• PO: Management of inflammatory disorders including:
  • Rheumatoid arthritis,
  • Osteoarthritis,
  • Ankylosing spondylitis.
• Primary dysmenorrhea.
• Relief of mild to moderate pain.
• Acute treatment of migraines (powder for oral solution).
• Topical: Management of:
  • Actinic keratosis (3% gel),
  • Osteoarthritis (Voltaren Gel, Pennsaid [for knees]).
  • Acute pain due to minor strains, sprains, and contusions (patch).

Contraindicated in:

• Hypersensitivity to diclofenac or other components of formulation
• Cross-sensitivity may occur with other NSAIDs, including aspirin
• Active GI bleeding/ulcer disease
• Coronary artery bypass graft surgery
• Exudative dermatitis, eczema, infectious lesions, burns, or wounds
• OB: Avoid use after 30 wk gestation.

Use Cautiously in:

• Severe renal/hepatic impairment
• Cardiovascular disease or risk factors for cardiovascular disease (may ↑ risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, especially with prolonged use or use of higher doses); avoid use in patients with recent MI or HF
• HF or edema
• History of porphyria
• History of peptic ulcer disease and/or GI bleeding
• Bleeding tendency or concurrent anticoagulant therapy
• OB: Use at or after 20 wk gestation may cause fetal or neonatal renal impairment; if treatment is necessary between 20 wk and 30 wk gestation, limit use to the lowest effective dose and shortest duration possible
• Pedi: Safety and effectiveness only established for patch in children ≥6 yr and diclofenac potassium (Zipsor) in children ≥12 yr
• Geri: Appears on Beers list. ↑ risk GI bleeding or peptic ulcer disease in older adults. Avoid chronic use unless other alternatives are not effective and the patient can take a gastroprotective agent; avoid short-term use in combination with oral or parenteral corticosteroids, anticoagulants, or antiplatelet agents unless other alternatives are not effective and the patient can take a gastroprotective agent..

CV: edema, HF, hypertension, MI.

Derm: pruritus, rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), eczema, EXFOLIATIVE DERMATITIS, photosensitivity, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

EENT: tinnitus.

F and E: hyperkalemia.

GI: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, GI BLEEDING, heartburn, HEPATOTOXICITY, nausea, vomiting.

GU: acute renal failure, hematuria.

Hemat: anemia, prolonged bleeding time.

Local: Topical only: contact dermatitis, dry skin, exfoliation.

Neuro: dizziness, headache, STROKE.
Misc: (INCLUDING ANAPHYLAXIS)HYPERSENSITIVITY REACTIONS .

Primarily noted for oral administration

Drug-Drug:

• ↑ adverse GI effects with aspirin, other NSAIDs, or corticosteroids.
• May ↓ effectiveness of diuretics or antihypertensives.
• May ↑ levels/risk of toxicity from cyclosporine, lithium, or methotrexate.
• ↑ risk of bleeding with anticoagulants, aspirin, clopidogrel, ticagrelor, prasugrel, corticosteroids, fibrinolytics, SNRIs, or SSRIs.
• CYP2C9 inhibitors, including voriconazole may ↑ levels/risk of toxicity.
• CYP2C9 inducers, including rifampin, may ↓ levels/effectiveness.
• Concurrent use of oral NSAIDs during topical diclofenac therapy should be minimized.

Drug-Natural Products:

• ↑ bleeding risk with arnica, chamomile, clove, dong quai, feverfew, garlic, ginger, ginkgo, Panax ginseng, and others.

(Generic available)

• Diclofenac potassium immediate-release tablets (Cataflam): 50 mg;
• Diclofenac potassium liquid-filled capsules (Zipsor): 25 mg;
• Diclofenac potassium powder for oral solution (Cambia): 50 mg/packet;
• Diclofenac capsules (Zorvolex): 18 mg; 35 mg;
• Diclofenac sodium delayed-release (enteric-coated) tablets: 25 mg; 50 mg; 75 mg;
• Diclofenac sodium extended-release tablets: 75 mg; 100 mg;
• Diclofenac sodium topical gel: 1% (Voltaren gel)^OTC; 3%;
• Diclofenac sodium topical solution: 1.5%; 2%;
• Diclofenac epolamine transdermal patch: 1.3%;
• Diclofenac sodium rectal suppository: 50 mg;
• In combination with: misoprostol (Arthrotec). See Appendix [not included in this PDA edition].

