Alti-Sulfasalazine Oral, Rectal
Name: Alti-Sulfasalazine Oral, Rectal
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Uses For Alti-Sulfasalazine
Sulfasalazine is used to treat and prevent ulcerative colitis. It works inside the bowels by helping to reduce the inflammation and other symptoms of the disease.
Sulfasalazine enteric-coated tablets are used to treat adults and children with rheumatoid arthritis in patients who have not been helped by or who cannot tolerate other medicines (eg, salicylates or NSAIDs) for rheumatoid arthritis.
This medicine is available only with your doctor's prescription.
Before Using Alti-Sulfasalazine
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 have not been performed on the relationship of age to the effects of sulfasalazine tablets and enteric-coated tablets to treat ulcerative colitis in children younger than 2 years of age. Safety and efficacy have not been established in children younger than 2 years of age.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfasalazine enteric-coated tablets to treat juvenile rheumatoid arthritis in children. However, safety and efficacy have not been established in children younger than 6 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulfasalazine in the elderly.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
Breast Feeding
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
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 taking 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.
- Ketorolac
- Methenamine
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.
- Aceclofenac
- Acemetacin
- Amtolmetin Guacil
- Azathioprine
- Bromfenac
- Bufexamac
- Celecoxib
- Clonixin
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Dipyrone
- Droxicam
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
- Ibuprofen
- Indomethacin
- Ketoprofen
- Lornoxicam
- Loxoprofen
- Lumiracoxib
- Meclofenamate
- Mefenamic Acid
- Meloxicam
- Mercaptopurine
- Morniflumate
- Nabumetone
- Naproxen
- Nepafenac
- Niflumic Acid
- Nimesulide
- Nimesulide Beta Cyclodextrin
- Oxaprozin
- Oxyphenbutazone
- Parecoxib
- Phenylbutazone
- Piketoprofen
- Piroxicam
- Proglumetacin
- Propyphenazone
- Proquazone
- Riluzole
- Rofecoxib
- Sulindac
- Tenoxicam
- Tiaprofenic Acid
- Tolfenamic Acid
- Tolmetin
- Valdecoxib
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.
- Aminolevulinic Acid
- Cyclosporine
- Digoxin
- Warfarin
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:
- Allergy to sulfa drugs or salicylates or
- Bowel blockage or
- Porphyria (enzyme problem) or
- Urinary bladder blockage—Should not be used in patients with these conditions.
- Asthma, bronchial—Use with caution. May increase risk of having an allergic reaction.
- Blood or bone marrow problems (eg, agranulocytosis, aplastic anemia) or
- Kidney disease or
- Liver disease—Use with caution. May make these conditions worse.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—May cause hemolytic anemia (blood disorder) in patients with this condition.
- Infection—May decrease your body's ability to fight infection.
In Summary
Commonly reported side effects of sulfasalazine include: gastric distress, headache, nausea, oligospermia, vomiting, and anorexia. Other side effects include: fever. See below for a comprehensive list of adverse effects.
Usual Adult Dose for Crohn's Disease - Acute
3 to 6 g/day orally in divided doses
Comments:
-This dose has been recommended for mild to moderate active ileocolonic or colonic disease; not approved by US FDA.
-Maintenance benefits have not been consistent after medical inductive therapy.
Precautions
Safety and efficacy have not been established in ulcerative colitis patients younger than 2 years. Safety and efficacy have not been established in polyarticular-course juvenile rheumatoid arthritis patients younger than 6 years. This drug is not recommended for the treatment of systemic-course juvenile rheumatoid arthritis.
Consult WARNINGS section for additional precautions.
Dialysis
Critical assessment prior to use recommended for patients with renal dysfunction.
Other Comments
Administration advice:
-Adjust dose to each patient's response and tolerance.
-Administer daily dose in evenly divided doses preferably after meals; dose intervals should not exceed 8 hours.
-Swallow delayed-release tablets whole.
-The manufacturer product information should be consulted for desensitization information.
General:
-Delayed-release tablets are primarily for patients who cannot use uncoated tablets due to GI intolerance.
-Ulcerative colitis rarely remits completely; risk of relapse can be greatly reduced by continued use of this drug at maintenance dose.
-Rheumatoid arthritis rarely remits; continued use of this drug is suggested.
Monitoring:
-General: For toxicity; serum sulfapyridine levels
-Hematologic: CBC including differential white cell count (before starting, every second week during first 3 months, monthly during second 3 months, once every 3 months thereafter, and as indicated)
-Hepatic: Liver function tests (before starting, every second week during first 3 months, monthly during second 3 months, once every 3 months thereafter, and as indicated)
-Renal: Renal function including urinalysis (initially, at least monthly for first 3 months, periodically thereafter as indicated)
Patient advice:
-Maintain adequate fluid intake in order to prevent crystalluria and stone formation.
-An orange-yellow discoloration of urine or skin may occur.
-If delayed-release tablets pass undisintegrated, discontinue the product at once.
-If using for rheumatoid arthritis, follow up with physician to determine the need for continued use.
Administrative Information
LactMed Record Number
442
Last Revision Date
20161011
Disclaimer
Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.