Usage
- Diclofenac + Pantoprazole is prescribed for the relief of pain and inflammation associated with musculoskeletal and joint disorders such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, gout, and other painful conditions like migraines. It is also used to prevent gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk requiring continuous NSAID treatment.
- Pharmacological Classification: Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), and Pantoprazole is a proton pump inhibitor (PPI).
- Mechanism of Action: Diclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, thereby alleviating pain and inflammation. Pantoprazole suppresses gastric acid secretion by inhibiting the H+/K+ ATPase in gastric parietal cells, thus protecting the gastric mucosa from NSAID-induced damage.
Alternate Names
- No widely recognized alternate names exist for the combination product itself. However, the individual components may have regional variations.
- Brand Names: A number of brand names market this fixed-dose combination, though they can vary by region.
How It Works
- Pharmacodynamics: Diclofenac exerts analgesic and anti-inflammatory effects by inhibiting COX-1 and COX-2 enzymes, decreasing prostaglandin production. Pantoprazole profoundly inhibits gastric acid secretion by irreversibly binding to the H+/K+ ATPase pump on the surface of parietal cells, irrespective of the stimulus.
- Pharmacokinetics: Diclofenac is well-absorbed orally, metabolized primarily by the liver (CYP2C9), and excreted mainly through the kidneys. Pantoprazole is also absorbed orally, metabolized primarily by the liver (CYP2C19), and excreted through the kidneys. The co-administration of diclofenac and pantoprazole has not been shown to cause clinically significant pharmacokinetic interactions.
- Mode of Action: Diclofenac acts by inhibiting COX enzymes. Pantoprazole acts by inhibiting the H+/K+ ATPase pump.
- Receptor binding, enzyme inhibition, or neurotransmitter modulation: Diclofenac inhibits COX enzymes. Pantoprazole inhibits the H+/K+ ATPase pump.
- Elimination pathways: Diclofenac is eliminated primarily through renal excretion of metabolites. Pantoprazole is eliminated through a combination of hepatic metabolism and renal excretion.
Dosage
Standard Dosage
Adults:
- The standard dose is one tablet of Diclofenac (commonly 75 mg) + Pantoprazole (commonly 40 mg) per day, taken orally. The dosage and duration should be as directed by the doctor.
Children:
- This combination is generally not recommended for children under 12 years old due to limited safety and efficacy data. Dosage adjustments should be made based on the weight or age and under strict medical supervision.
Special Cases:
- Elderly Patients: No specific dose adjustment is typically required for elderly patients, but caution is advised due to potential age-related decline in organ function.
- Patients with Renal Impairment: Dose adjustments are usually not necessary for patients with mild to moderate renal impairment. Close monitoring is recommended. In severe renal impairment, caution is advised.
- Patients with Hepatic Dysfunction: In patients with severe hepatic impairment, the dose of pantoprazole should not exceed 20mg per day. Combination therapy is contraindicated in patients with moderate to severe hepatic dysfunction when used for H. pylori eradication.
- Patients with Comorbid Conditions: Careful consideration and dose adjustments may be necessary in patients with certain comorbid conditions like diabetes, cardiovascular diseases, or those with preexisting hypomagnesemia or hypocalcemia.
Clinical Use Cases
- Dosage recommendations for specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations are determined by the primary condition being managed and the specific clinical requirements, rather than the Diclofenac + Pantoprazole combination itself.
Dosage Adjustments
- Dosage modifications are made based on individual patient characteristics, including renal or hepatic dysfunction, metabolic disorders, and other factors affecting drug metabolism.
Side Effects
Common Side Effects
- Headache, nausea, vomiting, diarrhea, constipation, abdominal pain, gas, dizziness, skin rash.
Rare but Serious Side Effects
- Nephrotoxicity, liver damage, pancreatitis, severe allergic reactions (including anaphylaxis), gastrointestinal bleeding, Stevens-Johnson Syndrome.
Long-Term Effects
- Long-term use of diclofenac can increase the risk of cardiovascular events (e.g., heart attack, stroke) and gastrointestinal complications (e.g., ulcers, bleeding). Long-term PPI use has been associated with an increased risk of infections (e.g., Clostridium difficile), vitamin B12 deficiency, hypomagnesemia, and potentially osteoporosis.
