Bambang Pharmaceutical Depot Inc.
Diclofenac Sodium (Curafen) 100mg Film Coated Non Selective COX Inhibitor Tablet 100's
Diclofenac Sodium (Curafen) 100mg Film Coated Non Selective COX Inhibitor Tablet 100's
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Product Description:
Diclofenac Sodium (Curafen) 100mg is a non-selective COX (cyclooxygenase) inhibitor that belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs). It is formulated as film-coated tablets, available in packs of 100 tablets. Curafen is commonly used for the relief of pain, inflammation, and swelling associated with various conditions such as osteoarthritis, rheumatoid arthritis, and acute pain from injury or surgery. Diclofenac works by inhibiting the cyclooxygenase enzymes (COX-1 and COX-2), which are responsible for the production of prostaglandins – chemicals in the body that promote inflammation, pain, and fever.
Indications:
Diclofenac Sodium (Curafen) 100mg is indicated for the treatment of:
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Osteoarthritis:
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Relief of symptoms such as joint pain and inflammation associated with osteoarthritis.
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Rheumatoid Arthritis:
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Used for reducing inflammation, swelling, and pain in patients suffering from rheumatoid arthritis.
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Ankylosing Spondylitis:
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Used to reduce the inflammation and stiffness of joints in patients with ankylosing spondylitis.
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Acute Pain:
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Management of pain due to injuries, strains, sprains, or postoperative conditions.
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Dysmenorrhea (painful menstruation):
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Relief of moderate pain associated with menstrual cramps.
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Other Painful Conditions:
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Musculoskeletal pain, gout attacks, and back pain.
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Dosage:
The usual dosage of Diclofenac Sodium (Curafen) 100mg will depend on the condition being treated. The general dosing guidelines are:
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For Osteoarthritis and Rheumatoid Arthritis:
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Initial dose: 100mg to 150mg per day, in divided doses (morning and evening).
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Maintenance dose: 75mg to 100mg per day, in divided doses.
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For Acute Pain (e.g., postoperative pain, musculoskeletal pain):
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Initial dose: 100mg to 150mg per day, usually for a short duration (up to 7 days).
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For Dysmenorrhea (Painful Menstruation):
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The typical dose is 50mg to 100mg once or twice a day as needed, starting at the onset of menstrual cramps.
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For Ankylosing Spondylitis:
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100mg to 150mg per day, usually divided into two doses.
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Administration:
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Tablets should be taken with food or after meals to reduce gastrointestinal irritation.
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Curafen tablets should be swallowed whole, not chewed or crushed.
Note: The dosage should be individualized according to the patient's response and tolerance. The lowest effective dose should be used for the shortest duration necessary to manage symptoms.
Side Effects:
Like other NSAIDs, Diclofenac Sodium (Curafen) can cause a range of side effects. Common side effects include:
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Gastrointestinal:
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Stomach upset, nausea, vomiting, dyspepsia (indigestion), abdominal pain, and diarrhea.
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More serious side effects include gastric ulcers, bleeding, or perforation (especially in the elderly or in long-term use).
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Central Nervous System:
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Headache, dizziness, fatigue, and somnolence (drowsiness).
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Cardiovascular:
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Increased risk of heart attack, stroke, and hypertension (high blood pressure), particularly with long-term use or in patients with existing heart conditions.
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Kidneys:
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Renal impairment, including acute kidney failure (especially in patients with pre-existing kidney issues or dehydration).
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Liver:
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Elevated liver enzymes (AST, ALT), jaundice, and liver dysfunction.
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Skin Reactions:
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Rash, itching, or more serious reactions such as Stevens-Johnson Syndrome or toxic epidermal necrolysis (rare but severe).
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Allergic Reactions:
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Anaphylaxis, angioedema, and respiratory issues (e.g., shortness of breath, wheezing).
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Hematologic:
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Rarely, blood-related issues such as anemia, thrombocytopenia, or leukopenia.
