Drug Facts
Active ingredient: | Purpose |
Corinz™ Antiseptic Cleansing and Moisturizing Oral
Rinse: |
Cetylpyridinium chloride 0.05% | Antiseptic Rinse |
Uses
Suction Swab with Corinz Antiseptic Cleansing and Moisturizing
Oral Rinse
- Aids in the removal of secretions and debris and helps reduce
the chance of infection in minor oral irritation.
Suction Toothbrush CHG compatible*
- Aids in the removal of dental plaque, debris and secretions.
Oropharyngeal Suction Catheter Non-sterile
- Aids in the removal of secretions from the oropharyngeal
cavity only.
Warnings
Stop use and ask a doctor if:
- Sore mouth symptoms do not improve in 7 days.
- Swelling, rash or fever develops.
- Irritation, pain or redness persists or worsens.
Keep out of
reach of children.
If more than used for antisepsis
is accidentally swallowed, get medical help or contact a Poison Control
Center right away.
Directions
Suction Swab with Corinz Antiseptic Cleansing and Moisturizing
Oral Rinse
-
Before opening, turn package over, burst solution
packet with thumbs.
- Peel lid to open.
- Attach Suction Swab to suction line.
- Clean teeth and oral cavity for approximately one minute.
- To suction, place thumb over port.
- To clear tubing, rinse with sterile saline or appropriate
solution.
- Discard Suction Swab. Reattach Covered Yankauer to suction
line.
- Use up to 4 times daily or as directed by a dentist or doctor.
- Children under 12 years of age: supervise use.
- Children under 3 years of age: consult a dentist or doctor.
- Use a bite block when performing oral care on patients with
altered levels of consciousness or those who cannot comprehend commands.
- Ensure foam is intact after use. If not, remove any particles
from oral cavity.
Suction Toothbrush CHG compatible*
- Peel lid to open.
- Remove Suction Toothbrush and attach to suction line.
- When using with a cleansing solution, refer to the product
packaging for indications, instructions and warnings.
- To suction, place thumb over port.
- To clear tubing, rinse with sterile saline or appropriate
solution.
- Discard Suction Toothbrush. Reattach Covered Yankauer to
suction line.
- Use Swab for additional cleansing as needed.
- Use two times daily or as directed by a dentist or doctor.
- Children under 12 years of age: supervise use.
- Children under 3 years of age: consult a dentist or doctor.
- Use a bite block when performing oral care on patients with
altered levels of consciousness or those who cannot comprehend commands.
- Ensure foam is intact after use. If not, remove any particles
from oral cavity.
Oropharyngeal Suction Catheter Non-sterile
- Peel lid to open.
- Attach Suction Catheter to suction line.
- Suction secretions from the oropharyngeal cavity.
- To suction, place thumb over port.
- To clear tubing, rinse with sterile saline or appropriate
solution.
- Discard Suction Catheter. Reattach Covered Yankaurer to
suction line.
- Use a bite block when performing oral care on patients with
altered levels of consciousness or those who cannot comprehend commands.
Oropharyngeal Suction
Catheter Non-sterile
Caution
- Federal (U.S.A.) law restricts this device to sale by or
on the order of a physician or licensed practitioner.
Inactive ingredients
Suction
Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse
Water, glycerin, xylitol, spearmint
flavor, potassium sorbate, polysorbate 20, polysorbate 80, hydroxyethylcellulose,
citric acid, sodium saccharin, menthol.
Questions?
Call toll-free 800-323-2220.
LATEX FREE • FOR SINGLE USE ONLY • MADE IN
U.S.A.
CHLORHEXIDINE GLUCONATE ORAL RINSE,
0.12%
DESCRIPTION
Chlorhexidine Gluconate is an oral rinse containing 0.12% chlorhexidine
gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate)
in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan
diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1.
Chlorhexidine Gluconate 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 provides
antimicrobial activity during oral rinsing. The clinical significance
of 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 bacterial resistance, overgrowth of potentially opportunistic
organisms or other adverse changes in the oral microbial ecosystem.
Three months after Chlorhexidine Gluconate Oral Rinse 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 in 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
µg/g in humans 30 minutes after they ingested a 300 mg dose of the
drug. Detectable levels of chlorhexidine gluconate were not present
in the plasma of these subjects 12 hours after the compound was administered.
Excretion of chlorhexidine gluconate occurred primarily through the
feces (~90%). Less than 1% of the chlorhexidine gluconate ingested
by these subjects was excreted in the urine.
INDICATIONS
AND USAGE
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 Oral Rinse
has not been tested among patients with acute necrotizing ulcerative
gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis,
see PRECAUTIONS.
CONTRAINDICATIONS
Chlorhexidine Gluconate Oral Rinse should
not be used by persons who are known to be hypersensitive to chlorhexidine
gluconate or other formula ingredients.
WARNINGS
The effect of Chlorhexidine Gluconate
Oral Rinse on periodontitis has not been determined. An increase in
supragingival calculus was noted in clinical testing in Chlorhexidine
Gluconate Oral Rinse users compared with control users. It is not
known if Chlorhexidine Gluconate Oral Rinse use results in an increase
in subgingival calculus. Calculus deposits should be removed by a
dental prophylaxis at intervals not greater than six months. Anaphylaxis,
as well as serious allergic reactions, have been reported during postmarketing
use with dental products containing chlorhexidine, see CONTRAINDICATIONS.
