Alcofen
Generic Name
Diclofenac Sodium
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
alcofen 50 mg tablet | ৳ 0.70 | ৳ 7.00 |
Description
Overview of the medicine
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, swelling, and stiffness caused by various conditions like arthritis, muscle aches, and menstrual cramps. It works by blocking the body's production of certain natural substances that cause inflammation.
Uses & Indications
Dosage
Adults
The usual adult dosage is 50 mg two to three times daily. The maximum recommended daily dose is 150 mg. Doses should be adjusted according to patient response and tolerability.
Elderly
Lower doses may be necessary in elderly patients due to an increased risk of adverse effects, especially gastrointestinal bleeding and renal impairment. Use with caution and monitor closely.
Renal_impairment
Use with caution in mild to moderate renal impairment. Dose reduction may be required. Diclofenac is contraindicated in severe renal impairment (creatinine clearance <30 mL/min).
How to Take
Take Alcofen 50 mg tablet orally, preferably with food or milk, to minimize gastrointestinal discomfort. Swallow the tablet whole with a glass of water. Do not crush, chew, or break sustained-release tablets if applicable.
Mechanism of Action
Diclofenac inhibits the activity of cyclooxygenase (COX-1 and COX-2) enzymes, which are involved in the synthesis of prostaglandins. Prostaglandins are inflammatory mediators that contribute to pain, fever, and inflammation. By reducing prostaglandin synthesis, diclofenac exerts its anti-inflammatory, analgesic, and antipyretic effects.
Pharmacokinetics
Onset
Analgesic effects typically begin within 30 minutes to 1 hour.
Excretion
Approximately 60% of the dose is excreted in the urine as metabolites, and about 35% is eliminated in the bile and feces.
Half life
The elimination half-life of the parent drug is approximately 1-2 hours, but active metabolites may have a longer duration of action.
Absorption
Rapidly and completely absorbed from the gastrointestinal tract following oral administration. Peak plasma concentrations are typically reached within 2-3 hours.
Metabolism
Extensively metabolized in the liver, primarily via hydroxylation and subsequent glucuronidation. CYP2C9 is the main enzyme involved in its metabolism.
Side Effects
Contraindications
- Hypersensitivity to diclofenac, aspirin, or other NSAIDs
- Active gastrointestinal ulceration, bleeding, or perforation
- Severe heart failure (NYHA Class II-IV)
- Severe renal or hepatic impairment
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Third trimester of pregnancy
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Methotrexate
Increased plasma concentrations of methotrexate, potentially leading to increased toxicity. Use with caution.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding when co-administered.
Lithium/Digoxin
Increased plasma concentrations of lithium and digoxin, leading to potential toxicity. Monitor levels.
Other NSAIDs/Aspirin
Avoid concomitant use due to increased risk of adverse effects, especially GI events.
Warfarin/Anticoagulants
Increased risk of bleeding due to enhanced anticoagulant effect.
Diuretics/ACE Inhibitors
Reduced hypotensive effect of diuretics and ACE inhibitors; increased risk of renal impairment, especially in dehydrated patients.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms of diclofenac overdose typically include lethargy, drowsiness, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Rare symptoms include hypertension, acute renal failure, respiratory depression, and coma. Management is primarily supportive and symptomatic. Gastric lavage and activated charcoal may be considered within an hour of ingestion. There is no specific antidote.
Pregnancy & Lactation
Diclofenac is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. In the first and second trimesters, it should only be used if the potential benefit outweighs the potential risk to the fetus. Diclofenac passes into breast milk in small amounts; use with caution during lactation, and only if clearly needed after consulting a healthcare professional.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
The shelf life of Alcofen 50 mg tablet is typically 2 to 3 years from the date of manufacture, provided it is stored under recommended conditions.
Availability
Pharmacies and hospitals
Approval Status
Approved by regulatory authorities worldwide
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Diclofenac, the active ingredient in Alcofen 50 mg, has been extensively studied in numerous clinical trials globally. These trials have demonstrated its efficacy and safety in managing various pain and inflammatory conditions, leading to its widespread approval and use.
Lab Monitoring
- Complete Blood Count (CBC) – for anemia and bleeding risk
- Liver function tests (LFTs) – for liver damage
- Renal function tests (Creatinine, BUN) – for kidney impairment
- Blood pressure monitoring – due to risk of hypertension
- Fecal occult blood test – if GI bleeding is suspected
Doctor Notes
- Prescribe the lowest effective dose for the shortest possible duration to minimize risks.
- Monitor for signs of gastrointestinal bleeding, cardiovascular events, and renal impairment, especially in high-risk patients.
- Counsel patients on proper administration, potential side effects, and drug interactions.
- Consider prescribing a proton pump inhibitor (PPI) concurrently for patients at high risk of GI complications.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not take more than the recommended dose, as it may increase the risk of side effects.
- Inform your doctor about any other medications, supplements, or herbal products you are taking.
- Report any unusual or persistent symptoms such as stomach pain, black stools, swelling, or changes in urination to your doctor immediately.
- Avoid lying down for at least 10 minutes after taking the tablet to prevent esophageal irritation.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Alcofen 50 mg tablet may cause dizziness, drowsiness, or visual disturbances in some individuals. If you experience these effects, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Avoid or limit alcohol consumption during treatment.
- Maintain a healthy and balanced diet.
- Regular exercise, if appropriate for your condition, can help manage pain and improve overall well-being.
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