Ace-Bex Cap 20’s (Aceclofenac)-Potential Overview

Generic Information

• Brand Name: Ace-Bex Cap
• Generic Name: Aceclofenac
• Strength: 100 mg per capsule
• Pack Size: 20 capsules
• Pharmaceutical Class:
  • Class: Nonsteroidal Anti-inflammatory Drug (NSAID)
  • Type: Anti-inflammatory, Analgesic

Indications for Use

Ace-Bex (Aceclofenac) is used to treat the following conditions:

1. Pain Relief:
   • For moderate pain relief due to musculoskeletal conditions, joint pain, or injuries.
2. Rheumatoid Arthritis and Osteoarthritis:
   • For reducing inflammation, pain, and stiffness in arthritis patients.
3. Acute Pain Conditions:
   • Effective in treating acute pain such as sprains, strains, and dental pain.
4. Dysmenorrhea (Menstrual Pain):
   • Used for the relief of primary dysmenorrhea (painful menstruation).

Common Side Effects

• Gastrointestinal:
  • Upset stomach, nausea, diarrhea, constipation, bloating
• Central Nervous System:
  • Headache, dizziness
• Dermatological:
  • Rash, itching
• Others:
  • Fluid retention, swelling in extremities

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)
  • High blood pressure
• Renal:
  • Kidney damage, elevated creatinine, or reduced urine output
• Hepatic:
  • Liver toxicity, jaundice, elevated liver enzymes
• Allergic Reactions:
  • Anaphylaxis, swelling of the throat or lips

Dosage and Usage Instructions

1. For Adults:
   • Typical Dosage:
     • 1 capsule (100 mg) taken twice daily, preferably after meals.
   • Maximum Dose:
     • Do not exceed 2 capsules per day.
2. For Acute Pain or Inflammation:
   • Initial dose may be increased to 200 mg/day (2 capsules) for severe pain.

Usage Instructions:

• Take with food or milk to reduce gastrointestinal upset.
• Swallow the capsules whole with a full glass of water.
• Missed Dose: If a dose is missed, take it as soon as possible, unless it’s nearly time for the next dose. Do not double the dose to make up for a missed one.

Drug Interactions

1. With Food:
   • Food may reduce the potential for gastrointestinal irritation. It does not significantly affect the absorption of Aceclofenac.
2. With Other Medications:
   • Other NSAIDs (e.g., Ibuprofen, Diclofenac): Avoid combining with other NSAIDs due to an increased risk of gastrointestinal irritation, ulcers, and bleeding.
   • Anticoagulants (e.g., Warfarin): Increased bleeding risk due to the anti-coagulant effects of NSAIDs.
   • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Use with caution, as NSAIDs can reduce the effectiveness of diuretics and increase the risk of kidney damage.
   • Antihypertensive Medications: NSAIDs may interfere with the blood pressure-lowering effects of ACE inhibitors and diuretics.
   • Methotrexate: Risk of increased toxicity with concurrent use of methotrexate.
   • Lithium: Increased lithium levels may occur, leading to potential toxicity.
3. Other Interactions:
   • Alcohol: Increased risk of gastrointestinal bleeding and liver damage when taken with alcohol.

Regulatory Approval and Manufacturer

• Regulatory Approval:
  • Aceclofenac is approved in many countries for the treatment of pain and inflammation, including the EU, India, and other parts of Asia and Africa. It is commonly prescribed for the treatment of arthritis and musculoskeletal pain.
• Manufacturer:
  • Ace-Bex is typically manufactured by pharmaceutical companies in India, with various regional manufacturers across different 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 primarily inhibits the cyclooxygenase (COX) enzymes, particularly COX-2, leading to decreased production of prostaglandins, chemicals in the body that mediate inflammation, pain, and fever.
2. Therapeutic Effects:
   • Anti-inflammatory: Reduces swelling, redness, and heat in inflamed tissues.
   • Analgesic: Provides pain relief for musculoskeletal pain, arthritis, and other inflammatory conditions.
   • Antipyretic: Lowers fever by inhibiting prostaglandin production in the hypothalamus.

Pharmacokinetics

1. Absorption:
   • Aceclofenac is rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1-3 hours after oral administration. The bioavailability is approximately 100%.
2. Distribution:
   • It is highly protein-bound (99%) in the bloodstream, primarily to albumin. It is widely distributed throughout the body, including inflamed tissues where it exerts its therapeutic effects.
3. Metabolism:
   • Aceclofenac is extensively metabolized in the liver to inactive metabolites, primarily via hydroxylation. These metabolites do not contribute to the therapeutic effects but are important for excretion.
4. Excretion:
   • The drug is excreted mainly via the urine (60-70%) in the form of metabolites. Small amounts are excreted in feces.
5. Half-Life:
   • The elimination half-life of Aceclofenac is approximately 4 hours. This relatively short half-life is why the drug is typically taken twice daily.

Drug Interactions

1. With Food:
   • Food may reduce gastrointestinal discomfort but does not affect the drug’s overall absorption.
2. With Other Medications:
   • Anticoagulants (e.g., Warfarin): Increased risk of bleeding when used together. Monitor for signs of bleeding and adjust anticoagulant dose accordingly.
   • Other NSAIDs (e.g., Ibuprofen, Naproxen): Using two NSAIDs together can increase the risk of adverse gastrointestinal effects and kidney damage.
   • Methotrexate: Use with caution, as there may be an increased risk of methotrexate toxicity.
   • Diuretics or Antihypertensive Drugs: May reduce the effectiveness of blood pressure medications.
3. Other Interactions:
   • Lithium: NSAIDs may increase lithium levels in the blood, potentially leading to toxicity.

Clinical Considerations

1. Pregnancy Category:
   • Category C: There is limited data on the safety of Aceclofenac during pregnancy. It should be avoided during the third trimester due to potential risks to the fetus, including premature closure of the ductus arteriosus.
2. Lactation:
   • Excretion in Breast Milk: Aceclofenac is excreted in breast milk in small amounts. It is recommended to avoid its use during breastfeeding unless the benefits outweigh the potential risks.
3. Pediatric Use:
   • Safety in Children: Safety and efficacy in children under 18 years have not been established. Aceclofenac is generally not recommended for pediatric use.
4. Geriatric Use:
   • Older adults may be more susceptible to the adverse effects of NSAIDs, particularly gastrointestinal and renal side effects. Use with caution and consider dose adjustment.
5. Other Considerations:
   • Gastrointestinal Issues: Use caution in patients with a history of gastrointestinal problems, such as ulcers or bleeding.
   • Kidney and Liver Dysfunction: Patients with impaired liver or kidney function may require dosage adjustments or closer monitoring.