Asacol-Mesalamine
Why
is this drug prescribed?
Rowasa Suspension Enema, Pentasa, and Asacol are used to treat mild
to moderate ulcerative colitis (inflammation of the large intestine
and rectum). Rowasa Suspension Enema is also prescribed for inflammation
of the lower colon, and inflammation of the rectum.
Rowasa Suppositories and Canasa Suppositories are used to treat inflammation of the rectum.
What
is the most important information I should know about mesalamine oral?
• Tell your doctor if you have any type of kidney or liver disease,
or if you are allergic to aspirin. You may not be able to use mesalamine,
or you may need a dosage adjustment or special tests during treatment.
• Do not crush, break, or chew a mesalamine tablet or capsule.
Swallow the pill whole. It is specially formulated to release the
medicine after it has passed through your stomach into your intestines.
• Call your doctor if you find undissolved tablets in your stool.
• Stop using mesalamine and call your doctor at once if you
have severe stomach pain, cramping, fever, headache, and bloody diarrhea.
How
should I take this medicine?
Take mesalamine tablets or capsules by mouth. Follow the directions
on the prescription label. Swallow the tablets or capsules whole with
a full glass of water; do not crush or chew. Take your doses at regular
intervals. Do not take your medicine more often than directed.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
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What
if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time
for your next dose, take only that dose. Do not take double or extra
doses.
Asacol
Oral Side Effects
Flu-like symptoms, vomiting, nausea, dizziness, weakness, headache,
constipation, abdominal/back pain, upset stomach, diarrhea, or gas
may occur. If any of these effects persist or worsen, notify your
doctor or pharmacist promptly.
Whole or partial tablets may occasionally be seen in your stool. If this occurs frequently, notify your doctor. You may not be receiving enough of the medication.
Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Infrequently, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor immediately if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, headache.
Tell your doctor immediately if any of these unlikely but serious side effects occur: vomit that looks like coffee grounds, black/tarry stools, vision changes, eye pain, tingling of the hands/feet, painful straining during a bowel movement.
Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the eyes/skin, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, chest pain, shortness of breath, change in the amount of urine, a man's ability to father a child.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.
If you notice other effects not listed above, contact your doctor or pharmacist.
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Asacol
Asacol medicine is an anti-inflammatory used to treat ulcerative colitis. It may also be used for other conditions as determined by your doctor.
David's Drug Store ExplainsWhy is this drug prescribed?Asacol Suspension Enema, Pentasa, and Asacol are used to treat mild to moderate ulcerative colitis (inflammation of the large intestine and rectum). Asacol Suspension Enema is also prescribed for inflammation of the lower colon, and inflammation of the rectum.
Asacol Suppositories and Canasa Suppositories are used to treat inflammation of the rectum.
David's Drug Store Lets You KnowThe most important fact about this drug
Mesalamine, the active ingredient in these products, has been known to cause side effects such as:
Bloody diarrhea
Cramping
Fever
Rash
Severe headache
Sudden, severe stomach painIf you develop any of these symptoms, stop taking this medication and consult your doctor.
David's Drug Store Lets You Know About Food And Drug InteractionsAsacol is not known to interact with food or any other drug.
Food - Results of a study in fed and fasted subjects given a single dose of Asacol tablets showed that the extent of drug absorption was the same under both conditions.32 The peak plasma concentration of mesalamine appeared later in the fed state, possibly as a result of differences in the rate of gastric emptying.
David's Drug Store ExplainsHow should you use this medication?
To Use Asacol Suspension Enema
1. Asacol Suspension Enema comes in boxes of 7 bottles each. After the foil on the box has been unwrapped, all Asacol Suspension Enemas should be used promptly, following your doctor's instructions. The Suspension Enema is normally off-white to tan in color, but may darken over time once its foil cover is unwrapped. You may still use the enema if it is slightly discolored, but do not use Asacol Suspension Enema if it is dark brown. If you have any questions about using Asacol Suspension Enema, contact your doctor.
2. Use Asacol Suspension Enema at bedtime.
3. Shake the bottle thoroughly.
4. Uncover the applicator tip.
5. You may find it easier to use Asacol Suspension Enema if you lie down on your left side, extending your left leg and bending your right leg forward for a comfortable balance. An alternative position is on your knees with your hips in the air and your head and shoulders down on the bed.
6. Pointing the applicator tip slightly towards the navel, gently insert the tip into the rectum.
7. Tilt the bottle slightly towards the back, then squeeze it slowly to discharge the contents.
8. Remain in position for at least 30 minutes to allow thorough distribution of the medicine. Retain the enema all night (8 hours) for best results.To Use Asacol or Canasa Suppositories
1. Asacol Suppositories should be used twice a day. Canasa Suppositories can be used 2 or 3 times a day.
2. You should handle the suppositories as little as possible, because they are designed to melt at body temperature.
3. Remove one suppository from the strip of suppositories.
4. While holding the suppository upright, carefully remove the wrapper.
5. Using gentle pressure, insert the suppository (with the pointed end first) completely into the rectum. A small amount of lubricating gel may be used on the tip of the suppository to assist insertion.
