Periostat


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Related to Periostat: doxycycline, Atridox

doxycycline

Adoxa, Oracea, Vibramycin

doxycycline calcium

Vibramycin Calcium

doxycycline hyclate

Alodox, Apo-Doxy (CA), Doryx, Doxy 100, Doxytab, Novo-Doxylin (CA), Oraxyl, Periostat, Vibramycin-D (UK), Vibramycin Hyclate

doxycycline monohydrate

Monodox

Pharmacologic class: Tetracycline

Therapeutic class: Anti-infective

Pregnancy risk category D

Action

Unclear. Thought to inhibit bacterial protein synthesis at 30S and 50S ribosomal subunit and to alter cytoplasmic membrane of susceptible organisms.

Availability

Capsules: 50 mg, 100 mg, 150 mg

Capsules (coated pellets): 40 mg, 75 mg, 100 mg

Powder for injection: 100 mg, 200 mg

Powder for oral suspension: 25 mg/5 ml

Syrup: 50 mg

Tablets: 20 mg, 50 mg, 75 mg, 100 mg

Indications and dosages

Rosacea

Adults: 40 mg P.O. daily in the morning

Infections caused by various organisms, including Mycoplasma, Chlamydia, and Rickettsia organisms, and Borrelia burgdorfer

Adults and children weighing more than 45 kg (99 lb): 100 mg P.O. q 12 hours on first day, followed by 100 to 200 mg P.O. once daily; or 50 to 100 mg P.O. q 12 hours; or 200 mg I.V. once daily; or 100 mg I.V. q 12 hours on first day, followed by 100 to 200 mg I.V. once daily; or 50 to 100 mg I.V. q 12 hours

Children weighing 45 kg (99 lb) or less: 2.2 mg/kg P.O. q 12 hours on first day, followed by 2.2 to 4.4 mg/kg/day P.O. once daily; or 1.1 to 2.2 mg/kg P.O. q 12 hours; or 4.4 mg/kg I.V. once daily; or 2.2 mg/kg I.V. q 12 hours on first day, followed by 2.2 to 4.4 mg/kg I.V. once daily; or 1.1 to 2.2 mg/kg I.V. q 12 hours

Gonorrhea in penicillin-allergic patients

Adults and children weighing more than 45 kg (99 lb): 100 mg P.O. q 12 hours for 7 days; or 300 mg P.O. initially, followed by another 300 mg P.O. 1 hour later

Lyme disease

Adults and children weighing more than 45 kg (99 lb): 100 mg P.O. b.i.d. for 10 to 30 days

Periodontitis

Adults and children weighing more than 45 kg (99 lb): 20 mg P.O. b.i.d. for up to 9 months

Anthrax

Adults and children weighing more than 45 kg (99 lb): 100 mg P.O. b.i.d. for 60 days; or 100 mg I.V. q 12 hours for 60 days, changing to oral route when appropriate

Children weighing 45 kg (99 lb) or less: 2.2 mg/kg P.O. b.i.d. for 60 days; or 100 mg I.V. q 12 hours for 60 days, changing to oral route when appropriate

Prevention of malaria caused by Plasmodium falciparum in short-term travelers (less than 4 months)

Adults: 100 mg/day P.O. starting 1 to 2 days before travel begins and continuing during and for 4 weeks after travel

Children: 2 mg/kg/day P.O., up to adult dosage of 100 mg/day, starting 1 to 2 days before travel begins and continuing during and for 4 weeks after travel

Off-label uses

• Traveler's diarrhea

• Pleural effusion

Contraindications

• Hypersensitivity to drug, other tetracyclines, or bisulfites (with some drug products)

Precautions

Use cautiously in:

• renal disease, hepatic impairment, nephrogenic diabetes insipidus, cachexia

• pregnant or breastfeeding patients

• children younger than age 8.

Administration

• Obtain specimens for culture and sensitivity testing, as ordered, before first dose.

Don't give in conjunction with methoxyflurane anesthetic. Severe or fatal kidney damage may result.

