Source: Υπουργείο Υγείας (CY) Revision Year: 2014 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Tetracycline is contraindicated in the case of:
Aluminium salts: concomitant administration significantly reduces the absorption of tetracycline.
Antacids: these frequently contain aluminium and magnesium salts and concomitant administration significantly reduces the absorption of tetracycline.
Anticoagulants: plasma prothrombin activity is depressed by tetracyclines, therefore lower dosage of concurrent anticoagulants may be required.
Bismuth subcitrate/susalicylate: The absorption of tetracycline may be decreased with concurrent administration, it is recommended the doses be staggered and antibiotic efficacy monitored.
Calcium salts: concomitant administration significantly reduces the absorption of tetracycline.
Cholestyramine: Concomitant administration reduces tetracycline absorption therefore tetracycline should be administered one hour before or four to six hours after the cholestyramine.
Cisatracurium/doxacurium: Tetracycline may enhance the neuromuscular blockade effect, dose reduction may be required.
Digoxin: In some patients, coadministration of tetracycline may result in digoxin metabolism inhibition resulting in higher serum levels. Dose adjustment may be required and patients should be monitored for signs of digoxin toxicity.
Iron salts: concomitant administration significantly reduces the absorption of tetracycline.
Isotretinoin: Concomitant administration may result in an increased risk of benign intracranial hypertension.
Magnesium salts: concomitant administration significantly reduces the absorption of tetracycline.
Methoxyflurane: Concomitant administration results in nephrotoxicity, including fatalities. The use of tetracycline in patients undergoing anaesthesia with methoxyflurane should be avoided.
Oral contraceptives: the efficacy of oral contraceptives may be reduced during concomitant tetracycline administration. Patients should be cautioned to use additional non-hormonal contraceptive measures. There may be an increased incidence of breakthrough bleeding (see also section 4.4- Warnings).
Zinc salts: concomitant administration significantly reduces the absorption of tetracycline.
Penicillins: tetracycline should not be used with penicillin.
Milk: the absorption of tetracycline is significantly reduced by milk or other dairy products.
Glucose in urine: False positive results may be obtained with this test using copper reduction methods. Tests relying on enzymatic glucose oxidase methods do not give false positive results.
Animal studies have shown that tetracyclines cross the placental barrier and are found in foetal tissue. There is evidence of toxic effects on the developing foetus, frequently related to skeletal development retardation. In animals treated early in pregnancy there is evidence of embryotoxicity. Tetracycline hydrochloride should not be used in pregnancy unless such use is essential. In such cases, the maximum daily dosage should not exceed 1g. Use of tetracyclines during foetal tooth development, second and third trimesters, may cause a permanent grey-yellow-brown discolouration of the teeth. This can occur during both long term use and following repeated short dose therapy. There are also reports of enamel hypoplasia.
Tetracycline is found in breast milk. This may cause permanent tooth discolouration in the developing infant and enamel hypoplasia. If tetracycline is administered during lactation, breast-feeding should be discontinued.
Headache, dizziness, visual disturbances and rarely impaired hearing have been reported with tetracycline administration. Patients should be warned about the possible hazards of driving or operating machinery during treatment.
Undesirable effects are usually mild and transient and resolve on therapy discontinuation.
The reported undesirable side effects are listed by body system with the following frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Not known: In common with all antibiotics, overgrowth of resistant organisms may cause glossitis, stomatitis or staphylococcal enterocolitis, vaginitis.
Very rare: Haemolytic anaemia.
Not known: eosinophilia, agranulocytosis, aplastic anemia, neutropenia and thrombocytopenia.
Not known: Hypersensitivity reactions may occur, and cross-sensitivity between different tetracycline antibiotics is possible. Reactions include anaphylaxis, anaphylactoid purpura, angioneurotic oedema, pericarditis, worsening of systemic lupus erythematosus and urticaria.
Not known: Following long term administration of tetracyclines, there have been reports of brown-black microscopic discolouration of the thyroid gland. There are no known associated abnormalities of thyroid gland function.
Not known: Anorexia
Not known: Tinnitus.
Not known: There have been reports of bulging fontanelles in infants and benign intracranial hypertension in adults, headache and dizziness. If there is evidence of raised intracranial pressure therapy should be terminated. Tetracycline has the potential to cause neuromuscular blockade, this usually occurs at high dosage levels.
Very common: diarrhoea, nausea and vomiting. These are dose related.
Rare: There are rare reports of pseudomembranous colitis and this possibility should be considered in cases of severe or persistent diarrhoea. Rare reports of pancreatitis. There have been reported cases of oesophagitis and esophageal ulcerations, especially in patients taking tetracycline immediately before going to bed.
Tooth discoloration in patients under twelve years old and rarely in adults have been reported. Few cases of oesophagitis & oesophageal ulceration in patients taking oral tetracyclines in solid dose form usually where medication was taken immediately before retiring or with inadequate fluids.
Not known: Tetracycline can cause hepatotoxicity, including jaundice and fatty infiltrations. Hepatitis and hepatic steatosis have been reported.
Rare: Urticaria, maculopapular and erythematosus rashes, angioneurotic edema, exfoliative dermatitis, fixed drug eruptions including balanitis, erythema multiforme, Steven-Johnson syndrome and photosensitivity reactions. These are usually reversible on therapy cessation.
Very rare: Fanconi’s syndrome, characterized by renal tubular disease, polyuria/polydipsia, hyperphosphaturia, hypercalciuria, glycosuria and amino aciduria.
Not known: In patients with significant renal impairment and elevated serum levels of tetracycline there are reports of azotaemia, hyperphosphataemia and acidosis.
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
Not applicable.
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