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| Product NDC Code | 68047-714 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Doxycycline hyclate |
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| Type | Generic | ||||||
| Pharm Class | Tetracycline-class Drug [EPC], Tetracyclines [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 283535 | ||||||
| Application Number | ANDA065287 | ||||||
| Labeler Name | Larken Laboratories, Inc. | ||||||
| Packages |
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Overdosage of Doxycycline Hyclate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE 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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS, contact Larken Laboratories, Inc. at 1-601-855-7678 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
| 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%) |
Drug and or laboratory test interactions
Information about any known interference by the drug with laboratory tests.Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Doxycycline Hyclate Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacterial antibiotics, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of members of the β-lactam (e.g. penicillin) class of antibiotics, it is not advisable to administer these antibiotics concomitantly. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron containing preparations, and by bismuth subsalicylate. Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Concurrent use of tetracyclines may render oral contraceptives less effective.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY 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. Mechanism of Action Doxycycline has been shown to inhibit collagenase activity in vitro. 1 Additional studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with adult periodontitis. 2,3 The clinical significance of these findings is not known. Microbiology Doxycycline is a member of the tetracycline class of antibiotics. The dosage of doxycycline achieved with this product during administration is well below the concentration required to inhibit microorganisms commonly associated with adult periodontitis. Clinical studies with this product demonstrated no effect on total anaerobic and facultative bacteria in plaque samples from patients administered this dose regimen for 9 to 18 months. This product should not be used for reducing the numbers of or eliminating those microorganisms associated with periodontitis. Pharmacokinetics The pharmacokinetics of doxycycline following oral administration of doxycycline hyclate tablets were investigated in 4 volunteer studies involving 107 adults. Additionally, doxycycline pharmacokinetics have been characterized in numerous scientific publications. 4 Pharmacokinetic parameters for doxycycline hyclate tablets following single oral doses and at steady-state in healthy subjects are presented as follows: Pharmacokinetic Parameters for Doxycycline Hyclate Tablets N C max Mean ± SD (ng/mL) T max Mean and range (hr) Cl/F (L/hr) t1/2 (hr) Single dose 20 mg (tablet) 20 362±101 1.4 (1.0-2.5) 3.85±1.3 18.1±4.85 Steady-State 20 mg BID Steady-State data were obtained from normal volunteers administered a bioequivalent formulation. 30 790±285 2 (0.98-12.0) 3.76±1.06 Not Determined Absorption: Doxycycline is well absorbed after oral administration. In a single-dose study, concomitant administration of doxycycline hyclate tablets with a 1000 calorie, high-fat, high-protein meal which included dairy products, in healthy volunteers, resulted in a decrease in the rate and extent of absorption and delay in the time to maximum concentrations. Distribution: Doxycycline is greater than 90% bound to plasma proteins. Its apparent volume of distribution is variously reported as between 52.6 and 134 L. 4,6 Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is variously reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. 5,6 Half-life averaged 18 hours in subjects receiving a single 20 mg doxycycline dose. Special Populations Geriatric Use Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric Use Doxycycline pharmacokinetics have not been evaluated in pediatric patients (See WARNINGS section). Gender: Doxycycline pharmacokinetics were compared in 9 men and 11 women under fed and fasted conditions. While female subjects had a higher rate (C max ) and extent of absorption (AUC), these differences are thought to be due to differences in body weight/lean body mass. Differences in other pharmacokinetic parameters were not significant. Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated. Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function. Hemodialysis does not alter the half-life of doxycycline. Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency. Drug Interactions (See PRECAUTIONS section) Clinical Study In a randomized, multi-centered, double-blind, 9-month Phase 3 study involving 190 adult patients with periodontal disease [at least two probing sites per quadrant of between 5 and 9 mm pocket depth (PD) and attachment level (ALv)], the effects of oral administration of 20 mg twice a day of doxycycline hyclate (using a bioequivalent capsule formulation) plus scaling and root planing (SRP) were compared to placebo control plus SRP. Both treatment groups were administered a course of scaling and root planing in 2 quadrants at Baseline. Measurements of ALv, PD and bleeding-on-probing (BOP) were obtained at Baseline, 3, 6, and 9 months from each site about each tooth in the two quadrants that received SRP using the UNC-15 manual probe. Each tooth site was categorized into one of three strata based on Baseline PD: 0-3 mm (no disease), 4-6 mm (mild/moderate disease), ≥ 7 mm (severe disease). For each stratum and treatment group, the following were calculated at month 3, 6, and 9: mean change in ALv from baseline, mean change in PD from baseline, mean percentage of tooth sites per patient exhibiting attachment loss of ≥ 2 mm from baseline, and percentage of tooth sites with bleeding on probing. The results are summarized in the following table. Clinical Results at Nine Months of Doxycycline Hyclate Capsules, 20 mg, as an Adjunct to SRP(Bioequivalent to Doxycycline Hyclate Tablets, 20 mg) Parameter Baseline Pocket Depth 0-3 mm 4-6 mm ≥ 7 mm Number of Patients (Doxycycline Hyclate Tablets 20mg BID) 90 90 79 Number of Patients (Placebo) 93 93 78 Mean Gain (SD) in ALv Alv=Clinical Attachment Level Doxycycline Hyclate 20 mg BID 0.25 (0.29) mm 1.03 (0.47) mm p<0.050 vs. the placebo control group. 1.55 (1.16)mm Placebo 0.20 (0.29) mm 0.86 (0.48) mm 1.17 (1.15) mm Mean Decrease (SD SD=Standard Deviation ) in PD PD=Pocket Depth Doxycycline Hyclate 20 mg BID 0.16 (0.19) mm p<0.010 vs. the placebo control group. 0.95 (0.47) mm 1.68 (1.07)mm Placebo 0.05 (0.19) mm 0.69 (0.48) mm 1.20 (1.06) mm % of Sites (SD ) with loss of ALv ≥ 2 mm Doxycycline Hyclate 20 mg BID 1.9 (4.2)% 1.3 (4.5)% 0.3 (9.4)% Placebo 2.2 (4.1)% 2.4 (4.4)% 3.6 (9.4)% % of Sites (SD ) with BOP BOP=Bleeding on Probing Doxycycline Hyclate 20 mg BID 39 (19)% 64 (18)% 75 (29)% Placebo 46 (19)% 70 (18)% 80 (29)%
| N | C max | T max | Cl/F | t1/2 (hr) | |
|---|---|---|---|---|---|
| Single dose 20 mg (tablet) | 20 | 362±101 | 1.4 (1.0-2.5) | 3.85±1.3 | 18.1±4.85 |
| Steady-State 20 mg BID | 30 | 790±285 | 2 (0.98-12.0) | 3.76±1.06 | Not Determined |
| Parameter | Baseline Pocket Depth | ||
|---|---|---|---|
| 0-3 mm | 4-6 mm | ≥ 7 mm | |
| Number of Patients (Doxycycline Hyclate Tablets 20mg BID) | 90 | 90 | 79 |
| Number of Patients (Placebo) | 93 | 93 | 78 |
| Mean Gain (SD) in ALv | |||
| Doxycycline Hyclate 20 mg BID | 0.25 (0.29) mm | 1.03 (0.47) mm | 1.55 (1.16)mm |
| Placebo | 0.20 (0.29) mm | 0.86 (0.48) mm | 1.17 (1.15) mm |
| Mean Decrease (SD | |||
| Doxycycline Hyclate 20 mg BID | 0.16 (0.19) mm | 0.95 (0.47) mm | 1.68 (1.07)mm |
| Placebo | 0.05 (0.19) mm | 0.69 (0.48) mm | 1.20 (1.06) mm |
| % of Sites (SD | |||
| Doxycycline Hyclate 20 mg BID | 1.9 (4.2)% | 1.3 (4.5)% | 0.3 (9.4)% |
| Placebo | 2.2 (4.1)% | 2.4 (4.4)% | 3.6 (9.4)% |
| % of Sites (SD | |||
| Doxycycline Hyclate 20 mg BID | 39 (19)% | 64 (18)% | 75 (29)% |
| Placebo | 46 (19)% | 70 (18)% | 80 (29)% |
