Description
Birch triterpenes topical is used to treat wounds in patients with dystrophic and junctional epidermolysis bullosa (EB).
This medicine is available only with your doctor's prescription.
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 have not been performed on the relationship of age to the effects of birch triterpenes topical in children younger than 6 months of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of birch triterpenes topical 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.
Proper Use
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away with water.
To use the gel:
- Wash your hands with soap and water before and after using this medicine or you may wear gloves.
- Clean the wound as instructed by your provider before applying the medicine. Apply this medicine at each dressing change until the wound is healed.
- You can apply this medicine directly to the wound, or to the non-adhesive dressing surface that will be in contact with the wound.
- Applying directly to the wound: Apply a thin layer of this medicine to the affected area of the skin. Cover the entire wound surface. Do not rub in the gel. Cover the wound with non-adhesive wound dressing.
- Applying directly to a dressing: Apply a layer of this medicine directly to the sterile, non-adhesive dressing. Cover the entire dressing with this medicine. Cover the wound with the dressing so that the gel is in direct contact with the wound.
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 topical dosage form (gel):
- For dystrophic and junctional epidermolysis bullosa (EB):
- Adults and children 6 months of age and older—Apply a thin layer (1 millimeter) to the affected area of the skin once a day.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For dystrophic and junctional epidermolysis bullosa (EB):
Missed Dose
If you miss a dose of this medicine, apply 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.
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.
This medicine is for one-time use only. Throw away opened tube right away.
Precautions
It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.
This medicine may cause serious allergic reactions, including dermatitis and urticaria. Check with your doctor right away if you or your child have blistering, crusting, irritation, itching, or reddening of the skin, skin rash, severe itching, burning, redness, stinging, swelling, or irritation on the skin where the medicine is applied.
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 immediately if any of the following side effects occur:
Incidence not known
- Diarrhea
- fever
- joint or muscle pain
- nausea
- numbness or tingling of the face, hands, or feet
- redness and soreness of the eyes
- sores in mouth
- stomach pain
- swelling of the feet or lower legs
- vomiting
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
- Itching or pain at the application site
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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