Promethazine and phenylephrine

FDA label, Amneal Pharmaceuticals LLC, oral, effective 2024-10-30. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

DOSAGE AND ADMINISTRATION It is important that promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is measured with an accurate measuring device (see Precautions-Information for Patients ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured.

It is strongly recommended that an accurate measuring device be used. A pharmacist can provide instructions for measuring the correct dose. Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use in Pediatric Patients ).

Drug interactions

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Label text (5 paragraphs)

Drug Interactions: Promethazine CNS Depressants - Promethazine may increase, prolong, or intensify the sedative action of other central-nervous system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricylic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized.

Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine - Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics - Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Monoamine oxidase inhibitors (MAOI) - Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Phenylephrine Drug Phenylephrine with prior administration of monoamine oxidase inhibitors (MAOI). Effect Cardiac pressor response potentiated. May cause acute hypertensive crisis. Drug Phenylephrine with tricyclic antidepressants. Effect Pressor response increased. Drug Phenylephrine with ergot alkaloids. Effect Excessive rise in blood pressure. Drug Phenylephrine with bronchodilator sympathomimetic agents and with epinephrine or other sympathomimetics.

Effect Tachycardia or other arrhythmias may occur. Drug Phenylephrine with atropine sulfate Effect Reflex bradycardia blocked; pressor response enhanced. Drug Phenylephrine with prior administration of propranolol or other β -adrenergic blockers. Effect Cardiostimulating effects blocked. Drug Phenylephrine with prior administration of phentolamine or other α-adrenergic blockers. Effect Pressor response decreased. Drug Phenylephrine with diet preparations, such as amphetamines or phenylpropanolamine. Effect Synergistic adrenergic response. Drug/Laboratory Test Interactions: The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride.

Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine.

Contraindications

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI).

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for promethazine and phenylephrine. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine.

Lactation

Nursing Mothers: It is not known whether promethazine or phenylephrine are excreted in human milk. Caution should be exercised when promethazine and phenylephrine is administered to a nursing woman.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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