6. The suppository should be retained for 1 to 3 hours or longer for best results.To take Pentasa or Asacol
Swallow the capsule or tablet whole. Do not break, crush, or chew it before swallowing.
You may notice what looks like small beads in your stool. These are just empty shells that are left after the medication has been absorbed into your body. However, if this continues, check with your doctor.
David's Drug Store ExplainsWhat to do if you If you miss a dose...
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.
David's Drug Store - Storage instructions...
Store these products at room temperature. Keep suppositories away from direct heat, light, and humidity. Do not refrigerate.
David's Drug Store Inform You AboutDrugs that Raise Stomach pH
A crossover study 36 was conducted to determine the effects of an H2 receptor antagonist (cimetidine) and an antacid (Asilone®) on release of mesalamine from Asacol tablets. Neither drug appeared to influence mesalamine release or the rate and extent of mesalamine absorption. In another crossover study,37 raising the intragastric pH by the simultaneous administration of famotidine did not increase the absorption of mesalamine from Asacol tablets. Hussain et al.38 evaluated the effects of omeprazole, a proton pump inhibitor, on the absorption of mesalamine from Asacol tablets. Six healthy volunteers were given Asacol tablets, 400 mg three times daily for three weeks. Concomitant omeprazole was administered in doses of 20 mg/d and 40 mg/d during the second and third weeks, respectively. Analyses conducted on Days 7, 14, and 21 of the study indicated that mesalamine and N-Ac-5-ASA serum levels, 24-hour urinary excretion, and 2-hour fecal excretion were comparable on all three days. The investigators concluded that concurrent administration of omeprazole in doses up to 40 mg does not influence the steady state kinetics of delayed-release mesalamine (Asacol tablets).David's Drug Store ExplainsWhat side effects may occur?
Side effects cannot be anticipated. If any side effects develop or change in intensity, tell your doctor immediately. Only your doctor can determine whether it is safe to continue using this medication.
More common side effects generally include:
Diarrhea, dizziness, flu-like symptoms, gas, headache, nausea, stomach painOther typical side effects may include:
Abdominal pain, acne, back pain, belching, bloating, chest pain, chills, constipation, fever, hair loss, hemorrhoids, indigestion, insomnia, itching, joint pain, leg pain, liver disorders, menstrual problems, muscle pain, nasal inflammation, rash, rectal pain or bleeding, sore throat, stomach and intestinal bleeding, sweating, swelling of the arms and legs, tiredness, urinary burning, vomiting, weakness
Although quite rare, other problems are possible. If you notice any unusual symptoms, check with your doctor.David's Drug Store WarnsWhy should this drug not be prescribed?
These products should not be used by anyone who is allergic or sensitive to mesalamine or their other ingredients.Pentasa, Canasa, and Asacol should not be used if you areallergic or sensitive to salicylates (aspirin), foods, preservatives, or dyes.
David's Canadian Drug Lets You KnowSpecial warnings about this medication
Your doctor should check your kidney function while you are taking mesalamine, especially if you have a history of kidney disease or you are using other anti-inflammatory drugs such as Dipentum.
Because older adults tend to have weaker kidneys,mesalamine is more likely to trigger side effects within this age group. The drug also seems more prone to cause blood disorders in older adults. If you are 65 or older, be sure to tell the doctor about any change in your health.
You should use mesalamine cautiously if you are allergic to sulfasalazine (Azulfidine). If you develop a rash or fever, you should stop using the medication and notify your doctor.
Some people using mesalamine have developed flare-ups of their colitis. Inflammation of the pancreas has also been reported.Rare cases of pericarditis, in which the membrane surrounding the heart becomes inflamed, have been reported with products containing mesalamine. Symptoms may include chest, neck, and shoulder pain, and shortness of breath.
Asacol Suspension Enema contains a sulfite that may cause allergic reactions in some people. These reactions may include shock and severe, possibly fatal asthma attacks. Most people aren't sensitive to sulfites. However, some people with asthma might be sensitive and should take any medication containing sulfites cautiously.Asacol Suspension Enema may stain clothes and fabrics. Canasa Suppositories can also stain surfaces, including marble, granite, plastic, and painted surfaces.
David's Drug - Precautions
General
Some sulfasalazine adverse events are probably caused by its mesalamine, rather than its sulfapyridine component. Patients who experience such mesalamine-related adverse events while taking sulfasalazine may experience similar reactions when switched to Asacol tablets. Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Asacol tablets or to other compounds which contain or are converted to mesalamine.
