Perio GS
Izun Pharmaceuticals Corporation
Perio GS
FULL PRESCRIBING INFORMATION: CONTENTS*
- PERIO GS DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATION AND USAGE
- PERIO GS CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- PERIO GS ADVERSE REACTIONS
- OVERDOSAGE
- PERIO GS DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
FULL PRESCRIBING INFORMATION
Rx only
DESCRIPTION
Perio GS is a combination of three homeopathic botanical ingredients that provides topical, site-specific treatment of gingivitis and reduces inflammation.
Botanical Ingredients:
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Each Perio GS applicator contains: Centella asiatica 2x, Echinacea purpurea 2x, and Sambucus nigra 2x (1.0:0.09:0.05, 5.5mg) and the inactive ingredients methylhydroxypropylcellulose, polyacrylic acid, glycerol (water-free), strawberry flavor and titanium dioxide on a backing application layer consisting of ethyl cellulose, acacia gum, castor oil, iron oxide (red), and polysorbate 80.
CLINICAL PHARMACOLOGY
The exact mechanism of action of Perio GS is not fully understood. However, various cellular and biochemical pathways appear to be modulated by the product's ingredients. In vitro studies have also shown that homeopathic extracts of the three herbs (S. nigra, C. asiatica and E. purpurea) are effective in reducing several mediators of gingival inflammation process in which the gingivitis is a result from the presence of various oral pathogenic bacteria. In addition, the homeopathic extracts were also shown to induce fibroblast repair activity, a key step in tissue repair and the deposition of components of the extracellular matrix.
The inflammation reducing properties of the Perio GS have also been demonstrated in clinical trials in which the Perio GS produced a significant decrease on crevicular β-glucuronidase levels, a marker of gingivitis as well as a clinical indicator of inflammation. In a placebo-controlled clinical study, Perio GS was effective in the site-specific treatment of gingivitis and gingival inflammation. In 50 patients with at least mild gingival inflammation and edema, treated with Perio GS for 3 days produced a significant improvement in important measures associated with periodontal disease. Specifically, mean Gingival Index (GI) scores were statistically significantly reduced on days 4 and 15 of the study compared to placebo and a greater percentage of patients receiving Perio GS had lower GI scores (1 point or greater) as compared to patients receiving the placebo treatment by day 15.
INDICATION AND USAGE
Perio GS is indicated for application as part of a professional program for the site-specific, acute treatment of gingivitis (gingival inflammation) as characterized by redness and swelling of the gingivae, including bleeding upon probing.
CONTRAINDICATIONS
Perio GS is contraindicated in patients with a known hypersensitivity to Echinacea (cone flower) or any of its ingredients (see ADVERSE REACTIONS ).
WARNINGS
If inflammation persists or worsens or if new symptoms occur, the patient should be carefully re-evaluated because these could be signs of a more serious condition.
PRECAUTIONS
General:
Adverse effects with Perio GS are rare. Perio GS exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal or central nervous system effects.
A temporary bitter taste may occur in some patients with use. This is temporary and ceases with discontinuance of the product.
Information for Patients:
Patients should abstain from brushing or rinsing for 2 hours following application of Perio GS. After Perio GS is removed, normal tooth brushing and flossing should continue.
Perio GS must be removed prior to retiring at night to avoid any potential aspiration.
Use of this product is not meant to substitute or replace a regimen of complete oral health care, including regular brushing, flossing and periodic visits to a dental professional which are needed to maintain healthy teeth and gums.
Drug Interactions:
Perio GS is not known to interact with any other medications.
Drug/Laboratory Test Interactions:
Perio GS is not known to interact with any laboratory tests.
Carcinogenesis:
No studies have been performed to evaluate the carcinogenicity of Perio GS. No evidence of mutagenicity was observed in an in vitro bacterial or mammalian cell gene mutagenicity assays with the herbal extract used in the Perio GS.
Pregnancy:
Animal reproduction studies have not been conducted with Perio GS. However, Health Canada's Compliance Policy for Natural Health Products (2006) lists the elder flower (Sambucus) as a botanical with a history of safe use in pregnant and breastfeeding women and the German Commission E expert panel (1998) considers oral Echinacea, in recommended doses, safe for use in pregnancy and lactation. No animal reproduction studies have been conducted with Centella. Therefore, Perio GS should be used with caution in pregnant woman.
Nursing Mothers:
It is not known whether any of the ingredients in Perio GS are excreted in human milk. However, because many drugs are excreted in human milk, Perio GS should be administered with caution to nursing mothers.
Pediatric Use:
Perio GS has not been evaluated in children less than 18 years of age (see DOSAGE and ADMINISTRATION ).
ADVERSE REACTIONS
In rare cases, patients with hypersensitivity to botanicals of the Asteraceae/Compositae family may experience an allergic reaction after administration of Perio GS including anaphylactic reaction. Perio GS ingredients of the Asteraceae/Compositae family are:
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No hypersensitivity reactions have been reported with Perio GS, but caution should be taken by those patients with hypersensitivity to the Compositae family.
Some patients in clinical studies have reported a bitter or bad taste. This effect is temporary and resolves upon cessation of treatment.
OVERDOSAGE
Due to the low concentration of active ingredients in homeopathic preparations and low amount of active ingredients on each topical applicator patch, adverse reactions following overdosage are extremely unlikely. However, care must be taken not to exceed the recommended dosage.
DOSAGE AND ADMINISTRATION
Adults: Apply Perio GS directly on the inflamed gingival sites according to the following dosing regimen: two topical applicator patches per site on day 1 and one topical applicator patch daily per site for the remaining four days. The patch should be removed by the patients after 2 hours and before retiring at night to avoid any potential for choking. Patients should be instructed in the proper application and application site of the Perio GS for in-home use.
HOW SUPPLIED
Perio GS are supplied in unit dose packages of 6 patches.
Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Avoid freezing and excessive heat. Protect from light.
Keep out of reach of children.
CAUTION: Rx only
Perio GS is a registered trademark with Izun Pharmaceuticals Corporation
Issued: May 22, 2009
Izun
Pharma Ltd
How to Use The Perio GS
- Open foil pouch carefully, exposing the entire Perio GS
- Peel off the Perio GS
- Gently grasp either the upper or lower lip and retract away from the mouth, exposing the teeth & gums
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Apply the
light side
of the Perio GS along the gum at the margin of the tooth and press gently into place
- Perio GS should be kept in place for a 2 hour period after which it can be discarded
PRINCIPAL DISPLAY PANEL
IZUN NDC 49589-101-06
Pharmaceuticals
Active Ingredients
Centella asiatica 2x
Echinacea purpurea 2x
Sambucus nigra 2x
Perio GS
1 card x 6 Gel Strips
Rx ONLY Homepathic
Perio GSHydrocotyle asiatica, Echinacea purpurea, and Sambucus Nigra Flower GEL
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