Aceclofenac + Zinc Carnosine

Usage

• Aceclofenac + Zinc Carnosine is prescribed for the relief of pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Zinc Carnosine is specifically indicated for gastric ulcers, offering a gastroprotective effect. It can also be used for nutritional deficiencies, particularly zinc deficiency.
• Pharmacological Classification: Aceclofenac is a Non-Steroidal Anti-Inflammatory Drug (NSAID), and Zinc Carnosine is a mucosal protective agent.
• Mechanism of Action: Aceclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, thereby decreasing pain and inflammation. Zinc carnosine stabilizes and protects the gastric mucosa, mitigating potential gastrointestinal side effects associated with NSAID use.

Alternate Names

• Aceclofenac Zinc Carnosine
• Polaprezinc (for Zinc Carnosine)
• Brand Name: Zacy Safe (and possibly others)

How It Works

• Pharmacodynamics: Aceclofenac inhibits COX-1 and COX-2 enzymes, reducing prostaglandin synthesis and mitigating inflammation and pain. Zinc carnosine has a local gastroprotective effect on the gastric mucosa, helping prevent NSAID-induced ulcers. It promotes healing and may have anti-inflammatory and antioxidant properties.
• Pharmacokinetics: Aceclofenac is well-absorbed orally, metabolized in the liver, and primarily excreted in the urine. Zinc carnosine has low systemic absorption, acting locally in the gastrointestinal tract.
• Mode of Action: Aceclofenac’s action on COX enzymes reduces prostaglandin production, which are key mediators of inflammation and pain. Zinc carnosine binds to the gastric mucosa forming a protective barrier and possibly promoting ulcer healing.
• Elimination: Aceclofenac is primarily excreted through the kidneys. The elimination pathway of Zinc Carnosine isn’t extensively characterized but may involve excretion through feces.

Dosage

Standard Dosage

Adults:

Aceclofenac: 100 mg twice daily. Zinc Carnosine: 75 mg twice daily or 150mg once daily. This delivers approximately 34 mg of elemental zinc.

Children:

Aceclofenac + Zinc Carnosine is generally not recommended for children due to a lack of safety and efficacy data. For Zinc Carnosine alone, safety and efficacy haven’t been established for children under 12. Its use requires direct medical supervision.

Special Cases:

• Elderly Patients: Aceclofenac: Initiate therapy with the lowest effective dose. Monitor for adverse events, especially gastrointestinal bleeding and renal impairment. Zinc Carnosine: A reduced dose of 100 mg/day (approximately 23 mg elemental zinc) is recommended.

• Patients with Renal Impairment: Aceclofenac: Exercise caution. Dose reduction may be required. Zinc Carnosine: Limited data available, exercise caution.

• Patients with Hepatic Dysfunction: Aceclofenac: Initiate at the lowest recommended dose. Monitor liver function tests. Dose adjustment may be required. Zinc Carnosine: Patients should be under medical supervision.

• Patients with Comorbid Conditions: Consider risk factors for cardiovascular disease, gastrointestinal complications, and drug interactions.

Clinical Use Cases

The combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. These settings generally necessitate specialized analgesics and anesthetic agents.

Dosage Adjustments

Adjustments should be patient-specific, considering factors like age, renal/hepatic function, and comorbidities. Close monitoring of renal and liver function, along with gastrointestinal symptoms, is recommended.

Side Effects

Common Side Effects

• Diarrhea
• Nausea
• Indigestion
• Headache
• Abdominal pain
• Dizziness
• Vomiting
• Flatulence
• Constipation
• Skin rash
• Heartburn
• Loss of appetite
• Visual disturbance

Rare but Serious Side Effects

• Gastrointestinal bleeding
• Anaphylactic reaction
• Steven-Johnson syndrome
• Meningitis
• Skin peeling
• Wheezing
• Swelling
• Severe itching or burning

Long-Term Effects

Long-term use of NSAIDs like Aceclofenac can potentially increase the risk of cardiovascular events and gastrointestinal issues such as ulcers and bleeding.

Adverse Drug Reactions (ADR)

Severe gastrointestinal symptoms (severe abdominal pain, bloody or black stools, persistent vomiting), signs of liver injury (jaundice, dark urine, right upper quadrant pain), or changes in renal function necessitate immediate intervention.

Contraindications

• Hypersensitivity to Aceclofenac, Zinc Carnosine, or other NSAIDs.
• Active peptic ulcer disease.
• Severe hepatic impairment.
• Severe renal impairment.
• History of gastrointestinal bleeding.
• Aspirin triad (asthma, nasal polyps, and aspirin sensitivity).
• Pregnancy (third trimester).
• Breastfeeding.

Drug Interactions

• Anticoagulants (e.g., warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of gastrointestinal ulceration.
• Diuretics: Reduced diuretic effect.
• Lithium: Increased lithium levels.
• Methotrexate: Increased methotrexate toxicity.
• Other NSAIDs: Increased risk of adverse effects.
• Alcohol: Use with caution; interactions are unknown.
• Some antibiotics (quinolones, tetracyclines): Reduced antibiotic absorption.
• Blood pressure medications (ACE inhibitors): May decrease zinc levels.
• Cisplatin: May increase zinc excretion.
• Deferoxamine: Increases zinc loss in urine.
• Immunosuppressants: Counteracts immune-boosting effects of zinc.

Pregnancy and Breastfeeding

Aceclofenac + Zinc Carnosine is contraindicated during the third trimester of pregnancy and not recommended during breastfeeding due to potential fetal and neonatal risks. Consult a physician if considering use during pregnancy or lactation.

Drug Profile Summary

• Mechanism of Action: NSAID (Aceclofenac) + Gastroprotective (Zinc Carnosine)
• Side Effects: Diarrhea, nausea, gastrointestinal bleeding (rare), headache, abdominal pain, others.
• Contraindications: Hypersensitivity, peptic ulcer, severe hepatic/renal impairment, pregnancy (third trimester), breastfeeding.
• Drug Interactions: Anticoagulants, corticosteroids, other NSAIDs, certain antibiotics, ACE inhibitors.
• Pregnancy & Breastfeeding: Contraindicated in the third trimester; not recommended during breastfeeding.
• Dosage: Aceclofenac 100mg twice daily; Zinc Carnosine 75mg twice daily (adults). Elderly patients may require lower doses.
• Monitoring Parameters: Renal and liver function, gastrointestinal symptoms.

Popular Combinations

This drug combination is not typically combined with other drugs. Zinc carnosine may be included in formulations with other gastroprotectants or antacids.

Precautions

• General Precautions: Pre-screening for allergies, metabolic disorders, organ dysfunction, history of GI bleeding, renal/hepatic function assessment.
• Pregnant Women: Avoid, especially during the third trimester.
• Breastfeeding Mothers: Not recommended.
• Children & Elderly: Use with caution, dose adjustment may be needed for the elderly. Aceclofenac is generally avoided in children. Zinc carnosine isn’t recommended for children under 12 without medical supervision.
• Lifestyle Considerations: Alcohol use requires caution. Limit processed food and saturated fat intake.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Aceclofenac + Zinc Carnosine?

A: The standard adult dose is Aceclofenac 100 mg twice daily and Zinc Carnosine 75 mg twice daily. Dosage adjustments are needed for elderly patients and those with hepatic/renal impairment.

Q2: What are the primary uses of this medication?

A: This combination is mainly used to treat pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, with the added benefit of protecting the gastric mucosa from NSAID-induced damage. Zinc Carnosine is also indicated in gastric ulcer treatment.

Q3: How does this combination medication work?

A: Aceclofenac reduces pain and inflammation by inhibiting COX enzymes and prostaglandin synthesis. Zinc Carnosine protects the stomach lining by forming a protective barrier and promoting mucosal healing.

Q4: Are there any major drug interactions I should be aware of?

A: Yes, it can interact with anticoagulants, corticosteroids, other NSAIDs, some antibiotics (quinolones, tetracyclines), blood pressure medications (ACE inhibitors), and others. Consult a comprehensive drug interaction resource before co-prescribing.

Q5: Can this medication be used during pregnancy or breastfeeding?

A: It is contraindicated during the third trimester of pregnancy and generally not recommended during breastfeeding.

Q6: What are the common side effects patients might experience?

A: Common side effects include diarrhea, nausea, indigestion, headache, abdominal pain, and dizziness. Rare but serious side effects can include gastrointestinal bleeding and allergic reactions.

Q7: What precautions should I take when prescribing this medication?

A: Assess for allergies, renal and hepatic function, history of gastrointestinal bleeding, and comorbid conditions. Monitor patients for any adverse events.

Q8: Is there a specific reason to combine Aceclofenac and Zinc Carnosine?

A: The combination is primarily designed to provide pain and inflammation relief while mitigating the gastrointestinal risks associated with NSAID use.

Q9: Are there any dietary restrictions while taking this medication?

A: While not specific to this combination, a healthy diet low in processed foods and saturated fats is generally recommended to minimize inflammation and support overall health.

Q10: Is there an age limit for this medication?

A: It is not recommended for children. Elderly patients should be started on lower doses and closely monitored.