Promethazine HCl/Phenylephrine HCl/Codeine Phosphate

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|Promethazine HCl/Phenylephrine HCl/Codeine Phosphate

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Promethazine HCl/Phenylephrine HCl/Codeine Phosphate

Pronouncation: (Pro-METH-uh-zeen HIGH-droe-KLOR-ide/fen-ill-EFF-rin HIGH-droe-KLOR-ide/KOE-deen FOSS-fate)
Class: Antihistamine, Decongestant, Antitussive, Narcotic Analgesic

Trade Names:
Prometh VC w/Codeine
- Syrup 6.25 mg promethazine HCl/5 mg phenylephrine HCl/10 mg codeine phosphate/5 mL

Mechanism of Action

Pharmacology

Promethazine

Competitively antagonizes histamine at H 1 -receptor sites and produces sedative as well as antiemetic effects.

Phenylephrine

Stimulates postsynaptic alpha-receptors, resulting in rise in arterial peripheral vasoconstriction.

Codeine

Stimulates opiate receptors in the CNS in addition to causing respiratory depression, peripheral vasodilation, inhibition of intestinal peristalsis, stimulation of the chemoreceptors that cause vomiting, increased bladder tone, and suppression of cough.

Indications and Usage

Temporary relief of coughs and upper respiratory tract symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Patients with hypertension; peripheral vascular insufficiency; known hypersensitivity to any component of the product; hypersensitivity or idiosyncratic reaction to promethazine or other phenothiazines; patients receiving MAO inhibitors; treatment of lower respiratory tract symptoms, including asthma.

Dosage and Administration

Adults

PO 1 tsp (5 mL) q 4 to 6 hr (max, 30 mL/24 hr).

Children 6 yr through 11 yr

PO ½ to 1 tsp (2.5 to 5 mL) q 4 to 6 hr (max, 30 mL/24 hr).

Children under 6 yr (weight 18 kg or 40 lbs)

PO ¼ to ½ tsp (1.25 to 2.5 mL) q 4 to 6 hr (max, 9 mL/24 hr).

Children under 6 yr (weight 16 kg or 35 lbs)

PO ¼ to ½ tsp (1.25 to 2.5 mL) q 4 to 6 hr (max, 8 mL/24 hr).

Children under 6 yr (weight 14 kg or 30 lbs)

PO ¼ to ½ tsp (1.25 to 2.5 mL) q 4 to 6 hr (max, 7 mL/24 hr).

Children under 6 yr (weight 12 kg or 25 lbs)

PO ¼ to ½ tsp (1.25 to 2.5 mL) q 4 to 6 hr (max, 6 mL/24 hr).

Drug Interactions

Codeine CNS depressants (eg, tranquilizers, sedatives, alcohol)

Causes additive CNS depression.

MAO inhibitors (eg, isocarboxazid)

Excessive narcotic or MAO inhibitor interaction may occur.

Quinidine

May decrease the analgesic effect of codeine by interference with metabolism of codeine to morphine.

Promethazine Alcohol, barbiturates, narcotic analgesics, sedative-hypnotics, tricyclic antidepressants, tranquilizers, or other CNS depressants

Sedative effects of promethazine is additive with these agents.

Phenylephrine Alpha-adrenergic blockers (eg, phentolamine)

Decreased pressor response.

Anorexiants (eg, amphetamines, phenylpropanolamine)

Synergistic adrenergic response.

Atropine

Reflex bradycardia may be blocked or pressor response enhanced.

Beta-adrenergic blockers (eg, propranolol)

Cardiostimulating effects may be blocked.

Bronchodilators, sympathomimetic agents

Tachycardia or other arrhythmias may occur.

Ergot derivatives

Excessive increase in BP may occur.

MAO inhibitors (eg, isocarboxazid)

Because acute hypertensive crisis may occur, coadministration of these agents is contraindicated.

Tricyclic antidepressants

Pressor effects of phenylephrine may be increased.

Laboratory Test Interactions

Codeine

Increased plasma levels of amylase or lipase, making determination of these enzyme levels unreliable for 24 hr after taking codeine.

Promethazine

False-negative or false-positive interpretations of diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG; increased blood glucose tests.

Adverse Reactions

Cardiovascular

Codeine

Circulatory depression; tachycardia; bradycardia; palpitation; faintness; syncope; orthostatic hypotension.

Phenylephrine

Hypertension.

Promethazine

Increased or decreased BP.

CNS

Codeine

Lightheadedness; dizziness; sedation; euphoria; dysphoria; headache; transient hallucination; disorientation; convulsions.

Phenylephrine

Restlessness; anxiety; nervousness; dizziness; tremor; weakness.

Promethazine

Sedation; sleepiness; dizziness; confusion; disorientation; extrapyramidal symptoms (including oculogyric crisis); torticollis; tongue depression.

Dermatologic

Promethazine

Rash; photosensitivity.

EENT

Visual disturbances

Promethazine

Blurred vision.

GI

Codeine

Nausea; vomiting; constipation; biliary tract spasm increased colonic motility (in patients with chronic ulcerative colitis).

Promethazine

Dry mouth; nausea; vomiting.

Genitourinary

Codeine

Oliguria; urinary retention; antidiuretic effect.

Hematologic

Promethazine

Leukopenia; thrombocytopenia; agranulocytosis.

Respiratory

Codeine

Respiratory depression.

Phenylephrine

Respiratory distress.

Miscellaneous

Codeine

Allergy (including pruritus, giant urticaria, angioneurotic edema, laryngeal edema); flushing; sweating; weakness.

Phenylephrine

Precordial pain.

Precautions

Pregnancy

Category C .

Lactation

Codeine

Excreted in breast milk.

Promethazine and phenylephrine

Undetermined.

Children

Safety and efficacy not established in children under 2 yr.

Special Risk Patients

Use with caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, thyroid disease, diabetes mellitus, Addison disease, ulcerative colitis, prostatic hypertrophy, pyloroduodenal obstruction caused by symptomatic prostatic hypertrophy or narrowing of the bladder, CV disease, recent GI or urinary tract surgery, head injury or increased intracranial pressure, and in atopic children (because of possible histamine release), in the very young or elderly or debilitated patient; patients receiving tricyclic antidepressants or diet preparations (eg, amphetamines).

Dependency

Codeine has abuse potential. Psychological and physical dependence as well as tolerance may occur.

Seizure threshold

Seizure threshold may be lowered; use with caution in persons with known seizure disorders or when given in combination with narcotics or local anesthetics that may also affect seizure threshold.

Sleep apnea

Avoid use in patients with history of sleep apnea.

Overdosage

Symptoms

Codeine

Respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold clammy skin, bradycardia, hypotension, apnea, circulatory collapse, cardiac arrest, death, promethazine is additive to depressant effects of codeine

Phenylephrine

Hypertension, headache, convulsions, cerebral hemorrhage, vomiting, ventricular premature beats, short paroxysms of ventricular tachycardia, bradycardia

Promethazine

Range from mild depression of the CNS and CV system to profound hypotension, respiratory depression, and unconsciousness; stimulation (especially in children and geriatric patients); paradoxical hyperexcitability and nightmares in children; convulsions; dry mouth; fixed dilated pupils; flushing; GI symptoms

Patient Information

  • Explain name, dose, action, and potential side effects of drug.
  • Advise patient to take prescribed dose q 4 to 6 hr prn.
  • Advise caregiver to use dosing spoon or syringe when giving suspension to children.
  • Advise patient to take with food or milk if GI upset occurs.
  • Advise patient that if a dose is missed to take as soon as remembered unless it is nearing time for the next dose. Caution patient not to double the dose to catch up.
  • Advise patient that if allergy symptoms are not controlled, to not increase the dose of medication but to inform the health care provider.
  • Caution patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to avoid alcohol and other CNS depressants because of risk of excessive sedation.
  • Caution patient not to take any OTC antihistamines or decongestants while taking this medication unless advised by health care provider.
  • If patient is to have allergy skin testing, advise against taking the medication for at least 6 days before the skin testing.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: abnormal muscle movements, unusual sensitivity to sunlight, nervousness, dizziness, excessive drowsiness.
  • Caution patient not to take any prescription or OTC medications or dietary supplements unless advised by health care provider.




