drug-information.ru

|Promethazine HCl/Phenylephrine HCl/Codeine Phosphate

Promethazine HCl/Phenylephrine HCl/Codeine Phosphate

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

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

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

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

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

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

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

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

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

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

Drug Interactions

Causes additive CNS depression.

Excessive narcotic or MAO inhibitor interaction may occur.

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

Sedative effects of promethazine is additive with these agents.

Decreased pressor response.

Synergistic adrenergic response.

Reflex bradycardia may be blocked or pressor response enhanced.

Cardiostimulating effects may be blocked.

Tachycardia or other arrhythmias may occur.

Excessive increase in BP may occur.

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

Pressor effects of phenylephrine may be increased.

Laboratory Test Interactions

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

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

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

Hypertension.

Increased or decreased BP.

CNS

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

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

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

Dermatologic

Rash; photosensitivity.

EENT

Visual disturbances

Blurred vision.

GI

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

Dry mouth; nausea; vomiting.

Genitourinary

Oliguria; urinary retention; antidiuretic effect.

Hematologic

Leukopenia; thrombocytopenia; agranulocytosis.

Respiratory

Respiratory depression.

Respiratory distress.

Miscellaneous

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

Precordial pain.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

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

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

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

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.