Mesacol Enema Rectal Suspension

MESACOL ENEMA RECTAL SUSPENSION

Mesacol Enema Rectal Suspension, manufactured by SUN PHARMA LABORATORIES LTD., is a specialized medication designed for the localized treatment of inflammatory bowel conditions.

• Name:

  • Brand Name: Mesacol Enema
  • Common Name: Mesalamine (also known as Mesalazine)

• Composition:

  • Active Ingredient: Mesalamine (an aminosalicylate)

• Uses: Mesacol Enema is prescribed for the treatment of active mild to moderate inflammatory conditions of the lower bowel. It is primarily used for:

  • Ulcerative colitis
  • Ulcerative proctitis (inflammation of the rectum)
  • Proctosigmoiditis (inflammation involving the rectum and sigmoid colon) The medication works by reducing inflammation in the intestinal lining, which helps to alleviate symptoms such as abdominal pain, diarrhea, and rectal bleeding, and can also prevent future disease flare-ups.

• Dosage and Administration:

  • Mesacol Enema is for rectal use only.
  • The typical dosage is one rectal instillation (4 grams), administered once daily, preferably at bedtime.
  • It should be retained for approximately eight hours.
  • Treatment duration typically ranges from 3 to 6 weeks, depending on clinical response.
  • Before administration, wash hands and ensure the rectal area is clean and dry. Shake the bottle vigorously for at least 30 seconds.
  • Lie on your left side with your left leg outstretched and your right leg bent, or assume a knee-to-chest position. Gently insert the applicator tip into the rectum, pointing towards the navel, and steadily squeeze the bottle.
  • Remain in the position for at least 30 minutes after administration to allow for optimal drug spread.

• Side Effects:

  • Common: Diarrhea, stomach pain/abdominal discomfort, headache, nausea, rectal discomfort/irritation, rash, itching, fever, runny or stuffy nose, sensitivity to light.
  • Serious (seek immediate medical attention if experienced): Allergic reactions (severe rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing), new or worsening chest pain, shortness of breath, kidney problems (decreased urination, swelling), liver problems (yellowing skin/eyes, dark urine, severe abdominal pain), or symptoms resembling acute intolerance syndrome (cramping, bloody diarrhea, fever, severe headache).

• Precautions:

  • Do not use if allergic to mesalamine, salicylates (like aspirin), sulfites, or any other components of the enema.
  • Use with caution in elderly patients.
  • Inform your doctor if you have kidney or liver disease, as Mesacol Enema is not recommended for severe impairment and should be used cautiously in mild to moderate cases. Renal function should be assessed before and during treatment.
  • Not recommended for use in children under 18 years of age.
  • Consult your doctor if pregnant, planning pregnancy, or breastfeeding.
  • Inform your doctor about all current medications, including herbal supplements, especially nephrotoxic drugs, NSAIDs, azathioprine, mercaptopurine, thioguanine, or warfarin, due to potential interactions.
  • Avoid alcohol consumption as it may exacerbate ulcerative colitis.
  • Stay well-hydrated by drinking plenty of fluids.
  • May increase sensitivity to the sun; use sun protection.

• Storage:

  • Store in a cool, dry place, away from direct sunlight, typically between 10ºC to 25ºC (50ºF to 77ºF) or below 30ºC (86ºF).
  • Keep out of the sight and reach of children and pets.
  • Discard any unused medication after the expiration date.
  • Once a foil-wrapped unit is opened, any remaining bottles should be discarded after 14 days.
  • Slight darkening of the suspension is acceptable, but discard if the contents become dark brown.

What is Mesacol Enema Rectal Suspension used for?

Mesacol Enema Rectal Suspension is primarily used to treat inflammatory bowel conditions such as ulcerative colitis and ulcerative proctitis. It is specifically indicated for active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis, which are conditions where the lining tissue of the inner rectum and lower parts of the large intestine become inflamed. It helps to reduce symptoms like diarrhea, bleeding, and stomach pain by alleviating inflammation in the bowel.

How does Mesacol Enema Rectal Suspension work?

