Diclofenac Medication Monograph

Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at 888-689-2271

Información por escrito acerca de esta receta se le a presentado a usted. Favor de leer esta información antes de tomar el medicamento. Si usted tiene preguntas tocante esta receta, un farmacéutico estará presente durante horas de negocio para contestar sus preguntas

Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at: Quejas sobre la practica de farmacia pueden ser reportadas al Concilio Farmacia del Estado de Tejas:

William P. Hobby Building Ste. 3-600, 333 Guadalupe Street, Box 21

Austin, Texas 78701-3942 Tel: (512) 305-8000 www.tsbp.state.tx.us

 

Diclofenac is a Nonsteroidal Anti-Inflammatory Drug (NSAID) that is used to treat pain and inflammation

Indications: Relief of osteoarthritis pain in joints amenable to topical therapy (eg, ankle, elbow, foot, hand, knee, wrist), relief of pain associated with acute, localized joint/muscle injuries (eg, sports injuries, strains)

Renal Dosing: There are no dosage adjustments provided in the manufacturer’s labeling; avoid use in patients with advanced renal disease

Hepatic Impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution

Contraindications: Hypersensitivity to diclofenac (eg, anaphylactic reaction, serious skin reactions) or any component of the formulation; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs); use in the setting of coronary artery bypass graft surgery; use on non intact or damaged skin, including exudative dermatitis, eczema, infected lesions, burns, or wounds

Warnings/Precautions:

Anaphylactoid reactions: Even in patients without prior exposure, anaphylactoid reactions may occur; patients with “aspirin triad” (bronchial asthma, aspirin intolerance, rhinitis) may be at increased risk. Contraindicated in patients who experience bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy

Cardiovascular events: [US Boxed Warning]: NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including MI and stroke. New-onset hypertension or exacerbation of hypertension may occur (NSAIDs may also impair response to ACE inhibitors, thiazide diuretics, or loop diuretics); may contribute to cardiovascular events; monitor blood pressure. May cause sodium and fluid retention, use with caution in patients with edema. Avoid use in patients with heart failure. Avoid use in patients with recent MI. Use the lowest effective dose for the shortest duration of time to reduce risk of cardiovascular events

Gastrointestinal events: [US Boxed Warning]: NSAIDs cause an increased risk of serious gastrointestinal inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. Avoid use in patients with active GI bleeding. Use caution with a history of GI ulcers, concurrent therapy known to increase the risk of GI bleeding, advanced hepatic disease, coagulopathy, smoking, use of alcohol, or in elderly or debilitated patients. Use the lowest effective dose for the shortest duration of time to reduce risk of GI adverse events

Hematologic effects: Platelet adhesion and aggregation may be decreased; may prolong bleeding time; patients with coagulation disorders or who are receiving anticoagulants should be monitored closely. Anemia may occur. Rarely, NSAID use has been associated with potentially severe blood dyscrasias

Hepatic effects: Transaminase elevations have been observed with oral chronic use; closely monitor patients with any abnormal LFT. Rare (sometimes fatal) severe hepatic reactions have occurred with NSAID use

Hyperkalemia: NSAID use may increase the risk of hyperkalemia, particularly in the elderly, diabetics, renal disease, and with concomitant use of other agents capable of inducing hyperkalemia (eg, ACE inhibitors). Monitor potassium

Renal effects: NSAID use may compromise existing renal function; dose-dependent decreases in prostaglandin synthesis may result from NSAID use, reducing renal blood flow, which may cause renal decompensation. Long-term NSAID use may result in renal papillary necrosis and other renal injury/toxicity

Skin reactions: May cause potentially fatal serious skin adverse events, including exfoliative dermatitis,
Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN); may occur without warning; discontinue use at first sign of skin rash (or any other hypersensitivity). Do not apply topical products to open skin wounds, infected areas, inflammations, or exfoliative dermatitis

Coronary artery bypass graft surgery: [US Boxed Warning]: Use is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Risk of MI and stroke may be increased with use following CABG surgery

Drug Interactions:Please speak with your doctor or pharmacist about other medications you take

Adverse Reactions: Itching, application site rash, contact dermatitis, xeroderma, application site pain, desquamation

Storage: Room temperature

Patient Education:

What should I tell my doctor about before taking this medication?

If you are allergic to this drug, any part of this drug, or any other drugs, foods, or substances; if you have an allergy to aspirin or NSAIDs; if you have ever had asthma caused by a salicylate drug like aspirin or a drug like this one; if you have any of these health problems: dehydration, GI (gastrointestinal) bleeding, heart failure (weak heart), kidney disease, or liver disease; if you have had a recent heart attack; if you are having trouble getting pregnant or you are having your fertility checked; if you are pregnant or may be pregnant; if you are taking any other NSAID, a salicylate drug like aspirin, or pemetrexed; if you are breast-feeding or plan to breast-feed

When and how do I apply this medication?

Apply to the affected area or joint and rub into skin gently, making sure to apply to the entire affected area or joint

Apply to clean, dry, intact skin; do not apply to open wounds, eyes, or mucous membranes. Do not cover with occlusive dressings or apply heat, sunscreens, cosmetics, lotions, moisturizers, or insect repellents.
Showering/bathing should be avoided for ≥1 hour following application. Wash hands immediately after application (unless hands are treated joint, then wait ≥1 hour to wash hands). Avoid sunlight to exposure areas. Avoid wearing clothes or gloves for ≥10 minutes after application

What side effects should I call my doctor about right away?

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest; trouble breathing, swallowing, or talking; or swelling of the mouth, face, lips, tongue, or throat; signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop; signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight; signs of kidney problems like unable to pass urine, blood in the urine, or a big weight gain; signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; numbness or tingling; or shortness of breath; skin irritation; chest pain or pressure or a fast heartbeat; shortness of breath, or swelling in the arms or legs; weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight; feeling very tired or weak; flu-like signs; very bad back pain; very bad belly pain; signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes