Voltaren Gel: Black Box Warnings

Voltaren Gel: Adult Dosing

Dosage forms: 1% gel

osteoarthritis

lower extremity joints

Dose: apply 4 g qid; Max: 32 g/day total, 16 g/joint/day; Info: includes knees, ankles, feet; use supplied dosing card; avoid occlusive dressings or heat; D/C if abnormal liver or renal tests persist or worsen

upper extremity joints

Dose: apply 2 g qid; Max: 32 g/day total, 8 g/joint/day; Info: includes elbows, wrists, hands; use supplied dosing card; avoid occlusive dressings or heat; D/C if abnormal liver or renal tests persist or worsen

renal dosing

see below

advanced renal dz: avoid use or closely monitor renal fxn

hepatic dosing

not defined

hepatic impairment: caution advised

Voltaren Gel: Peds Dosing

This information is currently unavailable or not applicable for this drug.

Voltaren Gel: Contraindications/Cautions

• hypersens. to drug/class/compon.
• ASA/NSAID-induced asthma or urticaria
• aspirin triad
• CABG surgery (periop pain)
• pregnancy, 3rd trimester
• avoid use on open wounds/inflamed skin
• avoid sun/UV light exposure
• avoid concomitant topical product use at appl. site
• caution if cardiovascular dz
• caution if cardiac risk factors
• caution if HTN
• caution if CHF
• caution if fluid retention
• caution if PUD/GI bleed hx
• caution if corticosteroid use
• caution if anticoagulant use
• caution if coagulopathy
• caution if alcohol use
• caution if smoker
• caution in elderly or debilitated pts
• caution if impaired liver fxn
• caution if elevated liver transaminases
• caution if impaired renal fxn
• caution if dehydration
• caution if diuretic use
• caution if ACEI or ARB use
• caution if asthma
• caution if prolonged use

Voltaren Gel: Drug Interactions

Contraindicated

• cidofovir

Avoid/Use Alternative

• aspirin

• aspirin, buffered/pravastatin

• aspirin/caffeine/CNS depressant combos

• aspirin/caffeine/orphenadrine

• aspirin/dipyridamole

• aspirin/muscle relaxant combos

• aspirin/opiate combos

• COX 2 inhibitors

• mycophenolate mofetil

• mycophenolic acid

• NSAIDs

• sumatriptan/naproxen sodium

Monitor/Modify Tx

• amlodipine/A2R blocker combos

• enalapril/felodipine

• lithium

Caution Advised

• A2R blocker/HCTZ combos

• ACE inhibitor/HCTZ combos

• ACE inhibitors

• acetaminophen/butalbital

• acetaminophen/caffeine/CNS depressant combos

• acetaminophen/opiate combos

• acetaminophen/propoxyphene

• acetaminophen/tramadol

• acetaminophens

• adefovir

• angiotensin II receptor blockers

• antiplatelets

• beta blocker/thiazide combos

• beta blockers, systemic

• bisphosphonates, oral

• bivalirudin

• budesonide

• corticosteroids, systemic

• cyclosporine

• darunavir

• dasatinib

• desvenlafaxine

• diuretics, loop

• diuretics, potassium-sparing

• diuretics, potassium-sparing/HCTZ

• diuretics, thiazide

• donepezil

• drospirenone

• drotrecogin alfa

• eplerenone

• erlotinib

• ethanol

• fondaparinux

• galantamine

• heparins

• hydralazine

• hydralazine/isosorbide dinitrate

• hydrocodone/ibuprofen

• ibritumomab tiuxetan

• ibuprofen/oxycodone

• iloprost inhaled

• lansoprazole/naproxen

• leflunomide

• methotrexate

• neostigmine

• NSAIDs, ophthalmic

• olanzapine/fluoxetine

• omega-3-acid

• pemetrexed

• pentosan polysulfate sodium

• pentoxifylline

• platelet GP IIb/IIIa inhibitors

• polyethylene glycol/electrolytes

• probenecid

• pyridostigmine

• quinolones, all

• rivastigmine

• sirolimus

• sodium phosphate

• SSRIs, all

• sulfinpyrazone

• tacrine

• tacrolimus

• thrombin inhibitors

• thrombolytics

• tipranavir

• treprostinil

• valproic acid derivatives

• warfarin

• zoledronic acid

Voltaren Gel: Adverse Reactions

Serious Reactions

• anaphylactoid rxns
• bronchospasm
• exfoliative dermatitis
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• HTN
• renal papillary necrosis
• nephrotoxicity
• hepatotoxicity
• GI bleed
• GI ulceration/perforation
• MI
• stroke
• thromboembolism
• anemia
• prolonged bleeding time

Common Reactions

• application site rxn

Voltaren Gel: Safety Monitoring

Pregnancy: C, see Contraind/Caut.

