Mediaven

Mediaven may be available in the countries listed below.

Ingredient matches for Mediaven

Naftazone

Naftazone is reported as an ingredient of Mediaven in the following countries:

• Belgium


• Luxembourg


• Switzerland

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Aescusan

Aescusan may be available in the countries listed below.

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Escin

Escin is reported as an ingredient of Aescusan in the following countries:

• Russian Federation

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Anaromat

Anaromat may be available in the countries listed below.

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Anastrozole

Anastrozole is reported as an ingredient of Anaromat in the following countries:

• Bulgaria

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Technetium [99mTc] Bicisate

Technetium [99mTc] Bicisate may be available in the countries listed below.

Ingredient matches for Technetium [99mTc] Bicisate

Technetium (99mTc) Bicisate

Technetium [99mTc] Bicisate (BAN) is also known as Technetium (99mTc) Bicisate (Rec.INN)

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Glossary

BAN	British Approved Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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Duracain

Duracain may be available in the countries listed below.

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Bupivacaine

Bupivacaine hydrochloride (a derivative of Bupivacaine) is reported as an ingredient of Duracain in the following countries:

• Switzerland

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Zisul

Zisul may be available in the countries listed below.

Ingredient matches for Zisul

Zinc Sulfate

Zinc Sulfate is reported as an ingredient of Zisul in the following countries:

• Bangladesh

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Flubendazole

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

P02CA05

CAS registry number (Chemical Abstracts Service)

0031430-15-6

Chemical Formula

C16-H12-F-N3-O3

Molecular Weight

313

Therapeutic Category

Anthelmintic

Chemical Name

Carbamic acid, [5-(4-fluorobenzoyl)-1H-benzimidazol-2-yl]-, methyl ester

Foreign Names

• Flubendazolum (Latin)
• Flubendazol (German)
• Flubendazole (French)
• Flubendazol (Spanish)

Generic Names

• Flubendazole (OS: DCF, USAN, BAN)
• R 17889 (IS: Janssen)
• Flubendazole (PH: BP 2010, Ph. Eur. 6)
• Flubendazolum (PH: Ph. Eur. 6)

Brand Names

• Cofamix Flubendazole (veterinary use)
  Coophavet, France



• Concentrat (veterinary use)
  Sogeval, France



• Feedmix Flubendazole (veterinary use)
  Dopharma, Netherlands



• Feritrex
  Patric, Colombia



• Flicum
  Distriquimica, Spain



• Flubendazol Genfar
  Genfar, Colombia



• Flubendazol (veterinary use)
  aniMedica, Germany; Bioptive, Germany; Chevita, Germany; Selecta, Germany



• Flubendazole (veterinary use)
  Laboratoires Franvet, France



• Flubenol KH (veterinary use)
  Janssen-Cilag, Austria



• Flubenol (veterinary use)
  Bayer Animal Health, South Africa; Biokema, Switzerland; Boehringer Ingelheim, Sweden; Botéba, Netherlands; Dopharma, Netherlands; Esteve Farma Lda., Portugal; Floris, Netherlands; Janssen Animal Health, Belgium; Janssen Animal Health, Germany; Janssen Animal Health, United Kingdom; Janssen Animal Health, Ireland; Janssen Animal Health, Netherlands; Janssen Pharmaceutica N.V., Luxembourg; Janssen Santé Animale, France; Janssen-Cilag, Austria; Janssen-Cilag Vet., Italy; Nutritech, New Zealand; Orion, Finland; Schippers, Netherlands



• Flubenvet (veterinary use)
  Janssen Animal Health, United Kingdom; Janssen-Cilag Vet., Italy



