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

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

DexKetoprofen 50 mg , the active ingredient in KETESSE 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..

KETESSE 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. KETESSE Ampoules contain the preservative Benzyl Alcohol ,which is not suitable for children less than 13 years old.

KETESSE ampoules 

Facts about KETESSE ampoules

  • KETESSE is an NSAID indicated for use in adults for the management of mild to moderate pain. 
  • Avoid use KETESSE after 30 weeks gestation because this may affect the baby’s circulation.  
  • Nursing Mothers: Use DexKetoprofen ( KETESSE ) with caution as DexKetoprofen may be present/ secreted in human milk.
  • The usual adult dose is one or two ampoules (50 to 100 mg) each day for three or five days.
  • Your doctor may also prescribe another drug to protect the stomach to be taken at the same time with KETESSE , 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 KETESSE for the shortest possible time, particularly if you are underweight or elderly.
  • Before taking KETESSE , tell your doctor if you have kidney or liver problems.

DOSING  AND ADMINISTRATION

KETESSE is indicated for intramuscular and intravenous injection.

Adults:

  • The recommended dose is 50 mg dexketoprofen every 8-12 hours. If necessary, the administration can be repeated every 6 hours. The total daily dose should not exceed 150 mg dexketoprofen.
  • The drug is intended for short-term (not more than 2 days) administration in acute pain syndrome period. Subsequently it is possible to switch the patient to an oral analgesic treatment

Elderly:

No dose adjustment is generally required in elderly patients. However because of the physiological decline in renal function a lower dose is recommended: usual daily dose in elderly patients with mild renal function impairment should not exceed 50 mg a day.

Hepatic dysfunction:

The total daily dose should be reduced to 50 mg in patients with mild to moderate compromised liver function (Child-Pugh score 5 – 9), and hepatic function should be closely monitored. KETESSE is contraindicated for patients with severe hepatic impairment.

Renal dysfunction:

  • Total daily dose should not exceed 50 mg in patients with moderate renal impairment (creatinine clearance 50 – 80 ml/min). The drug should not be used in patients with severe renal dysfunction (creatinine clearance <50 ml/min).
  • Method of administration of solution for injections/concentrate for preparation of solution for infusions
  • KETESSE may be mixed in small volumes (e.g., in a syringe) with injectable solutions of heparin, lidocaine, morphine and theophylline.

Intramuscular injection:

The content of one ampoule (2 mL) should be injected slowly deep into the muscle.

Intravenous infusion:

  • The content of one ampoule (2 mL) is dissolved in 30-100 mL saline solution, glucose solution or Ringer’s solution (lactate). The solution should be diluted aseptically and protected from natural daylight. The prepared solution (should be clear) is injected as a slow intravenous infusion for 10-30 minutes.
  • The solution of KETESSE diluted in 100 mL saline or glucose solution may be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.
  • The drug is intended for a single use only and any unused solution should be discarded. Prior to administration, the solution should be inspected visually to make sure it is clear and colorless. The solution containing particulate matters should not be used.

Intravenous injection (bolus injection):

  • If necessary, the content of one ampoule (2 mL) is injected intravenously over no less than 15 seconds.

CONTRAINDICATIONS

  • hypersensitivity to dexketoprofen or other NSAIDs, or to any of the excipients of the drug;
  • history of attacks of asthma, bronchospasm, acute rhinitis, urticaria or angioneurotic oedema that were caused by previous use of substances with a similar mechanism of action (e.g. acetylsalicylic acid and other NSAIDs);
  • patients with active peptic ulcer or history of recurrent episodes of peptic ulcer (two or more episodes);
  •  gastrointestinal bleeding (including those related to previous NSAIDs therapy), other active bleeding;
  • Crohn’s disease, nonspecific ulcerative colitis;
  • severely impaired hepatic function (Child-Pugh score 10 – 15);
  • severe renal dysfunction (creatinine clearance <50 ml/min);
  • bronchial asthma (including in past medical history);
  • severe heart failure;
  • hemorrhagic diathesis or other coagulopathies;
  • the third trimester of pregnancy and lactation period;
  • pediatric use.
  • The drug is contraindicated for epidural, subthecal or intrathecal injection due to its ethanol content.

