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:

Akorn

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. STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]. 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 at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev.720:08 02/20

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
AKORN
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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, 0.12%
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 0.206μg/g in humans 30