Profenid capsules .. relieves pain- lowers fever- treats inflammation

Profenid capsules (ketoprofen) is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.it is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.

Profenid capsules is used in adults and children who are at least 6 months old.

Profenid capsules is a Prescription and OTC drug.

Profenid capsules

Composition

Profenid capsules contains: ketoprofen ………………….50 mg .

Therapeutic Indications     

Profenid capsules is used in the following cases:

  • Analgesic for headache pain.
  • Analgesic for dental pain.
  • Calming menstrual symptoms and pain (menstrual pain).
  • Antipyretic in fever.
  • Analgesic for arthralgia.
  • Analgesic for spine pain.
  • Rheumatoid arthritis.
  • Ankylosing spondylitis.
  • Gout.

Dosage and Administration         

  • Adults and Children aged 12 years and over: one capsule every 8 – 12 hours . Maximum daily dose: 300 mg ketoprofen.
  • Children under 12 years:  half capsule  every 8 – 12 hours, up to two times a day. Maximum daily dose: 200 mg ketoprofen.
  • Children under 6 years:  Profenid capsules is contraindicated in children under the age of 12 years.
  • Elderly: Older adults may have reduced kidney function. Since ketoprofen is removed from the body by the kidneys, this may cause increased side effects. If you’re older than 75 years, your doctor may give you a lower dosage of ketoprofen and monitor your kidney function.
  • Hepatic dysfunction:  Caution should be exercised when administering Profenid to patients with severe hepatic impairment.
  • Renal dysfunction:  Caution should be exercised when administering Profenid to patients with moderate to severe renal impairment.
  • The stated dose should not be exceeded.
  • Keep out of the reach and sight of children.

Contraindications       

Profenid is contraindicated in:

  • Individuals with known hypersensitivity to the product or any of its components.
  • Immediately before or after heart surgery.
  • Patients with severe hypertension or coronary artery disease.
  • History of induce asthma or urticaria with NSAIDs.
  • Patients with GIT ulcers.
  • Profenid should not to be used in children under the age of 9 years. 

Warnings and Precautions  

  • ketoprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
  • ketoprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ketoprofen, especially in older adults.
  • Do not take more than your recommended dose. An ketoprofen overdose can damage your stomach or intestines. Use only the smallest amount of medication needed to get relief from your pain, swelling, or fever.
  • As with other sympathomimetic agents Profenid should be used with caution in patients with hypertension, heart disease, diabetes.
  • Care is advised in the administration of ketoprofen to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease.
  • As with all medicines, if you are pregnant or currently taking any other medicine, consult your doctor or pharmacist before taking this product.

Drug Interactions     

  • Concomitant use of Profenid with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure (see Contraindications).
  • Because of the pseudoephedrine content,  Profenid capsules may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, betanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents (see Warnings and Precautions).
  • Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of ketoprofen, the plasma half-life of which can be prolonged. Alcohol can increase the hepatotoxicity of ketoprofen overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of ketoprofen.
  • Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic ketoprofen levels by increasing first pass metabolism or clearance.
  • The speed of absorption of ketoprofen may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
  • The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of ketoprofen with increased risk of bleeding; occasional doses have no significant effect.

Profenid and Pregnancy 

Ketoprofen is a category C pregnancy drug. That means two things:

  • Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  • There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or plan to become pregnant. This drug should be used during pregnancy only if the potential benefit justifies the potential risk.

If you become pregnant while taking this drug, call your doctor right away.

Profenid and Lactation

  • it isn’t known if ketoprofen passes into breast milk and causes harm to your child. You and your doctor may decide whether you’ll take ketoprofen or breastfeed.

Effects on ability to drive and to use machines            

  • None known.

For-Arabic-Information

Profenid capsules -Arabic-Information

Undesirable Effects

ketoprofen

ketoprofen has been widely used and, when taken at the usual recommended dosage, side effects are mild and infrequent and reports of adverse reactions are rare.

The more common side effects that can occur with ketoprofen include:

  • upset stomach or stomach pain.
  • nausea.
  • diarrhea.
  • headache.
  • dizziness.
  • drowsiness.
  • Skin rash and other allergic reactions occur rarely.
  • heartburn.
  • nausea, vomiting, diarrhea.
  • constipation, gas.

Overdose

ketoprofen

  • The symptoms of overdose are presented in individuals that consumed more than 300 mg/day.
  • Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.
  • May rarely cause metabolic acidosis, abnormal hepatic function, hyperkalemia, renal failure, dyspnea, respiratory depression, coma, acute renal failure, and apnea (primarily in very young pediatric patients)            

Pharmacological Properties     

Pharmacodynamic properties: 

  • ketoprofen has analgesic, antipyretic actions and anti-inflammatory properties.
  • ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase enzymes (COX-1 and COX-2) and subsequent synthesis of prostaglandins and related compounds at peripheral sites within injured tissue.

Pharmacokinetic properties

  • Peak plasma ketoprofen concentration usually occurs between 0.5 to 2 hours after oral ingestion.
  • ketoprofen is distributed uniformly throughout most body fluids and 99% bound to plasma proteins.
  • Rapidly and extensively metabolized in the liver, primarily via conjugation to glucuronic acid. No active metabolites have been identified.
  • In a 24 hour period, approximately 80% of an administered dose of ketoprofen is excreted in the urine, primarily as the glucuronide metabolite.
  • The plasma half-life of ketoprofen after therapeutic doses is in the range of 1-4 hours for Conventional capsules.  

Storage & Packaging  

  • Store ketoprofen capsules at room temperature from 68°F to 77°F (20°C to 25°C).
  • Keep this medication away from light.
  • Don’t store this medication in moist or damp areas, such as bathrooms..        

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