Description
INDICATIONS AND USAGE:
BARAVIT has been found effective in active stages of the following:
- Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
- Moderate to severe ankylosing spondylitis.
- Moderate to severe osteoarthritis.
- Acute painful shoulder (bursitis and/or tendinitis).
- Acute gouty arthritis.
CONTRAINDICATIONS:
- BARAVIT is contraindicated in patients with known hypersensitivity to one of its components.
- BARAVIT should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic/anaphylactoid reactions to NSAIDs have been reported in such patients.
- BARAVIT is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
WARNINGS:
Cardiovascular Thrombotic diseases; Hypertension; Congestive Heart Failure and Edema; Gastrointestinal diseases – Risk of Ulceration, Bleeding, and Perforation; Renal diseases.
Advanced Renal Disease: Treatment with BARAVIT is not recommended in these patients with adverse renal disease. If BARAVIT therapy must be initiated, close monitoring of the patient’s renal function is advisable.
Anaphylactic/Anaphylactoid Reactions: As with other NSAIDs, anaphylactic/anaphylactoid reactions may occur in patients without known prior exposure to BARAVIT. BARAVIT should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency help should be sought in cases where an anaphylactic/anaphylactoid reaction occurs.
Skin Reactions: NSAIDs, including BARAVIT, can cause skin adverse events such as exfoliative dermatitis, Stevens-Johnson’s Syndrome, and toxic epidermal necrolysis, which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensibility.
Pregnancy: In late pregnancy, as with other NSAIDs, BARAVIT should be avoided because it may cause premature closure of the ductus arteriosus.
Ocular Effects: Corneal deposits and retinal disturbances, including those of the macula, have been observed in some patients who had received prolonged therapy with BARAVIT. Examination at periodic intervals is desirable in patients where therapy is prolonged.
Central Nervous System Effects: BARAVIT may aggravate depression or other psychiatric disturbances, epilepsy, and Parkinsonism, and should be used with considerable caution in patients with these conditions. If severe CNS adverse reactions develop, BARAVIT should be discontinued.
BARAVIT may cause drowsiness; therefore, patients should be cautioned about engaging in activities requiring mental alertness and motor coordination, such as driving a car. BARAVIT may also cause headache. Headache which persists despite dosage reduction requires cessation of therapy with BARAVIT.
PRECAUTIONS:
General: BARAVIT cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency.
Hepatic Effects: A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more severe hepatic reaction while on therapy with BARAVIT. Severe hepatic reactions, including jaundice and cases of fatal hepatitis, have been reported with BARAVIT as with other non-steroidal anti-inflammatory drugs.
Hematological Effects: Patients on long-term treatment with NSAIDs, including BARAVIT, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
Preexisting Asthma: BARAVIT should not be administered to patients with aspirin-sensitive asthma and should be used with caution in patients with preexisting asthma.
Laboratory Tests: Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs and symptoms of GI bleeding.
DRUG INTERACTIONS:
ACE-Inhibitors and Angiotensin II Antagonists: BARAVIT can reduce the antihypertensive effects of captopril and losartan.
Aspirin: When BARAVIT is administered with aspirin, its protein binding is reduced, although the clearance of free indomethacin is not altered. The use of BARAVIT in conjunction with aspirin or other salicylates is not recommended.
Beta-adrenoceptor blocking agents: Blunting of the antihypertensive effect of beta-adrenoceptor blocking agents by non-steroidal anti-inflammatory drugs including BARAVIT has been reported.
Cyclosporine: Administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporine has been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin.
Diflunisal: In normal volunteers receiving indomethacin, the administration of diflunisal decreased the renal clearance and significantly increased the plasma levels of indomethacin. In some patients, combined use of BARAVIT and diflunisal has been associated with fatal gastrointestinal hemorrhage. Therefore, diflunisal and BARAVIT should not be used concomitantly.
Digoxin: BARAVIT given concomitantly with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
Diuretics: In some patients, the administration of BARAVIT can reduce the diuretic, natriuretic, and, antihypertensive effects of loop, potassium-sparing, and thiazide diuretics. This response has been attributed to inhibition of renal prostaglandin synthesis.
Lithium: BARAVIT produced a clinically relevant elevation of plasma lithium and reduction in renal lithium clearance in psychiatric patients and normal subjects with steady state plasma lithium concentrations. This effect has been attributed to inhibition of prostaglandin synthesis.
Methotrexate: Caution should be used if NSAIDs are administered simultaneously with methotrexate.
NSAIDs: The concomitant use of BARAVIT with other NSAIDs is not recommended due to the increased possibility of gastrointestinal toxicity, with little or no increase in efficacy.
Oral anticoagulants: Clinical studies have shown that BARAVIT does not influence the hypoprothrombinemia produced by anticoagulants.
Probenecid: When BARAVIT is given to patients receiving probenecid, the plasma levels of indomethacin are likely to be increased. Therefore, a lower total daily dosage of BARAVIT may produce a satisfactory therapeutic effect. When increases in the dose of BARAVIT are made, they should be made carefully and in small increments.
Pregnancy: Pregnancy category C: BARAVIT should be used during the first trimester only if the potential benefit justifies the potential risk to the fetus under medical prescription. BARAVIT should not be used during the second and third trimesters.
ADVERSE REACTIONS:
The adverse reactions for BARAVIT are the following:
GASTROINTESTINAL: nausea (with or without vomiting), dyspepsia (including indigestion, heartburn and epigastric pain), diarrhea, abdominal distress or pain, constipation, anorexia, bloating (includes distention), flatulence, peptic ulcer.
CENTRAL NERVOUS SYSTEM: headache, dizziness, vertigo, somnolence, depression and fatigue (including malaise and listlessness), anxiety (includes nervousness), muscle weakness.
SPECIAL SENSES: tinnitus.
CARDIOVASCULAR: hypertension.
INTEGUMENTARY: pruritus, rash; urticaria.
OVERDOSAGE:
The following symptoms may be observed following overdosage: nausea, vomiting, intense headache, dizziness, mental confusion, disorientation, or lethargy. There have been reports of paresthesias, numbness, and convulsions.
Treatment is symptomatic and supportive. The stomach should be emptied as quickly as possible if the ingestion is recent. If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac. If the patient is unable to vomit, gastric lavage should be performed. Once the stomach has been emptied, 25 or 50 g of activated charcoal may be given. Depending on the condition of the patient, close medical observation and nursing care may be required. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage have been reported as adverse reactions of indomethacin. Use of antacids may be helpful.
DOSAGE AND ADMINISTRATION:
Pediatric Use: BARAVIT ordinarily should not be prescribed for pediatric patients 14 years of age and under.
Adult Use:
Dosage Recommendations for Active Stages of the Following:
- Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: 2-3 capsules daily. If this is well tolerated, increase the daily dosage by 1 or by 2 capsules, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 6 to 8 capsules is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 4 capsules, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 8 capsules. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 1 capsule or, if required, by 2 capsules daily.
- Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 3-6 capsules daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7-14 days.
- Acute gouty arthritis.
Suggested Dosage: 2 capsules 3 times daily until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
HOW SUPPLIED:
Boxes of 30 capsules.
