Zipsor

Zipsor is a prescription medication used to treat mild to moderate pain in adults (18 years of age or older). Zipsor belongs to a group of drugs called NSAIDs, which work by stopping the substances in the body that cause inflammation and pain.

Zipsor comes in a capsule form and is typically taken four times per day.

Common side effects of Zipsor include stomach pain, constipation, diarrhea, and dizziness. Do not drive or operate heavy machinery until you know how Zipsor can affect you.

Zipsor is a prescription medication used to treat mild to moderate pain in adults due to a variety of conditions.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• PD-Rx Pharmaceuticals, Inc.

The most common side effects of Zipsor include the following:

• stomach pain
• constipation
• diarrhea
• dyspepsia
• nausea
• vomiting
• dizziness
• headache
• somnolence
• itching
• increased sweating

This is not a complete list of Zipsor side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

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 Zipsor drug interactions. Ask your doctor or pharmacist for more information.

• Do not use Zipsor if you are allergic to diclofenac (the active ingredient), any inactive ingredient, or aspirin.
• Zipsor is an NSAID medication. NSAIDs have been linked to stomach and intestinal bleeding, ulcers, heart attack, stroke, congestive heart failure, allergic reactions, and worsening asthma.
• Tell your doctor right away if you experience symptoms of ulcers or bleeding including:
  • black, tarry stools
  • blood in stools
  • stomach pain
  • vomiting blood
• Call 911 if you experience heart attack symptoms:
  • chest discomfort (uncomfortable pressure, fullness, or pain in chest)
  • shortness of breath
• Zipsor can also cause or worsen existing hypertension. Blood pressure should be monitored closely during treatment with Zipsor treatment.
• Fluid retention and swelling have been observed in those who have taken NSAIDs. Zipsor should be used with caution in patients with fluid retention or heart failure.
• Kidney injury may occur with long-term use. Zipsor should be used with caution in patients at greatest risk of this, including the elderly, those with impaired kidney function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors.
• Severe allergic reactions have occurred in patients with the aspirin triad or in patients without prior exposure to Zipsor. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Serious skin adverse events have occurred with Zipsor use. Discontinue Zipsor if rash or other signs of a skin reaction occur.
• Zipsor can cause dizziness. Do not drive or operate heavy machinery until you know how Zipsor can affect you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zipsor, there are no specific foods that you must exclude from your diet when receiving Zipsor.

Before using Zipsor, tell your doctor if you:

• are allergic to any medications, foods, or dyes
• have asthma or nasal polyps
• have heart, liver, or kidney disease
• have ulcers or stomach bleeding
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C before 30 weeks gestation. Zipsor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

This medication falls into category D starting 30 weeks gestation. Zipsor can cause your unborn baby harm when administered to a pregnant woman starting at 30 weeks gestation. NSAIDs can adversely affect the development of the unborn baby's cardiovascular system. Use during pregnancy (particularly late pregnancy) should be avoided.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Zipsor is excreted in human breast milk or if it will harm your nursing baby. Because many drugs pass into human milk and because of the potential for problems in nursing infants from Zipsor, a decision should be made with your physician whether to breastfeed or take Zipsor.

Take Zipsor exactly as prescribed.

Zipsor comes in capsule form and is most commonly taken 4 four times per day. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Zipsor at the same time.

Take this medication exactly as prescribed by your doctor. 

The recommended dose of Zipsor (diclofenac) is one 25 mg capsule taken by mouth four times per day.

If you take too much Zipsor, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Cardiovascular Risk

• Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• Zipsor is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

• NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events.