PRECAUTIONS
GENERAL
- For patients having coexisting gingivitis and periodontitis,
the presence or absence of gingival inflammation following treatment
with Chlorhexidine Gluconate Oral Rinse should not be used as a major
indicator of underlying periodontitis.
- Chlorhexidine Gluconate Oral Rinse can cause staining of
oral surfaces, such as tooth surfaces, restorations, and the dorsum
of the tongue. Not all patients will experience a visually significant
increase in toothstaining. In clinical testing, 56% of Chlorhexidine
Gluconate Oral Rinse users exhibited a measurable increase in facial
anterior stain, compared to 35% of control users after six months;
15% of Chlorhexidine Gluconate Oral Rinse users developed what was
judged to be heavy stain, compared to 1% of control users after six
months. Stain will be more pronounced in patients who have heavier
accumulations of unremoved plaque. Stain resulting from use of Chlorhexidine
Gluconate Oral Rinse does not adversely affect health of the gingivae
or other oral tissues. Stain can be removed from most tooth surfaces
by conventional professional prophylactic techniques. Additional time
may be required to complete the prophylaxis. Discretion should be
used when prescribing to patients with anterior facial restorations
with rough surfaces or margins. If natural stain cannot be removed
from these surfaces by a dental prophylaxis, patients should be excluded
from Chlorhexidine Gluconate Oral Rinse treatment if permanent discoloration
is unacceptable. Stain in these areas may be difficult to remove by
dental prophylaxis and on rare occasions may necessitate replacement
of these restorations.
- Some patients may experience an alteration in taste perception
while undergoing treatment with Chlorhexidine Gluconate Oral Rinse.
Rare instances of permanent taste alteration following Chlorhexidine
Gluconate Oral Rinse use have been reported via post-marketing product
surveillance.
PREGNANCY: TERATOGENIC
EFFECTS
Pregnancy
Category B. Reproduction Studies have been performed in rats and rabbits
at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day
respectively, and have not revealed evidence of harm to fetus. However,
adequate and well-controlled studies in pregnant women have not been
done. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only
if clearly needed.
NURSING MOTHERS
It is not known whether this drug is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised
when Chlorhexidine Gluconate Oral Rinse is administered to nursing
women. In parturition and lactation studies with rats, no evidence
of impaired parturition or of toxic effects to suckling pups was observed
when chlorhexidine gluconate was administered to dams at doses that
were over 100 times greater than that which would result from a person’s
ingesting 30 mL of Chlorhexidine Gluconate Oral Rinse per day.
PEDIATRIC USE
Clinical effectiveness and safety
of Chlorhexidine Gluconate Oral Rinse have not been established in
children under the age of 18.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
In a drinking water study in rats,
carcinogenic effects were not observed at doses up to 38 mg/kg/day.
Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. The highest doses
of chlorhexidine used in a mouse dominant-lethal assay and a hamster
cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively.
No evidence of impaired fertility was observed in rats at doses up
to 100 mg/kg/day.
ADVERSE REACTIONS
The most common side effects associated with
chlorhexidine gluconate 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 use of chlorhexidine gluconate 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 Chlorhexidine
Gluconate Oral Rinse 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 Chlorhexidine Gluconate Oral Rinse. There have been
cases of parotid gland swelling and inflammation of the salivary glands
(sialadenitis) reported in patients using Chlorhexidine Gluconate
Oral Rinse.
OVERDOSAGE
Ingestion of 1 or 2 ounces of Chlorhexidine Gluconate Oral Rinse
by a small child (~10 kg body weight) might result in gastric distress,
including nausea, or signs of alcohol intoxication. Medical attention
should be sought if more than 4 ounces of Chlorhexidine Gluconate
Oral Rinse is ingested by a small child or if signs of alcohol intoxication
develop.
DOSAGE AND ADMINISTRATION
Chlorhexidine Gluconate Oral Rinse therapy
should be initiated directly following a dental prophylaxis. Patients
using Chlorhexidine Gluconate Oral Rinse should be reevaluated and
given a thorough prophylaxis at intervals no longer than six months.
Recommended use is twice daily oral rinsing for 30 seconds, morning
and evening after toothbrushing. Usual dosage is 15 mL of undiluted
Chlorhexidine Gluconate Oral Rinse. Patients should be instructed
to not rinse with water, or other mouthwashes, brush teeth, or eat
immediately after using Chlorhexidine Gluconate Oral Rinse. Chlorhexidine
Gluconate Oral Rinse is not intended for ingestion and should be expectorated
after rinsing.
HOW SUPPLIED
Chlorhexidine Gluconate Oral Rinse is supplied as a blue liquid in
single dose 0.5 fluid ounce (15mL) amber plastic bottles with child-resistant
dispensing closures. 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].
Keep out of reach of children
Manufactured for:
Sage
Products LLC
Cary, IL 60013
1-800-323-2220
Revised: September, 2013
QCARE
RX ORAL CLEANSING AND SUCTIONING SYSTEM
0.12% Chlorhexidine
Gluconate Oral Rinse Label