Solaraze topical

Actinic Keratoses

Treatment of actinic keratoses.1 2 3 4

Contraindications

• Known hypersensitivity to diclofenac or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Sensitivity Reactions

Sensitivity reactions, including anaphylaxis, possible in patients without prior exposure to diclofenac.1 Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps).1

General Precautions

Use with caution in patients with active GI ulceration or bleeding.1

For external use only; avoid contact with eyes.1 Do not apply to open skin wounds, infected lesions, or exfoliative dermatitis.1

Safety and efficacy of concomitant use with other topical products (e.g., sunscreens, cosmetics, other topical medications) unknown.1

Specific Populations

Category B.1 Avoid use in third trimester (possible premature closure of ductus arteriosus) or in late pregnancy (possible delay in labor or parturition).1

Discontinue nursing or the drug because of potential risk to nursing infants.1

Safety and efficacy not established in children.1 Actinic keratoses generally are not seen in the pediatric population; diclofenac sodium gel should not be used by children.1

Actinic keratoses occur frequently in an older patient population.1 No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Use with caution in patients with severe hepatic impairment.1

Use with caution in patients with severe renal impairment.1

Common Adverse Effects

Contact dermatitis, rash, dry skin, exfoliation (scaling).1

NSAIAs

Potential pharmacologic interaction with oral NSAIAs including analgesic/anti-inflammatory dosages of aspirin.1

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure osteoarthritis and will help you only as long as you continue to use it.

Diclofenac topical 3% gel is also used to treat actinic keratosis, a skin problem that may become cancerous if not treated. The exact way that topical diclofenac helps this condition is unknown.

Diclofenac topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.

Diclofenac topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Application site reactions, including skin rash, pain, tingling, or burning sensation
• flu-like syndrome (body ache, headache, fever, with or without chills)
• itching skin

• Blood in the urine
• cough
• dry, itching, or burning eyes
• eye pain
• headaches, including migraines
• increased sensitivity of the skin
• nasal congestion
• pain or tenderness around the eyes and cheekbones
• redness of the skin
• redness or swelling of the eyes
• skin rash other than at the application site
• sore throat
• tightness in the chest
• troubled breathing
• ulcers or sores on the skin, other than at the application site

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning skin
• dry skin
• scaly skin
• thickened skin
• tingling skin

• Acne
• back pain
• belching
• bleeding skin
• chest pain
• diarrhea
• heartburn
• indigestion
• joint pain
• lack or loss of strength
• loss or thinning of the hair
• muscle pain
• neck pain
• runny nose
• stomach upset or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also Warning section.

Rash, scaling, dry skin, swelling, or itching may occur at the application site. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: swelling of the ankles/feet/hands, sudden/unexplained weight gain, unusual tiredness, signs of kidney problems (such as change in the amount of urine).

Other medications similar to this medication may rarely cause serious bleeding from the stomach or intestines. If you notice any of the following rare but very serious side effects, stop using this medication and get medical help right away: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), liver disease, stomach/intestine problems (such as bleeding, ulcers), heart disease (such as previous heart attack), high blood pressure, stroke, swelling (edema, fluid retention), diabetes, blood disorders (such as anemia), bleeding/clotting problems, growths in the nose (nasal polyps).

Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medicine may rarely cause stomach bleeding. Daily use of alcohol and tobacco while using this medicine may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.

Your condition may get worse when exposed to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Wear protective clothing when outdoors. Ask your doctor if you should use sunscreen along with this medication.

Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding, kidney problems and worsening heart problems.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

It is unknown if this form of diclofenac passes into breast milk. Consult your doctor before breast-feeding.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, change in the amount of urine, slow/shallow breathing.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure, complete blood count, liver and kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all regular medical and laboratory appointments.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.