COMPOSITIONS :
Benostan® Film coated caplet 500 mg, each film coated caplet contains : Mefenamic acid 500 mg.
DESCRIPTIONS :
Benostan® containing Mefenamic acid as active ingredient is available in 500 mg film coated caplet and 50 mg/5 ml suspension.
INDICATIONS :
For the relief mild to moderate pain such as headache, toothache, primary dysmenorrhea, including pain caused by trauma, muscular pain and pain after surgery.
DOSAGE AND ADMINISTRATIONS :
Adults and children > 14 years :
The recommended dose is 500 mg (1 film coated caplet or 50 ml) as an initial dose, followed by 250 mg (½ film coated caplet or 25 ml) every 6 hours as needed.
OVERDOSAGE :
Should accidental overdosage occurs, the stomach should be emptied by inducing emesis or by the administration of activated charcoal to adsorbed Mefenamic acid.
CONTRAINDICATIONS :
- Patients who have hypersensitivity to Mefenamic acid.
- Patients experiencing bronchospasm, allergic rhinitis and urticaria when treated with Acetosal.
- Patients with peptic ulcer and duodenal ulcer.
- Patients with severe renal failure.
WARNINGS :
CARDIOVASCULAR EFFECTS
- Cardiovascular Thrombotic Events
Clinical trials of severe COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increase risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal.
All NSAIDs, both COX-2 selective and nonselective, may have similar risk. Patients with known CV disease or risk factor for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the sign and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of Acetyl salicylic acid mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of Acetyl salicylic acid and an NSAID does increase the risk of serious GI events (see GI WARNINGS, Gastrointestinal (GI) Effect – Risk of GI Ulceration, Bleeding and Perforation).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain the first 10 – 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
- Hypertension
NSAIDs, including Mefenamic acid can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking Thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Mefenamic acid, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment with Mefenamic acid and throughout the course of therapy.
- Congestive Heart Failure and Edema
Fluid retention and edema have been observed in some patients taking NSAIDs. Mefenamic acid should be used with caution in patients with fluid retention or hearts failure.
GASTROINTESTINAL (GI) EFFECTS
- Risk of GI Ulceration, Bleeding and Perforation
NSAIDs, including Mefenamic acid, can cause serious gastrointestinal events, including inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop serious upper GI adverse events of NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 – 6 months and in about 2 – 4% of patients treated for one year. These trends with longer duration of use, increasing the like hood of developing a serious GI event at some time, during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should prescribed with extreme caution in patients with prior history of ulcer disease or gastrointestinal bleeding. Patients with prior history of ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed compared to patients with neither of these risk factor. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age and poor general health status. Most spontaneous reports of fatal GI events are in the elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, in patients treated with NSAIDs, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
PRECAUTIONS:
- Should be taken after meals.
- Used with caution in pregnant women or nursing mothers.
- Safety of usage in pediatric patients below the age of 14 have not been established certainly.
PRESENTATIONS :
Benostan® Film coated caplet 500 mg Box, 10 blisters @ 10 film coated caplet
Reg. No. DKL8802313409A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
