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General Information on Diclofenac Sodium and Misoprostol

Generic Name : Diclofenac Sodium and Misoprostol

Pronunciation : dye-KLOE-fen-ak SOE-dee-um MYE-soe-PROST-ol

Latest prescription information about Diclofenac Sodium and Misoprostol. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
ICD Code : Y45.3 | Therapeutic Classification : Anti- Inflammatory Agents

Trade Names/Brand Names of Diclofenac Sodium and Misoprostol

International- Arthrotec.

Why is Diclofenac Sodium and Misoprostol Prescribed? (Indications)

This combination medication is an NSAID, prescribed for pain in the knee joints caused by osteoarthritis (OA) and rheumatoid arthritis (RA) in patients at high risk of developing NSAID-induced gastric and stomach ulcers and their complications. 

When should Diclofenac Sodium and Misoprostol not to be taken? (Contraindications)

Contraindicated in patients with known hypersensitivity, treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery, pregnant and breast feeding women.

What is the dosage of Diclofenac Sodium and Misoprostol?

Osteoarthritis: The recommended dosage is 50 mg/200 mcg three times daily. 50 mg/200 mcg or 75 mg/200 mcg twice daily can be given to patients experiencing intolerance, but are not effective in preventing ulcers. Dosages of diclofenac higher than 150 mg/day and misoprostol 800 mcg/day in osteoarthritis are not recommended.
Rheumatoid Arthritis: The recommended dosage is 50 mg/200 mcg three or four times daily. 50 mg/200 mcg or 75 mg/200 mcg twice daily can be given to patients experiencing intolerance, but are not effective in preventing ulcers. Dosages of diclofenac higher than 225 mg/day and misoprostol 800 mcg/day in Rheumatoid arthritis are not recommended.

How should Diclofenac Sodium and Misoprostol be taken?

It comes as a tablet to take by mouth with food as directed by your physician.

What are the warnings and precautions for Diclofenac Sodium and Misoprostol?

Caution should be exercised in patients with history of cardiovascular risk, heart attack, stroke, gastrointestinal risk, hypertension, heart failure, impaired kidney function, liver dysfunction, asthma and elderly.

It may cause dizziness or drowsiness, do not drive a car or operate machinery while taking this medication.

Do not administer this medication to women who are pregnant, it can cause abortion, premature birth or birth defects.

What are the side effects of Diclofenac Sodium and Misoprostol?

  Gastrointestinal - Gastrointestinal bleeding, esophageal ulceration, vomiting of blood, gastrointestinal stromal tumors (GST), rectal bleeding, peptic ulcer, gastrointestinal perforation.
  Gynecological - Postmenopausal vaginal bleeding, breast pain, painful periods, intermenstrual bleeding, vaginal discharge, menstrual disorders, excessive bleeding.
  Cardiovascular System - Irregular heartbeat, atrial fibrillation, congestive heart failure(CHF), hypertension, hypotension, palpitations, inflammation of a vein, loss of consciousness, premature ventricular contractions.
  Central Nervous System - Coma, convulsions, depression, dizziness, hallucinations, psychotic reaction, drowsiness, headache, meningitis, stroke, insomnia, pain in one or more nerves, anxiety, impaired concentration, confusion, disorientation, abnormal dreams , irritability, nervousness, fear.
  Skin - Photosensitivity, skin ulceration, Stevens-Johnson syndrome, acne, rash, increased sweating, toxic epidermal necrolysis(TEN).
  Genitourinary - Urinary bladder inflammation, RBC in urine, interstitial nephritis, nephrotic syndrome, papillary necrosis, proteinuria, renal failure, urinary tract infection.
  Hematologic-Lymphatic - Low level of WBC, blood disorders, eosinophilia, enlargement of lymph nodes, reduction in RBC.
  Liver and Biliary System - Abnormal hepatic function, hepatitis, jaundice, liver failure, pancreatitis.
  Hypersensitivity - Swelling, laryngeal/pharyngeal edema, hives.
  Respiratory - Pneumonia, pulmonary embolism, respiratory depression.
  Male Reproductive Disorders - Impotence, perineal pain.
  Musculoskeletal System - Joint pain, muscle pain.
  Miscellaneous - Blood infection, weakness, fever, chills, death.

What are the other precautions for Diclofenac Sodium and Misoprostol?

Avoid excess dosage.

What are the storage conditions for Diclofenac Sodium and Misoprostol?

Store tablets at or below 77F, in a moisture-free area.


Schedule : H

Prescription drugs - Drugs to be sold only under the prescription of a Registered Medical Practitioner.
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