Mesacol Enema contains Mesalazine (also known as 5-aminosalicylic acid or 5-ASA), which is an aminosalicylate. It works directly on the inflamed lining of the rectum and lower colon to reduce inflammation. It achieves this by suppressing the production of chemical messengers, such as prostaglandins, which are responsible for causing inflammation, swelling, ulceration, and pain in the intestines. The mechanism of action is thought to be topical rather than systemic.

What is the usual dosage and how should it be administered?

For adults, the usual dosage of Mesacol Enema Rectal Suspension is one rectal instillation (4 grams in 60 mL) once a day, preferably at bedtime. It should be retained for approximately eight hours to allow the medication to spread and work effectively. The typical course of therapy ranges from 3 to 6 weeks, depending on symptoms and sigmoidoscopic findings.

To administer, shake the bottle well, and ensure your bowels are emptied beforehand. Lie on your left side with your left leg extended and your right leg bent forward for balance. Gently insert the applicator tip into the rectum, pointing it slightly towards your navel, and steadily squeeze the bottle to discharge the medication. Remain in this position for at least 30 minutes, ideally for 8 hours (e.g., overnight), to allow the medicine to spread. It is for rectal use only and should not be taken orally.

What are the possible side effects?

Common side effects of Mesacol Enema Rectal Suspension may include headache, diarrhea, nausea, rectal discomfort or irritation, abdominal pain, and rash. Some patients may experience cramping or feel an urgent need to have a bowel movement after administration.

Serious but rare side effects can include allergic reactions (rash, hives, swelling of the face/lips/tongue, difficulty breathing), kidney or liver injury, inflammation of the heart muscle, and a mesalamine-induced acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash). If these severe symptoms occur, discontinue use and contact your doctor immediately.

Is it safe during pregnancy or breastfeeding?

If you are pregnant or planning to become pregnant, Mesacol Enema Rectal Suspension should be used with caution and only if clearly necessary, after consulting your doctor. While some studies in humans have shown limited harm, animal studies have shown harmful effects on the developing baby. It is important to maintain control of your inflammatory bowel disease during pregnancy.

For breastfeeding mothers, Mesacol Enema should also be used with caution and only if necessary, as small amounts of mesalamine can pass into breast milk. While many have used it without issues, rare cases of diarrhea in infants have been reported. Consult your doctor to weigh the risks and benefits, and monitor your baby for symptoms like diarrhea, vomiting, rash, or irritability.

Can it be taken with other medications?

Mesacol Enema Rectal Suspension can interact with certain medications. Concurrent use with nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of kidney damage. Additionally, using it with azathioprine or 6-mercaptopurine, or other myelotoxic drugs, may increase the risk of blood disorders. Always inform your doctor about all medications, herbs, and supplements you are taking to avoid potential interactions.

What precautions should be taken?

Several precautions should be taken when using Mesacol Enema Rectal Suspension:

• Allergies: Do not use if you are allergic to mesalamine, salicylates (like aspirin), sulfites, or any other ingredients in the enema.
• Kidney and Liver Conditions: Use with caution in patients with kidney or liver disease. It is not recommended for those with severe kidney or liver problems. Your doctor may monitor kidney and liver function before and during treatment.
• Acute Intolerance Syndrome: Be aware of symptoms resembling an inflammatory bowel disease flare, such as cramping, acute abdominal pain, and bloody diarrhea, which could indicate an acute intolerance syndrome. Discontinue use if suspected.
• Hydration: Drink plenty of fluids during treatment to help prevent kidney stone formation.
• Sun Sensitivity: Mesalamine can increase sensitivity to the sun. Wear protective clothing and sunscreen if you cannot avoid sun exposure.
• Staining: The medication may stain clothing, fabrics, and other surfaces.
• Urine Discoloration: Your urine may appear reddish-brown when it comes into contact with surfaces or water treated with bleach. If urine is discolored before contact with surfaces, consult your doctor.

What happens if a dose is missed?

If you miss a dose of Mesacol Enema Rectal Suspension, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

How should it be stored?

Mesacol Enema Rectal Suspension should be stored at controlled room temperature, typically between 20° to 25°C (68° to 77°F), and protected from direct sunlight, moisture, and heat. Keep it out of the reach of children. Once the foil-wrapped unit of enemas is opened, they should be used promptly as directed by your physician. The contents may darken over time, but slight darkening will not affect potency; however, enemas with dark brown contents should be discarded. Do not freeze the enema.