Application Information

This drug has been submitted to the FDA under the reference 020610/001.

Names and composition

"COLAZAL" is the commercial name of a drug composed of BALSALAZIDE DISODIUM.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
020610/001 COLAZAL BALSALAZIDE DISODIUM CAPSULE/ORAL 750MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020610/001 COLAZAL BALSALAZIDE DISODIUM CAPSULE/ORAL 750MG
022205/001 GIAZO BALSALAZIDE DISODIUM TABLET/ORAL 1.1GM
077806/001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM CAPSULE/ORAL 750MG
077807/001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM CAPSULE/ORAL 750MG
077883/001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM CAPSULE/ORAL 750MG
206336/001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM TABLET/ORAL 1.1GM
206529/001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM TABLET/ORAL 1.1GM
206909/001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM TABLET/ORAL 1.1G

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Answered questions

Where can i buy colazal 750 without prescription since i don't a valid insurance?
where can i buy colazal 750 without prescription since i don't a valid insurance and prescription. please list me any website, i really need some help. thanks Asked by Vincenzo Baublitz 1 year ago.

Are you close to the Mexican border? If not, look for online pharmacies in Mexico. Be patient -- it can take 3-4 weeks to receive it in the mail. But, be warned -- buying it without a prescription from outside the country makes you guilty of "international drug traffic" in the US government's eyes. Answered by Timothy Murff 1 year ago.


What is the medicine colazal for?
Asked by Keli Cherenfant 1 year ago.

