Description
Anacaulase-bcdb topical gel is used to remove eschar (dead tissue) in patients with deep partial thickness or full thickness thermal burns.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Gel/Jelly
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of anacaulase-bcdb topical gel in children. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anacaulase-bcdb topical gel in the elderly.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Allergy to bromelain, pineapples, papayas, or papain—Should not be used in patients with this condition.
- Bleeding problems or
- Blood clotting problems, uncontrolled or
- Low platelet count—Use with caution. May make these conditions worse.
- Burn wounds where medical devices (eg, implant, pacemakers, shunts) or vital body parts (eg, large blood vessels) could be exposed during eschar removal or
- Wounds contaminated with radioactive and hazardous substance—Use is not recommended in patients with this condition.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is applied on the skin only.
Your doctor may apply ointments to protect open wounds (eg, laceration, abraded skin, incision) before applying the gel.
Precautions
It is very important that your doctor check your progress closely to make sure this medicine is working properly and to check for unwanted effects.
This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
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.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Pale skin
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- confusion
- cough or hoarseness
- difficult, burning, or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- eye pain
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- frequent urge to urinate
- general feeling of illness
- headache
- lower back or side pain
- muscle aches
- sore throat
- stomach pain
- stuffy or runny nose
- sweating
Incidence not known
- Chest tightness
- difficulty swallowing
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
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:
More common
- Trouble sleeping
- vomiting
Less common
- Change in hearing
- constipation
- ear drainage
- ear pain
- scar
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.
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