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Serious side effects requiring immediate medical attention include:
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Chest pain, shortness of breath, or swelling of the legs (signs of a heart attack or heart failure).
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Unexplained bruising or bleeding.
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Severe abdominal pain (possible indication of gastrointestinal bleeding or ulcer).
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Severe headache, blurred vision, or confusion (possible signs of stroke).
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Severe skin reactions (blisters, peeling).
Contraindications:
Diclofenac Sodium (Curafen) should not be used in the following conditions:
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Hypersensitivity:
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Contraindicated in patients who have a known allergy to diclofenac or other NSAIDs (such as ibuprofen, naproxen).
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Active or History of Gastrointestinal Bleeding/Ulcers:
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Contraindicated in patients with active gastrointestinal bleeding, peptic ulcer disease, or a history of recurrent ulcers.
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Severe Liver Disease:
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Contraindicated in patients with severe liver dysfunction or liver failure.
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Severe Renal Impairment:
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Contraindicated in patients with severe renal impairment (e.g., acute kidney failure, chronic kidney disease in advanced stages).
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Severe Heart Disease:
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Contraindicated in patients with severe heart failure, uncontrolled hypertension, or history of myocardial infarction (heart attack) or stroke.
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Pregnancy:
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Diclofenac is contraindicated in the third trimester of pregnancy due to potential risks to the fetus, including premature closure of the ductus arteriosus. It should be used with caution during the first and second trimesters, only if absolutely necessary.
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Breastfeeding:
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Caution should be exercised when using diclofenac during breastfeeding, as it can pass into breast milk. The benefits should outweigh any potential risks.
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Children:
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Diclofenac is generally not recommended for use in children under 14 years of age, unless prescribed by a healthcare provider for specific conditions.
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Precautions:
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Cardiovascular Risk:
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NSAIDs like diclofenac may increase the risk of heart attack and stroke, especially with prolonged use or in patients with pre-existing cardiovascular conditions. Use the lowest effective dose for the shortest duration.
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Gastrointestinal Risk:
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Use with caution in patients with a history of gastric ulcers, gastritis, or gastrointestinal bleeding. Prolonged use may increase the risk of peptic ulcers or gastrointestinal bleeding.
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Renal Function:
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Use with caution in patients with renal dysfunction or those on diuretics. Renal function should be monitored during treatment.
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Liver Function:
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Liver enzymes (AST, ALT) should be monitored, especially during prolonged therapy. Use with caution in patients with mild to moderate liver disease.
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Elderly Patients:
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Elderly patients are at higher risk for gastrointestinal bleeding, kidney problems, and heart complications. Monitoring is essential in this population.
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Drug Interactions:
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Anticoagulants: Concurrent use with warfarin or other anticoagulants may increase the risk of bleeding.
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Other NSAIDs: Avoid concurrent use with other NSAIDs, as this may increase the risk of side effects.
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Diuretics: Diuretic therapy may increase the risk of kidney toxicity.
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Lithium: Diclofenac may increase the plasma levels of lithium, requiring close monitoring.
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Pregnancy and Breastfeeding:
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As mentioned earlier, Diclofenac should be avoided during late pregnancy and used with caution during early pregnancy and while breastfeeding.
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Summary:
Diclofenac Sodium (Curafen) 100mg is a non-selective NSAID that is effective for treating inflammation, pain, and swelling associated with conditions like osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. The typical dose ranges from 100mg to 150mg per day depending on the condition.
Common side effects include gastrointestinal disturbances (e.g., stomach pain, nausea), headache, and dizziness, while serious side effects can include gastrointestinal bleeding, cardiovascular events, and renal dysfunction. Diclofenac is contraindicated in patients with a history of gastric ulcers, severe liver or kidney disease, and those who are pregnant (third trimester). It should be used cautiously in elderly patients and those with cardiovascular or renal conditions.
As with any medication, Diclofenac Sodium (Curafen) should be used under the guidance of a healthcare provider to minimize risks and ensure appropriate use.
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