CHLORHEXIDINE GLUCONATE rinse

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)

זמין מ:

Lyne Laboratories, Inc.

INN (שם בינלאומי):

CHLORHEXIDINE GLUCONATE

הרכב:

CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Chlorhexidine Gluconate Oral Rinse 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. Chlorhexidine gluconate has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS. This product should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients. Clinical effectiveness and safety of chlorhexidine gluconate have not been established in children under the age of 18.

leaflet_short:

Chlorhexidine Gluconate Oral Rinse USP 0.12% is supplied as a blue liquid in the following sizes: 16 fluid ounce or 1 pint (473 mL) (NDC 0374-5080-02) amber plastic bottles with child-resistant dispensing closures. 1/2 fluid ounce (15 mL) (NDC 0374-5080-01) amber plastic unit-dose cups. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Termperature]. Dispense in original container or in amber glass bottles. ​What to expect when using Chlorhexidine Gluconate Oral Rinse ​Your dentist has prescribed Chlorhexidine Gluconate Oral Rinse to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use Chlorhexidine Gluconate Oral Rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use. Chlorhexidine Gluconate Oral Rinse should not be swallowed. If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately. Chlorhexidine Gluconate Oral Rinse should not be used by persons who have a sensitivity to it or its components. Chlorhexidine Gluconate Oral Rinse may cause some tooth discoloration, or increases in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain or tartar at least every six months, or more frequently if your dentist advises. If you have any questions or comments about Chlorhexidine Gluconate Oral Rinse, contact your dentist or Pharmacist. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. ​Keep this and all drugs out of the reach of children. ​Manufactured by: ​Lyne Laboratories, Inc. Brockton, MA 02301 R2-07/15

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
LYNE LABORATORIES, INC.
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CHLORHEXIDINE GLUCONATE ORAL RINSE USP 0.12%
RX ONLY
DESCRIPTION
This product is an oral rinse containing 0.12% chlorhexidine gluconate
(1,1'-hexamethylene bis [5-(p-
chlorophenyl) biguanide]di-D-gluconate) in a base containing water,
11.6% alcohol, glycerin, PEG-40
sorbitan diisostearate, peppermint oil, saccharin sodium, and FD&C
Blue #1. The pH may be adjusted
with hydrochloric acid or sodium hydroxide. The solution is
near-neutral (pH range 5–7).
Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid.
Its molecular formula is C
H
Cl
N
•2C
H
O
, molecular weight 897.77 and its structural formula is:
CLINICAL PHARMACOLOGY
Chlorhexidine gluconate provides antimicrobial activity during oral
rinsing. The clinical significance
of chlorhexidine gluconate’s antimicrobial activities is not clear.
Microbiological sampling of plaque
has shown a general reduction of counts of certain assayed bacteria,
both aerobic and anaerobic,
ranging from 54–97% through six months’ use.
Use of chlorhexidine gluconate oral rinse in a six-month clinical
study did not result in any significant
changes in bacterial resistance, overgrowth of potentially
opportunistic organisms or other adverse
changes in the oral microbial ecosystem. Three months after
chlorhexidine gluconate use was
discontinued, the number of bacteria in plaque had returned to
baseline levels and resistance of plaque
bacteria to chlorhexidine gluconate was equal to that at baseline.
PHARMACOKINETICS: Pharmacokinetic studies with 0.12% chlorhexidine
gluconate oral rinse indicate
approximately 30% of the active ingredient, chlorhexidine gluconate,
is retained in the oral cavity
following rinsing. This retained drug is slowly released into the oral
fluids. Studies conducted on
human subjects and animals demonstrate chlorhexidine gluconate is
poorly absorbed from the
gastrointestinal tract. The mean plasma level of chlorhexidine
gluconate reached a peak of 0.206