Promethazine Hydrochloride/Phenylephrine Hydrochloride
 Promethazine Injection

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|Promethazine Hydrochloride/Phenylephrine Hydrochloride Promethazine Injection

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Promethazine Hydrochloride/Phenylephrine Hydrochloride

Pronouncation: (Pro-METH-uh-zeen HIGH-droe-KLOR-ide/fen-ill-EFF-rin HIGH-droe-KLOR-ide)
Class: Antihistamine, Decongestant

Trade Names:
Prometh VC Plain
- Syrup 5 mg phenylephrine HCl and 6.25 promethazine HCl

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.

Indications and Usage

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

Contraindications

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

Dosage and Administration

Adults and Children 12 yr and over

PO 1 tsp (5 mL) every 4 to 6 h (max, 6 tsp [30 mL] in 24 h).

Children 6 to under 12 yr

PO ½ to 1 tsp (2.5 to 5 mL) every 4 to 6 h (max, 6 tsp [30 mL] in 24 h).

Children 2 to under 6 yr

PO ¼ to ½ tsp (1.25 to 2.5 mL) every 4 to 6 h.

General Advice

  • Give with food or milk if GI upset occurs.
  • Use dosing spoon or syringe for pediatric doses.

Storage/Stability

Store syrup at controlled room temperature (59° to 86°F). Keep tightly capped and protect from light.

Drug Interactions

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

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

Promethazine

Hypertension; hypotension.

Phenylephrine

Hypertension.

CNS

Promethazine

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

Phenylephrine

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

Dermatologic

Promethazine

Rash; photosensitivity.

EENT

Promethazine

Blurred vision.

GI

Promethazine

Nausea; vomiting; dryness of mouth.

Hematologic

Promethazine

Leukopenia; thrombocytopenia; agranulocytosis.

Respiratory

Phenylephrine

Respiratory distress.

Miscellaneous

Phenylephrine

Precordial pain.

Precautions

Pregnancy

Category C .

Lactation

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, pyloroduodenal obstruction, urinary bladder obstruction due to symptomatic prostatic hypertrophy or narrowing of the bladder neck, thyroid disease, diabetes mellitus, cardiovascular disease, hepatic function impairment.

Cholestatic jaundice

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

Range from mild depression of the CNS and cardiovascular 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, hypertension, headache, cerebral hemorrhage, vomiting, ventricular tachycardia.

Patient Information

  • Explain name, dose, action, and potential side effects of drug.
  • Advise patient to take prescribed dose every 4 to 6 h as needed.
  • 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 to not double the dose to catch up.
  • Advise patient that if allergy symptoms are not controlled not to increase the dose of medication but to inform 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 to not take 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 these 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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