Voltaren

Arthritis Management

Voltaren is primarily used to treat the symptoms of chronic inflammatory conditions. It helps reduce the pain, inflammation, and stiffness associated with:

• Osteoarthritis: A condition where the protective cartilage on the ends of bones wears down over time.
• Rheumatoid arthritis: An autoimmune disorder that causes painful swelling and joint deformity.
• Ankylosing spondylitis: A type of arthritis that primarily affects the spine and large joints.

Topical Treatment

Topical forms of Voltaren, such as gels and solutions, are used to treat joint pain caused by osteoarthritis in specific areas of the body. These products are applied directly to the skin to target pain in joints that are close to the surface, including the:

• Hands, wrists, and elbows
• Knees, ankles, and feet

The topical gel is specifically indicated for osteoarthritis pain and is not typically used for immediate relief of acute injuries, such as strains or sprains. It is also not generally used for arthritis pain in the hips, back, or shoulders.

General Pain and Inflammation

As an NSAID, Voltaren works by blocking the body's production of certain natural substances that cause inflammation. By reducing this swelling, the medication helps improve physical function and allows for easier movement of the affected joints.

How Voltaren Works

Voltaren belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking the action of certain enzymes in the body known as cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2).

These enzymes are responsible for producing prostaglandins, which are hormone-like substances that the body creates in response to injury or illness. Prostaglandins play a key role in several bodily functions, including:

• Triggering the sensation of pain
• Causing inflammation and swelling
• Increasing body temperature to cause a fever

By inhibiting these enzymes, Voltaren lowers the levels of prostaglandins. This reduction helps to ease pain and decrease the swelling and redness associated with inflammation. Depending on the form used, the medication may work throughout the entire body or be absorbed through the skin to target a specific area.

Common Side Effects

Common side effects of Voltaren may include:

• Stomach pain, gas, nausea, vomiting, diarrhea, or constipation
• Headache, dizziness, or drowsiness
• Itching or sweating
• Ringing in the ears
• Skin irritation, redness, or dryness at the application site (for topical gel)

Serious Side Effects

Seek medical attention immediately if you experience any of the following serious symptoms:

• Signs of a heart attack or stroke, such as chest pain, shortness of breath, slurred speech, or sudden weakness on one side of the body
• Signs of stomach bleeding, such as black, bloody, or tarry stools, or coughing up blood
• Liver issues, including nausea, pain in the upper stomach, dark urine, or yellowing of the skin or eyes
• Kidney problems, such as changes in the amount of urine or swelling in the legs and feet
• Severe skin reactions, including a rash with blistering or peeling, fever, and sore throat
• Signs of an allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat

Cardiovascular and Gastrointestinal Risks

Nonsteroidal anti-inflammatory drugs (NSAIDs), including Voltaren, may increase the risk of serious cardiovascular thrombotic events, myocardial infarction (heart attack), and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Voltaren is also associated with an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal and may occur at any time during use without warning symptoms.

Contraindications

• Heart Surgery: Voltaren is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
• Allergic Reactions: This medication should not be used by individuals who have experienced asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions have been reported in such patients.

Organ System Precautions

• Liver Health: Elevations in one or more liver tests may occur. Rare but severe hepatic reactions, including liver failure and jaundice, have been reported. Periodic monitoring of liver enzymes is often recommended during long-term treatment.
• Kidney Health: Long-term use of NSAIDs can result in renal papillary necrosis and other kidney injuries. Patients with impaired renal function, heart failure, or liver dysfunction are at higher risk.
• Hypertension and Heart Failure: Voltaren can lead to the onset of new hypertension or worsening of pre-existing high blood pressure. It may also cause fluid retention and edema, which can complicate heart failure.

Skin and Hypersensitivity Reactions

Serious skin reactions, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), can occur without warning. Treatment should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Pregnancy and Fertility

Use of Voltaren during pregnancy, particularly starting at 30 weeks gestation, should be avoided because it may cause premature closure of the fetal ductus arteriosus. Use around 20 weeks or later may also lead to fetal renal dysfunction and low amniotic fluid levels. NSAIDs may also delay or prevent ovulation, potentially affecting female fertility.

