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«PRESCRIBING INFORMATION Pr VIBRAMYCIN* CAPSULES doxycycline hyclate capsules USP doxycycline 100 mg Pr VIBRA-TABS* FILM COATED TABLETS doxycycline ...»

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In a one year chronic toxicity study, groups of four rhesus monkeys each received doxycycline in oral doses of 0, 5, 25 and 50 mg/kg/day, respectively. Oral dosage of 100 mg/kg produced severe gastrointestinal symptoms, e.g., vomiting and diarrhea. In one out of 4 monkeys receiving the 50 mg/kg/day dose, occasional anorexia and diarrhea were observed during the first six months.

Significant pathologic changes noted in monkeys sacrificed after receiving doxycycline for 1 year at dose levels of 50 mg/kg/day were: 1) grossly, very light brown discoloration of the thyroid gland in one of the four monkeys, and 2) microscopically, brownish intracytoplasmic inclusions in the acinar cells of thyroid follicles of three out of four monkeys. Bone and dentin exhibited slight to moderate ultraviolet fluorescence.

Two monkeys, in another study, receiving the 25 mg/kg/day dosage, were sacrificed after 6 and 8 months on test, respectively. Significant gross and histopathologic findings were slight yellow ultraviolet fluorescence of the endosteum and periosteum of bone, and microscopic appearance of small amounts of granular intracytoplasmic material in the acinar cells of thyroid follicles.

The highlights of the chronic toxicity studies can be summarized as follows:

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2) Yellow staining of bones and teeth, which is thought to be due to formation of a tetracycline-calcium-phosphate complex.

Otherwise doxycycline was well tolerated by the rat and monkey at doses up to and including 500 and 50 mg/kg/day for 18 and 12 months, respectively. In dogs, however, repeated daily oral administration of large doses of doxycycline resulted in certain hepatic functional and histopathologic changes which are reversible after drug withdrawal. No adverse hepatic effects were noted in the hamster (1 month), rats (18 months) or monkeys (12 months) for doses up to and including 500, 500 and 50 mg/kg/day, respectively. In view of this and in view of the lack of notable toxicity in our wide human clinical program, it is our opinion that this is a species specific phenomenon, for the dog only.

d) Reproduction and Teratogenic Studies Doxycycline has no teratologic effects in rats, rabbits or monkeys.

Breeding rats received doxycycline by gavage in doses of 50 and 250 mg/kg/day prior to and throughout two consecutive litters. There was no evidence that doxycycline interfered with the reproductive process in rats.

Pregnant female white New Zealand rabbits received doxycycline orally in doses of 8 and 40 mg/kg/day, respectively, from day 8 to day 16 of pregnancy. Spina bifida and partial anencephaly in one pup each in the control and the 8 mg/kg group, respectively, are believed to be spontaneous and drug-induced.

In teratogenic studies using a limited number of monkeys, doxycycline, in doses ranging from 1 to 50 mg/kg/day, did not produce any teratologic effects.

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Doxycycline Hyclate with Ascorbic Acid Studies in mice and rats showed the LD50 of VIBRAMYCIN I.V. to be 75 mg/kg in mice and 88 mg/kg in rats of doxycycline (using a preparation of doxycycline hyclate equivalent to 100 mg of doxycycline with 480 mg of ascorbic acid as a sterile powder).

No signs of drug toxicity were seen in dogs receiving 20 to 21 daily doses of VIBRAMYCIN I.V. at a dose level of 5 mg/kg when administered as a 0.5% solution at a rate of 1 mg/kg/min. Dogs receiving 14, 16 or 17 daily intravenous doses of 10 mg VIBRAMYCIN I.V. per kg of bodyweight, or 4 daily 60 minute infusions of 300 mg VIBRAMYCIN I.V., or 300 mg degraded VIBRAMYCIN I.V. evidenced serum alkaline phosphatase and serum glutamic pyruvic transaminase elevations. No morphological basis for these enzyme elevations was established although moderate bile ductular proliferation was seen in 1 of 2 dogs receiving 4 daily intravenous infusions of degraded VIBRAMYCIN I.V.

