Mesalamine-Mesalazine Enema Rectal Suspension 4gm-60ml

Mesalamine (Mesalazine) Rectal Suspension Enema 4g/60mL – Quick Overview

Mesalamine 4g/60mL rectal suspension enema (Rowasa®) is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis in adults. It works by reducing inflammation directly in the lining of the colon and rectum. This medicine is prescription-only and requires evaluation of kidney function before starting.

Medical Supervision & Regulatory Status

Mesalamine rectal suspension enema is FDA-approved since its initial approval in 1987, and available only by prescription in the United States. Renal function should be evaluated before initiating therapy, so medical supervision is required both before starting and periodically throughout treatment.

Clinical Context

Distal ulcerative colitis, proctosigmoiditis, and proctitis are forms of inflammatory bowel disease affecting the lower colon and rectum, causing symptoms such as rectal bleeding, diarrhea, cramping, and urgency. Left inadequately managed, ongoing inflammation can worsen symptoms and impact quality of life.

Delivering anti-inflammatory medication directly to the site of inflammation is a treatment strategy used for disease limited to the distal colon and rectum, because it allows higher local drug concentration with less systemic absorption compared to oral therapy alone.

Mesalamine rectal suspension fits into therapy as a topical (rectal) 5-aminosalicylate treatment, used specifically for disease confined to the distal colon, often as first-line therapy for mild to moderate flares in this location.

How Mesalamine Rectal Suspension Works

Mesalamine belongs to the 5-aminosalicylate (5-ASA) class of anti-inflammatory medicines. It is believed to work by blocking the production of certain natural chemicals that may cause pain and swelling in the lining of the colon and rectum.

Administered rectally, mesalamine is poorly absorbed from the colon and is excreted principally in the feces, with the extent of absorption dependent on how long the medication is retained. This allows the medicine to act largely at the local tissue level rather than throughout the body.

By reducing local inflammation in the affected area, mesalamine does not cure the underlying disease, but may relieve mild-to-moderate pain and decrease the frequency of diarrhea and bloody stools associated with these conditions.

What is Mesalamine Rectal Suspension Enema 4g/60mL?

Drug Class: 5-Aminosalicylate (5-ASA), anti-inflammatory
Active Ingredient: Mesalamine 4 grams in 60 mL aqueous suspension
Mechanism: Locally reduces inflammation in the colon and rectal lining
Form: Rectal suspension enema, single-use disposable bottle
Dosing Frequency: One rectal instillation once daily, preferably at bedtime
Regulatory Status: FDA-approved, prescription-only (Rx)

Uses / Indications

Active mild to moderate distal ulcerative colitis: Used to treat inflammation limited to the distal colon.
Proctosigmoiditis: Treats inflammation involving the rectum and sigmoid colon.
Proctitis: Treats inflammation limited to the rectum.
Effectiveness may be reduced in patients with disease extending higher into the colon or those on concurrent prednisone, per clinical trial data.

How to Use / Dosage

The recommended dosage is one rectal instillation (4 grams) once a day, preferably at bedtime, retained for approximately eight hours, typically for 3 to 6 weeks depending on symptoms and clinical findings. Best results are achieved if the bowel is emptied immediately before the medication is administered. Shake the bottle well to ensure the suspension is uniform before use. Drink plenty of fluids during treatment to help prevent kidney stones, unless otherwise directed by a doctor. If a dose is missed, use it as soon as remembered unless it is close to the next scheduled dose — do not double up. Do not stop this medication without consulting your doctor, even if symptoms improve, since the full course supports lasting benefit.

Side Effects

Most people tolerate this rectal suspension reasonably well, though side effects can occur and should be discussed with a doctor. Common effects may include abdominal discomfort, gas, nausea, and headache. Serious effects, though less common, may include kidney function changes, acute intolerance syndrome, and severe skin reactions.

