Ibuprofen Suspension

Ibuprofen Suspension

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Questions & Answers

Side Effects & Adverse Reactions

Cardiovascular Effects
Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).

Hypertension

NSAIDs, including ibuprofen, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure And Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Ibuprofen should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects
Risk Of Ulceration, Bleeding, And Perforation

NSAIDs, including ibuprofen, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of ibuprofen in patients with advanced renal disease. Therefore, treatment with ibuprofen is not recommended in these patients with advanced renal disease. If ibuprofen therapy must be initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to ibuprofen. Ibuprofen should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS - Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including ibuprofen, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, ibuprofen should be avoided because it may cause premature closure of the ductus arteriosus.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Carefully consider the potential benefits and risks of Ibuprofen Oral Suspension and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

In Pediatric Patients, Ibuprofen Oral Suspension is indicated:

For reduction of fever in patients aged 6 months up to 2 years of age.
For relief of mild to moderate pain in patients aged 6 months up to 2 years of age.
For relief of signs and symptoms of juvenile arthritis.

In Adults, Ibuprofen Oral Suspension is indicated:

For treatment of primary dysmenorrhea.
For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see PRECAUTIONS - Drug Interactions).

History

There is currently no drug history available for this drug.

Other Information

The active ingredient in Ibuprofen Oral Suspension USP is ibuprofen, which is a member of the propionic acid group of non steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74° to 77°C. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43 ± 0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C13H18O2 and it has the following structural formula:

Chemical Structure

Ibuprofen Oral Suspension USP is a sucrose-sweetened, orange-colored, berry-flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include: anhydrous citric acid, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum, D&C yellow #10 and FD&C red #40, and artificial flavors (strawberry/vanillin).

Ibuprofen Suspension Manufacturers


  • Cardinal Health
    Ibuprofen Suspension [Cardinal Health]
  • Rebel Distributors Corp
    Ibuprofen Suspension [Rebel Distributors Corp]
  • Rite Aid Corporation
    Ibuprofen Suspension [Rite Aid Corporation]
  • Major Pharmaceuticals
    Ibuprofen Suspension [Major Pharmaceuticals]
  • Hannaford Brothers Company
    Ibuprofen Suspension [Hannaford Brothers Company]
  • H.j. Harkins Company, Inc.
    Ibuprofen Suspension [H.j. Harkins Company, Inc.]
  • Perrigo New York Inc
    Ibuprofen Suspension [Perrigo New York Inc]
  • Hyvee Inc
    Ibuprofen Suspension [Hyvee Inc]
  • Western Family Foods Inc
    Ibuprofen Suspension [Western Family Foods Inc]
  • Major Pharmaceuticals
    Ibuprofen Suspension [Major Pharmaceuticals]
  • Vistapharm, Inc.
    Ibuprofen Suspension [Vistapharm, Inc.]
  • Stat Rx Usa Llc
    Ibuprofen Suspension [Stat Rx Usa Llc]
  • Rite Aid Corporation
    Ibuprofen Suspension [Rite Aid Corporation]
  • Cvs Pharmacy
    Ibuprofen Suspension [Cvs Pharmacy]
  • Actavis Mid Atlantic Llc
    Ibuprofen Suspension [Actavis Mid Atlantic Llc]
  • Physicians Total Care, Inc.
    Ibuprofen Suspension [Physicians Total Care, Inc.]
  • Preferred Pharmaceuticals, Inc
    Ibuprofen Suspension [Preferred Pharmaceuticals, Inc]
  • Pharmaceutical Associates, Inc.
    Ibuprofen Suspension [Pharmaceutical Associates, Inc.]
  • Kroger Company
    Ibuprofen Suspension [Kroger Company]
  • Perrigo New York Inc
    Ibuprofen Suspension [Perrigo New York Inc]
  • Perrigo New York Inc
    Ibuprofen Suspension [Perrigo New York Inc]
  • Kroger Company
    Ibuprofen Suspension [Kroger Company]
  • Atlantic Biologicals Corps
    Ibuprofen Suspension [Atlantic Biologicals Corps]

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