Balsalazide (Systemic) VA CLASSIFICATION Primary: GA400 Commonly used brand name(s): Colozal. Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s). †Not commercially available in Canada. Category: Bowel disease (inflammatory) suppressant — Indications Accepted Ulcerative colitis (treatment)—Balsalazide is indicated for the treatment of mildly to moderately active ulcerative colitis.{01} Pharmacology/Pharmacokinetics Physicochemical characteristics: Molecular weight— 437.32{01} Mechanism of action/Effect: Mesalamine (5–aminosalicylic acid), a therapeutically active byproduct cleaved from balsalazide by bacterial azoreduction, is created in the colon and acts to diminish colon inflammation by inhibiting the production of arachidonic acid metabolites.{01} Absorption: Low variable; intact balsalazide is poorly absorbed systemically{01} Protein binding: Very high (³ 99%) {01} Biotransformation: Cleaved in the colon via bacterial azoreduction to 5–aminosalicylic acid (5–ASA) and 4–aminobenzoyl-beta-alanine, the inactive carrier moiety.{01} Half-life: Could not be determined because of the great variability in the balsalazide plasma concentration versus time profiles of the healthy subjects studies.{01} Time to peak concentration: Approximately 1 to 2 hours after single oral doses of 1.5 grams or 2.25 grams.{01} Elimination: Renal— Less than 1% of dose recovered as parent compound, 25% of dose recovered as N-acetylated metabolites.{01} Feces— Less than 1% of dose recovered as parent compound, 65% of dose recovered as N-acetylated metabolites, 5–ASA and carrier moiety.{01} Precautions to Consider Cross-sensitivity and/or related problems Patients allergic to salicylates may also be allergic to balsalazide.{01} Carcinogenicity/Tumorigenicity Rats given balsalazide disodium orally at doses up to 2 grams per kg of body weight per day (2.4 times the recommended human dose on a body surface area basis for a 50-kg person of average height) for 24 months did not exhibit any tumorigenic effects.{01} Mutagenicity Long–term studies evaluating the mutagenic potential of balsalazide disodium in humans have not been done{01}. Genotoxicity was detected in the in vitro Chinese hamster lung cell (CH V79/HGPRT) forward mutation test .{01}However, the genotoxic potential of balsalazide disodium was not demonstrated in the following tests: the Ames test, the human lymphocyte chromosomal aberration test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, or the mouse micronucleus test {01}. Four–aminobenzoyl–β–alanine, a metabolite of balsalazide was shown to be genotoxic in the human lymphocyte chromosomal aberration test and non–genotoxic in the Ames test and the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test{01}. N–acetyl–4–aminobenzoyl–β–alanine, another metabolite of balsalazide, was not shown to be genotoxic in any of the three previously mentioned tests done on 4–aminobenzoyl–β–alanine{01}. Pregnancy/Reproduction Fertility— Adequate and well-controlled studies in humans have not been done{01}. Fertility was not affected when rats and rabbits were administered balsalazide disodium at oral doses up to 2 grams per kg of body weight per day (2.4 and 4.7 times the recommended human dose based on body surface area, respectively) {01}. Pregnancy— Adequate and well controlled studies have not been done in humans{01}. . No evidence of teratogenicity was found when rats and rabbits were administered up to 2 grams per kg of body weight per day (2.4 and 4.7 times the recommended human dose based on body surface area, respectively) of balsalazide disodium.{01} FDA Pregnancy Category B.{01} Breast-feeding It is not known whether balsalazide is distributed into breast milk{01}. Pediatrics No information is available on the relationship of age to the effects of balsalazide in the pediatric population. Safety and efficacy have not been established.{01}. Geriatrics No information is available on the relationship of age to the effects of balsalazide in geriatric patients. However, elderly patients are more likely to have age-related renal function impairment, which may require caution in elderly patients receiving balsalazide.{01} Laboratory value alterations The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance): With physiology/laboratory test values Alanine aminotransferase (ALT [SGPT]){01} and Alkaline phosphatase{01} and Aspartate aminotransferase (AST [SGOT]){01} and Bilirubin{01} and Gamma-glutamyl transferase (GGT){01} and Lactate dehydrogenase (LDH){01} (enzyme elevations were reported in post marketing clinical studies{01}) Medical considerations/Contraindications The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance). Risk-benefit should be considered when the following medical problems exist Hypersensitivity to salicylates, mesalamine, or any other components of balsalazide disodium.