Oral Dispersible Tablet
Cardiovascular Risk
- NSAIDs may cause increased risk of serious cardiovascular thrombotic events, Myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see PRECAUTIONS AND WARNINGS).
- PROXIME® oral dispersible tablet is contraindicated for the treatment of peri-operative pain in coronary bypass surgery (see PRECAUTIONS AND WARNINGS).
- NSAlDs cause an increased risk of serious gastrointestinal adverse reactions including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These reactions can occur at any time during use, without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal adverse reactions (see PRECAUTIONS AND WARNINGS).
Acetosal .............................................. 100 mg
Glycine ................................................ 45 mg
PHARMACOLOGY
Acetosal inhibits cyclooxygenase enzyme activity. This reaction is probably caused by irreversible acetylation process. This inhibition activity prevents the formation of thromboxane A2, a vasoconstrictor agent which induces platelet aggregation that may cause blood clotting. It prevents formation of prostacyclin which is a vasodilator and inhibits platelet aggregation in the blood vessel walls.
INDICATIONS
As prevention of Myocardial infarct, unstable angina or transient ischemic attacks (TIA).
CONTRA-INDICATIONS
- Patients with allergy (including asthma), peptic ulcer or those who are ever or often experiencing hemorrhage beneath the skin (on medical advice).
- Patients with anticoagulant therapy (on medical advice).
- Patients with hemophilia and thrombocytopenia.
- Do not use this drug for patients with chicken pox and flu symptoms.
- Patients with known hypersensitivity to any of the ingredients.
- Children under 12 years of age.
- Gastric irritation, nausea and vomiting.
- Long term use may cause gastrointestinal bleeding and gastritis.
- Hypersensitivity reactions (dyspnea attack, dermatitis).
- Thrombocytopenia.
- Caution should be taken on patients with impaired liver function, pregnancy and lactating mothers, or dehydration. Do not use for patients in the last trimester of pregnancy.
- Consult with medical doctor before using this drug on patients with anticoagulant therapy.
- Should be taken with food or after meals.
- If tinnitus, hearing disorders and dizziness occurred, discontinue the therapy,
- If there were manifestation of permanent gastric disorders, consult to medical doctor.
- Using this drug with alcohol may increase the risk of gastric bleeding.
Cardiovascular thrombotic events
Clinical trials with various selective COX-2 and non-selective NSAIDs for 3 years has shown increase risk of cardiovascular thrombotic events, myocard infarction and stroke which can be fatal. NSAIDs. both selective and non-selective COX-2, may cause similar risk. The risk may be greater on patients with known cardiovascular disease or risk factors for cardiovasculardisease. To reduce the risk of adverse reactions, NSAIDs should be given wtth the lowest effective dose and shortest duration possible. Medical doctors and patients should remain alert for the development of the adverse reactions, although there were no cardiovascular symptoms before. Patients should be given the information about the signs and/or symptoms of serious cardiovascular effects and the way that should be taken if that symptoms occur.
It has not been clinically established that concurrent use of Acetosal may reduce the increased risk of cardiovascular thrombotic events associated with NSAIDs, Concurrent use of NSAIDs with Acetosal does increase risk of gastrointestinal side effects (see WARNING Gastrointestinal Tract).
Two large, controlled, clinical trials of a selective COX-2 NSAIDs for the treatment of pain in the first 10 -14 days following coronary bypass surgery found an increased incidence of Myocardial infarction and stroke (see CONTRA-INDICATIONS).
Hypertension
NSAIDs including PROXIME® oral dispersible tablet, may lead to the onset of new hypertension or worsening of pre-existing hypertension, which may cause the increased incidence of cardiovascular events. NSAIDs may reduce antihypertension effects of thiazid and strong diuretics. NSAIDs including PROXIME® oral dispersible tablet should be used with caution in patients with hypertension. Blood pressure should be closely monitored during the initiation of therapy and throughout the course of therapy.
Congestive heart failure and edema
Fluid retention and edema have been observed in some patients taking NSAIDs. Therefore, PROXIME® oral dispersible tablet should be used with caution in patients with fluid retention or heart failure.
Gastrointestinal Effects
Risk of ulceration, bleeding anda perforation
NSAIDs including PROXIME® oral dispersible tablet can cause serious gastrointestinal events including inflammation, bleeding, ulceration and perforation of the stomach and intestine, which may be fatal. This serious doverse reactions can occur at any time, with or without warning symptoms. Only one in flve patients who developed a serious upper gastrointestinal adverse reactions showed the symptoms. Ulcer in the upper gastrointestinal tract, bleeding or perforation caused by NSAIDs were occured on 1 of the patients treated for 3 - 6 months and 2 - 4 of patients treated for one year. Longer duration of use may increase the likelihood of developing serious gastrointestinal adverse reactions. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior hystory of ulcer disease and/or gastrointestinal bleeding who use NSAIDs have 10-fold increased risk for developing a gastrointestinal bleed compared to patients without either of these risk factors.
Other factors that increase the risk of gastrointestinal bleeding include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAIDs therapy, smoking, use of alcohol, older age and poor general health status. Most spontaneous reports of fatal gastrointestinal events are in elderly or debilitated patients. Therefore, special care should be taken in treating this population.
To reduce the risk for gastrointestinal adverse reactions in patients treated with NSAIDs. the lowest effective dose should be used for the shortest possible duration. Medical doctors and patients should remain alert for signs and symptoms of gastrointestinal ulceration and
bleeding during therapy with NSAIDs. If a serious gastrointestinal adverse reaction is suspected. Immediately initiate additional evaluation and treatment. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
DRUG INTERACTIONS
- Do not used concurrently with oral anticoagulants since it may increase anticoagulants activity.
- High dose Acetosal may increase oral hypoglycemic effect especially chlorpropamid.
- Do not use concurrently with corticosteroids or other NSAIDs because this may increase bleeding or lead to decreased renal function,
- Concurrent use with spironolactone, furosemide and uricosuric reduce the effect of the drug.
- Adult: 1 tablet daily.
- Myocardial infarction; Up to a maximum dose of 300 mg daily.
- TIA: Up to a maximum dose of 1000 mg daily.
Disperse PROXIME® oral dispersible tablet on patient's tongue without water.
PROXIME® oral dispersible tablet has a pleasant taste and is easy to be swallowed. If you preferred, PROXIME® oral dispersible tablet can be swallowed wholly with water.
OVERDOSAGES
- Salicylate in the stomach is eliminated by induction of vomiting or gastric emptying, followed by administration of activated charcoal in order to remove the salicylate and prevent absorbtion.
- The administration of activated charcoal every 4 or 6 hours may increase clearance rate.
PRESENTATIONS
Box of 3 strips @ 10 tablets,
Reg. No.: DKL0722244581A1
STORAGE
Keep in a cool (15°-25°C) and dry place.
Manufactured by:
PT SANBE FABMA
Bandung - Indonesia
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