• Flumoxal
  Janssen, Argentina



• Flunet
  Chefar, Ecuador



• Fluoben
  Anglopharma, Colombia



• Flutelmium (veterinary use)
  Janssen Animal Health, Netherlands



• Fluvermal
  Janssen, Burkina Faso; Janssen, Benin; Janssen, Central African Republic; Janssen, Congo; Janssen, Cote D'ivoire; Janssen, Cameroon; Janssen, Colombia; Janssen, Cyprus; Janssen, Algeria; Janssen, Ecuador; Janssen, Gabon; Janssen, Guinea; Janssen, Lebanon; Janssen, Madagascar; Janssen, Mali; Janssen, Mauritania; Janssen, Niger; Janssen, Peru; Janssen, Portugal; Janssen, Saudi Arabia; Janssen, Sudan; Janssen, Senegal; Janssen, Togo; Janssen, Yemen; Janssen-Cilag, United Arab Emirates; Janssen-Cilag, Egypt; Janssen-Cilag, Jordan; McNeil, France



• Fluvermox
  Janssen, Venezuela



• Frommex (veterinary use)
  Klat, Germany; Serumber, Germany



• Fugos
  Interpharm, Ecuador; Procaps, Colombia



• Helmiflu
  Caribe, Colombia



• Helminex
  Unimed, Peru



• Mansonil (veterinary use)
  Bayer Animal, Netherlands



• MS Wormguard (veterinary use)
  Schippers, Netherlands



• Solubenol (veterinary use)
  Janssen Animal Health, Belgium; Janssen Animal Health, Germany; Janssen Animal Health, Ireland; Janssen Animal Health, Netherlands; Janssen Pharmaceutica, Austria; Janssen Santé Animale, France; Janssen-Cilag Vet., Italy



• Teniverme
  Basi, Portugal



• Totaal Wormpasta (veterinary use)
  Beaphar, Netherlands



• Vermicat (veterinary use)
  Ceva, Germany

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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Felden

Felden may be available in the countries listed below.

Ingredient matches for Felden

Piroxicam

Piroxicam is reported as an ingredient of Felden in the following countries:

• Austria


• Denmark


• Finland


• Iceland


• Switzerland


• Turkey

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Cost

Cost may be available in the countries listed below.

Ingredient matches for Cost

Ketamine

Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Cost in the following countries:

• Argentina

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Sandoz Schmerzgel

Sandoz Schmerzgel may be available in the countries listed below.

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Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Sandoz Schmerzgel in the following countries:

• Germany

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Terbinafine Tatsumi

Terbinafine Tatsumi may be available in the countries listed below.

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Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafine Tatsumi in the following countries:

• Japan

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Till

Till may be available in the countries listed below.

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Triclosan

Triclosan is reported as an ingredient of Till in the following countries:

• Tunisia

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Agruvit

Agruvit may be available in the countries listed below.

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Ascorbic Acid

Ascorbic Acid calcium salt (a derivative of Ascorbic Acid) is reported as an ingredient of Agruvit in the following countries:

• Italy

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Utinor

Utinor may be available in the countries listed below.

UK matches:

• Utinor 400mg Tablets
• Utinor Tablets 400mg (SPC)

Ingredient matches for Utinor

Norfloxacin

Norfloxacin is reported as an ingredient of Utinor in the following countries:

• Italy


• Malta


• United Kingdom

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Glossary

SPC	Summary of Product Characteristics (UK)

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Gadoxetic Acid

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

V08CA10

CAS registry number (Chemical Abstracts Service)

0135326-11-3

Chemical Formula

C23-H30-Gd-N3-O11

Molecular Weight

681

Therapeutic Categories

Contrast medium

Diagnostic agent

Chemical Names

Dihydrogen [N-[(2S)-2-]bis(carboxymethyl)amino]-3-(p-ethoxyphenyl)propyl]-N-[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]gadolinate(2-) (WHO)

Dihydrogen [N-{(2S)-2-[bis(carboxymethyl)amino]-3-(4-ethoxyphenyl)propyl}-N-{2-[bis(carboxymethyl)amino]ethyl}glycinato(5-)]gadolinat(2-) (IUPAC)

Gadolinium ethoxybenyldiethylenetriaminepentaacetic acid

Foreign Names

• Acidum gadoxeticum (Latin)
• Gadoxetsäure (German)
• Acide gadoxetique (French)
• Acido gadoxetico (Spanish)

