Setolac Er 300 Mg Tablet (10 Tab)

SETOLAC ER 300 MG TABLET (10 TAB) by ZUVENTUS HEALTHCARE LTD.

Setolac ER 300 mg Tablet is an extended-release non-steroidal anti-inflammatory drug (NSAID) prescribed for the management of pain and inflammation.

• Name:

  • Common Name: Setolac 300 ER Tablet
  • Brand Name: SETOLAC ER

• Composition:

  • Active Ingredient: Etodolac 300 mg (specifically S-Etodolac 300 mg).
  • Setolac ER 300 mg Tablet works by inhibiting the production of prostaglandins, chemical messengers in the body responsible for pain, inflammation, swelling, and fever.

• Uses: Setolac ER 300 mg Tablet is used for the short-term relief of pain, inflammation, and swelling associated with various conditions, including:

  • Rheumatoid arthritis
  • Osteoarthritis
  • Ankylosing spondylitis
  • Acute pain (e.g., injuries, surgeries, dental pain, muscular pain)
  • Menstrual pain (dysmenorrhea)
  • Gout

• Dosage and Administration:

  • The usual adult dose is one 300 mg tablet once daily.
  • It should be taken orally, swallowed whole with a glass of water, preferably with or after food or milk to minimize stomach upset.
  • Do not chew or crush the tablet.
  • The dosage and duration of treatment should be strictly as advised by a healthcare professional, based on the individual's condition and response to therapy.
  • Not recommended for children under 18 years of age.

• Side Effects:

  • Common Side Effects: Vomiting, stomach pain (abdominal pain, epigastric pain), nausea, indigestion (dyspepsia, heartburn), dizziness, drowsiness, visual disturbances (blurred vision), headache, diarrhea, constipation, flatulence, bloating, and loss of appetite.
  • Serious Side Effects (Rare but possible): Allergic reactions (rashes, itching, difficulty breathing, swelling of the face or throat), gastrointestinal bleeding or ulceration (symptoms include black/tarry stools, vomiting blood, severe stomach pain), increased risk of heart attack or stroke (especially with high doses and prolonged use), liver problems (nausea, fatigue, lethargy, jaundice), and kidney problems (painful urination, protein or blood in urine, renal failure). If any serious side effects occur, seek immediate medical attention.

• Precautions:

  • Do not take if you are allergic to etodolac, aspirin, or other NSAIDs.
  • Contraindicated in patients with severe heart failure, recent heart bypass surgery, active or a history of recurrent peptic ulcers, or gastrointestinal bleeding/perforation.
  • Use with caution in individuals with a history of asthma, liver or kidney disease, high blood pressure, fluid retention, heart problems, bleeding disorders, or diabetes.
  • Not recommended during the last trimester of pregnancy as it may harm the unborn child or cause delivery problems. Consult a doctor if pregnant, breastfeeding, or planning a pregnancy, as NSAIDs may affect female fertility.
  • Avoid alcohol consumption as it can increase drowsiness and the risk of stomach problems or bleeding.
  • May cause dizziness, drowsiness, or blurred vision; exercise caution when driving or operating machinery.
  • Do not exceed the prescribed dose or duration of treatment.
  • Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements, as interactions can occur. Specific interactions include other NSAIDs, antihypertensives, diuretics, cardiac glycosides (like Digoxin), Lithium, Methotrexate, and Zidovudine. It may also affect bilirubin tests.
  • This medication can increase skin sensitivity to sunlight; use sunscreen when outdoors.
  • For prolonged treatment, regular monitoring of kidney function, liver function, and blood components may be necessary.

• Storage:

  • Store in a cool, dry place at room temperature (below 25°C or 10-30°C).
  • Protect from light and moisture.
  • Keep out of the sight and reach of children and pets.
  • Do not use after the expiry date.

SETOLAC ER 300 MG TABLET contains Etodolac, a non-steroidal anti-inflammatory drug (NSAID), and is used to manage pain and inflammation.

