aspirin/chlorpheniramine/phenylephrine (OTC)

Frequency Not Defined

Dysrhythmias

Hypotension

Tachycardia

Agitation

Cerebral edema

Coma

Confusion

Dizziness

Headache

Subdural or intracranial hemorrhage

Lethargy

Hives

Rashes

May potentiate peptic ulcer and cause stomach distress or heartburn

Dyspepsia

GI bleeding

Ulceration and perforation

Nausea

Vomiting

Prolonged prothrombin time

Palpitations

Sedation

Fatigue

Confusion

Depression

Tremors

Irritability

Insomnia

Euphoria

Hemolytic anemia

Thrombocytopenia

Agranulocytosis

Anorexia

Wheezing

Thickening of bronchial secretions

Restlessness

Headache

Hypertension

Severe peripheral and visceral vasoconstriction

Contraindications

Hypersensitivity

Liver damage

Hypoprothrombinemia

Vitamin K deficiency

Bleeding disorders

Asthma

Due to association of aspirin with Reye syndrome, do not use in children (<16 y) with viral infections

Narrow-angle glaucoma

Symptomatic prostate hypertrophy

Bladder-neck obstruction

Stenosing peptic ulcer

Cautions

Aspirin: May cause transient decrease in renal function & aggravate chronic kidney disease; avoid use in patients with severe anemia, with history of blood coagulation defects, or taking anticoagulants

Chlorpheniramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates

Phenylephrine: Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe arteriosclerosis

Pregnancy category D; avoid during pregnancy, especially during third trimester (risk for premature closure of ductus arteriosus)

Lactation: Excreted in breast milk; do not breast feed

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Aspirin is a stronger inhibitor of both prostaglandin synthesis and platelet aggregation than other salicylic acid derivatives. Acetyl group is responsible for inactivation of cyclooxygenase via acetylation.

Aspirin is hydrolyzed rapidly in plasma, and elimination follows zero order pharmacokinetics. Aspirin irreversibly inhibits platelet aggregation by inhibiting platelet cyclooxygenase. This, in turn, inhibits conversion of arachidonic acid to PGI2 (potent vasodilator and inhibitor of platelet activation) and thromboxane A2 (potent vasoconstrictor and platelet aggregate).

Chlorpheniramine blocks muscle responses in histamine and acts as an antagonism of the constrictor effects of histamine on respiratory smooth muscle.

Phenylephrine is a vasoconstrictor and a decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue. It shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia.