TETRACYCLINE-250 LENNON TABLETS
TETRACYCLINE-500 LENNON TABLETS
(and dosage form):
TETRACYCLINE-250 LENNON TABLETS
TETRACYCLINE-500 LENNON TABLETS
(i) 250 mg Tetracycline Hydrochloride.
(ii) 500 mg Tetracycline Hydrochloride.
A20.1.1 Broad and medium spectrum antibiotics.
Tetracycline is a bacteriostatic antibiotic and inhibits bacterial protein synthesis (30S ribosomes). It is particularly effective in vitro against the following organisms (in vitro activity does no necessarily imply in vivo efficacy);
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumonia, Chlamydia trachomatis (see also below ), Chlamydia psittaci, Borrelia recurrensis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin sensitive Neisseria gonorrhoeae and Rickettsiae.
Tetracycline is also effective against the following organisms in vitro:
Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelli, Bacillus anthracis*, Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae, Neisseria meningitidis contacts (only Minocycline).
Tetracycline may also show some effect against the following organisms:
Bacteroides species and Fusobacterium nucleatum.
Many strains of the following are resistant:
Fungi and yeasts (except Actinomyces),
Pseudomonas aeruginosa (all strains),
* = in vitro sensitivity tests must be performed.
Tetracycline is adequately but incompletely absorbed from the intestinal tract. Effective blood levels are reached in about two to four hours after oral administration and are maintained with the recommended dosages. Absorption is diminished by the presence of iron aluminium calcium and magnesium. Tetracycline Lennon is widely distributed into pleural and peritoneal fluid, saliva semen and prostatic fluid, and under certain circumstances, into cerebrospinal fluid. It passes the placental barrier readily and is also present in the milk of lactating patients. It is concentrated by the liver and excreted, via the biliary tract, into the intestine from which it is partially reabsorbed. Excretion in the urine also takes place.
Tetracycline Lennon is useful in infections produced by susceptible strains of Mycoplasma, Chlamydia, rickettsia and bacteria.
Infectious diseases include Rocky Mountain spotted fever, murine typhus, recrudescent epidemic typhus, scrub typhus, Q fever, lymphogranuloma venereum, psittacosis tularemia and brucellosis.
Tetracycline Lennon may be used in the treatment of gonorrhoea, syphilis and anthrax in cases where the patient is hypersensitive to penicillin.
Tetracycline Lennon is not recommended for use in cases of renal dysfunction or liver damage.
The use of Tetracycline Lennon in pregnancy, lactation or childhood should be avoided. When administered to women during the latter half of pregnancy, to nursing mothers, or during childhood up to the age of 12 years, permanent discoloration of the child's teeth, enamel hypoplasia and retarded bone growth may occur.
Tetracycline Lennon should not be given to patients with known hypersensitivity to any of this group of antibiotics. It should be avoided in patients with systemic lupus erythematosus. Symptoms of myasthenia gravis may be exacerbated by tetracyclines.
Absorption of Tetracycline Lennon is diminished by milk, alkalis, aluminium hydroxide, and the salts of other (trivalent and divalent cations including calcium iron and magnesium when these are taken concomitantly.
Because of possible antagonism of the action of the penicillins by predominantly bacteriostatic tetracyclines it has been recommended that the two types of antibiotic should not be given concomitantly, especially when a rapid bactericidal action is necessary.
Photosensitivity may occur.
Pseudotumor cerebri may occur.
Do not use concomitantly with hepatotoxic medicines.
DOSAGE AND DIRECTIONS FOR USE:
Tetracycline Lennon should be taken either one hour before meals or two hours after meals. The maximum dose should not exceed 3 g daily.
The usual dose depending on the severity of the infection is:
Adults and children of 12 years and older: 250 - 500 mg every six hours.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal side-effects including nausea, vomiting, diarrhoea, glossitis and enterocolitis. Oesophageal ulceration has also been reported. Oral candidiasis, vulvovaginitis and pruritus ani occur mainly due to overgrowth with Candida albicans and there may be overgrowth of resistant coliform organisms such as Pseudomonas spp. and Proteus spp. causing diarrhoea. More serious super-infection with resistant staphylococci causing enterocolitis and also pseudomembranous colitis due to Clostridium difficile have been reported.
Usual therapeutic doses given to patients with renal disease increase the severity of uraemia with increased excretion of nitrogen and losses of sodium accompanied by acidosis and hyperphosphataemia. These effects are related to the dose and the severity of renal impairment and are probably due to the anti-anabolic effects of the tetracycline.
Severe and sometimes fatal hepatotoxicity associated with fatty changes in the liver and pancreatitis has been reported in pregnant women given tetracycline intravenously for pyelonephritis, and in patients with renal impairment or those given high doses.
Tetracyclines are deposited in deciduous and permanent teeth causing discoloration and enamel hypoplasia. They are also deposited in calcifying areas in bone and the nails and when given in therapeutic doses to young infants or women during the late stages of pregnancy, tetracyclines interfere with bone growth. An increase in intracranial pressure, which may be associated with a bulging fontanelle in infants, has been reported in patients given tetracyclines.
Allergic reactions to tetracycline and its analogues have been reported, usually as skin reactions; cross-sensitisation between tetracyclines is common. Photosensitivity of the skin and nails has occurred, and onycholysis may be associated with nail discoloration. A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with tetracycline.
Haemolytic anaemia, eosinophilia, neutropenia and thrombocytopenia have been reported. The use of out-of-date or deteriorated tetracyclines has been associated with the development of a reversible Fanconi-type syndrome characterised by polyuria and polydipsia with nausea, proteinuria, glycosuria, acidosis, aminoaciduria, hypophosphataemia, and hypokalaemia; these effects have been attributed to the presence of degradation products.
Tetracycline may interfere with some diagnostic tests including determination of urine catecholamines or glucose.
Interactions: Doses of anticoagulants may need to be reduced if given concomitantly with tetracyclines. Tetracyclines may diminish the effectiveness of oral contraceptives.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of sensitivity reactions, treatment should be withdrawn. See "Side-effects and special precautions". Treatment is symptomatic and supportive.
250 mg Tablet - Pink, film coated, biconvex tablet with a diameter of 10,42 mm.
500 mg Tablet - Pink, film coated, biconvex tablet with a diameter of 12,80 mm.
Packs of 100 and 1000 tablets.
Store below 25°C and keep container tightly closed.
Protect from moisture.
KEEP OUT OF REACH OF CHILDREN.
250 mg Tablets - L/20.1.1/384.
500 mg Tablets - L/20.1.1/385.
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
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