Ketoprofen

Ketoprofen

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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 WARNINGS: Gastrointestinal Effects).

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

Hypertension

NSAIDs, including ketoprofen immediate-release capsules and ketoprofen extended-release capsules, can lead to onset of new hypertension or worsening of preexisting 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 ketoprofen immediate-release capsules and ketoprofen extended-release capsules, 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. Peripheral edema has been observed in approximately 2% of patients taking ketoprofen. Ketoprofen immediate-release capsules and ketoprofen extended-release capsules should be used with caution in patients with fluid retention, or heart failure.

Gastrointestinal Effects
Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including ketoprofen immediate-release capsules and ketoprofen extended-release capsules, 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 to 6 months, and in about 2% to 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 increased 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 non-steroidal 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 greater 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 ketoprofen immediate-release capsules or ketoprofen extended-release capsules in patients with advanced renal disease. Therefore, treatment with ketoprofen immediate-release capsules or ketoprofen extended-release capsules is not recommended in these patients with advanced renal disease. If ketoprofen immediate-release capsules or ketoprofen extended-release capsules 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 ketoprofen immediate-release capsules or ketoprofen extended-release capsules. Ketoprofen immediate-release capsules or ketoprofen extended-release capsules 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: General: Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including ketoprofen immediate-release capsules and ketoprofen extended-release capsules, 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, Ketoprofen immediate-release capsules and ketoprofen extended-release capsules 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 ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.

History

There is currently no drug history available for this drug.

Other Information

Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula:

Structural Formula

Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4).

Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C.

Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents:

50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6

75 mg - FD&C Blue No.1 and FD&C Green No. 3.

The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.

Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate.

In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents:

black iron oxide
FD&C Blue No. 2
yellow iron oxide.

The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.

Ketoprofen Manufacturers


  • Rebel Distributors Corp
    Ketoprofen Capsule [Rebel Distributors Corp]
  • Stat Rx Usa Llc
    Ketoprofen Capsule [Stat Rx Usa Llc]
  • Redpharm Drug Inc.
    Ketoprofen Tablet [Redpharm Drug Inc.]
  • Preferred Pharmaceuticals, Inc
    Ketoprofen Capsule [Preferred Pharmaceuticals, Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Ketoprofen Capsule [Pd-rx Pharmaceuticals, Inc.]
  • H.j. Harkins Company, Inc.
    Ketoprofen Capsule [H.j. Harkins Company, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Ketoprofen Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Rebel Distributors Corp
    Ketoprofen Capsule [Rebel Distributors Corp]
  • Physicians Total Care, Inc.
    Ketoprofen Capsule Ketoprofen Capsule, Extended Release [Physicians Total Care, Inc.]
  • Bryant Ranch Prepack
    Ketoprofen Capsule [Bryant Ranch Prepack]
  • Avkare, Inc.
    Ketoprofen (Ketoprofen) Capsule [Avkare, Inc.]
  • A-s Medication Solutions Llc
    Ketoprofen Capsule [A-s Medication Solutions Llc]
  • Teva Pharmaceuticals Usa Inc
    Ketoprofen Capsule [Teva Pharmaceuticals Usa Inc]
  • Aidarex Pharmaceuticals Llc
    Ketoprofen Capsule [Aidarex Pharmaceuticals Llc]
  • Proficient Rx Lp
    Ketoprofen Capsule [Proficient Rx Lp]
  • Mylan Pharmaceuticals Inc.
    Ketoprofen Capsule Ketoprofen Capsule, Extended Release [Mylan Pharmaceuticals Inc.]
  • Bryant Ranch Prepack
    Ketoprofen Capsule [Bryant Ranch Prepack]

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