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hcl/phenylephrine hcl/codeien phosphate, promethazine hcl/phenylephrine hcl/codein ephosphate, promethazine hcl/phenylephrine hcl/codeinep hosphate, promethazine hcl/phenylephrine hcl/codeine hposphate, promethazine hcl/phenylephrine hcl/codeine pohsphate, promethazine hcl/phenylephrine hcl/codeine phsophate, promethazine hcl/phenylephrine hcl/codeine phopshate, promethazine hcl/phenylephrine hcl/codeine phoshpate, promethazine hcl/phenylephrine hcl/codeine phospahte, promethazine hcl/phenylephrine hcl/codeine phosphtae, promethazine hcl/phenylephrine hcl/codeine phosphaet, ppromethazine hcl/phenylephrine hcl/codeine phosphate, prromethazine hcl/phenylephrine hcl/codeine phosphate, proomethazine hcl/phenylephrine hcl/codeine phosphate, prommethazine hcl/phenylephrine hcl/codeine phosphate, promeethazine hcl/phenylephrine hcl/codeine phosphate, prometthazine hcl/phenylephrine hcl/codeine phosphate, promethhazine hcl/phenylephrine hcl/codeine phosphate, promethaazine hcl/phenylephrine hcl/codeine phosphate, promethazzine hcl/phenylephrine hcl/codeine phosphate, promethaziine hcl/phenylephrine hcl/codeine phosphate, promethazinne hcl/phenylephrine hcl/codeine phosphate, promethazinee hcl/phenylephrine hcl/codeine phosphate, promethazine hcl/phenylephrine hcl/codeine phosphate, promethazine hhcl/phenylephrine hcl/codeine phosphate, promethazine hccl/phenylephrine hcl/codeine phosphate, promethazine hcll/phenylephrine hcl/codeine phosphate, promethazine hcl//phenylephrine hcl/codeine phosphate, promethazine hcl/pphenylephrine hcl/codeine phosphate, promethazine hcl/phhenylephrine hcl/codeine phosphate, promethazine hcl/pheenylephrine hcl/codeine phosphate, promethazine hcl/phennylephrine hcl/codeine phosphate, promethazine hcl/phenyylephrine hcl/codeine phosphate, promethazine hcl/phenyllephrine hcl/codeine phosphate, promethazine hcl/phenyleephrine hcl/codeine phosphate, promethazine hcl/phenylepphrine hcl/codeine phosphate, promethazine hcl/phenylephhrine hcl/codeine phosphate, promethazine hcl/phenylephrrine hcl/codeine phosphate, promethazine hcl/phenylephriine hcl/codeine phosphate, promethazine hcl/phenylephrinne hcl/codeine phosphate, promethazine hcl/phenylephrinee hcl/codeine phosphate, promethazine hcl/phenylephrine hcl/codeine phosphate, promethazine hcl/phenylephrine hhcl/codeine phosphate, promethazine hcl/phenylephrine hccl/codeine phosphate, promethazine hcl/phenylephrine hcll/codeine phosphate, promethazine hcl/phenylephrine hcl//codeine phosphate, promethazine hcl/phenylephrine hcl/ccodeine phosphate, promethazine hcl/phenylephrine hcl/coodeine phosphate, promethazine hcl/phenylephrine hcl/coddeine phosphate, promethazine hcl/phenylephrine hcl/codeeine phosphate, promethazine hcl/phenylephrine hcl/codeiine phosphate, promethazine hcl/phenylephrine hcl/codeinne phosphate, promethazine hcl/phenylephrine hcl/codeinee phosphate, promethazine hcl/phenylephrine hcl/codeine phosphate, promethazine hcl/phenylephrine hcl/codeine pphosphate, promethazine hcl/phenylephrine hcl/codeine phhosphate, promethazine hcl/phenylephrine hcl/codeine phoosphate, promethazine hcl/phenylephrine hcl/codeine phossphate, promethazine hcl/phenylephrine hcl/codeine phospphate, promethazine hcl/phenylephrine hcl/codeine phosphhate, promethazine hcl/phenylephrine hcl/codeine phosphaate, promethazine hcl/phenylephrine hcl/codeine phosphatte, promethazine hcl/phenylephrine hcl/codeine phosphatee, etc.



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