Introduction

Diclofenac sodium and misoprostol are combined in a medication used primarily for the treatment of osteoarthritis and rheumatoid arthritis. This combination aims to provide effective pain relief while mitigating the gastrointestinal side effects commonly associated with nonsteroidal anti-inflammatory drugs (NSAIDs) like diclofenac.

Uses

The combination of diclofenac sodium and misoprostol is used to:

  • Treat pain and inflammation associated with osteoarthritis and rheumatoid arthritis
  • Reduce the risk of gastrointestinal complications, such as ulcers and bleeding, associated with long-term NSAID use
  • Provide relief from other musculoskeletal conditions where NSAIDs are indicated

Brand Name Arthrofen
Type Tablet
Weight 75 mg+200 mcg
Generic Diclofenac Sodium + Misoprostol
Manufacturer Healthcare Pharmaceuticals Ltd.
Available in English বাংলা

Mechanism of Action

Diclofenac sodium is an NSAID that works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, which are involved in the production of prostaglandins that mediate pain and inflammation. Misoprostol is a prostaglandin E1 analog that protects the gastrointestinal mucosa by increasing mucus and bicarbonate secretion and enhancing mucosal blood flow, thereby reducing the risk of NSAID-induced ulcers.

How Long Does It Take to Work?

The effects of diclofenac sodium typically begin within 30 minutes to 1 hour after administration, with peak effects usually observed within 2-4 hours. Misoprostol also begins to exert its protective effects within a few hours, with maximal protection from gastrointestinal irritation generally seen within 1-2 weeks of consistent use.

Absorption

Diclofenac sodium is well absorbed from the gastrointestinal tract. Its absorption can be affected by food, but it is generally well-absorbed with peak plasma levels occurring within 1-2 hours after oral administration. Misoprostol is also absorbed from the gastrointestinal tract, with peak plasma levels occurring within 30-60 minutes after administration.

Route of Elimination

Diclofenac sodium is primarily metabolized by the liver and excreted via the kidneys. It undergoes extensive hepatic metabolism to inactive metabolites. Misoprostol is metabolized to inactive metabolites, primarily in the liver, and excreted in the urine.

Dosage

Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.

Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.

The typical dosage for the combination of diclofenac sodium and misoprostol is:

  • Diclofenac sodium 50 mg and misoprostol 200 mcg, taken orally twice daily (morning and evening)
Dosage may be adjusted based on patient needs and response to therapy. Always follow healthcare provider instructions for precise dosing.

Administration

This combination medication is administered orally in the form of tablets. It should be taken with food or milk to minimize gastrointestinal irritation and to enhance absorption. It is important to follow the prescribed dosage schedule and not to exceed the recommended dose.

Side Effects

Common side effects include:

  • Gastrointestinal symptoms such as nausea, vomiting, diarrhea, and abdominal pain
  • Headache
  • Dizziness
Serious side effects may include:
  • Gastrointestinal bleeding or ulcers
  • Severe allergic reactions (e.g., rash, swelling, difficulty breathing)
  • Kidney or liver dysfunction

Toxicity

Toxicity may result from excessive use of diclofenac sodium, leading to:

  • Severe gastrointestinal bleeding or perforation
  • Renal impairment
  • Hepatic toxicity
Misoprostol toxicity can lead to:
  • Severe diarrhea
  • Abdominal cramping
  • Uterine contractions (in pregnant women)
In case of suspected toxicity, discontinue use and seek medical attention immediately. Treatment may involve supportive care and symptom management.

Precautions

Precautions should be taken in individuals with:

  • History of gastrointestinal disorders, such as peptic ulcers or bleeding
  • Renal or hepatic impairment
  • Cardiovascular disease
  • Pregnancy or potential pregnancy (due to misoprostol)
Regular monitoring for gastrointestinal, renal, and hepatic effects is recommended during therapy.

Interaction

Interactions may include:

  • Other NSAIDs or anticoagulants: Increased risk of bleeding and gastrointestinal complications
  • Medications affecting liver enzymes (e.g., CYP450 inducers or inhibitors)
  • Antihypertensive medications: NSAIDs may reduce their effectiveness
Monitor for potential interactions and adjust therapy as needed.

Disease Interaction

The combination should be used with caution in patients with:

  • Active or history of gastrointestinal disease
  • Chronic kidney or liver disease
  • Cardiovascular disease

Drug Interaction

Drug interactions may include:

  • Anticoagulants (e.g., warfarin): Increased risk of bleeding
  • Other NSAIDs: Increased risk of gastrointestinal adverse effects
  • Diuretics or antihypertensives: Reduced efficacy of antihypertensive effects

Food Interactions

Food interactions are minimal but taking the medication with food can help reduce gastrointestinal irritation. Avoid excessive alcohol intake as it can increase the risk of gastrointestinal bleeding.