Generic Names

• Gd-EOB-DTPA (IS)
• Gadoxetate Disodium (OS: USAN)
• Eovist (IS)
• SHL-569B (IS)
• ZK-139834 (IS)

Brand Names

• Eovist
  Bayer, United States



• Primovist
  Bayer, Austria; Bayer, Switzerland; Bayer, Germany; Bayer, Spain; Bayer, United Kingdom; Bayer, Hungary; Bayer, Italy; Bayer, Latvia; Bayer, Sweden; Bayer Animal Health, Luxembourg; Bayer Schering, Australia; Bayer Schering, Finland; Bayer Schering Pharma, Norway; Schering, Czech Republic; Schering, Estonia; Schering, Lithuania; Schering, Malta; Schering, Poland; Schering, Slovenia



• Primovist EOB
  Bayer Yakuhin, Japan

International Drug Name Search

Glossary

IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

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Targocid

Targocid may be available in the countries listed below.

UK matches:

• Targocid 200mg & 400mg (SPC)

Ingredient matches for Targocid

Teicoplanin

Teicoplanin is reported as an ingredient of Targocid in the following countries:

• Argentina


• Australia


• Austria


• Belgium


• Brazil


• Bulgaria


• Chile


• Costa Rica


• Croatia (Hrvatska)


• Czech Republic


• Denmark


• Dominican Republic


• El Salvador


• Finland


• France


• Germany


• Ghana


• Greece


• Guatemala


• Hong Kong


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• India


• Indonesia


• Ireland


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• Japan


• Kenya


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• Netherlands


• New Zealand


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• Oman


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• Peru


• Poland


• Romania


• Serbia


• Singapore


• Slovakia


• Slovenia


• South Africa


• Spain


• Sri Lanka


• Sweden


• Switzerland


• Taiwan


• Thailand


• Tunisia


• Turkey


• Uganda


• United Kingdom


• Venezuela


• Zimbabwe

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Glossary

SPC	Summary of Product Characteristics (UK)

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Emtemox

Emtemox may be available in the countries listed below.

Ingredient matches for Emtemox

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Emtemox in the following countries:

• Germany

International Drug Name Search

Dipentum

olsalazine sodium

Dosage Form: capsule
Dipentum®

(olsalazine sodium capsules)

Rx Only

Dipentum Description

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 C14H8N2Na2O6 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 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.

Dipentum - Clinical Pharmacology

After oral administration, olsalazine has limited systemic bioavailability. Based on oral and intravenous dosing studies, approximately 2.4% of a single 1.0 g oral dose is absorbed. Less than 1% of olsalazine is recovered in the urine. The remaining 98 to 99% of an oral dose will reach the colon, where each molecule is rapidly converted into two molecules of 5-aminosalicylic acid (5-ASA) by colonic bacteria and the low prevailing redox potential found in this environment. The liberated 5-ASA is absorbed slowly resulting in very high local concentrations in the colon.

The conversion of olsalazine to mesalamine (5-ASA) in the colon is similar to that of sulfasalazine, which is converted into sulfapyridine and mesalamine. It is thought that the mesalamine component is therapeutically active in ulcerative colitis (A.K. Azad-Kahn et al, LANCET, 2:892-895, 1977). The usual dose of sulfasalazine for maintenance of remission in patients with ulcerative colitis is 2 grams daily, which would provide approximately 0.8 gram of mesalamine to the colon. More than 0.9 gram of mesalamine would usually be made available in the colon from 1 gram of olsalazine.

The mechanism of action of mesalamine (and sulfasalazine) is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways (i.e., prostanoids) and through the lipoxygenase pathways (i.e., leukotrienes [LTs] and hydroxyeicosatetraenoic acids [HETEs]) is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.

