Usage
Aceclofenac + Rabeprazole is prescribed for the relief of pain and inflammation in musculoskeletal disorders such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, particularly in patients with a history of or at risk for NSAID-induced gastrointestinal (GI) toxicity. It is also used to manage other painful conditions, including toothache, lower back pain, ear and throat pain and post-operative pain.
It is a combination drug belonging to the pharmacological classifications of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Proton Pump Inhibitors (PPIs).
The mechanism of action involves Aceclofenac inhibiting cyclooxygenase (COX) enzymes, reducing prostaglandin production, which in turn decreases pain and inflammation. Rabeprazole inhibits the H+/K+ ATPase enzyme system in gastric parietal cells, suppressing gastric acid secretion and mitigating the GI risks associated with NSAIDs.
Alternate Names
No widely recognized alternate names exist for the combination product itself. However, it is marketed under various brand names like:
- Acemiz Rab
- Altraday
- Critcid-A
- Dolostat+R
- MicoRab-R
- Noblinac R
- Rabistrum ACF
- Rodeo-A
- StayHappi Aceclofenac+Rabeprazole
How It Works
Pharmacodynamics: Aceclofenac, an NSAID, exerts its analgesic and anti-inflammatory effects by inhibiting COX-1 and COX-2 enzymes. This leads to a decrease in prostaglandin synthesis, mediators of pain and inflammation. Rabeprazole, a PPI, irreversibly binds to the H+/K+-ATPase pump in gastric parietal cells, reducing gastric acid secretion. This protects the gastric mucosa from NSAID-induced damage.
Pharmacokinetics: Aceclofenac is well-absorbed orally, reaching peak plasma concentration in 1-3 hours. It is metabolized in the liver and excreted primarily through the kidneys. Rabeprazole is also absorbed orally but is acid-labile. The enteric coating protects it from gastric acid degradation. It is metabolized by CYP450 enzymes, primarily CYP2C19 and CYP3A4, in the liver. Excretion occurs mainly through renal and biliary routes.
Mode of Action: Aceclofenac exerts its effects through non-selective COX inhibition. Rabeprazole blocks the final step of gastric acid production by inhibiting the proton pump, thereby reducing acid secretion.
Dosage
Standard Dosage
Adults: The usual dose is one capsule or tablet containing 200mg Aceclofenac and 20mg Rabeprazole, administered once daily, preferably with food.
Children: Use is not recommended for children under 18 years old as safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Caution should be exercised due to increased risk of adverse reactions, especially GI bleeding. Dose reduction may be necessary.
- Patients with Renal Impairment: Dose reduction may be required for patients with moderate to severe renal impairment.
- Patients with Hepatic Dysfunction: Dose reduction is recommended. Severe hepatic impairment is a contraindication.
- Patients with Comorbid Conditions: Careful consideration is needed for patients with cardiovascular disease, asthma, or a history of peptic ulcers.
Clinical Use Cases
The use of Aceclofenac + Rabeprazole in specific medical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be determined on a case-by-case basis with careful risk-benefit assessment. Dosages in these settings are not standardized and should be guided by clinical judgment and patient response.
Dosage Adjustments
Dosage adjustments are based on patient-specific factors like renal/hepatic dysfunction and comorbidities. Close monitoring for efficacy and adverse effects is crucial, especially in high-risk patients.
Side Effects
Common Side Effects:
- Nausea
- Flatulence
- Indigestion
- Diarrhea
- Constipation
- Dizziness
- Headache
- Skin rash
Rare but Serious Side Effects:
- Gastrointestinal bleeding
- Peptic ulcer perforation
- Acute renal failure
- Stevens-Johnson syndrome
- Liver toxicity
Long-Term Effects:
- Increased risk of osteoporosis with prolonged PPI use
- Potential for increased risk of cardiovascular events with long-term NSAID use
Contraindications
- Hypersensitivity to Aceclofenac, Rabeprazole, or any components of the formulation
- Active or history of recurrent peptic ulcer/hemorrhage
- Severe hepatic impairment
- Severe heart failure
- Third trimester of pregnancy
- Aspirin-induced asthma or related conditions
- Concurrent use with Rilpivirine (anti-HIV medication)
Drug Interactions
- Anticoagulants (warfarin, heparin)
- Antiplatelet agents (clopidogrel)
- Corticosteroids
- Methotrexate
- Lithium
- SSRIs (fluoxetine, sertraline)
- Alcohol
Pregnancy and Breastfeeding
Aceclofenac + Rabeprazole is categorized as Pregnancy Category C. It is contraindicated in the third trimester and should be used with caution during earlier stages. It is not recommended during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Aceclofenac: COX inhibitor; Rabeprazole: Proton pump inhibitor
- Side Effects: Nausea, dyspepsia, GI bleeding, headache, dizziness.
- Contraindications: Hypersensitivity, active peptic ulcer, severe hepatic impairment, pregnancy (third trimester).
- Drug Interactions: Anticoagulants, antiplatelets, corticosteroids, SSRIs.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: Adults: 200mg/20mg once daily.
- Monitoring Parameters: Liver function tests, renal function tests, signs of GI bleeding.
Popular Combinations
This combination itself is a popular therapy. Co-administration with other analgesics or anti-inflammatory medications should be done cautiously due to increased risk of adverse effects.
Precautions
General precautions involve screening for allergies, pre-existing medical conditions, and drug interactions. Special precautions apply to pregnant/breastfeeding women, children, elderly individuals, and those with renal or hepatic impairment. Lifestyle considerations include avoiding alcohol and driving restrictions if dizziness occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Rabeprazole?
A: The standard adult dose is 200mg Aceclofenac + 20mg Rabeprazole once daily. Dosage adjustments may be needed for special populations.
Q2: What are the main uses of this combination drug?
A: Primarily for managing pain and inflammation in conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, especially when GI protection is needed.
Q3: Can this drug be used during pregnancy or breastfeeding?
A: It is contraindicated in the third trimester of pregnancy and generally not recommended during breastfeeding.
Q4: What are the common side effects?
A: Common side effects include nausea, indigestion, diarrhea, constipation, headache, and dizziness.
Q5: What are the serious side effects to watch out for?
A: Serious side effects include gastrointestinal bleeding, peptic ulcers, and severe allergic reactions.
Q6: What are the major drug interactions?
A: Significant interactions can occur with anticoagulants, antiplatelets, corticosteroids, and some antidepressants.
Q7: What precautions should be taken before prescribing this medication?
A: Assess for allergies, history of peptic ulcers, hepatic/renal function, and concomitant medications.
Q8: Are there any long-term risks associated with Aceclofenac + Rabeprazole?
A: Long-term use may increase the risk of osteoporosis and potentially cardiovascular events.
Q9: How does Rabeprazole protect against Aceclofenac’s side effects?
A: Rabeprazole reduces stomach acid, minimizing the risk of GI ulcers and bleeding often associated with NSAIDs like Aceclofenac.
Q10: Can this combination be used for acute pain management?
A: While primarily indicated for chronic inflammatory conditions, it can also be used for short-term pain management following surgeries or trauma. It is important to weigh the risks and benefits, particularly if the pain is expected to resolve rapidly.