David's Drug Store ExplainsExacerbation of Symptoms of Ulcerative Colitis
Symptoms which resemble an exacerbation of the symptoms of ulcerative colitis - primarily diarrhea, cramping, and abdominal pain - have been reported with mesalamine.40,46 Other symptoms which can accompany the diarrhea and abdominal pain include rectal bleeding, nausea, fever, headache, malaise and, very infrequently, arthralgias, rash, and conjunctivitis. Such exacerbations were reported in 3% of Asacol-treated patients in controlled clinical trials. The onset of the event is usually in the first few days of therapy and neither the occurrence nor the severity of the symptoms appear to be dose-related.39,40 The symptoms usually abate promptly when Asacol tablets are discontinued. Since this event is likely due to a hypersensitivity to mesalamine, patients who experienced similar symptoms with other mesalamine products, sulfasalazine, olsalazine, balsalazide, or rectally administered mesalamine may experience a similar reaction when switched to Asacol tablets.
David's Drug Store ExplainsRenal Events Associated with Asacol Tablets and Mesalamine TherapyRenal impairment, including minimal change nephropathy, and acute and chronic interstitial nephritis, has been reported in patients taking Asacol tablets as well as other compounds which contain or are converted to mesalamine. In animal studies (rats, dogs, and monkeys), the kidney was the principal target organ for toxicity. Uncoated mesalamine administered to rats at doses of 170 mg/kg/day for 6 months caused mild histologic renal damage,47 and at higher doses (320-360 mg/kg/day) caused renal papillary necrosis.48,49 In dogs, renal damage and/or papillary necrosis occurred following dosing with uncoated mesalamine at 60 mg/kg/day for 1 year,50 and in monkeys following a single oral dose of 500 mg/kg.51 There was no renal toxicity when delayed-release Asacol tablets were given to dogs at doses of 2 g/d for one year.52 This was approximately 4.5 times the usual human dose (based on a dose of 2.4 g/day in a 50 kg person). While the Asacol tablets formulation limits systemic absorption, caution should be exercised when using Asacol tablets (or other compounds which contain or are converted to mesalamine) in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy.
David's Drug Store Warns AboutPossible food and drug interactions when taking this medication
If these products are taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Asacol Suspension Enema, Asacol Suppositories, and Canasa Suppositories with sulfasalazine (Azulfidine).
David's Drug Store Tells You
Special information if you are pregnant or breastfeedingPregnant women should use mesalamine only if clearly needed. Mesalamine has been found in breast milk. If this medication is essential to your health your doctor may advise you to discontinue breastfeeding until your treatment is finished.
David's Drug Store - Recommended dosage
Asacol Suspension Enema
The usual dose is 1 rectal enema (60 milliliters) per day, preferably used at bedtime and retained for about 8 hours. Treatment time usually lasts from 3 to 6 weeks, although improvement may be seen within 3 to 21 days.Suppositories
The usual dose is one rectal suppository (500 milligrams) 2 times a day. To get the most benefit from the suppository, it should be retained for 1 to 3 hours or longer. Treatment time usually lasts from 3 to 6 weeks, although improvement may be seen within 3 to 21 days. The dosage of Canasa may be increased to 3 suppositories daily if response is unsatisfactory after 2 weeks of therapy.
Pentasa Capsules
The usual dose is 4 capsules taken 4 times a day for a total of 16 capsules daily.
Asacol Tablets
The recommended dose for the treatment of ulcerative colitis is 2 tablets 3 times a day for 6 weeks.
To prevent a relapse, the usual dosage is 4 tablets a day, taken in 2 or more smaller doses, for 6 months.
David's Drug Store Explains About
Geriatric UseClinical studies of Asacol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing Asacol. Reports from uncontrolled clinical studies and post-marketing reporting systems suggest a higher incidence of blood dyscrasias, i.e., agranulocytosis, neutropenia, pancytopenia, in subjects receiving Asacol who are 65 years or older. Caution should be taken to closely monitor blood cell counts during drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. As stated in the "Precautions" section, it is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy.
David's Drug Store Warns About
OverdosageBoth mesalamine and its primary metabolite, N-Ac-5-ASA are excreted by the kidney. However, there are no data on whether or not Asacol is dialyzable.
Two cases of pediatric overdosage have been reported. A 3-year-old male who ingested 2 g of Asacol tablets was treated with ipecac and activated charcoal; no adverse events occurred. Another 3-year-old male, weighing approximately 16 kg, ingested an unknown amount of a maximum of 24 g of Asacol tablets crushed in solution (i.e., uncoated mesalamine). He was treated with orange juice and activated charcoal and experienced no adverse events. In dogs, single doses of 6 g of delayed-release Asacol tablets resulted in renal papillary necrosis but were not fatal. This was approximately 12.5 times the usual human dose (based on a dose of 2.4 g/day in a 50 kg person). Single oral doses of uncoated mesalamine in mice and rats of 5000 mg/kg and 4595 mg/kg, respectively, or of 3000 mg/kg in cynomolgus monkeys, caused significant lethality.
David's Drug Store More About - Overdosage
There have been no proven reports of serious effects resulting from overdoses of Asacol or Canasa. An overdose of Pentasa or Asacol could cause any of the following symptoms:
Confusion, diarrhea, drowsiness, headache, hyperventilation, ringing in the ears, sweating, vomiting
Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.
David's Drug Store Explains About
Dosage and AdministrationFor the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 g for a duration of 6 weeks.
For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.
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