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.Mechanism of Action Doxycycline has been shown to inhibit collagenase activity in vitro. 1 Additional studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with adult periodontitis. 2,3 The clinical significance of these findings is not known.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmacokinetics The pharmacokinetics of doxycycline following oral administration of doxycycline hyclate tablets were investigated in 4 volunteer studies involving 107 adults. Additionally, doxycycline pharmacokinetics have been characterized in numerous scientific publications. 4 Pharmacokinetic parameters for doxycycline hyclate tablets following single oral doses and at steady-state in healthy subjects are presented as follows: Pharmacokinetic Parameters for Doxycycline Hyclate Tablets N C max Mean ± SD (ng/mL) T max Mean and range (hr) Cl/F (L/hr) t1/2 (hr) Single dose 20 mg (tablet) 20 362±101 1.4 (1.0-2.5) 3.85±1.3 18.1±4.85 Steady-State 20 mg BID Steady-State data were obtained from normal volunteers administered a bioequivalent formulation. 30 790±285 2 (0.98-12.0) 3.76±1.06 Not Determined Absorption: Doxycycline is well absorbed after oral administration. In a single-dose study, concomitant administration of doxycycline hyclate tablets with a 1000 calorie, high-fat, high-protein meal which included dairy products, in healthy volunteers, resulted in a decrease in the rate and extent of absorption and delay in the time to maximum concentrations. Distribution: Doxycycline is greater than 90% bound to plasma proteins. Its apparent volume of distribution is variously reported as between 52.6 and 134 L. 4,6 Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is variously reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. 5,6 Half-life averaged 18 hours in subjects receiving a single 20 mg doxycycline dose.
| N | C max | T max | Cl/F | t1/2 (hr) | |
|---|---|---|---|---|---|
| Single dose 20 mg (tablet) | 20 | 362±101 | 1.4 (1.0-2.5) | 3.85±1.3 | 18.1±4.85 |
| Steady-State 20 mg BID | 30 | 790±285 | 2 (0.98-12.0) | 3.76±1.06 | Not Determined |
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION 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 22 H 24 N 2 O 8 •HCl) 2 •C 2 H 6 O•H 2 O 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. doxycycline-hyclate-molecular-structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION 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).
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE 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.
Spl product data elements
Usually a list of ingredients in a drug product.Doxycycline Hyclate Doxycycline Hyclate HYPROMELLOSE 2910 (3 MPA.S) SILICON DIOXIDE HYPROMELLOSE 2910 (6 MPA.S) ANHYDROUS LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE DOXYCYCLINE HYCLATE DOXYCYCLINE ANHYDROUS STRAW LL714 BICONVEX
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Doxycycline hyclate has not been evaluated for carcinogenic potential in long-term animal studies. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors). Doxycycline hyclate demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline hyclate is a weak clastogen. Oral administration of doxycycline hyclate to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline hyclate induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 10 times the amount of doxycycline hyclate contained in the recommended daily dose of doxycycline hyclate tablets for a 60 kg human when compared on the basis of body surface area estimates (mg/m 2 ). Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of doxycycline hyclate tablets on human fertility is unknown.
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.Laboratory Tests In long term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.
Microbiology
MicrobiologyMicrobiology Doxycycline is a member of the tetracycline class of antibiotics. The dosage of doxycycline achieved with this product during administration is well below the concentration required to inhibit microorganisms commonly associated with adult periodontitis. Clinical studies with this product demonstrated no effect on total anaerobic and facultative bacteria in plaque samples from patients administered this dose regimen for 9 to 18 months. This product should not be used for reducing the numbers of or eliminating those microorganisms associated with periodontitis.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 2: 60 count Label Figure 3: 100 count Label 63d79530-figure-02 63d79530-figure-03
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx Only 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 bacteria.
Doxycycline Hyclate: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Information for Patients Patients should be counseled that antibacterial drugs including Doxycycline Hyclate Tablets, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Doxycycline Hyclate Tablets, USP are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Doxycycline Hyclate Tablets, USP or other antibacterial drugs in the future.