In 8 dogs receiving daily intravenous doses of 10 mg VIBRAMYCIN I.V./kg/day (0.5% solution), 5 of 24 vessels used for injections evidenced degrees of thrombosis with recanalization.

Thrombosis in 3 of 6 sites occurred in 2 dogs receiving infusions of degraded VIBRAMYCIN I.V. (30 mg/kg-0.5% solution). Injection site thrombosis did not occur in 6 dogs (18 sites) receiving daily doses of 5 mg VIBRAMYCIN I.V./kg bodyweight administered as a 0.5% solution at a rate of 1 mg/kg/min (approximately 1 mL/min).

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VIBRAMYCIN/VIBRA-TABS - GENERAL

1 Aitchison WRC, Grant IWB, Gould JC. Treatment of acute exacerbations in chronic bronchitis. Brit J Clin Pract 1968; 22:343-45.

2. Barteaux JW. Clinical experience with doxycycline, a new tetracycline. Intl J Clin Pharmacol Ther Toxicol 1968; 1:404-405.

Clinical Research Reports, Medical Division, Pfizer Co. Ltd. Montreal

1. Colemore JP, Braden B, Wilkerson R. Effectiveness of doxycycline treatment in chronic urinary tract infections. Antimicrob Agents Chemother 1966; 118-120.

2. Domescik G, McLone DG, Scotti A, Mackey DM. Use of a single dose of doxycycline monohydrate for treating gonorrheal urethritis in men. Public Health Reports 1969; 84:182-83.

3. Gallai Z, Sylvestre L, Breault JP. Doxycycline in the treatment of acute gonorrhea in couples. Presented at the 6th International Congress of Chemotherapy. Aug. 11-14 1969, Tokyo, Japan.





4. Gallai Z, Sylvestre L, Breault JP. Instant treatment of acute gonococcal urethritis with doxycycline. Presented at the second world congress of the Int. Soc. of Tropical Dermatology. Aug. 16-18 1969, Kyoto, Japan.

5. Grossan M. Management of infections of the ear, nose and throat with a new tetracycline antibiotic: doxycycline. EENT Month 1968; 47:321-24.

6. Hany A, Petite J, Robert M, Fabre J. La doxycycline en clinique (fre). Chemotherapy 1968; 13(Suppl):59-63.

7. Hinton NA. The effect of oral tetracycline HCI and doxycycline on the intestinal flora. Curr Ther Res 1970; 12:341-52.

8. Huang NN, Shang K, Basavanand N. Doxycycline treatment of children with cystic fibrosis of pancreas. Antimicrob Agents Chemother 1966;127-133.

9. Isenberg D. In Vitro activity of doxycycline against bacteria from clinical material.

Appl Microbiol 1967; 15(5):1074-78.

10. Kalfopoulos P at al. Absorption digestive de la doxycycline chez l'homme comparee a celle des autres tetracyclines. Policlinique de medecine (Pr. J. Fabre) et Clinique Medicale Therapeutique (Pr. R.S. Mach) de l'universite de Geneve.

28

11. Lassus A. The treatment of gonorrhea with doxycycline as a single dose.

Chemotherapy 1968; 13(6):366-68.

12. Lundberg C, Gullers K, MaImborg AS. Antibiotics in sinus secretions. Lancet 1968;

2:107-108.

13. Migliardi JR, Schach von Wittenau M. Pharmacokinetic properties of doxycycline in man. In: Proceedings of the 5th Intl Cong of Chemother, Vienna, pp. 167-172, 1967.

14. Monnier J, Bourse R, Onfray J. Doxycycline: In Vitro bacteriostatic activity and serum levels in man. Antibiotica 1966; 4:268-82.

15. Neuvonen PJ, Gothoni G, Hackman R, Bjorksten KAF. Interference of iron with the absorption of tetracyclines in man, Brit Med J 1970; 4:532-34.

