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promethazine/codeine/phenylephrine (Rx)Brand and Other Names:Prometh VC with Codeine Syrup

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral liquid: Schedule V

  • promethazine/codeine/phenylephrine
  • (6.25mg/10mg/5mg)/5mL
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Cough

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

5 mL PO q4-6hr, not to exceed 30 mL/24 hr

Administration

Administer with special measuring device for accurate dose

Dosage Forms & Strengths

promethazine/codeine/phenylephrine

oral liquid: Schedule V

  • promethazine/codeine/phenylephrine
  • (6.25mg/10mg/5mg)/5mL
more...

Cough

<6 years: Contraindicated

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

>12 years: 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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Adverse Effects

>10%

Codeine

  • Constipation
  • Drowsiness

Frequency Not Defined (Promethazine)

Sedation (common)

Confusion (common)

Disorientation (common)

Adverse anticholinergic effects (dry mouth, blurred vision)

Photosensitivity

Extrapyramidal symptoms

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)

Frequency Not Defined (Phenylephrine)

HTN

Reflex bardycardia

Anxiety

Headache

Burning

Rebound congestion

Sneezing

Pulmonary edema

Extravasation

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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

In addition, 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)

Contraindications

Promethazine

  • Hypersensitivity
  • Newborn/premature infants, <2 yr (risk of potentially fatal respiratory depression)
  • Subcutaneous or intra-arterially administration
  • BPH
  • 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
  • Postoperative use in children following tonsillectomy and/or adenoidectomy (see Black Box Warnings)

Phenylephrine

  • Hypersensitivity to phenylephrine or sulfites
  • Severe hypertension
  • Ventricular tachycardia
  • Closed angle glaucoma
  • Do not use within 14 days of MAO inhibitors
  • Risk of hypertension

Cautions

Promethazine

  • Caution in CVD, asthma, hepatic impairment, peptic ulcer, respiratory impairment
  • 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

  • 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

Phenylephrine

  • Caution in cerebrovascular insufficiency, CVD, HTN, DM, thyroid disease, prostatic hypertrophy, geriatrics
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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.

more...
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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

Phenylephrine: Strong alpha effects resulting in increased PVR and BP and decreased cardiac output and renal perfusion

Promethazine

Onset: 20 min

Duration: 4-6 hr

Bioavailability: 25% (PO)

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

Phenylephrine

Half-Life: 2-3 hr

Onset (blood pressure): 10-15 min (SC/IM)

Duration (blood pressure): 15-20 min (IV); 1-2 hr (IM)

Vd: 26-61 L

Bioavailability: ≤ 38%

Metabolism: Extensivly in intestinal wall, moderately in liver

Metabolites: M-hydroxymandelic acid (inactive)

Excretion: Urine: 80-90%

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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Images

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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.
6 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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Code Definition
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Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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