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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 26.06.2023
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Each chip contains Chlorhexidine Gluconate 2.5 mg in a biodegradable matrix of hydrolyzed gelatin (cross-linked with glutaraldehyde).
Burnheal also contains glycerin and purified water as excipients.
Burnheal, an antimicrobial agent, is 1, 1'-hexamethylenebis [5-(p-chlorophenyl)biguanide] di-D-gluconate. Molecular Formula: C22H30Cl2N10·2C6H12O7. Molecular Weight: 897.8.
Burnheal® (Burnheal
Oral Rinse USP, 0.12%) is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Burnheal® has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
Burnheal is a germicidal mouthwash that reduces bacteria in the mouth.
Burnheal is used to treat gingivitis (swelling, redness, bleeding gums). Burnheal is usually prescribed by a dentist.
Burnheal is not for treating all types of gingivitis. Use the medication only to treat the condition your dentist prescribed it for. Do not share this medication with another person, even if they have the same gum symptoms you have.
Burnheal may also be used for purposes not listed in this medication guide.
One Burnheal is inserted into a periodontal pocket with probing pocket depth (PD) 5 mm or greater. Up to 8 chips may be inserted in a single visit. Treatment is recommended to be administered once every three months in pockets with PD remaining 5 mm or greater. The periodontal pocket should be isolated and the surrounding area dried prior to chip insertion.
The Burnheal should be grasped using forceps (such that the rounded end points away from the forceps) and inserted into the periodontal pocket to its maximum depth. If necessary, the Burnheal can be further maneuvered into position using the tips of the forceps or a flat instrument. The Burnheal does not need to be removed since it biodegrades completely.
In the unlikely event of Burnheal dislodgement (in the two pivotal clinical trials, only 8 chips were reported lost), several actions are recommended, depending on the day of Burnheal loss. If dislodgement occurs 7 days or more after placement, the dentist should consider the subject to have received a full course of treatment. If dislodgement occurs within 48 hours after placement, a new Burnheal should be inserted. If dislodgement occurs more than 48 hours after placement, the dentist should not replace the Burnheal, but reevaluate the patient at 3 months and insert a new Burnheal if the pocket depth has not been reduced to less than 5 mm.
How supplied
Burnheal (Burnheal) 2.5 mg is supplied as a small, orange-brown, rectangular chip (rounded at one end), in cartons of 20 chips (NDC 52096-001-22). Each chip is individually packed in a separate compartment of an aluminum blister pack.
Store at 20° - 25°C with excursions permitted to 15° - 30° C (59° - 86°F).
Manufactured by: Dexcel® Pharma Technologies Ltd, HaMarpeh 7 St.,Jerusalem 91237, Israel. Distributed by: Adrian Pharmaceuticals, Spring Hill, Florida 34606. Iss. 01/10
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What is the most important information I should know about Burnheal?
You should not use this medication if you are allergic to Burnheal.
If you have periodontal disease, you may need special treatments while you are using Burnheal.
Burnheal is not for treating all types of gingivitis. Use the medication only to treat the condition your dentist prescribed it for. Do not share this medication with another person, even if they have the same gum symptoms you have.
Do not give this medication to a child or teenager without a doctor's advice.
Do not add water to Burnheal. Do not rinse your mouth with water or other mouthwashes right after using Burnheal.
Avoid eating, drinking, or brushing your teeth just after using this medication.
Do not use any other mouthwash unless your doctor has told you to.
Burnheal can stain teeth, dentures, tooth restorations, your tongue, or the inside of your mouth. Talk with your dentist about ways to remove staining from these surfaces. Stains may be harder to remove from false teeth that have scratches in their surfaces.
Visit your dentist at least every 6 months for preventive tooth and gum care.
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Rinse your mouth with Burnheal twice daily after brushing your teeth.
Measure your dose using the cup provided with the medication. Swish the medicine in your mouth for at least 30 seconds, then spit it out. Do not swallow the mouthwash.
Do not add water to the oral rinse. Do not rinse your mouth with water or other mouthwashes right after using Burnheal.
Burnheal may leave an unpleasant taste in your mouth. Do not rinse your mouth to remove this taste after using the medication. You may rinse the medicine away and reduce its effectiveness.
Use this medication for the full prescribed length of time. Your symptoms may improve before your gingivitis is completely cleared. Burnheal will not treat a viral or fungal infection such as cold sores, canker sores, or oral thrush (yeast infection).
Visit your dentist at least every 6 months for preventive tooth and gum care.
Store Burnheal at room temperature away from moisture and heat.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Gingivitis:
Oral rinse: Antimicrobial dental rinse for gingivitis treatment
Periodontitis: Periodontal chip: Adjunctive therapy to scaling and root planning procedures to reduce pocket depth in patients with periodontitis
Off Label Uses
Medication-related osteonecrosis of the jaw (MRONJ), adjunctive therapy:
Oral rinse:
Based on a position paper by the American Association of Maxillofacial Surgeons (AAOMS), Burnheal is an effective and recommended adjunctive treatment strategy in the management of medication-related osteonecrosis of the jaw (MRONJ) (stage 1 and above [eg, patients with exposed and necrotic bone or fistulae that probes to bone]).
Oropharyngeal decontamination to reduce the risk of ventilator-associated or hospital-acquired pneumonia, Cardiac surgical patients:
Oral rinse:
Data from a prospective, randomized, double-blind, placebo-control trial and a prospective, randomized, case-controlled trial in patients undergoing coronary artery bypass grafting, valve, or other open heart surgical procedures who received Burnheal 0.12% oral rinse during the perioperative period showed a decreased rate in hospital-acquired pneumonia. However, the trials used in both meta-analyses were heterogeneous and included patients in a variety of settings (eg, cardiothoracic, general ICU, mixed medical-surgical ICU, trauma ICU). The trials also displayed significant variability with Burnheal treatment regimens. Burnheal concentration varied from 0.12%, 0.2%, or 2% across studies. Frequency of administration, Burnheal dosage form (oral rinse, gel, paste, foam), and technique of application also varied across studies. In the US, Burnheal for use in the oral cavity is commercially available only as 0.12% solution. Additional trials may be necessary to further define the role of Burnheal in this condition.
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What other drugs will affect Burnheal?
Burnheal is incompatible with the soap, and detergents containing anionic group (saponins, sodium lauryl sulfate, sodium carboxymethyl cellulose).
Burnheal Pharmaniaga is compatible with any medication containing cationic group (cetrimonium bromide, benzalkonium chloride).
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What are the possible side effects of Burnheal?
The most common side effects associated with Burnheal oral rinses are (1) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation; and (3) an alteration in taste perception; see WARNINGS and PRECAUTIONS.
Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of Burnheal rinse.
The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%.
Among post marketing reports, the most frequently reported oral mucosal symptoms associated with Burnheal are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.
Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using Burnheal.
There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using Burnheal.