VOLTAREN ARTHRITIS PAIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VOLTAREN ARTHRITIS PAIN (VOLTAREN ARTHRITIS PAIN).
Non-selective cyclooxygenase (COX-1 and COX-2) inhibitor, reducing prostaglandin synthesis.
| Metabolism | Hepatic metabolism via CYP2C9; also undergoes conjugation (glucuronidation) and hydroxylation. |
| Excretion | Renal (65% as metabolites, <1% unchanged); biliary/fecal (35% as metabolites). |
| Half-life | Approximately 2 hours; terminal half-life may be prolonged in elderly (up to 4 hours) or hepatic impairment. |
| Protein binding | >99% bound to albumin. |
| Volume of Distribution | 0.1–0.2 L/kg; primarily distributes to synovial fluid (concentrations up to 50% of plasma). |
| Bioavailability | Oral: 100% (immediate-release); topical: approximately 6% systemic absorption. |
| Onset of Action | Oral: 30 minutes; topical: 2–4 hours. |
| Duration of Action | Oral: 4–6 hours; topical: 6–8 hours; clinical effect may persist longer with regular dosing. |
| Molecular Weight | 296.15 |
Oral: 50 mg twice daily or 75 mg twice daily for osteoarthritis; immediate-release: 50 mg three times daily for rheumatoid arthritis. Maximum daily dose: 150 mg.
| Dosage form | GEL |
| Renal impairment | GFR >30 mL/min: no adjustment. GFR 10-30 mL/min: dose reduction to 50 mg once daily or avoid use. GFR <10 mL/min: contraindicated. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% (maximum 75 mg/day). Child-Pugh C: contraindicated. |
| Pediatric use | For juvenile idiopathic arthritis: 1-2 mg/kg/day in 2-3 divided doses, maximum 3 mg/kg/day or 150 mg/day. For children <1 year: not recommended. |
| Geriatric use | Start at lowest effective dose (e.g., 50 mg once daily). Increase cautiously; maximum 100 mg/day. Monitor renal function and GI bleeding risk. |
| 1st trimester | Avoid: NSAIDs are associated with increased risk of miscarriage and congenital malformations, particularly cardiac defects, if used in early pregnancy. |
| 2nd trimester | Caution: Use only if clearly needed and at the lowest effective dose for the shortest duration; avoid during weeks 20-30 due to risk of oligohydramnios and fetal renal impairment. |
| 3rd trimester | Contraindicated: NSAIDs can cause premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment; avoid after 30 weeks gestation. |
Clinical note
Comprehensive clinical and safety monograph for VOLTAREN ARTHRITIS PAIN (VOLTAREN ARTHRITIS PAIN).
| Placental transfer | Diclofenac crosses the human placenta; present in fetal serum at concentrations similar to maternal serum. |
| Breastfeeding | Diclofenac is excreted into breast milk in low amounts (less than 1% of maternal dose). However, due to potential adverse effects on the infant's cardiovascular and renal systems, caution is advised. Use only if clearly needed and monitor the infant for side effects. |
■ FDA Black Box Warning
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIDs are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
| Serious Effects |
Hypersensitivity to diclofenac or any componentHistory of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsSevere uncontrolled heart failureActive peptic ulcer or gastrointestinal bleedingHistory of gastrointestinal bleeding or perforation related to previous NSAID therapySevere hepatic or renal impairment (eGFR < 30 mL/min/1.73 m2)Coronary artery bypass graft (CABG) surgery perioperative painThird trimester of pregnancy
| Precautions | Cardiovascular thrombotic events; gastrointestinal bleeding, ulceration, and perforation; hypertension; congestive heart failure and edema; renal toxicity; anaphylactoid reactions; serious skin reactions; hematologic toxicity; ophthalmic effects; hepatic effects; asthma; masking of inflammation and fever. |
Loading safety data…
| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | First trimester: Risk of miscarriage and congenital malformations (cardiac, gastroschisis) increased; avoid use. Second trimester: Possible oligohydramnios and fetal renal impairment. Third trimester: High risk of premature closure of ductus arteriosus, persistent pulmonary hypertension, oligohydramnios; contraindicated after 30 weeks gestation. |
| Fetal Monitoring | Monitor fetal ultrasound for oligohydramnios and ductus arteriosus patency if used beyond 20 weeks. Maternal monitoring of blood pressure, renal function, and gastrointestinal symptoms. Discontinue if oligohydramnios or ductal constriction detected. |
| Fertility Effects | Reversible inhibition of ovulation via cyclooxygenase inhibition affecting prostaglandin synthesis; may delay or prevent conception. Use in women attempting to conceive should be limited. |
| Food/Dietary |
| No specific food interactions with topical diclofenac. However, high-fat meals may increase systemic absorption if gel is applied over large areas; advise avoiding excessive intake of fatty foods when using large doses. Alcohol may increase risk of gastrointestinal irritation if oral NSAIDs are taken concurrently; avoid excessive alcohol consumption. |
| Clinical Pearls | Voltaren Arthritis Pain (diclofenac sodium topical gel 1%) is indicated for osteoarthritis of superficial joints (e.g., hands, knees). Apply 2-4 g per affected joint four times daily. Maximum total daily dose is 32 g for upper extremities and 16 g for lower extremities. Avoid contact with eyes and mucous membranes. Use for at least 4 weeks to assess efficacy. Do not apply to open wounds or infected areas. Concurrent use of oral NSAIDs increases risk of GI and renal toxicity; consider cumulative dose. Monitor for signs of local site reactions or systemic effects, especially in elderly or those with renal impairment. |
| Patient Advice | Apply the gel to clean, dry skin only on the painful joint. Do not use on broken skin, cuts, or infections. · Use the enclosed dosing card to measure the correct amount: 2 to 4 grams per joint, up to four times daily. · Do not exceed 32 grams per day for hands, wrists, elbows, or 16 grams per day for knees, ankles, or feet. · Wash hands immediately after applying unless treating hands; then wait 1 hour before washing. · Allow the gel to dry for several minutes before covering the area with clothing or gloves. · Avoid applying sunscreen, cosmetics, lotions, or other topical products to the treated skin. · Do not use heat (e.g., heating pad) or bandage the treated area. · Inform your doctor if you have a history of stomach ulcers, bleeding, kidney disease, or are taking blood thinners. · Stop use and contact your doctor if you develop a rash, swelling, or worsening pain in the treated area. · Keep out of reach of children and pets. In case of accidental ingestion, seek medical attention. |