DOXYCYCLINE HYCLATE TABLETS, USP

/DOXYCYCLINE HYCLATE TABLETS, USP
DOXYCYCLINE HYCLATE TABLETS, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

DOXYCYCLINE HYCLATE TABLETS, USP

ID:

687a913e-1f37-26e1-e053-2a91aa0a5f82

Code:

34391-3

DESCRIPTION


id: 687a913e-1f39-26e1-e053-2a91aa0a5f82
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Doxycycline hyclate tablets are available as a 20 mg formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is: with a structural formula of (C
22H
24N
2O
8•HCl)
2•C
2H
6O•H
2O 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, 12a–octahydro-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-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.

Inactive Ingredients:


id: 687a913e-1f3a-26e1-e053-2a91aa0a5f82
displayName: INACTIVE INGREDIENT SECTION
FDA Article Code: 51727-6

Colloidal silicon dioxide, hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium oxide. Each tablet contains 23 mg of doxycycline hyclate equivalent to 20 mg of doxycycline.

CLINICAL PHARMACOLOGY


id: 687a913e-1f3b-26e1-e053-2a91aa0a5f82
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

After oral administration, doxycycline hyclate is rapidly and nearly completely absorbed from the gastrointestinal tract. Doxycycline is eliminated with a half-life of approximately 18 hours by renal and fecal excretion of unchanged drug.

INDICATIONS AND USAGE


id: 687a913e-1f41-26e1-e053-2a91aa0a5f82
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Doxycycline hyclate tablets are 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CONTRAINDICATIONS


id: 687a913e-1f42-26e1-e053-2a91aa0a5f82
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

WARNINGS


id: 687a913e-1f43-26e1-e053-2a91aa0a5f82
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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 AND IN PREGNANT OR NURSING MOTHERS UNLESS THE POTENTIAL BENEFITS MAY BE ACCEPTABLE DESPITE THE POTENTIAL RISKS. All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracyclines in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Doxycycline can cause fetal harm when administered to a pregnant woman. 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. The catabolic action of the tetracyclines may cause and increase in BUN. Previous studies have not observed an increase in BUN with the use of doxycycline in patients with impaired renal function. 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.

PRECAUTIONS


id: 687a913e-1f44-26e1-e053-2a91aa0a5f82
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

ADVERSE REACTIONS


id: 687a913e-1f52-26e1-e053-2a91aa0a5f82
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4


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, 20 mg(Bioequivalent to Doxycycline Hyclate Tablets, 20 mg) vs. Placebo
Adverse Reaction Doxycycline Hyclate

Capsules 20 mg BID

(n=213)

Placebo

(n=215)

Note: Percentages are based on total number of study participants in each treatment group.
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(<1%) 6 (3%)
Bronchitis 7 (3%) 5 (2%)
Muscle Pain 2 (1%) 6 (3%)

Adverse Reactions for Tetracyclines:
The following adverse reactions have been observed in patients receiving tetracyclines:
Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See
DOSAGE AND ADMINISTRATION Section).
Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See
WARNINGS Section).
Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See
WARNINGS Section).
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

OVERDOSAGE


id: 687a913e-1f53-26e1-e053-2a91aa0a5f82
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

DOSAGE AND ADMINISTRATION


id: 687a913e-1f54-26e1-e053-2a91aa0a5f82
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

THE DOSAGE OF DOXYCYCLINE HYCLATE TABLETS 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. Doxycycline hyclate tablets 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months. Doxycycline should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if 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).

HOW SUPPLIED


id: 687a913e-1f55-26e1-e053-2a91aa0a5f82
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Doxycycline hyclate are white film coated, round, biconvex tablet, debossed LL714 on one side and plain on the other side containing doxycycline hyclate equivalent to 20 mg doxycycline. Bottle of 60 tablets (NDC 68047-714-60) and Bottle of 100 tablets (NDC 68047-714-01).

REFERENCES


id: 687a913e-1f57-26e1-e053-2a91aa0a5f82
displayName: REFERENCES SECTION
FDA Article Code: 34093-5

Golub L.M., Sorsa T., Lee H-M, Ciancio S., Sorbi D., Ramamurthy N.S., Gruber B., Salo T., Konttinen Y.T.: Doxycycline Inhibits Neutrophil (PMN)-type Matrix Metalloproteinases in Human Adult Periodontitis Gingiva. J. Clin. Periodontol 1995; 22: 100-109.
Golub L.M., Ciancio S., Ramamurthy N.S., Leung M., McNamara T.F.: Low-dose Doxycycline Therapy: Effect on Gingival and Crevicular Fluid Collagenase Activity in Humans. J. Periodont Res 1990; 25: 321-330.
Golub L.M., Lee H.M., Greenwald R.A., Ryan M.E., Salo T., Giannobile W.V.: A Matrix Metalloproteinase Inhibitor Reduces Bone-type Collagen Degradation Fragments and Specific Collegenases in Gingival Crevicular Fluid During Adult Periodontitis. Inflammation Research 1997; 46: 310-319.
Saivain S., Houin G.: Clinical Pharmacokinetics of Doxycycline and Minocycline. Clin. Pharmacokinetics 1988; 15; 355-366.
Schach von Wittenau M., Twomey T.: The Disposition of Doxycycline by Man and Dog. Chemotherapy 1971; 16: 217-228.
Campistron G., Coulais Y., Caillard C., Mosser J., Pontagnier H., Houin G.: Pharmacokinetics and Bioavailability of Doxycycline in Humans. Arzneimittel Forschung 1986; 36: 1705-1707.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: 687a913e-1f58-26e1-e053-2a91aa0a5f82
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Figure 2: 60 count Label Figure 3: 100 count Label