diclofenac/misoprostol (Rx)

Brand and Other Names:Arthrotec
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

diclofenac/misoprostol

tablet

  • 50mg/200mcg
  • 75mg/200mcg
more...

Osteoarthritis

50 mg/200 mcg: 1 tab PO three times daily; not to exceed 200 mcg misoprostol/dose or 800 mcg/day

75mg/200mcg: 1 tab PO three 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

Rheumatoid Arthritis

50 mg/200 mcg: 1 tab PO three or four times daily; not to exceed 200 mcg misoprostol/dose or 800 mcg/day

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

Administration

Swallow tablet whole, do not chew or crush

Do not take with antacids

Safety & efficacy not established

Next:

Interactions

Interaction Checker

and diclofenac/misoprostol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >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

            Postmarketing reports

            Increased alanine aminotransferase

            Increased alkaline phosphatase

            Increased aspartate aminotransferase

            Increased BUN

            Dehydration

            Glycosuria

            Gout

            Hypercholesterolemia

            Hyperglycemia

            Hyperuricemia

            Hypoglycemia

            Hyponatremia

            Periorbital edema porphyria

            Weight changes

            Fluid retention

            Previous
            Next:

            Warnings

            Black Box Warnings

            Cardiovascular Risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with risk factors for or existing cardiovascular disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)

            Gastrointestinal Risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use & without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Women with childbearing potential

            • Advise patient or abortificient property and warn not to give to others; not for women of childbearing potential unless patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or complications from gastric or duodenal ulcers associated with NSAID use
            • Prescribe to patients of childbearing potential only if the following conditions are met:
            • Has had a negative serum pregnancy test within 2 wk prior to beginning therapy
            • Is capable of complying with effective contraceptive measures
            • Has received both oral and written warnings of hazards of misoprostol, the risk of possible contraception failure, and danger to other women of childbearing potential should the drug be taken by mistake
            • Will begin diclofenac only on second or third day of the next normal menstrual period

            Contraindications

            Hypersensitivity drugs or related products

            Perioperative pain in the setting of coronary artery bypass graft (CABG) surgery; active gastrointestinal bleeding

            Patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

            Cautions

            Women of childbearing potential (see mfr's package insert for restrictions)

            Avoid pregnancy during & for at least 1 month after treatment

            May cause blurred vision, drowsiness, dizziness

            Transaminase elevation observed with chronic use

            Hypokalemia may occur when administered with drugs capable of inducing hyperkalemia; risk may increase in diabetics, renal disease, the elderly

            NSAIDs reported to cause serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome

            May increase risk of aseptic meningitis especially in patients with mixed connective tissue disorders and systemic lupus erythematous

            Severe bronchospasm may occur in patients with asthma

            Use caution in hepatic impairment, porphyria (avoid if possible), hypertension, renal impairment

            Avoid use of diclofenac/misoprostol with concomitant NSAIDs including COX inhibitors

            Use lowest effective dose in patients with known cardiovascular (CV) disease or risk factors for CV

            Concurrent use of aspirin with NSAIDs in mitigating CV thrombotic events not shown conclusively; increased risk of serious GI adverse reactions likely

            Use caution in patients with hypertension; monitor blood pressure closely during initiation of NSAID treatment and throughout the course of therapy

            Fluid retention and edema may occur with therapy; use with caution in patients with heart failure

            Serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of stomach, small intestine, or large intestine, which can be fatal may occur

            Renal papillary necrosis and other renal injury reported with NSAID long-term therapy

            Toxic epidermal necrolysis, reported with NSAID use, especially within first month of therapy; discontinue use at first appearance of skin rash

            Use of NSAIDs may diminish ability to diagnose conditions associated with pain or inflammation

            Anemia reported with NSAID use; monitor

            Use caution in patients with coagulation disorders or receiving anticoagulants; NSAIDs inhibit platelet aggregation

            Not for administration to patients with aspirin-sensitive asthma; use caution in patients with preexisting asthma

            NSAIDs may diminish antihypertensive effect of ACE-inhibitors

            Not recommended in patients with advanced renal disease

            Drug-induced hepatotoxicity reported in first month, and may occur within 1-6 months, but can occur at any time during therapy

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: Enters breast milk; use with caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            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)

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous