Profenac PLUS 50/200

Rheumatoid arthritis, Osteoarthritis, Joint and muscular pains

Swallow tablet whole, do not chew or crush Do not take with antacids

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

Safety & efficacy not established

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

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).

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

>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

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

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.