Ketoprofen

Name: Ketoprofen

What else should I know about ketoprofen?

What preparations of ketoprofen are available?

Capsules (immediate release): 50 and 75 mg; Capsules (extended-release): 100, 150 and 200 mg. Oral Film: 12.5 mg

How should I keep ketoprofen stored?

Ketoprofen should be stored in a sealed container at room temperature, 15 C to 30 C (59 F to 86 F), avoiding moisture and protected from excessive heat.

Dosing & Uses

Dosage Forms & Strengths

tablet/capsule

  • 50mg
  • 75mg

capsule, extended-release

  • 200mg

oral film

  • 12.5mg (OTC)

Pain Management

Immediate-release: 25-50 mg PO q6-8hr as necessary

Extended-release: 200 mg PO qDay; not recommended for acute pain

Rheumatoid Arthritis or Osteoarthritis

Immediate-release: 75 mg PO q8hr or 50 mg PO q6hr

Extended-release: 200 mg PO qDay

Dysmenorrhea

Immediate-release: 25-50 mg q6-8hr PRN

Extended-release: Not recommended for acute pain

Administration

Take with food or 8-12 oz water to avoid GI effects

Other Indications & Uses

Gout

Off-label: vascular headache

Safety and efficacy not established

Pain Management

Initial: 25-50 mg PO q6-8hr; increase to 150-300 mg/day; not to exceed 300 mg

Uses of Ketoprofen

Ketoprofen is used in the treatment of:

  • Arthritis, Rheumatoid
  • Dysmenorrhea
  • Osteoarthritis

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ketoprofen Brand Names

Ketoprofen may be found in some form under the following brand names:

  • Actron

  • Orudis

  • Orudis KT

  • Oruvail

Ketoprofen Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • ANISINDIONE/KETOPROFEN
  • DABIGATRAN/KETOPROFEN
  • DICUMAROL/KETOPROFEN
  • KETOPROFEN/KETOROLAC
  • KETOPROFEN/LITHIUM
  • KETOPROFEN/METHOTREXATE
  • KETOPROFEN/PHENPROCOUMON
  • KETOPROFEN/PRALATREXATE
  • KETOPROFEN/RIVAROXABAN
  • KETOPROFEN/WARFARIN

This is not a complete list of Ketoprofendrug interactions. Ask your doctor or pharmacist for more information.

Forms of Medication

Ketoprofen is available in the following forms:

  • Extended Release Capsule
  • Injectable Solution
  • Oral Capsule
  • Oral Tablet
  • Rectal Suppository
  • Topical Cream
  • Topical Gel

Uses for Ketoprofen

Consider potential benefits and risks of ketoprofen therapy as well as alternative therapies before initiating therapy with the drug.1 Use lowest possible effective dosage and shortest duration of therapy consistent with patient’s treatment goals.1

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.1 36 96 97 98 99 100 101 102 103 104 105 106 107 108 131 132 134 135 136 137 138 139 147 148 150 153 154 158 205

Has been used in the symptomatic treatment of ankylosing spondylitis†.97 104 105 106 108 109 138 142 143 144 146 175 205

Pain

Relief of pain.1 121 160 166 171 173 174 235 236 238 239

Dysmenorrhea

Symptomatic management of primary dysmenorrhea.1 50 161 164 234

Ketoprofen Description

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

C16H14O3          M.W. 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, USP is a white or practically white, crystalline 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.

Ketoprofen capsules USP contain 50 mg or 75 mg of Ketoprofen, USP for oral administration.

Inactive Ingredients

Drug Product

Lactose, magnesium stearate, and sodium starch glycolate.

Capsule Shell Constituents

Gelatin, printing ink, sodium lauryl sulfate, titanium dioxide, D&C Red #28, and FD&C Blue #1.

How is Ketoprofen Supplied

Ketoprofen capsules USP are available as follows:

50 mg: Blue cap and light blue body, imprinted “93” over "3193" on the cap and on the body, in bottles of 100 (NDC 0093-3193-01).

75 mg: Blue cap and white body, imprinted “TEVA” on the cap and “3195” on the body, in bottles of 100 (NDC 0093-3195-01) and 500 (NDC 0093-3195-05).

Keep tightly closed.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Distributed By:
TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454

Rev. L 7/2015

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:
• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
o with increasing doses of NSAIDs
o with longer use of NSAIDs
  Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
  Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
o anytime during use
o without warning symptoms
o that may cause death
  The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
o increasing doses of NSAIDs o older age
o longer use of NSAIDs o poor health
o smoking o advanced liver disease
o drinking alcohol o bleeding problems

NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not take NSAIDs?

