PENNSAID, Solaraze, Voltaren, Voltaren-XR
Classifications: NONSTEROIDAL ANALGESIC, ANTI-INFLAMMATORY DRUG (NSAID)
Therapeutic: ANALGESIC, NSAID; ANTIPYRETIC
Diclofenac Sodium: Delayed release tablet; sustained release tablet; ophth solution; gel;
topical solution. Diclofenac
Potassium: Tablet; powder for solution. Diclofenac Epolamine: Transdermal patch
ACTION & THERAPEUTIC EFFECT
Diclofenac competitively
inhibits both cyclooxygenase (COX) isoenzymes, COX-1 and COX-2, by blocking arachidonic
acid conversion to other chemicals, thus leading to its analgesic, antipyretic,
and anti-inflammatory effects. It appears to be a potent inhibitor of
cyclooxygenase, thereby decreasing the synthesis of prostaglandins. Nonsteroidal anti-inflammatory drug (NSAID) with analgesic
and antipyretic activity.
Analgesic and antipyretic effects in symptomatic
treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Also
acute gout; juvenile rheumatoid
arthritis; various rheumatic conditions. Ophthalmic: Cataract surgery; photophobia associated with refractive surgery. Topical: Treatment of actinic keratosis. Transdermal: Acute pain.
Hypersensitivity to diclofenac, NSAIDS, or salicylate; patients in whom asthma, urticaria, angioedema,
bronchospasm, severe rhinitis, history of GI bleeding; hepatic porphyria; shock,
or other sensitivity reaction is precipitated by aspirin or other NSAIDS; perioperative CABG pain.
Patients receiving anticoagulant therapy;
diabetes mellitus; history of GI disease or bleeding; hepatic disease; GU tract
problems such as dysuria, cystitis, hematuria, nephritis, nephrotic syndrome,
patients who must restrict their sodium intake; impaired hepatic function; SLE;
heart failure, cardiac disease; hypertension; older adults, children; pregnancy
(category C), lactation.
Adult: PO 150–200 mg/day in 3–4 divided doses or 75 mg delayed release daily
or 100 mg sustained release daily
Child: PO 25 mg b.i.d. or t.i.d. Osteoarthritis
Adult: PO 100–150 mg/day in 3–4 divided doses; 75 mg delayed release daily;
100 mg sustained release daily Topical (gel)
4 g for each knee, ankle or foot
q.i.d. (solution) 40 drops to each affected knee q.i.d.
Adult: PO 25 mg q.i.d. and 25 mg at bedtime
Adult: Ophthalmic 1 drop of 0.1% solution in affected eye q.i.d. beginning 24 h
after surgery and continuing for 2 wk
Adult: Topical Apply to affected area b.i.d. for 60–90 days
- Ensure that sustained release forms of drug are
not chewed or crushed. Must be swallowed whole.
- Minimize gastric irritation by administering it
with a full glass of milk or food.
- Store at 15°–30° C (59°–86° F) away from heat
and direct light.
- Do not apply gel or patch to areas of skin
irritation.
- Massage gel into skin of entire affected area.
Do not wash area within 1 hr of application.
- Avoid application of any other topical products
to treated area.
- Do not apply external heat or occlusive dressing
to treated area.
CNS: Dizziness, headache,
drowsiness. Special Senses: Tinnitus. Skin: Rash, pruritus.
GI: Dyspepsia, nausea, vomiting,
abdominal pain, cramps, constipation, diarrhea, indigestion, abdominal
distension, flatulence, peptic ulcer; liver enzymes, transaminases increased,
liver test abnormalities. CV: Fluid retention, hypertension,
CHF. Respiratory: Asthma. Body as a
Whole: Back, leg, or joint pain. Endocrine: Hyperglycemia.
Hematologic: Prolonged bleeding time;
inhibits platelet aggregation.
DIAGNOSTIC
TEST INTERFERENCE
Liver
function test values may be increased. Liver
function test abnormalities may return to normal despite
continued use; however, if significant
abnormalities occur, clinical signs and symptoms consistent with liver
disease develop, or systemic manifestations such as
eosinophilia or rash occur, the medication should be discontinued. Serum
uric acid concentrations may be
decreased because of increased renal clearance.
Drug: Increases cyclosporine-induced
nephrotoxicity; increases methotrexate levels
(increases toxicity); may decrease BP-lowering effects of DIURETICS; may
increase levels and toxicity of lithium; may
increase digoxin levels. Herbal: Feverfew, garlic,
ginger, ginkgo may increase risk of bleeding.
Absorption: Readily
absorbed from GI tract; 50–60% reaches systemic circulation. Peak: 2–3 h. Distribution:
Widely distributed including synovial fluid and into breast milk; 99% protein bound. Metabolism: Extensively metabolized in liver. Elimination: 50–70% in urine, 30–35% in feces. Half-Life: 1.2–2 h (PO); 12 h (transdermal).
Diclofenac has been
associated with increased risk of serious, potentially fatal, CV thrombotic events
(i.e., MI and stroke). Risk may increase with duration of use and may be
greater in those with risk factors for CV disease.
Assessment & Drug Effects
- Monitor for signs and symptoms of GI irritation
and ulceration especially in the the older adult.
- Monitor for and report promptly S&S of CV
thrombotic events (i.e., angina, MI, TIA, or stroke).
- Monitor BP for new onset or worsening of
preexisting hypertension.
- Monitor diabetics closely for loss of diabetic
glycemic control.
- Monitor for increased serum sodium and potassium
in patients receiving potassium-sparing diuretics.
- Monitor for S&S of CHF, including weight
gains greater than 1 kg (2 lb)/24 h.
- Monitor lab tests: Periodic LFTs, serum uric
acid concentrations, Hct, PT/INR, and blood glucose.
Patient & Family Education
- Seek immediate medical attention if you
experience S&S of adverse cardiovascular effects, such as chest pain,
shortness of breath, weakness, or slurring of speech.
- Report immediately to prescriber S&S of
serious GI irritation, such as stomach pain, frequent indigestion, tarry
stools, or vomiting blood.
- Be alert for S&S of adverse skin reactions.
Report promptly development of rash, blisters, or other skin reactions.
- Do not take aspirin or other OTC analgesics
without permission of the prescriber.
- Avoid alcohol or other CNS depressants.
- Do not drive or engage in other potentially
hazardous activities until reaction to drug is known.
- Diabetics should monitor blood glucose carefully
for loss of glycemic control.
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