ibuprofen/pseudoephedrine

Ibuprofen/pseudoephedrine is a combination medication used for temporary relief from symptoms of common cold and flu, including headache, fever, sinus pressure, nasal congestion, minor aches and pains. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that reduces inflammation, and pseudoephedrine is a decongestant that relieves nasal and sinus congestion, making breathing easier. Ibuprofen/pseudoephedrine combo drug is available over the counter (OTC) in the U.S.

Ibuprofen and pseudoephedrine work in different ways to relieve cold and flu symptoms, and the combination is more effective than either of the drug as a single agent.

• Ibuprofen blocks the activity of enzymes known as cyclooxygenases (COX-1 and COX-2), essential for biosynthesis of prostaglandin. Prostaglandins are fatty compounds that regulate many processes in the body and are primary mediators of inflammation. Inhibition of prostaglandin synthesis inhibits the movement and aggregation of inflammatory cells and the release of proinflammatory proteins (cytokines).
• Pseudoephedrine works by stimulating alpha and beta receptors, protein molecules that regulate contraction of the smooth muscles in the respiratory tract and around blood vessels. This results in dilation of the respiratory passage and constriction of blood vessels in the mucous tissue, reducing congestion and making breathing easier.

• Do not take ibuprofen/pseudoephedrine if you are hypersensitive to any component of the combo medication.
• Do not take ibuprofen/pseudoephedrine in the following conditions:
  • Immediately before or after cardiac surgery
  • History of allergic reaction such as asthma or hives to NSAIDs
• Do not administer ibuprofen/pseudoephedrine to children below 12 years.
• Do not take ibuprofen/pseudoephedrine:
  • For longer than 3 days for fever and longer than 7 days for nasal congestion
  • Concurrently or within 14 days of treatment with monoamine oxidase inhibitor (MAOI) antidepressant medications
• Use ibuprofen/pseudoephedrine with caution in the following conditions:
  • Mild-to-moderate high blood pressure (hypertension)
  • Cardiac disease
  • Impaired liver function
  • Impaired kidney function
  • Thyroid disease
  • High blood sugar (hyperglycemia)
  • Diabetes mellitus
  • Enlarged prostate (benign prostate hyperplasia)
  • Peptic ulcer disease
  • Seizure disorder
  • Glaucoma, a progressive eye disease with high intraocular pressure that gradually damages the optic nerve
• Avoid ibuprofen/pseudoephedrine in general, if you are pregnant. If NSAIDs are required, check with your physician before taking, and limit use to minimum effective dosage for as short a duration as possible.

Warnings specific for ibuprofen:

• May cause serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal. Risk is higher for patients with a history of peptic ulcer disease or patients older than 60 years of age.
• May reduce the benefit of heart-protective low dose of aspirin.
• Use with caution in patients taking anticoagulant or antiplatelet therapy, and monitor patients.
• NSAIDs, except aspirin, can increase the risk for heart attack, heart failure and stroke that can be fatal. Risk is higher with use of high doses for prolonged periods.
• Long-term use of NSAIDs can cause kidney injury. The risk is higher in older people.
• Can cause fluid retention and edema. Use with caution in patients with edema or congestive heart failure.
• Can cause high blood potassium levels (hyperkalemia) in elderly patients and patients with diabetes or kidney disease, or with concurrent use of other medications that can increase potassium levels. Monitor potassium levels in such patients.
• Discontinue use if a patient develops blurred vision, blind spots or other vision problems.
• Can cause serious skin reactions including exfoliative dermatitis, toxic epidermal necrolysis and Stevens Johnson syndrome.
• There have been reports of fever, rash, abdominal pain, nausea, liver dysfunction, and meningitis in patients with collagen-vascular disease, especially systemic lupus erythematosus (SLE).

Warnings specific for pseudoephedrine:

• May aggravate poorly controlled hypertension.
• Elderly patients are more sensitive to side effects.
• Can reduce breastmilk production in lactating women.

