DRUGS & SUPPLEMENTS

Mesalamine

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Mesalamine uses


INDICATIONS AND USAGE

Mesalamine Rectal Suspension, USP is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

CONTRAINDICATIONS

Mesalamine Rectal Suspension, USP is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.

WARNINGS

Mesalamine Rectal Suspension, USP 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. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low. Sulfite sensitivity is seen more frequently in asthmatic or in atopic nonasthmatic persons. 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. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite(s) in epinephrine injection should not deter the administration of the drug for treatment of serious allergic or other emergency situations.

PRECAUTIONS

Mesalamine has been implicated in the production of an acute intolerance syndrome characterized by cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required. The patient's history of sulfasalazine intolerance, if any, should be re-evaluated. If a rechallenge is performed later in order to validate the hypersensitivity it should be carried out under close supervision and only if clearly needed, giving consideration to reduced dosage. In the literature one patient previously sensitive to sulfasalazine was rechallenged with 400 mg oral Mesalamine; within eight hours she experienced headache, fever, intensive abdominal colic, profuse diarrhea and was readmitted as an emergency. She responded poorly to steroid therapy and two weeks later a pancolectomy was required.

Although renal abnormalities were not noted in the clinical trials with Mesalamine Rectal Suspension, USP, the possibility of increased absorption of Mesalamine and concomitant renal tubular damage as noted in the preclinical studies must be kept in mind. Patients on Mesalamine Rectal Suspension, USP, especially those on concurrent oral products which liberate Mesalamine and those with preexisting renal disease, should be carefully monitored with urinalysis, BUN and creatinine studies.

In a clinical trial most patients who were hypersensitive to sulfasalazine were able to take Mesalamine enemas without evidence of any allergic reaction. Nevertheless, caution should be exercised when Mesalamine is initially used in patients known to be allergic to sulfasalazine. These patients should be instructed to discontinue therapy if signs of rash or fever become apparent.

While using Mesalamine Rectal Suspension, USP some patients have developed pancolitis. However, extension of upper disease boundary and/or flare-ups occurred less often in the Mesalamine Rectal Suspension, USP treated group than in the placebo-treated group.

Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, may occur after commencing Mesalamine.

Rare instances of pericarditis have been reported with Mesalamine containing products including sulfasalazine. Cases of pericarditis have also been reported as manifestations of inflammatory bowel disease. In the cases reported with Mesalamine Rectal Suspension, USP there have been positive rechallenges with Mesalamine or Mesalamine containing products. In one of these cases, however, a second rechallenge with sulfasalazine was negative throughout a 2 month follow-up. Chest pain or dyspnea in patients treated with Mesalamine Rectal Suspension, USP should be investigated with this information in mind. Discontinuation of Mesalamine Rectal Suspension, USP may be warranted in some cases, but rechallenge with Mesalamine can be performed under careful clinical observation should the continued therapeutic need for Mesalamine be present.

Information for Patients

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mesalamine caused no increase in the incidence of neoplastic lesions over controls in a two-year study of Wistar rats fed up to 320 mg/kg/day of Mesalamine admixed with diet. Mesalamine is not mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537, TA1538. There were no reverse mutations in an assay using E. coli strain WP2UVRA. There were no effects in an in vivo mouse micronucleus assay at 600 mg/kg and in an in vivo sister chromatid exchange at doses up to 610 mg/kg. No effects on fertility were observed in rats receiving up to 320 mg/kg/day. The oligospermia and infertility in men associated with sulfasalazine have not been reported among patients treated with Mesalamine.

Pregnancy

Teratologic studies have been performed in rats and rabbits at oral doses up to five and eight times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus. There are, however, no adequate and well controlled studies in pregnant women for either sulfasalazine or 5-ASA. Because animal reproduction studies are not always predictive of human response, 5-ASA should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether Mesalamine or its metabolite are excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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ADVERSE REACTIONS

Clinical Adverse Experience

Mesalamine Rectal Suspension, USP is usually well tolerated. Most adverse effects have been mild and transient.

ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1 % OF Mesalamine RECTAL SUSPENSION TREATED PATIENTS
Mesalamine RECTAL SUSPENSION USP PLACEBO
SYMPTOM N=815

N

% N=128

N

%
Abdominal Pain/Cramps/Discomfort 66 8.10 10 7.81
Headache 53 6.50 16 12.50
Gas/Flatulence 50 6.13 5 3.91
Nausea 47 5.77 12 9.38
Flu 43 5.28 1 0.78
Tired/Weak/Malaise/Fatigue 28 3.44 8 6.25
Fever 26 3.19 0 0.00
Rash/Spots 23 2.82 4 3.12
Cold/Sore Throat 19 2.33 9 7.03
Diarrhea 17 2.09 5 3.91
Leg/joint Pain 17 2.09 1 0.78
Dizziness 15 1.84 3 2.34
Bloating 12 1.47 2 1.56
Back Pain 11 1.35 1 0.78
Pain on Insertion of Enema Tip 11 1.35 1 0.78
Hemorrhoids 11 1.35 0 0.00
Itching 10 1.23 1 0.78
Rectal Pain 10 1.23 0 0.00
Constipation 8 0.98 4 3.12
Hair Loss 7 0.86 0 0.00
Peripheral Edema 5 0.61 11 8.59
UTI/Urinary Burning 5 0.61 4 3.12
Rectal Pain/Soreness/Burning 5 0.61 3 2.34
Asthenia 1 0.12 4 3.12
Insomnia 1 0.12 3 2.34

In addition, the following adverse events have been identified during post-approval use of products which contain (or are metabolized to) Mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease.

Hair Loss

Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in seven of 815 Mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either Mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss.

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OVERDOSAGE

There have been no documented reports of serious toxicity in man resulting from massive overdosing with Mesalamine. Under ordinary circumstances, Mesalamine absorption from the colon is limited.

DOSAGE AND ADMINISTRATION

The usual dosage of Mesalamine Rectal Suspension, USP in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. While the effect of Mesalamine Rectal Suspension, USP may be seen within three to twenty-one days, the usual course of therapy would be from three to six weeks depending on symptoms and sigmoidoscopic findings. Studies available to date have not assessed if Mesalamine Rectal Suspension, USP will modify relapse rates after the 6-week short-term treatment. Mesalamine Rectal Suspension, USP is for rectal use only.

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.

HOW SUPPLIED

Mesalamine Rectal Suspension, USP, for rectal administration is an off-white to tan colored suspension. Each disposable enema bottle contains 4.0 grams of Mesalamine in 60 mL aqueous suspension. Enema bottles are supplied in boxed, foil-wrapped trays as follows:

Carton of 7 Bottles - NDC 45802-098-51

Carton of 28 Bottles - NDC 45802-098-28

Combo Kit with 7 Bottles and Wipes - NDC 45802-923-41

Combo Kit with 28 Bottles and Wipes - NDC 45802-923-49

Mesalamine Rectal Suspension USP, Enemas are for rectal use only.

KEEP OUT OF REACH OF CHILDREN

Patient instructions are included.

Store at 20-25°C (68-77°F).. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician.

Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.

NOTE: Mesalamine Rectal Suspension, USP will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

Rx Only

MADE IN ISRAEL

MANUFACTURED BY PERRIGO, YERUHAM 80500, ISRAEL

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 11/09

2N900 RC J5

PATIENT INSTRUCTIONS

How to Use this Medication.

Best results are achieved if the bowel is emptied immediately before the medication is given.

NOTE: Mesalamine Rectal Suspension, USP will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

1. Remove the Bottles

a. Remove the bottles from the protective foil pouch by tearing or by using scissors as shown, being careful not to squeeze or puncture bottles. Mesalamine Rectal Suspension, USP enema is an off-white to tan colored suspension. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.

2. Prepare the Medication for Administration

a. Shake the bottle well to make sure that the medication is thoroughly mixed.

b. Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the medication to be discharged.

3. Assume the Correct Body Position

a. Best results are obtained by lying on the left side with the left leg extended and the right leg flexed forward for balance.

b. An alternative to lying on the left side is the "knee-chest" position as shown here.

4. Administer the Medication

a. Gently insert the lubricated applicator tip into the rectum to prevent damage to the rectal wall, pointed slightly toward the navel.

b. Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back, squeeze slowly to instill the medication. Steady hand pressure will discharge most of the medication. After administering, withdraw and discard the bottle.

c. Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the medication all night, if possible.

Rx Only

MADE IN ISRAEL

MANUFACTURED BY PERRIGO, YERUHAM 80500, ISRAEL

DISTRIBUTED BY PERRIGO, ALLEGAN, MI 49010

Rev. 11/09

Remove the Bottles Image Prepare the Medication for Administration Image Assume the Correct Body Position Image #1 Assume the Correct Body Position Image #2 Administer the Medication Image

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Mesalamine pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Mesalamine available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Mesalamine destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Mesalamine Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Mesalamine pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."MESALAMINE KIT [PERRIGO NEW YORK INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Mesalamine?

Depending on the reaction of the Mesalamine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mesalamine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Mesalamine addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Mesalamine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Mesalamine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported side effects

Did you get side effects while taking the Mesalamine drug, or were there no side effects?
According to the survey conducted by website sDrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Mesalamine medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects1
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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