Ace-Bex-P Cap 3×10’s (Aceclofenac and Acetaminophen)-Potential Overview

Generic Information

• Brand Name: Ace-Bex-P Cap
• Generic Names: Aceclofenac and Acetaminophen
• Strength: Each capsule contains 100 mg of Aceclofenac and 500 mg of Acetaminophen (Paracetamol)
• Pack Size: 3×10’s (30 capsules in total)
• Pharmaceutical Class:
  • Class: Nonsteroidal Anti-inflammatory Drug (NSAID) and Analgesic
  • Type: Combination drug (NSAID + Analgesic)

Indications for Use

Ace-Bex-P is a combination drug used for the treatment of various conditions involving pain and inflammation. It is commonly used for:

1. Pain Relief:
   • Moderate pain relief from conditions like musculoskeletal pain, joint pain, and post-operative pain.
2. Rheumatoid Arthritis and Osteoarthritis:
   • Used for the relief of pain, inflammation, and stiffness associated with rheumatoid arthritis and osteoarthritis.
3. Acute Pain Conditions:
   • For the treatment of acute pain, including pain due to sprains, strains, and minor injuries.
4. Dysmenorrhea (Menstrual Pain):
   • Effective in the treatment of primary dysmenorrhea (painful menstruation).

Common Side Effects

• Aceclofenac-related side effects:
  • Upset stomach, nausea, or vomiting
  • Diarrhea or constipation
  • Dizziness or headache
  • Rash or itching
• Acetaminophen-related side effects:
  • Liver toxicity in case of overdose
  • Allergic reactions (rare)
  • Skin rash or redness

Serious Side Effects (Less Common)

• Aceclofenac:
  • Severe allergic reactions such as anaphylaxis
  • Gastrointestinal bleeding or ulcers
  • Renal impairment or acute kidney failure
  • Cardiovascular risks (e.g., hypertension, heart attack)
  • Liver toxicity (elevated liver enzymes, jaundice)
• Acetaminophen:
  • Severe liver damage (especially in overdose)
  • Hepatitis
  • Jaundice
  • Kidney damage (rare)

Dosage and Usage Instructions

1. For Adults:
   • Typical Dosage:
     • 1 capsule (100 mg Aceclofenac + 500 mg Acetaminophen) taken twice daily after meals.
   • Maximum Dose:
     • Do not exceed 2 capsules per day without medical supervision.
2. For Acute Pain or Inflammation:
   • The dose may vary depending on the severity of symptoms, but generally, 1 capsule twice daily is adequate for most patients.

Usage Instructions:

• Take the capsules with food to minimize gastrointestinal irritation.
• Swallow the capsules whole with a full glass of water.
• Missed Dose: If a dose is missed, take it as soon as remembered, unless it is 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 gastrointestinal irritation, but does not significantly alter the absorption of the drug.
2. With Other Medications:
   • Other NSAIDs (e.g., Ibuprofen, Diclofenac): Concurrent use increases the risk of gastrointestinal side effects such as ulcers and bleeding.
   • Anticoagulants (e.g., Warfarin): NSAIDs like Aceclofenac can increase the risk of bleeding, particularly when taken with blood thinners.
   • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Concurrent use may increase the risk of kidney damage, especially in patients with pre-existing kidney disease.
   • Antihypertensive Medications: NSAIDs may reduce the effectiveness of certain blood pressure medications, such as ACE inhibitors and diuretics.
   • Alcohol: Drinking alcohol with acetaminophen can increase the risk of liver damage.
3. Other Interactions:
   • Lithium: NSAIDs may increase lithium levels, leading to potential toxicity.
   • Methotrexate: Increased risk of methotrexate toxicity.

Regulatory Approval and Manufacturer

• Regulatory Approval:
  • Aceclofenac and Acetaminophen combination products are approved by regulatory authorities in many countries, including the US, Europe, and India. This combination is commonly used for the treatment of pain and inflammation.
• Manufacturer:
  • Manufactured by various pharmaceutical companies depending on the region. The specific manufacturer may vary, but the drug is commonly produced by companies in countries such as India and Turkey.