Pharmacokinetics

The pharmacokinetics of olsalazine are similar in both healthy volunteers and in patients with ulcerative colitis. Maximum serum concentrations of olsalazine appear after approximately 1 hour and, even after a 1.0 g single dose, are low (e.g., 1.6 to 6.2 µmol/L). Olsalazine has a very short serum half-life, approximately 0.9 hour. Olsalazine is more than 99% bound to plasma proteins. It does not interfere with protein binding of warfarin. The urinary recovery of olsalazine is below 1%. Total recovery of oral 14C-labeled olsalazine in animals and humans ranges from 90 to 97%. Approximately 0.1% of an oral dose of olsalazine is metabolized in the liver to olsalazine-O-sulfate (olsalazine-S). Olsalazine-S, in contrast to olsalazine has a half-life of 7 days. Olsalazine-S accumulates to steady state within 2 to 3 weeks.

Patients on daily doses of 1.0 g olsalazine for 2 to 4 years show a stable plasma concentration of olsalazine-S (3.3 to 12.4 µmol/L). Olsalazine-S is more than 99% bound to plasma proteins. Its long half-life is mainly due to slow dissociation from the protein binding site. Less than 1% of both olsalazine and olsalazine-S appears undissociated in plasma.

5-aminosalicylic acid (5-ASA)

Serum concentrations of 5-ASA are detected after 4 to 8 hours. The peak levels of 5-ASA after an oral dose of 1.0 g olsalazine are low (i.e., 0 to 4.3 µmol/L). Of the total 5-ASA found in the urine, more than 90% is in the form of N-acetyl-5-ASA (Ac-5-ASA). Only small amounts of 5-ASA are detected.

N-acetyl-5-ASA (Ac-5-ASA), the major metabolite of 5-ASA found in plasma and urine, is acetylated (deactivated) in at least two sites, the colonic epithelium and the liver. Ac-5-ASA is found in the serum, with peak values of 1.7 to 8.7 µmol/L after a single 1.0 g dose. Approximately 20% of the total 5-ASA is recovered in the urine, where it is found almost exclusively as Ac-5-ASA. The remaining 5-ASA is partially acetylated and is excreted in the feces. From fecal dialysis, the concentration of 5-ASA in the colon following olsalazine has been calculated to be 18 to 49 mmol/L. No accumulation of 5-ASA or Ac-5-ASA in plasma has been detected. 5-ASA and Ac-5-ASA are 74 and 81%, respectively, bound to plasma proteins.

Animal Toxicology

Preclinical subacute and chronic toxicity studies in rats have shown the kidney to be the major target organ of olsalazine toxicity. At an oral daily dose of 400 mg/kg or higher, olsalazine treatment produced nephritis and tubular necrosis in a 4-week study; interstitial nephritis and tubular calcinosis in a 6-month study, and renal fibrosis, mineralization, and transitional cell hyperplasia in a 1-year study.

Clinical Studies

Two controlled studies have demonstrated the efficacy of olsalazine as maintenance therapy in patients with ulcerative colitis. In the first, ulcerative colitis patients in remission were randomized to olsalazine 500 mg B.I.D. or placebo, and relapse rates for a six month period of time were compared. For the 52 patients randomized to olsalazine, 12 relapses occurred, while for the 49 placebo patients, 22 relapses occurred. This difference in relapse rates was significant (p<0.02).

In the second study, 164 ulcerative colitis patients in remission were randomized to olsalazine 500 mg B.I.D. or sulfasalazine 1 gram B.I.D., and relapse rates were compared after six months. The relapse rate for olsalazine was 19.5% while that for sulfasalazine was 12.2%, a non-significant difference.

Indications and Usage for Dipentum

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 (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/LaboratoryTest 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 (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 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).

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 (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).

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: 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.

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 5 g/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.

Dipentum Dosage and Administration

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

How is Dipentum Supplied

Beige colored capsules, containing 250 mg olsalazine sodium imprinted with "Dipentum® 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

by UCB Manufacturing, Inc.

Rochester, NY 14623 USA

For Medical Inquiries, call 1-888-317-0001

Dipentum is a registered trademark

© 2009, ALAVEN Pharmaceutical LLC, Marietta, GA

All rights reserved. Printed in U.S.A.

