Sulfadiazine

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, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

• Tablet

Before using Sulfadiazine, you must know all about the risks and complications associated with it. 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 Population: Because of sulfadiazine's toxicity, use in infants younger than 2 months of age is not recommended.

Geriatric Population: No information is available on the relationship of age to the effects of sulfadiazine in geriatric patients. However, elderly patients are more likely to have age-related kidney and liver problems, which may require caution in patients receiving sulfadiazine.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding|: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: 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.

• Methenamine

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.

• Acetohexamide
• Cyclosporine

Other Interactions: 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:

• Asthma 
• Blood problems (e.g., agranulocytosis, aplastic anemia) 
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem) 
• Kidney disease 
• Liver disease—Use with caution. May have an increased chance of side effects

Proper usage of Sulfadiazine requires strict adherence to your doctor’s orders. This medicine should not be given to infants younger than 2 months of age unless directed by your child's doctor. Sulfadiazine may cause serious unwanted effects in this age group.

Take this medicine with a full glass (8 ounces) of water. Several additional glasses of water should be taken during the day unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. If you need help in planning the best times to take your medicine, check with your doctor.

To help clear up your infection completely, keep using this medicine for the full treatment time, even if you feel better after the first few doses. If you stop taking this medicine too soon, your symptoms may return.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For treatment of infections:

• Adults—2000 to 4000 milligrams (mg) per day, divided and given in 3 to 6 doses per day.
• Children and infants 2 months of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 75 milligrams (mg) per kilogram (kg) of body weight per day (mg/kg/day), divided and given in 4 to 6 doses per day. Your doctor may increase your dose to 150 mg/kg/day, but the total dose is usually not more than 6000 mg per day.
• Infants younger than 2 months of age—Use is not recommended.

For prevention of rheumatic fever:

• Adults and children 30 kilograms (kg) or more—1000 milligrams (mg) per day as a single dose.
• Adults and children less than 30 kilograms (kg)—500 milligrams (mg) per day as a single dose.

Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

In using Sulfadiazine, you must be careful and take some precautions as advised by your doctor.

Check with your doctor right away if you have:

• fever
• chills
• pale skin
• pinpoint red or purple spots on the skin
• a sore throat
• pain in the upper stomach
• yellow eyes or skin

These may be symptoms of a serious blood problem. Do not take other medicines unless they have been discussed with your doctor.

This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

As with many medications, there are several potential side effects associated with Sulfadiazine. 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:

Rare:

• anxiety
• blurred vision
• changes in menstrual periods
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• decreased sexual ability in males
• depression
• dizziness
• dry, puffy skin
• fast heartbeat
• feeling cold
• headache
• increased hunger
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• swelling of front part of the neck
• unusual tiredness or weakness
• weight gain

Incidence not known:

• abdominal or stomach pain
• back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• bleeding under the skin
• blindness or vision changes
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bluish-colored lips, fingernails, or palms
• burning of the face or mouth
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• chest pain
• cloudy urine
• clumsiness or unsteadiness
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• cough or hoarseness
• cracks in the skin
• darkened urine
• decrease in the amount of urine
• diarrhea
• difficulty with breathing
• difficulty with moving
• dizziness or lightheadedness
• feeling of discomfort
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• headache
• hearing loss
• indigestion
• itching
• joint or muscle pain
• light-colored stools
• loss of appetite and weight
• loss of heat from the body
• lower back or side pain
• muscle pain or stiffness
• nosebleeds
• not able to pass urine
• pain or burning while urinating
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red or purple spots on the skin
• rapid heart rate
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• redness of the white part of the eyes
• scaly skin
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness and unsteady walk
• shortness of breath
• sore throat
• soreness of the muscles
• sores, ulcers, or white spots on the lips or in the mouth
• sudden decrease in amount of urine
• swelling around the eyes
• swelling of the face, hands, legs, and feet
• swelling or inflammation of the mouth
• swollen lymph glands
• swollen or painful glands
• tightness in the chest
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• upper right abdominal pain
• vision changes
• vomiting
• weakness in the hands or feet
• wheezing
• yellow eyes or skin

Some side effects 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:

Incidence not known:

• the feeling of constant movement of self or surroundings
• hives or welts
• the sensation of spinning
• sleeplessness
• trouble with sleeping
• unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.