Common side effects of ibuprofen/pseudoephedrine include:

• Dizziness
• Confusion
• Drowsiness
• Excitability
• Insomnia
• Anxiety
• Headache
• Weakness
• Tremor
• Convulsion
• Central nervous system (CNS) stimulation
• Irregular heart rhythm (arrhythmia)
• Palpitations
• Congestive heart failure (CHF)
• High blood pressure (hypertension)
• Blood clot block in blood vessels (thromboembolism)
• Bronchospasm
• Nausea
• Vomiting
• Gastrointestinal upset
• Constipation
• Abdominal pain
• Low red blood cell count due to rapid destruction (hemolytic anemia)
• Anemia from lack of production of new red cells (aplastic anemia)
• Low count of neutrophil immune cells (neutropenia)
• Severe skin reactions including:
  • Exfoliative dermatitis
  • Toxic epidermal necrolysis
  • Steven's Johnson syndrome
• Liver toxicity (hepatotoxicity)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Tablet

• 200 mg/30 mg

Liquid gel capsule

• 200 mg/30 mg

Cold Symptoms

Adult and Pediatric:

Children below 12 years

• Safety and efficacy not established

Adults and children above 12 years

• Temporary relief of symptoms (headache, fever, sinus pressure, nasal congestion, minor aches and pains) associated with the common cold or flu.
• 1 tablet/capsule orally every 4-6 hours as needed; may increase to 2 tablets/capsules every 4-6 hours if necessary while symptoms persist
• Not to exceed 6 tablets/capsules/24 hours

Renal impairment

• eGFR 30 to 60 mL/min/1.73 m2: Avoid use with intercurrent disease that increases risk of acute kidney injury
• eGFR below 30 mL/min/1.73 m2: Avoid use

Hepatic impairment

• No dose adjustment described in manufacturer labeling; use with caution

Administration

• Take with food or milk if stomach upset occurs

Overdose

• Ibuprofen/pseudoephedrine overdose can cause vomiting, stomach pain, diarrhea, ringing in the ears, severe drowsiness, agitation, sweating, coughing up blood, weak or shallow breathing, fainting, or convulsions.
• Overdose may be treated with symptomatic and supportive care, including gastric lavage, administration of activated charcoal and/or inducing vomiting to eliminate the undigested drug.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of ibuprofen/pseudoephedrine include:
  • dihydroergotamine
  • dihydroergotamine inhaled
  • dihydroergotamine intranasal
  • ergoloid mesylates
  • ergonovine
  • ergotamine
  • isocarboxazid
  • linezolid
  • methylergonovine
  • phenelzine
  • procarbazine
  • rasagiline
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Ibuprofen/pseudoephedrine has serious interactions with at least 52 different drugs.
• Ibuprofen/pseudoephedrine has moderate interactions with at least 302 different drugs.
• Ibuprofen/pseudoephedrine has mild interactions with at least 35 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate and well-controlled studies on the safety of ibuprofen/pseudoephedrine use in pregnant women. In general, avoid taking ibuprofen/pseudoephedrine during pregnancy. If NSAID is necessary, limit use to minimum effective dosage for the shortest duration possible, between 20 and 30 weeks of pregnancy. Do not take for prolonged periods.
• Animal studies indicate an increased risk for loss of pregnancy in early stages because ibuprofen inhibits the synthesis of prostaglandin. Use of ibuprofen in late pregnancy can delay labor, increase stillbirth risk, and cause premature closure of ductus arteriosus, a fetal vascular connection, and fetal kidney dysfunction.
• Pseudoephedrine can cause fetal harm if used in the first trimester of pregnancy because of its vasoconstrictive effects.
• Ibuprofen may be present in breastmilk in very low levels, however, pseudoephedrine is excreted in breastmilk and can cause irritability and excessive crying in the breastfed infant. Pseudoephedrine may also reduce milk production. If possible, avoid breastfeeding for one or two hours after taking ibuprofen/pseudoephedrine, when the drug is at its peak concentration in breastmilk.
• Avoid taking any OTC drug, including ibuprofen/pseudoephedrine, without first checking with your healthcare provider if you are pregnant or breastfeeding.

• Take ibuprofen/pseudoephedrine exactly as prescribed or as per label instructions.
• Do not take higher than recommended doses, more frequently than prescribed, or for prolonged periods.
• Discontinue ibuprofen/pseudoephedrine and see your physician if your fever lasts longer than 3 days or nasal congestion lasts longer than a week.
• Discontinue ibuprofen/pseudoephedrine and report to your physician immediately if you develop:
  • Allergic reactions
  • Severe skin reactions
  • Vision problems
  • Symptoms of heart problems or stroke, such as chest pain, breathing difficulty, slurred speech or weakness on one side of the body
  • Symptoms such as fever, rash, nausea and abdominal pain
• Store ibuprofen/pseudoephedrine safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.