Demeclocycline Hydrochloride 150mg Capsules Ref.[2725] Active ingredients: Demeclocycline

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.

Patients taking oral contraceptives should be warned that if diarrhoea or breakthrough bleeding occur there is a possibility of contraceptive failure.

LEDERMYCIN may increase muscle weakness in patients with myasthenia gravis.

LEDERMYCIN should not be used with penicillins.

Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anti-coagulants such as Coumarins and phenindione may be required.

Absorption of LEDERMYCIN is impaired by the concomitant administration of milk and dairy products, food, iron, calcium, zinc, magnesium and particularly aluminium salts commonly used as antacids.

Absorption of tetracyclines is possibly reduced by kaolin, quinapril tablets (quinapril tablets contain magnesium carbonate), strontium ranelate, sucralfate, tripotassium dicitratobismuthate. The concomitant use of tetracyclines may reduce the efficacy of oral contraceptives; an increased incidence of breakthrough bleeding may also be experienced (See section 4.4 Special warnings and precautions for use).

There is a possible increased risk of benign intracranial hypertension with concomitant use of tetracyclines and retinoids, e.g. acitretin, isotretinoin, tretinoin. There is increased risk of ergotism when tetracyclines given with ergotamine and methysergide.

Typhoid Vaccine (oral): Antibacterials inactivate oral typhoid vaccine and therefore Ledermycin should be avoided for 3 days before and after oral typhoid vaccine.

LEDERMYCIN is contra-indicated during pregnancy and lactation.

Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

The use of tetracyclines during tooth development (last half of pregnancy and children to the age of 12 years) may cause permanent discoloration of the teeth (yellow-grey-brown). This adverse reaction is more common during long term use of the drugs but has been observed following repeated short term courses. Enamel hypoplasia has also been reported.

Tetracyclines have been found in the milk of lactating women who are taking a drug in this class. Permanent tooth discoloration may occur in the developing infant and enamel hypoplasia has been reported. Therefore, LEDERMYCIN should not be administered to lactating women.

Headache, dizziness, visual disturbances and rarely impaired hearing have been reported with tetracyclines and patients should be warned about the possible hazards of driving or operating machinery during treatment.

Gastrointestinal disturbances including nausea, vomiting, diarrhoea and rarely dysphagia have been reported. There have been a few cases of oesophagitis and oesphageal ulceration in patients taking oral tetracyclines in solid dose form, usually where medication was taken immediately before retiring or with inadequate fluids.

As with all antibiotics, overgrowth of resistant organisms may cause candidiasis, pseudomembranous colitis (Clostridium difficile overgrowth) glossitis, stomatitis, vaginitis, or staphylococal enterocolitis.

In common with other tetracyclines, transient increases in liver function test values, hepatitis, jaundice and hepatic failure have been reported rarely. A few cases of pancreatitis have been reported.

The most commonly reported dermatological reaction is photosensitivity. Erythematous, and maculo-papular rashes, pruritus, bullous dermatoses, exfoliative dermatitis and skin discolouration have occurred occasionally but serious skin reactions are rare.

Headache, dizziness, visual disturbances and rarely impaired hearing have been reported with tetracyclines. Bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported. Treatment should cease if evidence of raised intracranial pressure, such as severe or persistant headache or blurred vision are noted. While the condition and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility of permanent sequelae exists. There have been isolated cases of myasthenia.

Hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis and exacerbation of systemic lupus erythmatosus may occur.

Renal dysfunction, especially in patients with pre-existing renal impairment, and rarely, acute renal failure or nephritis, have been reported with tetracyclines.

Reversible nephrogenic diabetes insipidus can occur especially if treatment is prolonged and/or at high dosages.

Haemolytic anaemia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and eosinophilia have been reported rarely. 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.

None.