Misoclo50 mg+200 mcg

Diclofenac sodium and misoprostol combination tablets are used for the treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis, in patients who require an NSAID for their arthritis and who are at risk of developing NSAID-induced gastric or duodenal ulcers. The misoprostol component is included specifically to reduce this ulcer risk, not as an independent arthritis treatment.

Contains diclofenac sodium and misoprostol as active ingredients, marketed in two fixed-dose strengths: diclofenac sodium 50 mg with misoprostol 200 mcg, and diclofenac sodium 75 mg with misoprostol 200 mcg. Confirm the exact strength on the specific product dispensed, since the two strengths are used differently for different arthritis diagnoses and tolerability.

Diclofenac sodium and misoprostol is a combination tablet that pairs an NSAID (diclofenac) used to relieve arthritis pain and inflammation, with misoprostol, a prostaglandin analogue included specifically to reduce the risk of stomach and duodenal ulcers that NSAIDs can cause. It is intended for patients who need ongoing NSAID therapy for osteoarthritis or rheumatoid arthritis and who are at increased risk of NSAID-related ulcers. This combination carries an important pregnancy warning, since misoprostol can cause miscarriage, premature labour, or birth defects.

Therapeutic Class: NSAID with Gastroprotective Agent

Diclofenac is well absorbed orally and highly protein-bound; misoprostol is rapidly absorbed and converted to its active metabolite, misoprostol acid. When combined in this fixed-dose product, the pharmacokinetics of each component are not meaningfully altered compared to the individual agents. Misoprostol has a short half-life, which is why it needs to be dosed multiple times daily to maintain its gastroprotective effect throughout the day.

• Taken orally, typically with food to help reduce gastrointestinal upset
• Swallow the tablet whole; do not crush or chew, as this may affect the release characteristics
• Take doses at evenly spaced intervals through the day as prescribed

The following should be assessed by a healthcare professional before combining with this medicine:

• Other NSAIDs or aspirin, which increases the risk of gastrointestinal bleeding and ulceration
• Anticoagulants such as warfarin, and antiplatelet agents, which increase bleeding risk
• Lithium and digoxin, whose blood levels may be raised by diclofenac, requiring monitoring
• ACE inhibitors, angiotensin receptor blockers, and diuretics, which may have reduced effectiveness and increased risk of kidney impairment when combined with NSAIDs
• Methotrexate, whose toxicity may be increased when combined with NSAIDs
• Magnesium-containing antacids, which may worsen the diarrhoea sometimes caused by misoprostol

Common side effects

• Diarrhoea (a well-recognized, dose-related effect of the misoprostol component, usually mild to moderate and self-limiting)
• Abdominal pain or cramping
• Nausea, indigestion
• Headache
• Flatulence

Serious side effects (seek urgent medical attention)

• Signs of gastrointestinal bleeding: black or bloody stools, vomiting blood, severe stomach pain
• Signs of a heart attack or stroke: chest pain, shortness of breath, weakness on one side of the body
• Signs of a serious allergic reaction: swelling of the face or throat, difficulty breathing, severe rash
• Signs of kidney problems: reduced urination, swelling of the legs or ankles
• Vaginal bleeding or spotting in women, which should be reported to a doctor, given the abortifacient property of misoprostol if pregnancy occurs

Pregnancy

This combination must not be taken during pregnancy. Misoprostol can cause abortion, often with incomplete expulsion, uterine bleeding, and, rarely, uterine rupture, and can also cause birth defects. Women of childbearing potential must have a negative pregnancy test within 2 weeks before starting treatment and must use effective contraception during treatment; if pregnancy is suspected, stop the medicine immediately and contact a doctor. Patients must be advised of this abortifacient property and warned never to give this medicine to another person.

Breastfeeding

Both diclofenac and misoprostol are excreted in breast milk; this combination is not recommended for use by nursing mothers.

• Pregnancy warning: This is one of the most important precautions for this medicine - it must never be used or shared by anyone who is or could become pregnant without effective contraception and a confirmed negative pregnancy test.
• NSAIDs, including diclofenac, are associated with an increased risk of serious cardiovascular thrombotic events, including heart attack and stroke.
• NSAIDs increase the risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation, which can occur without warning symptoms.
• Diarrhoea related to the misoprostol component is dose-dependent and usually develops early in treatment and is self-limiting, but can occasionally be severe, particularly if taken with magnesium-containing antacids.
• Use with caution in patients with renal, hepatic, or cardiovascular impairment.

Overdose of the diclofenac component may cause nausea, vomiting, abdominal pain, gastrointestinal bleeding, drowsiness, and effects on kidney function or blood pressure. Misoprostol overdose has not had its toxic threshold fully established in humans, but may cause sedation, tremor, seizures, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension, or bradycardia. Suspected overdose requires prompt medical evaluation and treatment in a healthcare facility.

Store at room temperature (15-30°C), away from moisture and excess heat, as directed on the product label.

• Women of childbearing potential: Must use effective contraception and confirm a negative pregnancy test before starting, given the serious pregnancy risk from misoprostol.
• Elderly: Increased risk of NSAID-related gastrointestinal and cardiovascular complications; use with caution and at the lowest effective dose.
• Renal impairment: Contraindicated in severe impairment; use with caution and appropriate monitoring in mild to moderate impairment.
• Hepatic impairment: Contraindicated in severe impairment; use with caution in milder impairment.

This combination is generally used for ongoing management of chronic arthritis symptoms, for as long as an NSAID with gastroprotection is clinically needed, at the lowest effective dose, with periodic medical review, particularly regarding gastrointestinal and cardiovascular risk.

Drug Class: Phenylacetic acid derivative NSAID (diclofenac) combined with a synthetic prostaglandin E1 analogue (misoprostol)

Diclofenac works by inhibiting cyclooxygenase enzymes, reducing the production of prostaglandins that cause pain and inflammation in arthritis, but this same mechanism also reduces protective prostaglandins in the stomach lining, increasing ulcer risk. Misoprostol works by replacing this protective prostaglandin activity in the stomach - it reduces gastric acid secretion and enhances the mucosal protective barrier, counteracting the ulcer-promoting effect of the NSAID.

Safety and effectiveness of this combination have not been established in patients younger than 18 years, and it is not recommended for use in children.