MEDOCYCLINE Hard capsule Ref.[28286] Active ingredients: Tetracycline

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Tetracycline hydrochloride is a broad spectrum bacteriostatic antibiotic used for the treatment of infections caused by susceptible Gram positive or Gram negative bacteria.

It is effective in the treatment of infections caused by the following organisms: Borrellia recurrentis (relapsing fever), Calymmatobacterium granulomatis (granuloma inguinale), Chlamydia sp. (inclusion conjunctivitis, psittacosis, lymphogranuloma venereum, trachoma), Francisella tularensis (tularaemia), Haemophilus ducreyi (chancroid), Leptospira sp. (meningitis, jaundice), Mycoplasma pneumoniae (non-gonococcal urethritis), Pseudomonas (Burkholderia) mallei (glanders), Pseudomonas (Burkholderia) pseudomallei (melioidosis), Rickettsiae sp. (typhus fever, Q fever, rocky mountain spotted fever), Vibrio sp. (cholera).

Tetracycline is also effective, alone or used in combination with streptomycin, in the treatment of infections due to Brucella sp. (brucellosis), Yersinia pestis (bubonic plague).

Other sensitive organisms include: Actinomyces israelii, Bacillus anthracis (pneumonia), Clostridium sp. (gas gangrene, tetanus), Entamoeba histolytica (dysentery), Neisseria gonorrhoeae (gonorrhoea), Treponema pallidum (syphilis) and Treponema pertenue (yaws).

4.2. Posology and method of administration

Posology

Adults

General: The usual adult dosage is 250mg every six hours. In severe infections, this may be increased to 500mg every six hours.

Specific:

  • Brucellosis: 500mg four times a day for three weeks. Concomitant streptomycin parenteral therapy is required.
  • Trachomatis: Treatment of uncomplicated urethral, endocervical or rectal trachomatis due to Chlamydia trachomatis can be treated with 500mg four times a day for at least seven days.
  • Gonorrhoea: Patients hypersensitive to penicillin may be treated with tetracycline. An initial loading dose of 1.5g should be given followed by 500mg every six hours for four days, giving a total dose of 9g.
  • Lyme disease: 250mg to 500mg, four times a day for three to four weeks.
  • Group A beta haemolytic streptococcus: Treatment of these infections should continue for at least ten days.
  • Acne vulgaris: Dosage should be adjusted to give the required response. Maintenance therapy regimes have varied between 250mg every other day to 500mg once a day.

Paediatric population:

  • Children under 12 years of age: not recommended (see section 4.3).
  • Children over 12 years of age: the recommended dose is 25mg/kg bodyweight to 50mg/kg bodyweight per day, divided into two or four equal doses. The maximum dosage should not exceed the recommended adult dosage.

Elderly

No dosage reduction is necessary unless there is concomitant renal or hepatic impairment.

Renal impairment

The dosage interval should be prolonged in renal impairment due to prolongation of elimination half-life.

The following intervals are recommended:

Mild renal failure: glomerular filtration rate >50ml/minute, dose every eight to twelve hours.

Moderate renal failure: glomerular filtration rate 10ml to 50ml/minute, dose every twelve to twenty four hours.

Severe renal failure: glomerular filtration rate <10ml/minute, use should be avoided, but if essential should be given every twenty four hours. It is suggested that serum levels should be monitored.

Hepatic impairment

Due to tetracycline’s anti-anabolic effects, resulting in endogenous nitrogen requiring hepatic metabolism, use should be avoided if possible. Should it be essential, the maximum dose is 1g per day and blood levels in excess of 10g/ml should be avoided. Caution should be exercised in administration to such patients.

Method of administration

Medocycline capsules are for oral administration. They should be administered one hour before or two hours after, food.

Food, antacids containing aluminum, calcium or magnesium and iron-containing preparation may impair absorption of tetracycline. Capsules should be swallowed whole with plenty of water, while sitting or standing.

4.9. Overdose

There is no specific antidote for tetracycline overdosage. Gastric lavage is recommended. The oral administration of milk or antacids will decrease the absorption of tetracycline. Treatment should be symptomatic and supportive.

6.3. Shelf life

4 years.

6.4. Special precautions for storage

Store below 25°C in the original package, in order to protect from light.

6.5. Nature and contents of container

Medocycline capsules are packed in PVC/Alu blisters.

Packs of 100 capsules are available.

6.6. Special precautions for disposal and other handling

No special precautions for disposal.

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