Phenylephrine + Promethazine

Cough

Oral Adults: For the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Oral 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 Hypersensitivity Children <12 years (risk of potentially fatal respiratory depression) BPH Narrow-angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease, or peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds) Pyloroduodenal obstruction, stenosing peptic ulcer, bladder neck obstruction Severe CNS depression Coma Severe respiratory depression A history of an idiosyncratic reaction to promethazine or to other phenothiazines Phenylephrine Hypersensitivity to phenylephrine or sulfites Severe hypertension Ventricular tachycardia Closed-angle glaucoma Do not use within 14 days of MAO inhibitors Risk of 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 e

C 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.

Frequency Not Defined (Promethazine) Sedation (common) Confusion (common) Disorientation (common) Adverse anticholinergic effects (dry mouth, blurred vision) Photosensitivity Extrapyramidal symptoms Tachycardia Bradycardia Leukopenia (rare) Agranulocytosis (rare) Obstructive jaundice Frequency Not Defined (Phenylephrine) HTN Reflex bardycardia Anxiety Headache Burning Rebound congestion Sneezing Pulmonary edema Extravasation

Promethazine: Antidopaminergic effect due to blocking mesolimbic dopamine receptors and alpha-adrenergic receptors in the brain; antihistaminic effect due to blocking H1-receptors Phenylephrine: Strong alpha effects resulting in increased PVR and BP and decreased cardiac output and renal perfusion