REMYCIN Hard capsule Ref.[28312] Active ingredients: Doxycycline

Posology

Adults and children aged 12 years to less than 18 years

The usual dose of Remycin 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 (administered as a single dose or divided into two equal doses with a 12 hour interval), followed by a maintenance dose of 100 mg/day. In the management of more severe infections, (particularly chronic infections of the urinary tract), 200 mg daily should be given throughout the treatment period.

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).

Method of administration

Remycin should be taken with adequate amounts of fluid (at least 100 ml of water). This should be done in the sitting or standing position and the patient should be advised to remain upright for at least thirty minutes after taking a dose. Remycin capsules should be taken well before bedtime to reduce the risk of oesophageal irritation and ulceration. If gastric irritation occurs, it is recommended that Remycin be given with food or milk. Studies indicate that the absorption of doxycycline 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 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.

Dosage recommendations in specific infections:

Sexually transmitted diseases: 100 mg twice daily for 7 days is recommended in the following infections: uncomplicated urethral, endocervical or rectal infection caused by Chlamydia trachomatis; non-gonococcal urethritis caused by Ureaplasma urealyticum.

Uncomplicated gonococcal infections (except anorectal infections in men): Doxycycline 100 mg twice daily for 7 days together with intramuscular ceftriaxone.

Acute epididymo-orchitis caused by Chlamydia trachomatis or Neisseria gonorrhea: Doxycycline 100 mg twice daily for 10 days together with intramuscular ceftriaxone.

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

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

Early Lyme disease (Stage 1 and 2): 100 mg twice daily for 10-30 days according to clinical signs, symptoms and response.

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 Remycin; quinine dosage recommendations vary in different areas.

Prophylaxis of malaria: 100 mg daily in adults. Prophylaxis can begin 1-2 days before travel to malarious areas. It should be continued daily during travel in the malarious areas and for 4 weeks after the traveler leaves the malarious area.

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

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

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 treatment of leptospirosis: 100 mg twice daily for 7 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.

Infections due to susceptible strains of Bacillus anthracis: Adults: 100 mg of doxycycline, by mouth, twice a day for 60 days.

Paediatric population: See sections 4.3 and 4.4.

Use in the elderly: Remycin may be prescribed in the usual dose with no special precautions. No dosage adjustment is necessary in the presence of renal impairment.

Use in patients with impaired hepatic function: Remycin should be administered with caution to patients with hepatic impairment or those receiving potentially hepatotoxic drugs.

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

Rocky Mountain spotted fever:

Remycin 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 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.

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.

5 years.

Store below 25°C. Protect from light and moisture.

PVC/Aluminium blisters. Pack sizes of 10, 100 and 1000 hard capsules.
PP containers with PE closures. Pack sizes of 500 and 1000 hard capsules.

Not all pack sizes may be marketed.

Not applicable.