OraPharma offers a comprehensive suite of products to address a range of patient concerns—from the foundation of gums, bone, and teeth to post-procedure pain management.

ARESTIN INDICATION & IMPORTANT SAFETY INFORMATION

INDICATIONARESTIN® (minocycline HCl) Microspheres, 1mg is indicated as an adjunct to scaling and root planing (SRP) 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 SRP.

    IMPORTANT SAFETY INFORMATION
  • ARESTIN is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines. 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, as well as acute photosensitivity reactions.
  • THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.
  • Tetracyclines, including oral minocycline, have been associated with 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, diagnostic tests should be performed and ARESTIN treatment discontinued.
  • The use of ARESTIN in an acutely abscessed periodontal pocket or for use in the regeneration of alveolar bone has not been studied.
  • The safety and effectiveness of ARESTIN has not been established in immunocompromised patients or in those with coexistent oral candidiasis. Use with caution if there is a predisposition to oral candidiasis.
  • In clinical trials, the most frequently reported nondental treatment-emergent adverse events were headache, infection, flu syndrome, and pain.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information.

NEUTRASAL® INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONSNeutraSal® is indicated for dryness of the mouth (hyposalivation, xerostomia) and dryness of the oral mucosa due to drugs that suppress salivary secretion.

    IMPORTANT SAFETY INFORMATION
  • Not intended to prevent xerostomia or oral mucositis.
  • Patients should avoid eating or drinking for at least 15 minutes after use
  • Solution should not be swallowed but be spit out.
  • Not intended for systemic use to treat any diseases of the throat or upper gastrointestinal tract
  • Not intended for use as an antacid
  • No adverse events anticipated if swallowed accidentally
  • Contains sodium; consult with patients on a low sodium diet
  • No known interactions with medicinal or other products

Please click here for Instructions for Use.

INDICATION FOR OSSIX BoneOSSIX Bone is a sterile, biocompatible bone grafting material aimed to fill, augment, or reconstruct periodontal and bony defects of the maxillo-facial complex.

    IMPORTANT SAFETY INFORMATION FOR OSSIX Bone | BONE GRAFTING MATERIAL
  • OSSIX Bone must not be used in:
    • Patients with known collagen hypersensitivity.
    • Patients with a sensitivity to porcine-derived materials.
    • Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
    • Patients with acute or chronic infection (osteomyelitis) at the surgical site.
    • Patients with vascular impairment at the implant site.
    • Patients with uncontrolled periodontal disease.
    • Patients that have received or are currently receiving treatment with bisphosphonates.
    • OSSIX Bone should not be used in the presence of infected wounds at the site of implantation.
  • OSSIX Bone is intended for a single use only. Do not re-sterilize or reuse.
  • As OSSIX Bone contains collagen, allergic reactions (e.g. erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

Click here for Instructions for Use.

INDICATION FOR OSSIX® PLUS AND OSSIX® VOLUMAX | RESORBABLE COLLAGEN MEMBRANESOSSIX PLUS and OSSIX VOLUMAX biodegradable collagen membranes are intended for use during the process of guided tissue regeneration (GTR) and guided bone regeneration (GBR) as a biodegradable barrier.

    IMPORTANT SAFETY INFORMATION FOR OSSIX® PLUS AND OSSIX® VOLUMAX
  • OSSIX PLUS and OSSIX VOLUMAX must not be used in:
    • Patients with known collagen hypersensitivity
    • Patients with a sensitivity to porcine-derived materials
    • Patients suffering from autoimmune disease and connective tissue disease, such as systemic lupus erythematosus, dermatomyositis, etc.
  • OSSIX PLUS and OSSIX VOLUMAX are intended for use as a single use device. Do not resterilize.
  • Treatment of high risk patients, such as smokers and patients with uncontrolled diabetes or periodontal disease, may be impaired. Infection control and good oral hygiene should be achieved prior to surgical intervention.
  • Clinical and post marketing experience with Ossix, the bovine counterpart, reveals an excellent safety profile during long-term experience. Adverse reactions with a porcine collagen membrane were not observed. Yet, as the membrane is of a collagen origin, allergic reactions (e.g., erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

Click here for Instructions for Use.

INDICATION FOR OSSIX GRAFT | PARTICULATE ALLOGRAFT

OSSIX GRAFT Particulate Allograft products consist of cortical bone matrix and may be used in a variety of reconstructive, periodontal, and oral maxillofacial procedures. OSSIX GRAFT contains Human Cellular and Tissue Based Product (HCT/P).

