Dental Sales Flyer - April 2025 - 60

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to
use ARESTIN safely and effectively. See full Prescribing Information.
ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg
Rx only
INDICATIONS AND USE
ARESTIN®
pocket depth in patients with adult periodontitis. ARESTIN®
is indicated as an adjunct to scaling and root planing procedures for reduction of
may be used as part of a periodontal
maintenance program which includes good oral hygiene and scaling and root planing.
CONTRAINDICATIONS
ARESTIN®
should not be used in any patient who has a known sensitivity to minocycline or
tetracyclines.
WARNINGS
THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF
OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT
DISCOLORATION OF THE TEETH (YELLOW-GRAY BROWN). This adverse reaction is more
common during long-term use of the drugs, but has been observed following repeated shortterm
courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE,
SHOULD NOT BE USED IN THIS AGE GROUP, OR IN PREGNANT OR NURSING WOMEN, UNLESS
THE POTENTIAL BENEFITS ARE CONSIDERED TO OUTWEIGH THE POTENTIAL RISKS. Results of
animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can
have toxic effects on the developing fetus (often related to retardation of skeletal development).
Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any
tetracyclines are used during pregnancy, or if the patient becomes pregnant while taking
this drug, the patient should be apprised of the potential hazard to the fetus. Photosensitivity
manifested by an exaggerated sunburn reaction has been observed in some individuals taking
tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised
that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the
first evidence of skin erythema.
PRECAUTIONS
Hypersensitivity Reactions
The following adverse events have been reported with minocycline products when taken orally.
Hypersensitivity reactions and hypersensitivity syndrome that included, but were not limited to,
anaphylaxis, anaphylactoid reaction, angioneurotic edema, urticaria, rash, eosinophilia, and
one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis may
be present. Swelling of the face, pruritus, fever, and lymphadenopathy have been reported with
the use of ARESTIN.
Some of these reactions were serious. Post- marketing cases of
anaphylaxis and serious skin reactions such as Stevens -Johnson syndrome and erythema
multiforme have been reported with oral minocycline.
Autoimmune Syndromes
Tetracyclines, including oral minocycline, have been associated with the development of
autoimmune syndromes including a lupus-like syndrome manifested by arthralgia, myalgia, rash,
and swelling. Sporadic cases of serum sickness-like reaction have presented shortly after oral
minocycline use, manifested by fever, rash, arthralgia, lymphadenopathy, and malaise. In
symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be
performed to evaluate the patients. No further treatment with ARESTIN®
should be administered
to the patient.
The use of ARESTIN®
in an acutely abscessed periodontal pocket has not been studied and is
not recommended.
While no overgrowth by opportunistic microorganisms, such as yeast, was noted during clinical
studies, as with other antimicrobials, the use of ARESTIN®
may result in overgrowth of nonsusceptible
microorganisms including fungi. The effects of treatment for greater than 6 months
has not been studied.
ARESTIN®
candidiasis. The safety and effectiveness of ARESTIN®
should be used with caution in patients having a history of predisposition to oral
has not been established for the
treatment of periodontitis in patients with coexistent oral candidiasis.
ARESTIN®
has not been clinically tested in pregnant women.
has not been clinically tested in immunocompromised patients (such as those
immunocompromised by diabetes, chemotherapy, radiation therapy, or infection with HIV).
If superinfection is suspected, appropriate measures should be taken.
ARESTIN®
ARESTIN®
has not been clinically tested for use in the regeneration of alveolar bone, either in
preparation for or in conjunction with the placement of endosseous (dental) implants or in the
treatment of failing implants.
Information for Patients
After treatment, patients should avoid chewing hard, crunchy, or sticky foods (i.e., carrots,
taffy, and gum) with the treated teeth for 1 week, as well as avoid touching treated areas.
Patients should also postpone the use of interproximal cleaning devices around the treated sites for 10
days after administration of ARESTIN®
, they should notify the dentist promptly if pain, swelling, or other problems occur.
hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in
studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Minocycline
demonstrated no potential to cause genetic toxicity in a battery of assays which included a
