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Minocycline Hydrochloride (Arestin)

Trade Name : Arestin

OraPharma, Inc.

POWDER

Strength 1 mg/1

MINOCYCLINE HYDROCHLORIDE Tetracycline-class Drug [EPC],Tetracyclines [CS]

Delivery Process

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Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Minocycline Hydrochloride (Arestin) which is also known as Arestin and Manufactured by OraPharma, Inc.. It is available in strength of 1 mg/1 per ml. Read more

Minocycline Hydrochloride (Arestin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx only
  • 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) or PGLA, for professional subgingival administration into periodontal pockets. Each unit-dose cartridge delivers minocycline hydrochloride equivalent to 1 mg of minocycline free base.
  • The molecular formula of minocycline hydrochloride is CHNOu00b7HCl, and the molecular weight is 493.94. The structural formula of minocycline hydrochloride is:
  • No data
  • 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 which includes good oral hygiene and scaling and root planing.
  • ARESTIN should not be used in any patient who has a known sensitivity to minocycline or tetracyclines.
  • 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 short-term 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.
  • No data
  • The most frequently reported non-dental, treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain.
  • The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor ARESTIN compromise clinical attachment.
  • To report SUSPECTED ADVERSE REACTIONS, contact OraPharma at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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 ). 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.
  • 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 does not have to be removed, as it is bioresorbable, nor is an adhesive or dressing required.
  • 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 cartridges in 1 tray with desiccant in a heat-sealed, foil-laminated, resealable pouch. There are 2 pouches in each box.
  • Each unit-dose cartridge contains the product identifier u201cOP-1.u201d
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F)/60% RH: excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). Avoid exposure to excessive heat.
  • Distributed by:
  • OraPharma, a division of Bausch Health US, LLCBridgewater, NJ 08807 USA
  • U.S. Patent Numbers: 6,682,348 and 7,699,609
  • ARESTIN is a trademark of Bausch Health Companies Inc. or its affiliates.
  • u00a9 2020 Bausch Health Companies Inc. or its affiliates
  • Rev. 06/2020
  • 9546404
  • NDC
  • Microsphere Delivery Systemn- Arrayn- Array
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F)n- /60% RH: excursions permitted ton- 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F).
  • Avoid exposure to excessive heat
  • For Subgingival Application
  • Rx only
  • To order: Call 1-866-ARESTIN (273-7846)or visit our Web site at www.ArestinProfessional.com
  • Arrayn- ora
  • 2 resealable foil pouchesn- 12 cartridges per pouchn- 1 mg of minocycline
  • Microsphere Delivery SystemArestinn minocycline HCl 1 mgMICROSPHERES
  • For use only with the patient listed on the prescription label. Rx Pack: Not for dental professional resalen For Subgingival ApplicationRx onlyPouch contains 1 cartridgeCartridge contains 1 mg minocyclinen
  • For more information, call 1-866-ARESTIN(273-7846) or visit n
  • Distributed by:
  • OraPharma, a division of Bausch Health US, LLCBridgewater, NJ 08807 USA
  • u00a9 2020 Bausch Health Companies Inc. or its affiliates
  • Usual Dosage:

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Comparator Sourcing for Clinical Trials

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Name Patient Supply

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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