{01} Pyloric stenosis{01}. (prolonged gastric retention of balsalazide capsules may occur{01}) Renal function impairment, or history of{01} (Although there have been no reports of renal toxicity in patients who have taken balsalazide or nephrotoxic effects in rats and dogs given the equivalent of 21 times the recommended human dose, other mesalamine products have been shown to cause renal toxicity in animals and patients; therefore, caution is warranted {01}) Side/Adverse Effects Note: In clinical trials, 3 cases of exacerbation of the symptoms of colitis, possibly related to balsalazide treatment, have been reported in 259 patients receiving balsalazide at a dose of 6.75 grams per day.{01} The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive: Those indicating need for medical attention only if they continue or are bothersome Incidence more frequent Abdominal pain {01} diarrhea{01} Incidence less frequent or rare anorexia {01}(loss of appetite) Arthralgia {01}(joint pain) constipation {01} coughing {01} cramps {01} dry mouth {01} dyspepsia {01}(heart burn or upset stomach) fatigue {01} fever {01} flatulence {01} flu-like disorder {01} insomnia {01}(trouble sleeping or getting to sleep) jaundice{01} (yellowish skin) myalgia {01}(muscle pain) pharyngitis {01}(flu–like symptoms ) rhinitis {01}( stuffy nose) urinary tract infection {01}(blood in urine; lower back pain; pain or burning while urinating) Note: In post marketing studies, hepatotoxicity, including jaundice, elevated liver function tests, and hepatocellular damage, have been reported. Although some of these cases were fatal, no fatalities were found in these events.{01} Overdose For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing). Treatment of overdose There are no reported cases of an overdose with balsalazide disodium. However, a 3-year-old boy who ingested 2 grams of another mesalamine product was treated with ipecac and activated charcoal with no adverse reactions.{01} If an overdose does occur, treatment should be primarily symptomatic and supportive with special attention paid to the correction of electrolyte levels.{01} Supportive care—Patients in whom overdose is confirmed or suspected should be referred for psychiatric consultation. Patient Consultation As an aid to patient consultation, refer to Advice for the Patient, Balsalazide (Systemic). In providing consultation, consider emphasizing the following selected information (» = major clinical significance): Before using this medication » Conditions affecting use, especially: Sensitivity to balsalazide, balsalazide metabolites, or salicylates Proper use of this medication » Proper dosing Taking as soon as possible; not taking if almost time for next scheduled dose; not doubling doses Proper storage Precautions while using this medication » Regular visits to physician to check progress » Contacting physician if condition gets worse For oral dosing forms: The recommended dose, frequency, and length of treatment should not be exceeded. {01}. Oral Dosage Forms BALSALAZIDE DISODIUM CAPSULES Usual Adult Dose Ulcerative colitis , active (treatment) Oral, three 750-mg balsalazide capsules three times a day for a total daily dose of 6.75 grams for a duration of eight weeks. Treatment may last up to twelve weeks in some patients.{01} Usual adult prescribing limits The safety and effectiveness of balsalazide disodium treatments over a period of time greater than 12 weeks has not been established.{01} Usual Pediatric Dose Safety and efficacy have not been established.{01} Usual Geriatric Dose See Usual adult dose. Strength(s) usually available U.S.— 750 milligram (Rx) [Colozal ( colloidal silicon dioxide) (magnesium stearate)] Packaging and storage: Store at 25 °C (77 °F), excursions permitted to 15°C–30°C (59°F–86°F){01} Developed: 11/10/2000 References 1. Product Information: Colazal™, balsalazide disodium. Salix Pharmaceuticals, Palo Alto, CA, (PI revised 7/2000) reviewed 10/2000. Ads by Google Digoxin Information About Digoxin Used For Pulmonary Hypertension. www.PPH-net.org/ HIV medicine, come clean If the average VT shrink gets $45K, what is pharma gifting AIDS docs? www.openthebooks.org Metered dose inhalers Need Info On Asthma Inhalers? See Our Asthma Inhalers Site. Understanding-AsthmaFacts.com Link to this page Printable Version Printable Version Email Page Email Page * Help All Services A-Z Drug List Drugs & Medications Diseases & Conditions News & Articles Pill Identifier Interactions Checker Drug Side Effects Drug Image Search New Drug Approvals New Drug Applications FDA Drug Alerts Clinical Trial Results Patient Care Notes Medical Encyclopedia Medical Dictionary Community Forums For Professionals Drug Imprint Codes Medical Abbreviations Veterinary Drugs Contact Us News FeedsRSS Feeds Lower Your Blood Pressure - The All Natural Way The only non-drug medical device clinically proven to lower blood pressure www.resperate.com Lose 15 Pounds This Month Oprah and CBS featured Hoodia, a natural diet miracle. 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Subscribe to Google Co-op Add to Yahoo MyWeb Add to Live Bookmarks Add to Facebook Add to Del.icio.us Add to StumbleUpon Add to Spurl Add to Simpy Add to Reddit Add to Furl Answered by Noma Morabito 1 year ago.