16. Pankey GA. Sinusitis. Current Therapy 1971, edited by Howard F. Conn. M.D., W.B.

Saunders Co. Toronto, pp. 125-27.

17. Roberge R, Lauchance W. Etude de la doxycycline en clinique et en laboratoire.

Saguenay Med 1968; 15:101-107.

18. Rosenblatt JE, Barrett JE, Brodie JL, Kirhy WM. Comparison of In Vitro Activity and Clin. Pharm. of Doxycycline and other tetracyclines. Antimicrobial Agents Chemother 1966; 6:134-41.

19. Schach von Wittenau M. Some pharmacokinetic aspects of doxycycline metabolism in man. Chemotherapy 1968; 13(Suppl):41-50.

20. Steigbigel NH, Reed CW, Finland M. Susceptibility of common pathogenic bacteria to seven tetracycline antibiotics in vitro. Amer J Med Sci 1968; 255:179-95.

21. Sylvestre L, Gallai Z. Traitement minute de la gonorrhee par un nouveau derive de l'oxytetracycline: la doxycycline. Union Med Can 1968; 97:639-40.

22. Sylvestre L, Gallai Z. Instant treatment of gonorrhea with a new oxytetracycline derivative: doxycycline (preliminary report), Intl Clin Pharm Ther Toxicol 1968;

1:401-403.

23. Williamson GM. Laboratory studies of Vibramycin (doxycycline) International Symposium. New resource in antibiotic therapy: doxycycline, Buenos Aires, June 14-15, 1967.

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VIBRAMYCIN/VIBRA-TABS IN RENAL INSUFFICIENCY

1. Edel. Doxycycline in renal insufficiency. VI Intern Congress of Chemotherapy. Tokyo, August 1969.

2. Fabre J, Pitton JS, Kunz JP. Distribution and excretion of doxycycline in man. Chemotherapy 1966; 11:73-85.

3. Fabre J Pitton JS, Virieux C, Laurencet FL, Bernhardt JP, Godel JC. Doxycycline absorption, distribution of a new broad-spectrum antibiotic in man. Schweiz Med Wochenschr 1967;

97(28):915-24.(translation)

4. Fabre J. Medicaments et fonctions renales. HeIv Med Acta 1967; 47(34):24-41.

5. Fabre J, Kunz JP, Virieux C, Laurencet JL, Pitton JS. Le comportement de la doxycycline chez I'homme. Chemotherapy 1968; 13(Suppl):2340.

6. Giromini M, Wasem R, Merier G, Fabre J. Influence de I'anurie et des hemodialyses sur le comportement des antibiotiques. Praxis 1969; 38:1181-87.

7. Laurencet FL, Fabre J. Influence de l'insuffisance renale sur le comportement de la doxycycline. J Urol Nephrol 1968; 74:1038-47.

8. Little PJ, Bailey FIR. Tetracyclines and renal failure. N Z Med J 1970; 72:183-84.

9. Mahon WA, Wittenberg JVP, Tuffnel PG. Studies on the absorption and distribution of doxycycline in normal patients and in patients with severely impaired renal function. Can Med Assoc J 1970; 103:1031-34.

10. Merier G, Laurencet FL, Rudhardt M, Chuit A, Fabre J. Behaviour of doxycycline in renal insufficiency. Helv Med Acta 1969; 35:124-34.

11. Porpaczy P. Doxycycline (Vibramycin) in renal insufficiency. Wien Klin Wschr. 1970;

82:710-14.

12. Ritzerfeld W, Westerboer S, Geller R. Doxycyclin in serum, diallysate and urine in patients with renal functional disease. Intl J Clin Pharmacol Ther Toxicol 1970; 3:325-29.

13. Schach von Wittenau M, Twomey TM. The disposition of doxycycline by man and dog.

Chemotherapy 1971; 16:217-28.