Rev. 4E 02/2009

160-0209-01

CIA71870B

CIA60030

PRINCIPAL DISPLAY PANEL - 250 mg Bottle

NDC 68220-160-10

100 Capsules

Dipentum®

(olsalazine sodium capsules)

250 mg

Rx only

Dipentum  olsalazine sodium  capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68220-160 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength olsalazine sodium (olsalazine) olsalazine sodium 250 mg

Inactive Ingredients Ingredient Name Strength magnesium stearate   ferrosoferric oxide   caramel   gelatin   titanium dioxide

Product Characteristics Color WHITE (Beige) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code Dipentum;250;mg Contains

Packaging # NDC Package Description Multilevel Packaging 1 68220-160-10 100 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019715	07/31/1990

Labeler - Alaven Pharmaceutical LLC (140210829)

Revised: 10/2009Alaven Pharmaceutical LLC

More Dipentum resources

• Dipentum Side Effects (in more detail)
• Dipentum Use in Pregnancy & Breastfeeding
• Drug Images
• Dipentum Drug Interactions
• Dipentum Support Group
• 0 Reviews for Dipentum - Add your own review/rating

• Dipentum Concise Consumer Information (Cerner Multum)


• Dipentum Monograph (AHFS DI)


• Dipentum Advanced Consumer (Micromedex) - Includes Dosage Information


• Dipentum MedFacts Consumer Leaflet (Wolters Kluwer)

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Auronal

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Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Paroxetina Decrox in the following countries:

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Diflucan IV

Generic Name: fluconazole (Intravenous route)

floo-KON-a-zole

Commonly used brand name(s)

In the U.S.

• Diflucan IV

In Canada

• Diflucan

Available Dosage Forms:

• Solution


• Injectable

Therapeutic Class: Antifungal

Chemical Class: Triazole

Uses For Diflucan IV

Fluconazole injection is used to treat serious fungal or yeast infections, such as vaginal candidiasis, oropharyngeal candidiasis (thrush, oral thrush), esophageal candidiasis (candida esophagitis), other candida infections (including urinary tract infections, peritonitis [inflammation of the lining of the abdomen or stomach], and infections that may occur in different parts of the body), or fungal (cryptococcal) meningitis. This medicine works by killing the fungus or yeast, or preventing its growth.

Fluconazole injection is also used to prevent candidiasis in patients having bone marrow transplants, who receive cancer or radiation treatment.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using Diflucan IV

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluconazole injection in children 6 months to 13 years of age. However, safety and efficacy have not been established in infants younger than 6 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluconazole injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving fluconazole injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin


• Astemizole


• Bepridil


• Cisapride


• Clozapine


• Crizotinib


• Dasatinib


• Dronedarone


• Granisetron


• Lapatinib


• Levomethadyl


• Lumefantrine


• Mesoridazine


• Nilotinib


• Ondansetron


• Pimozide


• Quetiapine


• Salmeterol


• Sorafenib


• Sparfloxacin


• Sunitinib


• Terfenadine


• Thioridazine


• Vardenafil


• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Ajmaline


• Alprazolam


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Anisindione


• Apomorphine


• Aprindine


• Arsenic Trioxide


• Asenapine


• Atorvastatin


• Azithromycin


• Bretylium


• Cerivastatin


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clopidogrel


• Colchicine


• Desipramine


• Dibenzepin


• Dicumarol


• Dihydroergotamine


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Enflurane


• Eplerenone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Erythromycin


• Everolimus


• Fentanyl


• Flecainide


• Fluoxetine


• Foscarnet


• Gatifloxacin


• Gemifloxacin


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Iloperidone


• Imipramine


• Isoflurane


• Isradipine


• Levofloxacin


• Lidoflazine


• Lopinavir


• Lorcainide


• Lovastatin


• Mefloquine


• Methylergonovine


• Moxifloxacin


• Nevirapine


• Nitrofurantoin


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Phenindione


• Phenprocoumon


• Pirmenol


• Posaconazole


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quinidine


• Quinine


• Ranolazine


• Rifabutin


• Risperidone


• Sertindole


• Simvastatin


• Sirolimus


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Telavancin


• Telithromycin


• Tetrabenazine


• Tolvaptan


• Toremifene


• Trazodone


• Triazolam


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Vandetanib


• Vasopressin


• Vemurafenib


• Voriconazole


• Warfarin


• Zolmitriptan


• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil


• Amlodipine


• Atevirdine


• Carbamazepine


• Celecoxib


• Cyclosporine


• Etravirine


• Felodipine


• Fosphenytoin


• Glimepiride


• Losartan


• Methadone


• Midazolam


• Nicardipine


• Nifedipine


• Omeprazole


• Phenytoin


• Prednisone


• Ramelteon


• Rifampin


• Rifapentine


• Rosuvastatin


• Saquinavir


• Tacrolimus


• Tipranavir


• Tretinoin


• Trimetrexate


• Valdecoxib


• Vincristine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Electrolyte problems (mineral imbalance) or


• Heart disease—Use with caution. These conditions may increase your chance of having heart rhythm problems and make the effects of this medicine worse.

• Heart rhythm problems (e.g., QT prolongation) or


• Liver disease—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of fluconazole

This section provides information on the proper use of a number of products that contain fluconazole. It may not be specific to Diflucan IV. Please read with care.

A nurse or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins.

Your doctor will give you or your child a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using Diflucan IV

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve, or if they become worse, check with your doctor. You may need to use this medicine for several months before your infection gets better.

You or your child should not use astemizole (Hismanal®), cisapride (Propulsid®), pimozide (Orap®), quinidine (Cardioquin®), or terfenadine (Seldane®) while receiving this medicine because of the risk of unwanted side effects.

Using this medicine for a long time or using it too much while you are pregnant (especially during the first trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may rarely cause serious liver problems. Stop using this medicine and check with your doctor right away if you or your child are having more than one of these symptoms: abdominal or stomach pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

This medicine may rarely cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you receive the medicine.

Serious skin reactions can occur in certain people during treatment with this medicine. Check with your doctor right away if you or your child start having a skin rash, itching, or any other skin changes while you are using this medicine.

This medicine may rarely cause a heart rhythm problem called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Check with your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Diflucan IV Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

• Abdominal or stomach pain


• chills


• clay-colored stools


• cough


• dark urine


• diarrhea


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever


• general feeling of tiredness or weakness


• headache


• hives


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of appetite


• nausea and vomiting


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• shortness of breath


• skin rash


• stomach pain, continuing


• tightness in the chest


• unpleasant breath odor


• unusual tiredness or weakness


• upper right abdominal or stomach pain


• vomiting of blood


• wheezing


• yellow eyes and skin

Incidence not known

• Black, tarry stools


• blistering, peeling, or loosening of the skin


• chest pain or discomfort


• convulsions


• decreased urine


• dry mouth


• fainting


• hoarseness


• increased thirst


• irregular or slow heart rate


• joint or muscle pain


• loss of bladder control


• lower back or side pain


• mood changes


• muscle pain or cramps


• muscle spasm or jerking of all extremities


• numbness or tingling in the hands, feet, or lips


• painful or difficult urination


• pale skin


• red skin lesions, often with a purple center


• red, irritated eyes


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• sudden loss of consciousness


• swollen glands


• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Fearfulness, suspiciousness, or other mental changes


• seeing, hearing, or feeling things that are not there

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acid or sour stomach


• belching


• change in taste or bad, unusual, or unpleasant (after) taste


• heartburn


• indigestion


• stomach discomfort or upset

Incidence not known

• Hair loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Diflucan IV side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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• Diflucan IV Use in Pregnancy & Breastfeeding
• Drug Images
• Diflucan IV Drug Interactions
• Diflucan IV Support Group
• 26 Reviews for Diflucan IV - Add your own review/rating

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• Cryptococcal Meningitis, Immunocompetent Host
• Cryptococcal Meningitis, Immunosuppressed Host
• Cryptococcosis
• Esophageal Candidiasis
• Fungal Infection Prophylaxis
• Fungal Infection, Internal and Disseminated
• Fungal Peritonitis
• Fungal Pneumonia
• Histoplasmosis
• Onychomycosis, Fingernail
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• Oral Thrush
• Tinea Versicolor
• Vaginal Yeast Infection

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Flamasacard may be available in the countries listed below.

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Aspirin

Acetylsalicylic Acid is reported as an ingredient of Flamasacard in the following countries:

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In the US, Atridox (doxycycline systemic) is a member of the drug class mouth and throat products and is used to treat Periodontitis.

US matches:

• Atridox

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QV Wash may be available in the countries listed below.

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Levaxin may be available in the countries listed below.

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Amitrip may be available in the countries listed below.

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Rabeprazole

Pronunciation: ra-BEP-ra-zole
Generic Name: Rabeprazole
Brand Name: Aciphex

Rabeprazole is used for:

Treating heartburn or irritation of the esophagus caused by gastroesophageal reflux disease (GERD). It may be used for short-term treatment of ulcers of the small intestine. It may be used with certain antibiotics to treat ulcers of the small intestine and to help prevent them from coming back. It may be used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Rabeprazole is a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

Do NOT use Rabeprazole if:

• you are allergic to any ingredient in Rabeprazole or to similar medicines (eg, omeprazole)


• you are taking dasatinib or certain HIV protease inhibitors (eg, atazanavir)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rabeprazole:

Some medical conditions may interact with Rabeprazole. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have low blood potassium or magnesium levels, liver problems, or stomach or bowel cancer


• if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Rabeprazole. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased


• Clarithromycin or voriconazole because they may increase the risk of Rabeprazole's side effects


• Anticoagulants (eg, warfarin), cyclosporine, or digoxin because the risk of their side effects may be increased by Rabeprazole


• Azole antifungals (eg, ketoconazole), clopidogrel, dasatinib, HIV protease inhibitors (eg, atazanavir, indinavir), iron, mycophenolate, or nilotinib because their effectiveness may be decreased by Rabeprazole

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rabeprazole may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rabeprazole:

Use Rabeprazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Rabeprazole by mouth with or without food.


• Swallow Rabeprazole whole. Do not break, crush, or chew before swallowing.


• You may take antacids while you are taking Rabeprazole if you are directed to do so by your doctor.


• If you also take an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before taking Rabeprazole.


• If you also take sucralfate, take Rabeprazole at least 30 minutes before taking sucralfate.


• Continue to take Rabeprazole even if you feel well. Do not miss any doses.


• If you miss a dose of Rabeprazole, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rabeprazole.

Important safety information:

• Rabeprazole may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Rabeprazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds, or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.


• Rabeprazole may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Rabeprazole in high doses, for longer than a year, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information.


• Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Rabeprazole for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).


• Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Rabeprazole.


• Rabeprazole may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Rabeprazole.


• Rabeprazole should be used with extreme caution in Asian patients; the risk of side effects may be increased in these patients.


• Use Rabeprazole with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.


• Rabeprazole should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rabeprazole while you are pregnant. It is not known if Rabeprazole is found in breast milk. Do not breast-feed while taking Rabeprazole.

Possible side effects of Rabeprazole:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; unusual bruising or bleeding; unusual tiredness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Rabeprazole side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Rabeprazole:

Store Rabeprazole at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rabeprazole out of the reach of children and away from pets.

General information:

• If you have any questions about Rabeprazole, please talk with your doctor, pharmacist, or other health care provider.


• Rabeprazole is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Rabeprazole. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Rabeprazole resources

• Rabeprazole Side Effects (in more detail)
• Rabeprazole Use in Pregnancy & Breastfeeding
• Rabeprazole Drug Interactions
• Rabeprazole Support Group
• 31 Reviews for Rabeprazole - Add your own review/rating

• AcipHex Monograph (AHFS DI)


• Aciphex Consumer Overview


• Aciphex Prescribing Information (FDA)


• rabeprazole Advanced Consumer (Micromedex) - Includes Dosage Information

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