More Related Content Similar to Mesacol Tablets (Generic Mesalamine Tablets) (20) More from Clearsky Pharmacy (20) Mesacol Tablets (Generic Mesalamine Tablets)1. © Clearsky Pharmacy ( www.clearskypharmacy.biz )
Mesacol Tablets (Generic Mesalamine Tablets)
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesacol Tablets (Generic Mesalamine Tablets) are indicated
for the treatment of mildly to moderately active ulcerative
colitis (an inflammatory bowel disease) in patients 5 years of
age and older. This medicine is also used for the
maintenance of remission of ulcerative colitis in adults. It
works inside the bowels to reduce inflammation and other
symptoms of the disease.
The safety and effectiveness of Mesacol for the maintenance
of remission of ulcerative colitis in pediatric patients have not
been established.
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Mesacol Tablets (Generic Mesalamine Tablets)
Active Ingredient
The active ingredient contained in Mesacol tablets is
Mesalamine (Mesalazine). Each delayed release Mesacol
tablet contains 400 mg or 800 mg of Mesalamine.
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Mesacol Tablets (Generic Mesalamine Tablets)
Chemical Structure
The structure of Mesalamine (Mesalazine) is given below:
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesacol Tablets are manufactured by Sun
Pharmaceutical Industries Limited, India in the
strengths of 400 mg and 800 mg.
( Website: https://sunpharma.com/ )
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesalamine Tablets – Brand Names
Mesalamine tablets are available under
various drug trade names that include
Asacol, Apriso, Mesacol, Mesacol OD,
Coolgut, Cosacol, Inflacol, Meslo, Mezakool,
Rowasa, Salofalk 'GR', Tidocol Tab and
Vegaz OD.
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Mesacol Tablets (Generic Mesalamine Tablets)
Uses of Mesacol Tablets
Mesacol tablets manufactured by Sun Pharmaceutical Industries
Limited, India are used to treat a certain bowel disease called
ulcerative colitis. This medicine works by decreasing swelling in the
colon. Mesacol is used for induction and maintenance of remission
in adult patients with mildly to moderately active ulcerative colitis.
Mesacol is also used for treatment of mildly to moderately active
ulcerative colitis in pediatric patients weighing at least 24 kg.
Treatment with Mesacol helps to reduce symptoms of ulcerative
colitis such as diarrhea, rectal bleeding, and stomach pain.
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesacol Tablets Dosage
The dosage of Mesacol tablets (Levothyroxine Sodium) is
given below:
The recommended dosage is orally, with or without food.
Swallow Mesacol tablets whole. Do not cut, break or chew
the tablets.
Treatment of mildly to moderately active Ulcerative Colitis
(UC) in Adults: 800 mg (two 400 mg tablets) three times daily
for 6 weeks.
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesacol Tablets Dosage
The dosage of Mesacol tablets (Levothyroxine Sodium) is
given below:
Treatment of mildly to moderately active Ulcerative Colitis
(UC) in Pediatric Patients 5 years or older: Total daily dosage
is weight-based up to a maximum of 2.4 grams/day divided
into two daily doses.
Maintenance of remission of mildly to moderately active UC
in Adults: 1.6 grams (four 400 mg tablets) daily in two to four
divided doses
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesacol Tablets Contraindications
Mesacol tablets are contraindicated in persons with a
hypersensitivity (allergy) to Mesalamine (Mesalazine) or any
of the other ingredients of this medicine.
Also contraindicated in patients with a known or suspected
hypersensitivity to Salicylates or Aminosalicylates.
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Mesacol Tablets (Generic Mesalamine Tablets)
Storage Instructions
Mesacol Tablets (Generic Mesalamine Tablets)
have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to
77°F) with excursions permitted between 15°
to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.
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Mesacol Tablets (Generic Mesalamine Tablets)
Warnings
Renal impairment may occur. Assess renal function at the
beginning of treatment and periodically during treatment.
