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

-- [ Page 1 ] --

PRESCRIBING INFORMATION

Pr

VIBRAMYCIN* CAPSULES

doxycycline hyclate capsules USP

doxycycline 100 mg

Pr

VIBRA-TABS* FILM COATED TABLETS

doxycycline hyclate tablets USP

doxycycline 100 mg

Antibiotic

PFIZER CANADA INC. DATE OF REVISION

17 300 Trans-Canada Highway 22 December 2015 Kirkland, Quebec H9J 2M5 Submission Control #187868 *Pfizer Canada Inc.

2

NAME OF DRUGS

Pr

VIBRAMYCIN* CAPSULES

doxycycline hyclate capsules USP doxycycline 100 mg Pr

VIBRA-TABS* FILM COATED TABLETS

doxycycline hyclate tablets USP doxycycline 100 mg

THERAPEUTIC CLASSIFICATION

Antibiotic

ACTION

Doxycycline hyclate is a broad-spectrum antibiotic and is active against a wide range of Gram-negative and Gram-positive organisms. Doxycycline exerts its bacteriostatic effect by the inhibition of protein synthesis.

INDICATIONS AND CLINICAL USE

VIBRAMYCIN/VIBRA-TABS (doxycycline hyclate) may be indicated for the treatment

of:

Pneumonia: Single and multilobe pneumonia and bronchopneumonia due to susceptible strains of Streptococcus pneunomiae and other Streptococcus spp., Staphylococcus spp., H. influenzae and Klebsiella pneumoniae.

3 Other Respiratory Tract Infections: Pharyngitis, tonsillitis, sinusitis, otitis media, bronchitis caused by susceptible strains of -hemolytic Streptococcus, Staphylococcus spp., Streptococcus pneunomiae and H. influenzae.

Genitourinary Tract Infections: Pyelonephritis, cystitis, urethritis caused by susceptible strains of Klebsiella spp., Enterobacter aerogenes, E. coli, Enterococcus spp., Staphylococcus spp., Streptococcus spp. and gonococcal urethritis caused by Neisseria gonorrhoeae.

In adult patients with urethritis, cervicitis and vaginitis with a positive test for Chlamydia trachomatis and/or Ureaplasma ure

–  –  –

Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs.

Appropriate culture and susceptibility studies should be carried out prior to initiation of therapy with VIBRAMYCIN/VIBRA-TABS and if clinically indicated during treatment.

Consideration may be given to the initiation of therapy before obtaining results of these tests, however modification of such treatment may be required once the results become available.

CONTRAINDICATIONS

VIBRAMYCIN/VIBRA-TABS (doxycycline hyclate) is contraindicated in individuals who have shown hypersensitivity to VIBRAMYCIN/VIBRA-TABS (doxycycline hyclate), and to any of its inert ingredients or to any other tetracycline, and in patients with myasthenia gravis.

VIBRAMYCIN/VIBRA-TABS (doxycycline hyclate) is contraindicated in patients taking isotretinoin (see PRECAUTIONS AND DRUG INTERACTIONS).

–  –  –

General VIBRAMYCIN/VIBRA-TABS (doxycycline hyclate) like other tetracyclines, may form a stable calcium complex in any bone-forming tissue, though in vitro it binds calcium less strongly than other tetracyclines. It should be anticipated that the use of VIBRAMYCIN/VIBRA-TABS during tooth development (last trimester of pregnancy, during lactation, neonatal period and early childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Though more commonly associated with long term use of tetracyclines, this effect has also been known to occur after short courses. Enamel hypoplasia has also been reported.

5 VIBRAMYCIN/VIBRA-TABS should, therefore, not be used in these age groups unless other drugs are unlikely to be effective or are contraindicated.

Carcinogenesis and Mutagenesis Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with the related antibiotics, oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors).

Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in-vitro mammalian cell assays have been reported for related antibiotics (tetracycline).

Gastrointestinal Instances of esophageal lesions (esophagitis and ulcerations), sometimes severe, have been reported in patients receiving doxycycline. The patients must be instructed to take VIBRAMICIN/VIBRA-TABS with a full glass of water, to keep in orthostatic position after the administration and not to go to bed within 1-2 hours after the intake. If symptoms such as dysphagia and retrosternal pain occur, VIBRAMYCIN/VIBRA-TABS should be discontinued and an esophagic lesion must be investigated (see PRECAUTIONS,

ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION and

INFORMATION FOR THE PATIENT).

VIBRAMYCIN/VIBRA-TABS should not be prescribed to patients with obstructive esophagic pathology, such as stenosis and achalasia.





Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including VIBRAMYCIN/VIBRA-TABS. CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, 6 toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent. CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. CDAD may cause significant morbidity and mortality.

CDAD can be refractory to antimicrobial therapy.

If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile. Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe cases. (see ADVERSE REACTIONS) Skin Photosensitivity reaction 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 VIBRAMYCIN/VIBRA-TABS, and treatment should be discontinued at the first evidence of skin erythema (see PRECAUTIONS, ADVERSE REACTIONS and INFORMATION FOR THE PATIENT). The use of sunscreen or sunblock prior to sun or UV light exposure should be considered in patients taking VIBRAMYCIN/VIBRATABS.

Hypersensitivity Hypersensitivity adverse drug reactions that included, but not limited to anaphylactic reaction, angionedema, dyspnea, tachycardia, hypotension, pericarditis, urticaria, rash, 7 erythema multiforme, Stevens-Johnson and toxic epidermal necrolysis have been reported with VIBRAMYCIN/VIBRA-TABS use. Some of these reactions were serious. If an allergic reaction occurs, administration of VIBRAMYCIN/VIBRA-TABS should be discontinued and appropriate therapy should be initiated.