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.Clinical Study In a randomized, multi-centered, double-blind, 9-month Phase 3 study involving 190 adult patients with periodontal disease [at least two probing sites per quadrant of between 5 and 9 mm pocket depth (PD) and attachment level (ALv)], the effects of oral administration of 20 mg twice a day of doxycycline hyclate (using a bioequivalent capsule formulation) plus scaling and root planing (SRP) were compared to placebo control plus SRP. Both treatment groups were administered a course of scaling and root planing in 2 quadrants at Baseline. Measurements of ALv, PD and bleeding-on-probing (BOP) were obtained at Baseline, 3, 6, and 9 months from each site about each tooth in the two quadrants that received SRP using the UNC-15 manual probe. Each tooth site was categorized into one of three strata based on Baseline PD: 0-3 mm (no disease), 4-6 mm (mild/moderate disease), ≥ 7 mm (severe disease). For each stratum and treatment group, the following were calculated at month 3, 6, and 9: mean change in ALv from baseline, mean change in PD from baseline, mean percentage of tooth sites per patient exhibiting attachment loss of ≥ 2 mm from baseline, and percentage of tooth sites with bleeding on probing. The results are summarized in the following table. Clinical Results at Nine Months of Doxycycline Hyclate Capsules, 20 mg, as an Adjunct to SRP(Bioequivalent to Doxycycline Hyclate Tablets, 20 mg) Parameter Baseline Pocket Depth 0-3 mm 4-6 mm ≥ 7 mm Number of Patients (Doxycycline Hyclate Tablets 20mg BID) 90 90 79 Number of Patients (Placebo) 93 93 78 Mean Gain (SD) in ALv Alv=Clinical Attachment Level Doxycycline Hyclate 20 mg BID 0.25 (0.29) mm 1.03 (0.47) mm p<0.050 vs. the placebo control group. 1.55 (1.16)mm Placebo 0.20 (0.29) mm 0.86 (0.48) mm 1.17 (1.15) mm Mean Decrease (SD SD=Standard Deviation ) in PD PD=Pocket Depth Doxycycline Hyclate 20 mg BID 0.16 (0.19) mm p<0.010 vs. the placebo control group. 0.95 (0.47) mm 1.68 (1.07)mm Placebo 0.05 (0.19) mm 0.69 (0.48) mm 1.20 (1.06) mm % of Sites (SD ) with loss of ALv ≥ 2 mm Doxycycline Hyclate 20 mg BID 1.9 (4.2)% 1.3 (4.5)% 0.3 (9.4)% Placebo 2.2 (4.1)% 2.4 (4.4)% 3.6 (9.4)% % of Sites (SD ) with BOP BOP=Bleeding on Probing Doxycycline Hyclate 20 mg BID 39 (19)% 64 (18)% 75 (29)% Placebo 46 (19)% 70 (18)% 80 (29)%
| Parameter | Baseline Pocket Depth | ||
|---|---|---|---|
| 0-3 mm | 4-6 mm | ≥ 7 mm | |
| Number of Patients (Doxycycline Hyclate Tablets 20mg BID) | 90 | 90 | 79 |
| Number of Patients (Placebo) | 93 | 93 | 78 |
| Mean Gain (SD) in ALv | |||
| Doxycycline Hyclate 20 mg BID | 0.25 (0.29) mm | 1.03 (0.47) mm | 1.55 (1.16)mm |
| Placebo | 0.20 (0.29) mm | 0.86 (0.48) mm | 1.17 (1.15) mm |
| Mean Decrease (SD | |||
| Doxycycline Hyclate 20 mg BID | 0.16 (0.19) mm | 0.95 (0.47) mm | 1.68 (1.07)mm |
| Placebo | 0.05 (0.19) mm | 0.69 (0.48) mm | 1.20 (1.06) mm |
| % of Sites (SD | |||
| Doxycycline Hyclate 20 mg BID | 1.9 (4.2)% | 1.3 (4.5)% | 0.3 (9.4)% |
| Placebo | 2.2 (4.1)% | 2.4 (4.4)% | 3.6 (9.4)% |
| % of Sites (SD | |||
| Doxycycline Hyclate 20 mg BID | 39 (19)% | 64 (18)% | 75 (29)% |
| Placebo | 46 (19)% | 70 (18)% | 80 (29)% |
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.REFERENCES 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.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.Labor and Delivery The effect of tetracyclines on labor and delivery is unknown.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from doxycycline, the use of doxycycline hyclate tablets in nursing mothers is contraindicated. (See WARNINGS Section).
