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(Diclofenac Potassium)

The active ingredient in Zipsor is diclofenac potassium.

Diclofenac works by blocking enzymes called cyclooxygenase (COX-1 and COX-2), which are involved in the production of prostaglandins. These chemicals are responsible for pain, inflammation, and swelling. By reducing prostaglandin production, diclofenac helps relieve pain and inflammation. This mechanism of action makes it effective for treating moderate acute pain.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Zipsor. However, the following is a synopsis of the general guidelines for the use of Zipsor:

• Take Zipsor exactly as prescribed by your healthcare provider.
• Swallow the liquid-filled capsules whole with water.
• It is usually taken multiple times a day depending on your prescribed dose.
• Use the lowest effective dose for the shortest duration possible.
• Do not take more than prescribed.
• Avoid taking with other NSAIDs such as ibuprofen or naproxen unless directed.
• Avoid drinking alcohol, as it may increase the risk of gastrointestinal side effects.
• If you miss a dose, take it as soon as you remember unless it is close to your next dose. Do not take two doses at once.

Some mild or common side effects of Zipsor seen in clinical trials as compared to placebo include:

• Stomach pain.
• Dyspepsia or heartburn.
• Nausea.
• Constipation.
• Abdominal pain.

Some individuals may experience serious side effects while using Zipsor. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of an allergic reaction such as hives, skin rash, or trouble breathing.
• Chest pain or signs of a heart attack.
• Shortness of breath or fluid retention.
• Severe gastrointestinal problems such as bleeding, ulceration, or perforation.
• Skin reactions such as rash, blisters, or peeling.
• Dark urine or signs of liver problems.
• Signs of GI bleeding: Black, bloody, or tarry stools; coughing up blood or vomit that looks like coffee grounds.

These are not all of the possible side effects of Zipsor. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Zipsor, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Heart disease, high blood pressure, or a history of heart bypass surgery.
• A history of gastrointestinal issues such as ulcers or bleeding.
• Kidney problems or liver disease.
• Asthma or sensitivity to NSAIDs.
• Anemia or bleeding disorders.

Additional precautions:

• NSAIDs may increase the risk of cardiovascular thrombotic events such as heart attack or stroke.
• Risk may increase with duration of use.
• Gastrointestinal bleeding and ulceration can occur without warning.
• Avoid use around the time of coronary artery bypass graft (CABG) surgery.
• Use caution when combining with corticosteroids or anticoagulants.
• Monitor for signs of fluid retention or weight gain.

Boxed Warning

Zipsor (diclofenac potassium) carries a boxed warning for,, risk of serious cardiovascular (CV) thrombotic events, including heart attack and stroke, which can be fatal. It also carries a boxed warning for serious, potentially fatal gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines.

Zipsor should not be used in the following situations:

• Known hypersensitivity to diclofenac or other NSAIDs.
• History of asthma, hives, or allergic reactions after taking NSAIDs.
• Use in the setting of coronary artery bypass graft surgery.

Zipsor is designed for rapid absorption and may begin to relieve pain within a short time after taking a dose. The exact onset may vary, but it is typically used for short-term relief of acute pain.

When Zipsor is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Anticoagulants, which may increase the risk of bleeding.
• Diuretics, which may reduce effectiveness and increase kidney risk.
• Methotrexate, which may increase toxicity.
• Lithium, which may increase blood levels and toxicity.
• Other NSAIDs or over-the-counter pain relievers, which may increase side effects.

Zipsor is available as liquid-filled capsules containing diclofenac potassium. The typical dosing is multiple times daily for short-term use, as determined by your healthcare provider.

It should be stored at room temperature, away from the reach of children or pets.

Zipsor is manufactured by Assertio Therapeutics.

Yes, Zipsor is available as a generic medication. The generic name is diclofenac potassium.

Zipsor can usually be stopped once pain improves or the prescribed course is complete.

• Do not continue longer than recommended without medical advice.
• If you have been using it regularly, consult your healthcare provider before stopping.
• Follow your provider’s guidance for pain management.

No, you should not take Zipsor (diclofenac) if you are pregnant, particularly in the third trimester (30 weeks of pregnancy or later), unless explicitly told to do so by your doctor. Zipsor is a nonsteroidal anti-inflammatory drug (NSAID) that can cause serious harm to an unborn baby.

Yes, Zipsor (diclofenac) can generally be used while breastfeeding, but it should be used with caution and preferably under the guidance of a doctor.