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mesalamine
Overview
What is Rowasa?
The active ingredient in ROWASA® (mesalamine) Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid.
The empirical formula is CHNO, representing a molecular weight of 153.14. The structural formula is:
Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.
What does Rowasa look like?
What are the available doses of Rowasa?
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What should I talk to my health care provider before I take Rowasa?
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How should I use Rowasa?
ROWASA® (mesalamine) Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.
The usual dosage of ROWASA® (mesalamine) Rectal Suspension Enema 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 ROWASA® (mesalamine) Rectal Suspension Enema may be seen within 3 to 21 days, the usual course of therapy would be from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Studies available to date have not assessed if ROWASA® (mesalamine) Rectal Suspension Enema will modify relapse rates after the 6-week short-term treatment. ROWASA® (mesalamine) Rectal Suspension Enema 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.
What interacts with Rowasa?
ROWASA® (mesalamine) Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.
What are the warnings of Rowasa?
Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with ketorolac tromethamine. Do not use ketorolac tromethamine for more than five days. However, even short-term therapy is not without risk. In addition to past history of ulcer disease, other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids, or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of ketorolac tromethamine until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated.
ROWASA® (mesalamine) Rectal Suspension Enema 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.
What are the precautions of Rowasa?
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 ROWASA® (mesalamine) Rectal Suspension Enema, 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 ROWASA® (mesalamine) Rectal Suspension Enema, especially those on concurrent oral products which liberate mesalamine and those with preexisting renal disease, should be carefully monitored with urinalysis, BUN (blood urea nitrogen), 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 ROWASA® (mesalamine) Rectal Suspension Enema, some patients have developed pancolitis. However, extension of upper disease boundary and/or flare-ups occurred less often in the ROWASA® (mesalamine) Rectal Suspension Enema 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 ROWASA® (mesalamine) Rectal Suspension Enema, 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 ROWASA® (mesalamine) Rectal Suspension Enema should be investigated with this information in mind. Discontinuation of ROWASA® (mesalamine) Rectal Suspension Enema 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Mesalamine caused no increase in the incidence of neoplastic lesions over controls in a 2-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 mouse micronucleus assay at 600 mg/kg and in an 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 has very rarely 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(s) 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.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-210-5949 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the side effects of Rowasa?
Clinical Adverse Experience
ROWASA® (mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient.
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, elevated liver enzymes, nephrogenic diabetes insipidus and intracranial hypertension. 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.
| SYMPTOM | % | % | ||
|---|---|---|---|---|
| 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 |
Hair Loss
Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 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.
What should I look out for while using Rowasa?
ROWASA® (mesalamine) Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.
ROWASA® (mesalamine) Rectal Suspension Enema 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.
What might happen if I take too much Rowasa?
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.
How should I store and handle Rowasa?
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].ROWASA® (mesalamine) Rectal Suspension Enema 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:NDC 0037-0066-01........................... Professional SampleNDC 0037-0066-05........................... Carton of 7 BottlesNDC 0037-0066-14........................... Carton of 14 BottlesNDC 0037-0066-03........................... Carton of 28 BottlesROWASA® (mesalamine) Rectal Suspension Enemas are for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.ROWASA® (mesalamine) Rectal Suspension Enema 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:NDC 0037-0066-01........................... Professional SampleNDC 0037-0066-05........................... Carton of 7 BottlesNDC 0037-0066-14........................... Carton of 14 BottlesNDC 0037-0066-03........................... Carton of 28 BottlesROWASA® (mesalamine) Rectal Suspension Enemas are for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.ROWASA® (mesalamine) Rectal Suspension Enema 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:NDC 0037-0066-01........................... Professional SampleNDC 0037-0066-05........................... Carton