Pentasa

Tablet: The recommended adult dose of Pentasa (Mesalamine) depends on the product selected. Swallow the tablets whole, ensuring that you do not break the outer coating. Take the tablets only as directed by your doctor. Do not change the number or frequency of tablets taken without first consulting your doctor.

Suppository, rectal suspension, and enema: The usual dose for suppositories, rectal suspension, and enema is 1 g to 4 g daily, usually at bedtime, or as prescribed by your doctor.

For the proper administration of these dosage forms, check with your pharmacist.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Pentasa (Mesalamine) exactly as prescribed by your doctor. Ulcerative colitis and Crohn's disease never completely go away. Once a flare-up of the illness has been controlled, your doctor will recommend a smaller dose to be taken daily to reduce the chance of the symptoms from flaring up again. It is important to not stop the medication suddenly, even when you are feeling well. Doing so may cause the illness to flare up again.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store all forms of Pentasa (Mesalamine) at room temperature, protect them from light and moisture, and keep them out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea; it may cause stomach ache; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause nausea or, rarely, vomiting; it may cause a sore throat. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Pentasa

Extended-release Tablets

500 mg
Each round, flat, white-grey-to-pale brown, speckled, extended-release tablet, marked "PENTASA" on one side and marked "500" above and "mg" below a score line on the other, contains 500 mg of 5-ASA. Nonmedicinal ingredients: cellulose, ethylcellulose, magnesium stearate, povidone, and talc. Pentasa (Mesalamine) does not contain gluten.

1 g
Each oblong, white-grey-to-pale brown, speckled, extended-release tablet, embossed "PENTASA" on both sides contains 1g of 5-ASA. Nonmedicinal ingredients: cellulose, ethylcellulose, magnesium stearate, povidone, and talc. Pentasa (Mesalamine) does not contain gluten.

Rectal Suspension
Each unit dose (100 mL) of rectal suspension enema contains 1 g or 4 g of 5-ASA. Nonmedicinal ingredients: hydrochloric acid (to adjust the pH to 4.8), purified water, sodium acetate, sodium edetate, and sodium metabisulfite.

Suppositories
Each suppository contains 1 g of 5-ASA. Nonmedicinal ingredients: magnesium stearate, polyethylene glycol, povidone, and talc.

Do not use Pentasa (Mesalamine) if you:

• are allergic to 5-aminosalicylic acid or any ingredients of the medication
• are allergic to other salicylates (e.g., Asa)
• are not able to swallow tablets whole
• have a gastric (stomach) or duodenal (intestinal) ulcer
• have a urinary tract obstruction
• have severely decreased kidney function
• have severely decreased liver function

Do not give Pentasa (Mesalamine) to children under 2 years of age.

There may be an interaction between 5-aminosalicylic acid and any of the following:

• 6-mercaptopurine
• antacids (e.g., aluminum hydroxide, calcium carbonate, sodium bicarbonate)
• Azathioprine
• Digoxin
• Furosemide
• H2 antagonists (e.g., Cimetidine, Famotidine, Ranitidine)
• Heparin
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Methotrexate
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Naproxen, Ibuprofen) proton pump inhibitors (e.g., Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole)
• Spironolactone
• Sulfinpyrazone
• sulfonylureas (e.g., Glyburide, Gliclazide)
• Thioguanine
• varicella (chicken pox) vaccine
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Pentasa (Mesalamine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Pentasa (Mesalamine).

Acute intolerance syndrome: Pentasa (Mesalamine) has been known to cause symptoms similar to those of worsening Crohn's disease or ulcerative colitis. If you experience the sudden onset of symptoms such as cramping, acute abdominal pain and bloody diarrhea, headache, rash, and possibly fever, contact your doctor immediately.

Allergy: Some people who are allergic to Sulfasalazine or acetylsalicylic acid (ASA) also experience allergic reactions to Pentasa (Mesalamine) (5-ASA). Before you take 5-ASA, inform your doctor about any previous adverse reactions you have had to medications, especially sulfasalazine or ASA.

Contact your doctor at once if you experience signs of an allergic reaction such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Breathing Problems: 5-ASA may increase the risk of allergic or hypersensitivity reactions for people who have conditions that affect their breathing. If you have Asthma or COPD (Chronic Obstructive Pulmonary Disease) (COPD) discuss with your doctor how Pentasa (Mesalamine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pentasa (Mesalamine), and whether any special monitoring is needed.

Fertility: Pentasa (Mesalamine) may cause a decrease in sperm production for men. If this is a concern, talk to your doctor.

Heart problems: People with heart problems may be at an increased risk of side effects of 5-ASA. If you have heart problems or a history of heart problems, including heart infections, discuss with your doctor how Pentasa (Mesalamine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pentasa (Mesalamine), and whether any special monitoring is needed.

Kidney function: Pentasa (Mesalamine) is removed from the body by the kidneys. 5-ASA may not be removed from the body as quickly as expected if your kidneys are not working properly. This increases the likelihood of experiencing side effects. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Pentasa (Mesalamine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pentasa (Mesalamine), and whether any special monitoring is needed.

5-ASA may also cause decreased kidney function and possibly kidney failure. If you notice a decrease in your amount of urine, swelling in your hands and lower legs, or unusual tiredness contact your doctor as soon as possible.

Liver function: The use of Pentasa (Mesalamine) by people with reduced liver function has not been well studied. If you have reduced liver function or liver disease, discuss with your doctor how Pentasa (Mesalamine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pentasa (Mesalamine), and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor as soon as possible.

Slow stomach emptying: The tablet form of 5-ASA may not work as well for people with a condition known as pyloric stenosis. If you have pyloric stenosis or have a history of slow emptying of the stomach, discuss with your doctor how Pentasa (Mesalamine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pentasa (Mesalamine), and whether any special monitoring is needed.

Tablets in stool: Infrequently, what looks to be intact or partially intact tablets may appear in the stool. If this occurs repeatedly, consult your doctor.

Pregnancy: 5-aminosalicylic acid crosses the placenta and may affect the developing baby if taken by the mother during pregnancy. It should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Pentasa (Mesalamine), contact your doctor immediately.

Breast-feeding: Pentasa (Mesalamine) passes into breast milk. If you are a breast-feeding mother and are taking 5-aminosalicylic acid, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Pentasa (Mesalamine) for use by children have not been established.

This enema is to be administered via the rectum. To use: Lie on your left side, with your right knee bent. Insert the lubricated nozzle of the enema applicator into your rectum, with the nozzle pointed towards your navel. Squeeze the applicator until the entire dose is expelled, then withdraw the nozzle. Remain lying in this position to retain the enema inside as long as possible. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Use it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed.