Sulfasalazine 500mg (sulfasalazine) - Generic

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SAAZ is the international generic and equivalent of Sulfasalazine

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Sulfasalazine 500mg (sulfasalazine) - Generic

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What is Generic Sulfasalazine (sulfasalazine) ?
Generic Sulfasalazine (sulfasalazine) affects a substance in the body that causes inflammation, tissue damage, and diarrhea.Generic Sulfasalazine (sulfasalazine) is used to treat moderate to severe ulcerative colitis. It is also used to treat rheumatoid arthritis in children and adults who have received other arthritis medications without successful treatment of symptoms.Generic Sulfasalazine (sulfasalazine) may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Generic Sulfasalazine (sulfasalazine) ?
You should not use this medication if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to Generic Sulfasalazine (sulfasalazine), sulfa drugs, aspirin, or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others). Before using Generic Sulfasalazine (sulfasalazine), tell your doctor if you have asthma, kidney or liver disease, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.Also tell your doctor about all other medications you use, especially digoxin (digitalis, Lanoxin), folic acid (Folicin, FA-8), or vitamin or mineral supplements that contain folic acid.Do not crush, break, or chew a Generic Sulfasalazine (sulfasalazine) tablet. Swallow the pill whole. The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating. For best results, keep using the medication as directed. Generic Sulfasalazine (sulfasalazine) will not cure ulcerative colitis, but it can reduce the number of attacks you have. If you are treating arthritis, do not stop using any of your other arthritis medications until your doctor tells you to. 


What should I discuss with my healthcare provider before taking Generic Sulfasalazine (sulfasalazine) ?
You should not use this medication if you are allergic to Generic Sulfasalazine (sulfasalazine), or if you have: a blockage in your bladder or intestines;porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);if you are allergic to sulfa drugs (such as Bactrim, Septra, Cotrim, and others); orif you are allergic to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).Before using Generic Sulfasalazine (sulfasalazine), tell your doctor if you are allergic to any drugs, or if you have:asthma;glucose-6-phosphate dehydrogenase (G6PD) deficiency;kidney disease; orliver disease.If you have any of these conditions, you may need a dose adjustment or special tests to safely take Generic Sulfasalazine (sulfasalazine).FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Generic Sulfasalazine (sulfasalazine) can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. 


How should I take Generic Sulfasalazine (sulfasalazine) ?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take this medication after a meal. Do not crush, break, or chew a Generic Sulfasalazine (sulfasalazine) tablet. Swallow the pill whole. The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating. For best results, keep using the medication as directed. Generic Sulfasalazine (sulfasalazine) will not cure ulcerative colitis, but it can reduce the number of attacks you have. If you are treating arthritis, do not stop using any of your other arthritis medications until your doctor tells you to. Your symptoms may not improve right away when you start taking Generic Sulfasalazine (sulfasalazine), and you may still need your other medications for awhile. To be sure this medication is not causing harmful effects, your liver and kidney function may need to be checked with blood and urine tests on a regular basis. Do not miss any scheduled appointments.
 


Store Generic Sulfasalazine (sulfasalazine) at room temperature away from moisture and heat. 


What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, or seizure (convulsions).


What should I avoid while taking Generic Sulfasalazine (sulfasalazine) ?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Generic Sulfasalazine (sulfasalazine).


Side effects of Generic Sulfasalazine (sulfasalazine) 
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Generic Sulfasalazine (sulfasalazine) and call your doctor at once if you have any of these serious side effects: fever, sore throat, or other flu symptoms;pale skin, easy bruising;dark urine, jaundice (yellowing of the skin or eyes);pain or burning when you urinate;urinating less than usual or not at all;the appearance of a whole tablet in your stool; orfever, sore throat, and headache with a severe blistering, peeling, and red skin rash.


Less serious side effects may include:
mild nausea, vomiting, diarrhea, upset stomach;loss of appetite;headache, ringing in your ears;dizziness, spinning sensation;white patches or sores inside your mouth or on your lips;sleep problems (insomnia); ormild itching or skin rash.This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. 


What other drugs will affect Generic Sulfasalazine (sulfasalazine) ?


Before taking Generic Sulfasalazine (sulfasalazine), tell your doctor if you are using any of the following drugs:digoxin (digitalis, Lanoxin);folic acid (Folicin, FA-8); orvitamin or mineral supplements that contain folic acid.This list is not complete and there may be other drugs that can interact with Generic Sulfasalazine (sulfasalazine). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.


Generic Name sulfasalazine
Search Name Sulfasalazine Generic 500mg Tab
Supply Name SAAZ
Brand Generic GENERIC
Presentation Foil in Box
Dosage Tab
USA Brand Sulfasalazine
Manufacture Ipca Lab
Strength 500mg
Search Terms Sulfasalazine ,SAAZ ,sulfasalazine
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to sulfasalazine: oral tablet, oral tablet enteric coated

Along with its needed effects, sulfasalazine 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 immediately if any of the following side effects occur while taking sulfasalazine:

More common
- Aching of joints
- fever
- headache (continuing)
- increased sensitivity of the skin to sunlight
- itching
- skin rash
- vomiting

Less common
- Back, leg, or stomach pains
- bleeding gums
- bluish color of the fingernails, lips, skin, palms, or nail beds
- chills
- dark urine
- difficulty breathing
- fever
- general body swelling
- headache
- loss of appetite
- nausea
- nosebleeds
- pale skin
- sore throat
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellowing of the eyes or skin