Diclofenac

• PO (Adults): Acute pain: 18–35 mg 3 times daily; Osteoarthritis: 35 mg 3 times daily.

Diclofenac Potassium

• PO (Adults): Analgesic/antidysmenorrheal (Cataflam): 100 mg initially, then 50 mg 3 times daily as needed; Mild-to-moderate acute pain (Zipsor): 25 mg 4 times daily; Rheumatoid arthritis (Cataflam): 50 mg 3–4 times daily; Osteoarthritis (Cataflam): 50 mg 2–3 times daily; Osteoarthritis (Cambia): one packet (50 mg) given as a single dose.
• PO (Children ≥12 yr): Mild-to-moderate acute pain (Zipsor): 25 mg 4 times daily;.

Diclofenac Sodium

• PO (Adults): Rheumatoid arthritis (delayed-release [enteric-coated] tablets): 50 mg 3–4 times daily or 75 mg twice daily (usual maintenance dose 25 mg 3 times daily). Rheumatoid arthritis (extended-release tablets): 100 mg once daily; if unsatisfactory response, dose may be ↑ to 100 mg twice daily. Osteoarthritis (delayed-release [enteric-coated] tablets): 50 mg 2–3 times daily or 75 mg twice daily. Osteoarthritis (extended-release tablets): 100 mg once daily. Ankylosing spondylitis (delayed-release [enteric-coated] tablets): 25 mg 4 times daily, with an additional 25 mg given at bedtime, if necessary.
• Topical (Adults): 3% topical gel: Apply to lesions twice daily for 60–90 days; Voltaren gel: Lower extremities (knees, ankles, feet): Apply 4 g to affected area 4 times daily (maximum of 16 g per joint/day); Upper extremities (elbows, wrists, hands): Apply 2 g to affected area 4 times daily (maximum of 8 g per joint/day). Maximum total body dose should not exceed 32 g/day; Pennsaid: Apply 40 drops to affected knee(s) 4 times daily.
• Rect (Adults): Insert 50 mg or 100 mg as single dose to substitute for final oral daily dose (max combined dose [rectal and oral]: 100 mg/day).

Diclofenac Epolamine

• Topical (Adults and Children ≥6 yr): Flector: Apply 1 patch to most painful area twice daily. Licart: Apply 1 patch to most painful area once daily.

diclofenac (Oral): Zorvolex

diclofenac potassium (Oral): Cambia, Cataflam, Lofena, Zipsor

diclofenac sodium (Oral): Voltaren XR

diclofenac sodium (Topical Gel): Solaraze

diclofenac sodium (Topical Solution): Pennsaid

Diclofenac Epolamine (Topical Patch): Flector, Licart

• Inhibits prostaglandin synthesis.

• Suppression of pain and inflammation.
• Relief of acute migraine attacks.
• .
  Topical (3% gel): Clearance of actinic keratosis lesions.

Therapeutic Classification: antirheumatics, nonopioid analgesics

Pharmacologic Classification:

Absorption: Undergoes first-pass metabolism by liver which results in 50% bioavailability. Oral diclofenac sodium is a delayed-release dose form. Diclofenac potassium is an immediate-release dose form. 6–10% of topical gel is systemically absorbed.

Distribution: Crosses the placenta.

Protein Binding: >99%.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP2C9 isoenzyme to several metabolites; 65% excreted in urine, 35% in bile.