Adverse Drug Reactions (ADR)
- Any signs of severe allergic reactions, gastrointestinal bleeding, significant changes in liver or kidney function tests, or severe skin reactions.
Contraindications
- Hypersensitivity to diclofenac, pantoprazole, or any components of the formulation.
- Active peptic ulcer disease or gastrointestinal bleeding.
- Severe heart failure, hepatic disease, or renal disease.
- Last trimester of pregnancy.
- Known hypersensitivity to any of the medications used for H. Pylori combination therapy.
Drug Interactions
- Diclofenac can interact with anticoagulants (e.g., warfarin), increasing bleeding risk.
- Pantoprazole can interact with drugs whose absorption depends on gastric pH (e.g., ketoconazole, iron salts) and some antiretroviral medications (e.g., rilpivirine, atazanavir).
- Both drugs can interact with numerous other medications; consult a comprehensive drug interaction database for detailed information.
- Alcohol should be avoided as it can exacerbate the gastrointestinal side effects of diclofenac.
Pregnancy and Breastfeeding
- Pregnancy: Diclofenac should be avoided during the third trimester due to the risk of premature closure of the ductus arteriosus. Use during the first and second trimesters should only be considered if clearly needed. Pantoprazole has limited data in pregnant women.
- Breastfeeding: Small amounts of both drugs are excreted in breast milk. Consult with a healthcare professional to weigh the potential benefits and risks before use.
Drug Profile Summary
- Mechanism of Action: Diclofenac inhibits COX enzymes reducing prostaglandin synthesis. Pantoprazole inhibits H+/K+ ATPase suppressing gastric acid secretion.
- Side Effects: Common: Headache, nausea, GI upset. Serious: GI bleeding, nephrotoxicity, hepatic dysfunction.
- Contraindications: Hypersensitivity, active peptic ulcer, severe heart/liver/kidney disease, last trimester of pregnancy.
- Drug Interactions: Anticoagulants, drugs requiring acidic pH for absorption, some antiretrovirals.
- Pregnancy & Breastfeeding: Use with caution; weigh benefits and risks.
- Dosage: Adults: One tablet (Diclofenac 75 mg + Pantoprazole 40 mg) daily. Adjust for special populations.
- Monitoring Parameters: Kidney and liver function tests, signs of GI bleeding, blood pressure, electrolytes.
Popular Combinations
- This combination itself is a popular pairing intended to reduce gastrointestinal side effects associated with diclofenac.
Precautions
- General Precautions: Assess for pre-existing medical conditions, drug allergies, and concomitant medications.
- Specific Populations: Monitor pregnant/breastfeeding women and patients with renal/hepatic impairment, children, and the elderly closely.
- Lifestyle Considerations: Advise patients to avoid alcohol.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Diclofenac + Pantoprazole?
A: The typical adult dose is one tablet (Diclofenac 75 mg + Pantoprazole 40 mg) daily. Dosages may vary; consult prescribing information.
Q2: Can this combination be used in children?
A: It’s generally not recommended for children under 12 due to limited safety and efficacy data.
Q3: Is it safe to take this during pregnancy?
A: Diclofenac should be avoided during the third trimester. Use with caution during the first and second trimesters only if clearly needed. Pantoprazole’s safety during pregnancy hasn’t been fully established.
Q4: What are the most common side effects?
A: Common side effects include headache, nausea, vomiting, diarrhea, and abdominal pain.
Q5: Are there any serious side effects to be aware of?
A: Yes, serious side effects like gastrointestinal bleeding, kidney problems, and liver damage can occur. Seek immediate medical attention if these arise.
Q6: Can I drink alcohol while taking this medication?
A: Alcohol should be avoided as it can increase the risk of gastrointestinal side effects.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double the dose to catch up.
Q8: How should this medication be stored?
A: Store at room temperature away from moisture and heat.
Q9: Can patients with kidney problems take this medication?
A: Dose adjustment may be necessary in patients with severe renal impairment. Close monitoring is recommended.
Q10: Is this a suitable treatment for managing acute pain?
A: Yes, this combination can be used to manage acute pain conditions like migraines, but it’s also prescribed for chronic inflammatory conditions as well. The suitability depends on the individual patient’s specific needs and overall clinical picture.