Pregnancy Use

The use of diclofenac sodium and misoprostol during pregnancy is generally contraindicated, particularly in the third trimester, due to potential risks to the fetus. Misoprostol can induce uterine contractions, and diclofenac may affect fetal cardiovascular function. Consult a healthcare provider for alternative treatments if pregnancy is suspected or confirmed.

Lactation Use

Both diclofenac sodium and misoprostol are excreted in breast milk, but their effects on a nursing infant are not well studied. Caution is advised, and the medication should only be used if the benefits outweigh the potential risks. Consult a healthcare provider for guidance on breastfeeding while using this medication.

Acute Overdose

Acute overdose of diclofenac sodium can result in:

  • Severe gastrointestinal bleeding or ulceration
  • Kidney dysfunction
  • Central nervous system symptoms such as headache, dizziness, and confusion
Misoprostol overdose may cause:
  • Severe diarrhea
  • Abdominal cramping
  • Excessive uterine contractions (if pregnant)
In case of overdose, discontinue use and seek medical attention immediately. Treatment may involve supportive care and management of symptoms.

Contraindication

The combination is contraindicated in individuals with:

  • Active or history of gastrointestinal ulcers or bleeding
  • Severe renal or hepatic impairment
  • Pregnancy (due to misoprostol)
  • Hypersensitivity to diclofenac or misoprostol

Use Direction

Follow the specific instructions provided by your healthcare provider or product label. The medication should be taken with food or milk to reduce gastrointestinal irritation. Adhere to the prescribed dosage and schedule and report any adverse effects or issues to a healthcare provider.

Storage Conditions

Store diclofenac sodium and misoprostol tablets at room temperature, between 15°C and 30°C (59°F and 86°F). Keep in a dry place, away from light and moisture. Ensure that the medication is kept out of reach of children and is not used beyond its expiration date.

Volume of Distribution

The volume of distribution for diclofenac is approximately 0.1-0.2 L/kg. Misoprostol's volume of distribution is not well documented but is distributed throughout the body’s tissues.

Half Life

The half-life of diclofenac is approximately 1-2 hours, while the half-life of misoprostol is about 20-40 minutes. The effects of diclofenac can last longer due to its binding to tissue sites, and misoprostol’s protective effects may extend beyond its plasma half-life.

Clearance

Diclofenac is primarily cleared by hepatic metabolism with a significant portion excreted in the urine. Misoprostol is also cleared through hepatic metabolism and urinary excretion.

See in details version Arthrofen Tablet 75 mg+200 mcg also Arthrofen Tablet 75 mg+200 mcg in bangla

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Uses

Some Frequently Asked Questions About Arthrofen Tablet 75 mg+200 mcg

1. What is Arthrofen Tablet 75 mg+200 mcg used for?

This combination is used to treat arthritis pain and inflammation while protecting the stomach from ulcers caused by NSAIDs.

2. How does Arthrofen Tablet 75 mg+200 mcg work?

  • Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain and inflammation.
  • Misoprostol is a prostaglandin that protects the stomach lining and prevents ulcers.

3. What conditions is this medication prescribed for?

  • Osteoarthritis
  • Rheumatoid arthritis
  • Joint pain with a high risk of NSAID-induced ulcers

4. How should this medication be taken?

Take it with food to reduce stomach irritation. Swallow the tablet whole, do not crush or chew it.

5. How often should I take Arthrofen Tablet 75 mg+200 mcg?

It is usually taken two to three times a day as prescribed by your doctor.

6. Can I take this medication on an empty stomach?

No, it should be taken with food to lower the risk of stomach irritation and ulcers.

7. What are the common side effects?

  • Stomach pain
  • Nausea
  • Diarrhea
  • Dizziness
  • Indigestion
  • Gas or bloating

8. Can I take Arthrofen Tablet 75 mg+200 mcg if I am pregnant?

No, this medication can cause serious birth defects, miscarriage, or premature labor.

9. Why does this medication have a pregnancy warning?

Misoprostol can cause uterine contractions, leading to miscarriage or birth defects.

10. What should I do if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not double up on doses.

11. Can I stop taking this medication suddenly?

Consult your doctor before stopping, as discontinuing NSAIDs abruptly may worsen your condition.

12. Can I drink alcohol while taking this medication?

No, alcohol increases the risk of stomach bleeding and irritation.

13. How long does it take for this medication to work?

Pain relief usually begins within a few hours, but full benefits may take a few days.

14. Can this medication cause stomach ulcers?

Misoprostol helps protect against ulcers, but prolonged NSAID use still carries some risk.