    IMPORTANT SAFETY INFORMATION FOR OSSIX GRAFT
  • OSSIX GRAFT is contraindicated in:
    • Active or latent infection at the surgical implantation site.
    • Sensitivity or allergies to any of the processing agents listed under the Processing section of the Instructions for Use. Processing agents may include some or all of the following: Bacitracin, Polymyxin B Sulfate, Gentamicin, Allowash, alcohol and/or hydrogen peroxide.
    • Use in immunocompromised patients.
  • As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted.
  • Single patient, single use only. Do not sterilize or re-sterilize.
  • Do not use if the packaging or labeling is damaged or has flaws. Do not use if the expiration date has been exceeded.
  • Recommended storage conditions and the maintenance of the tissue for transplantation are the responsibility of the hospital or clinician. Do not use if tissue has not been stored according to the recommended storage instructions.
  • Prior to clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the product.
  • Antibiotic acceptability must be discussed with the patient to discern patient status regarding antibiotic sensitivity.
  • Use standard practices for handling and disposal of human tissue.
  • Inherent uncertainty exists in medical and social histories and lab testing which may not detect known or unknown pathogens. Therefore, the following complications may occur with tissue transplantation:
    • Transmission of diseases of unknown etiology;
    • bacterial or fungal infection;
    • Immune rejection of implanted HCT/P; or
    • Loss of function and/or integrity of implanted HCT/P due to resorption, fragmentation, and/or disintegration.
  • Maintain documentation about the disposition of each tissue to enable tracking from the donor to the consignee or final disposition. Complete the Allograft Tracing Record (ATR) and preprinted labels included with every graft.
  • Although efforts have been made to ensure the safety of allograft material, current technologies may not preclude the transmission of disease. Adverse outcomes potentially attributable to the tissue or unanticipated or adverse events must be reported immediately to your distributor. USA: 1-800-321-4576.

Click here for Instructions for Use.

SPRIX INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGESPRIX® (ketorolac tromethamine) is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

    Limitations of Use
  • Sprix is not for use in pediatric patients less than 2 years of age.

IMPORTANT SAFETY INFORMATION ABOUT SPRIX

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDS) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • SPRIX® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDS cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Use SPRIX at the lowest effective dosage for shortest duration consistent with individual patient treatment goals.

    ContraindicationsSPRIX is contraindicated in the following patients:
  • Known hypersensitivity to ketorolac or any components of the drug product.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
  • In the setting of coronary artery bypass graft (CABG) surgery.
  • Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.
  • Use as a prophylactic analgesic before any major surgery.
  • Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.
  • Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
  • Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical.
  • Concomitant use with probenecid or pentoxifylline.

Warnings and PrecautionsHepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Hypertension: NSAIDs, including SPRIX, can lead to new onset or worsening of preexisting hypertension. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: Avoid use of SPRIX in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If SPRIX is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Renal Toxicity and Hyperkalemia: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury and may cause a dose-dependent reduction in prostaglandin formation, which may precipitate overt renal decompensation. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of SPRIX in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

Exacerbation of Asthma Related to Aspirin Sensitivity: SPRIX is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without known aspirin sensitivity).

Serious Skin Reactions: NSAIDs, including SPRIX, can cause serious skin adverse reactions, which can be fatal. These serious events may occur without warning. Discontinue SPRIX at the first appearance of skin rash or any other sign of hypersensitivity.

Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.

Hematologic Toxicity: Anemia has occurred in patients treated with NSAIDs. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Do not use SPRIX in patients for whom hemostasis is critical.

Limitations of Use: The total duration of use of SPRIX alone or sequentially with other forms of ketorolac is not to exceed 5 days. SPRIX should not be used concomitantly with other forms of ketorolac, aspirin, or other NSAIDs.

Adverse ReactionsThe most common adverse reactions (incidence ≥2%) in patients treated with SPRIX and occurring at a rate at least twice that with placebo include: nasal discomfort; rhinalgia; increased lacrimation; throat irritation; oliguria; rash; bradycardia; decreased urine output; increased ALT and/or AST; hypertension; rhinitis.

Drug InteractionsDrugs that interfere with hemostasis: increased risk of serious bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs); concomitant use with pentoxifylline is contraindicated. Monitor patients for bleeding who are concomitantly taking SPRIX with drugs that interfere with hemostasis.

ACE inhibitors, angiotensin receptor blockers (ARBs), and beta-blockers: may diminish the antihypertensive effect of these drugs; monitor blood pressure.

ACE Inhibitors and ARBs: In elderly, volume depleted, or those with renal impairment may result in deterioration of renal function; monitor for signs of worsening renal function.

Diuretics: reduces the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. During concomitant use of SPRIX with diuretics look for signs of worsening renal function and assure diuretic efficacy and antihypertensive effects.

Digoxin: has been reported to increase the serum concentration and prolong the half-life of digoxin, monitor serum digoxin levels.

Use in Specific PopulationsPregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of SPRIX in women who have difficulties conceiving.

Please click here for Full Prescribing Information, including BOXED WARNING and MEDICATION GUIDE.

To report SUSPECTED ADVERSE REACTIONS, contact Egalet US Inc. at 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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