• Reconstitute powder for injection with dextrose 5% in water, normal saline solution, lactated Ringer's solution, or dextrose 5% in lactated Ringer's solution.

• Don't infuse solutions with concentrations above 1 mg/ml.

• Infuse 100-mg dose over at least 1 hour.

• Complete infusion within 12 hours of dilution, unless diluted with lactated Ringer's solution or dextrose 5% in lactated Ringer's solution; in this case, complete infusion within 6 hours.

Don't give during last half of pregnancy or to children under age 8 unless other drugs are likely to be ineffective or are contraindicated. Drug may retard bone growth and cause tooth discoloration and malformation.

• Be aware that capsules with coated pellets contain immediate- and delayed-release pellets.

Adverse reactions

CNS: paresthesia, pseudotumor cerebri

CV: phlebitis, thrombophlebitis, pericarditis

EENT: vestibular reactions, hoarseness, pharyngitis

GI: nausea, vomiting, diarrhea, esophagitis, epigastric distress, enterocolitis, anogenital lesions or inflammation, glossitis, oral candidiasis, black hairy tongue, pancreatitis

GU: dark yellow or brown urine, vaginal candidiasis

Hematologic: hemolytic anemia, neutropenia, thrombocytopenia

Hepatic: hepatotoxicity

Musculoskeletal: bone growth retardation (in children younger than age 8)

Skin: photosensitivity, maculopapular or erythematous rash, hyperpigmentation, urticaria

Other: tooth enamel defects, increased appetite, phlebitis at I.V. site, superinfection, hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug. Adsorbent antidiarrheals; antacids; calcium, iron, and magnesium preparations: decreased doxycycline absorption

Barbiturates, carbamazepine, hormonal contraceptives containing estrogen, phenytoin, rifamycin: decreased doxycycline efficacy

Cholestyramine, colestipol: decreased oral absorption of doxycycline

Methoxyflurane: increased nephrotoxicity

Penicillin: decreased penicillin activity

Sucralfate: prevention of doxycycline absorption from GI tract

Warfarin: enhanced warfarin effects

Drug-diagnostic tests. Alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, blood urea nitrogen (BUN), eosinophils: increased levels

Hemoglobin, neutrophils, platelets, white blood cells: decreased levels

Urine catecholamines: false elevations

Drug-food. Calcium-containing foods: decreased drug absorption

Drug-behaviors. Alcohol use: decreased anti-infective effect of doxycycline

Sun exposure: increased risk of photosensitivity

Patient monitoring

• Evaluate I.V. site regularly. Apply cool compresses as needed.

Monitor for hypersensitivity reactions, including anaphylaxis.

• Monitor hepatic profile, CBC, BUN, and creatinine levels.

• Assess for hypercoagulability in patients taking warfarin concurrently.

• Monitor for digoxin toxicity in patients taking digoxin concurrently.

Patient teaching

• Advise patient to take with 8 oz of water to ensure passage into stomach.

• Tell patient to take on empty stomach at least 1 hour before meals or 2 hours afterwards.

• Instruct patient to take at least 1 hour before bedtime to prevent esophagitis.

Tell patient to immediately report painful swallowing, abdominal pain, easy bruising or bleeding, or signs of hypersensitivity (such as rash).

• Advise female patient to tell prescriber if she is pregnant.

• Instruct patient to avoid alcohol use and large amounts of calcium-containing foods (such as dairy products and some green leafy vegetables, such as spinach).

