose

Hepatic Impairment

Caution; may need to initiate at a lower dose

Administration

Administer with special measuring device for accurate dose

Cough

<6 years: Use contraindicated

6-12 years: 2.5-5 mL PO q4-6hr; not to exceed 30 mL/24hr

>12 years: 6.25 mg/10 mg (5 mL) PO q4-6hr; not to exceed 30 mL/24 hr

Administration

Administer with special measuring device for accurate dose

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Interactions

Interaction Checker

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            Adverse Effects

            >10% (Codeine)

            Constipation

            Drowsiness

            Frequency Not Defined (Promethazine)

            Sedation (common)

            Confusion (common)

            Disorientation (common)

            Adverse anticholinergic effects (dry mouth, blurred vision)

            Photosensitivity

            EPS

            Tachycardia

            Bradycardia

            Leukopenia (rare)

            Agranulocytosis (rare)

            Obstructive jaundice

            Frequency Not Defined (Codeine)

            Confusion

            Dizziness

            False feeling of well being

            Headache

            Lightheadedness

            Malaise

            Paradoxical CNS stimulation

            Restlessness

            Seizure (with excessive doses)

            Weakness

            Blurred vision

            Hypotension (especially with IV use)

            Tachycardia

            Bradycardia

            Dyspnea

            Respiratory depression

            Anorexia

            Nausea

            Vomiting

            Xerostomia

            Rash

            Urticaria

            Ureteral spasm

            Urination decreased

            LFT's increased

            Histamine release

            Anaphylactoid reaction (rare)

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            Warnings

            Black Box Warnings

            Because of the potential for fatal respiratory depression, do not administer promethazine and codeine concurrently to children <6 years of age

            Postmarketing cases of respiratory depression, including fatalities have been reported with the use of promethazine in children <2 years of age

            Postoperative pain in children

            • Deaths have occurred in children with obstructive sleep apnea who receive codeine for postoperative pain following tonsillectomy and/or adenoidectomy
            • Codeine is converted to morphine by the liver; these children had evidence of being ultra-rapid metabolizers (via CYP2D6) of codeine, which is an inherited (genetic) ability that causes codeine to be converted rapidly into life-threatening or fatal amounts of morphine (see Pharmacology)
            • 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 use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol

            Contraindications

            Postoperative use in children following tonsillectomy and/or adenoidectomy (see Black Box Warnings)

            Promethazine

            • Hypersensitivity
            • Newborn/premature infants, <2 years (risk of potentially fatal respiratory depression)
            • Subcutaneous or intra-arterially administration
            • Benign prostatic hypertrophy
            • Narrow angle glaucoma
            • Pyloroduodenal obstruction, stenosing peptic ulcer, bladder neck obstruction
            • Severe CNS depression
            • Coma, severe respiratory depression

            Codeine

            • Absolute: acute abdominal condition, diarrhea associated w/ toxins, pseudomembranous colitis, respiratory depression
            • Relative: asthma (acute), inflammatory bowel disease, respiratory impairment

            Cautions

            Concomitant use of opioids, including promethazine HCl and codeine phosphate oral Solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol

            Promethazine

            • Caution in CVD, asthma, hepatic impairment, peptic ulcer, respiratory impairment; the impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; avoid use of promethazine HCl and codeine phosphate oral solution in patients on these medications
            • Anaphylaxis in susceptible individuals
            • May impair ability to drive or perform hazardous tasks
            • Monitor closely with cardiovascular disease, hepatic impairment, Reye syndrome, history of sleep apnea
            • Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia
            • Antiemetic effect may obscure toxicity of chemotherapeutic drugs

            Codeine

            • Caution in cardiac arrhythmias, drug abuse/dependence, emotional lability, gallbladder disease, head injury, hepatic impairment, hypothyroidism, increased ICP, prostatic hypertrophy, renal impairment, seizures w/ epilepsy, urethral stricture, urinary tract surgery
            • Risk of life threatening side effects in nursing babies, especially if mother is an ultra rapid metabolizer of codeine
            • Ibuprofen is more effective than codeine for pain from musculoskeletal injuries in children
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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: codeine excreted in breast milk; promethazine undetermined; use while nursing not recommended due to infant risk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Promethazine: Antidopaminergic effect due to blocking mesolimbic dopamine receptors and alpha-adrenergic receptors in the brain; antihistaminic effect due to blocking H1-receptors

            Codeine: Narcotic agonist analgesic with antitussive activity, mu receptor agonist

            Promethazine

            Onset: 20 min

            Duration: 4-6 hr

            Bioavailability: 25% (oral)

            Protein Bound: 93%

            Vd: 12.9-17.7 L/hr

            Metabolism: Hepatic P450 enzyme CYP2D6

            Metabolites: Promethazine sulfoxide and glucuronides (inactive)

            Excretion: Urine, feces

            Dialyzable: no

            Codeine

            Half-Life: 3-4 hr

            Onset: 30-60 min

            Metabolism: Inactive but metabolized to morphine by CYP2D6 (missing in 5-10% of population)

            Duration: 4-6 hr

            Peak Plasma Time: 0.5-1 hr

            Vd: 3-6 L/kg

            Bioavailability: 53%

            Protein Bound: 25%

            Excretion: Urine (90%), feces

            Pharmacogenomics

            10% of codeine is metabolized to morphine by CYP2D6; the active morphine metabolite has a higher affinity for opioid receptors

            CYP2D6 poor metabolizers may not achieve adequate analgesia

            Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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