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 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:
- have kidney problems
- have liver problems
- have a history of allergic reaction to the medicine sulfasalazine (Azulfidine)
How should I use Rowasa?
- Use Rowasa exactly as prescribed by your doctor.
- It is important for you to stay well hydrated during treatment with Rowasa. Be sure to drink plenty of fluids while taking Rowasa.
- The recommended dose of Rowasa is one bottle (4 grams) instilled once daily at bedtime for 3 to 6 weeks. Your doctor will tell you what dose is right for you.
- Empty your bowels before instilling Rowasa if possible.
- Remove the Rowasa bottles from their protective foil pouch by tearing the pouch or using scissors. Take care not to squeeze or puncture the bottles.
- Rowasa suspension is an off-white to tan color. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect how Rowasa works, however, enemas with dark brown contents should be discarded.
- To prepare Rowasa
- Shake the bottle well to make sure the suspension is thoroughly mixed.
- Remove the protective sheath from the applicator tip. Hold the bottle at the neck the suspension does not come out.
- Position yourself in the correct body position to administer Rowasa.
- Lie down on your left side with your left leg extended and your right leg flexed forward for balance.
- Alternatively you can put both knees on the ground and fold the top half of your body over so that your head is on the ground, your knees are close to your chest and your bottom is in the air.
- Administer Rowasa
- Gently insert the lubricated applicator tip into your rectum to prevent damage to the rectal wall. Point the applicator tip slightly towards your navel.
- Grasp the bottle firmly, then tilt it slightly so that the nozzle is aimed towards your back. Squeeze the bottle slowly to instill the medication. Apply steady hand pressure to squeeze the medication out of the bottle.
- After administering, withdraw the applicator tip and attached bottle and discard.
- Remain in position for at least 30 minutes to allow Rowasa to spread internally. Retain the medication all night, if possible.
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.
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:
- Abdominal pain, cramps or discomfort
- Gas or flatulence
- Tiredness, weakness, malaise or fatigue
- Rash or spots
- A cold or sore throat
- Leg or joint pain
- Back pain
- Pain on insertion of enema tip
- Rectal pain
- Hair loss
- Peripheral edema
- Urinary tract infection or urinary burning
- Rectal pain soreness or burning
Products containing the active ingredient mesalamine have been reported to cause:
- Kidney problems, including kidney stones
- Acute intolerance syndrome and other allergic reactions
- Liver problems
- Severe skin reactions
- Sun sensitivity
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.
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.
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.
- Store Rowasa at 20° to 25°C (68° to 77°F).
- Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your doctor.
- Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.
Keep out of reach of children.
What are the ingredients in Rowasa and sfRowasa?
Active ingredient: mesalamine
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.
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.
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.
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.
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.
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- Drug class: 5-aminosalicylates
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