Sulfazin
Generic Name
Sulfazin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sulfazin 500 mg tablet | ৳ 5.22 | ৳ 52.20 |
Description
Overview of the medicine
Sulfazin (Sulfasalazine) is an anti-inflammatory and immunomodulatory drug used to treat inflammatory bowel diseases (like ulcerative colitis and Crohn's disease) and certain types of arthritis (like rheumatoid arthritis). It works by reducing inflammation in the body.
Uses & Indications
Dosage
Adults
Ulcerative Colitis: Initial 1-2 g/day, gradually increasing to 4-6 g/day. Maintenance: 2 g/day. Rheumatoid Arthritis: Initial 500 mg/day, gradually increasing to 2-3 g/day.
Elderly
Start with lower doses and monitor renal function closely. Generally, similar adult doses may be used with caution.
Renal_impairment
Use with caution or avoid in severe renal impairment. Dose reduction may be necessary in moderate impairment.
How to Take
Take Sulfazin tablets orally, preferably after meals or with food, to minimize gastrointestinal upset. Swallow tablets whole; do not crush, chew, or break them. Drink plenty of water throughout the day.
Mechanism of Action
Sulfazin is poorly absorbed orally and reaches the colon where it is metabolized by bacterial azoreductases into two main components: sulfapyridine (SP) and 5-aminosalicylic acid (5-ASA). SP has systemic anti-inflammatory effects, while 5-ASA primarily acts topically in the colon to reduce inflammation.
Pharmacokinetics
Onset
For ulcerative colitis, effects may be seen within a few days to weeks. For rheumatoid arthritis, it may take several weeks to months for full therapeutic effect.
Excretion
The parent drug and its metabolites are primarily excreted in the urine and feces.
Half life
Parent drug: 5.7-10 hours. Sulfapyridine: 6-17 hours. 5-ASA: 6-16 hours.
Absorption
Poorly absorbed orally (10-15% of parent drug). The unabsorbed portion reaches the colon.
Metabolism
Cleaved in the colon by bacterial enzymes into sulfapyridine and 5-aminosalicylic acid (5-ASA). Sulfapyridine is extensively metabolized in the liver (acetylation, hydroxylation). 5-ASA is metabolized in the gut mucosal wall and liver.
Side Effects
Contraindications
- Hypersensitivity to sulfasalazine, sulfonamides, or salicylates
- Patients with porphyria
- Intestinal or urinary obstruction
- Children under 2 years of age for systemic treatment
Drug Interactions
Digoxin
May decrease digoxin absorption, leading to reduced efficacy.
Warfarin
May potentiate the anticoagulant effect of warfarin, increasing bleeding risk.
Folic Acid
Inhibits absorption and metabolism of folic acid, potentially leading to folate deficiency. Folic acid supplementation is often recommended.
Methotrexate
Concurrent use may increase the risk of myelosuppression, especially in slow acetylators.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, crystalluria, CNS toxicity (e.g., convulsions), and blood dyscrasias. Management involves gastric lavage or induced emesis, alkalinization of urine to prevent crystalluria, forced diuresis, and supportive care. Monitor renal function and blood counts.
Pregnancy & Lactation
Pregnancy Category B. While studies in animals have shown no harm, adequate and well-controlled studies in pregnant women are lacking. Sulfasalazine inhibits folate absorption, so folic acid supplementation is crucial during pregnancy. Small amounts are excreted in breast milk; generally considered compatible with breastfeeding, but monitor infant for diarrhea or rash.
Side Effects
Contraindications
- Hypersensitivity to sulfasalazine, sulfonamides, or salicylates
- Patients with porphyria
- Intestinal or urinary obstruction
- Children under 2 years of age for systemic treatment
Drug Interactions
Digoxin
May decrease digoxin absorption, leading to reduced efficacy.
Warfarin
May potentiate the anticoagulant effect of warfarin, increasing bleeding risk.
Folic Acid
Inhibits absorption and metabolism of folic acid, potentially leading to folate deficiency. Folic acid supplementation is often recommended.
Methotrexate
Concurrent use may increase the risk of myelosuppression, especially in slow acetylators.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, crystalluria, CNS toxicity (e.g., convulsions), and blood dyscrasias. Management involves gastric lavage or induced emesis, alkalinization of urine to prevent crystalluria, forced diuresis, and supportive care. Monitor renal function and blood counts.
Pregnancy & Lactation
Pregnancy Category B. While studies in animals have shown no harm, adequate and well-controlled studies in pregnant women are lacking. Sulfasalazine inhibits folate absorption, so folic acid supplementation is crucial during pregnancy. Small amounts are excreted in breast milk; generally considered compatible with breastfeeding, but monitor infant for diarrhea or rash.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, depending on storage conditions.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies worldwide, including DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of sulfasalazine in the treatment of inflammatory bowel disease and rheumatoid arthritis since its introduction. Ongoing research continues to explore its role in other inflammatory conditions.
Lab Monitoring
- Complete Blood Count (CBC) with differential (before starting treatment and every 2-4 weeks for the first 3 months, then periodically)
- Liver Function Tests (LFTs) (before starting and periodically)
- Renal Function Tests (RFTs) (before starting and periodically)
- Urinalysis (periodically to detect crystalluria or proteinuria)
Doctor Notes
- Emphasize the importance of patient compliance with regular monitoring (CBC, LFTs, RFTs).
- Advise folic acid supplementation for all patients, especially women of childbearing potential.
- Educate patients on potential serious adverse reactions and when to seek medical attention.
Patient Guidelines
- Take medication as prescribed and do not stop without consulting your doctor.
- Drink plenty of fluids to prevent kidney stones.
- Report any unusual bleeding, bruising, fever, rash, sore throat, or yellowing of skin/eyes immediately to your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Sulfazin may cause dizziness or headache in some individuals. Patients should be cautioned about operating machinery or driving until they know how the drug affects them.
Lifestyle Advice
- Maintain good hydration throughout the day.
- Consider folic acid supplementation as advised by your doctor, especially if pregnant or planning pregnancy.
- Avoid prolonged exposure to sunlight as Sulfazin may increase photosensitivity.
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