Drug Guide
Ibuprofen; Phenylephrine Hydrochloride
Classification
Therapeutic: Decongestant and Nonsteroidal Anti-Inflammatory Drug (NSAID)
Pharmacological: NSAID (Ibuprofen), Sympathomimetic (Phenylephrine)
FDA Approved Indications
- Temporary relief of nasal congestion, sinus pressure, headache, body aches, fever, and inflammatory pain associated with colds or flu
Mechanism of Action
Ibuprofen inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis, thereby decreasing inflammation, pain, and fever. Phenylephrine stimulates alpha-adrenergic receptors in nasal blood vessels, leading to vasoconstriction and relief of nasal congestion.
Dosage and Administration
Adult: 200-400 mg every 4-6 hours as needed, not exceeding 1200 mg/day without medical advice.
Pediatric: Not generally recommended for children under 12 without medical guidance.
Geriatric: Adjust dose based on renal and hepatic function; usual dosing applies.
Renal Impairment: Use with caution; consider dose adjustments or avoidance in severe impairment.
Hepatic Impairment: Use with caution; monitor for increased adverse effects.
Pharmacokinetics
Absorption: Well absorbed orally.
Distribution: Widely distributed; crosses inflamed tissues.
Metabolism: Ibuprofen is metabolized in the liver via hydroxylation and carboxylation; phenylephrine undergoes hepatic metabolism.
Excretion: Renal excretion of metabolites; Ibuprofen half-life approximately 2 hours.
Half Life: Ibuprofen: ~2 hours; Phenylephrine: approximately 2.5 hours.
Contraindications
- Known hypersensitivity to NSAIDs or phenylephrine.
- Use in patients with severe hypertension, coronary artery disease, or other cardiovascular diseases (due to phenylephrine).
Precautions
- Use cautiously in patients with hypertension, cardiovascular disease, or on monoamine oxidase inhibitors (MAOIs).
- Pregnancy Category C (first and second trimester); avoid in third trimester due to risk of fetal constriction.
Adverse Reactions - Common
- Nausea, dyspepsia, stomach pain (Common)
- Nasal dryness, sneezing (from phenylephrine) (Common)
Adverse Reactions - Serious
- Allergic reactions such as rash, itching, swelling (Rare)
- Elevated blood pressure, tachycardia (Rare)
- Gastrointestinal bleeding or ulceration (Rare)
Drug-Drug Interactions
- Other NSAIDs or anticoagulants (risk of bleeding)
- MAOIs (risk of hypertensive crisis)
- Sympathomimetics (potential for increased cardiovascular effects)
Drug-Food Interactions
- Caution with caffeine or other stimulants
Drug-Herb Interactions
- St. John's Wort, Ginseng (may increase blood pressure)
Nursing Implications
Assessment: Monitor for signs of allergic reaction, gastrointestinal bleeding, blood pressure, and medication effectiveness.
Diagnoses:
- Risk for bleeding, risk for cardiovascular complications.
- Pain related to inflammation.
- Ineffective airway clearance (if congestion persists).
Implementation: Administer with food or milk to minimize GI upset. Monitor blood pressure and assess for allergic reactions.
Evaluation: Effective reduction of nasal congestion, headache, and fever without adverse effects.
Patient/Family Teaching
- Take with food or milk to reduce stomach upset.
- Do not exceed recommended dose duration.
- Report any signs of allergic reactions, increased blood pressure, or gastrointestinal bleeding.
- Inform about potential interactions with other medications.
Special Considerations
Black Box Warnings:
- NSAIDs may increase risk of cardiovascular thrombotic events, myocardial infarction, and stroke. Use with caution in patients with cardiovascular disease.
Genetic Factors: Cytochrome P450 enzyme variation can affect metabolism of ibuprofen.
Lab Test Interference: NSAIDs can affect renal function tests and bleeding parameters.
Overdose Management
Signs/Symptoms: Nausea, vomiting, gastrointestinal bleeding, dizziness, seizures, coma.
Treatment: Supportive care; activated charcoal within 1 hour of ingestion; monitoring and supportive measures for breathing, circulation, and renal function.
Storage and Handling
Storage: Store at room temperature between 20-25°C (68-77°F).
Stability: Stable under recommended storage conditions.