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PERIOSTAT®
(doxycycline hyclate) 20 mg Tablets
Periostat® (doxycycline hyclate) is available as a 20 mg tablet formulation of doxycycline for oral administration.
The structural formula of doxycycline hyclate is:
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with an empirical formula of (C22H24N2O8•HCl)2•C2H6O•H2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12 apentahydroxy - 6 - methyl - 1 , 1 1 - dioxo - 2 -naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water.
Inert ingredients in the formulation are: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. Each tablet contains 23 mg of doxycycline hyclate equivalent to 20 mg of doxycycline.
Periostat® (doxycycline hyclate) is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
THE DOSAGE OF PERIOSTAT® (doxycycline hyclate) DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS.
Periostat® (doxycycline hyclate) 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months. Periostat® (doxycycline hyclate) should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if Periostat® (doxycycline hyclate) is taken close to meal times, allow at least one hour prior to or two hours after meals. Safety beyond 12 months and efficacy beyond 9 months have not been established.
Administration of adequate amounts of fluid along with the tablets is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS Section).
Periostat® (doxycycline hyclate) (white tablet imprinted with a PS20) containing doxycycline hyclate equivalent to 20 mg doxycycline. Bottle of 60 (NDC 64682-008-01), Bottle of 100 (NDC 64682-008-02) and Bottle of 1000 (NDC 64682-008-03).
Storage: All products are to be stored at controlled room temperatures of 15°C - 30°C (59°F - 86°F) and dispensed in tight, light-resistant containers (USP).
Manufactured by: Pharmaceutical Manufacturing Research Services, Inc., Horsham, PA 19044. Marketed by: CollaGenex Pharmaceuticals, Inc., Newtown, PA, 18940. FDA revision date: 3/31/2004
Adverse Reactions in Clinical Trials of a bioequivalent form of doxycycline hyclate capsules: In clinical trials of adult patients with periodontal disease 213 patients received 20 mg BID over a 9 - 12 month period. The most frequent adverse reactions occurring in studies involving treatment with a bioequivalent form of doxycycline hyclate capsules or placebo are listed below:
Incidence (%) of Adverse Reactions in Clinical Trials of
Doxycycline Hyclate Capsules, 20mg (Bioequivalent to Doxycycline Hyclate Tablets,
20mg) vs. Placebo
| Adverse Reaction | Doxycycline Hyclate Capsules 20 mg BID (n=213) |
Placebo (n=215) |
| Headache | 55 (26%) | 56 (26%) |
| Common Cold | 47 (22%) | 46 (21%) |
| Flu Symptoms | 24 (11%) | 40 (19%) |
| Tooth Ache | 14 (7%) | 28 (13%) |
| Periodontal Abscess | 8 (4%) | 21 (10%) |
| Tooth Disorder | 13 (6%) | 19 (9%) |
| Nausea | 17 (8%) | 12 (6%) |
| Sinusitis | 7 (3%) | 18 (8%) |
| Injury | 11 (5%) | 18 (8%) |
| Dyspepsia | 13 (6%) | 5 (2%) |
| Sore Throat | 11 (5%) | 13 (6%) |
| Joint Pain | 12 (6%) | 8 (4%) |
| Diarrhea | 12 (6%) | 8 (4%) |
| Sinus Congestion | 11 (5%) | 11 (5%) |
| Coughing | 9 (4%) | 11 (5%) |
| Sinus Headache | 8 (4%) | 8 (4%) |
| Rash | 8 (4%) | 6 (3%) |
| Back Pain | 7 (3%) | 8 (4%) |
| Back Ache | 4 (2%) | 9 (4%) |
| Menstrual Cramp | 9 (4%) | 5 (2%) |
| Acid Indigestion | 8 (4%) | 7 (3%) |
| Pain | 8 (4%) | 5 (2%) |
| Infection | 4 (2%) | 6 (3%) |
| Gum Pain | 1 (
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