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Ibuprofen, Phenylephrine, and Chlorpheniramine

Pronunciation

(eye byoo PROE fen, fen il EF rin, & klor fen IR a meen)

Index Terms

  • Chlorpheniramine, Ibuprofen, and Phenylephrine
  • Ibuprofen, Phenylephrine Hydrochloride, and Chlorpheniramine Maleate
  • Phenylephrine, Chlorpheniramine, and Ibuprofen

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Advil Allergy & Congestion: Ibuprofen 200 mg, phenylephrine hydrochloride 10 mg, and chlorpheniramine maleate 4 mg

Brand Names: U.S.

  • Advil Allergy & Congestion [OTC]

Pharmacologic Category

  • Alkylamine Derivative
  • Alpha-Adrenergic Agonist
  • Analgesic, Nonopioid
  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, First Generation
  • Nonsteroidal Anti-inflammatory Drug (NSAID), Oral

Pharmacology

Ibuprofen: Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties.

Phenylephrine: Stimulates postsynaptic alpha-receptors, resulting in vasoconstriction, which reduces nasal congestion.

Chlorpheniramine: Competitively antagonizes histamine at histamine 1 receptor sites.

Use: Labeled Indications

Common cold/upper respiratory allergies: Temporarily relief of common cold, hay fever, and other upper respiratory symptoms (eg, runny nose, itchy watery eyes; itching of the nose or throat, sneezing, nasal congestion, sinus pressure, headache, minor body aches and pains, fever).

Contraindications

When used for self-medication, do not use if you are hypersensitive to any other pain reliever/fever reducer; in children <12 years; prior to or following cardiac surgery; or in combination with or within 14 days of stopping a monoamine oxidase inhibitor (MAOI).

Dosing: Adult

Common cold/upper respiratory allergies: Oral: One tablet (ibuprofen 200 mg/phenylephrine 10 mg/chlorpheniramine 4 mg) every 4 hours. Maximum: 6 tablets (ibuprofen 1,200 mg/phenylephrine 60 mg/chlorpheniramine 24 mg) per 24 hours

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Common cold/upper respiratory allergies: Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Administration

Administer with food or milk if GI upset occurs.

Dietary Considerations

Take with food or milk if GI upset occurs.

Storage

Store at 20°C° to 25°C (68°F to 77°F). Avoid excessive heat >40°C (104°F).

Adverse Reactions

See individual agents.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid reactions: Even in patients without prior exposure anaphylactoid reactions may occur; patients with "aspirin triad" (bronchial asthma, aspirin intolerance, rhinitis) may be at increased risk. Do not use in patients who experience bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy.

• Cardiovascular events: NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including fatal MI and stroke. Risk may occur early during treatment and may increase with duration of use. New-onset hypertension or exacerbation of hypertension may occur (NSAIDS may also impair response to ACE inhibitors, thiazide diuretics, or loop diuretics); may contribute to cardiovascular events; monitor blood pressure; use with caution in patients with hypertension. May cause sodium and fluid retention; use with caution in patients with edema. Avoid use in heart failure (ACCF/AHA [Yancy 2013]). Avoid use in patients with a recent MI unless benefits outweigh risk of cardiovascular thrombotic events. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of cardiovascular events; alternate therapies should be considered for patients at high risk.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• GI events: NSAIDs cause an increased risk of serious GI inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. These events may occur at any time during therapy and without warning. Avoid use in patients with active GI bleeding. In patients with a history of acute lower GI bleeding, avoid use of non-aspirin NSAIDs, especially if due to angioectasia or diverticulosis (Strate 2016). Use caution with a history of GI ulcers, concurrent therapy known to increase the risk of GI bleeding (eg, aspirin, anticoagulants and/or corticosteroids, selective serotonin reuptake inhibitors), advanced hepatic disease, coagulopathy, smoking, use of alcohol, or in elderly or debilitated patients. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of GI adverse events; alternate therapies should be considered for patients at high risk.

• Hematologic effects: Platelet adhesion and aggregation may be decreased; may prolong bleeding time; patients with coagulation disorders or who are receiving anticoagulants should be monitored closely. Anemia may occur. Rarely, NSAID use has been associated with potentially severe blood dyscrasias (eg, agranulocytosis, thrombocytopenia, aplastic anemia).

• Hyperkalemia: NSAID use may increase the risk of hyperkalemia, particularly in the elderly, diabetics, renal disease, and with concomitant use of other agents capable of inducing hyperkalemia (eg, ACE-inhibitors). Monitor potassium closely.

• Renal effects: NSAID use may compromise existing renal function; dose-dependent decreases in prostaglandin synthesis may result from NSAID use, reducing renal blood flow which may cause renal decompensation (usually reversible). Patients with impaired renal function, dehydration, hypovolemia, heart failure, hepatic impairment, those taking diuretics and ACE inhibitors, and the elderly are at greater risk of renal toxicity. Rehydrate patient before starting therapy; monitor renal function closely.

• Skin reactions: NSAIDs may cause serious skin adverse events including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN); discontinue use at first sign of skin rash (or any other hypersensitivity).

Disease-related concerns:

• Aseptic meningitis: May increase the risk of aseptic meningitis, especially in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders.

• Asthma: Do not administer to patients with aspirin-sensitive asthma; severe bronchospasm may occur. Use caution in patients with other forms of asthma.

• Diabetes: Use with caution in patients with diabetes mellitus.

• Hepatic impairment: Use with caution in patients with hepatic impairment. Patients with advanced hepatic disease are at an increased risk of GI bleeding with NSAIDs.

• Increased intraocular pressure: Use with caution in patients with increased intraocular pressure.

• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.

• Renal impairment: Use with caution in patients with renal impairment.

• Thyroid disease: Use with caution in patients with thyroid disease.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), contact a health care provider before use if you have a breathing problem such as emphysema or chronic bronchitis or have a history or stomach problems such as heartburn. Discontinue use and contact health care provider if signs of stomach bleeding occur (eg, feeling faint, vomiting blood, bloody or black stools); if symptoms of heart problems or stroke occur (eg, chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, leg swelling); pain gets worse or lasts >7 days; fever gets worse or lasts >3 days; nasal congestion lasts >7 days; redness or swelling is present in the painful area; nervousness, dizziness or sleepiness occurs; symptoms continue or get worse; or if any new symptoms occur. Avoid alcoholic beverages.

Monitoring Parameters

Relief of symptoms; signs and symptoms of GI adverse effects (abdominal pain, bleeding); signs and symptoms of hypersensitivity.

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