Pentasa Rectal Foam

The active ingredient in Pentasa is mesalamine. It is also known as 5-aminosalicylic acid (5-ASA). It is an anti-inflammatory agent that will decrease the inflammation that can be seen in the colon. It can be used to decrease severe symptoms, including rectal bleeding.

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 Pentasa rectal foam. However, the following is a synopsis of the general guidelines for the use of Pentasa rectal foam:

• This medication requires rectal administration and is used once daily at bedtime before bowel movements.
• Follow these instructions when using the rectal foam:
• Remove the plastic flap that’s found under the dome-shaped pump.
• Attach a new applicator to the nozzle head and shake the bottle for 20 seconds.
• Twist the dome that’s found on the base until you see that the gap aligns with the nozzle.
• Put your finger on the top of the dome, and after this, turn the bottle upside down with the dome pointing straight down.
• While lying down on your left side, insert the applicator tip into the rectum. Ensure the applicator tip is lubricated with petrolatum.
• Push the dome down to fill the applicator with a dose of foam and slowly release the dome so the foam can come out.
• Wait in that position for 10 - 15 seconds, and then the applicator can slowly be removed.
• After this, ensure the applicator is put into a plastic bag so it can be discarded appropriately.
• Ensure a sun safety routine is practiced, which includes a broad-spectrum sunscreen with at least SPF 30, and wearing protective clothing.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose.

The most common side effects of Pentasa rectal foam seen in clinical trials include:

• Dizziness
• Flatulence
• Headache
• Itching skin
• Irritation in the rectal area
• Back pain
• Hair loss
• Inflammation in the large intestine
• Photosensitivity

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

• Allergic reaction: trouble breathing, skin reactions including hives, skin rash, trouble breathing, or swelling of the face, eyes, or tongue
• Skin reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS)/ Toxic epidermal necrolysis (TEN) with symptoms such as black, tarry stools, blisters, chest pain, chills, cough, itching, joint or muscle pain, diarrhea, red skin lesions, often with a purple center, sore throat, ulcers or white spots in or around the mouth, trouble breathing, bleeding or bruising, or unusual tiredness or weakness
• Inflammation in the heart: chest pain, heart palpitations, or shortness of breath
• Kidney disease: decreased urination, fatigue, and swelling of the legs, feet, arms, or hands
• Kidney stones: Lower back pain, bloody urine, and stomach pain
• Acute Intolerance Syndrome: abdominal pain, cramping, and bloody diarrhea
• Liver problems: increased liver enzymes, yellowing of the eyes and skin, loss of appetite, or dark urine
• Low blood cell count: sore throat, fever, and chills

These are not all of the possible side effects of Pentasa rectal foam. 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 Pentasa rectal foam, 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:

• Kidney problem
• History of pericarditis or myocarditis
• Liver disease or impaired liver function
• Breathing problem
• Hypersensitivity to sulfasalazine
• Gastrointestinal ulcer
• Eczema

Do not use Pentasa rectal foam if you have:

• Known allergy to salicylates or aspirin
• Known allergy to mesalazine or any of its inactive ingredients

This rectal foam will improve symptoms within 1 - 3 weeks.

When Pentasa 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:

• Azathioprine
• Blood thinners, including warfarin
• 6-mercaptopurine
• NSAIDs (nonsteroidal anti-inflammatory drugs), including Ibuprofen

The formulations available include a rectal foam, mesalazine enema, and rectal suppositories.

This medication should be stored at controlled room temperature and away from light and extreme temperatures, and out of reach of children.

The pharmaceutical company that manufactures Pentasa is Ferring Pharmaceuticals.

There are lower-cost alternatives to the brand-name Pentasa.

Before stopping this medication, consult your healthcare provider, as tapering is required for this medication.

It is not known if or how Pentasa Rectal Foam could affect pregnancy or harm an unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Pentasa can pass into the breast milk during lactation. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.