DEMECLOCYCLINE HYDROCHLORIDE

Posology For Antibiotic Use Adults (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. Elderly Use with caution in elderly patients. (See Section

The following undesirable effects have been reported for Demeclocycline hydrochloride.

The undesirable effects are listed according to their frequency:

Not known (cannot be estimated from the available data) System organ class Frequency Undesirable effects Blood and lymphatic system disorders Not Known Haemolytic anaemia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and eosinophiliaa Immune system disorders Not Known Hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis and exacerbation of systemic lupus erythematosus Nervous system disorders Not Known Headache, dizziness, bulging fontanelles (in infants), benign intracranial hypertension (in juveniles and adults), raised intracranial pressure (such as severe or persistent headache or blurred vision) b, myasthenia Eye disorders Not Known Visual disturbances Ear and labyrinth disorders Not Known Impaired hearing Gastrointestinal disorders Not Known Nausea, vomiting, diarrhoea, dysphagia, oesophagitis, oesphageal ulceration,c candidiasis, pseudomembranous colitis (Clostridium difficile overgrowth) glossitis, stomatitis, vaginitis, or staphylococcal enterocolitis, pancreatitis Skin and subcutaneous tissue disorders Not Known Photosensitivity, erythematous, maculo-papular rashes, pruritus, bullous dermatoses, exfoliative dermatitis, skin discolouration, serious skin reactions Renal and urinary disorders Not Known Renal dysfunction, especially in patients with pre- existing renal impairment, acute renal failure or nephritis, reversible nephrogenic diabetes insipidus (prolonged and/or at high dosages) Hepatobiliary disorders Not Known Hepatitis, jaundice, hepatic failure Investigations Not Known Transient increases in liver function test values a.

When given over prolonged periods, tetracyclines have been reported to produce brown-black discoloration of the thyroid gland. No abnormalities of thyroid function are known to occur. b. While the condition and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility of permanent sequelae exists.

c. In patients taking oral tetracyclines in solid dose form, usually where medication was taken immediately before retiring or with inadequate fluids. Reporting of Adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4 Special warnings and special precautions for use) Paediatric population Not recommended for children under 12 years of age. For the treatment of Chronic Hyponatraemia due to SIADH Adults only 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.

Method of administration Oral administration. 1. The use of LEDERMYCIN is contraindicated in patients with acute porphyria, patients who are pregnant or breast-feeding, children under 12 years of age, patients with a history of hypersensitivity to tetracyclines and patients with renal impairment.

4 Special warnings and precautions for use LEDERMYCIN should be used with caution in patients with renal or hepatic dysfunction, or in conjunction with other potentially hepatotoxic or nephrotoxic drugs. Concurrent use with the anaesthetic methoxyflurane increases the risk of kidney failure.

The anti-anabolic action of the tetracyclines may cause an increase in BUN. The treatment of chronic hyponatraemia may necessitate the administration of high doses of LEDERMYCIN for prolonged periods, so increasing the potential for nephrotoxicity (manifested by rises in plasma urea and creatinine) and photoallergic reactions.

Cross-resistance between tetracyclines may develop in micro-organisms and cross sensitisation in patients. LEDERMYCIN should be discontinued if there are signs/symptoms of overgrowth of resistant organisms including candida, enteritis, glossitis, stomatitis, vaginitis, pruritis ani or staphylococcal enterocolitis.

Lower doses are indicated in cases of renal impairment to avoid excessive systemic accumulation and if therapy is prolonged, serum level determinations are advisable. Patients who have known liver disease should not receive more than 1g daily.

In long term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be performed. LEDERMYCIN has the greatest potential of the tetracycline analogues for causing photo-allergic reactions in hypersensitive persons.

Such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort. Exacerbation of pre-existing SLE has been reported with tetracyclines. LEDERMYCIN may increase muscle weakness in patients with myasthenia gravis.

3 Contra-indications and Section