Brand Name: Alce
Generic Name: Celecoxib
Active Ingredient(s): Celecoxib 200 mg

For the General Public:

Uses:
Alce (Celecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation associated with conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain.

Dosage:

• Adults: Typically, 200 mg once daily or 100 mg twice daily. Your doctor may adjust the dose based on your condition.
• Children: Not recommended for children under 2 years or weighing less than 10 kg.

Possible Side Effects:

• Common Side Effects: Stomach upset, diarrhea, dizziness, or headache.
• Serious (Less Common) Side Effects: Allergic reactions, severe stomach pain, gastrointestinal bleeding, swelling of the limbs, or chest pain.

Important Information:

• Dosage Instruction: Take exactly as prescribed. Do not exceed the recommended dose.
• Usage Instruction: Take with food or milk to reduce the risk of stomach upset.
• General Information:
  • Do not take this medication if you are allergic to celecoxib, sulfa drugs, or other NSAIDs.
  • Inform your doctor if you have a history of heart disease, stroke, or gastrointestinal ulcers.
  • If you miss a dose, take it as soon as you remember unless it’s close to your next dose. Do not double the dose.

Drug Interactions:

• Interactions with Other Medications: May interact with aspirin, anticoagulants, ACE inhibitors, or diuretics.
• Interactions with Food: Avoid excessive alcohol consumption, as it may increase the risk of gastrointestinal bleeding.

Regulatory Approval & Manufacturer:
Approved by [regulatory body] and manufactured by [manufacturer name].

Antidotes (If Overdose or Misuse by Patients):
Symptoms of overdose may include severe stomach pain, vomiting, drowsiness, or breathing difficulties. Seek immediate medical attention. Treatment involves supportive care and activated charcoal if appropriate.

For Pharmacists:

Medicine Name: Alce
Brand: Alce
Active Ingredient(s): Celecoxib 200 mg

Indications:
Indicated for the management of:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain
• Primary dysmenorrhea

Pharmacodynamics:

• Mechanism of Action:
  Celecoxib selectively inhibits cyclooxygenase-2 (COX-2), an enzyme responsible for the synthesis of prostaglandins involved in pain and inflammation, while sparing COX-1, which protects the gastric mucosa.
• Pharmacological Effects:
  Reduces pain, swelling, and inflammation with a lower risk of gastrointestinal side effects compared to traditional NSAIDs.
• Receptor Binding:
  Specifically binds to COX-2 enzymes, reducing prostaglandin synthesis at sites of inflammation.

Pharmacokinetics:

• Absorption: Rapidly absorbed with peak plasma concentrations achieved within 3 hours after oral administration.
• Distribution: Highly protein-bound (~97%).
• Metabolism: Metabolized in the liver primarily by CYP2C9 to inactive metabolites.
• Elimination: Excreted in feces (57%) and urine (27%).
• Half-Life: Approximately 11 hours.
• Bioavailability: Well absorbed; unaffected by food.
• Effect of Food: May delay peak plasma levels but does not affect overall absorption.

Dosage and Administration:

• Adults:
  • Osteoarthritis: 200 mg once daily or 100 mg twice daily.
  • Rheumatoid arthritis: 100–200 mg twice daily.
  • Acute pain or dysmenorrhea: Initial dose of 400 mg followed by 200 mg if needed on the first day, then 200 mg twice daily as needed.
• Pediatric: Dosage based on weight (for specific conditions).
• Special Populations:
  • Renal impairment: Use with caution; not recommended in severe renal impairment.
  • Hepatic impairment: Adjust dosage; contraindicated in severe hepatic impairment.

Contraindications:

• Known hypersensitivity to celecoxib, sulfonamides, or NSAIDs.
• History of asthma, urticaria, or allergic reactions to aspirin or other NSAIDs.
• Active gastrointestinal bleeding or peptic ulcer disease.

Warnings and Precautions:

• Use with caution in patients with cardiovascular disease or risk factors, as it may increase the risk of thrombotic events.
• Monitor for gastrointestinal bleeding, especially in older adults or those with a history of ulcers.
• Avoid in patients with severe renal or hepatic impairment.

Drug-Drug Interactions:

• May enhance the effects of anticoagulants, increasing the risk of bleeding.
• Reduced effectiveness when combined with ACE inhibitors or diuretics.
• Increased risk of toxicity when used with lithium or methotrexate.

Drug-Food Interactions:

• Alcohol: Increases the risk of gastrointestinal bleeding; limit consumption.

Adverse Reactions:

• Common: Headache, dyspepsia, diarrhea, and abdominal pain.
• Serious: Gastrointestinal bleeding, cardiovascular events (e.g., heart attack, stroke), or severe skin reactions.

Therapeutic Effects:

• Effectively reduces pain and inflammation with a lower risk of gastrointestinal side effects.

Storage:
Store at room temperature (15°C to 30°C) in a dry place, away from light and moisture.

Packaging:
Available in tablet form, typically in packs of 10 tablets.

Clinical Considerations:

• Pregnancy Category: C (Avoid in the third trimester due to risk of premature closure of the ductus arteriosus).
• Lactation Category: Excreted in breast milk; use with caution.
• Pediatric Category: Use under close supervision for approved indications.
• Geriatric Category: Use with caution due to increased sensitivity to adverse effects.

Conclusion:

Alce Tab 10’s (Celecoxib 200 mg) is an effective treatment for pain and inflammation associated with arthritis and other conditions. Its COX-2 selectivity provides pain relief with a reduced risk of gastrointestinal complications compared to traditional NSAIDs. Proper adherence to dosage and monitoring for side effects is essential. Pharmacists should ensure patients are educated about potential drug interactions and the importance of follow-up care with healthcare providers.