Details for: FLAMAZINE CRM 1%
Company: SMITH & NEPHEW INC
|DIN||DIN name||Active Ingredient(s)||Strength||Dosage Form||Route of Administration|
|00323098||FLAMAZINE CRM 1%||SILVER SULFADIAZINE||1 %||CREAM||TOPICAL|
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is 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.
What it does
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.
When it should not be used
- it is during the last month of your pregnancy.
- it is during the first few months after birth for newborn or premature infants.
- you are allergic to silver sulfadiazine, cetyl alcohol, propylene glycol or any of the other ingredients of FLAMAZINE.
What the medicinal ingredient is
- Silver sulfadiazine
What the non-medicinal ingredients are
- Cetyl alcohol
- Distilled water
- Glyceryl stearate
- Liquid paraffin
- Polysorbate 60 – vegetable grade
- Polysorbate 80 – vegetable grade
- Propylene glycol
What dosage form it comes in
- FLAMAZINE Cream 1% is supplied in 500g jars and 20g or 50g tubes
Warnings and precautions
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 had allergic reactions to sulfonamides.
- have a glucose-6-phosphate dehydrogenase (G6PD) 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 your white blood cell count while you are taking FLAMAZINE.
- 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 unborn child. 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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- 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 healthcare professional may need to run blood tests if you are taking any of these medicines while taking FLAMAZINE.
Proper use of this medication
- For topical (body surface) useonly.
- 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.
- Clean the wound.
- Apply a 3mm – 5mm layer of the cream to the burned area using a sterile (germ-free) glove and/or sterile 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 3mm – 5mm layer of the cream to the affected area using a sterile (germ-free) glove and/or sterile 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.
- Fill ulcer wound with cream to a depth of at least 3mm – 5mm.
- Apply cream to wound area only and 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.
An overdose of topically applied silver sulfadiazine is unlikely to cause life-threatening symptoms although the exact effects are unknown. Overdose of sulfadiazine by mouth may lead to diarrhoea or a feeling of sickness.
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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking FLAMAZINE. If you experience any side effects not listed here, contact your healthcare professional.
Common side effects:
- Leukopenia (lowered white blood cells) has been reported in burns patients treated with FLAMAZINE. Your doctor may order blood tests to monitor your white blood cell level while you are taking FLAMAZINE.
|Symptom / effect||Talk to your healthcare professional Only if severe||Talk to your healthcare professional In all cases||Stop taking drug and get immediate medical help|
Application site rash
(including eczema and contact
dermatitis) with symptoms of:
|Argyria (skin discolouration): blue-grey discolouration of the skin||✔|
Renal failure (kidney failure)
with symptoms of:
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional
How to store
Store between 8ºC and 25ºC and protect from light.
Dispose of FLAMAZINE 500g jars 24 hours after opening.
Dispose of FLAMAZINE 20g or 50g tubes 7 days after opening.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website (http://www.smith-nephew.com/canada) or by calling 1-800-463-7439.
This leaflet was prepared by Smith & Nephew Inc.
This information is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.
Last Revised August 20, 2018