What is Solaraze?

Therapeutic ClassificationsAnti-Inflammatory

Pharmacologic ClassificationsNSAID

Blackbox WarningTOP

Topical route (Gel/Jelly;Solution)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac sodium is contraindicated in the setting of coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .

Topical application route (Patch, Extended Release)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac epolamine is contraindicated in the setting of coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .

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OverviewTOP

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.

Proper UseTOP

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. This medicine is not for long-term use.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To use the skin patch:

Use this medicine exactly as directed by your doctor. It will work only if applied correctly.
Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands. If it gets into your eyes, wash the eyes right away with water or saline. If eye irritation persists for more than one hour, call your doctor.
Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
Apply the patch to a clean, dry, intact skin area. Choose an area with little or no hair and free of scars, cuts, or irritation. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well. If the patch begins to peel off, the edges of the patch may be taped down.
If the patch still peels off, it may be used with a mesh netting sleeve (eg, Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) to hold the patch applied to the ankles, knees, or elbows. The mesh netting sleeve must not be occlusive and must allow air to pass through.
Do not use the patch when you take a bath or shower.
To help you remember to use your medicine, try to get into the habit of using it at regular times. If you are using the skin patch, try to change it at the same time and day of the week.

To use the topical gel:

Wash your hands before and after using this medicine.
For Voltaren® 1% topical gel: Use the enclosed dosing card to measure the correct dose. The gel should be applied within the oblong area of the dosing card up to the 2 or 4 gram line (2 grams for each elbow, wrist, or hand, and 4 grams for each knee, ankle, or foot).
Apply the medicine very carefully to clean, dry skin, and avoid getting any in your eyes, nose, or mouth.
Do not apply this medicine to areas with broken skin or open wounds, infection, or severely peeling skin.
Apply enough medicine each time to cover the entire affected area.
Do not use heating pads or cover the treated area with a bandage unless your doctor has told you to.
Do not use cosmetics (eg, makeup or sunscreens) or other skin care products on the same skin areas where you have applied this medicine.
For Voltaren® 1% topical gel: After applying this medicine, do not shower, bathe, or wash the affected area for at least 1 hour. Wait for at least 10 minutes before covering the treated skin with gloves or clothing.

To use the topical solution:

Use this medicine exactly as directed by your doctor. It will work only if applied correctly. Do not apply this medicine anywhere on your body other than where your doctor tells you.
Wash your hands with soap and water before and after applying the solution. If you get this medicine in your eyes, wash the eyes right away with water or saline. If eye irritation persists for more than 1 hour, call your doctor.
Apply the solution to a clean, dry, intact skin area. Choose an area free of open wounds scars, cuts, or irritation.
Put 10 drops of the solution at a time on your hand or directly to your knee. Apply the solution evenly on the front, back, and sides of your knee.
After using the Pennsaid® solution, wait for at least 30 minutes before showering or bathing.
Do not use external heat or dressings to the treated knee. Avoid wearing clothing or applying skin care products, such as sunscreen, insect repellant, lotion, moisturizer, or cosmetics, over the treated knee until the skin is completely dry.
Avoid skin-to-skin contact between other people and the treated knee until the skin is completely dry.
Protect the treated knee from sunlight.

DosingTOP

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage form (gel):
- For actinic keratosis using Solaraze® 3% gel:
  - Adults—Apply to affected skin area two times a day.
  - Children—Use and dose must be determined by your doctor.
- For osteoarthritis of the hands, elbows, or wrists using Voltaren® 1% gel:
  - Adults—Apply 2 grams to the affected skin areas four times a day (a total of 8 grams each day). However, the total dose should not exceed 32 grams per day over all affected joints. Use the enclosed dosing card to measure the appropriate dose.
  - Children—Use and dose must be determined by your doctor.
- For osteoarthritis of the knees, ankles, or feet using Voltaren® 1% gel:
  - Adults—Apply 4 grams to the affected skin areas four times a day (a total of 16 grams each day). However, the total dose should not exceed 32 grams per day over all affected joints. Use the enclosed dosing card to measure the appropriate dose.
  - Children—Use and dose must be determined by your doctor.
For topical dosage form (solution):
- For osteoarthritis of the knee:
  - Adults—40 drops (10 drops at a time) on each affected knee four times a day.
  - Children—Use and dose must be determined by your doctor.
For transdermal dosage form (skin patch):
- For acute pain:
  - Adults—One patch applied to the painful area two times a day.
  - Children—Use and dose must be determined by your doctor.

Missed DoseTOP

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Use & StorageTOP

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of diclofenac topical in the pediatric population. Safety and efficacy have not been established.

GeriatricTOP

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac topical in the elderly. However, elderly patients are more likely to have age-related kidney, heart, or stomach problems, which may require caution and an adjustment in the dose for patients receiving diclofenac topical.

PregnancyTOP

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast FeedingTOP

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab
Aceclofenac
Acemetacin
Acenocoumarol
Amiloride
Amineptine
Amitriptyline
Amitriptylinoxide
Amoxapine
Amtolmetin Guacil
Anagrelide
Apixaban
Ardeparin
Argatroban
Aspirin
Balsalazide
Bemiparin
Bendroflumethiazide
Benzthiazide
Betamethasone
Betrixaban
Bismuth Subsalicylate
Bivalirudin
Bromfenac
Budesonide
Bufexamac
Bumetanide
Cangrelor
Celecoxib
Ceritinib
Certoparin
Chlorothiazide
Chlorthalidone
Choline Magnesium Trisalicylate
Choline Salicylate
Cilostazol
Citalopram
Clomipramine
Clonixin
Clopamide
Clopidogrel
Cortisone
Cyclopenthiazide
Cyclosporine
Dabigatran Etexilate
Dalteparin
Danaparoid
Deferiprone
Deflazacort
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Diazoxide
Dibenzepin
Diclofenac
Diflunisal
Digoxin
Dipyridamole
Dipyrone
Dothiepin
Doxepin
Droxicam
Duloxetine
Edoxaban
Enoxaparin
Eplerenone
Epoprostenol
Eptifibatide
Escitalopram
Ethacrynic Acid
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Feverfew
Floctafenine
Flufenamic Acid
Fluocortolone
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Furosemide
Ginkgo
Gossypol
Heparin
Hydrochlorothiazide
Hydrocortisone
Hydroflumethiazide
Ibuprofen
Iloprost
Imipramine
Indapamide
Ketoprofen
Lepirudin
Levomilnacipran
Lithium
Lofepramine
Lornoxicam
Loxoprofen
Lumiracoxib
Magnesium Salicylate
Meadowsweet
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Mesalamine
Methotrexate
Methyclothiazide
Methylprednisolone
Metolazone
Milnacipran
Morniflumate
Nabumetone
Nadroparin
Naproxen
Nefazodone
Nepafenac
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nortriptyline
Olsalazine
Opipramol
Oxaprozin
Oxyphenbutazone
Paramethasone
Parecoxib
Parnaparin
Paroxetine
Pemetrexed
Pentosan Polysulfate Sodium
Pentoxifylline
Phenindione
Phenprocoumon
Phenylbutazone
Phenyl Salicylate
Piketoprofen
Piroxicam
Polythiazide
Pralatrexate
Prasugrel
Prednisolone
Prednisone
Proglumetacin
Propyphenazone
Proquazone
Protein C
Protriptyline
Reboxetine
Reviparin
Rivaroxaban
Rofecoxib
Salicylamide
Salicylic Acid
Salsalate
Sertraline
Sibutramine
Sodium Salicylate
Spironolactone
Sulfasalazine
Sulindac
Tacrolimus
Tenofovir Disoproxil Fumarate
Tenoxicam
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tinzaparin
Tirofiban
Tolfenamic Acid
Tolmetin
Torsemide
Treprostinil
Triamterene
Trichlormethiazide
Trimipramine
Trolamine Salicylate
Valdecoxib
Venlafaxine
Vilazodone
Vorapaxar
Vortioxetine
Warfarin
Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Alacepril
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Candesartan
Captopril
Carteolol
Carvedilol
Celiprolol
Cilazapril
Ciprofloxacin
Delapril
Enalapril
Enalaprilat
Eprosartan
Esmolol
Fosinopril
Imidapril
Irbesartan
Labetalol
Levobunolol
Lisinopril
Losartan
Metipranolol
Metoprolol
Moexipril
Nadolol
Nebivolol
Olmesartan
Oxprenolol
Penbutolol
Pentopril
Perindopril
Pindolol
Practolol
Propranolol
Quinapril
Ramipril
Sotalol
Spirapril
Telmisartan
Temocapril
Timolol
Trandolapril
Valsartan
Zofenopril

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

PrecautionsTOP

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure this medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid medicine or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.

This medicine may cause a serious allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. Do not use this medicine during the latter part of a pregnancy unless your doctor tells you to.

If your symptoms become worse, check with your doctor.

Diclofenac may cause redness, soreness, scaling, and peeling of the affected skin. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

While using this medicine, your skin may become more sensitive to sunlight than usual, and too much sunlight may increase the effects of the medicine. During this period of time:

Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.
Wear protective clothing, including a hat and sunglasses.
Do not use a sunlamp or tanning bed or booth.
Make sure you have discussed the use of a sun block product with your doctor.

If you have a severe reaction from the sun, check with your doctor.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Chemical ClassificationsTOP

Acetic Acid (class)