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mesalamine
Overview
What is sfRowasa?
The active ingredient in sfROWASA (mesalamine) Rectal Suspension, 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 unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, purified water, sodium benzoate, 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 sfRowasa look like?
What are the available doses of sfRowasa?
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What should I talk to my health care provider before I take sfRowasa?
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How should I use sfRowasa?
sfROWASA (mesalamine) Rectal Suspension is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.
The usual dosage of sfROWASA (mesalamine) Rectal Suspension 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 sfROWASA (mesalamine) Rectal Suspension 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 sfROWASA (mesalamine) Rectal Suspension will modify relapse rates after the 6-week, short-term treatment. sfROWASA (mesalamine) Rectal Suspension 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 sfRowasa?
sfROWASA (mesalamine) Rectal Suspension is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.
What are the warnings of sfRowasa?
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What are the precautions of sfRowasa?
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 **sfROWASA (mesalamine) Rectal Suspension, 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 sfROWASA (mesalamine) Rectal Suspension, 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 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 **sfROWASA (mesalamine) Rectal Suspension, some patients have developed pancolitis. However, extension of upper disease boundary and/or flare-ups occurred less often in the **sfROWASA (mesalamine) Rectal Suspension 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 **sfROWASA (mesalamine) Rectal Suspension, 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 **sfROWASA (mesalamine) Rectal Suspension should be investigated with this information in mind. Discontinuation of sfROWASA (mesalamine) Rectal Suspension 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.
What are the side effects of sfRowasa?
Sorry No records found
What should I look out for while using sfRowasa?
sfROWASA (mesalamine) Rectal Suspension is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.
What might happen if I take too much sfRowasa?
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 sfRowasa?
Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.sfROWASA (mesalamine) Rectal Suspension for rectal administration is an off-white to tan colored suspension. Each disposable bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Bottles are supplied in boxed, foil-wrapped trays as follows:NDC 0037-0022-60……… Sample – 1 bottleNDC 0037-0022-07……… Carton of 7 BottlesNDC 0037-0022-14……… Carton of 14 BottlesNDC 0037-0022-28……… Carton of 28 BottlessfROWASA (mesalamine) Rectal Suspension is for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.sfROWASA (mesalamine) Rectal Suspension for rectal administration is an off-white to tan colored suspension. Each disposable bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Bottles are supplied in boxed, foil-wrapped trays as follows:NDC 0037-0022-60……… Sample – 1 bottleNDC 0037-0022-07……… Carton of 7 BottlesNDC 0037-0022-14……… Carton of 14 BottlesNDC 0037-0022-28……… Carton of 28 BottlessfROWASA (mesalamine) Rectal Suspension is for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.sfROWASA (mesalamine) Rectal Suspension for rectal administration is an off-white to tan colored suspension. Each disposable bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Bottles are supplied in boxed, foil-wrapped trays as follows:NDC 0037-0022-60……… Sample – 1 bottleNDC 0037-0022-07……… Carton of 7 BottlesNDC 0037-0022-14……… Carton of 14 BottlesNDC 0037-0022-28……… Carton of 28 BottlessfROWASA (mesalamine) Rectal Suspension is for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.sfROWASA (mesalamine) Rectal Suspension for rectal administration is an off-white to tan colored suspension. Each disposable bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Bottles are supplied in boxed, foil-wrapped trays as follows:NDC 0037-0022-60……… Sample – 1 bottleNDC 0037-0022-07……… Carton of 7 BottlesNDC 0037-0022-14……… Carton of 14 BottlesNDC 0037-0022-28……… Carton of 28 BottlessfROWASA (mesalamine) Rectal Suspension is for rectal use only.KEEP OUT OF REACH OF CHILDRENPatient instructions are included.sfROWASA (mesalamine) Rectal Suspension for rectal administration is an off-white to tan colored suspension. Each disposable bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Bottles are supplied in boxed, foil-wrapped trays as follows:NDC 0037-0022-60……… Sample – 1 bottleNDC 0037-0022-07……… Carton of 7 BottlesNDC 0037-0022-14……… Carton of 14 BottlesNDC 0037-0022-28……… Carton of 28 BottlessfROWASA (mesalamine) Rectal Suspension is 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 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 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
sfROWASA (mesalamine) Rectal Suspension is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.Use with Opioids
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
Use with Other CNS Depressants
If alprazolam tablets are to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed, particularly with compounds which might potentiate the action of benzodiazepines. The benzodiazepines, including alprazolam, produce additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistaminics, ethanol and other drugs which themselves produce CNS depression.
Use with Imipramine and Desipramine
The steady state plasma concentrations of imipramine and desipramine have been reported to be increased an average of 31% and 20%, respectively, by the concomitant administration of alprazolam tablets in doses up to 4 mg/day. The clinical significance of these changes is unknown.
Drugs that inhibit alprazolam metabolism via cytochrome P450 3A
The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). Drugs which inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam (see and for additional drugs of this type).
Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam)
Fluoxetine - Coadministration of fluoxetine with alprazolam increased the maximum plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased half-life by 17%, and decreased measured psychomotor performance.
Propoxyphene - Coadministration of propoxyphene decreased the maximum plasma concentration of alprazolam by 6%, decreased clearance by 38%, and increased half-life by 58%.
Oral Contraceptives - Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%.
Available data from clinical studies of benzodiazepines other than alprazolam suggest a possible drug interaction with alprazolam for the following: diltiazem, isoniazid, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from studies of alprazolam suggest a possible drug interaction with alprazolam for the following: sertraline and paroxetine. However, data from an drug interaction study involving a single dose of alprazolam 1 mg and steady state dose of sertraline (50 to 150 mg/day) did not reveal any clinically significant changes in the pharmacokinetics of alprazolam. Data from studies of benzodiazepines other than alprazolam suggest a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. Caution is recommended during the coadministration of any of these with alprazolam (see ).
Drugs demonstrated to be inducers of CYP3A
Carbamazepine can increase alprazolam metabolism and therefore can decrease plasma levels of alprazolam.
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 **sfROWASA (mesalamine) Rectal Suspension, 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 sfROWASA (mesalamine) Rectal Suspension, 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 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 **sfROWASA (mesalamine) Rectal Suspension, some patients have developed pancolitis. However, extension of upper disease boundary and/or flare-ups occurred less often in the **sfROWASA (mesalamine) Rectal Suspension 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 **sfROWASA (mesalamine) Rectal Suspension, 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 **sfROWASA (mesalamine) Rectal Suspension should be investigated with this information in mind. Discontinuation of sfROWASA (mesalamine) Rectal Suspension 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.
To Report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-210-5950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ADVERSE REACTIONS
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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