bacterial reverse mutation assay (Ames test), an in vitro mammalian cell gene mutation test
(L5178Y/TK+/- mouse lymphoma assay), an in vitro mammalian chromosome aberration test,
and an in vivo micronucleus assay conducted in ICR mice.
Fertility and general reproduction studies have provided evidence that minocycline impairs
fertility in male rats.
Teratogenic Effects: (See WARNINGS.)
Labor and Delivery:
The effects of tetracyclines on labor and delivery are unknown.
Nursing Mothers
Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in
nursing infants from the tetracyclines, a decision should be made whether to discontinue
nursing or discontinue the drug, taking into account the importance of the drug to the mother. (See
WARNINGS.)
Pediatric Use
Since adult periodontitis does not affect children, the safety and effectiveness of ARESTIN®
in
pediatric patients cannot be established.
ADVERSE REACTIONS
The most frequently reported nondental treatment-emergent adverse events in the 3 multicenter US
trials were headache, infection, flu syndrome, and pain.
Table 5: Adverse Events (AEs) Reported in ≥3% of the Combined
Clinical Trial Population of 3 Multicenter US Trials by Treatment Group
SRP Alone
N=250
SRP + Vehicle
N=249
Number (%) of Patients
Treatment-emergent AEs
Total Number of AEs
Periodontitis
Tooth Disorder
Tooth Caries
Dental Pain
Gingivitis
Headache
Infection
Stomatitis
Mouth Ulceration
Flu Syndrome
Pharyngitis
Pain
Dyspepsia
Infection Dental
Mucous Membrane Disorder
62.4%
543
25.6%
12.0%
9.2%
8.8%
7.2%
7.2%
8.0%
8.4%
1.6%
3.2%
3.2%
4.0%
2.0%
4.0%
2.4%
71.9%
589
28.1%
13.7%
11.2%
8.8%
8.8%
11.6%
9.6%
6.8%
3.2%
6.4%
1.6%
1.2%
3.6%
0.8%
compromise clinical attachment.
SRP + ARESTIN®
N=423
68.1%
987
16.3%
12.3%
9.9%
9.9%
9.2%
9.0%
7.6%
6.4%
5.0%
5.0%
4.3%
4.3%
4.0%
3.8%
3.3%
The change in clinical attachment levels was similar across all study arms, suggesting that
neither the vehicle nor ARESTIN®
Postmarketing Experience
The following adverse reaction has been identified during postapproval use of minocycline products
when taken orally. Because this reaction is reported voluntarily from a population of uncertain size,
it is not always possible to reliably estimate their frequency or establish a causal relationship to
drug exposure.
Skin and subcutaneous tissue disorders: Acute febrile neutrophilic dermatosis (Sweet's syndrome)
To report SUSPECTED ADVERSE REACTIONS, contact OraPharma at 1-800-3214576
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION
ARESTIN®
is provided as a dry powder, packaged in a unit dose cartridge with a deformable tip
(see Figure 1), which is inserted into a spring-loaded cartridge handle mechanism (see Figure
2) to administer the product.
The oral health care professional removes the disposable cartridge from its pouch and connects the
cartridge to the handle mechanism (see Figures 3-4). ARESTIN®
is a variable dose product,
dependent on the size, shape, and number of pockets being treated. In US clinical trials, up to
122 unit dose cartridges were used in a single visit and up to 3 treatments, at 3-month intervals,
were administered in pockets with pocket depth of 5 mm or greater.
. Patients should be advised that although some mild to
moderate sensitivity is expected during the first week after SRP and administration of
ARESTIN®
Patients should be notified to inform the dentist if itching, swelling, rash, papules, reddening,
difficulty breathing, or other signs and symptoms of possible hypersensitivity occur.
Carcinogenicity, Mutagenicity, Impairment of Fertility
Dietary administration of minocycline in long-term tumorigenicity studies in rats resulted in
evidence of thyroid tumor production. Minocycline has also been found to produce thyroid
The administration of ARESTIN®
does not require local anesthesia. Professional subgingival
administration is accomplished by inserting the unit-dose cartridge to the base of the periodontal
pocket and then pressing the thumb ring in the handle mechanism to expel the powder while
gradually withdrawing the tip from the base of the pocket. The handle mechanism should be
sterilized between patients. ARESTIN®
is an adhesive or dressing required.
Manufactured for:
OraPharma, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807
© 2017 Valeant Pharmaceuticals North America LLC ARE.0136.USA.17 9546401 Rev. 05/2017
Distributed by:
OraPharma a division of Bausch Health US, LLC, Bridgewater, NJ 08807
© 2024 Bausch Health Companies Inc. or its affiliates. ARE.0262.USA.24 Rev. 5/2024 9546405
Manufactured for:
OraPharma, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807
© 2017 Valeant Pharmaceuticals North America LLC ARE.0136.USA.17 9546401 Rev. 05/2017
does not have to be removed, as it is bioresorbable, nor

http://www.fda.gov/medwatch

Dental Sales Flyer - April 2025

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