What is Setolac ER 300 MG Tablet used for?

Setolac ER 300 MG Tablet is primarily used for the short-term relief of mild to moderate pain, inflammation, and swelling associated with conditions such as osteoarthritis and rheumatoid arthritis. It can also be used to alleviate acute pain, including dental pain, muscular pain, and postoperative pain, as well as pain related to gout.

How does Setolac ER 300 MG Tablet work?

This medicine works by blocking the action of certain chemical messengers in the body known as cyclo-oxygenase (COX) enzymes. These enzymes are responsible for producing prostaglandins, which are chemicals that cause pain, swelling, and inflammation at sites of injury or damage. By inhibiting prostaglandin synthesis, Setolac ER 300 MG Tablet reduces these symptoms.

What is the usual dosage for Setolac ER 300 MG Tablet?

The typical adult dosage for Setolac ER 300 MG Tablet is one tablet once daily, or as directed by your doctor. The tablet should be swallowed whole with a glass of water, either with or after food, to help prevent stomach upset. It should not be crushed, chewed, or broken. Doses exceeding 300 mg per day have not had their safety established.

What are the possible side effects of Setolac ER 300 MG Tablet?

Common side effects can include stomach pain, nausea, vomiting, indigestion, diarrhea, headache, loss of appetite, dizziness, drowsiness, and visual disturbances. More serious, but less common, side effects may include allergic reactions, gastrointestinal bleeding, stomach ulcers, and liver or kidney problems, especially with prolonged use. If you experience persistent or severe side effects, consult your doctor.

Is Setolac ER 300 MG Tablet safe during pregnancy or breastfeeding?

Pregnancy: Setolac ER 300 MG Tablet is generally considered unsafe during pregnancy, particularly in the last trimester, as it can harm the developing baby's heart and kidneys, potentially delay labor, and increase bleeding risks. During the first six months of pregnancy, it should only be used if absolutely necessary and under a doctor's guidance, at the lowest effective dose for the shortest duration. It may also affect female fertility.

Breastfeeding: It is likely unsafe to use Setolac ER 300 MG Tablet while breastfeeding, as limited information suggests the medicine may pass into breast milk and could be harmful to the infant. Avoid use unless deemed essential by your doctor.

Can Setolac ER 300 MG Tablet be taken with other medications?

Setolac ER 300 MG Tablet can interact with various medications. It should not be taken concurrently with other painkillers like aspirin or other NSAIDs due to an increased risk of side effects, particularly stomach bleeding. It may reduce the effectiveness of blood pressure medications (antihypertensives) and diuretics. There is also an increased risk of bleeding when taken with blood thinners (anticoagulants) and it can raise lithium levels. Corticosteroids taken with Setolac ER can further increase the risk of gastrointestinal bleeding. Always inform your doctor about all other medicines you are taking.

What precautions should be taken while using Setolac ER 300 MG Tablet?

Several precautions are important:

• Avoid alcohol consumption as it can increase drowsiness and the risk of stomach bleeding.
• Use with caution if you have a history of heart problems, high blood pressure, fluid retention, asthma, kidney or liver issues, or stomach ulcers/bleeding.
• Since it can cause dizziness, drowsiness, or visual disturbances, avoid driving or operating heavy machinery if you experience these effects.
• Long-term treatment may require regular monitoring of kidney and liver function, as well as blood components.
• Be aware that this medicine can increase skin sensitivity to sunlight, so use sunscreen when outdoors.
• It is not recommended for children.
• Do not exceed the prescribed dose or duration of treatment.

What happens if a dose is missed?

If you miss a dose of Setolac ER 300 MG Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one.

How should Setolac ER 300 MG Tablet be stored?

Store Setolac ER 300 MG Tablet in its original packaging at room temperature (below 25°C), protecting it from moisture, heat, and direct light. Keep it out of sight and reach of children and pets. Do not use the medicine after its expiry date.