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 KETESSE Ampoules 

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

  1. you think you may be allergic to DexKetoprofen , Benzyl Alcohol, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of KETESSE 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 KETESSE Injection or Infusion, if the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because KETESSE 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.

KETESSE and Pregnancy

DexKetoprofen 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 KETESSE Injection during the last 3 months of pregnancy as it may affect the baby’s circulation.  

Are you trying for a baby? Having KETESSE 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. 

KETESSE and Lactation

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

Will there be any problems with driving or using machinery?

Very occasionally people have reported that KETESSE 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

  • KETESSE solution for intramuscular and intravenous injection must not be mixed in a small volume (e.g., in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine or hydroxyzine, as this will result in a precipitation of the solution. The diluted solutions for infusion should not be mixed with promethazine or pentazocine.
  • KETESSE should not be co-administered (in one syringe, in one bottle, etc.) with other drugs (solvents), other than those specified in this instruction.
  • The use of KETESSE with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided.
  • Before starting treatment with dexketoprofen trometamol and in case of any history of esophagitis, gastritis and/or peptic ulcer, one should make sure of their remission. Patients with symptoms of GIT pathology and history of gastrointestinal diseases should be monitored for digestive disorders, especially gastrointestinal bleeding.
  • Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding: oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin.
  • Caution should be exercised when prescribing the drug to patients with hepatic and/or renal dysfunction, as well as to patients with arterial hypertension and/or heart failure, as they may experience renal function deterioration, fluid retention and edemas in association with NSAID therapy.
  • You should take the lowest dose of KETESSE 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 KETESSE . The risk is higher if you are taking high doses for a long time.  If at any time while taking KETESSE 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, KETESSE 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 KETESSE .  KETESSE Ampoules contain the preservative, Benzyl Alcohol. which is not used in newborns and infants.
  • KETESSE 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 KETESSE Ampoules, as KETESSE Ampoules can sometimes worsen wound healing in your gut after surgery.

Overdose

DexKetoprofen

  • The symptomatology following overdose is not known. Similar medicinal products have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) disorders.
  • In case of accidental overdose, immediately institute symptomatic treatment depending on the patient’s state.
  • Dexketoprofen trometamol may be removed from the body by dialysis.       

Pharmacological Properties     

Pharmacodynamic properties: 

  • KETESSE is a nonsteroidal antiinflammatory drug (NSAID), a propionic acid derivative. It exerts analgesic, anti inflammatory, and antipyretic actions. The mechanism of action is associated with inhibition of the activity of cyclooxygenase-1 and cyclooxygenase-2 and with a decrease in the biosynthesis of prostaglandins that play a key role in the pathogenesis of inflammation, pain and fever.
  • The analgesic effect of the drug occurs within 30 minutes after parenteral administration. The duration of analgesic effect following injection of 50 mg is 4-8 hours.
  • In a combined therapy with opioid analgesics, dexketoprofen trometamol significantly (up to 30-45%) reduces the need for opioids.

Pharmacokinetic properties

Absorption:

Following intramuscular injection of dexketoprofen trometamol, peak serum concentration is achieved after an average 20 minutes (10-45 minutes). After a single injection in a dose of 25-50 mg, AUC is dose proportional following both intramuscular and intravenous administration. The relevant pharmacokinetic parameters are similar after a single and repeated intramuscular or intravenous injection, indicating that no drug accumulation occurs.

Distribution:

Dexketoprofen trometamol is characterized by a high plasma protein binding (99%). Mean value of Vd is below 0.25 L/kg.

Elimination:

The main elimination route for dexketoprofen is its conjugation with glucuronic acid followed by renal excretion. The elimination half-life of dexketoprofen trometamol is about 1-2.7 hours.

Pharmacokinetics in special populations:

In elderly subjects, there is an increase in the duration of elimination half-life (both after single and repeated intramuscular or intravenous injection) up to an average of 48%, and a decrease in total body clearance was observed.

Storage & Packaging  

    • Store DexKetoprofen 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
KETESSE ampoules.. Arabic Information

Tags and Categories:#DEXKETOPROFEN, #ANALGESICS PRODUCTS, #MENARINI, ITALY, #AMPOULES, #K_letter, حرف_ك.