CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate rinse

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

CHLORHEXIDINE GLUCONATE

Composition:

CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chlorhexidine gluconate oral rinse, 0.12% should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Product summary:

Chlorhexidine Gluconate Oral Rinse, 0.12% is a blue, peppermint flavored liquid in: A 16 fl oz (473 mL) amber plastic bottle with a child-resistant closure and dosage cup for consumer use, and in 15 mL unit dose in trays of ten cups. It should be dispensed in original container or in amber glass. 16 oz. - 68788-9426-4 Store above freezing 0°C (32°F). Rx only Keep out of reach of children What To Expect When Using Chlorhexidine Gluconate Oral Rinse, 0.12% Your dentist has prescribed chlorhexidine gluconate oral rinse, 0.12% 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 increase 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. • Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. • To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor. • Chlorhexidine gluconate oral rinse may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of chlorhexidine gluconate oral rinse. • To avoid taste interference, rinse with chlorhexidine gluconate oral rinse after meals. Do not rinse with water or other mouthwashes immediately after rinsing with chlorhexidine gluconate oral rinse. If you have any questions or comments about chlorhexidine gluconate oral rinse, contact your dentist or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Hi-Tech Pharmacal Co., Inc. at 1- 800- 262- 9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. STORE ABOVE FREEZING 0°C (32°F). Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev.720:06 2/14 Repackaged by Preferred Pharmaceuticals, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
PREFERRED PHARMACEUTICALS, INC.
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CHLORHEXIDINE GLUCONATE ORAL RINSE, 0.12%
DESCRIPTION
Chlorhexidine Gluconate Oral Rinse, 0.12% is an oral rinse containing
0.12% chlorhexidine gluconate
(1, 1 -hexamethylene bis [5-(p-chlorophenyl) biguanide] di- D-
gluconate) in a base containing 11.6%
v/v alcohol, FD&C Blue No. 1, glycerin, natural and artificial
peppermint flavor, PEG-40 sorbitan
diisostearate, saccharin sodium, and purified water. Chlorhexidine
Gluconate Oral Rinse, 0.12% is a
near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a
salt of chlorhexidine and gluconic
acid. Its chemical structure is:
CLINICAL PHARMACOLOGY
Chlorhexidine gluconate oral rinse, 0.12% provides antimicrobial
activity during oral rinsing. The
clinical significance of 0.12% chlorhexidine gluconate oral rinse’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 bacteria resistance, overgrowth of potentially
opportunistic organisms or other adverse
changes in the oral microbial ecosystem. Three months after
chlorhexidine gluconate oral rinse 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 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