VIBRAMYCIN Capsule, Tablet Ref.[50938] Active ingredients: Doxycycline

Dosage

It must be remembered that the usual dosage and frequency of administration of VIBRAMYCIN differs from that of most other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects. Therapy should be continued at least 24 to 48 hours after symptoms and fever have subsided. When used in streptococcal infections, therapy should be continued for 10 days to prevent the development of rheumatic fever or glomerulonephritis.

The usual dose of VIBRAMYCIN in adults is 200 mg on the first day of treatment (administered as a single dose or as 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day (administered as a single dose or as 50 mg every 12 hours). In the management of more severe infections (particularly chronic infections of the urinary tract), 200 mg daily should be given throughout the treatment period.

For children above 8 years of age: The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg/kg of body weight (given as a single daily dose or divided into two doses on the first day of treatment), followed by 2.2 mg/kg of body weight (given as a single daily dose or divided into two doses), on subsequent days. For more severe infections, up to 4.4 mg/kg of body weight may be used. For children over 45 kg, the usual adult dose should be used (see section 4.4 Special Warnings and Precautions for Use: Use in Children).

Tick- and louse-borne relapsing fevers and louse-borne typhus have been successfully treated with a single oral dose of 100 or 200 mg, according to severity. As an alternative to reduce the risk of persistence or relapse of tick-borne relapsing fever, doxycycline 100 mg every 12 hours for seven days is recommended.

Early Lyme disease (Stage 1 and 2): VIBRAMYCIN 100 mg orally twice daily for 14-60 days, according to clinical signs, symptoms and response.

Uncomplicated urethral, endocervical or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth, twice daily for seven days.

Acute epididymo-orchitis caused by C. trachomatis or N. gonorrhoeae: Ceftriaxone 250 mg IM or other appropriate cephalosporin in a single dose, plus doxycycline 100 mg by mouth twice daily for 10 days.

Non-gonococcal urethritis (NGU) caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg, by mouth, twice daily for seven days.

Lymphogranuloma venereum caused by Chlamydia trachomatis: VIBRAMYCIN 100 mg orally twice daily for a minimum of 21 days.

Uncomplicated gonococcal infections of the cervix, rectum or urethra where gonococci remain fully sensitive: VIBRAMYCIN 100 mg by mouth twice daily for seven days plus co-treatment with an appropriate cephalosporin or quinolone is recommended, such as the following: Cefixime 400 mg orally in a single dose or Ceftriaxone 125 mg intramuscularly (IM) in a single dose or Ciprofloxacin 500 mg orally in a single dose or Ofloxacin 400 mg orally in a single dose.

Uncomplicated gonococcal infections of the pharynx, where gonococci remain fully sensitive: VIBRAMYCIN 100 mg by mouth twice daily for seven days, plus co-treatment with an appropriate cephalosporin or quinolone is recommended, such as the following: Ceftriaxone 125 mg IM in a single dose or Ciprofloxacin 500 mg orally in a single dose or Ofloxacin 400 mg orally in a single dose.

Primary and secondary syphilis: Non-pregnant penicillin-allergic patients who have primary or secondary syphilis can be treated with the following regimen: VIBRAMYCIN 100 mg orally twice daily for two weeks, as an alternative to penicillin therapy.

Latent and tertiary syphilis: Non-pregnant penicillin-allergic patients who have tertiary or secondary syphilis can be treated with the following regimen: VIBRAMYCIN 100 mg orally twice daily for two weeks, as an alternative to penicillin therapy if the duration of the infection is known to have been less than one year. Otherwise, doxycycline should be administered for four weeks.

Acute pelvic inflammatory disease (PID):

Inpatient: VIBRAMYCIN 100 mg every 12 hours, plus cefoxitin 2 g IV every 6 hours or cefotetan 2 g IV every 12 hours for at least four days and at least 24 to 48 hours after patient improves. Then continue doxycycline 100 mg by mouth twice daily to complete 14 days total therapy.

Out-Patient: VIBRAMYCIN 100 mg by mouth twice daily for 14 days as adjunctive therapy with Ceftriaxone 250 mg IM once or Cefoxitin 2 g IM, plus probenecid 1 g orally in a single dose concurrently once, or other parenteral third-generation cephalosporin (e.g., ceftizoxime or cefotaxime).

Acne Vulgaris: 50-100 mg daily for up to 12 weeks.

For treatment of chloroquine-resistant falciparum malaria: 200 mg daily for at least seven days. Due to the potential severity of the infection, a rapid-acting schizonticide such as quinine should always be given in conjunction with doxycycline; quinine dosage recommendations vary in different areas.

For prophylaxis of malaria: 100 mg daily in adults; for children over 8 years of age the dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis can begin 1-2 days before travel to malarious areas. It should be continued daily during travel in the malarious areas and for four weeks after the traveler leaves the malarious area.

For the treatment and selective prophylaxis of cholera in adults: 300 mg in a single dose.

For the prevention of scrub typhus: 200 mg as a single oral dose.

For the prevention of traveler’s diarrhea in adults: 200 mg on the first day of travel (administered as a single dose or as 100 mg every 12 hours) followed by 100 mg daily throughout the stay in the area. Data on the use of the drug prophylactically are not available beyond 21 days.

For the prevention of Leptospirosis: 200 mg orally on a weekly basis throughout the stay in the area and 200 mg at the completion of the trip. Data on the use of the drug prophylactically are not available beyond 21 days.

For the treatment of Leptospirosis: 100 mg orally twice daily for seven days.

Inhalational anthrax (post-exposure):

ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.

CHILDREN: weighing less than 45 kg; 2.2 mg/kg of body weight, by mouth, twice a day for 60 days. Children weighing 45 kg or more should receive the adult dose (see section 4.4 Special Warnings and Precautions for Use: Use in Children).

Rocky Mountain spotted fever:

Doxycycline is the first line treatment for adults and children of all ages:

ADULTS: 100 mg every 12 hours.

CHILDREN: weighing less than 45 kg: 2.2 mg/kg body weight given twice a day. Children weighing 45 kg or more should receive the adult dose (see section 4.4 Special Warnings and Precautions for Use: Use in Children).

Patients should be treated for at least 3 days after the fever subsides and until there is evidence of clinical improvement. Minimum course of treatment is 5-7 days.11,12

Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.

Administration

Capsules and film-coated tablets: Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to reduce the risk of esophageal irritation and ulceration.

If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. Studies indicate that the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

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 overdosage.

Please see pack for expiry of product.

Store in a dry place at room temperature.

Avoid exposure to heat and sunlight.

VIBRAMYCIN 100 mg capsules are available in the pack of 120s.

VIBRAMYCIN 100 mg tablets are available in the pack of 30s.