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5th
May 2009 Dolphin has added seven more formulations to its growing
Sri Lanka Portfolio
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28th
April 2009 The Board of Directors of the Company in its 154th
meeting held on Tuesday, 28 April, 2009 has recommended 50% cash and 25% stock
dividend (bonus share)
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| D-Tetra Capsule |
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| Back |
| COMPOSITION |
D-Tetra 250 capsule : Each capsule contains Tetracycline Hydrochloride BP
500 mg.
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| PHARMACOLOGY |
Tetracycline (Tetrax®) has its main mechanism of action on protein synthesis,
and an energy-dependent active transport system pumps the drug through
the inner cytoplasmic membrane of bacteria. Once inside the bacterial cell,
tetracycline (Tetrax®) binds specifically to the 30s ribosomes and inhibit
bacterial protein synthesis.
Many Gram positive aerobic Cocci are susceptible, but many strains of
staphylococci, streptococci and even some pneumococci are resistant to
tetracycline (Tetrax®). Thus, tetracycline is not the drug of choice in
infections due to gram positive aerobes.
Pseudomonas and many Enterobacteriaceae are resistant. Urinary
concentrations are adequate for some community - acquired E. coli and
consequently, tetracycline (Tetrax®) is still used in uncomplicated initial UTIs.
Tetracycline (Tetrax®) is also active against and is the drug of choice for
Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V.
vulnificus.
Tetracycline (Tetrax®) is also active against anaerobic species of bacteria
and since concentrations of the drug are quite high in the gastrointestinal
contents, the enteric flora are usually altered by the drug.
Tetracycline HCl is incompletely absorbed from the gastro-intestinal tract,
about 60 to 80% of a dose of tetracycline usually being available. It is widely
distributed through the body tissues and fluids.
Tetracycline HCl has a half-life of about 12 hours. It is excreted in the urine
and in the faeces.
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| INDICATION |
Tetracycline (Tetrax®) is the drug of choice in the following infections :
1. Ricketsial infection (Rocky Mountain spotted fever, endemic and scrub
typhus fever and human ehrlichiosis).
2. Mycoplasma pneumoniae infections in adults. Outbreaks of pneumonia
caused by this organism are common in barracks and institutions. Most
cases occur in children and young adults. Maculopapular rashes,
haemolytic anaemia and meningo-encephalitis occur rarely.
3. Chlamydial Infections - Chlamydia psittaci: This organism is the cause of
psittacosis (ornithosis), a systemic illness contracted from infected
birds. The pneumonia associated with it may be extensive, and severe
systemic upset and death are common.Headache is a prominent early
symptom.
4. Non-gonococcal or non specific urethritis: Inflammation of the urethra
not resulting from gonococcal, chlamydial, or other specific infectious
agents.
5. Lyme disease
6. Brucellosis
7. Miscellaneous infections, including granuloma inguinale, cholera,
glanders, relapsing fever and V. vulnifians.
Other common uses of tetracycline (Tetrax®) include the following :
1. Urinary Tract Infections with susceptible organisms (including the acute
urethral syndrome in women).
2. Bronchitis in patients with known underlying chronic lung diseases.
3. Pelvic inflammatory disease and other sexually transmitted diseases
(STDs) regimen.
4. Travelers diarrhoea.
5. Acne vulgaris.
6. Prostatitis.
7. As an alternative agent in the penicillin allergic patient with syphilis.
8. Anaerobic infections with susceptible organisms.
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| DOSAGE AND ADMINISTRATION |
The usual adult oral dosage of Tetrax® is 1-2 g daily given in 2-4 divided
doses. The usual oral dosage of Tetrax® for children older than 8 years of age
in 25-50 mg/kg daily given in 2-4 divided doses. Alternatively some
clinicians recommended that children should receive 0.6-1.2 g/m2 daily.
Tetrax® should be taken preferably one hour before or 2 hours after meals.
Some specific indications along with some information on dosage is given
in the table :
Infection Dosage and duration Remarks
Acne vulgaris 250 mg four times daily Duration of therapy is
or 500 mg 12 hourly for determined by
1 week ; 125-250 mg for individual progress
several weeks or months
Acute 1-2 g daily in divided
staphylococcal infections doses for 10-14 days
Acute streptococcal 1-2 g daily in divided Prolonged therapy is
infections doses for 10 days needed to avoid risk of
rheumatic fever or
glomerulonephritis
Amoebiasis 1 g daily in four divided Given in association
doses or 500 mg 12 hourly with amoebicidal
for 7 days agents
Brucellosis 500 mg four times daily Prolonged therapy is
plus 1 g streptomycin twice necessary to avoid
daily for 1 week ; then relapse
500 mg four times daily
(no streptomycin) for 1 week
Subacute bacterial 1-2 g daily in divided doses Usually given in
endocarditis for 6 weeks combination with a
bactericidal agent
Syphilis Total 30-40 g given in Serology and spinal
divided doses over 10-15 fluid examination
days should follow the
administration of
tetracycline (Tetrax®).
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| CONTRAINDICATION AND PRECAUTION |
Tetracycline Hydrochloride is contraindicated in patients hypersensitive to
any of the member of tetracycline groups, since cross-sensitivity may occur
Tetracycline Hydrochloride should be avoided in patients with systemic
lupus erythematosus. Tetracycline Hydrochloride is considered to be
contraindicated in renal impairment, particularly if severe ; if it must be
given, doses should be reduced. Care should be taken if Tetracycline
Hydrochloride is given to patients with impaired liver function and high
doses should be avoided. Potentiality hepatotoxic drugs (including
erythromycin, chloramphenicol, isoniazide and sulphonamides) should not
be given concomitantly.
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| SIDE EFFECT |
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Teeth and bone: Tetracycline (Tetrax®) can cause depression of bone growth,
permanent graybrown discoloration of the teeth and enamel hypoplasia
when given during tooth development (i.e. during the later half of
pregnancy, during infancy and in childhood).
Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are
uncommon. Photosensitivity reactions consisting of a red rash on areas
exposed to intense sunlight can occur with tetracycline (Tetrax®).
Gastrointestinal effects - Epigastric distress and nausea are commonly seen
after oral administration, and these symptoms are somewhat dose related.
Vomiting can occur.
Accentuated prerenal azotemia - Tetracycline (Tetrax®) appears to aggravate
pre-existing renal failure by inhibiting protein synthesis, which increases the
azotemia from amino acid metabolism.
Superinfections with oral and anogenital candidiasis are relatively common
in patients taking tetracycline (Tetrax®).
Esophageal ulcerations - In most cases, the patients were taking the
capsules with little or no fluid before going to bed. To help minimize this, oral
doses should be given with adequate amounts of fluid.
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| USE IN PREGNANCY, LACTATION AND CHILDREN |
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Tetracycline should not be used during pregnancy because of the risk of
hypertoxicity in the mother as well as the effects on the developing foetus.
Use in pregnancy potentially during breast-feeding and in children up to the
age of 8, or some authorise say 12 years, may result in impaired bone growth
and permanent discoloration of the child's teeth.
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| HOW SUPPLIED |
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D-Tetra 250 capsule: Box containing 10 x 10 capsules in strip pack.
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