Is my daughter's colazal dose too high. Her bowel movements are the exact same color of the medicine.?
She is 9 and taking 3 capsules 3 x a day for crohn's disease. Asked by Annemarie Buerkle 1 year ago.

Ewwwwwwwwwww! Answered by Tonie Klimek 1 year ago.

hi gater, i am a female crohn's pt. diagnosed at the age of 12. See if she can be a candidate for Entocort, Remicade, or Humira. For some reason, a lot of crohn's pts. I know don't respond well to Colazal or Pentasa so these newer meds I just mentioned seem to keep the CD in remission. Are you aware of the crohn's and colitis website? log on and you can find information on medications, latest treatments, information on children with CD, diet, and even locate a local chapter near you so you can meet other parents like yourself and she can meet other kids her own age. CCFA has a tol free hotline as well as online chat M-F 9 am - 5 pm (EST) that is run by healthcare professionals. In the summer they have camps just for kids with IBD so they don't feel so alone. My parents joined the local CCFA chapter after I was diagnosed w/Crohns so they could educate themselves about what I was going through and how to handle future flareups. CCFA even has educational meetings where you can hear GIs, colorectal surgeons, insurance reps, drug reps, and even dieticians talk about what IBD (crohns or ulcerative colitis)is, how it's treatment, what to eat, what to expect during surgery and during recovery time,side effects of medications, etc. As for the dosage question, ask your pharmacist or call the GI for answers.It may be that the colazol isn't getting absorbed in her gut and the dose may need to be changed or a new treatment given altogether. You are entitled to get a 2nd opinion if surgery should be cld for in the future. Don't be afraid to ask for one. I wish her the best of health. Answered by Lorna Goergen 1 year ago.

Are you sure she's on colazal? how old is your daughter? Just wondering because it shouldn't be given under age of 14 and it's for ulcerative colitis... as long as she's having formed stools it seems to be working, but call and ask her doctor. Answered by Twanna Vanis 1 year ago.


How does sulfasalazine measure up to other 5-ASA drugs such as Asacol and Colazal for Ulcerative Colitis?
I am a 23 year old male who was diagnosed with UC 8 years ago and have gone through a variety of treatments. Originally I was prescribed Asacol as well as a large dose of prednisone. I eventually went into remission and came off the steroid, but continued to take Asacol as my maintenance drug. Remission lasted for... Asked by Mary Scheidt 1 year ago.

I am a 23 year old male who was diagnosed with UC 8 years ago and have gone through a variety of treatments. Originally I was prescribed Asacol as well as a large dose of prednisone. I eventually went into remission and came off the steroid, but continued to take Asacol as my maintenance drug. Remission lasted for 3 or 4 years. My symptoms started reoccurring and progressively worsened for a while, and I found that while on Asacol they were actually worse. I also know that some common side effects of Asacol are similar to the actually symptoms of UC. I had more frequent stools, increased urgency and increased bleeding. I tried Colazal as well, but I experienced nausea and again, increased urgency. At this point I was frequently having embarrasing accidents. When I was not on medication, but kept to some natural remedies that I also take, I did not experience this as badly. My GI doc, however, wants me to try sulfasalazine rather than stay off everything... any advice / input? Answered by Demetria Mackinnon 1 year ago.

hi jacob, I have crohn's disease, a type of IBD like UC. I have had it since the age of 12. Ask your GI about the newer treatments for UC b/c the 5ASA meds don't seem to last long on some patients plus they tend to cause nausea as well. If he doesn't listen to you, then get another opinion. You the ability to hire/fire your doctors at any time so don't feel guilty. A pt. should feel comfortable discussing their concerns during their appt. and be able to work as a team w/his physician to get the UC in remission. Remicade has been approved for colitis as well as a few others. Can't remember the names but if you go to the Crohn's & Colitis Foundation of America website, they have all the latest treatments listed. You can call their hotline or chat online w/a medical professional M-F 9 am - 5pm (EST) 1-888-my-gut-pain. I hope this helps. I can totally relate to what you are going through. I went through symptoms when I was in my 20s so I talked w/my GI and he worked w/me to find a treatment that agreed w/me, thus, fewer side effects & I was able to be on it for a long time until my white cell count dropped. Then he found another medication and I haven't had any trouble since. Happy New Year. Answered by Eli Straub 1 year ago.


Is their a doctor or someone to help me possibly?
Sorry, I have UC and was taking the medicine for about 18-24 months, and my Predisone dosage has been as high as 60 mg. I stopped taking them because I was sick of the side effects, which coincidently is what is basically happening to me. Thanks for all your answers so far, I am waiting for a call back from my doctor. Asked by Annabel Messing 1 year ago.

I have had chronic fatigue, muscle and joint pain ever since I stopped taking my medications. I have not told my doctor I stopped my medicine because I know what he would say. I was on Predisone 25 mg/day, Immuran 225 mg/day, Colazal, 750 mg x 9/day, Cipro 500 mg x 2/day, and Remicade every 8 weeks (maintenance doseage). Am I experiencing serious problems or just withdrawal? The symptoms are getting worse, and I take 4 to 6 B12 viatims just to make it to the evening. Thanks for your help, and I am looking forward to your advice. Answered by Jane Rocha 1 year ago.

You must be a fellow Crohn's (or Colitis) sufferer. And if you were on that many medications, you have been through some hard times with it. It would definitely through your body for a complete loop and can cause some possibly dangerous side effects by coming off of all of them. I don't know why you came off of all of them - were you finally feeling like you were doing well enough to be without them, were you afraid of the side effects of having all of that in your system, were you just tired of taking so many pills? Believe me, I know all about not wanting to talk to your doctor. I stopped my maintenance Remicade, too (I didn't feel like it helped anymore and I was tired of wasting half a day with a needle in my arm). I've also lowered my dose of Immuran on my own. I do believe in my doctor and know that he is one of the top in the field, but I know my body and he doesn't. He has often put me on way too many meds that overwhelmed my body and made me worse. However, generally if I was upfront with him and told him how the meds were affecting me, he'd help me take it down a bit. Where I"m going with all of this is: you've been through the rough times before. You'll know if your disease symptoms are starting back or not. In fact, you actually may need to take some Iron to help your energy since we tend to be anemic. If it gets worse, bite the bullet and talk to your doctor. See if you can only be on a couple of meds - like the Immuran and Colazal and stay off the steroids and antibiotic. Good luck and I hope you start feeling better! Answered by Lane Kotaki 1 year ago.

I've been a patient all my life and learned from the best doctors. They alway's told me never ever stop medication by yourself as if you do your doctor can't be held responsibile for what you did. Any time you stop a number of medications like you've done without reducing the medication you can experiece withdrawl and have more side effects than what it's worth. Predisone is suppose to be taken and if you come off it the doctor is suppose to reduce the number of pills so you don't go through withdrawl. You can't stop all these on yourself. You need to call the doctor and tell him what you did becuase I guarantee you he will be mad and stick you right back on these meds. Call him ASAP as this is very important to your health. Also call your pharmacist and tell him what you did as he can tell you what withdrawl symptons your getting and from what medications. Please call RIGHT AWAY. Answered by Chelsie Woodbury 1 year ago.

Did you stop all at once, if you did that is what your problem is, you are going through a "with drawl" type symptoms. If you are going to stop taking medications that you have been on for an extended time you have to do it slowly. You should tell your doctor what you are doing because he or she can not make you take the medicine but they can at least help you get off it or find something else to take. Good Luck Answered by Luisa Tresch 1 year ago.

Ok so coming off all your meds like that cold turkey is not good. Your body has grown accustom to having them in you....when you stop taking them like t hat it throws everything outta whack. BUt out of all the meds you mentioned the one that jumps out at me is Prednisone. Under no circumstances should you ever just stop taking this medication. It can have very very bad withdraw symptoms and also can cause you to act differently...possibly harm yourself or another person. Im allergic to Prednisone but my MIL takes it on a regular basis and so does my 6 yr old son. I have seen first hand the body reaction to the cold turkey approach. Please contact a doctor you can trust soon. Hope this helps...good luck. Answered by Timothy Langrum 1 year ago.

You need to contact a doctor. You may be adrenally suppressed from the 25 mg prednisone you were on, and stopping the drug abruptly can be dangerous. You need some labs and a physical. Call your own MD, who will know how long you've been on that dose of steroid and discuss it. Now. Not to mention that you were obviously on potent immunosuppression for a reason. . . Crohns? UC? Rheumatoid arthritis? Why did you stop your drugs?? Answered by Isiah Kalichman 1 year ago.

You can be going through withdrawal--absolutely. Also sounds like you are going through rebound pain as well. When you stop medications like that (Prednisone is dangerous to stop suddenly, too) it can cause a worsening of your symptoms. You don't say why you stopped them? You already know the answer here. You have to tell your doctor what you did and get your butt back on your meds ASAP. Answered by Bernice Labarriere 1 year ago.

It is impossible for someone over the internet to access such a serious situation even for a nurse. You need to go to a doctor you can trust, immediately. Answered by Latisha Quiambao 1 year ago.

There is a truly the best doctor! Try Mercola.com Good luck. Answered by Odis Zinzow 1 year ago.

i would suggest going to your doctor even though you already know what he will say. it might be something more serious than what you described. either that or go to another doctor or try starting a disscussion on webmd.com Answered by Olimpia Notoma 1 year ago.

you need to wean off of meds.. and your doctor should know. If you can't tell him, switch doctors... Answered by Griselda Berg 1 year ago.


How long do you have to take the medcine colozar?
Asked by Glendora Baranga 1 year ago.

Colazal (Balsalazide disodium) is for mildly to moderately active Ulcerative Colitis. 2.25 grams three times a day for 8 weeks, 12 weeks maximum Answered by Kaylene Gandolfi 1 year ago.


Bleeding from Ulcerative Colitis?
I've been taking 1 pill of Colazal 750mg for over a week now and have bled everytime I go to the bathroom. I also have stomach cramps throughout the day and really bad smelling gas. Should I stop taking the Colazal? My doctor has put me on Asacol, Lialda and Dipentum in the past and they all cause similar... Asked by Sheri Cronin 1 year ago.

I've been taking 1 pill of Colazal 750mg for over a week now and have bled everytime I go to the bathroom. I also have stomach cramps throughout the day and really bad smelling gas. Should I stop taking the Colazal? My doctor has put me on Asacol, Lialda and Dipentum in the past and they all cause similar problems as the Colazal. However, my doctor insists that I continue the Colazal for a couple more weeks. Should I take matters into my own hands and stop the Colazal? I'm concerned that I am losing too much blood. Answered by Basil Sanner 1 year ago.

Tell your Dr that you would like a CBC (complete blood count) done, it will let him know if you are anemic. If you are not satisfied with what your Dr is doing or agree with his treatment plan, get a second opinion. You may also want to see if you can find a holistic/natural practioner who can help with complementary therapy that may help reduce the side effects of your medication and suggest dietary changes that will help build/keep blood count up within normal limits. Answered by Lorrie Carris 1 year ago.


Is it normal for Ulcerative Colitis drugs to cause pain?
To answer the first question below, yes, we are pretty sure it's Ulcerative Colitis. I had two different doctors give me two colonoscopies five years apart from each other and they both said it looks like UC. Plus, I once also took Remicade (which is used to treat Crohn's) and that didn't work for... Asked by Belle Bickle 1 year ago.

I've taken Asacol, Dipentum, Lialda and Colazal and all these drugs make me have bad stomach cramps, really bad smelling gas, and an urgency to run to the bathroom every few hours. When I am taken off these drugs, I feel fine. However, my doctor says that I need to stay on them. Are these drug interactions normal? Answered by Lucilla Lu 1 year ago.

To answer the first question below, yes, we are pretty sure it's Ulcerative Colitis. I had two different doctors give me two colonoscopies five years apart from each other and they both said it looks like UC. Plus, I once also took Remicade (which is used to treat Crohn's) and that didn't work for me either. Answered by Fletcher Granath 1 year ago.

Is the diagnosis of Ulcerative Colitis definite? My Dr originally thought I had Ulcerative Colitis, but it turned out to be Crohn's Disease, and when I was on the drugs for Ulcerative Colitis, I had those same symptoms. (turns out alot of people with CD have awful smelling gas as a result of the disease). It is sometimes difficult for the diagnosis, because CD and UC are so similar. Just some food for thought... Answered by Veda Bisio 1 year ago.


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