ZurigTab 80 Mg 20s

1. Generic Information Overview:

Drug Name: ZurigTab
Active Ingredient: Febuxostat
Strength: 80 mg
Form: Tablet
Pack Size: 20 tablets

2. Pharmaceutical Class:

• Class: Xanthine Oxidase Inhibitor
• Type: Antihyperuricemic agent

3. Indications for Use:

ZurigTab (Febuxostat) is primarily used to manage gout and hyperuricemia (high levels of uric acid in the blood). It is typically prescribed for:

• Chronic gout in adults.
• To lower serum uric acid levels in patients with gout, particularly in cases where other treatments (like allopurinol) are not suitable or effective.

4. Common Side Effects:

Common side effects associated with ZurigTab include:

• Headache
• Nausea
• Liver enzyme elevation
• Diarrhea
• Rash
• Fatigue

5. Serious Side Effects (Less Common):

Less common but serious side effects may include:

• Cardiovascular events: Such as heart attack, stroke, or chest pain.
• Severe allergic reactions: Including anaphylaxis, rash, and swelling of the face, lips, or tongue.
• Liver damage: Including symptoms like yellowing of the skin or eyes (jaundice), dark urine, or upper stomach pain.
• Skin rashes that may indicate more severe skin conditions.

6. Dosage & Usage Instructions:

Initial dose:

• 40 mg once daily (if serum uric acid levels are not reduced to the target level after 2 weeks, the dose can be increased to 80 mg daily).

Maintenance dose:

• The typical dose is 80 mg daily after the initial adjustment period.

Administration:

• The tablets should be taken once daily, with or without food.
• It is important to drink plenty of fluids to help reduce the risk of uric acid crystal formation.

7. Drug Interactions:

• Medications affecting liver enzymes: Drugs like azathioprine or mercaptopurine, which are metabolized by the same liver enzymes (xanthine oxidase), may interact with febuxostat and increase the risk of toxicity.
• Theophylline: Febuxostat may increase levels of theophylline, leading to toxicity.
• Antacids: There are no known significant interactions between febuxostat and antacids, but it is still best to monitor any adverse reactions.
• Other urate-lowering therapies: When used in combination with other gout medications (e.g., colchicine, allopurinol), dosage adjustments may be needed.

Food interactions:
There are no major food interactions, but it is recommended to avoid alcohol, as it can exacerbate gout and increase uric acid levels.

8. Regulatory Approval and Manufacturer:

• Approval: Approved by the FDA for the treatment of gout and hyperuricemia in adults.
• Manufacturer: Zydus Cadila (Indian pharmaceutical company).

Pharmacist-Related Data:

1. Drug Name and Chemical Details:

• Drug Name: ZurigTab
• Chemical Name: Febuxostat
• Chemical Formula: C16H16N2O3S
• Molecular Weight: 316.38 g/mol

2. Pharmacodynamics:

Mechanism of Action:

Febuxostat works by inhibiting xanthine oxidase, an enzyme responsible for converting purines (found in certain foods) to uric acid. By blocking this enzyme, febuxostat decreases the production of uric acid, thereby lowering blood uric acid levels. This helps reduce the formation of urate crystals, which can cause gout.

Therapeutic Effects:

• Reduces uric acid levels in the blood.
• Prevents gout attacks by lowering uric acid, thus minimizing the risk of crystal formation in joints.
• It can be used in patients who are intolerant to allopurinol, another common xanthine oxidase inhibitor.

3. Pharmacokinetics:

Absorption:

• Febuxostat is rapidly absorbed after oral administration.
• The bioavailability is approximately 49% after a single dose, which can be affected by food intake (though absorption is generally unaffected by food).

Distribution:

• Volume of Distribution (Vd): Approximately 60 L.
• Febuxostat is widely distributed in the body, including in the joints, where gout attacks are most common.

Metabolism:

• Febuxostat is extensively metabolized in the liver primarily by the cytochrome P450 enzyme system (CYP1A2 and CYP2C9).
• Its metabolites are generally less active than the parent compound.

Excretion:

• Excreted mainly via urine (approximately 50%), with the rest eliminated in feces.
• Less than 5% of the administered dose is excreted as unchanged febuxostat in urine.

Half-Life:

• The half-life of febuxostat is approximately 5 to 8 hours.

4. Drug Interactions:

With Food:

• No significant food interactions, but it is recommended to avoid excessive alcohol, which can worsen gout.

With Other Medications:

• Allopurinol (and other xanthine oxidase inhibitors): Concurrent use can increase the risk of severe adverse effects.
• Azathioprine and mercaptopurine: These medications require dose adjustment due to the risk of increased toxicity.
• Warfarin: Febuxostat can increase the anticoagulant effect of warfarin, requiring careful monitoring.

Other Interactions:

• May interact with drugs that affect the liver enzyme system, including inhibitors or inducers of CYP450 enzymes.

5. Clinical Considerations:

Pregnancy Category:

• Category C: The safety of febuxostat during pregnancy has not been established. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Lactation:

• It is not known if febuxostat is excreted in breast milk. The manufacturer recommends caution, and it is typically avoided during breastfeeding unless the potential benefits outweigh the risks.

Pediatric Use:

• Not recommended for use in children under 18 years of age.

Geriatric Use:

• Elderly patients may be at increased risk of side effects, particularly liver dysfunction. Dose adjustments may be necessary based on liver function and the overall health of the patient.

Other Considerations:

• Hepatic impairment: Use with caution in patients with liver impairment, as the drug is metabolized by the liver.
• Renal impairment: Febuxostat does not require dose adjustment in patients with mild-to-moderate renal impairment. However, caution is advised in patients with severe renal dysfunction.