aspirin/doxylamine/dextromethorphan/phenylephrine (Alka-Seltzer Plus Night Cold and Cough Effervescent)

Dosing and uses of Alka-Seltzer Plus Night Cold and Cough Effervescent (aspirin/doxylamine/dextromethorphan/phenylephrine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

aspirin/doxylamine/dextromethorphan/phenylephrine

effervescent tablet

• 500mg/10mg/6.25mg/7.8mg

 

Relief of Cold Symptoms

Alka-Seltzer Plus Night Cold & Cough Effervescent: 2 tablets fully dissolved in 4 oz of water qHS; may be taken q4-6hr; not to exceed 8 tablets/day

 

Pediatric dosage forms and strengths

aspirin/doxylamine/dextromethorphan/phenylephrine

effervescent tablet

• 500mg/10mg/6.25mg/7.8mg

 

Relief of Cold Symptoms

Alka-Seltzer Plus Night Cold & Cough Effervescent

• <12 years old: Do not use
• >12 years old: 2 tablets fully dissolved in 4 oz of water qHS; may be taken q4-6hr; not to exceed 8 tablets/day

 

Alka-Seltzer Plus Night Cold and Cough Effervescent (aspirin/doxylamine/dextromethorphan/phenylephrine) adverse (side) effects

Frequency not defined

Dysrhythmias

Hypotension

Tachycardia

Agitation

Cerebral edema

Coma

Confusion

Dizziness

Headache

Subdural or intracranial hemorrhage

Lethargy

Hives

Rash

May potential peptic ulcer & cause stomach distress or heartburn

Dyspepsia

GI bleeding

Ulceration & perforation

Nausea

Vomiting

Prolonged prothrombin time

Sedation

Sleepiness

Urinary retention

Xerostomia

Increased appetite

Thickening of mucus in nose or throat

Restlessness

Headache

Hypertension

Severe peripheral & visceral vasoconstriction

 

Warnings

Contraindications

Hypersensitivity

Liver damage

Hypoprothrombinemia

Vitamin K deficiency

Bleeding disorders

Asthma

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

Use within 14 days of MAO inhibitor therapy

Narrow-angle glaucoma

Symptomatic prostate hypertrophy

Bladder-neck obstruction

 

Cautions

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

Dextromethorphan: Do not take for persistent or chronic cough associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm unless directed by a healthcare provider; may decrease respiration rate

Doxylamine: May exacerbate angle closure glaucoma, hyperthyroidism, peptic ulcer, or urinary tract obstruction; xerostomia may occur

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

 

Pregnancy and lactation

Pregnancy category: D, avoid aspirin 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.

 

Pharmacology of Alka-Seltzer Plus Night Cold and Cough Effervescent (aspirin/doxylamine/dextromethorphan/phenylephrine)

Mechanism of action

Aspirin: Stronger inhibitor of both prostaglandin synthesis & platelet aggregation than other salicylic acid derivatives; acetyl group responsible for inactivation of cyclooxygenase via acetylation; hydrolyzed rapidly in plasma, & 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)

Doxylamine: competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity and penetrates CNS, which causes pronounced tendency to induce sedation

Dextromethorphan: cough suppressant that acts centrally on the cough center in medulla

Phenylephrine: vasoconstrictor & decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia