DRUGS & SUPPLEMENTS

Dipentum

Name: Dipentum drug & pharmaceuticals. Dipentum available forms, doses, prices
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Published: 2021-11-11T10:10:10+00:00

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Dipentum uses

Indications and usage
Contraindications
Precautions
Adverse reactions
Drug abuse and dependency
Overdosage
Dosage and administration
How supplied
Dipentum reviews

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Hypersensitivity to olsalazine, other salicylates, or any of the excipients.

PRECAUTIONS

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.

Information for Patients

Patients should be instructed to take olsalazine with food. The drug should be taken in evenly divided doses. Patients should be informed that about 17% of subjects receiving olsalazine during clinical studies reported diarrhea sometime during therapy. If diarrhea occurs, patients should contact their physician.

Drug Interactions

The co-administration of salicylates and low molecular weight heparins or heparinoids may result in an increased risk of bleeding 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.

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. 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.

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 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. 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.

ADVERSE REACTIONS

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, 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).

	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.

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, 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 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 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, 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

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.

OVERDOSAGE

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.

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.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Beige colored capsules, containing 250 mg Dipentum imprinted with “DIPENTUM^® 250 mg” on the capsule shell, available as:

Bottles of 100’s	NDC 53014-726-71
Bottles of 300’s	NDC 53014-726-82

Store at 20-25°C (77°F). Excursions permitted to 15° to 30°C (59° to 86°F).

For Medical Information

Contact: Medical Affairs Department

Phone: (866) 822-0068

Fax: (770) 970-8859

Manufactured for:

UCB, Inc.

Smyrna, GA 30080

by UCB Manufacturing, Inc.

Rochester, NY 14623 USA

Dipentum is a registered trademark of UCB Pharma Limited.

Rev. 2E 12/2006

Dipentum pharmaceutical active ingredients containing related brand and generic drugs:

Olsalazine Sodium

Dipentum available forms, composition, doses:

Capsules; Oral; Olsalazine Sodium 250 mg
Tablets; Oral; Olsalazine Sodium 500 mg

Dipentum destination | category:

Human:
Anti-inflammatory agents

Dipentum Anatomical Therapeutic Chemical codes:

A07EC03 - Olsalazine

Dipentum pharmaceutical companies:

References

Dailymed."DIPENTUM (OLSALAZINE SODIUM) CAPSULE [UCB, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"Olsalazine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"Olsalazine". http://www.drugbank.ca/drugs/DB0125... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dipentum?

Depending on the reaction of the Dipentum after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dipentum 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 Dipentum 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.

Review

sdrugs.com conducted a study on Dipentum, 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 Dipentum 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.