Marcofen 300 mg

Ibuprofen 300 mg.

Warnings

Black Box Warnings

Cardiovascular risk

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
  • Risk may increase with duration of use
  • Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
  • NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery

Gastrointestinal risk

  • NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
  • GI adverse events may occur at any time during use and without warning symptoms
  • Elderly patients are at greater risk for serious GI events

Contraindications

Absolute

  • Aspirin allergy
  • Perioperative pain in setting of coronary artery bypass graft (CABG) surgery
  • Preterm infants with untreated proven or suspected infection; bleeding with active intracranial hemorrhage or GI bleed; thtombocytopenia, coagulation defects, proven or necrotizing enterocolitis, significant renal impairment, congenital heart disease where patency or the PDA is necessary for pulmonary or systemic blood flow

Cautions

Use caution in asthma (bronchial), cardiac disease, congestive heart failure (CHF), hepatic or renal impairment, hypertension. bleeding disorder, duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus (SLE), ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)

Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion; and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers

Junior Advil (100 mg): Doses higher than recommended may cause stomach bleeding

May cause serious adverse reactions, including exfoliative dermatitis, toxic epidermal necrolysis, Steven's Johnson syndrome reported

Children's and Junior Advil (50 mg, 100 mg): May cause severe and persistent sore throat

Fever, rash, abdominal pain, nausea, liver dysfunction, and meningitis have occurred in patients with collagen-vascular disease, especially SLE

Blurred vision, scotomate, and changes in color vision reported; discontinue therapy if symptoms occur

Platelet aggregation and adhesion may be decreased; monitor patients with coagulation disorders receiving the therapy

Risk of hyperkalemia may increase in patients with diabetes, the elderly, renal disease, or with concomitant use of agents that can induce hyperkalemia including ACE inhibitors; monitor potassium closely

May cause drowsiness and dizziness; may impair physical or mental abilities to operate heavy machinery or driving

NSAIDS, except aspirin, increase risk of heart attack, heart failure, and stroke; which can be fatal; the risk is higher if patients use more than it was directed or for longer than needed

Use caution in patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, glaucoma, have trouble urinating due to an enlarged prostate gland, or had a stroke

Patients should inform healthcare professional if they have symptoms of heart problems or stroke, chest pain, trouble breathing weakness in one part or side of body, slurred speech, leg swelling

Not for use right before or after heart surgery

Heart Failure (HF) risk

  • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
  • NSAIDS should be avoided or withdrawn whenever possible
  • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Marcofen 300 mg only for the indication prescribed.

Verified References
  • FDA Dec 17, 2017
  • CDC Dec 17, 2017
  • Mayo Clinic Dec 17, 2017
  • Drugs.com accessed Dec 17, 2017
  • Medscape accessed Dec 17, 2017
  • Epocrates accessed Dec 17, 2017
  • Webmd accessed Dec 17, 2017