Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
For the treatment of infections caused by tetracycline-sensitive organisms. For example, LEDERMYCIN is highly effective in the treatment of infections caused by Borrelia recurrentis (relapsing fever), Calymmatobacterium granulinatis (granuloma inguinale), Chlamydia species (psittacosis, lymphogranuloma vereneum, trachoma, inclusion conjunctivitis), Francisella tularensis (tularaemia), Haemophilus ducreyi (chancroid), Leptospira (meningitis, jaundice), Mycoplasma pneumoniae (non-gonococcal urethritis), Pseumomonas mallei and pseudomallei (glanders and melioidosis), Rickettsiae (typhus fever, Q fever, rocky mountain spotted fever), Vibrio species (cholera). It is also highly effective, alone or in combination with streptomycin, in the treatment of infections due to Brucella species (brucellosis) and Yersinia pestis (bubonic plague). Severe acne vulgaris.
Other sensitive organisms include: Actinomyces israelii, Bacillus anthracis (pneumonia), Clostridium species (gas gangrene, tetanus), Entamoeba histolytica (dysentery), Neisseria gonorrhoeae and anaerobic species, Treponema pallidum and pertenue (syphilis and yaws).
For the treatment of chronic hyponatraemia associated with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) secondary to malignant disease, where water restriction is ineffective and the patient does not have concomitant cirrhosis.
(Capsules) - 600mg daily in 2 or 4 divided doses. For primary atypical pneumonia, the average daily dose is 900mg in 3 divided doses for 6 days.
Use with caution in elderly patients. (See Section 4.3 Contra-indications and Section 4.4 Special warnings and special precautions for use)
Not recommended for children under 12 years of age.
Initially: 900mg-l200mg daily in divided doses
Maintenance dose: 600-900mg daily in divided doses
LEDERMYCIN should be swallowed whole with plenty of fluid while sitting or standing. Doses should be taken an hour before or 2 hours after meals as absorption of LEDERMYCIN is impaired by milk and food. Antibiotic therapy should be continued for one to three days after characteristic symptoms of fever have subsided. The incidence of rheumatic fever or glomerulonephritis following streptococcal infections suggests that therapy of a streptococcal infection should be continued for 8 full days even though symptoms have subsided.
LEDERMYCIN therapy in the treatment of chronic hyponatraemia due to SIADH should not be withdrawn without commencing other methods of control.
Oral administration.
No specific antidote. Gastric lavage plus oral administration of milk or antacids. Maintain fluid and electrolyte balance.
Shelf life: 36 months.
Do not store above 25°C.
Blister pack-Store in original package in order to protect from light and moisture.
Container/Bottle – Keep the container/bottle tightly closed in the outer carton in order to protect from light and moisture.
Polypropylene containers: 20, 28 or 100 capsules.
Screw capped glass bottles: 100 capsules.
Blister pack: 20 capsules.
HDPE ø 45 mm round 50 ml plastic container containing 28 capsules.
No special requirements.
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