14. Schach von Wittenau, Twomey TM, Swindell AC. The disposition of doxycycline by the rat.

Chemotherapy. 1971; 17(l):26-39.

15. Stein W, Schoog M, Franz HE. Doxycycline serum levels in patients with renal insufficiency (Ger). Arzneim Forsch (Drug Research). 1969; 19:827-28.

–  –  –

17. Zech P, Traeger J. Tolerance de la doxycycline dans l'insuffisance renale severe. Lyon Med 1969; 999:943-45.

VIBRAMYCIN /VIBRA-TABS IN GONORRHEA

1. Caldwell JG, Wessler S, Avioli LV. Current therapy of gonorrhea. JAMA 1971; 218:714-17.

2. Ketterer WA. Homosexuality and venereal disease. Medical Aspects of Human Sexuality.

December 1971; 1(4):43-50.

3. Neumann HH, Baecker JM. Treatment of gonorrhea. Penicillin or tetracyclines? JAMA 1972;

219:471-74.

4. Smart WH, Lighter AC. Gonorrhea, the silent epidemic. A Scientific Exhibit, 23rd Clinical Convention of the A.M.A., Denver, Colorado. November 30-December 3, 1969.

VIBRAMYCIN/VIBRA-TABS IN CHLAMYDIA TRACHOMATIS AND UREAPLASMA

UREALYTICUM INFECTlONS

1. Cunha BA, Comer JB, Jonas M. Symposium on antimicrobial therapy: The tetracyclines.

Med Clin North Am 1982;66(l):293-302.

2. Health and Welfare Canada, Bureau of Epidemiology. Canada Diseases Weekly Report 1981;7(21):101-108.

3. Jaffe HW. Nongonococcal urethritis: Treatment of men and their sexual partners. Rev Infect Dis 1982;4(6 Suppl):S772-S777.

4. Johannisson G, Sernryd A, Lycke E. Susceptibility of Chlamydia trachomatis to antibiotics in vitro and in vivo. Sex Trans Dis 1979;6(2):50-57.

5. Lassus A, Perko RL, Stubb S, Mattila R, Jansson E. Doxycycline treatment of nongonococcal urethritis with special reference to T-strain mycoplasmas. Br J Vener Dis 1971;47:126-130.

6. McNeil PJ, Fiumara NJ, Caliando JJ, Benes S, McCormack WM. Evaluation of doxycycline hyclate in the treatment of nongonococcal urethritis. Sex Transm Dis 1981;8(2 Suppl):127-131.

7. Root TE, Edwards LID, Spengler PJ. Nongonococcal urethritis: A survey of clinical and laboratory features. Sex Transm Dis 1980;7(2):59-65.

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9. Thompson SE, ed. Urogenital chlamydial infections: an international perspective with a focus on doxycycline. Proceedings of a symposium held in conjunction with The Second World Congress of Sexually Transmitted Diseases, Paris, June 1986. Clin Ther 1986;9(Suppl A):1-39.

32

–  –  –

Read this carefully before you start taking Vibramycin/Vibra-Tabs and each time you get a refill.

This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Vibramycin/Vibra-Tabs.

What is Vibramycin/Vibra-Tabs used for?

 Vibramycin/Vibra-Tabs is used to treat infections caused by germs (bacteria).

 Vibramycin/Vibra-Tabs is NOT used to treat viral infections (e.g. the common cold).

How does Vibramycin/Vibra-Tabs work?

 Vibramycin/Vibra-Tabs is an antibiotic. It stops the bacteria’s ability to make what it needs to grow new cells. This helps get rid of the infection.

What are the ingredients in Vibramycin/Vibra-Tabs?

Medicinal ingredients:

 Vibramycin/Vibra-Tabs: doxycycline hyclate.

Non-medicinal ingredients:

 Vibramycin: FD & C Blue #1 dye, gelatin, magnesium stearate/sodium lauryl sulfate, microcrystalline cellulose, sulfur dioxide, titanium dioxide.



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