Rheumatoid arthritis, Osteoarthritis, Joint and muscular pains Diclofenac Sodium and Misoprostol combination is contraindicated in women who are pregnant because of the abortive property of the Misoprostol component.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Diclofenac, a phenylacetic acid derivative is a prototypical NSAID. It has potent anti-inflammatory, analgesic and antipyretic actions. It reversibly inhibits the enzyme, cyclooxygenase, thus resulting in reduced synthesis of prostaglandin precursors.Misoprostol is a synthetic prostaglandin E1 analogue. It protects the GI mucosa by inhibiting basal, stimulated and nocturnal acid secretion and by reducing the volume of gastric secretions and increasing bicarbonate and mucus secretion. It also induces contractions of smooth muscle fibres of the myometrium and relaxation of the cervix uteri.

Administration: Swallow tablet whole, do not chew or crush Do not take with antacids Adult Dose: Osteoarthritis 50 mg/200 mcg, 75mg/200mcg: 1 tab PO three times daily; not to exceed 200 mcg misoprostol/dose or 800 mcg/day Rheumatoid Arthritis 50 mg/200 mcg, 75mg/200mcg: 1 tab PO three or four times daily; not to exceed 200 mcg misoprostol/dose or 800 mcg/day If not tolerated may reduce frequency to twice daily Three times daily dose of misoprostol is more protective than when given twice daily Child Dose: Safety & efficacy not established

May increase serum levels of methotrexate. Concomitant use w/ other NSAIDs or anticoagulants (e.g. warfarin) is associated w/ higher risk of GI bleeding. Increased risk of nephrotoxicity w/ ciclosporin or triamterene. May increase the risk of developing corneal complications in patients w/ significant pre-existing corneal inflammation when use concomitantly w/ ophth preparation containing corticosteroids. Colestyramine and colestipol reduce the bioavailability of diclofenac. Decreased plasma concentration when administered after sucralfate. Ophth application of diclofenac may reduce the efficacy of ophth acetylcholine and carbachol. May increase serum levels of lithium and digoxin. May increase effects of oxytocin. Increased risk of misoprostol-induced diarrhoea with magnesium-containing antacids.

Diclofenac Sodium and Misoprostol combination is contraindicated in women who are pregnant because of the abortive property of the Misoprostol component.

>10% Rash including erythematous, rash macular and maculo-papular (18%),Pyrexia (15%),Urticaria (13%),Flushing (13%) 1-10% Hypertension (10%),Hyperhydrosis (8%),Decreased oxygen saturation (8%),Cough (8%),Tachypnea (8%),Tachycardia (8%),Urticaria (8%),Anaphylaxis (7%),Chest discomfort (7%),Muscle twitching (7%),Erythema (5%),Vomiting (5%),Rigors (5%),Pallor (5%),Cyanosis (5%),Agitation (5%),Tremor (5%),Myalgia (5%),Flushing (5%),Peripheral edema (3%),Pruritus (3%),Rash, papular (3%),Throat tightness (3%) <1% Fatigue,Malaise,Chills,Edema,Atrial fibrillation,Congestive heart failure,Myocardial infarction,Phlebitis,Vasculitis,Syncope,Dysphagia,Enteritis,Peptic ulcer,Vaginitis,Breast pain,Dysmenorrhea,Uterine cramping,Ulcerative stomatitis,Impotence,Perineal pain,Glycosuria,Alopecia

Lactation: Diclofenac Sodium has been found in the milk of nursing mothers. It is unlikely that Misoprostol is excreted into milk since the drug is rapidly metabolized throughout the body. Excretion of the active metabolite (Misoprostol acid) into milk is possible, but has not been studied. Because of the potential for serious adverse reactions in nursing infants, Diclofenac Sodium and Misoprostol combination is not recommended for use by nursing mothers.

Precaution: Patients with an underlying condition such as inflammatory bowel disease or those in whom dehydration should be monitored carefully if Diclofenac Sodium 50 mg plus Misoprostol 200 mcg is prescribed. The pharmacological activity in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Lactation: Enters breast milk; use with caution

Misoprostol: Convulsions, sedation, tremor, dyspnoea, diarrhoea, abdominal pain, fever, palpitations, hypotension, bradycardia. Management: Supportive treatment.Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely

Store in a cool and dry place below 25º C. Protect from light.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Diclofenac: Inhibits cyclooxygenase-1 (COX-1) & -2 (COX-2), thereby inhibiting prostaglandin synthesis; has anti-inflammatory, antipyresis, and analgesic properties. Misoprostol: Replaces protective prostaglandins consumed by prostaglandin-inhibiting therapies (NSAID-induced ulcers).

Pregnancy Category: X Lactation: Enters breast milk; use with caution