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SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytetracycline Dihydrate (100% Material)
A yellow sugar-coated tablet
Oxytetracycline is a bacteriostatic broad-spectrum antibiotic, active against a wide variety of Gram-positive and Gram-negative organisms.
Infections caused by oxytetracycline-sensitive organisms include:
1) Respiratory tract infections
: Pneumonia, whooping cough and other lower respiratory tract
infections due to susceptible strains of Streptococcus pneumonia
, Haemophilus influenza, Klebsiella pneumonia
and other organisms. Mycoplasma pneumoniae
pneumonia. Treatment of chronic bronchitis (including the prophylaxis of acute exacerbations).
2) Urinary tract infections
: caused by susceptible strains of the Klebsiella species. Enterobacter
species, Escherichia coli, Streptococcus faecalis
and other organisms.
3) Sexually transmitted diseases
: Infections due to Chlamydia trachomatis
uncomplicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma
urealyticum. Oxytetracycline is also indicated in chancroid, granuloma inguinale and lymphogranuloma venereum. Oxytetracycline is an alternative drug in the treatment of gonorrhoea and syphilis.
4) Skin Infections
: Acne vulgaris when antibiotic therapy is considered necessary and severe
5) Ophthalmic infections
: Trachoma, although the infectious agent, as judged by
immunofluorescence, is not always eliminated. Inclusion conjunctivitis may be treated with oral oxytetracycline alone or in combination with topical agents.
6) Rickettsial infections
: Rocky Mountain spotted fever, typhus group, Q fever and Coxiella
7) Other infections: Stagnant loop syndrome. Psittacosis, brucellosis (in combination with
streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia, glanders, melioidosis and acute intestinal amoebiasis (as an adjunct to amoebicides). Oxytetracycline is an alternative drug in the treatment of leptospirosis, gas-gangrene and tetanus.
Posology and Method of Administration
For oral administration.
Oxytetracycline should be given one hour before or two hours after meals, since food, milk
and some dairy products interfere with the absorption.
Therapy should be continued for at least three days after symptoms have subsided.
All infections due to Group A beta-haemolytic streptococci should be treated for at least 10
days. Adults (including the elderly) and children over 12 years:
The minimum recommended dosage is 250 mg every six hours. Therapeutic levels are attained
more rapidly by the administration of 500 mg initially, followed by 250 mg every six hours.
For severe infections, the dosage may be increased to 500 mg every six hours. Dosage recommendations in specific infections:
Acne vulgaris & Severe Rosacea: Oxytetracycline 250-500mg daily in divided doses should
be administered for at least 3 months.
Streptococci Infections: A therapeutic dose of oxytetracycline should be administered for at
least 10 days.
Brucellosis: Oxytetracycline 500mg, four times daily in combination with streptomycin.
Sexually transmitted diseases: Oxytetracycline 500mg four times daily for 7 days is
recommended in the following infections: uncomplicated gonococcal infections (except
anorectal infections in man); uncomplicated urethral, endocervical or rectal infection caused
by Chlamydia trachomatis;
non-gonococcal urethritis caused by Ureaplasma urealyticum.
Acute epididymal-orchitis caused by Chlamydia trachomatis
, or Neisseria gonorrhoeae,
Oxytetracycline 500mg four times daily for 10 days.
Primary and secondary syphilis: Oxytetracycline 500mg, four times daily for 15 days. Syphilis
of more than a year’s duration, (latent syphilis of uncertain or more than a year’s duration,
cardiovascular or late benign syphilis) except neurosyphilis, should be treated with
Oxytetracycline 500mg, four times daily for 30days. Patient compliance with this regimen
may be difficult so care should be taken to encourage optimal compliance. Close follow-up,
including laboratory tests is recommended. Use in the Elderly:
Usual adult dose. Caution should be observed as subclinical renal
insufficiency may lead to drug accumulation. Renal Impairment:
In general, tetracyclines are contraindicated in renal impairment and the
dosing recommendations only apply if use of this class of drug is deemed absolutely essential.
Total dosage should be decreased by reduction of recommended individual doses and /or by
extending time intervals between doses.
