Ketoprofen Suppositories by Pharmel Inc.

Brand Name

Ketoprofen Suppositories by Pharmel Inc.

Common Name

ketoprofen

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Ketoprofen belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used for the symptomatic treatment of rheumatoid arthritis, and osteoarthritis., and ankylosing spondylitis.

Ketoprofen can also be used to treat pain associated with menstrual cramps and for the relief of pain after surgery (including dental surgery), pain after giving birth, and mild to moderate pain associated with sprains and strains. Ketoprofen relieves pain and reduces swelling and inflammation by reducing a substance in the body that leads to inflammation and pain.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended adult dose for rheumatoid arthritis and osteoarthritis is 150 mg to 200 mg daily. If given as a short-acting tablet, the dose should be divided into 3 or 4 equal doses throughout the day. Once the dose has been established, some people can take their daily dose in 2 equal doses. If the maintenance dose is 200 mg, then the extended-release tablet may be taken once daily.

For treatment of menstrual cramps and mild-to-moderate pain, the recommended adult dose is 25 mg to 50 mg 3 or 4 times daily as needed.

The enteric-coated tablets or sustained-release tablets should be taken 1 or 2 hours before meals or at least 2 hours after meals. Ketoprofen short-acting capsules should be taken immediately after a meal or with food to reduce stomach upset.

You should not lie down for about 15 to 30 minutes after taking the medication. If stomach upset occurs and does not go away, contact your doctor. Ketoprofen tablets and capsules should always be swallowed whole.

The total daily dose of ketoprofen should not exceed 200 mg except during severe flare-ups of rheumatic arthritis, when the dose may be increased to a maximum of 300 mg daily. In general, to reduce the risk of side effects, the lowest dose for the shortest period of time should be used.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Who should NOT take this medication?

Do not use this medication if you:

• are allergic to ketoprofen or any ingredients of this medication
• are allergic to ASA or other NSAIDs (e.g., ibuprofen, ketorolac, diclofenac) or have had allergic symptoms (e.g., runny nose; asthma; itchy skin rash; nasal polyps; swelling of the face, throat, or tongue) caused by these medications
• have an ulcer or an inflammatory disease of the stomach or intestines (e.g., ulcerative colitis)
• are breast-feeding
• are in the third trimester of pregnancy (after 28 weeks)
• are planning to have or have recently had heart bypass surgery
• have bleeding in the brain or a bleeding disorder
• have high levels of potassium in the blood
• have severe uncontrolled heart failure
• have severely impaired or deteriorating kidney function
• have significant liver impairment or liver disease

Do not give this medication to children less than 12 years of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

A common side effect of nonsteroidal anti-inflammatory drugs (NSAIDs) is stomach upset. This can be minimized by taking the medication immediately after a meal, or with food or milk.

• altered sense of taste
• constipation
• diarrhea
• dizziness
• drowsiness
• dry mouth
• feeling gassy
• hair loss
• heartburn
• increased sweating
• lightheadedness
• loss of appetite
• mouth sores or swelling
• muscle pain
• nausea
• thirst
• vomiting
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety
• blurred vision or any vision changes
• confusion
• feeling of burning, prickliness, or numbness
• hearing problems, ringing in the ears
• high blood pressure
• increased frequency of infections (e.g., symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• skin rash
• spinning sensation
• swelling of feet or lower legs
• symptoms of heart failure (e.g., shortness of breath, wheezing, and chest tightness; fatigue; cough; fluid retention; swelling in the ankles, legs, and feet)
• symptoms of a urinary tract infection (e.g., increased need to urinate, pelvic or lower back pain, frequent urination during the night, cloudy urine, blood in the urine, burning or pain when urinating)
• unusual bruising or bleeding

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
• signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• symptoms of an asthma attack (e.g., increased shortness of breath, wheezing, difficulty breathing, cough, chest tightness, irregular heartbeat)
• symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the face, mouth, throat or tongue)
• symptoms of a stomach ulcer or bleeding (e.g., severe abdominal or stomach pain; bloody or black, tarry stools; spitting up blood; vomiting blood or material that looks like coffee grounds)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: If you have had a reaction to acetylsalicylic acid (ASA) or other NSAIDs (e.g., ibuprofen, ketorolac, naproxen) that included a runny nose, itchy skin rash, nasal polyps, or shortness of breath and wheezing, you should not take this medication. If you experience symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; wheezing; swelling of the face, tongue, or throat), get immediate medical attention.

In rare cases, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome) may occur. This reaction involves symptoms including fever, swollen glands, yellowing of the skin or eyes, flu-like symptoms with skin rash or blistering, or other organ involvement. Get immediate medical attention if you have symptoms of a severe allergic reaction.

Bladder problems: This medication may cause bladder pain, painful or difficult urination, or increased frequency of urination. If these symptoms occur without an explanation (e.g., infection), stop taking this medication and contact your doctor.

