Biofenac 100mg

Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of musculoskeletal system (osteochondrosis, osteoarthritis, periartropatii), post-traumatic inflammation of soft tissue and musculoskeletal system (sprains, bruises). Pain in the spine, neuralgia, myalgia, arthralgia, pain and inflammation after surgery or injury, pain in gout, migraine, algomenorrhea, pain with Bursitis, proctitis, colic (biliary and renal), pain in infectious and inflammatory diseases of ENT organs.

For local use: the inhibition of miosis during surgery for cataract prevention of cystoid macular edema associated with removal and lens implantation, inflammatory eye non-infectious nature, post-traumatic inflammation in penetrating and nonpenetrating wound of the eyeball.

Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.

Barium sulfate is taken by mouth or given rectally by enema. If taken by mouth, it makes the esophagus, the stomach, and/or the small intestine opaque to the x-rays so that they can be "photographed". If it is given by enema, the colon and/or the small intestine can be seen and photographed by x-rays.

The dose of barium sulfate will be different for different patients and depends on the type of test. The strength of the suspension and tablet is determined by how much barium they contain. Different tests will require a different strength and amount of suspension (some may require the tablet form), depending on the age of the patient, the contrast needed, and the x-ray equipment used.

Barium sulfate is to be used only by or under the direct supervision of a doctor.

FC tab: Usual Dose: 100 mg twice daily.

Renal Insufficiency: There is no evidence that the dosage of Biofenac 100mg needs to be modified in patients with mild renal impairment, but as with other NSAIDs, caution should be exercised.

Hepatic Insufficiency: There is some evidence that the dose of Biofenac 100mg should be reduced in patients with hepatic impairment and it is suggested that an initial dose of 100 mg be used.

SR tab: Adults: 1 tablet daily.

Children: There are no clinical data on the use of Biofenac 100mg in children.

Gel: Adults: Gently rub 2-4 g (a circular shaped mass approximately 2-2.5 cm in diameter) 3-4 times daily. Maximum Daily Dose: 16 g. Maximum Weekly Dose: 112 g. A period of at least 4 hrs should be left between applications. The dose should not be applied >4 times in a 24-hr period. After application, the hands should be washed unless this is the treated site. Do not use for >14 days unless recommended by the physician.

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What is the most important information I should know about Biofenac 100mg?

Hypersensitivity to Biofenac 100mg or any of the excipients of Biofenac 100mg. Not to be given to those patients who have history of: Shock (cerebrovascular accident); heart attack (myocardial infarction); coronary artery bypass graft; congestive heart failure (CHF) NYHA II-IV.

Active or history of recurrent peptic ulcer/hemorrhage (≥2 distinct episodes of proven ulceration or bleeding).

Patients who have previously shown hypersensitivity reactions (eg, asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs. Severe heart failure, hepatic failure and renal failure.

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Use in Children: There are no clinical data in children and therefore it is not recommended for use in children <18 years.

Use in Pregnancy: Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the fetal cardiovascular system (risk of closure of the ductus arteriosus) and on the possible risk of persistent pulmonary hypertension (HTN) of the new born, use in the last trimester of pregnancy is contraindicated. The regular use of NSAIDs during the last trimester of pregnancy may decrease uterine tone and contraction. The onset of labor may be delayed and the duration increased with an increased bleeding tendency in both mother and child. NSAIDs should not be used during the first 2 trimesters of pregnancy or labor unless the potential benefit to the patient outweighs the potential risk to the fetus.

Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits, treatment with Biofenac 100mg (10 mg/kg/day) resulted in a series of morphological changes in some fetuses.

Biofenac 100mg should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used.

It is used to relieve pain and swelling of joints (osteoarthritis), swelling of the small joints of hands and feet (rheumatoid arthritis), arthritis that mainly affect the spine (ankylosing spondylitis).

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What other drugs will affect Biofenac 100mg?

Lithium: Biofenac 100mg may increase plasma concentrations of lithium.

Cardiac Glycosides: NSAIDs may exacerbate cardiac failure and reduce the glomerular filtration rate in patients receiving glycosides due to increase plasma glycoside (including digoxin) levels.

Diuretics: Biofenac 100mg, like other NSAIDs, may inhibit the activity of diuretics. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Anticoagulants: Like other NSAIDs, Biofenac 100mg may enhance the activity of anticoagulants.

Methotrexate: Since NSAIDs may increase plasma levels, resulting in increased toxicity, caution should be exercised if NSAIDs and methotrexate are administered within 24 hrs of each other.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Other NSAIDs and Steroids: Concomitant therapy with aspirin, other NSAIDs and steroids may increase the frequency of adverse reactions, including the risk of gastrointestinal bleeding.

Cyclosporin: Cyclosporin nephrotoxicity may be increased by the effect of NSAIDs on renal prostaglandins.

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What are the possible side effects of Biofenac 100mg?

Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature.

Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Cardiovascular and Cerebrovascular: Edema, HTN and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombotic events.

The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastrointestinal disorders, in particular dyspepsia, abdominal pain, nausea and diarrhea, and occasional occurrence of dizziness. Edema, HTN and cardiac failure have been reported in association with NSAID treatment.

Investigations: Abnormal hepatic enzyme and serum creatinine levels have also been reported.

Other adverse reactions reported less commonly include: Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

Hepatic: Abnormal liver function, hepatitis and jaundice.

Neurological and Special Senses: Visual disturbances, optic neuritis, headaches, paresthesia, reports of aseptic meningitis with symptoms eg, stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Hematological: Agranulocytosis, aplastic anemia and hemolytic anemia.

Dermatological: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Photosensitivity.

If serious adverse reactions occur, Biofenac 100mg should be withdrawn.

The following is a table of adverse reactions reported during clinical studies and after authorization, grouped by system-organ class and estimated frequencies.

Biofenac 100mg also contains the following excipients: Medium chain triglycerides, hard fat, gelatin, D-sorbitol, concentrated glycerin, titanium dioxide, yellow no. 5, red no. 40 and purified water.