Pregnancy

Using Voltaren during pregnancy requires careful consideration and consultation with a healthcare provider. Medical experts generally advise against using nonsteroidal anti-inflammatory drugs (NSAIDs) like diclofenac starting at 20 weeks of pregnancy or later. Potential risks include:

• Kidney problems: Use after 20 weeks may cause rare but serious kidney issues in the unborn baby, leading to low levels of amniotic fluid.
• Heart issues: Use starting at 30 weeks may cause the premature closure of a vital blood vessel in the baby's heart (the ductus arteriosus).

If you are pregnant or planning to become pregnant, discuss the risks and benefits of using this medication with your doctor to determine the safest course of treatment.

Breastfeeding

It is not fully known how much diclofenac passes into human breast milk or how it might affect a nursing infant. Because many drugs are excreted in milk, caution is advised. Healthcare providers typically recommend weighing the necessity of the drug for the mother against the potential risks to the infant before using Voltaren while breastfeeding.

Topical Gel

Voltaren is commonly available as a topical gel. This formulation is applied directly to the skin over joints affected by osteoarthritis, such as the hands, wrists, elbows, knees, ankles, or feet. The gel is designed to provide localized relief by penetrating the skin at the site of application.

Oral Tablets

The oral forms of this medication are designed to manage pain and inflammation throughout the body. These include:

• Delayed-release tablets: These tablets are enteric-coated, which means they are designed to pass through the stomach and dissolve in the small intestine to help reduce stomach irritation.
• Extended-release tablets: These are formulated to release the medication slowly into the bloodstream over a longer period, typically allowing for once-daily dosing.

FDA Approval and Indications

Voltaren (diclofenac) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis. Depending on the specific formulation, it is also indicated for ankylosing spondylitis, acute pain, and primary dysmenorrhea.

Boxed Warning

The FDA has issued a boxed warning for Voltaren due to the following risks associated with nonsteroidal anti-inflammatory drugs (NSAIDs):

• Cardiovascular Risk: Use may increase the risk of serious cardiovascular thrombotic events, including heart attack and stroke, which can be fatal. This risk is present for all NSAIDs and may increase with longer use or in patients with existing heart disease.
• Gastrointestinal Risk: There is an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines. These conditions can be fatal and may occur at any time during treatment without warning.

Prescription and OTC Status

Voltaren is available in several regulated formats. While oral tablets and certain topical formulations remain prescription-only, the FDA approved a 1% diclofenac sodium topical gel for over-the-counter (OTC) use to treat arthritis pain in 2020.

Usage and Application

Voltaren gel is specifically indicated for the treatment of osteoarthritis pain in joints that are close to the skin surface. It is not intended for use on the shoulders, hips, or spine. To ensure the correct dose is applied, users should use the dosing card provided with the medication. The gel is typically applied four times daily to the affected joint.

• Upper body joints (hands, wrists, elbows): Usually 2 grams of gel per application.
• Lower body joints (knees, ankles, feet): Usually 4 grams of gel per application.

Application Instructions

After applying the gel, users should wash their hands unless the hands are the treated joint. If the gel is applied to the hands for pain, wait at least one hour before washing them. Avoid showering or bathing for at least one hour after application to ensure the medication is absorbed. Do not apply the gel to skin that is broken, infected, or has an open wound.

Safety Precautions

Because the medication is absorbed through the skin, it carries the same warnings as oral NSAIDs regarding serious cardiovascular events and gastrointestinal bleeding. Additionally, users should follow these skin-specific precautions:

• Do not cover the treated area with bandages or dressings that do not allow air to circulate.
• Avoid applying external heat, such as heating pads, to the treated joint.
• Protect the treated skin from direct sunlight and avoid tanning beds, as the medication may increase sensitivity to UV light.
• Do not use other topical products, such as sunscreens, lotions, or insect repellents, on the same area at the same time.

Common Side Effects

The most frequent side effects occur at the site of application and may include skin redness, itching, dryness, or a mild rash. If severe skin irritation or systemic symptoms like stomach pain or shortness of breath occur, medical attention should be sought immediately.