Drug: Dipentum

The active ingredient in DIPENTUM Capsules (olsalazine sodium) is the sodium salt of a salicylate, disodium 3,3'-azobis (6-hydroxybenzoate) a compound that is effectively bioconverted to 5-aminosalicylic acid (5-ASA), which has anti-inflammatory activity in ulcerative colitis. Its empirical formula is C14H8N2N2O6 with a molecular weight of 346.21. The structural formula is: Olsalazine sodium is a yellow crystalline powder, which melts with decomposition at 240°C. It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or basic conditions. DIPENTUM (olsalazine sodium capsules) is supplied in hard gelatin capsules for oral administration. The inert ingredient in each 250 mg capsule of olsalazine sodium is magnesium stearate. The capsule shell contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium dioxide.

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Olsalazine has been evaluated in ulcerative colitis patients in remission, as well as those with acute disease. Both sulfasalazine-tolerant and intolerant patients have been studied in controlled clinical trials. Overall, 10.4% of patients discontinued olsalazine because of an adverse experience compared with 6.7% of placebo patients. The most commonly reported adverse reactions leading to treatment withdrawal were diarrhea or loose stools (olsalazine 5.9%; placebo 4.8%), abdominal pain, and rash or itching (slightly more than 1% of patients receiving olsalazine). Other adverse reactions to olsalazine leading to withdrawal occurred in fewer than 1% of patients (Table 1). Table1: Adverse Reactions Resulting In Withdrawal From Controlled Studies Total
  Olsalazine
(N = 441) Placebo
(N = 208) Diarrhea/Loose Stools 26 (5.9%) 10 (4.8%) Nausea 3 2 Abdominal Pain 5 (1.1%) 0 Rash/Itching 5 (1.1%) 0 Headache 3 0 Heartburn 2 0 Rectal Bleeding 1 0 Insomnia 1 0 Dizziness 1 0 Anorexia 1 0 Light Headedness 1 0 Depression 1 0 Miscellaneous 4 (0.9%) 3 (1.4%) Total Number of Patients Withdrawn 46 (10.4%) 14 (6.7%) For those controlled studies, the comparative incidences of adverse reactions reported in 1% or more patients treated with olsalazine or placebo are provided in Table 2. Table2: Comparative Incidence (%) of Adverse Effects Reported By One Percent Or More of Ulcerative Colitis Patients Treated With Olsalazine Or Placebo in Double Blind Controlled Studies
Adverse Event Olsalazine
(N=441)
% Placebo
(N=208)
% Gastrointestinal Disorders   Diarrhea 11.1 6.7   Abdominal Pain/Cramps 10.1 7.2   Nausea 5.0 3.9   Dyspepsia 4.0 4.3   Bloating 1.5 1.4   Vomiting 1.0 -   Stomatitis 1.0 -   Increased Blood in Stool - 3.4 Metabolism and Nutrition Disorders   Anorexia 1.3 1.9 Nervous System Disorders   Headache 5.0 4.8   Insomnia - 2.4 General Disorders and Administration Site Conditions   Fatigue/Drowsiness/Lethargy 1.8 2.9 Psychiatric Disorders   Depression 1.5 - Ear and Labyrinth Disorders   Vertigo/Dizziness 1.0 - Skin and Subcutaneous Tissue Disorders   Rash 2.3 1.4   Itching 1.3 - Musculoskeletal and Connective Tissue Disorders   Arthralgia/Joint Pain 4.0 2.9 Infections and Infestations   Upper Respiratory Infection 1.5 - Over 2,500 patients have been treated with olsalazine in various controlled and uncontrolled clinical studies. In these as well as in post-marketing experience, olsalazine was administered mainly to patients intolerant to sulfasalazine. There have been rare reports of the following adverse effects in patients receiving olsalazine. These were often difficult to distinguish from possible symptoms of the underlying disease or from the effects of prior and/or concomitant therapy. A causal relationship to the drug has not been demonstrated for some of these reactions. Blood and Lymphatic System Disorders Anemia, Eosinophilia, Hemolytic anemia, Interstitial pulmonary disease, Leukopenia, Lymphopenia, Neutropenia, Reticulocytosis, Thrombocytopenia Cardiac Disorders Chest pains, Heart block second degree, Myocarditis, Palpitations, Pericarditis, Peripheral edema, Shortness of breath, Tachycardia A patient who developed thyroid disease 9 days after starting DIPENTUM (olsalazine sodium capsules) was given propranolol and radioactive iodine and subsequently developed shortness of breath and nausea. The patient died 5 days later with signs and symptoms of acute diffuse myocarditis. Ear and Labyrinth Disorders Tinnitus Eye Disorders Dry eyes, Vision blurred, Watery eyes Gastrointestinal Disorders Abdominal pain (upper), Diarrhea with dehydration, Dry mouth, Epigastric discomfort, Flare in symptoms, Flatulence, Increased blood in stool, Pancreatitis, Rectal bleeding, Rectal discomfort In a double-blind, placebo-controlled study, increased frequency and severity of diarrhea were reported in patients randomized to olsalazine 500 mg B.I.D. with concomitant pelvic radiation. Rare cases of granulomatous hepatitis and nonspecific, reactive hepatitis have been reported in patients receiving olsalazine. Additionally, a patient developed mild cholestatic hepatitis during treatment with sulfasalazine and experienced the same symptoms two weeks later after the treatment was changed to olsalazine. Withdrawal of olsalazine led to complete recovery in these cases. General Disorders and Administration Site Conditions Fever chills, Hot flashes, Irritability, Rigors Immune System Disorders Bronchospasm, Erythema nodosum Laboratory ALT (SGPT) or AST (SGOT) elevated beyond the normal range. Musculoskeletal and Connective Tissue Disorders Muscle cramps Nervous System Disorders Insomnia, Paraesthesia, Tremors Psychiatric Disorders Mood swings Renal and Urinary Disorders Dysuria, Hematuria, Interstitial nephritis, Nephrotic syndrome, Proteinuria, Urinary frequency Reproductive System and Breast Disorders Impotence, Menorrhagia Skin and Subcutaneous Tissue Disorders Alopecia, Erythema, Photosensitivity reaction Vascular Disorders Hypertension, Orthostatic hypotension Postmarketing The following events have been identified during post-approval use of products that contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine: Blood and Lymphatic System Disorders Aplastic anemia, Pancytopenia General Disorders and Administration Site Conditions Pyrexia Hepatobiliary Disorders Hepatic enzyme increased, Hepatitis, Increased bilirubin Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported. Musculoskeletal and Connective Tissue Disorders Myalgia Respiratory, Thoracic and Mediastinal Disorders Dyspnoea, Interstitial lung disease Skin and Subcutaneous Tissue Disorders Angioneurotic oedema Nervous System Disorders Paraesthesia, Peripheral neuropathy Renal and Urinary Disorders Interstitial nephritis Drug Abuse And Dependency Abuse None reported. Dependence Drug dependence has not been reported with chronic administration of olsalazine. Read the Dipentum (olsalazine sodium capsules) Side Effects Center for a complete guide to possible side effectsLearn More »

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The usual dosage in adults for maintenance of remission is 1.0 g/day in two divided doses.

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The co-administration of salicylates and low molecular weight heparins or heparinoids may result in an increased risk of bleeding (i.e., hematomas) following neuraxial anesthesia. Salicylates should be discontinued prior to the initiation of a low molecular weight heparin or heparinoid. If this is not possible, it is recommended to monitor patients closely for bleeding. Increased prothrombin time in patients taking concomitant warfarin has been reported. The co-administration of olsalazine and 6-mercaptopurine or thioguanine may result in an increased risk of myelosuppression. If co-administered with 6-mercaptopurine, it is recommended to use the lowest possible doses of each drug and to monitor the patient, especially for leukopenia. In case of co-administration with thioguanine, careful monitoring of blood counts is recommended. It is recommended not to give salicylates for six weeks after the varicella vaccine to avoid a possible increased risk of developing Reye's syndrome. Drug/Laboratory Test Interactions None known. Last reviewed on RxList: 8/19/2009
This monograph has been modified to include the generic and brand name in many instances.

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Olsalazine is indicated for the maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine.

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Hypersensitivity to olsalazine, other salicylates, or any of the excipients. Last reviewed on RxList: 8/19/2009
This monograph has been modified to include the generic and brand name in many instances.

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No overdosage has been reported in humans. The knowledge of overdosage is limited. Possible overdose symptoms include nausea, vomiting and diarrhea. It is recommended to check hematology, acid-base, electrolyte, liver and kidney status, and to provide supportive treatment. There is no specific antidote to DIPENTUM (olsalazine sodium capsules) . Maximum single oral doses of 5g/kg in mice and rats and 2 g/kg in dogs were not lethal. Symptoms of acute toxicity were decreased motor activity and diarrhea in all species tested. In addition, vomiting was reported in dogs.

