Solaraze

Solaraze is a prescription medication used to treat actinic keratoses (AK), a condition caused by long-term sun exposure in which the skin grows rough, dry, or scaly patches.

Solaraze belongs to a group of drugs called NSAIDs. The exact way it works for AK is not known.

Solaraze comes as a gel and is applied twice a day. 

Common side effects of Solaraze include irritation and redness at the site of application.

Solaraze is a prescription medication used to treat actinic keratoses (AK). This is a condition when the skin grows rough, dry, or scaly patch due to long-term sun exposure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• PharmaDerm, A division of Fougera Pharmaceuticals Inc.

The most common side effects of Solaraze include the following:

• itching
• redness
• irritation
• rash
• dryness
• scaling or peeling

This is not a complete list of Solaraze side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other NSAIDs such as aspirin, ibuprofen, or naproxen
• 'blood thinners' such as warfarin (Coumadin, Jantoven)
• voriconazole (Vfend)
• angiotensin-converting enzyme (ACE) blockers such as
  • benazepril (Lotensin, Lotensin HCT)
  • captopril (Capoten, Capozide)
  • enalapril (Vasotec, Vaseretic)
  • fosinopril (Monopril, Monopril HCT)
  • lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • moexipril (Univasc, Uniretic)
  • quinapril (Accupril, Accuretic, Quinaretic)
  • ramipril (Altace)
  • trandolapril (Mavik, Tarka)
• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• methotrexate (Trexall)
• lithium (Eskalith, Lithobid)
• cyclosporine (Gengraf, Neoral, Sandimmune)

This is not a complete list of Solaraze drug interactions. Ask your doctor or pharmacist for more information.

• Do not use Solaraze if you are allergic to diclofenac (the active ingredient), any inactive ingredient, or aspirin.
• Solaraze should be used with caution in patients with active gastrointestinal ulceration or bleeding
• Solaraze should be used with caution in patients whose kidney and liver are not working well. 
• Do not apply Solaraze to open skin wounds, infections, or exfoliative dermatitis.
• Avoid  Solaraze coming into contact with your eyes. 
• The safety of the concomitant use of sunscreens, cosmetics or other topical medications and Solaraze®is unknown.
• Solaraze is an NSAID medication. Although Solaraze is applied to the skin, some of the medication is absorbed into the blood stream. Therefore taking oral NSAIDS or aspirin may result in increased adverse effects with use of Solaraze.
• Avoid use use of sunlamps and minimize exposure to sunlight when using Solaraze

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Solaraze there are no specific foods that you must exclude from your diet when receiving Solaraze.

Before using Solaraze, tell your doctor if you:

• are allergic to any medications, foods, or dyes
• have asthma or nasal polyps
• have heart, liver, or kidney disease
• have ulcers or stomach bleeding
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless the benefits to the mother justify the potential risk to the fetus. 

Tell your doctor if you are breastfeeding or plan to breastfeed. Because there is a potential for serious adverse reactions in nursing infants from Solaraze, your doctor will decide whether you will stop breastfeeding or stop using this medication.

Solaraze gel is to be applied to the skin twice daily for 60 to 90 days. Use exactly as prescribed. Do not use more or less of it, or use it more often than prescribed by your doctor.

• Wash your hands.
• Apply a small amount of gel on the affected skin, covering it completely, gently smoothing the gel on affected area.
• Use this gel twice daily; apply it in the morning before dressing and at night before going to bed.
• Wash your hands after applying the gel. Do not rub or touch your eyes before washing your hands.
  • What to avoid:
    • Be careful not to get this medication in your eyes if you are applying it to your face.
    • Do not apply to open wounds (broken skin), infections, or red, scaly skin.
    • Wear protective clothing, and avoid prolonged sun exposure.
    • Do not use sunscreens, cosmetics, or other medications applied to the skin during treatment.
    • Do not cover treated areas with dressings or bandages.

Apply Solaraze to lesion areas twice daily. It is to be smoothed onto the affected skin gently.

• The amount needed depends upon the size of the lesion site.
• Assure that enough gel is applied to adequately cover each lesion. Normally 0.5 grams of gel is used on each 5 cm x 5 cm lesion site.
• The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be apparent for up to 30 days following cessation of therapy.

If you apply too much Solaraze, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.