Phenylephrine + Promethazine

Promethazine hydrochloride and Phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Phenylephrine is a potent postsynaptic-α-receptor agonist. It mainly causes vasoconstriction of the blood vessels in the nasal mucosa and consequently relieves nasal congestion associated with allergies or head colds. Promethazine is an H1 receptor-blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.

Adults and children 12 years and over: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 6 to under 12 years of age: ½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 2 to under 6 years of age: ¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.

Children under 2 years of age: Promethazine and Phenylephrine are not recommended for children under 2 years of age.

Promethazine: The sedative action of promethazine is additive to the sedative effects of other central nervous system depressants, including alcohol, narcotic analgesics, sedatives, hypnotics, tricyclic antidepressants, and tranquilizers; therefore, these agents should be avoided or administered in reduced dosage to patients receiving promethazine.

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 b- adrenergic blockers.
Effect: Cardio stimulating effects blocked.
Drug: Phenylephrine with prior administration of phentolamine or other a- adrenergic blockers.
Effect: Pressor response decreased.
Drug: Phenylephrine with diet preparations, such as amphetamines or phenylpropanolamine.
Effect: Synergistic adrenergic response.

Promethazine is contraindicated 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).

Nervous System: Sedation, sleepiness, occasional blurred vision, dryness of mouth, dizziness; rarely: confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion (usually in association with parenteral injection or excessive dosage).

Cardiovascular: Increased or decreased blood pressure.
Dermatologic: Rash; rarely: photosensitivity.
Hematologic: Rarely: leukopenia, thrombocytopenia; agranulocytosis (1 case).
Gastrointestinal: Nausea and vomiting.
Nervous System: Restlessness, anxiety, nervousness, and dizziness.
Cardiovascular: Hypertension (see Warning).
Other: Precordial pain, respiratory distress, tremor, and weakness.

Pregnancy Category C. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and Phenylephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine and Phenylephrine should be given to a pregnant woman only if clearly needed. Promethazine should be used cautiously in persons with cardiovascular disease or impairment of liver function. Phenylephrine should be used with caution in patients with cardiovascular disease, particularly hypertension.

Promethazine: Promethazine may cause marked drowsiness. Ambulatory patients should be cautioned against such activities as driving or operating dangerous machinery until it is known that they do not become drowsy or dizzy from promethazine therapy. The sedative action of promethazine hydrochloride is additive to the sedative effects of central nervous system depressants; therefore, agents such as alcohol, narcotic analgesics, sedatives, hypnotics, and tranquilizers should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride. When given concomitantly with promethazine hydrochloride, the dose of barbiturates should be reduced by at least one-half, and the dose of analgesic depressants, such as morphine or meperidine, should be reduced by one-quarter to one-half. Promethazine may lower seizure threshold. This should be taken into consideration when administering to persons with known seizure disorders or when giving in combination with narcotics or local anesthetics which may also affect seizure threshold. Sedative drugs or CNS depressants should be avoided in patients with a history of sleep apnea. Antihistamines should be used with caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck. Administration of promethazine has been associated with reported cholestatic jaundice.

Phenylephrin: Because phenylephrine is an acirenergic agent, it should be given with caution to patients with thyroid diseases, diabetes mellitus, and heart disease or those receiving tricyclic antidepressants. Men with symptomatic, benign prostatic hypertrophy can experience urinary retention when given oral or nasal decongestants. Phenylephrine can cause a decrease in cardiac output, and extreme caution should be used when administering the drug parenterally or orally to patients with arteriosclerosis, to elderly individuals, and/ or to patients with initially poor cerebral or coronary circulation. Phenylephrine should be used with caution in patients taking diet preparations, such as amphetamines or phenylpropanolamine, because synergistic adrenergic effects could result in serious hypertensive response and possible stroke.

Symptoms of overdosage with Promethazine and Phenylephrine are from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, sudden death, hypertension, headache, convulsions, cerebral hemorrhage and vomiting. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic.

Sedating Anti-histamine

Do not store above 30°C. Keep away from light and out of the reach of children.