Do not take NSAIDs:
• if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:
• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
• are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”
• new or worse high blood pressure • heart failure
• liver problems including liver failure • kidney problems including kidney failure
• low red blood cells (anemia) • life-threatening skin reactions
• life-threatening allergic reactions
• Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:
• shortness of breath or trouble breathing • slurred speech
• chest pain • swelling of the face or throat
• weakness in one part or side of your body

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
• nausea • vomit blood
• more tired or weaker than usual • there is blood in your bowel movement or it
• diarrhea

is black and sticky like tar
• itching • unusual weight gain
• your skin or eyes look yellow • skin rash or blisters with fever
• indigestion or stomach pain • swelling of the arms, legs, hands and feet
• flu-like symptoms

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs
• Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised July 2015

Index Terms

  • Orudis KT
  • Oruvail

Contraindications

Hypersensitivity to ketoprofen or any component of the formulation; history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; use in the setting of CABG surgery

Canadian labeling: Additional contraindications (not in US labeling): Active peptic ulcer or active inflammatory disease of the GI tract; inflammatory lesions or recent bleeding of the rectum or anus (suppository only)

Dosing Geriatric

U.S. labeling: Oral: Manufacturer labeling recommends that the initial dose should be decreased in patients >75 years but does not provide specific dosing recommendations; use caution when dosage changes are made.

Canadian labeling: Oral: Reduce initial dose by 33% to 50%; Rectal: Manufacturer labeling recommends that the initial dose should be decreased but does not provide specific dosing recommendation.

Administration

Oral: Administer with food to reduce GI upset. Do not crush or break extended release capsules.

Rectal suppository [Canadian product]: Insert suppository rectally.

For Healthcare Professionals

Applies to ketoprofen: compounding powder, oral capsule, oral capsule extended release, oral tablet

General

The most frequently reported side effects were gastrointestinal in nature and included dyspepsia, abdominal pain, nausea, diarrhea, constipation, and flatulence.[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia (up to 11.5%)
Common (1% to 10%): Abdominal pain, diarrhea, constipation, flatulence, anorexia, vomiting, stomatitis, nausea, gastralgia
Uncommon (0.1% to 1%): Gastritis
Rare (0.01% to 0.1%): Peptic ulcer
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Dry mouth, eructation, gastritis, rectal hemorrhage, melena, fecal occult blood, salivation, gastrointestinal (GI) perforation, hematemesis, intestinal ulceration, buccal necrosis, ulcerative colitis, microvesicular steatosis, ulcerative colitis exacerbated, Crohn's disease exacerbated, GI bleeding, mouth ulcer, sore tongue, GI hemorrhage[Ref]

Nervous system

Common (1% to 10%): Headache, central nervous system (CNS) inhibition, CNS excitation, somnolence, dizziness
Rare (less than 0.1%): Paresthesia
Frequency not reported: Amnesia, migraine, taste perversion, convulsions, drowsiness, dysgeusia, optic neuritis[Ref]

Cardiovascular

Frequency not reported: Hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation, shock, arrhythmia, myocardial infarction, heart failure exacerbated, atrial fibrillation, flushing, vasculitis[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, transaminases increased, bilirubin elevated
Frequency not reported: Hepatic dysfunction, hepatitis, cholestatic hepatitis, jaundice, liver function abnormal[Ref]

Renal

Frequency not reported: Renal failure/acute renal failure, interstitial nephritis, nephrotic syndrome, renal function tests abnormal, acute tubulopathy[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, nervousness
Frequency not reported: Confusion, dysphoria, hallucination, libido disturbance, nightmares, personality disorder, tension, anxiety, mood altered[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Pruritus
Frequency not reported: Purpura, alopecia, eczema, purpuric rash, sweating, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, angioedema, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, bruising[Ref]

Ocular

Common (1% to 10%): Visual disturbance
Frequency not reported: Conjunctivitis, conjunctivitis sicca, eye pain, retinal hemorrhage, retinal pigmentation change[Ref]

Genitourinary

Common (1% to 10%): Urinary tract irritated
Frequency not reported: Impotence, menometrorrhagia, hematuria, gynecomastia[Ref]

Hematologic

Rare (less than 0.1%): Anemia, hemorrhagic anemia
Frequency not reported: Hypocoagulability, agranulocytosis, hemolysis, thrombocytopenia, neutropenia, bone marrow failure, bone marrow aplasia, hemolytic anemia, leukopenia[Ref]

Respiratory

Rare (less than 0.1%): Asthma/asthma attack
Frequency not reported: Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, laryngeal edema[Ref]

Metabolic

Frequency not reported: Appetite increased, hyponatremia, diabetes mellitus aggravated, hyperkalemia[Ref]

Musculoskeletal

Frequency not reported: Myalgia[Ref]

Immunologic

Rare (less than 0.1%): Anaphylaxis
Frequency not reported: Allergic reaction[Ref]

Local

Frequency not reported: Rectal bleeding, rectal pain, rectal burning, rectal pruritus, rectal tenesmus[Ref]

Other

Common (1% to 10%): Malaise, tinnitus, edema, BUN increased
Uncommon (0.1% to 1%): Fatigue
Rare (less than 0.1%): Weight gain
Frequency not reported: Infection, pain, facial edema, chills, weight loss, thirst, vertigo, hearing impaired, septicemia, aseptic meningitis[Ref]

Some side effects of ketoprofen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Renal Dose Adjustments

Mild renal dysfunction: Maximum dose 150 mg/day
Moderate renal dysfunction: Data not available
Severe renal dysfunction (GFR less than 25 mL/min/1.73 m2) or end-stage renal impairment: Maximum dose 100 mg/day

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