Dipentum
- Generic Name: olsalazine sodium capsules
- Brand Name: Dipentum
- Drug Class: 5-Aminosalicylic Acid Derivatives
Dipentum (Olsalazine Sodium Capsules) side effects drug center
Dipentum Side Effects Center
What Is Dipentum?
Dipentum (olsalazine sodium) is a salicylate anti-inflammatory drug used to treat ulcerative colitis.
What Are Side Effects of Dipentum?
Common side effects of Dipentum include:
- headache,
- nausea,
- vomiting,
- heartburn,
- stomach discomfort,
- loss of appetite,
- skin rash,
- itching, muscle or
- joint pain, or
- urinating more often than usual
Dosage for Dipentum
The usual dosage of Dipentum in adults for maintenance of remission is 1.0 g/day in two divided doses.
What Drugs, Substances, or Supplements Interact with Dipentum?
Dipentum may interact with blood thinners, thioguanine, or mercaptopurine. Tell your doctor all medications and supplements you use.
Dipentum During Pregnancy and Breastfeeding
During pregnancy, Dipentum should be used only when prescribed. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Dipentum (olsalazine sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Dipentum Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using olsalazine and call your doctor at once if you have:
- severe or ongoing diarrhea;
- worsening colitis (fever, stomach pain, cramping, or bloody diarrhea);
- chest pain, shortness of breath, fast or pounding heartbeats;
- low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed;
- liver problems--loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- symptoms of kidney stones--sudden and severe pain in your lower back or side, blood in your urine, pain or burning when you urinate.
Common side effects may include:
- diarrhea, stomach pain;
- upset stomach;
- rash, itching;
- headache; or
- joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Dipentum (Olsalazine Sodium Capsules)
Dipentum Professional Information
SIDE EFFECTS
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).
Diarrhea
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.
Other adverse reactions to olsalazine leading to withdrawal occurred in fewer than 1% of patients (Table 1).
Table 1 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.
Table 2 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 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
Dyspnea, Interstitial lung disease
Skin And Subcutaneous Tissue Disorders
Angioneurotic edema
Nervous System Disorders
Paresthesia, Peripheral neuropathy
Renal And Urinary Disorders
Interstitial nephritis, nephrolithiasis
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-888-380-3276 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs
The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
Azathioprine Or 6-Mercaptopurine
The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity (e.g., thioguanine) may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of DIPENTUM and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
Low Molecular Weight Heparins Or Heparinoids
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.
Warfarin
Increased prothrombin time in patients taking concomitant warfarin has been reported. Monitor INR and prothrombin time and adjust the dosage of warfarin, as needed with concomitant use of DIPENTUM, to maintain the target INR range.
Varicella Vaccine
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.
Read the entire FDA prescribing information for Dipentum (Olsalazine Sodium Capsules)
&Copy; Dipentum Patient Information is supplied by Cerner Multum, Inc. and Dipentum Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.