Half-life: 2 hr.

diclofenac sodium (Oral): Voltaren, Voltaren SR

Diclofenac Sodium (Rectal Suppository): Voltaren

• Instruct patient to take diclofenac as directed and not take more than recommended. Advise patient to read Medication Guide before starting diclofenac and with each Rx refill in case of changes.
• Migraine: Advise patient that overuse (use more than 10 days/mo) may lead to exacerbation of headache (migraine-like daily headaches, or as a marked increase in frequency of migraine attacks). May require gradual withdrawal of diclofenac and treatment of symptoms (transient worsening of headache).
• Instruct patient to notify health care professional of medication regimen before treatment or surgery.
• Caution patient to avoid concurrent use of alcohol, aspirin, acetaminophen, other NSAIDs, or other OTC medications without consulting health care professional.
• May cause serious side effects: cardiovascular (MI or stroke), GI (ulcers, bleeding), skin (exfoliative dermatitis, SJS, TEN), and hypersensitivity (anaphylaxis). May occur without warning symptoms. Advise patient to stop medication and notify health care professional immediately if symptoms of cardiovascular side effects (chest pain, shortness of breath, weakness, slurring of speech), GI side effects (epigastric pain, dyspepsia, melena, hematemesis), skin side effects (skin rash, blisters, fever, itching), or hypersensitivity reactions (difficulty breathing or swelling of face or throat) occur. Inform patient that risk for heart attack or stroke that can lead to death increases with longer use of NSAIDs and in people who have heart disease and that risk of ulcer increases with concurrent use of corticosteroids and anticoagulants, longer use, smoking, drinking alcohol, older age, and having poor health.
• Advise patient to notify health care professional promptly if unexplained weight gain, swelling of arms and legs or hands and feet, nausea, fatigue, lethargy, rash, pruritus, yellowing of skin or eyes, itching, stomach pain, vomiting blood, bloody or tarry stools, or flu-like symptoms occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially other NSAIDs or aspirin.
• May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise women to avoid diclofenac in the 3rd trimester of pregnancy (after 29 wk); may cause premature closure of the fetal ductus arteriosus. Use of diclofenac after 20 wk may cause fetal renal dysfunction leading to oligohydramnios. May cause reversible infertility in women attempting to conceive; may consider discontinuing diclofenac.
• PO: Instruct patient to take diclofenac with a full glass of water and to remain in an upright position for 15–30 min after administration. Take missed doses as soon as possible within 1–2 hr if taking once or twice a day or unless almost time for next dose if taking more than twice a day. Do not double doses.
  • May cause drowsiness or dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Caution patient to wear sunscreen and protective clothing to prevent photosensitivity reactions.
• Topical: Advise patient to minimize use of concurrent NSAIDs during topical therapy. Instruct patient to read Medication Guide before starting therapy and with each Rx refill in case changes have been made.
  • Pennsaid: Instruct patient to avoid touching treated knee and allowing another person to touch knee until completely dry. Cover knee with clothing until completely dry. Avoid covering lesion with occlusive dressing or tight clothing, and avoid applying sunscreen, insect repellent, lotion, moisturizer, or cosmetics to the affected area. Do not use heating pads, sunlamps, and tanning beds. Protect treated knee from sunlight; wear protective clothes when in sunlight. Avoid showers or baths for at least 30 min after application.
  • Voltaren: Measure dose using the dosing card supplied in the drug product carton. Dosing card is clear polypropylene; use for each application. Apply gel within the rectangular area of the dosing card up to the 2-g or 4-g line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). Apply gel using dosing card. Use hands to gently rub gel into skin. After using dosing card, hold with fingertips, rinse, and dry. If treatment site is the hands, patient should wait at least one hr to wash hands.
  • 3% gel: Advise patient that it may take 60–90 days for complete healing of the lesion to occur.
• Transdermal: Instruct patient on correct application procedure for patch. Apply patch to most painful area. Change patch every 24 hr (Licart) or 12 hr (Flector). Remove patch if irritation occurs. Fold used patches so adhesive sticks to itself and discard where children and pets cannot get them. Encourage patient to read the NSAID Medication Guide that accompanies the prescription.
  • Do not wear patch during bathing or showering. Bathing should take place between scheduled patch removal and application.
  • Instruct patients if patch begins to peel off to tape the edges. Patient may overlay the topical system with a mesh netting sleeve to secure topical systems applied to ankles, knees, or elbows. Mesh netting sleeve (Curad® Hold Tite, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive.
  • Advise patient referred for MRI test to discuss patch with referring health care professional and MRI facility to determine if removal of patch is necessary prior to test and for directions for replacing patch.

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