Less common or rare
- Aching of muscles
- black, tarry stools
- blistering, peeling, or loosening of the skin
- bloating
- blood in the urine or stools
- bloody diarrhea
- bluish fingernails, lips, or skin
- chest pain
- constipation
- cough
- difficulty with swallowing
- dizziness
- fainting spells
- fast heartbeat
- general feeling of discomfort or illness
- general tiredness and weakness
- hives
- indigestion
- inflammation of the joints
- irregular heartbeat
- light-colored stools
- muscle aches
- muscle cramps or spasms
- muscle pain or stiffness
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rash
- red skin lesions, often with a purple center
- red, irritated eyes
- redness, blistering, peeling, or loosening of the skin
- sores, ulcers, or white spots in the mouth or on the lips
- swollen or painful glands
- tightness in the chest
- upper right abdominal or stomach pain

Incidence not known
- Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of sulfasalazine 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:

More common
- Abdominal or stomach pain or upset
- decreased weight

Less common
- Welts

Less common or rare
- Discoloration of the skin or urine
- hair loss or thinning of the hair
- swelling or inflammation of the mouth
USUAL ADULT DOSE FOR CROHN'S DISEASE - ACUTE

Initial dose: 500 mg orally 2 to 4 times a day, with food

Maintenance dose: 3 to 4 g per day orally in divided doses; some patients may require up to 6 g per day, especially if fast acetylators

USUAL ADULT DOSE FOR ULCERATIVE COLITIS - ACTIVE

Initial dose: 500 mg orally 2 to 4 times a day, with food

Maintenance dose: 3 to 4 g per day orally in divided doses; some patients may require up to 6 g per day, especially if fast acetylators

USUAL ADULT DOSE FOR ULCERATIVE COLITIS - MAINTENANCE

500 mg orally 4 times a day, with food

USUAL ADULT DOSE FOR CROHN'S DISEASE - MAINTENANCE

500 mg orally 2 to 4 times a day, with food

USUAL ADULT DOSE FOR RHEUMATOID ARTHRITIS

Delayed release tablet:
Initial dose:
Week 1: 500 mg orally once a day
Week 2: 500 mg orally twice a day
Week 3: 500 mg orally in the morning and 1000 mg in the evening

Maintenance dose: 1000 mg orally twice a day; may consider increasing to 3000 mg per day if the clinical response is inadequate after 12 weeks

Results of the Combinatietherapie Bij Reumatoide Artritis (COBRA) trial in early rheumatoid arthritis where sulfasalazine (SSZ) alone was compared with the combination of prednisolone, methotrexate and SSZ, reported that at 6 months the combination therapy retarded radiographic progression much better than SSZ alone (p less than 0.0001).

USUAL ADULT DOSE FOR UVEITIS

Study (n=10) - Acute anterior recurrent uveitis
Initial dose: 500 mg per day, then increased by 500 mg per week

Maintenance dose: 1 g twice a day for one year; in cases of new flare, dose was increased by 500 mg per week up to 3 g per day

USUAL PEDIATRIC DOSE FOR ULCERATIVE COLITIS

6 years or older:
Initial dose: 40 to 60 mg/kg/day orally divided into 3 to 6 doses
Maintenance dose: 30 mg/kg/day orally divided into 4 doses

USUAL PEDIATRIC DOSE FOR JUVENILE RHEUMATOID ARTHRITIS

Polyarticular-course:
Delayed release tablet:
6 years or older:
Initial dose: 10 mg/kg/day orally in 2 equally divided doses (increase weekly by 10 mg/kg/day)
Usual dose: 30 to 50 mg/kg/day orally divided in 2 doses
Maximum dose: 2 g per day

RENAL DOSE ADJUSTMENTS

Data not available

LIVER DOSE ADJUSTMENTS

Data not available

PRECAUTIONS

Sulfasalazine is contraindicated in patients with intestinal or urinary obstruction and patients with porphyria.

Only after critical assessment should sulfasalazine be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the use of sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. Patients should seek medical advice if clinical signs such as sore throat, fever, pallor, purpura, or jaundice occur as they may indicate serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done often in patients receiving sulfasalazine. Sulfasalazine treatment should be discontinued while waiting for blood test results.

Complete blood counts, including differential white cell count and liver function tests, should be performed prior to starting sulfasalazine and every second week during the first 3 months of therapy. During the second 3 months, the same tests should be done once monthly and thereafter once every 3 months, as clinically necessary. Urinalysis and an assessment of renal function should be done periodically during sulfasalazine therapy. Determination of serum sulfapyridine levels may be useful since concentrations greater than 50 mcg/mL appear to be associated with an increased incidence of adverse events.

Oligospermia and infertility have been reported in men treated with sulfasalazine; however, discontinuation of the drug appears to reverse these effects.

Sulfasalazine should be administered with caution to patients with severe allergy or bronchial asthma. Patients should be advised to discontinue therapy and contact their physician should they develop a rash, especially if rash is accompanied by lymphadenopathy, malaise, or fever. Sulfasalazine should be discontinued at once if toxic or hypersensitivity reactions occur.

Patients with glucose-6-phosphate dehydrogenase should be monitored closely for signs of hemolytic anemia which is often dose related.

Sulfasalazine delayed release tablets have passed undisintegrated in isolated cases. If this occurs, the product should be discontinued at once.

Safety and effectiveness have not been established for ulcerative colitis in pediatric patients less than 2 years of age.

DIALYSIS

Data not available

OTHER COMMENTS

Patients should be advised to maintain adequate fluid intake in order to prevent crystalluria and stone formation and that sulfasalazine may produce an orange-yellow discoloration of urine or skin.

Delayed release tablets should be swallowed whole.