Emergency Warning Signs — Seek immediate medical care if you experience:

• Worsening cramping, acute abdominal pain, or bloody diarrhea, sometimes with fever, headache, and rash (possible acute intolerance syndrome)
• Signs of a severe skin reaction, such as blistering, peeling, or widespread rash
• Signs of a severe allergic reaction (swelling of the face, lips, tongue, or throat; difficulty breathing)
• Decreased urination or unusual swelling (possible kidney problems)
• Unusual bruising or bleeding
• Persistent fever
• Signs of kidney stones, such as severe flank or back pain

Warnings & Precautions

Patients should be informed of the signs and symptoms of severe cutaneous adverse reactions and instructed to stop the medication and contact their healthcare provider at the first appearance of such a reaction or other sign of hypersensitivity. This product is contraindicated in patients with a known hypersensitivity to mesalamine, salicylates, or any component of the formulation, including patients who have had a similar reaction to mesalamine or other compounds that contain or are converted to salicylates. Acute intolerance syndrome, which may be difficult to distinguish from a disease flare, has occurred in about 3% of patients in controlled trials of mesalamine or sulfasalazine; if suspected, the medication should be promptly discontinued. Preclinical studies have shown the kidney to be the major target organ for mesalamine toxicity, so renal function should be assessed before and periodically during treatment. Use during pregnancy or breastfeeding should be discussed with a physician, as data on rectal use during breastfeeding are limited. This product is for rectal use only and safety and effectiveness in pediatric patients have not been established. The suspension will cause staining of direct contact surfaces including fabrics, flooring, and painted or finished surfaces, so care should be taken in choosing a suitable location for administration.

Who Should Not Use This Medication

People with a known hypersensitivity to mesalamine, salicylates, or any ingredient in the formulation
Individuals with significant pre-existing kidney impairment (without close physician evaluation)
Anyone who has previously experienced acute intolerance syndrome with mesalamine or sulfasalazine
Pediatric patients, as safety and effectiveness have not been established in this population

Storage Instructions

Store at controlled room temperature between 20°C and 25°C (68°F to 77°F), with excursions permitted to 15°C–30°C (59°F–86°F). Once the foil-wrapped unit of bottles is opened, all enemas should be used promptly as directed by your physician. A slight darkening of the suspension is normal, but enemas with dark brown contents should be discarded. Keep out of reach of children and pets.

Frequently Asked Questions

What is the cost of Mesalamine Rectal Suspension Enema 4g/60mL without insurance?

The cost without insurance depends on the seller, brand availability, and pack size, and may also vary by location and available discounts. Generic mesalamine enemas are often more affordable than brand-name Rowasa.

How can I order Mesalamine Rectal Suspension Enema online?

A valid prescription is required to order this medication. Typically, you upload a prescription or have your doctor send it directly, then order from a licensed pharmacy for home delivery. Always verify the pharmacy is properly licensed before ordering.

Is Mesalamine Rectal Suspension Enema available over the contuer?

No, it is not available over the counter in the United States or most other countries. Regulations may vary by region, but medical supervision is required due to the need for kidney function monitoring.

Does Mesalamine Rectal Suspension Enema require a prescription?

Yes, a prescription is required. Renal function should be evaluated before starting therapy, and ongoing monitoring supports safe use.

How long does it take to work?

Some symptom improvement may be noticed within the first couple of weeks, though the full treatment course typically runs 3 to 6 weeks depending on symptoms and clinical response.

Can I stop using it suddenly?

Stopping early, even if symptoms improve, should be discussed with your doctor, as completing the full recommended course supports more lasting symptom control.

Does this medication interact with other drugs?

It has minimal systemic absorption when used rectally, but you should still tell your doctor about all medications you take, particularly other salicylate-containing products, before starting therapy.

Resources

MedlinePlus – Mesalamine Rectal: https://medlineplus.gov/druginfo/meds/a601090.html

FDA – ROWASA (mesalamine) Rectal Suspension Prescribing Information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019618s033lbl.pdf

DailyMed (NIH) – ROWASA Mesalamine Suspension Label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e505ab99-1943-4216-a178-4d5dbe64e3b2

References

FDA – ROWASA (mesalamine) Rectal Suspension Full Prescribing Information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019618s033lbl.pdf

DailyMed (NIH) – ROWASA Mesalamine Suspension Label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e505ab99-1943-4216-a178-4d5dbe64e3b2

MedlinePlus – Mesalamine Rectal: https://medlineplus.gov/druginfo/meds/a601090.html

Medical Disclaimer

This content is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Consult a qualified specialist or physician before using Mesalamine (Mesalazine) Rectal Suspension Enema.