15. What should I do if I experience severe stomach pain?

Seek medical attention immediately, as it may indicate an ulcer or gastrointestinal bleeding.

16. Can I take antacids with this medication?

Avoid magnesium-containing antacids, as they may worsen diarrhea caused by Misoprostol.

17. Is Arthrofen Tablet 75 mg+200 mcg available over the counter?

No, it requires a doctor’s prescription.

18. Can I take this medication for general pain relief?

It is specifically prescribed for arthritis and conditions requiring long-term NSAID use.

19. Does this medication affect kidney function?

Yes, NSAIDs like Diclofenac can affect kidney function, especially in elderly patients or those with kidney disease.

20. Can I take this medication if I have high blood pressure?

NSAIDs can increase blood pressure. Consult your doctor if you have hypertension.

21. Can Arthrofen Tablet 75 mg+200 mcg cause allergic reactions?

Yes, signs of an allergic reaction include rash, swelling, difficulty breathing, or severe dizziness.

22. Can I take this medication with other pain relievers?

Avoid other NSAIDs like ibuprofen or aspirin unless directed by your doctor.

23. Can I take Arthrofen Tablet 75 mg+200 mcg with blood thinners?

It may increase the risk of bleeding. Inform your doctor if you are taking blood thinners.

24. What should I do if I experience diarrhea?

Diarrhea is a common side effect of Misoprostol. Stay hydrated and consult your doctor if it persists.

25. Can I take this medication if I have liver disease?

Diclofenac may affect liver function. Your doctor may need to adjust your dose.

26. What should I do if I take too much of this medication?

Seek immediate medical attention for symptoms like severe stomach pain, vomiting, drowsiness, or difficulty breathing.

27. Can I take Arthrofen Tablet 75 mg+200 mcg for a long time?

Long-term use increases the risk of heart problems and stomach ulcers. Your doctor will decide the safest duration.

28. Does this medication cause drowsiness?

Some people may feel dizzy or drowsy. Avoid driving if affected.

29. Can I take Arthrofen Tablet 75 mg+200 mcg with antidepressants?

NSAIDs may interact with some antidepressants, increasing bleeding risks. Inform your doctor.

30. Does this medication affect heart health?

NSAIDs can increase the risk of heart attack or stroke, especially with long-term use.

31. Can I take this medication if I have asthma?

NSAIDs may trigger asthma symptoms in some people. Consult your doctor first.

32. Can I use Arthrofen Tablet 75 mg+200 mcg for menstrual cramps?

It is not typically prescribed for menstrual pain. Consult your doctor for alternatives.

33. Can I take this medication if I am trying to conceive?

NSAIDs may affect fertility. If you are trying to get pregnant, discuss alternatives with your doctor.

34. Can this medication cause fluid retention?

Yes, NSAIDs can cause swelling or fluid retention, especially in patients with kidney or heart disease.

35. Can I take Arthrofen Tablet 75 mg+200 mcg while breastfeeding?

Misoprostol may pass into breast milk. Consult your doctor before use.

36. Is weight gain a side effect?

Unusual weight gain due to fluid retention may occur.

37. Can I take vitamin supplements with this medication?

Most vitamins are safe, but check with your doctor regarding interactions.

38. Can this medication affect blood sugar levels?

NSAIDs may affect blood sugar control in diabetic patients.

39. Does Arthrofen Tablet 75 mg+200 mcg cause constipation?

Misoprostol usually causes diarrhea, but constipation may also occur in some cases.

40. Can I split the tablet?

No, the tablet should be swallowed whole.

41. Can I take this medication if I have gout?

Diclofenac is sometimes used for gout pain, but consult your doctor.

42. What happens if I take this medication with caffeine?

There are no major interactions, but caffeine may increase stomach irritation.

43. Does this medication interact with antibiotics?

Some antibiotics may interact with NSAIDs. Inform your doctor about all medications you are taking.

44. Can this medication cause hair loss?

Hair loss is not a common side effect.

45. Can I take it with a blood pressure medication?

NSAIDs may reduce the effectiveness of some blood pressure medications.

46. Does this medication increase sun sensitivity?

Diclofenac may make your skin more sensitive to sunlight.

47. Can I stop this medication suddenly?

Consult your doctor before stopping.

48. Can this medication cause ringing in the ears?

Tinnitus is a rare side effect.

49. What should I do if my symptoms worsen?

Contact your doctor for alternative treatment options.

50. Can I use Arthrofen Tablet 75 mg+200 mcg for headaches?

It is not typically prescribed for headaches.

*** Taking medicines without doctor's advice can cause long-term problems.
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