Solaraze

Name: Solaraze

Solaraze Interactions

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.

Solaraze Precautions

  • 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 SolarazeĀ®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

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What are some things I need to know or do while I take Solaraze?

  • Tell all of your health care providers that you take Solaraze. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • If you smoke, talk with your doctor.
  • If you have asthma, talk with your doctor. You may be more sensitive to this medicine.
  • Talk with your doctor before you drink alcohol.
  • Do not use on skin that has any problems.
  • Do not use more than told. Unsafe side effects may happen.
  • Do not use longer than you have been told by the doctor.
  • Avoid sunlight on treated area.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If you are taking aspirin to help prevent a heart attack, talk with your doctor.
  • This medicine may cause harm if swallowed. If Solaraze is swallowed, call a doctor or poison control center right away.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • If you are 65 or older, use Solaraze with care. You could have more side effects.
  • NSAIDs like this medicine may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when Solaraze (diclofenac gel (3%)) is stopped. Talk with your doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
  • Do not give to a child. Talk with your doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Clinical studies

Clinical trials were conducted involving a total of 427 patients (213 treated with Solaraze® and 214 with a gel vehicle). Each patient had no fewer than five AK lesions in a major body area, which was defined as one of five 5 cm x 5 cm regions: scalp, forehead, face, forearm and hand. Up to three major body areas were studied in any patient. All patients were 18 years of age or older (male and female) with no clinically significant medical problems outside of the AK lesions and had undergone a 60-day washout period from disallowed medications (masoprocol, 5-fluorouracil, cyclosporine, retinoids, trichloroacetic acid/lactic acid/peel, 50% glycolic acid peel) and hyaluronan-containing cosmetics. Patients were excluded from participation for reasons of known or suspected hypersensitivity to any Solaraze® ingredient, pregnancy, allergies to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or other dermatological conditions which might affect the absorption of the study medication. Application of dermatologic products such as sunscreens, cosmetics, and other drug products was not permitted. Patients were instructed to apply a small amount of Solaraze® Gel (approximately 0.5 g) onto the affected skin, using their fingers, and gently smoothing the gel over the lesion. In addition, all patients were instructed to avoid sun exposure. Complete clearing of the AK lesions 30 days after completion of treatment was the primary efficacy variable. No long-term patient follow-ups, after the 30-day assessments, were performed for the detection of recurrence.

Complete Clearance of Actinic Keratosis Lesions 30 Days Post-Treatment (all locations)

Solaraze® Gel

Vehicle

p-value

Study 1 90 days treatment

27/58 (47%)

11/59 (19%)

<0.001

Study 2 90 days treatment

18/53 (34%)

10/55 (18%)

0.061

Study 3 60 days treatment

15/48 (31%)

5/49 (10%)

0.021

30 days treatment

7/49 (14%)

2/49 ( 4%)

0.221

Complete Clearance of Actinic Keratosis Lesions 30 Days Post-Treatment (by location)

Scalp

Forehead

Face

Arm/Forearm

Back of Hand

Study 1
90 days
treatment

Solaraze®

1/4 (25%)

17/30 (57%)

9/17 (53%)

4/12 (33%)

6/16 (38%)

Vehicle

3/9 (33%)

8/24 (33%)

5/17 (29%)

4/12 (33%)

0/14 (0)

p-value

0.7646

0.0908

0.1682

1.000

0.0650

Study 2
90 days
treatment

Solaraze®

2/6 (33%)

9/19 (47%)

4/5 (80%)

5/8 (63%)

1/17 (6%)

Vehicle

0/4 (0)

6/22 (27%)

2/8 (25%)

0/5 (0)

3/16 (19%)

p-value

0.4235

0.1870

0.0727

0.0888

0.2818

Study 3
60 days
treatment

Solaraze®

3/7 (43%)

13/31 (42%)

10/19 (53%)

0/1 (0)

2/8 (25%)

Vehicle

0/6 (0)

5/36 (14%)

2/13 (15%)

0/2 (0)

1/9 (11%)

p-value

0.2271

0.0153

0.0433

-

0.4637

30 days
treatment

Solaraze®

2/5 (40%)

4/29 (14%)

3/14 (21%)

0/0 (0)

0/9 (0)

Vehicle

0/5 (0)

2/29 (7%)

2/18 (11%)

0/1 (0)

1/9 (11%)

p-value

0.2299

0.3748

0.4322

-

0.6521

All data
combined

Solaraze®

8/22 (36%)

43/109 (39%)

26/55 (47%)

9/21 (43%)

9/50 (18%)

Vehicle

3/24 (13%)

21/111 (19%)

11/56 (20%)

4/20 (20%)

5/48 (10%)

p-value

0.0903

0.0013

0.0016

0.2043

0.3662

Contraindications

Solaraze® (diclofenac sodium) Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium.

Solaraze® (diclofenac sodium) Gel is contraindicated in the following patients:
- In the setting of coronary artery bypass graft (CABG) surgery.

Overdosage

Due to the low systemic absorption of topically-applied Solaraze® Gel, overdosage is unlikely. There have been no reports of ingestion of Solaraze®. In the event of oral ingestion, resulting in significant systemic side effects, it is recommended that the stomach be emptied by vomiting or lavage. Forced diuresis may theoretically be beneficial because the drug is excreted in the urine. The effect of dialysis or hemoperfusion in the elimination of diclofenac (99% protein-bound) remains unproven. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac. Supportive and symptomatic treatment should be given for complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression.

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