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Beige colored capsules, containing 250 mg olsalazine sodium imprinted with “DIPENTUM® (olsalazine sodium capsules) 250 mg” on the capsule shell, available as: Bottles of 100's....................NDC 68220-160-10 Store at 20-25°C (77°F). Excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Alaven Pharmaceutical LLC Marietta, GA USA. Manufactured by UCB Manufacturing, Inc. Rochester, NY 14623 USA. For Medical Inquiries, call 1-888-317-0001. Rev. 02/2009Last reviewed on RxList: 8/19/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Overall, approximately 17% of subjects receiving olsalazine in clinical studies reported diarrhea sometime during therapy. This diarrhea resulted in withdrawal of treatment in 6% of patients. This diarrhea appears to be dose related, although it may be difficult to distinguish from the underlying symptoms of the disease. Exacerbation of the symptoms of colitis thought to have been caused by mesalamine or sulfasalazine has been noted. Carcinogenesis, Mutagenesis, Impairment of Fertility In a two year oral rat carcinogenicity study, olsalazine was tested in male and female Wistar rats at daily doses of 200, 400, and 800 mg/kg/day (approximately 10 to 40 times the human maintenance dose, based on a patient weight of 50 kg and a human dose of 1 g). Urinary bladder transitional cell carcinomas were found in three male rats (6%, p=0.022, exact trend test) receiving 40 times the human dose and were not found in untreated male controls. In the same study, urinary bladder transitional cell carcinoma and papilloma occurred in 2 untreated control female rats (2%). No such tumors were found in any of the female rats treated at doses up to 40 times the human dose. In an eighteen month oral mouse carcinogenicity study, olsalazine was tested in male and female CD-1 mice at daily doses of 500, 1000, and 2000 mg/kg/day (approximately 25 to 100 times the human maintenance dose). Liver hemangiosarcomata were found in two male mice (4%) receiving olsalazine at 100 times the human dose, while no such tumor occurred in the other treated male mice groups or any of the treated female mice. The observed incidence of this tumor is within the 4% incidence in historical controls. Olsalazine was not mutagenic in in vitro Ames tests, mouse lymphoma cell mutation assays, human lymphocyte chromosomal aberration tests, or the in vivo rat bone marrow cell chromosomal aberration test. Olsalazine in a dose range of 100 to 400 mg/kg/day (approximately 5 to 20 times the human maintenance dose) did not influence the fertility of male or female rats. The oligospermia and infertility in men associated with sulfasalazine have not been reported with olsalazine. Pregnancy Teratogenic Effects Pregnancy Category C Olsalazine has been shown to produce fetal developmental toxicity as indicated by reduced fetal weights, retarded ossifications, and immaturity of the fetal visceral organs when given during organogenesis to pregnant rats in doses 5 to 20 times the human dose (100 to 400 mg/kg). There are no adequate and well-controlled studies in pregnant women. Olsalazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Small amounts of the active metabolite of olsalazine (5-ASA) may pass into breast milk. Harmful infant effects (diarrhea) have been reported when 5-ASA was used during breastfeeding. Unless the benefit of the treatment outweighs the risks, olsalazine should not be taken by breast-feeding women, or patients should be advised to discontinue breastfeeding if using olsalazine. Oral administration of olsalazine to lactating rats in doses 5 to 20 times the human dose produced growth retardation in their pups. Pediatric Use Safety and effectiveness in a pediatric population have not been established. Geriatric Use Clinical studies of DIPENTUM (olsalazine sodium capsules) 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, elderly patients should be treated with caution due to the greater frequency of decreased hepatic, renal, or cardiac function, co-existence of other disease, as well as concomitant drug therapy. Severe Allergies and/or Asthma Patients with severe allergies or asthma should be monitored for signs of worsening symptoms. Renal Patients with impaired renal function should be monitored. Although renal abnormalities were not reported in clinical trials with olsalazine, there have been rare reports from post-marketing experience (see ADVERSE REACTIONS, Postmarketing). Therefore, the possibility of renal tubular damage due to absorbed mesalamine or its n-acetylated metabolite, as noted in the Animal Toxicology section must be kept in mind, particularly for patients with pre-existing renal disease. In these patients, monitoring with urinalysis, BUN, and creatinine determinations is advised. Hepatic Patients with impaired hepatic function should be monitored (see ADVERSE REACTIONS, Postmarketing). Last reviewed on RxList: 8/19/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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