Flamazine: Uses, Side Effects and Dosage

What is FLAMAZINE used for?

• Treatment of infections caused by bacteria which can be killed by FLAMAZINE:

  • Infection in serious burn victims.
  • Infection in leg ulcers, burns, skin grafts, incisions and other clean lesions, abrasions, minor cuts and wounds.

Antibacterial drugs like FLAMAZINE treat only bacterial infections. They do not treat viral infections.

How does FLAMAZINE work?

This medicine kills bacteria or stops their growth. This helps reduce or prevent infections. The time taken for the medicine to work will vary by wound type.

What are the ingredients in FLAMAZINE?

Medicinal ingredients: silver sulfadiazine

Non-medicinal ingredients: cetyl alcohol, distilled water, glyceryl stearate, liquid paraffin, polysorbate 60, polysorbate 80, propylene glycol

FLAMAZINE comes in the following dosage forms:

FLAMAZINE is a white cream containing 1% silver sulfadiazine. FLAMAZINE is available in 20g or 50g tube and 500g jar.

Serious Warnings and Precautions

• Potentially life-threatening skin rashes (Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)) have been reported with the use of silver sulfadiazine, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of silver sulfadiazine, you must not be re-started on silver sulfadiazine at any time.

Do not use FLAMAZINE if:

• You are allergic to the medicinal ingredients in FLAMAZINE or any of its ingredients (see “What are the ingredients in FLAMAZINE”).

• You are a pregnant female at term.

• Your child is a premature infant or is a newborn infant during the first months of life (˂ 2 months of age).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FLAMAZINE. Talk about any health conditions or problems you may have, including if you:

• Have previously shown allergic reactions to sulfonamides.
• Have a history of glucose-6-phosphate dehydrogenase deficiency. Using sulfonamides like FLAMAZINE can lead to hemolysis (red blood cell breakdown).
• Have liver or kidney problems.
• Have previously had low white blood cell levels. Leukopenia (lowered white blood cell levels) has occurred after use of FLAMAZINE. Your doctor may order tests to monitor you white blood cell count while you are taking FLAMAZINE.
• Have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of silver sulfadiazine
• Are pregnant or are planning to become pregnant. FLAMAZINE may cause harm to unborn children. Only use this medicine if your doctor thinks the benefit is greater than the risk to the foetus. Do not use this medicine if you are in the last month of your pregnancy.
• Are breast feeding or intend to breast feed. FLAMAZINE can pass into breast milk and cause harm to your baby. Talk to your doctor about how to feed your baby when you are on FLAMAZINE.

Other warnings you should know about:

• Do not use this medicine for longer than advised by your doctor. This may lead to increased chance of side effects.
• If you are using FLAMAZINE to treat large wounds, it is important to drink lots of liquids prevent dehydration and kidney damage
• FLAMAZINE may increase the time for dead tissue (eschar) to separate from the body. It may also change the appearance of burn wounds.
• If you are using FLAMAZINE you should not smoke or go near open flames due to the risk of severe burns. Fabric (clothing, bedding, dressings etc.) that has been in contact with FLAMAZINE burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with FLAMAZINE:

• Enzymatic debriding agents (remove dead tissue from wounds).
• Oral hypoglycemic agents (for treatment of type 2 diabetes)
• Phenytoin (prevents seizures).
• Cimetidine (used for heartburn and ulcers).

Your doctor may need to run blood tests if you are taking any of these medicines while taking FLAMAZINE.

How to take FLAMAZINE:

• For topical (body surface) use only. Do not get it in your eyes, nose, mouth, or vagina.
• Although you may feel better in early treatment, FLAMAZINE should be used exactly as directed.
• Misuse or overuse of FLAMAZINE could lead to growth of bacteria that will not be killed by FLAMAZINE (resistance). This means that FLAMAZINE may not work for you in the future.
• Do not share your medicine. Each jar or tube of FLAMAZINE should be used on one person only.

Usual dose:

Burns: Clean the wound. Apply a 3 - 5 mm layer of the cream to be burned area using a sterile (germ-free) glove and/or spatula. Reapply cream if it comes off or rubs away. Reapply cream at least every 24 hours or more frequently if wound fluid levels are high.

Hand burns and finger injuries: Clean the wound. Apply a 3 - 5 mm layer of the cream to be affected area using a sterile (germ-free) glove and/or spatula. Place whole hand in a clear plastic bag or glove and close at the wrist. Move your hands and fingers as regularly as possible. Change the dressing every 3 days or more regularly if wound fluid levels are high.

Leg ulcers: Fill ulcer wound with cream to a depth of at least 3 – 5 mm. Avoid non-ulcerated areas. Apply an absorbent pad or gauze dressing. Apply pressure bandaging over the pad/dressing as advised by your doctor. Change the dressing every 2 or 3 days. Cleaning and removal of dead tissue should be performed before each reapplication of FLAMAZINE. Do not apply FLAMAZINE to leg ulcers which have large amounts of wound fluid.

Overdose:

Overdose of sulfadiazine by mouth may lead to diarrhoea or a feeling of sickness.

Missed Dose:

If you forget to use FLAMAZINE, apply it as soon as you remember. If it is close to the time when you are due to apply your next dose, wait and apply your next scheduled dose and then continue as before. Do not apply extra FLAMAZINE to make up for missed doses.

What are possible side effects from using FLAMAZINE?

These are not all the possible side effects you may have when taking FLAMAZINE. If you experience any side effects not listed here, tell your healthcare professional.

Common side effects are local reactions such as burning, itching and skin rash (e.g. eczema or contact dermatitis.

Leukopenia (lowered white blood cells) has been reported in burns patients treated with FLAMAZINE. This often occurs within 48-72 hours after therapy has commenced. Your doctor may order blood tests to monitor your white blood cell level while you are taking FLAMAZINE.

In large area wounds and/or after prolonged application, systemic absorption of silver can occur causing clinical argyria (blue-grey discolouration of the skin).

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store between 8°C and 25°C. Store FLAMAZINE in the original container to protect from light. To ensure sterility, 500g jars should be discarded 24 hours after opening and tubes of FLAMAZINE 7 days after opening. Keep out of reach and sight of children.

If you want more information about FLAMAZINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.smith-nephew.com, or by calling 1-800-463-7439.

Last Revised NOV 2, 2022