DEMECLOCYCLINE HYDROCHLORIDE Capsules Ref.[8475] 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.

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.

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.

Pregnancy

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.

Breast-feeding

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.

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).

Blood and lymphatic system disorders

Not Known: Haemolytic anaemia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and eosinophilia^a

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None.