• Stress importance of good oral hygiene.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.

doxycycline†

(dox-i-sye-kleen) ,

Apprilon

(trade name),

Atridox

(trade name),

Doryx

(trade name),

Doxy

(trade name),

Doxy Caps

(trade name),

Doxycin

(trade name),

Doxytab

(trade name),

Monodox

(trade name),

Oracea

(trade name),

Periostat

(trade name),

Vibramycin

(trade name),

Vibra-Tabs

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: tetracyclines
Pregnancy Category: UK
† As the recommendations for treating/preventing anthrax are still evolving, all health care professionals are urged the check the most current recommendations at the Centers for Disease Control and Prevention Web site (www.bt.cdc.gov)

Indications

Treatment of various infections caused by unusual organisms, including:
  • Mycoplasma,
  • Chlamydia,
  • Rickettsia,
  • Borellia burgdorferi.
Treatment of inhalational anthrax (postexposure) and cutaneous anthrax.Treatment of gonorrhea and syphilis in penicillin-allergic patients.Prevention of exacerbations of chronic bronchitis.Treatment of acne.Treatment of inflammatory lesions associated with rosacea (Oracea only).Malaria prophylaxis.

Action

Inhibits bacterial protein synthesis at the level of the 30S bacterial ribosome.
Low-dose products used in the management of periodontitis inhibit collagenase.

Therapeutic effects

Bacteriostatic action against susceptible bacteria.
Includes activity against some gram-positive pathogens:
  • Bacillus anthracis(anthrax),
  • Clostridium perfringens,
  • Clostridium tetani,
  • Listeria monocytogenes,
  • Nocardia,
  • Propionibacterium acnes,
  • Actinomyces israelii.
Active against some gram-negative pathogens:
  • Haemophilus influenzae,
  • Legionella pneumophila,
  • Yersinia enterocolitica,
  • Yersinia pestis,
  • Neisseria gonorrhoeae,
  • Neisseria meningitidis.
Also active against several other pathogens, including:
  • Mycoplasma,
  • Treponema pallidum,
  • Chlamydia,
  • Rickettsia,
  • Borrelia burgdorferi.

Pharmacokinetics

Absorption: Well absorbed from the GI tract.
Distribution: Widely distributed, some CSF and good bone penetration; crosses placenta and enters breast milk.
Metabolism and Excretion: 20–40% excreted unchanged in urine; some inactivation in intestine and some enterohepatic circulation with excretion in bile and feces.
Half-life: 14–17 hr (↑ in severe renal impairment).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
PO1–2 hr1.5–4 hr12 hr
IVrapidend of infusion12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Some products contain alcohol or bisulfites and should be avoided in patients with known hypersensitivity or intolerance.
Use Cautiously in: Cachectic or debilitated patients; Renal disease; Hepatic impairment; Nephrogenic diabetes insipidus; Obstetric: Pregnancy—risk of permanent staining of teeth in infant if used during last half of pregnancy, ; Lactation / Pediatric: Lactation or children <8 yr—permanent staining of teeth (unless used for anthrax; doxycycline may be used to treat anthrax in pregnant women and children due to the seriousness of the disease).

Adverse Reactions/Side Effects

Central nervous system

  • benign intracranial hypertension (higher in children)
  • headache

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • esophagitis
  • hepatotoxicity
  • pancreatitis

Dermatologic

  • drug rash with eosinophilia and systemic symptoms (life-threatening)
  • erythema multiforme (life-threatening)
  • stevens-johnson syndrome (life-threatening)
  • toxic epidermal necrolysis (life-threatening)
  • photosensitivity (most frequent)
  • rash

Hematologic

  • blood dyscrasias

Local

  • phlebitis at IV site

Miscellaneous

  • hypersensitivity reactions
  • superinfection

Interactions

Drug-Drug interaction

May ↑ effect of warfarin.May ↓ effectiveness of estrogen-containing oral contraceptives.Antacids, calcium, iron, and magnesium form insoluble compounds (chelates) and ↓ absorption of tetracyclines; this effect is least with doxycycline.Cholestyramine or colestipol ↓ absorption of tetracyclines.Adsorbent antidiarrheals may ↓ absorption.Barbiturates, carbamazepine, or phenytoin may ↓ effectiveness.Calcium in foods or dairy products ↓ absorption by forming insoluble compounds (chelates); this effect is minimal with doxycycline.

