ARESTIN Powder for solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

OraPharma, Inc.

Λέξεις κλειδιά

65976-100

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1. Description

ARESTIN (minocycline hydrochloride) microspheres, 1 mg is a subgingival sustained-release product containing the antibiotic minocycline hydrochloride incorporated into a bioresorbable polymer, Poly (glycolide-co-dl-lactide) ...

2. Clinical Pharmacology

Mechanism of Action The mechanism of action of ARESTIN as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis is unknown. Microbiology ...

3. Indications and Usage

ARESTIN is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN may be used as part of a periodontal maintenance program ...

4. Contraindications

ARESTIN should not be used in any patient who has a known sensitivity to minocycline or tetracyclines.

5. 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). ...

6. Precautions

Hypersensitivity Reactions and Hypersensitivity Syndrome The following adverse events have been reported with minocycline products when taken orally. Hypersensitivity reactions and hypersensitivity syndrome ...

6.2. 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 ...

6.6. Carcinogenesis, Mutagenesis, 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 hyperplasia in rats ...

6.7. Pregnancy

<u>Teratogenic Effects:</u> (See WARNINGS)

6.8. Labor and Delivery

The effects of tetracyclines on labor and delivery are unknown.

6.9. 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 ...

6.10. Pediatric Use

Since adult periodontitis does not affect children, the safety and effectiveness of ARESTIN in pediatric patients cannot be established.

7. Adverse Reactions

The most frequently reported non-dental, treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain. <b>Table 5. Adverse Events (AEs) Reported in ...

10. 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 ...

11. How Supplied

ARESTIN (minocycline hydrochloride) microspheres, 1 mg is supplied as follows: NDC 65976-100-01 1 unit-dose cartridge with desiccant in a heat-sealed, foil-laminated pouch NDC 65976-100-24 12 unit-dose ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F)/60% RH: excursions permitted to 15° to 30°C (59° to 86°F). Avoid exposure to excessive heat.

13. Clinical Studies

In 2 well-controlled, multicenter, investigator-blind, vehicle-controlled, parallel-design studies (3 arms), 748 subjects (study OPI-103A=368, study OPI-103B=380) with generalized moderate to advanced ...