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Rowasa

Generic name: mesalamine
Brand names: Rowasa, sfRowasa
Dosage form: rectal enema
Drug class: 5-aminosalicylates

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 4, 2023.

What is Rowasa?

Rowasa (mesalamine, sfRowasa) is an enema used in the treatment of inflammatory bowel disease including ulcerative colitis, proctosigmoiditis and proctitis. It is a liquid suspension for topical use that you instill into your rectum using a small bottle with an applicator tip.

Rowasa contains the drug mesalamine, which is also known as mesalazine or 5-aminosalicylic acid (5-ASA). It belongs to a class of drugs called aminosalicylates.

Rowasa is thought to work by blocking the enzyme cyclooxygenase (COX) and inhibiting prostaglandin production in the colon, which helps to reduce inflammation. COX and prostaglandins (a group of lipids) are both involved in generating an inflammatory response. Rowasa is thought to work locally to reduce inflammation in the epithelial cells that line the colon.

Rowasa was the first mesalamine product to be approved by the US Food and Drug Administration (FDA) for ulcerative colitis when it was approved in 1987.

Rowasa contains a sulfite called potassium metabisulfite, which some people are sensitive too, particularly people who have asthma or other atopic conditions. A sulfite-free Rowasa enema called sfRowasa is also available.

What is Rowasa used for?

Rowasa is a prescription medication used to treat active mild-to-moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

Important information

Rowasa is for rectal use only. Do not take Rowasa by mouth.

Who should not use Rowasa?

Do not use Rowasa, including sfRowasa, if you are, or suspect you are, hypersensitive to salicylates, aminosalicylates, sulfites or any other component of this medication.

What should I tell my doctor before using Rowasa?

Before using Rowasa, tell your doctor if you have any medical conditions, including if you:

How should I use Rowasa?

What happens if I miss a dose?

If you miss a dose of Rowasa, instill it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Instill the next dose at your regular time. Do not insert 2 doses at the same time.

What should I avoid while using Rowasa?

Rowasa can stain surfaces including fabrics, flooring, painted surfaces, marble, granite, vinyl and enamel. Keep Rowasa away from these surfaces to prevent staining.

If you have atopic dermatitis or eczema you may become more sensitive to the sun while using Rowasa. Avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.

Dosing information

The recommended adult dosage of Rowasa in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. The usual course of therapy is from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings.

See full prescribing information for further information about Rowasa dosing.

What are the side effects of Rowasa?

Most side effects of Rowasa are mild and transient.

Side effects of Rowasa include:

Products containing the active ingredient mesalamine have been reported to cause:

These are not all of the possible side effects of Rowasa.

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

Interactions

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

Using Rowasa with certain other medicines may affect each other. Using Rowasa with other medicines can cause serious side effects.

Especially tell your doctor if you take nonsteroidal anti-inflammatory drugs (NSAIDS), or medicines that contain azathioprine or 6-mercaptopurine. Taking Rowasa with NSAIDS may cause kidney problems. Taking Rowasa with azathioprine or 6-mercaptopurine may cause blood problems. Ask your doctor if you are not sure if you are taking one of these medicines.

Your doctor may do certain tests during treatment with Rowasa.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Entyvio, Stelara, prednisone, methylprednisolone, dexamethasone, hydrocortisone topical, hydrocortisone, budesonide, Humira, mesalamine

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Rowasa can harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. Rowasa can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you use Rowasa.

Storage

Keep out of reach of children.

What are the ingredients in Rowasa and sfRowasa?

Active ingredient: mesalamine

Inactive ingredients:

Rowasa: carbomer homopolymer type B (allyl pentaerythritol crosslinked), edetate disodium, potassium acetate, potassium metabisulfite, water, sodium benzoate, xanthan gum

sfRowasa: carbomer homopolymer type B (allyl pentaerythritol or allyl sucrose crosslinked), edetate disodium, potassium acetate, water, sodium benzoate, xanthan gum

Rowasa and sfRowasa are distributed by Meda Pharmaceuticals Somerset, New Jersey 08873-4120.

Popular FAQ

How long does it take for mesalamine to work?

Research studies looking at patients who received daily oral doses of 4 to 6 grams of mesalamine showed that 80% of patients achieved complete or significant clinical improvement within 4 weeks.

When is the best time to take mesalamine?

The best time to take or use mesalamine will depend on the specific product you are using and why you are using it (ulcerative colitis induction or maintenance, ulcerative proctitis). Some products may need to be taken with food while others are taken on an empty stomach. Check with your doctor.

How long can you take mesalamine?

Some forms of mesalamine are used long-term as a maintenance therapy in ulcerative colitis to help prevent symptoms from flaring up. Not all forms or brands of mesalamine are used long-term, so check with your doctor about your specific medicine. Call your doctor if your ulcerative colitis symptoms get worse after starting treatment.

Why is mesalamine so expensive?

Brand name products of mesalamine may be more expensive than generic options. Some, but not all mesalamine products are available as generics. Your insurance should help pay for generics, or if you are paying out-of-pocket, ask your healthcare provider if there is a more affordable option.

Is mesalamine an immunosuppressant?

Mesalamine is an antiinflammatory, not an immunosuppressant. It may be one of the first treatments used for ulcerative colitis (UC) to lessen symptoms like diarrhea, rectal bleeding, or stomach pain. Immunosuppression is not a listed side effect for mesalamine. Other medicines used for UC, like prednisone, can suppress the immune system.

What is the maximum dosage of mesalamine?

Mesalamine is available as delayed-release tablets or capsules, extended-release capsules, and rectal preparations like suppositories or enemas. The maximum dose will depend upon the specific product you are using and your diagnosis. Only use the dose prescribed by your doctor.

Can I stop taking mesalamine?

Mesalamine is used in some patients with ulcerative colitis as a maintenance (long-term) treatment to help you stay in remission (without active symptoms). Other treatments for ulcerative colitis or proctitis are only taken short-term. Ask your doctor when you can stop taking treatment.

What are 7 mesalamine side effects to be aware of?

Common side effects of mesalamine include stomach problems (such as burping, abdominal pain, constipation, and diarrhea); a headache or dizziness; nasal problems, such as nasal congestion, runny nose, sneezing, or itching; or a rash. For most people, these side effects lessen or go away after a few weeks of treatment. More serious side effects with mesalamine are less common or rare, but include allergic reactions, bloody diarrhea or blood in the urine, and an intolerance syndrome. Continue reading

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.