Acenac SR Cap 200 mg 30’s (Aceclofenac)-Potential Overview

Generic Information

• Brand Name: Acenac SR Cap
• Generic Name: Aceclofenac
• Strength: 200 mg per capsule
• Pack Size: 30 capsules
• Pharmaceutical Class:
  • Class: Nonsteroidal Anti-inflammatory Drug (NSAID)
  • Type: Anti-inflammatory, Analgesic

Indications for Use

Acenac SR (Aceclofenac) is prescribed for the treatment of:

1. Pain Relief:
   • Provides relief for moderate to severe pain, including musculoskeletal pain, back pain, and post-operative pain.
2. Osteoarthritis and Rheumatoid Arthritis:
   • Reduces inflammation, pain, and stiffness associated with osteoarthritis and rheumatoid arthritis.
3. Acute Pain:
   • Effective in treating acute pain conditions, such as sprains, strains, and dental pain.
4. Dysmenorrhea (Menstrual Pain):
   • Used to relieve primary dysmenorrhea (painful menstruation).

Common Side Effects

• Gastrointestinal:
  • Nausea, stomach pain, indigestion, constipation
• Central Nervous System:
  • Dizziness, headache
• Skin Reactions:
  • Rash, itching
• General Symptoms:
  • Swelling of extremities, fluid retention

Serious Side Effects (Less Common)

• Gastrointestinal:
  • Peptic ulcers, gastrointestinal bleeding, or perforation
  • Severe abdominal pain or black stools (signs of bleeding)
• Cardiovascular:
  • Increased risk of heart attack or stroke (with long-term use)
  • Elevated blood pressure
• Renal (Kidney):
  • Kidney damage, fluid retention, reduced urine output
• Liver:
  • Liver toxicity, jaundice, elevated liver enzymes
• Allergic Reactions:
  • Severe allergic reactions such as anaphylaxis, swelling of the throat or lips

Dosage and Usage Instructions

1. For Adults:
   • Usual Dosage:
     • 1 capsule (200 mg) taken once daily, preferably after meals.
   • Maximum Dose:
     • Do not exceed 200 mg per day.
2. For Acute Pain:
   • Initial dose may be increased to 400 mg/day (two capsules) for severe pain.

Usage Instructions:

• Take with food or milk to reduce gastrointestinal irritation.
• Swallow the capsules whole with a full glass of water.
• Missed Dose: If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not double the dose to make up for the missed dose.

Drug Interactions

1. With Food:
   • Food may reduce the risk of gastrointestinal irritation but does not significantly affect absorption.
2. With Other Medications:
   • Other NSAIDs (e.g., Ibuprofen, Naproxen): Avoid combining with other NSAIDs to prevent gastrointestinal irritation and other adverse effects.
   • Anticoagulants (e.g., Warfarin): Increased bleeding risk when taken with anticoagulants. Monitor for signs of bleeding.
   • Diuretics (e.g., Furosemide): May reduce the effectiveness of diuretics and increase the risk of kidney damage.
   • Antihypertensive Medications: NSAIDs may reduce the effectiveness of blood pressure medications.
   • Lithium: Increased lithium levels, leading to potential toxicity.
   • Methotrexate: Use with caution as NSAIDs can increase methotrexate toxicity.
3. Other Interactions:
   • Alcohol: Combining alcohol with Aceclofenac may increase the risk of gastrointestinal bleeding and liver damage.

Regulatory Approval and Manufacturer

• Regulatory Approval:
  • Aceclofenac is approved in several countries, including India, Europe, and parts of Asia, for its analgesic and anti-inflammatory properties.
• Manufacturer:
  • Acenac SR is typically manufactured by pharmaceutical companies in India, with varying manufacturers across different global markets.

Pharmacist-Related Data

Drug Name and Chemical Details

• Generic Name: Aceclofenac
• Chemical Formula: C16H15Cl2NO4
• CAS Number: 89796-99-6
• Molecular Weight: 353.2 g/mol

Pharmacodynamics

1. Mechanism of Action:
   • Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting the cyclooxygenase (COX) enzymes, particularly COX-2, leading to decreased production of prostaglandins. Prostaglandins are responsible for inflammation, pain, and fever, so by inhibiting their production, Aceclofenac reduces these symptoms.
2. Therapeutic Effects:
   • Anti-inflammatory: Reduces inflammation in conditions such as arthritis and other inflammatory diseases.
   • Analgesic: Provides pain relief for acute and chronic pain, including back pain, muscle pain, and dental pain.
   • Antipyretic: Lowers fever by inhibiting the production of prostaglandins in the hypothalamus.

Pharmacokinetics

1. Absorption:
   • Aceclofenac is well absorbed after oral administration. It reaches peak plasma concentrations within 1-3 hours. The bioavailability is approximately 100%.
2. Distribution:
   • It is highly protein-bound (99%), primarily binding to albumin in the blood. The drug is widely distributed throughout the body, including inflamed tissues, where it exerts its therapeutic effects.
3. Metabolism:
   • Aceclofenac is extensively metabolized in the liver, mainly via hydroxylation. The metabolites are inactive and are not responsible for the therapeutic effects of the drug.
4. Excretion:
   • The drug is excreted primarily in the urine (60-70%) as metabolites. A small amount is excreted in the feces.
5. Half-Life:
   • The elimination half-life of Aceclofenac is approximately 4 hours, which supports its administration once or twice a day for sustained efficacy.

Drug Interactions

1. With Food:
   • Taking Aceclofenac with food may help reduce gastrointestinal irritation but does not significantly affect its overall absorption or efficacy.
2. With Other Medications:
   • Anticoagulants (e.g., Warfarin): There is an increased risk of bleeding when used together. Regular monitoring of INR is recommended.
   • Methotrexate: Increased toxicity due to reduced elimination of methotrexate when used in combination.
   • Diuretics: NSAIDs like Aceclofenac can reduce the effectiveness of diuretics and may impair kidney function.
   • Lithium: Increased lithium toxicity, as NSAIDs can reduce lithium clearance.
3. Other Interactions:
   • Alcohol: Increases the risk of gastrointestinal side effects such as bleeding, ulcers, and liver damage.

Clinical Considerations

1. Pregnancy Category:
   • Category C: Aceclofenac should be avoided during pregnancy, especially during the third trimester, due to potential risks to the fetus, such as premature closure of the ductus arteriosus. Use only if the potential benefit justifies the potential risk to the fetus.
2. Lactation:
   • Aceclofenac is excreted in small amounts in breast milk. It is generally recommended to avoid the use of Aceclofenac during breastfeeding unless the benefits outweigh the potential risks.
3. Pediatric Use:
   • Safety and efficacy in children have not been established, and Aceclofenac is generally not recommended for pediatric use.
4. Geriatric Use:
   • Older adults may be more susceptible to the adverse effects of NSAIDs, such as gastrointestinal bleeding and kidney damage. Close monitoring is recommended, and dose adjustments may be necessary.
5. Other Considerations:
   • Gastrointestinal Issues: Patients with a history of peptic ulcers or gastrointestinal bleeding should use Aceclofenac with caution.
   • Kidney and Liver Function: Patients with pre-existing liver or kidney dysfunction may require dose adjustments or monitoring during therapy.