Route/Dosage

More common infections

Oral (Adults and Children >45 kg) Most infections—100 mg q 12 hr on the 1st day, then 100–200 mg once daily or 50–100 mg q 12 hr; Gonorrhea—100 mg q 12 hr for 7 days or 200 mg once daily for 7 days (delayed-release tablets) or 300 mg followed 1 hr later by another 300-mg dose; Malaria prophylaxis—100 mg once daily; Lyme disease—100 mg twice daily; Periodontitis–20 mg twice daily; Rosacea—40 mg once daily in morning.

Inhalational anthrax

Oral Intravenous (Adults) 100 mg q 12 hr IV change to 100 mg PO twice daily when clinically appropriate for a total of 60 days; one or two other anti-infectives may be added initially, depending on clinical situation.
Oral Intravenous (Children >8 yr and >45 kg) 100 mg q 12 hr IV change to 100 mg twice daily PO when clinically appropriate for a total of 60 days; one or two other anti-infectives may be added initially, depending on clinical situation.
Oral Intravenous (Children >8 yr ≤45 kg) 2.2 mg/kg q 12 hr IV change to 2.2 mg/kg twice daily PO when clinically appropriate for a total of 60 days; one or two other anti-infectives may be added initially, depending on clinical situation.
Oral Intravenous (Children ≤8 yr) 2.2 mg/kg q 12 hr IV change to 2.2 mg/kg twice daily PO when clinically appropriate for a total of 60 days; one or two other anti-infectives may be added initially, depending on clinical situation.

Cutaneous anthrax

Oral (Adults) 100 mg twice daily for 60 days; some patients may require intravenous therapy initially depending on clinical situation.
Oral (Children >8 yr and >45 kg) 100 mg q 12 hr; some patients may require intravenous therapy initially depending on clinical situation.
Oral (Children >8 yr and ≤45 kg) 2.2 mg/kg q 12 hr; some patients may require intravenous therapy initially depending on clinical situation.
Oral (Children ≤8 yr) 2.2 mg/kg q 12 hr; some patients may require intravenous therapy initially depending on clinical situation.

Availability (generic available)

Tablets: 20 mg, 50 mg, 75 mg, 100 mg, 150 mg
Capsules: 50 mg, 75 mg, 100 mg
Delayed-release capsules: 100 mg
Variable-release capsules (Oracea): 40 mg
Delayed-release tablets: 75 mg, 100 mg, 150 mg, 200 mg
Oral suspensionraspberry flavor: 25 mg/5 mL
Syrupraspberry-apple flavor: 50 mg/5 mL
Powder for injection: 100 mg/vial

Nursing implications

Nursing assessment

  • Infection: Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and during therapy.
    • Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome or toxic epidermal necrolysis. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
  • Intravenous: Assess IV site frequently; may cause thrombophlebitis.
  • Lab Test Considerations: Monitor renal and hepatic functions and CBC periodically during long-term therapy.
    • May cause ↑ AST, ALT, serum alkaline phosphatase, bilirubin, and amylase concentrations.
    • May cause false ↑ in urinary catecholamine levels.

Potential Nursing Diagnoses

Risk for infection (Indications,  Side Effects)
Noncompliance (Patient/Family Teaching)

