aspirin/doxylamine/dextromethorphan/phenylephrine (OTC)

Brand and Other Names:Alka-Seltzer Plus Night Cold & Cough Effervescent
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

aspirin/doxylamine/dextromethorphan/phenylephrine

effervescent tablet

  • 500mg/6.25mg/10mg/7.8mg
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Relief of Cold Symptoms

2 tablets fully dissolved in 4 oz of water qHS; may be taken q4-6hr; not to exceed 8 tablets/day

Dosage Forms & Strengths

aspirin/doxylamine/dextromethorphan/phenylephrine

effervescent tablet

  • 500mg/6.25mg/10mg/7.8mg
more...

Relief of Cold Symptoms

<12 years

  • Not recommended

>12 years

  • 2 tablets fully dissolved in 4 oz of water qHS; may be taken q4-6hr; not to exceed 8 tablets/day
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Interactions

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and aspirin/doxylamine/dextromethorphan/phenylephrine

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            Adverse 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

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            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 atherosclerosis

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            Pregnancy & 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.

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            Pharmacology

            Mechanism of Action

            Aspirin irreversibly inhibits platelet aggregation by inhibiting platelet cyclooxygenase; acetyl group responsible for inactivation of cyclooxygenase via acetylation; hydrolyzed rapidly in plasma, 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 is a cough suppressant that acts centrally on the cough center in medulla

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

            Pharmacokinetics

            Aspirin

            • Bioavailability: 80-100%
            • Onset: 5-30 min (PO); 1-2 hr (PR)
            • Duration: 3-6 hr (PO); >7 hr (PR)
            • Peak plasma time: 0.25-3 hr (PO); 4-5hr (PR)
            • Vd: 0.15-0.2 L/kg
            • Protein binding: 90-95%
            • Metabolism: Liver (microsomal enzyme system)
            • Half-life: 2-3 hr (low dose); 15-30 hr (higher dose)
            • Renal clearance: 80-100%
            • Excretion: Urine (80-100%)

            Doxylamine

            • Peak plasma time: 2-3 hr
            • Half-life: 10-12 hr
            • Excretion: Urine
            • Metabolism: Liver (CYP450)

            Dextromethorphan

            • Onset: 15-30 min
            • Duration: 3-6 hr
            • Metabolism: Hepatic P450 enzyme CYP2D6
            • Excretion: Urine
            • Half-life: 2-4 hr (extensive metabolizers); 24 hr (poor metabolizers)
            • Peak plasma time: 2-3 hr

            Phenylephrine

            • Half-life: 2-3 hr
            • Onset: 10-15 min
            • Duration: 15 min
            • Bioavailability: < 38%
            • Excretion: Urine (80-90%)
            • Peak plasma time: 0.75-2 hr
            • Vd: 26-61 L
            • Vdss: 340 L
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