See Special warnings and special precautions for Use. Use in Children under 12 years:
Oxytetracycline is contra-indicated in children under the
age of 12 years.
Known hypersensitivity to any of the tetracycline or any of the other ingredients in the formulation; chronic renal/ hepatic dysfunction; systemic lupus erythematosus; children under 12 years; pregnancy and breastfeeding women; patients receiving vitamin A or retinoid therapy.
Special Warnings and Precautions for Use
Tetracycline drugs may cause permanent tooth discoloration (yellow-grey-brown), if administered during tooth development, in the last half of pregnancy and in infancy upto twelve years of age. Enamel hypoplasia has also been reported. This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. The anti-anabolic action of tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired renal function, higher serum levels of oxytetracycline may lead to azataemia, hyperphosphataemia and acidosis. High doses of tetracyclines have been associated with a syndrome involving fatty liver degeneration and pancreatitis. The use of tetracyclines in general is contraindicated in renal impairment due to excessive systemic accumulation and used with caution in patients with hepatic impairment or those receiving drugs which may have hepatotoxic effects; high doses should be avoided. Care is advisable in patients with myasthenia gravis. Photosensitivity reactions may occur in hypersensitive persons and 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. In long-term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be performed. The use of antibiotics may occasionally result in the overgrowth of nonsuceptible organisms including Candida. Constant observation of patients is essential. If a resistant organism appears, the antibiotic should be discontinued and appropriate therapy instituted. When treating venereal disease, where co-existent syphilis is suspected, proper diagnostic procedures should be utilised. In all such cases monthly serological tests should be made for at least four months.
Interactions with other Medicaments and other forms of Interaction
The absorption of oxytetracycline may be impaired by the concomitant administration of divalent or trivalent cations such as aluminium, calcium or magnesium, oral iron or zinc preparations. Allow two to three hours between doses of oxytetracycline and antacids. Since oxytetracycline has been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require a downward adjustment of their anticoagulant dosage. Oxytetracycline may prolong the action of coumarin anticoagulants. Antidiarrhoeal preparations such as kaolin-pectin and bismuth subsalicylate hinder absorption of tetracyclines. Combination of tetracyclines with diuretics may be detrimental to renal function. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Oxytetracycline in conjunction with penicillin. A few cases of pregnancy or breakthrough bleeding have been attributed to the concurrent use of oxytetracycline with oral contraceptives and alternative contraceptive advice should be sought where necessary.
There have been reports of nephrotoxicity (increased blood urea nitrogen and serum creatinine) and death in some cases when oxytetracycline therapy has been combined with methoxyflurane. Oxytetracycline may increase hypoglycaemic effects of insulin and sulphonylureas in patients with diabetes mellitus. (See section 4.8 Undesirable effects) Benign intracranial hypertension has been reported following the concomitant use of tetracyclines and vitamin A or retinoid and therefore concurrent use in contraindicated.
Pregnancy and Lactation
Not to be used in pregnancy unless essential to the patient’s welfare.
Tetracycline cross the placenta and may have toxic effects on foetal tissues, particularly on skeletal development, (see “Warnings” on tooth development). If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus. Tetracyclines are also excreted in breast milk and are therefore contraindicated in nursing mothers. Use in newborns
, infants & Children:
All tetracyclines form stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was reversed when drug was discontinued.
Effects on Ability to Drive and Use Machines
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); Frequency not known (cannot be estimated from the available data). Blood and lymphatic disorders: Frequency not known: Haemolytic anaemia, thrombocytopenia, neutropenia, eosinophilia. Endocrine disorders: Frequency not known: brown-black microscopic discoloration of thyroid tissue in use over prolonged periods (No abnormalities of thyroid function are known to occur). Nervous system disorders: Frequency not known: Bulging fontanelles in infants, benign intracranial hypertension. (Treatment should cease if evidence of raised intracranial pressure develops.) Cardiac disorders: Frequency not known: Pericarditis. Gastrointestinal disorders: Rare: oesophagitis, oesophageal ulceration (Reported in patients receiving capsule and tablet forms of drugs in the tetracycline class. Most of these patients took medication immediately before going to bed.) Frequency not known: Gastrointestinal irritations giving rise to nausea, abdominal discomfort, vomiting, diarrhoea, anorexia, dysphagia (If gastric irritation occurs, tablets should be taken with food.). Pseudomembranous colitis, intestinal overgrowth of resistant organisms (Candida albicans, in particular), may occur and cause glossitis, rectal and vaginal irritation and inflammatory lesions (with candidial overgrowth) in the anogenital regions. Similarly, resistant staphylococci may cause enterocolitis. Tooth discolouration, pancreatitis.