of 7 BottlesNDC 0037-0066-14........................... Carton of 14 BottlesNDC 0037-0066-03........................... Carton of 28 BottlesROWASA® (mesalamine) Rectal Suspension Enemas are for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.ROWASA® (mesalamine) Rectal Suspension Enema 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:NDC 0037-0066-01........................... Professional SampleNDC 0037-0066-05........................... Carton of 7 BottlesNDC 0037-0066-14........................... Carton of 14 BottlesNDC 0037-0066-03........................... Carton of 28 BottlesROWASA® (mesalamine) Rectal Suspension Enemas are for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.ROWASA® (mesalamine) Rectal Suspension Enema 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:NDC 0037-0066-01........................... Professional SampleNDC 0037-0066-05........................... Carton of 7 BottlesNDC 0037-0066-14........................... Carton of 14 BottlesNDC 0037-0066-03........................... Carton of 28 BottlesROWASA® (mesalamine) Rectal Suspension Enemas are for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Preclinical studies have shown the kidney to be the major target organ for mesalamine toxicity. Adverse renal function changes were observed in rats after a single 600 mg/kg oral dose, but not after a 200 mg/kg dose. Gross kidney lesions, including papillary necrosis, were observed after a single oral >900 mg/kg dose, and after I.V. doses of >214 mg/kg. Mice responded similarly. In a 13-week oral (gavage) dose study in rats, the high dose of 640 mg/kg/day mesalamine caused deaths, probably due to renal failure, and dose-related renal lesions (papillary necrosis and/or multifocal tubular injury) were seen in most rats given the high dose (males and females) as well as in males receiving lower doses 160 mg/kg/day. Renal lesions were not observed in the 160 mg/kg/day female rats. Minimal tubular epithelial damage was seen in the 40 mg/kg/day males and was reversible. In a six-month oral study in dogs, the no-observable dose level of mesalamine was 40 mg/kg/day and doses of 80 mg/kg/day and higher caused renal pathology similar to that described for the rat. In a combined 52-week toxicity and 127-week carcinogenicity study in rats, degeneration in kidneys was observed at doses of 100 mg/kg/day and above admixed with diet for 52 weeks, and at 127 weeks increased incidence of kidney degeneration and hyalinization of basement membranes and Bowman's capsule were seen at 100 mg/kg/day and above. In the 12-month eye toxicity study in dogs, Keratoconjunctivitis Sicca (KCS) occurred at oral doses of 40 mg/kg/day and above. The oral preclinical studies were done with a highly bioavailable suspension where absorption throughout the gastrointestinal tract occurred. The human dose of 4 grams represents approximately 80 mg/kg but when mesalamine is given rectally as a suspension, absorption is poor and limited to the distal colon (see ). Overt renal toxicity has not been observed (see and ), but the potential must be considered.
Non-Clinical Toxicology
ROWASA® (mesalamine) Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.ROWASA® (mesalamine) Rectal Suspension Enema 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.
Prazosin hydrochloride capsules have been administered without any adverse drug interaction in limited clinical experience to date with the following: (1) cardiac glycosides-digitalis and digoxin; (2) hypoglycemics-insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide; (3) tranquilizers and sedatives-chlordiazepoxide, diazepam, and phenobarbital; (4) antigout-allopurinol, colchicine, and probenecid; (5) antiarrhythmics-procainamide, propranolol (see however), and quinidine; and (6) analgesics, antipyretics and anti-inflammatories-propoxyphene, aspirin, indomethacin, and phenylbutazone.
Addition of a diuretic or other antihypertensive agent to prazosin hydrochloride capsules have been shown to cause an additive hypotensive effect. This effect can be minimized by reducing the prazosin hydrochloride capsules dose to 1 mg to 2 mg three times a day, by introducing additional antihypertensive drugs cautiously, and then by retitrating prazosin hydrochloride capsules based on clinical response.
Concomitant administration of prazosin hydrochloride capsules with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension (see ).
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 ROWASA® (mesalamine) Rectal Suspension Enema, 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 ROWASA® (mesalamine) Rectal Suspension Enema, especially those on concurrent oral products which liberate mesalamine and those with preexisting renal disease, should be carefully monitored with urinalysis, BUN (blood urea nitrogen), 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 ROWASA® (mesalamine) Rectal Suspension Enema, some patients have developed pancolitis. However, extension of upper disease boundary and/or flare-ups occurred less often in the ROWASA® (mesalamine) Rectal Suspension Enema 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 ROWASA® (mesalamine) Rectal Suspension Enema, 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 ROWASA® (mesalamine) Rectal Suspension Enema should be investigated with this information in mind. Discontinuation of ROWASA® (mesalamine) Rectal Suspension Enema 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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