FLEXEN Ampoules .. relieves pain- lowers fever- treats inflammation

What FLEXEN Ampoules are? and what they are used for?

Ketoprofen 100 mg , the active ingredient in FLEXEN Ampoules, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. The intramuscular injection is used to treat a number of painful conditions including:

  1. ‘Flare-ups’ of joint or back pain .
  2. Attacks of gout.
  3. Pain caused by kidney stones and biliary colic.
  4. Pain caused by injuries. 
  5. Analgesic for headache pain.
  6. Analgesic for dental pain.
  7. Calming menstrual symptoms and pain (menstrual pain).
  8. Antipyretic in fever.
  9. Analgesic for arthralgia.
  10. Analgesic for spine pain.
  11. Rheumatoid arthritis.
  12. Ankylosing spondylitis..

FLEXEN Ampoules can either be given as an injection into the muscle, or as a slow infusion into a vein. The intravenous infusion is used in hospitals to prevent or treat pain following an operation. FLEXEN Ampoules contain the preservative Benzyl Alcohol ,which is not suitable for children less than 13 years old.

 FLEXEN ampoules

Facts about FLEXEN ampoules

  • FLEXEN is an NSAID indicated for use in adults for the management of mild to moderate pain. 
  • Avoid use FLEXEN after 30 weeks gestation because this may affect the baby’s circulation.  
  • Nursing Mothers: Use Ketoprofen ( FLEXEN) with caution as Ketoprofen may be present/ secreted in human milk.
  • The usual adult dose is one or two ampoules (100 to 200 mg) each day for two or three days.
  • Your doctor may also prescribe another drug to protect the stomach to be taken at the same time with FLEXEN, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.
  • Your doctor will prescribe the lowest dose of FLEXEN for the shortest possible time, particularly if you are underweight or elderly.
  • Before taking FLEXEN, tell your doctor if you have kidney or liver problems.

How to take FLEXEN Ampoules ?

⇒Your doctor will decide when and how to treat you with FLEXEN Ampoules. You will either be given an an intramuscular injection (an injection into a muscle), or an intravenous infusion (a drip into a vein). The intramuscular injection is usually injected into the buttocks. The usual dose is:

  • Adults: One or two ampoules (100 to 200 mg) each day for two or three days.
  • Elderly: Your doctor may give you a dose that is lower than the usual adult dose if you are elderly.
  • Children: Not suitable for children.

⇒A doctor, nurse or pharmacist will prepare the injection for you. If you have had an operation and are in hospital, the ampoule contents may be diluted and put into a drip bag before being given to you.

⇒A nurse or doctor will usually then give you the injection or infusion. You would not usually have to give the injection to yourself. The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well. If you think you have been given too much FLEXEN tell your doctor or nurse straight away. 

Common side effects

  • Stomach pain.
  • Heartburn.
  • nausea, vomiting.
  • Diarrhoea.
  • Indigestion.
  • Wind.
  • loss of appetite.
  • Headache.
  • Dizziness.
  • Vertigo.
  • Skin rash or spots.
  • Raised levels of liver enzymes in the blood.
  • Injection site reactions, symptoms include redness, swelling, change in the skin colour, inflammation, pain, and hypersensitivity. 

Things to consider before you start to take FLEXEN Ampoules 

Some people MUST NOT have this injection. Talk to your doctor if: 

  1. you think you may be allergic to Ketoprofen , Benzyl Alcohol, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of FLEXEN Ampoules. (These are listed at the end of the leaflet.). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction.
  2. you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces).
  3. you have had stomach or bowel problems after you have taken other NSAIDs.
  4. you have heart, kidney or liver failure.
  5.  if you have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear bypass blockages.
  6. if you have or have had problems with your blood circulation (peripheral arterial disease).
  7. you are more than six months pregnant.

You should also ask yourself these questions before having a FLEXEN Injection or Infusion, if the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because FLEXEN Ampoules might not be the right medicine for you. 

  • Do you suffer from any bowel disorders including ulcerative colitis or Crohn’s disease? 
  • Do you have kidney or liver problems, or are you elderly?
  • Do you suffer from any blood or bleeding disorder?
  • Do you have a condition called porphyria?
  • Have you ever had asthma? 
  • Are you breastfeeding?
  • Do you have angina, blood clots, high blood pressure, abnormally high levels of fat in your blood (raised cholesterol or raised triglycerides)? 
  • Do you have heart problems, or have you had a stroke, or do you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker)?  
  • Do you have diabetes? 
  • Do you smoke? 
  • Do you have Lupus (SLE) or any similar condition?
  • Could you be suffering from dehydration? 
  • Have you suffered any heavy loss of blood recently? 

Are you taking other medicines?

Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:

  1. Medicines to treat diabetes.
  2. Anticoagulants (blood thinning tablets like warfarin).
  3. Diuretics (water tablets).
  4. Lithium (used to treat some mental problems).
  5. Methotrexate (for some inflammatory diseases and some cancers).
  6. Cyclosporine and tacrolimus (used to treat some inflammatory diseases and after transplants).
  7. Trimethoprim (a medicine used to prevent or treat urinary tract infections).
  8. Quinolone antibiotics (for infections).
  9. Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen.
  10. Mifepristone (a medicine used to terminate pregnancy).
  11. Cardiac glycosides (for example digoxin), used to treat heart problems.
  12. Medicines known as SSRIs used to treat depression.
  13. Oral steroids (an anti-inflammatory drug).
  14. Medicines used to treat heart conditions or high blood pressure, for example beta-blockers or ACE inhibitors. 
  15. Voriconazole (a medicine used to treat fungal infections). 
  16. Phenytoin (a medicine used to treat seizures) .
  17. Colestipol/cholestyramine (used to lower cholesterol) .

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

FLEXEN 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.

Are you pregnant or planning to become pregnant? Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not have a FLEXEN Injection during the last 3 months of pregnancy as it may affect the baby’s circulation.  

Are you trying for a baby? Having FLEXEN Injections may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant. 

FLEXEN 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.

Will there be any problems with driving or using machinery?

Very occasionally people have reported that FLEXEN Ampoules have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery. 

Other special warnings

  • You should take the lowest dose of FLEXEN for the shortest possible time, particularly if you are underweight or elderly.  
  • There is a small increased risk of heart attack or stroke when you are taking any medicine like FLEXEN. The risk is higher if you are taking high doses for a long time.  If at any time while taking FLEXEN you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately.  
  • If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms. 
  • Because it is an anti-inflammatory medicine, FLEXEN may reduce the symptoms of infection, for example, headache and high temperature.
  • If you feel unwell and need to see a doctor, remember to tell him or her that you are taking FLEXEN.  FLEXEN Ampoules contain the preservative, Benzyl Alcohol. which is not used in newborns and infants.
  • FLEXEN Ampoules should not be used in children. 

Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking FLEXEN Ampoules, as FLEXEN Ampoules can sometimes worsen wound healing in your gut after surgery.

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, and 5.4 hours due to delayed absorption for Extended release (Sustained Release)(SR) capsules .   

Storage & Packaging  

    • Store ketoprofen tablets 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..
For Arabic Information
FLEXEN ampoules.. Arabic Information

Tags and Categories:#KETOPROFEN, #ANALGESICS PRODUCTS, #LIFE_PHARMA, ITALY, #AMPOULES, #F_letter, حرف_ف.