Pharmacist-Related Data

Drug Name and Chemical Details

• Generic Name:
  • Aceclofenac and Acetaminophen
• Chemical Formula:
  • Aceclofenac: C16H15Cl2NO4
  • Acetaminophen (Paracetamol): C8H9NO2
• CAS Numbers:
  • Aceclofenac: 89796-99-6
  • Acetaminophen: 103-90-2
• Molecular Weight:
  • Aceclofenac: 353.2 g/mol
  • Acetaminophen: 151.2 g/mol

Pharmacodynamics

1. Mechanism of Action:
   • Aceclofenac: A nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX), particularly COX-2, reducing the synthesis of prostaglandins involved in inflammation and pain.
   • Acetaminophen: Works centrally in the brain to inhibit prostaglandin synthesis, providing analgesic and antipyretic effects. It has a lesser anti-inflammatory effect compared to NSAIDs like aceclofenac.
2. Therapeutic Effects:
   • Aceclofenac: Reduces inflammation, pain, and swelling associated with conditions like arthritis, muscular pain, and injury.
   • Acetaminophen: Provides relief from mild to moderate pain and reduces fever without causing significant gastrointestinal irritation.

Pharmacokinetics

1. Absorption:
   • Aceclofenac: Well absorbed from the gastrointestinal tract with peak plasma concentrations reached within 1-3 hours after oral administration.
   • Acetaminophen: Rapidly absorbed from the gastrointestinal tract, with peak plasma levels achieved within 30-60 minutes of ingestion.
2. Distribution:
   • Aceclofenac: Widely distributed throughout the body with a high affinity for plasma proteins (99%).
   • Acetaminophen: Distributes throughout most body tissues and crosses the placenta. Approximately 20-25% of acetaminophen binds to plasma proteins.
3. Metabolism:
   • Aceclofenac: Metabolized primarily in the liver to inactive metabolites.
   • Acetaminophen: Metabolized in the liver, primarily via conjugation with glucuronide and sulfate to form non-toxic metabolites.
4. Excretion:
   • Aceclofenac: Excreted mainly via urine as metabolites, with a small amount excreted in feces.
   • Acetaminophen: Excreted mainly in the urine as glucuronide and sulfate conjugates.
5. Half-Life:
   • Aceclofenac: 4-10 hours (depending on individual factors like liver function).
   • Acetaminophen: 2-3 hours in healthy individuals.

Drug Interactions

1. With Food:
   • Food may delay the absorption of both drugs but does not significantly alter their overall bioavailability.
2. With Other Medications:
   • Anticoagulants (e.g., Warfarin): The combination of Aceclofenac and acetaminophen can increase the anticoagulant effect, increasing bleeding risk.
   • Methotrexate: Concurrent use may lead to an increased risk of methotrexate toxicity.
   • ACE inhibitors or Diuretics: NSAIDs may reduce the antihypertensive effect of ACE inhibitors or diuretics.
3. Other Interactions:
   • Alcohol: Increases the risk of liver toxicity, especially with acetaminophen.

Clinical Considerations

1. Pregnancy Category:
   • Aceclofenac: Category C (Risk cannot be ruled out). Aceclofenac should be avoided in the third trimester due to potential effects on fetal development.
   • Acetaminophen: Category C in pregnancy, though considered safer for use during pregnancy when necessary.
2. Lactation:
   • Aceclofenac: It is not recommended during breastfeeding due to limited data on its excretion in milk.
   • Acetaminophen: Considered safe for use during breastfeeding in therapeutic doses.
3. Pediatric Use:
   • Aceclofenac: Safety and efficacy not well established in children under 18 years.
   • Acetaminophen: Safe for use in children at appropriate doses, but overdose