Hepatobiliary system disorders: Frequency not known: Hepatotoxicity (hepatitis, jaundice and hepatic failure), fatty liver degeneration. Skin and subcutaneous tissue disorders: Uncommon: Exfoliative dermatitis Frequency not known: Macropapular and erythematous rashes, photo-erythema (Patients exposed to direct sunlight or ultraviolet light should be advised to discontinue treatment if any skin reaction occurs). Hypersensitivity reactions: urticaria, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus. Renal and urinary disorders: Frequency not known: Renal dysfunction.
There is no specific antidote to oxytetracycline. Overdosage may be treated with
gastric lavage and/or the administration of antacids or milk, is recommended.
Oxytetracycline is bacteriostatic antibiotic with a broad spectrum of activity against
bacteria and also some antiprotozoal properties
Oxytetracycline is incompletely and irregularly absorbed from the gastrointestinal tract. The degree of absorption is diminished by the soluble salts of divalent and trivalent metals, with which tetracyclines form stable complexes and to a variable degree by milk and food. Plasma concentrations will depend upon the degree of absorption. It is recommended that tetracyclines should be give before food. A dose of 500mg every 6 hours by mouth is reported to produce steady-state plasma concentrations of 3 to 4µg per ml. Peak plasma concentration occurs 1-3 hours after ingestion. In the circulation, 20 to 40% of oxytetracycline is bound to plasma protein. Oxytetracycline appears in the milk of nursing mothers where concentrations may be 60% or more of those in the plasma. Oxytetracycline diffuses across the placenta and appears in the foetal circulation at concentrations of about 25 to 75% of those in the maternal blood. Tetracyclines are widely distributed throughout the body tissues and fluids. Only small amounts appear in saliva, tears and intraocular fluids and lung. Oxytetracycline is retained at sites of new bone formation and recent calcification and in developing teeth. Since there is some enterohepatic reabsorption complete elimination is slow. Considerable quantities occur in the faeces after administration by mouth. Oxytetracycline is excreted in the bile where concentrations five to twenty five times those in plasma can occur.
Preclinical Safety Data
List of Excipients
Sandarac tablet varnish
French chalk for tablets
Opalux yellow AS2146
Special Precautions for Storage
Store in a cool dry place.
6.5 Nature and Contents of Container
Amber glass bottle and tin plate screw cap with aluminium faced pulpboard. The ullage is filled with cotton wool. Pack sizes: 1000, 112, 56, 28 Blister packs comprising of 250 micron PVC and 20 micron Aluminium foil Pack sizes: 10, 14,28, 30, 56, 84, 100 (Not all pack sizes may be marketed)
Instruction for Use/Handling
MARKETING AUTHORISATION HOLDER
Bristol Laboratories Ltd Unit3 , Canalside, Northbridge Road Berkhamsted Herts HP4 1EG United Kingdom
MARKETING AUTHORIZATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT
Chin J Pharmacoepidemiol 2002 , Vol. 11 , No. 1 © 1994-2009 China Academic Journal Electronic Publishing House. All rights reserved. http://www.cnki.net © 1994-2009 China Academic Journal Electronic Publishing House. All rights reserved. http://www.cnki.net Chin J Pharmacoepidemiol 2002 , Vol. 11 , No. 1+ 25/ 23) 1/ 2 = 7. 680 0 ; Zc = 7. 68 > Z(0. 05 ,1) = 2. 58 ,4. 612 3 , 56. 482 5 ,
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