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Tetracycline

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PRODUCT EXPIRY DATE: SEPT 2018

Tetracycline: the effective and versatile antibiotic

Tetracycline antibiotics are commonly used for the treatment of infections caused by bacteria. These bacterial infections include a wide range of conditions like pneumonia and other respiratory tract infections, infections of the skin, genitals and urinary tracts. Tetracycline is also very effective as an acne treatment.

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  • Tetracycline – The Safe, Versatile Treatment For Bacterial Infections

    Tetracycline (from the chemical compound Tetracycline Hydrochloride) offers a host of benefits when it comes to fighting off bacterial infections. Primary among them is its versatility. There are dozens of uses for Tetracycline - sinus infections, urinary infections, cholera, tetanus, all the way through to the most popular application of Tetracycline for acne.

    As well as the many uses for Tetracycline, further benefits include the convenience – it's available as a capsule or as a liquid taken orally. And it's relatively safe for such a potent, multi-faceted drug. Side effects are often mild and easily spotted. They include nausea, vomiting, and swelling of the mucous membranes. Recommended dosage is around 4-6 capsules daily, depending on the infection being treated.

    INGREDIENTS:

    Each capsule contains Main ingredient: 250 mg hydrochlorate tetracycline. 

    ExcipientS:

    Magnesium stearate, cornstarch, titanium dioxide, indigotin, gelatine.

    AVAILABLE IN:

    Boxed blister of 16 250-mg capsules 

    PHARMACEUTICAL CLASSIFICATION:

    Wide ranging anti-bacterial antibiotic

    THERAPEUTIC INDICATIONS:

    Infections resulting from micro-organisms that are sensitive to tetracycline, in particular:

    • Bacterial pneumonia and bronchial pneumonia
    • Acute infections in the urogenital area and renewal of acute phase
    • Surgical infections (infections of soft tissue, osteomyelitis)
    • Acute and subacute infections of the intestinal tract, bacterial and amoebic dysentery, dysenteric syndrome in adults and children
    • Acute and subacute endocarditis
    • Epidemic cerebrospinal meningitis and purulent meningitis in general
    • Brucellosis
    • Rickets
    • Problems related to ear, nose and throat (tonsillitis, otitis, sinusitis, mastoiditis), eyes (conjunctivitis, blepharitis, trachoma), gynaecological disorders (adnexitis, metritis, cervicitis, vulvovaginitis) and skin disorders (furuncolisis, impetigo).

    CONTRAINDICATIONS:

    Significant hypersensitivity towards tetracycline or other components of this drug.

    PRECAUTIONS:

    As occurs with other antibiotics, treatment with tetracycline can give rise to super-infections from bacterial agents or fungi.

    Bear in mind the possibility of enterocolitis as a result of resistant staphylococci or from Clostridium difficile.  In the treatment of gonococcal infections, be aware of the risk of its concealing the symptoms of co-existing syphilis.  In such cases, it is advisable to carry out serological controls for at least 4 months. 

    Given that tetracycline’s can depress prothrombinic activity, it may be necessary to adapt the dosages of anti-coagulants that may be used during the administration of tetracycline.

    Long-term treatment cycles require periodic controls of the haematic constitution and hepatic and renal functioning. 

    If tetracycline’s are employed in the treatment of infections from beta haemolytic Streptococcus (Group A), treatment should last no less than ten days.

    Use during pregnancy, nursing and early childhood 

    This product is only to be used during pregnancy, nursing and early childhood when absolutely necessary and always under a doctor’s direct supervision.

    INTERACTIONS:

    Taking this medicine with penicillin is inadvisable due to the possibility of interference following the respective anti-bacterial activities. 

    Antacid preparations with aluminium, calcium, magnesium, in addition to dairy products reduce the oral absorption of tetracycline.  Their simultaneous ingestion should thus be avoided.

    SPECIAL WARNING:

    In bone tissue in the process of formation, tetracycline can cause a stable calcium complex to form, although no particularly harmful effects have been reported in man. The use of tetracycline during the period of tooth formation (second half of pregnancy, post-natal period and early childhood may cause yellow-brown pigmentation to form on permanent teeth.  This has been verified above all in prolonged treatment with these antibiotics but has also been observed following brief but repeated treatments.

    Predisposed patients may suffer photosensitive reactions in the course of treatment.  Bear in mind this possibility and interrupt treatment as soon as any cutaneous erythema appears.

    In subjects suffering from renal insufficiency even normal doses of tetracycline can cause an accumulation in the circulation with the chance of hepatic damage.  In such cases it is necessary to adapt the dosage to the level of renal functionality, resorting, depending on the individual case, to controls of haematic levels (which must never exceed 15 mcg/ml) and hepatic functioning. Moreover, it must be remembered that tetracycline’s prompt an anti-anabolic action that might aggravate states of renal insufficiency. 

    To avoid irritating the oesophagus, take the product with a sufficient amount of water. 

    Using this product may occasionally cause super-infections in sensitive organisms. 

    Taking into account the possibility of resistant germs, when one is not sure of germ sensitivity with regard to the antibiotic, appropriate bacteriological tests are necessary.

    Tetracycline should not be used as a priority treatment in staphylococcal infections or those of the primary respiratory tracts (pharingo-tonsillitis, etc) from beta-haemolytic Streptococcus (A). 

    Tetracycline’s that are not in proper condition (expired) can produce polyuria, glycosuria, aminociduria, proteinuria.  Storing the product for too long in a warm, moist atmosphere can encourage the formation of nephrotoxic tetracycline derivatives.

    KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN:

    DIRECTIONS FOR USE:

    Recommended daily oral dosage varies from 15 to 25 mg/kg of body weight. In very serious cases, the dosage may be increased according to the doctor’s criterion.

    In an adult of average weight, this is in practice 4-6 250-mg capsules per day and thus one capsule every 6-4 hours. 

    The duration of treatment depends on the subsiding of fever and overall health improvement.

    Once the phase of acute fever has passed, it is advisable to prolong treatment, most likely with a reduced dosage, for some days in order to avoid the possibility of relapse.

    In acute staphylococcic infections and brucellosis, it is a good idea to prolong the treatment (approximately 2 weeks).  With subacute bacterial endocarditis, the treatment should be extended to at least 6 weeks.

    In each case the treatment will be stabilised by the doctor on the basis of the patient’s clinical response.

    Should one or more doses be missed, consult the doctor who has prescribed it before resuming treatment, for the correct restoration of the therapeutic pattern.

    ADVERSE EFFECTS:

    Throughout tetracycline treatment the following side effects can be seen:

    • Gastroenteric symptoms: anorexia, nausea, vomiting, diarrhoea, glossitis and other inflammations of the mucous membranes
    • Cutaneous symptoms: eruptions of an erythematous or maculopapular nature
    • Hypersensitive reactions: urticarial eruptions, anaphylactic purpura, angioneurotic oedema
    • Haematological alterations: extremely rare cases of haemolytic anaemia, neutropenia, trombocytopenia and eosinophilia 

    Should the patient notice any adverse effect other than those described here, he is advised to report it to his doctor or chemist.

    WARNING!  FINAL DATE FOR USING AND STORING THIS MEDICINE

    Do not use the medicine if the expiry date shown on its packaging has passed.  Remember that the expiry date shown refers to the unopened product when properly stored.

    The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.

    MADE IN EU

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