Mesalamine Rectal

What is Mesalamine Rectal?

• Mesalamine Rectal (Canasa; Rowasa; sfRowasa) is 5-aminosalicylic acid (5-ASA) used to treat ulcerative colitis, proctitis , and proctosigmoiditis.

Mesalazine structure

What are the uses of this medicine?

• Mesalamine Rectal (Canasa; Rowasa; sfRowasa) is used for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

How does this medicine work?

• Mesalamine (me sal’ a meen) is used to treat disease flares in ulcerative colitis and to maintain disease remission.
• Mesalamine has antiinflammatory, antioxidant and antimicrobial activity and is locally active in the large intestine in reducing inflammation and injury.
• Mesalamine appears to act by inhibition of lipooxygenase activity, thereby inhibiting production of leukotrienes and leading to reduction in interleukin 1 (IL-1) and tumor necrosis factor (TNF) alpha.
• Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes (LTs) and hydroxyeicosatetraenoic acids (HETEs) is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Canasa 1000 mg Suppositories are contraindicated in patients who have demonstrated hypersensitivity to mesalamine (5-aminosalicylic acid) or to the suppository vehicle [saturated vegetable fatty acid esters (Hard Fat, NF)], or to salicylates (including aspirin)
• Rowasa (mesalamine) Rectal Suspension Enema is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication.

What drug interactions can this medicine cause?

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

Be sure to mention any of the following:

• aspirin
• other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• azathioprine (Azasan, Imuran), mercaptopurine (Purinethol), or sulfasalazine (Azulfidine)

Is this medicine FDA approved?

• Mesalazine was approved for medical use in the United States in 1987.
• It is available as a generic medication and sold under many brand names worldwide.
• In 2020, it was the 184th most commonly prescribed medication in the United States, with more than 2 million prescriptions.

How should this medicine be used?

Recommended dosage:

• The recommended adult dosage of Rowasa (mesalamine) Rectal Suspension Enema in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours.
• The usual dosage of Canasa (mesalamine, USP) 1000 mg suppositories is one rectal suppository 1 time daily at bedtime.

Administration:

• Rectal mesalamine comes as a suppository and an enema to use in the rectum.
• The suppository and the enema are usually used once a day at bedtime.
• You should begin to feel better during the first few days or weeks of your treatment with rectal mesalamine.
• Continue to use rectal mesalamine until you finish your prescription, even if you feel better at the beginning of your treatment.
• Do not stop using rectal mesalamine without talking to your doctor.
• Mesalamine suppositories and enemas may stain clothing and other fabrics, flooring, and painted, marble, granite, enamel, vinyl, and other surfaces.
• Take precautions to prevent staining when you use these medications.
• Drink an adequate amount of fluids during treatment.

Rowasa (mesalamine) Rectal Suspension Enema:

• Patients should be instructed to shake the bottle well to make sure the suspension is homogeneous.
• The patient should remove the protective sheath from the applicator tip.
• Holding the bottle at the neck will not cause any of the medication to be discharged.
• The position most often used is obtained by lying on the left side (to facilitate migration into the sigmoid colon); with the lower leg extended and the upper right leg flexed forward for balance.
• An alternative is the knee-chest position.
• The applicator tip should be gently inserted in the rectum pointing toward the umbilicus.
• A steady squeezing of the bottle will discharge most of the preparation.
• The preparation should be taken at bedtime with the objective of retaining it all night.
• Patient instructions are included with every seven units.

Canasa suppositories:

• Detach one suppository from strip of suppositories.
• Hold suppository upright and carefully remove the plastic wrapper.
• Avoid excessive handling of suppository, which is designed to melt at body temperature.
• Insert suppository completely into rectum with gentle pressure, pointed end first.
• A small amount of lubricating gel may be used on the tip of the suppository to assist insertion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a suppository and an enema

This medicine is available in fallowing brand namesː

• Rowasa; Canasa

What side effects can this medication cause?

The most common side effects of this medicine include:

• Dizziness
• leg or joint pain, aching, tightness or stiffness
• heartburn
• gas
• hemorrhoids
• acne
• pain in the rectum
• slight hair loss

Mesalamine Rectal may cause some serious side effects which may include:

• chest pain
• shortness of breath

What special precautions should I follow?

• Rowasa (mesalamine) Rectal Suspension Enema contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Epinephrine is the preferred treatment for serious allergic or emergency situations even though epinephrine injection contains sodium or potassium metabisulfite with the above-mentioned potential liabilities.
• Hypersensitivity reactions have been reported in patients taking sulfasalazine. Discontinue Rowasa if an alternative etiology for the signs and symptoms cannot be established.
• Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure have been reported in patients given products that contain mesalamine or are converted to mesalamine. Evaluate renal function in all patients prior to initiation and periodically while on Rowasa therapy. Discontinue Rowasa if renal function deteriorates while on therapy.
• Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with Rowasa.
• Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine.
• Patients with pre‑existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.
• Cases of nephrolithiasis have been reported with the use of mesalamine, including stones with 100% mesalamine content. Mesalamine‑containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment.
• Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection.
• you should know that mesalamine may cause a serious reaction. Many of the symptoms of this reaction are similar to the symptoms of ulcerative colitis, so it may be difficult to tell if you are experiencing a reaction to the medication or a flare (episode of symptoms) of your disease. Call your doctor if you experience some or all of the following symptoms: stomach pain or cramping, bloody diarrhea, fever, headache, weakness, or rash.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures).
• Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• There is no specific antidote for mesalamine overdose.
• Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.

Can this medicine be used in pregnancy?

• There are no adequate and well controlled studies of mesalamine use in pregnant women.
• Mesalamine should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Rowasa: Active Ingredients:

• MESALAMINE

Inactive Ingredients:

• CARBOMER HOMOPOLYMER TYPE B
• EDETATE DISODIUM
• POTASSIUM ACETATE
• POTASSIUM METABISULFITE
• WATER
• SODIUM BENZOATE
• XANTHAN GUM

Canasa: Active Ingredients:

• MESALAMINE

Inactive Ingredients:

• FAT, HARD

Who manufactures and distributes this medicine?

Rowasa: Distributed by:

• MEDA PHARMACEUTICALS®
• Somerset, New Jersey

Canasa:

• Axcan Pharma US, Inc.
• Birmingham, AL

What should I know about storage and disposal of this medication?

Rowasa:

• Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted, please refer to current USP.

Canasa:

• Store below 25°C (77°F), do not freeze.
• Keep away from direct heat, light or humidity.

• Dailymed label info on Mesalamine Rectal
• FDA Mesalamine Rectal

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