Blood clotting: This medication may reduce the ability of the blood to clot. If you are taking anticoagulants (e.g., warfarin, heparin) or have hemophilia or another blood disorder (e.g., low platelets), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have a bleeding disorder, do not take this medication.

Drowsiness and dizziness: This medication can cause drowsiness and dizziness that may affect your ability to drive or operate machinery safely. Avoid potentially hazardous activities until you know how this medication affects you.

Fluid and electrolyte balance: NSAIDs such as ketoprofen can cause fluid retention and edema (swelling). This can lead to high blood pressure or worsening of heart failure. If you have heart failure or high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart attack and stroke: This medication may be associated with an increased risk of heart attack and stroke. The risk is increased with higher total daily doses and taking the medication over long periods of time. If you have a history of heart disease (e.g., heart attack, stroke, heart failure) or have risk factors for heart disease (e.g., high blood pressure, high cholesterol, diabetes, smoking, kidney disease) discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: This medication may mask the signs of infection (e.g., fever). If you notice other symptoms of infection (e.g., painful or frequent urination, productive cough) contact your doctor.

Kidney function: Long-term use of ketoprofen may lead to a higher risk of reduced kidney function. You have a higher risk of developing kidney problems if you are a senior, take diuretics (water pills), or already have kidney disease, liver disease, or heart failure. Your doctor will monitor your kidney function with blood tests if you take this medication for a long period of time.

Liver problems: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Ketoprofen may affect your liver function or cause liver problems. Your doctor will monitor your liver function with blood tests if you take this medication for a long period of time.

If you experience symptoms of liver problems (e.g., nausea, vomiting, feeling tired, yellowing of the skin or eyes) contact your doctor immediately. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Skin reactions: This medication can cause skin reactions, some of which may be severe. If you experience a skin rash, especially where the skin is blistering or peeling, stop taking this medication and contact your doctor.

This medication may make your skin more sensitive to sunlight (including sunlamps) and may cause sunburn, skin blisters, and skin redness, itching, or discolouration. If you have a reaction from the sun while taking this medication, contact your doctor.

Ulcers or bleeding in the stomach or intestines: Ketoprofen can cause stomach ulcers, perforations (holes), and bleeding from the stomach. These complications can occur at any time without warning, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding increases if you are taking higher doses of ketoprofen for longer periods of time.

Other factors that increase the risk of these complications include drinking excessive amounts of alcohol, increased age, smoking, poor health, H pylori infection, and taking certain medications (e.g., warfarin, ASA, clopidogrel, prednisone, citalopram, fluoxetine, paroxetine, sertraline).

If you currently have ulcers that are bleeding in the stomach or intestines, or have an inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), you should not take this medication. If you have a history of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stop taking the medication and get immediate medical attention if you experience symptoms or signs of stomach ulcers or bleeding in the stomach (black, tarry stools; blood in stools; stomach pain; vomiting blood or material that looks like coffee grounds). These reactions can occur at any time during treatment without warning.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If ketoprofen is taken during the earlier stages of pregnancy, there is also an increased risk of miscarriage. Use of ketoprofen at 20 weeks or later in pregnancy may increase the risk of kidney damage and complications due to low amniotic fluid in the developing baby. When ketoprofen is taken during the last 3 months of pregnancy, there is an increased risk of the child developing heart problems and the mother having a longer labour to deliver the baby. If you become pregnant while taking this medication, contact your doctor as soon as possible.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking ketoprofen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 12 years of age.

Seniors:  If you are a senior, you may have a higher risk of experiencing side effects from this medication. You should use the lowest effective dose under close medical supervision.

What other drugs could interact with this medication?

There may be an interaction between ketoprofen and any of the following:

• 5-ASA medications (e.g., mesalamine, olsalazine, sulfasalazine)
• acetylsalicylic acid (ASA)
• alcohol
• aliskiren
• aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
• angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• apixaban
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• bisphosphonates (e.g., alendronate, etidronate, pamidronate, risedronate)
• celecoxib
• cholestyramine
• clopidogrel
• colestipol
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• dabigatran
• dasatinib
• deferasirox
• desmopressin
• digoxin
• dipyridamole
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, spironolactone)
• drospirenone
• heparin
• herbs that may increase the risk of bleeding (e.g., cat's claw, dong quai, feverfew, garlic, ginger)
• hydralazine
• lithium
• low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• metformin
• methotrexate
• other NSAIDs (e.g., naproxen, ibuprofen, diclofenac)
• obinutuzumab
• omega-3 fatty acids
• pentoxifylline
• prasugrel
• prostaglandin eye drops (e.g., latanoprost, bimatoprost)
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin)
• rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, escitalopram, fluoxetine, paroxetine, sertraline)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
• sodium phosphates
• tacrolimus
• tenofovir
• teriflunomide
• ticagrelor
• tipranavir
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• vaccines
• vancomycin
• vitamin E
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Ketoprofen-Suppositories-by-Pharmel-Inc