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use The use of doxycycline hyclate tablets in infancy and childhood is contraindicated. (See WARNINGS section.)
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects Pregnancy Category D (See WARNINGS Section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues. Nonteratogenic effects (See WARNINGS Section).
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects Pregnancy Category D (See WARNINGS Section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Doxycycline hyclate are white film coated, round, biconvex tablets, 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). Storage and Handling Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP). Manufactured for: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com 500398-04 Rev. 07/21
Storage and handling
Information about safe storage and handling of the drug product.Storage and Handling Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP). Manufactured for: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com 500398-04 Rev. 07/21
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Prescribing Doxycycline Hyclate Tablets, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. While no overgrowth by opportunistic microorganisms such as yeast were noted during clinical studies, as with other antimicrobials, doxycycline hyclate tablets therapy may result in overgrowth of non-susceptible microorganisms including fungi. The use of tetracyclines may increase the incidence of vaginal candidiasis. Doxycycline hyclate tablets should be used with caution in patients with a history or predisposition to oral candidiasis. The safety and effectiveness of doxycycline hyclate tablets has not been established for the treatment of periodontitis in patients with coexistent oral candidiasis. If superinfection is suspected, appropriate measures should be taken.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Prescribing Doxycycline Hyclate Tablets, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. While no overgrowth by opportunistic microorganisms such as yeast were noted during clinical studies, as with other antimicrobials, doxycycline hyclate tablets therapy may result in overgrowth of non-susceptible microorganisms including fungi. The use of tetracyclines may increase the incidence of vaginal candidiasis. Doxycycline hyclate tablets should be used with caution in patients with a history or predisposition to oral candidiasis. The safety and effectiveness of doxycycline hyclate tablets has not been established for the treatment of periodontitis in patients with coexistent oral candidiasis. If superinfection is suspected, appropriate measures should be taken. Information for Patients Patients should be counseled that antibacterial drugs including Doxycycline Hyclate Tablets, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Doxycycline Hyclate Tablets, USP are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Doxycycline Hyclate Tablets, USP or other antibacterial drugs in the future. Laboratory Tests In long term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed. Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacterial antibiotics, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of members of the β-lactam (e.g. penicillin) class of antibiotics, it is not advisable to administer these antibiotics concomitantly. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron containing preparations, and by bismuth subsalicylate. Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Concurrent use of tetracyclines may render oral contraceptives less effective. Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test. Carcinogenesis, Mutagenesis, Impairment of Fertility Doxycycline hyclate has not been evaluated for carcinogenic potential in long-term animal studies. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors). Doxycycline hyclate demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline hyclate is a weak clastogen. Oral administration of doxycycline hyclate to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline hyclate induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 10 times the amount of doxycycline hyclate contained in the recommended daily dose of doxycycline hyclate tablets for a 60 kg human when compared on the basis of body surface area estimates (mg/m 2 ). Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of doxycycline hyclate tablets on human fertility is unknown. Pregnancy Teratogenic Effects Pregnancy Category D (See WARNINGS Section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues. Nonteratogenic effects (See WARNINGS Section). Labor and Delivery The effect of tetracyclines on labor and delivery is unknown. Nursing Mothers Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from doxycycline, the use of doxycycline hyclate tablets in nursing mothers is contraindicated. (See WARNINGS Section). Pediatric Use The use of doxycycline hyclate tablets in infancy and childhood is contraindicated. (See WARNINGS section.) Information for Patients Patients should be counseled that antibacterial drugs including doxycycline hyclate should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When doxycycline hyclate is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by doxycycline hyclate or other antibacterial drugs in the future.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API