VIBRAMYCIN/VIBRA-TABS has been associated with the development of autoimmune adverse drug reactions including exacerbation of systemic lupus erythematous, rash, peripheral edema, arthralgia, myalgia, serum sickness. If patients with autoimmune reactions are suspected, administration of VIBRAMYCIN/VIBRA-TABS should be discontinued and liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients.

Renal The anti-anabolic action of tetracyclines may cause an increase in BUN. Studies to date indicate that this anti-anabolic effect does not occur with the use of doxycycline in patients with impaired renal function.

Usage in Pregnancy VIBRAMYCIN/VIBRA-TABS should not be administered to pregnant women, unless in the judgment of the physician the potential benefit to the mother outweighs the risk to the fetus (see above WARNINGS section about use during tooth development).

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.

Usage During Lactation 8

Tetracyclines are excreted in the milk of lactating women. Accordingly the use of VIIBRAMYCIN/VIBRA-TABS is not recommended in women while they are breast feeding (see above WARNINGS section about use during tooth development).

Use in Newborns, Infants and Children The use of VIBRAMYCIN/VIBRA-TABS in children under 8 years is not recommended because safe conditions for its use have not been established (see above WARNINGS section about use during tooth development).

Doxycycline hyclate like other tetracyclines forms a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.

PRECAUTIONS

In clinical studies to date, administration of VIBRAMYCIN/VIBRA-TABS (doxycycline hyclate) did not lead to increased serum levels nor to an increase in the serum half-life of doxycycline in patients with impaired renal function. Modification of VIBRAMYCIN/VIBRA-TABS dosage for these patients is not necessary. Although no evidence of increased toxicity has been observed in such patients, the potential for increased hepatic or other toxicity should be considered until further data on the metabolic fate of doxycycline under these conditions become available.

Concurrent administration of VIBRAMYCIN/VIBRA-TABS with agents known to be hepatotoxic should be avoided.

–  –  –

Patients should be advised that the use of doxycycline might increase the incidence of vaginal candidiasis (see ADVERSE REACTIONS and INFORMATION FOR THE PATIENT).

Benign intracranial hypertension (pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline. Benign intracranial hypertension (pseudotumor cerebri) is usually transient, however cases of permanent visual loss secondary to benign intracranial hypertension (pseudotumor cerebri) have been reported with tetracyclines including doxycycline. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize. Concomitant use of isotretinoin and doxycycline should be avoided because isotretinoin is also known to cause benign intracranial hypertension (pseudotumor cerebri).

(see ADVERSE REACTIONS).

Cases of esophageal injury consisting of esophagitis and esophageal ulceration have been reported in patients receiving VIBRAMYCIN/VIBRA-TABS orally. Most of these patients took medication immediately before going to bed and/or without adequate amount of fluid (see DOSAGE AND ADMINISTRATION). If this should occur, VIBRAMYCIN/VIBRA-TABS should be discontinued until healing occurs.

Administration of antacids and/or cimetidine has provided relief in the treatment of such

cases. TO REDUCE THE RISK OF ESOPHAGEAL INJURY, PATIENTS SHOULD BE

ADVISED TO TAKE VIBRAMYCIN CAPSULES OR VIBRA-TABS FILM

COATED TABLETS WITH AN ADEQUATE AMOUNT OF FLUID WHILE

STANDING OR SITTING UPRIGHT. VIBRAMYCIN/VIBRA-TABS should not be given at bedtime.

–  –  –

Liver function tests should be carried out at regular intervals on patients receiving high doses for prolonged periods of time.

Drug interactions VIBRAMYCIN/VIBRA-TABS should be given with caution to patients receiving oral anticoagulants. Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Antacids containing aluminum, calcium or magnesium impair absorption and should not be given to patients taking VIBRAMYCIN/VIBRA-TABS.

The concurrent use of VIBRAMYCIN/VIBRA-TABS (doxycycline hyclate) with alcohol, barbiturates, phenytoin and carbamazepine (hepatic enzyme inducers) has been reported to result in a reduction of plasma half-life of doxycycline, thereby reducing the antimicrobial effectiveness of VIBRAMYCIN/VIBRA-TABS. This effect may last for several days after discontinuation of therapy with the interacting agent. Therefore, consideration should be given to re-adjustment of the daily dose of VIBRAMYCIN/VIBRA-TABS when administered concomitantly with alcohol and with drugs known to be enzyme inducers.

It has been reported that concurrent administration of ferrous sulphate (iron) lowered serum concentrations of doxycycline given orally and shortened the serum half-life after a single intravenous injection. In the event that iron and iron-containing products have to be given during treatment with VIBRAMYCIN/VIBRA-TABS, the interval between administration of each drug should be as wide as possible.

It has been reported that when subsalicylate bismuth was given simultaneously and as a multiple-dose regimen before oral VIBRAMYCIN/VIBRA-TABS there was a reduced 11 bioavailability of doxycycline. Also peak serum concentrations of doxycycline were significantly decreased when subsalicylate bismuth was given 2 hours before oral VIBRAMYCIN/VIBRA-TABS but not when given 2 hours after oral VIBRAMYCIN/VIBRA-TABS. Therefore subsalicylate bismuth should not be taken during therapy with oral VIBRAMYCIN/VIBRA-TABS.



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