Doxycycline hyclate

Generic

Generic for Vibramycin

ID: 53489064701

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Reviews

DOXYCYCLINE HYCLATE 20 MG TABLET 5348964701

📜 Prescription Required

FORM

Tablet

STRENGTH

20 mg

QUANTITY

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TL;DR — Quick Summary

Key facts from the full medication guide below

SPL UNCLASSIFIED SECTION DESCRIPTION CLINICAL PHARMACOLOGY Mechanism of Action Microbiology

🩺What it's for

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.

💊How to take it

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.

⚠️Serious risks

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.

📋Interactions & cautions

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 -lactam (e.g., penicillin) class of antibiotics, it is not advisable to administer these antibiotics concomitantly.

📦Storage & missed dose

Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

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Doxycycline Hyclate (Vibramycin/Vibra-Tabs) Prices

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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 Tablets20 mg BID) 90 90 79 Number of Patients (Placebo) 93 93 78 Mean Gain (SDSD = Standard Deviation) in ALvALv = Clinical Attachment Level Doxycycline Hyclate Tablets 20 mg BID 0.25 (0.29) mm 1.03 (0.47) mmp<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) in PDPD = Pocket Depth Doxycycline Hyclate Tablets20 mg BID 0.16 (0.19) mmp<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 Tablets 20 mg BID 1.9 (4.2)% 1.3 (4.5)% 0.3 (9.4)% Placebo 2.2 (4.1)% 2.4 (4.4)% 1.3.6 (9.4)% % of Sites (SD) with BOPBOP = Bleeding on Probing Doxycycline Hyclate Tablets 20 mg BID 39 (19)% 64 (18)% 75 (29)% Placebo 46 (19)% 70 (18)% 80 (29)%

Doxycycline hyclate was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately nine times that observed in female humans that used doxycycline hyclate (exposure comparison based upon AUC values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/day, or in either gender at the other dosages studied. 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 for a 60 kg human when compared on the basis of body surface area estimates (mg/m2). Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of doxycycline hyclate on human fertility is unknown.