Tetralysal

Tetralysal

lymecycline

Manufacturer:

Galderma

Distributor:

Zuellig
Full Prescribing Info
Contents
Lymecycline.
Description
Lymecycline (Tetralysal) contains 408 mg of lymecycline equivalent to 300 mg of tetracycline base as the active ingredient in a mixture of magnesium stearate (lubricant), levilite (glidant).
Action
Pharmacology: Effects on acne: The exact mechanisms by which tetracyclines reduce lesions of acne vulgaris have not been fully elucidated; however, the effect appears to result in part from the antibacterial activity and anti-inflammatory activity of the drugs. Following oral administration, the drugs inhibit the growth of susceptible organisms (mainly Propionibacterium acnes) on the surface of the skin and reduce the concentration of free fatty acids in sebum. The reduction in free fatty adds in sebum may be an indirect result of the inhibition of lipase-producing organisms which converts triglycerides into free fatty acids or may be a direct result of interference with lipase production in these organisms. Free fatty adds are comedogenic and pro inflammatory and are believed to be a possible cause of inflammatory lesions, e.g. papules, pustules, nodules, cysts, of acne. However, other mechanisms also appear to be involved because clinical improvement of acne vulgaris with oral tetracycline therapy does not necessarily corresponds with a reduction in the bacterial flora of the skin or a decrease in the free fatty acid content of sebum.
Tetracyclines provide bacteriostatic action at the available plasma and tissue concentrations and rare effective against intracellular and extracellular organisms. Their mechanism of action is based on an inhibition of ribosomal protein synthesis. Tetracyclines block the access of the bacterial aminoacyl-tRNA to the mRNA-ribosome complex by binding to the 30S subunit of the ribosome, thus preventing the addition of amino acids to the growing peptide chain in protein synthesis. When given at therapeutically attainable concentrations their toxic effects is limited to the bacterial effects.
Pharmacokinetics: Absorption: Absorption is rapid, effective plasma levels are reached within the first hour following drug intake. The peak plasma level is reached within 3 to 4 hours after oral administration. Concurrent milk has not been shown to significantly modify the absorption of lymecycline.
Distribution: Oral administration of 300 mg, in the adult, gives rise to: a peak plasma level of 1.6 to 4 ug/mL, a highly variable residual concentration (0.29 to 2.19 ug/mL), a plasma half-life of approximately 10 hours.
Repeated administration results in a steady mean plasma concentration between 2.3 to 5.8 ug/mL. Wide intra- and extra-cellular diffusion, under normal dosage conditions, results in effective concentrations in most body tissue and fluids, and notable in the lungs, bones, muscles, liver, bladder, prostate, bile and urine.
Excretion/elimination: The product is principally excreted in urine and secondarily in the bile. About 65% of the administered dose are eliminated within 48 hours.
Indications/Uses
Lymecycline (Tetralysal) 300 mg is a broad spectrum antibiotic which is recommended for the treatment of infections due to micro-organisms sensitive to lymecyclines.
Lymecycline (Tetralysal) 300 mg is also indicated in the treatment of acne.
Dosage/Direction for Use
The usual recommended dose for indications other than acne in the adult is 300 mg administered twice daily (2 capsules).
The recommended dose for acne is 300 mg/day for 10 to 15 days (1 capsule), then 150 mg everyday or 300 mg every other day as maintenance therapy. The usual duration of treatment is 12 weeks.
The capsules should be taken either one hour before meals or two hours after meals.
For severe infections, total daily doses of up to equivalent of 1.2 g may be given or as prescribed by the physician.
Overdosage
Acute overdosage is rare with antibiotics and there is no specific treatment. Should this happen, gastric emptying should be considered. Supportive measures should be instituted as required and high fluid intake maintained.
Contraindications
Patients hypersensitive to tetracyclines.
The use of this product is to be avoided in children under 8 years of age due to the risk of permanent dental staining and enamel hypoplasia.
Concurrent treatment with retinoids (see Interactions).
Lymecycline (Tetralysal) 300 mg should not be administered during pregnancy and lactation.
Warnings
Special Warnings: None.
Special Precautions
Caution should be exercised if the product is administered to patients with impaired renal or hepatics functions.
Overdosage could result in hepatotoxicity.
Due to the risks of photosensitivity, it is recommended to avoid exposure to direct sunlight and ultraviolet light during the treatment which should be discontinued if erythematous cutaneous manifestations occur.
The use of expired tetracyclines can lead to renal tubular acidosis (Pseudo-Fanconi syndrome) readily reversible when treatment is discontinued altogether.
Effects on the Ability to Drive and Use Machines: Not applicable.
Use In Pregnancy & Lactation
Tetracyclines readily cross the placental barrier and are distributed into milk.
Therefore, Tetralysal is contraindicated to pregnant or breast-feeding women.
Tetracyclines are selectively absorbed by developing bones and teeth and may cause dental staining and enamel hypoplasia in embryos and children.
Adverse Reactions
See table.

Click on icon to see table/diagram/image

Some adverse effects are reported with tetracycline therapy in general: Dental dyschromia and/or enamel hypoplasia may occur if the product is administered in children younger than 8 years of age.
Haemolytic anaemia, eosinophilia and other hematologic disorders have been reported with tetracycline therapy.
Extra-renal hyperazotemia linked to an anti-anabolic effect which may be intensified by the association with diuretics has been reported with tetracycline therapy.
Treatment should cease if any evidence of raised intracranial pressure develop during treatment with Tetralysal.
Drug Interactions
Oral Retinoids: risk of intracranial hypertension.
Simultaneous administration of iron preparations and anti-acids, magnesium/aluminium and calcium hydroxides, oxides and salts may decrease cycline absorption. Consequently a minimum 2-hour gap is necessary between the two treatments.
The effect of oral coumarin-type anticoagulants could be increased with an increased risk of haemorrhage.
Laboratory tests interferences: Lymecycline could cause false-positive urine glucose determinations. It could also interfere with fluorometric determinations of urine catecholamines resulting in falsely increased values (Hingerty's method).
Didanosine: the digestive absorption of cyclines is decreased due to the increase of the gastric pH by the association of an anti-acid in the DDI tablet.
Storage
Lymecycline (Tetralysal) 300 mg should be stored at a temperature not exceeding 25°C.
ATC Classification
J01AA04 - lymecycline ; Belongs to the class of tetracyclines. Used in the systemic treatment of infections.
Presentation/Packing
Cap 300 mg (hard gelatin size-0 capsules, red cap and yellow body) x 28's.
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