Lactation: Probably Safe

Monitoring Parameters: Cr at baseline, then if severe renal dz cont. periodically; ALT/AST w/in 4-8wk of tx initiation, then periodically if long-term tx; CBC, chemistry profile if long-term tx; BP

Voltaren Gel: Pharmacology

Metabolism: liver extensively; CYP450: 2C9, 3A4 substrate; Info: systemic exposure approx. 6% that of oral diclofenac

Excretion: urine 65% (<1% unchanged), bile 35%; Half-life: 1.9h

Class: NSAIDs

Mechanism Of Action
exact mechanism of action unknown; inhibits cyclooxygenase and lipoxygenase and reduces prostaglandin synthesis

Voltaren Gel: Manufacturer/Pricing

Manufacturer: Novartis Pharmaceuticals Corp. DEA/FDA: Rx

Voltaren Gel: Patient Education

• Generic Name: diclofenac topical

• Pronounced: die KLO feh nak

• Brand Names: Solaraze, Voltaren Topical

What is the most important information I should know about diclofenac topical?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have a history of stomach ulcer or bleeding, liver or kidney disease, high blood pressure, or congestive heart failure.

Do not use cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products not prescribed by your doctor. These products may interfere with diclofenac topical, or increase skin irritation.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds) while you are using diclofenac topical.

While the risk of absorbing diclofenac topical into your bloodstream is low, all non-steroidal anti-inflammatory drugs (NSAIDs) can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use diclofenac topical just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are using an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What is diclofenac topical?

Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Diclofenac topical 1% gel is used to treat joint pain in the hands, wrists, elbows, knees, ankles, or feet caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 3% gel is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body.

Diclofenac topical may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using diclofenac topical?

Do not use this medication if you are allergic to diclofenac (Cataflam, Voltaren).

While the risk of absorbing diclofenac topical into your bloodstream is low, all NSAIDs can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use diclofenac topical just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are using an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Before using diclofenac topical, tell your doctor if you are allergic to any drugs, or if you have:

• a history of asthma or severe allergic reaction after taking aspirin or any NSAID;
• a history of stomach ulcer or bleeding;
• liver disease;
• kidney disease;
• high blood pressure; or
• congestive heart failure.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use diclofenac topical.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Diclofenac topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use diclofenac topical?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

This medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use diclofenac topical on an open skin wound. Wait until the condition has fully healed before using diclofenac topical.

Do not cover the treated skin with a bandage or expose it to heat from a hot tub, heating pad, sauna, or heated water bed. Heat or bandaging can increase the amount of drug you absorb through your skin and may cause harmful effects.

Wash your hands after applying this medication, unless you are treating the skin on your hands. Do not wear gloves for at least 10 minutes after applying diclofenac topical to the hands.

After you apply this medication, wait at least 10 minutes before dressing. Do not bathe or shower for at least 1 hour after applying diclofenac topical.

To treat actinic keratosis (with Solaraze): Apply enough gel to cover each lesion and rub in gently. You may need to use the medication for up to 90 days. Follow your doctor's instructions.

Do not apply Solaraze gel more than 2 times daily and never use more than your prescribed dose.

To treat osteoarthritis pain (with Voltaren Topical gel): This medicine is supplied with dosing cards that show you how much gel to use for a 2-gram dose or a 4-gram dose. Squeeze the gel onto this card along the line for your dose. Use no more gel than will fit on the length of your dosing line. Wipe the card directly onto the treatment area and rub gently into the skin. Each dosing card is for only one use.

When treating arthritis pain in the foot, spread the gel out onto all areas of the foot including the toes and soles. When treating the hand, spread the gel out onto all areas of the hand including the fingers and palms.

When treating osteoarthritis, keep using any oral medications your doctor has prescribed.

Do not apply Voltaren Topical gel more than 4 times daily and never use more than your prescribed dose. Always use a dosing card to measure your dose. Fold the card and throw it away in a place where children and pets cannot get to it. A used dosing card will still have a small amount of diclofenac gel on it.

Store diclofenac topical at room temperature away from moisture and heat. Keep from freezing.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of diclofenac topical applied to the skin is unlikely to occur. Seek emergency medical attention if anyone has accidentally swallowed the medication.

What should I avoid while using diclofenac topical?

Do not use cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products not prescribed by your doctor. These products may interfere with diclofenac topical, or increase skin irritation.

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds) while you are using diclofenac topical.

While you are using diclofenac topical, avoid taking oral (pill form) NSAIDs such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

What are the possible side effects of diclofenac topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• swelling or rapid weight gain;
• urinating less than usual or not at all;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

• dryness or itching of treated skin;
• peeling or scaling of treated skin; or
• fever, chills, sore throat, body aches or other flu symptoms.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect diclofenac topical?

Before using diclofenac topical, tell your doctor if you are taking any of the following drugs:

• a blood thinner such as warfarin (Coumadin);
• cyclosporine (Neoral, Sandimmune);
• lithium (Eskalith, Lithobid);
• methotrexate (Rheumatrex, Trexall);
• diuretics (water pills) such as furosemide (Lasix).
• steroids (prednisone and others);
• aspirin or other NSAIDs such as etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or
• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

It is not likely that other drugs you take orally or inject will have an effect on topically applied diclofenac. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about diclofenac topical.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Voltaren Gel: Pill Pictures

This information is currently unavailable or not applicable for this drug.