Mesalamine-induced acute intolerance syndrome has been
reported. Observe patients closely for worsening of these
symptoms while on treatment.
Use caution when treating patients who are hypersensitive to
Sulfasalazine.
Mesalamine-induced cardiac hypersensitivity reactions
(myocarditis and pericarditis) have been reported.
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Mesacol Tablets (Generic Mesalamine Tablets)
Warnings
Hepatic failure has been reported in patients with pre-
existing liver disease. Use caution when treating patients
with liver disease.
Upper GI tract obstruction may delay onset of action.
Patients with pre-existing skin conditions have reported
more severe photosensitivity reactions.
Use of Mesalamine (Mesacol tablets) may lead to spuriously
elevated test results when measuring urinary
normetanephrine by liquid chromatography with
electrochemical detection.
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesacol Tablets Side Effects
The most common Mesalamine (Mesacol tablets) side
effects with an incidence rate of 5% or higher for the
treatment of mild to moderate ulcerative colitis in adults
are: eructation, abdominal pain, constipation, dizziness,
rhinitis, back pain, and rash.
The most common side effects with an incidence rate of
5% or higher for the treatment of mild to moderate
ulcerative colitis in pediatric Patients 5 years to 17 years of
age: nasopharyngitis, headache, abdominal pain,
dizziness, sinusitis, rash, cough and diarrhea.
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesacol Tablets Side Effects
Inform your doctor immediately in case you have any serious side effects,
including: signs of kidney problems (such as change in the amount of urine), dark
urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing
eyes/skin, chest pain, shortness of breath.
A very serious allergic reaction to this drug is rare. However, get medical help
right away if you notice any symptoms of a serious allergic reaction, including:
rash, itching/swelling (especially of the face/tongue/throat), severe dizziness,
trouble breathing.
Side effects leading to stopping Mesacol therapy included (each in one
patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache;
rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild
disorientation, mild indigestion and cramping; headache, nausea, aching,
vomiting, muscle cramps, a stuffy head, plugged ears, and fever.
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Mesacol Tablets (Generic Mesalamine Tablets)
Overdose
Mesacol (Mesalamine Tablets) is an aminosalicylate, and symptoms of
overdose can include tinnitus (ringing in the ears), vertigo (a spinning
sensation), headache, confusion, rapid breathing, drowsiness, sweating,
seizures, hyperventilation, dyspnea, vomiting, and diarrhea.
There is no specific antidote for Mesalamine overdose and treatment for
suspected acute severe toxicity with Mesacol tablets should be
symptomatic and supportive. This may include prevention of further
gastrointestinal tract absorption, correction of fluid electrolyte imbalance,
and maintenance of adequate renal function. Mesacol is a pH dependent
delayed-release medicine and this factor should be considered when
treating a suspected overdose.
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Mesacol Tablets (Generic Mesalamine Tablets)
Mesacol Tablets During Pregnancy
Mesalamine (Mesacol tablets) is classified by the US FDA as Pregnancy
Category C. No fetal harm was seen during animal reproduction studies of
Mesalamine in rats and rabbits at oral doses approximately 1.9 times (rat) and
3.9 times (rabbit) the recommended human dose. However, dibutyl phthalate
(DBP) is an inactive ingredient in Mesacol’s enteric coating, and in animal studies
in rats at doses greater than 190 times the human dose, maternal DBP was
associated with external and skeletal malformations and adverse effects on the
reproductive system of male offspring.
There are, however, no adequate and well-controlled studies of Mesacol
(Mesalamine Tablets) in pregnant women. Pregnant women must be advised of
the potential risk to the fetus. Because animal reproduction studies are not
always predictive of human response, this drug should be used during pregnancy
only if clearly needed.
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Mesacol Tablets (Generic Mesalamine Tablets)
For more details on
Mesacol Tablets click here
Mesacol Tablets (Generic Mesalamine Tablets) by Sun
Pharmaceutical Industries Limited, India.
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