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Arthrotec (diclofenac sodium/misoprostol) 

Indications 

• Arthrotec is used to relieve pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. 
• It helps reduce the risk of stomach ulcers in patients who are at high risk of developing them due to chronic NSAID use. 

Dosage and Administration 

• Take Arthrotec exactly as prescribed by your doctor, usually 2-4 times daily. 
• Swallow the tablets whole with a full glass of water, preferably with food or milk to reduce stomach upset. 
• Take your doses at the same time each day to maintain consistent levels of the medication in your body. 
• Inform your doctor about all other medications you are taking to avoid potential interactions. 
• Follow your doctor’s instructions regarding the duration of treatment and regular check-ups. 
• Do not take more than the prescribed dose. 
• Avoid crushing or chewing the tablets, as they are enteric coated to protect your stomach. 
• Do not consume alcohol while taking Arthrotec, as it can increase the risk of stomach bleeding. 

Mechanism of Action 

Arthrotec combines two active ingredients: Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID), and Misoprostol, a prostaglandin analog. Diclofenac works by reducing the production of prostaglandins, which are substances in the body that cause inflammation and pain. Misoprostol helps protect the stomach lining by decreasing acid secretion and increasing mucus production. 

Contraindications 

• Do not use Arthrotec if you are allergic to Diclofenac, Misoprostol, or any of its ingredients. 
• Avoid using it if you have active peptic ulcers or gastrointestinal bleeding. 
• Do not take Arthrotec if you have a history of inflammatory bowel disease or other gastrointestinal disorders. 
• Avoid using the medication if you have severe kidney or liver impairment without consulting your doctor. 

Side Effects 

Common Side Effects: 

• Stomach upset or pain 
• Nausea 
• Diarrhea 
• Dizziness 
• Headache 

Serious Side Effects: 

• Severe allergic reactions, including rash, itching, swelling, severe dizziness, and trouble breathing 
• Black or tarry stools, indicating gastrointestinal bleeding 
• Signs of liver problems, such as yellowing of the skin or eyes, dark urine 
• Signs of kidney problems, such as changes in urine output or swelling of the feet or ankles 
• Signs of heart problems, such as chest pain or shortness of breath 

Precautions 

• Inform your doctor about all other medications you are using, including over-the-counter products and supplements. 
• Notify your doctor if you have a history of gastrointestinal issues, liver disease, kidney disease, heart problems, or high blood pressure. 
• Use caution if you are elderly, as you may be more prone to side effects. 
• If you are of childbearing potential, use effective birth control while taking Arthrotec and for at least one month after stopping treatment. 
• Monitor your condition regularly and report any worsening symptoms to your doctor. 
• If you experience severe side effects or signs of an allergic reaction, seek medical attention immediately. 

Storage Instructions 

• Store Arthrotec at room temperature, between 20°C to 25°C (68°F to 77°F). 
• Keep the tablets in their original container, tightly closed. 
• Store Arthrotec out of reach of children and pets. 

References 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020607s031lbl.pdf