VIBRAMYCIN-D Dispersible Tablet Ref.[6808] Active ingredients: Doxycycline

Posology

Adults and children aged 12 years to less than 18 years

The usual dosage of Vibramycin for the treatment of acute infections in adults and children aged 12 years to less than 18 years is 200 mg on the first day (as a single dose or in divided doses) followed by a maintenance dose of 100 mg/day. In the management of more severe infections, 200 mg daily should be given throughout treatment.

Children aged 8 years to less than 12 years (see section 4.4)

The use of doxycycline for the treatment of acute infections in children aged 8 years to less than 12 years should be carefully justified in situations where other drugs are not available, are not likely to be effective or are contraindicated.

In such circumstance, the doses for the treatment of acute infections are:

• For children 45 kg or less – Initial dose: 4.4 mg/kg (in single or 2 divided doses) with maintenance dose: 2.2 mg/kg (in single or 2 divided doses). In the management of more severe infections, up to 4.4 mg/kg should be given throughout treatment.
• For children over 45 kg – Dose administered for adults should be used.

Children aged from birth to less than 8 years

Doxycycline should not be used in children aged younger than 8 years due to the risk of teeth discolouration (section 4.4 and 4.8)

Dosage recommendations in specific infections:

Acne vulgaris: 50 mg daily with food or fluid for 6 to 12 weeks.

Sexually transmitted diseases: 100 mg twice daily for 7 days is recommended in the following infections: uncomplicated gonococcal infections (except anorectal infections in men); uncomplicated urethral, endocervical or rectal infection caused by Chlamydia trachomatis; non-gonococcal urethritis caused by Ureaplasma urealyticum. Acute epididymo-orchitis caused by Chlamydia trachomatis or Neisseria gonorrhoea 100 mg twice daily for 10 days. Primary and secondary syphilis: Non-pregnant penicillin-allergic patients who have primary or secondary syphilis can be treated with the following regimen: doxycycline 200 mg orally twice daily for two weeks, as an alternative to penicillin therapy.

Louse and tick-borne relapsing fevers: A single dose of 100 or 200 mg according to severity.

Treatment of chloroquine-resistant falciparum malaria: 200 mg daily for at least 7 days. Due to the potential severity of the infection, a rapid-acting schizonticide such as quinine should always be given in conjunction with Vibramycin; quinine dosage recommendations vary in different areas.

Prophylaxis of malaria: 100 mg daily in adults and children over the age of 12 years. Prophylaxis can begin 1-2 days before travel to malarial areas. It should be continued daily during travel in the malarial areas and for 4 weeks after the traveller leaves the malarial area. For current advice on geographical resistance patterns and appropriate chemoprophylaxis, current guidelines or the Malaria Reference Laboratory should be consulted, details of which can be found in the British National Formulary (BNF).

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

For the prevention of travellers' diarrhoea 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 once each week 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.

Use in the elderly Vibramycin may be prescribed in the elderly in the usual dosages with no special precautions. No dosage adjustment is necessary in the presence of renal impairment. The Vibramycin-D dispersible tablet may be preferred for the elderly since it is less likely to be associated with oesophageal irritation and ulceration.

Use in patients with impaired hepatic function: See section 4.4.

Use in patients with renal impairment: Studies to date have indicated that administration of Vibramycin at the usual recommended doses does not lead to accumulation of the antibiotic in patients with renal impairment see section 4.4.

Rocky Mountain spotted fever:

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 paediatric population).

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.

Method of administration

Dispersible Tablets are for oral administration only.

Vibramycin-D tablets are administered by drinking a suspension of the tablets in a small amount of water. This should be done in the sitting or standing position and well before retiring at night to reduce the risk of oesophageal irritation and ulceration. If gastric irritation occurs, it is recommended that Vibramycin be given with food or milk. Studies indicate that the absorption of Vibramycin is not notably influenced by simultaneous ingestion of food or milk.

Exceeding the recommended dosage may result in an increased incidence of side effects. Therapy should be continued for 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.

Acute overdosage with antibiotics is rare. In the event of overdosage discontinue medication. Gastric lavage plus appropriate supportive treatment is indicated.

Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.

4 years.

Store below 25°C.

Aluminium/PVC blister strips, a single strip of 8 tablets in a carton box.

No special requirements.