Solaraze

DRUG DESCRIPTION

Solaraze® (diclofenac sodium) Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether. The chemical name for diclofenac sodium is:

Sodium [o-(2,6-dichloranilino) phenyl] acetate

Diclofenac sodium has a molecular weight of 318.13.

The CAS number is CAS-15307-79-6. The structural formula is represented below:

Solaraze® (diclofenac sodium) Illustration

Solaraze® Gel also contains benzyl alcohol, hyaluronate sodium, polyethylene glycol monomethyl ether, and purified water.

1 g of Solaraze® (diclofenac sodium) Gel contains 30 mg of the active substance, diclofenac sodium.

What are the possible side effects of diclofenac topical (Flector Patch, Solaraze, Voltaren 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,...

Read All Potential Side Effects and See Pictures of Solaraze »

What are the precautions when taking diclofenac sodium (Solaraze)?

Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver...

Read All Potential Precautions of Solaraze »


Solaraze Consumer (continued)

SIDE EFFECTS: Rash, scaling, dry skin, or itching may occur at 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: eye redness/itching, headache, shortness of breath, muscle pain, swelling at application site.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, easy bruising/bleeding, unexplained stiff neck, signs of infection (e.g., fever, persistent sore throat), persistent/severe headache, swelling hands/feet, sudden/unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), mental/mood changes (e.g., depression), fast/pounding heartbeat, fainting.

Other medications similar to this medication may infrequently cause serious bleeding from the stomach or intestines. Also, related drugs rarely have caused blood clots to form, resulting in heart attacks and strokes. If you notice any of the following rare but very serious side effects, stop using this medication and seek immediate medical attention: black/bloody stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, sudden vision changes, weakness on one side of the body, slurred speech.

This drug may rarely cause serious (possibly fatal) liver problems. Stop using diclofenac and tell your doctor immediately if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdomen pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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

PRECAUTIONS: Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach/intestine problems (e.g., bleeding, ulcers), heart disease (e.g., heart failure, history of heart attack), high blood pressure, stroke, swelling (edema, water retention), poorly controlled diabetes, a severe loss of body water (dehydration), blood disorders (e.g., anemia, bleeding/clotting problems), asthma, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist that you are using this medication.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

Your condition may get worse when exposed to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Wear protective clothing when outdoors. Ask your doctor whether 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 and kidney effects.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and problems with normal labor/delivery. Discuss the risks and benefits with your doctor.

Based on information from related drugs, this medication may pass into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Solaraze Patient Information Including Side Effects

Brand Names: Flector Patch, Solaraze, Voltaren Topical

Generic Name: diclofenac topical (Pronunciation: dye KLOE fen ak)

  • What is diclofenac topical (Solaraze)?
  • What are the possible side effects of diclofenac topical (Solaraze)?
  • What is the most important information I should know about diclofenac topical (Solaraze)?
  • What should I discuss with my healthcare provider before using diclofenac topical (Solaraze)?
  • How should I use diclofenac topical (Solaraze)?
  • What happens if I miss a dose (Solaraze)?
  • What happens if I overdose (Solaraze)?
  • What should I avoid while using diclofenac topical (Solaraze)?
  • What other drugs will affect diclofenac topical (Solaraze)?
  • Where can I get more information?

What is diclofenac topical (Solaraze)?

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

Diclofenac topical skin patch (Flector Patch) is used to treat pain caused by minor sprains, strains, or bruising.

Diclofenac topical 1% gel (Voltaren Topical) 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% (Solaraze) 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 are the possible side effects of diclofenac topical (Solaraze)?

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

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

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.

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.

Related Drug Centers
  • Flector Patch
  • Voltaren Gel
  • Solaraze


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