Implementation

  • Do not confuse Oracea with Orencia.
    • May cause yellow-brown discoloration and softening of teeth and bones if administered prenatally or during early childhood. Not recommended for children under 8 yr of age or during pregnancy or lactation, unless used for the treatment of anthrax.
    • The Oracea product is only indicated for rosacea, not for infections.
  • Oral: Administer around the clock, at least 1 hr before or 2 hr after meals. May be taken with food or milk if GI irritation occurs. Administer with a full glass of liquid and at least 1 hr before going to bed to avoid esophageal ulceration. Use calibrated measuring device for liquid preparations. Shake liquid preparations well. Do not administer within 1–3 hr of other medications.
    • Capsules may also be administered by carefully opening and sprinkling capsule contents on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a cool 8-ounce glass of water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. If mixture cannot be taken immediately, discard; do not stored for later use.
    • Do not open, break, crush or chew extended release capsules and tablets.
    • To prepare doses for infants and children exposed to anthrax (used only in a Declared Public Health Emergency): place one 100 mg tablet in a small bowl and crush to a fine powder with a metal spoon, leaving no large pieces. Add 4 level tsp of lowfat milk, lowfat chocolate milk, regular chocolate milk, chocolate pudding or an apple juice and sugar mixture made by combining 4 teaspoons of sugar and 4 teaspoons of apple juice. Mix food or drink and doxycycline powder until powder dissolves. Mixture is stable in a covered container for 24 hrs if refrigerated (if made with milk or pudding) or at room temperature (if made with juice). Number of teaspoons to administer/dose is based on child's weight (0–12.5 lbs—1/2tsp; 12.5–25 lbs—1 tsp; 25–37.5 lbs—11/2tsp; 37.5–50 lbs—2 tsp; 50–62.5 lbs—21/2tsp; 62.5–75 lbs—3 tsp; 75–87.5 lbs—31/2tsp; 87.5–100 lbs—4 tsp).
    • Avoid administration of calcium, antacids, magnesium-containing medications, sodium bicarbonate, or iron supplements within 1–3 hr of oral doxycycline.
  • Intravenous Administration
  • Intermittent Infusion: Reconstitute each 100 mg with 10 mL of sterile water or 0.9% NaCl for injection. Diluent: Dilute further in 100–1000 mL of 0.9% NaCl, D5W, D5/LR, Ringer’s, or lactated Ringer’s solution. Solution is stable for 12 hr at room temperature and 72 hr if refrigerated. If diluted with D5/LR or lactated Ringer’s solution, administer within 6 hr. Protect solution from direct sunlight. Concentration: Concentrations of less than 1 mcg/mL or greater than 1 mg/mL are not recommended.
  • Rate: Administer over a minimum of 1–4 hr. Avoid rapid administration. Avoid extravasation.
  • Y-Site Compatibility: acyclovir, alemtuzumab, alfentanyl, amifostine, amikacin, aminophylline, amiodarone, anidulafungin, argatroban, ascorbic acid, atracurium, atropine, azithromycin, aztreonam, benztropine, bivalirudin, bleomycin, bumetanide, buprenorphine, butorphanol, calcium chloride, calcium gluconate, carboplatin, carmustine, caspofungin, cefotaxime, ceftriaxone, chlorpromazine, cisatracurium, cisplatin, clindamycin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dactinomycin, daptomycin, dexmedetomidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dolasetron, dopamine, doxacurium, doxarubicin, enalaprilat, ephedrine, epinephrine, epirubicin, epoetin alfa, eptifibitide, ertapenem, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, fluconazole, fludarabine, gemcitabine, gentamicin, glycopyrrolate, granisetron, hetastarch, hydromorphone, idarubicin, ifosfamide, imipenem/cilastatin, insulin, irinotecan, isoproterenol, labetalol, leucovorin, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperidine, metaraminol, methyldopate, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, mitoxantrone, morphine, multivitamins, mycophenolate, nalbuphine, naloxone, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxaliplatin, oxytocin, paclitaxel, pamidronate, pancuronium, pantoprazole, papaverine, pentamidine, pentazocine, perphenazine, phentolamine, phenylephrine, phytonadione, potassium chloride, procainamide, prochlorperazine, promethazine, propofol, propranolol, protamine, pyridoxime, quinupristin/dalfopristin, ranitidine, remifentanil, rituximab, rocuronium, sargramostim, sodium acetate, streptokinase, succinylcholine, sufentanil, tacrolimus, telavancin, teniposide, theophylline, thiamine, thiotepa, ticarcillin/clavulanate, tirofiban, tobramycin, tolazoline, trastuzumab, vancomycin, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zoledronic acid
  • Y-Site Incompatibility: allopurinol, amphotericin B colloidal, amphotericin B lipid complex, amphotericin B liposome, ampicillin, ampicillin/sulbactam, azathioprine, cefazolin, cefoperazone, cefotetan, cefoxitin, ceftazidime, cefuroxime, chloramphenicol, dantrolene, dexamethasone, diazepam, diazoxide, erythromycin, fluorouracil, folic acid, furosemide, ganciclovir, heparin, hydrocortisone, indomethacin, ketorolac, methotrexate, methylprednisolone, nafcillin, oxacillin, palonosetron, pemetrexed, penicillin G, pentobarbital, phenobarbital, phenytoin, piperacillin/tazobactam, potassium acetate, sodium bicarbonate, trimethoprim/sulfamethoxazole

