Sulfadiazine

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• CYCLOSPORINE/SULFADIAZINE
• METHOTREXATE/SULFADIAZINE
• PRALATREXATE/SULFADIAZINE
• SULFADIAZINE/WARFARIN

This is not a complete list of Sulfadiazinedrug interactions. Ask your doctor or pharmacist for more information.

Sulfadiazine is available in the following forms:

• Injectable Solution
• Oral Powder
• Oral Suspension
• Oral Tablet

Antibacterial; intermediate-acting sulfonamide.a b

Specific Drugs

Sulfadiazine is used to treat or prevent infections in many different parts of the body. It belongs to the group of medicines known as sulfonamide antibiotics. It works by preventing the growth of bacteria. However, sulfadiazine will not work for colds, flu, or other virus infections.

sulfadiazine is available only with your doctor's prescription.

• Tell all of your health care providers that you take sulfadiazine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use longer than you have been told. A second infection may happen.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Be careful if you have G6PD deficiency. Anemia may happen.
• Talk with your doctor before you drink alcohol.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Use sulfadiazine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take with or without food.
• Take with a full glass of water.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Not hungry.
• Dizziness.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Sulfadiazine is contraindicated in the following circumstances: Hypersensitivity to sulfonamides.

In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis).

In pregnancy at term and during the nursing period, because sulfonamides cross the placenta and are excreted in breast milk and may cause kernicterus.

The sulfonamides should not be used for the treatment of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis.

Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias.

The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.

The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.

Sulfadiazine Tablets USP for oral administration are available as:

500 mg: white, unscored, capsule-shaped tablets, debossed “E 757” on one face and supplied as:

NDC 0185-0757-30 bottles of 30

NDC 0185-0757-01 bottles of 100

NDC 0185-0757-10 bottles of 1000

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for

Sandoz Inc.

Princeton, NJ 08540

Manufactured by

Epic Pharma, LLC

Laurelton, NY 11413

OS7190

Rev. 03/12

MF0757REV03/12

MG #16918

A 200 mg/mL oral suspension may be made with sulfadiazine powder and sterile water. Place 50 g sulfadiazine powder in a glass mortar. Add small portions of sterile water and mix to a uniform paste; mix while incrementally adding sterile water to almost 250 mL; transfer to a calibrated bottle, rinse mortar with sterile water, and add sufficient quantity of sterile water to make 250 mL. Label "shake well" and "refrigerate". Stable for 3 days refrigerated. Note: Suspension may also be prepared by crushing one-hundred 500 mg tablets; however, it is stable for only 2 days.

Secondary prophylaxis of rheumatic fever, if patient is intolerant of penicillin:
> 2 months and <=27 kg: 500 mg orally once a day.
>27 kg: 1 g orally once a day.

The optimal duration has not been definitely determined. The American Heart Association recommends that prophylaxis be continued for at least 5 years or until the patient reaches age 21 (whichever is longer) for rheumatic fever without carditis, and for 10 years in patients with carditis but no valvar heart disease. Prophylaxis is recommended for at least 10 years since the last episode or until the patient reaches age 40 for carditis and persistent valvar disease; lifelong prophylaxis may be required.

Secondary prophylaxis after acute treatment of toxoplasmic encephalitis:
Sulfadiazine 85 to 120 mg/kg/day (maximum adult dose, 4 to 6 g/day) orally in 2 to 4 divided doses plus pyrimethamine, 1 mg/kg or 15 mg/m2 (maximum dose 25 mg) orally once a day plus leucovorin 5 mg orally every 3 days.

Duration: Lifelong in HIV-infected patients.

Monitoring is recommended in patients with renal impairment.
Adults:
CrCl 25 to 50 mL/min: Increase dosing interval to every 12 hours.
CrCl 10 to 25 mL/min: Increase dosing interval to every 24 hours
CrCl < 10 mL/min: Generally avoid due to the high risk of crystalluria.

Monitoring is recommended in patients with hepatic impairment.