Summary of Product Characteristics (SmPC) - Oxymycin Oxytetracycline tablets 250 mg

1 NAME OF THE MEDICINAL PRODUCT

OXYMYCIN/Oxytetracycline Tablets 250 mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Oxytetracycline Dihydrate BP 269.80 mg

3 PHARMACEUTICAL FORM

Film-coated tablet

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Infections caused by oxytetracycline-sensitive organisms. These include acute and chronic bronchitis, pneumonia, urinary tract infections, brucellosis, pertussis, rickettsial fevers and psittacosis.

4.2 Posology and method of administration

Tablets should be swallowed whole with water one hour before or two hours after a meal.

Adults and children of 12 years and above:

250 mg every six hours. Dosage may be increased in severe infections to 250 mg every three hours after an initial loading dose of 1 g.

Children:

Not recommended for children under 12 years of age.

Elderly:

May be given at the usual adult dosage. The possibility of sub-clinical renal insufficiency should be kept in mind, as it may lead to drug accumulation.

Therapy should be continued for at least 24-48 hours after symptoms and fever have subsided.

4.3 Contraindications

Known hypersensitivity to tetracyclines. Renal impairment. Children under 12 years of age. Use during pregnancy or lactation.

4.4 Special warnings and precautions for use

Medicines and foods containing di-/tri-valent cations interfere with the absorption of oxytetracycline and doses should be maximally separated. If however, gastric irritation occurs the medicine should be taken with food.

OXYMYCIN should be used with caution in patients with hepatic or renal dysfunction, or in conjunction with other potentially hepatotoxic or nephrotoxic drugs.

OXYMYCIN should not be administered to children during the period of tooth development because of the likelihood of staining of teeth and deposition in the epiphysis.

Intestinal overgrowth of non-susceptible or resistant organisms (candida albicans in particular) may occur.

Photosensitivity reactions can sometimes occur. Susceptible patients should avoid direct exposure to natural or artificial sunlight and discontinue therapy at the first sign of skin discomfort.

Weak neuromuscular blockade may occur in patients suffering from Myasthenia Gravis Exacerbation of SLE (systemic lupus erythematosus) may occur.

OXYMYCIN is unsafe in acute porphyrias.

4.5 Interaction with other medicinal products and other forms of interaction

Tetracyclines bind to di-/tri-valent cations. Absorption from the gastrointestinal tract is impaired by the concomitant administration of iron, calcium, aluminium, magnesium bismuth and zinc salts (interactions with specified salts, antacids, Bismuth containing ulcer-healing drugs, quinapril which may contain a magnesium carbonate excipients). Dosages should be maximally separated.

Absorption of tetracyclines is impaired by food, milk, and milk products.

The concomitant use of tetracycline may reduce the efficacy of oral contraceptives and the concomitant use pf retinoids may increase the risk of benign intracranial hypertension. It is advisable to avoid giving tetracyclines in conjunction with penicillin.

Patients receiving concurrent anti-coagulant therapy should have the dose of those drugs reduced because tetracyclines depresses plasma prothrombin activity.

Atovaquone plasma concentration is recduced by tetracyclines.

Diuretics may aggravate nephrotoxicity by volume depletion.

4.6 Pregnancy and lactation

Do not use in pregnancy or lactation unless there are compelling reasons.

4.7 Effects on ability to drive and use machines

Does not affect ability to drive and use machines.

4.8 Undesirable effects

Nausea, vomiting, diarrhoea and on rare occasions dysphagia have been reported.

Skin reactions have occasionally occurred. The most common reaction is photosensitivity. Erythematous, and macro-papular rashes, pruritis, bullois dermatoses and exfoliative dermatitis have also been reported.

A few cases of pancreatitis and antibiotic-associated colitis have been reported.

Oesophagitis and oesophageal ulceration have been reported, usually when taken before bed or with inadequate fluids.

Hypersensitivity reactions include rash, exfoliative dermatitis, urticaria, angioedema anaphylaxis pericarditis and exacerbation of systemic lupus erythematosus.

Teeth discolouration has occurred, but it is usually only obvious after repeated doses.

Bulging fontanelles and benign intracranial hypertension in juveniles and adults have been reported indicated by headache and visual disturbances including blurring of vision, scotomata and diplopia. Permanent visual loss has been reported.

Overgrowth of resistant organisms may cause candidiasis, pseudomembranous colitis (Clostridium difficile overgrowth), glossitis, stomatitis, vaginitis and staphylococcal entero-colitis.

On rare occasions transient increase in liver function tests, hepatitis, jaundice and hepatic failure have been reported. Blood dyscrasias have also occurred.

4.9 Overdose

Although overdosage with antibiotics is rare, if it should occur gastric lavage supportive therapy and control of plasma electrolytes is indicated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Oxytetracycline is primarily a bacteriostatic antibiotic and has a similar spectrum of activity to other tetracyclines.

Oxytetracycline is a broad spectrum antibiotic to sensitive organisms.

5.2 Pharmacokinetic properties

Oxytetracycline is absorbed irregularly to the extent of about 60% of an oral dose, absorption occurring in the stomach and upper small intestine.

Peak plasma concentrations achieved 2-4 hours after an oral dose.

The mean plasma half-life is 9.2 hours. The plasma/protein bind is 27-35%. The drug is eliminated largely unchanged mostly in the urine, with some in the faeces. A small amount is metabolised in the liver.

5.3 Preclinical safety data

Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Core:

Maize starch

Pregelatinised maize starch

Povidone

Sodium starch glycollate

Sodium lauryl sulphate

Magnesium stearate

Coating:

Opaspray K-IF-3048 (E104 and E110) Hydroxypropylmethylcellulose

Ethylcellulose

Diethylphthalate

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 Months

6.4 Special precautions for storage

Store below 25°C in a dry place. Keep containers well closed. Protect from light.

6.5 Nature and contents of container

High density polystyrene or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene inserts.

Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Chelonia Healthcare Limited

Boumpoulinas 11, 3^rdFloor

NICOSIA

CYPRUS

P.C. 1060