Patient/Family Teaching

  • Instruct patient to take medication around the clock and to finish the drug completely as directed, even if feeling better. Take missed doses as soon as possible unless it is almost time for next dose; do not double doses. Advise patient that sharing of this medication may be dangerous.
    • Advise patient to avoid taking antacids, calcium, magnesium-containing medications, sodium bicarbonate, and iron supplements within 1–3 hr of oral doxycycline.
    • Instruct patient to notify health care professional immediately if rash, diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
    • Advise female patient to use a nonhormonal method of contraception while taking tetracyclines and until next menstrual period.
    • Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
    • Advise patient to report the signs of superinfection (black, furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools). Skin rash, pruritus, and urticaria should also be reported.
    • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
    • Instruct patient to notify health care professional of medication regimen before treatment or surgery.
    • Instruct patient to notify health care professional if symptoms do not improve within a few days for systemic preparations.
    • Caution patient to discard outdated or decomposed doxycycline; they may be toxic.
  • Malaria Prophylaxis: Advise patient to avoid being bitten by mosquitoes by using protective measures, especially from dusk to dawn (e.g., staying in wellscreened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellant). Doxycycline prophylaxis should begin 1-2 days before travel to the malarious area, continued daily while in the malarious area and after leaving the malarious area, should be continued for 4 more weeks to avoid development of malaria. Do not exceed 4 mo.

Evaluation/Desired Outcomes

  • Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.
  • Decrease in acne lesions.
    • Treatment of inhalational anthrax (postexposure) or treatment of cutaneous anthrax.
  • Prevention of malaria.
  • Reduction in inflammatory lesions associated with rosacea.

Periostat®

Dentistry A formulation of doxycycline for periodontitis as an adjunct to scaling and root planing procedures Active ingredient Doxycycline inhibits collagen breakdown that forms pockets between teeth and gums. See Periodontal disease.
References in periodicals archive ?
-- Significant new data presented in four papers at the American Association for Dental Research annual meeting in March highlighted several potential new benefits and applications of Periostat beyond its utility in treating adult periodontitis.
Periostat is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues, and by enhancing bone protein synthesis.
Only about 19% of the respondents reported using Periostat in their offices.
An open-label study and two ongoing studies funded by CollaGenex indicate that Periostat can treat and manage the symptoms of rosacea.
Licensing revenues during the two quarters ended June 30, 2000 and June 30, 1999 were derived from foreign marketing and distribution agreements for Periostat.
The third condition under investigation with Periostat is perioral dermatitis, which is also known as steroid withdrawal dermatitis.
For the nine months ended September 30, 1999, Periostat net sales were $9.8 million, contract revenues were $262,000, and license fees were $100,000.
have entered into a license and supply agreement that provides in part for the former to sell a branded version of the latter's Periostat (which will be provided as private label by CollaGenex under its new drug application).
The company recently announced that the FDA had granted final approval to the company to market it's lead product, Periostat, within the United States, as an adjunct therapy to scaling and root planing, the most common office-based procedure to treat adult periodontitis.
In one case the company is seeking the removal of an injunction prohibiting the FDA from granting ANDA approvals for doxycycline hyclate 20-mg tablets (the generic equivalent of CollaGenex Corp.'s periodontal drug Periostat); and is pursuing antitrust litigation against CollaGenex.
The availability of CollaGenex Pharmaceutical Inc.'s Periostat, which was okayed by the Food and Drug Administration (FDA) earlier this month, is also expected to encourage sales in other segments of the oral care category as consumers strive to more effectively address their dental problems.