Demeclocycline Hydrochloride 150mg Capsules (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Mercury Pharma Group |
---|---|
Διεύθυνση | No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK |
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Name of the medicinal product
Ledermycin Capsules 150mg. Demeclocycline Hydrochloride 150mg Capsules.
Qualitative and quantitative composition
LEDERMYCIN capsules each contain 150mg of demeclocycline hydrochloride.
Pharmaceutical form
Capsule, hard.
Therapeutic indications
For the treatment of infections caused by tetracycline-sensitive organisms. For example, LEDERMYCIN is highly effective in the treatment of infections caused by Borrelia recurrentis (relapsing fever), ...
Posology and method of administration
Oral administration. For Antibiotic Use Adults (capsules) - 600mg daily in 2 or 4 divided doses. For primary atypical pneumonia, the average daily dose is 900mg in 3 divided doses for 6 days. Elderly - ...
Contraindications
The use of LEDERMYCIN is contraindicated in patients with acute porphyria, patients who are pregnant or breast-feeding, children under 12 years of age, patients with a history of hypersensitivity to tetracyclines ...
Special warnings and precautions for use
LEDERMYCIN should be used with caution in patients with renal or hepatic dysfunction, or in conjunction with other potentially hepatotoxic or nephrotoxic drugs. Concurrent use with the anaesthetic methoxyflurane ...
Interaction with other medicinal products and other forms of interaction
LEDERMYCIN should not be used with penicillins. Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anti-coagulants such as Coumarins and phenindione may be required. Absorption ...
Pregnancy and lactation
LEDERMYCIN is contra-indicated during pregnancy and lactation. Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing ...
Effects on ability to drive and use machines
Headache, dizziness, visual disturbances and rarely impaired hearing have been reported with tetracyclines and patients should be warned about the possible hazards of driving or operating machinery during ...
Undesirable effects
Gastrointestinal disturbances including nausea, vomiting, diarrhoea and rarely dysphagia have been reported. There have been a few cases of oesophagitis and oesphageal ulceration in patients taking oral ...
Overdose
No specific antidote. Gastric lavage plus oral administration of milk or antacids. Maintain fluid and electrolyte balance.
Pharmacodynamic properties
Tetracyclines have a broad spectrum of anti-microbial activity and act by interfering with bacterial protein synthesis. They are active against a large number of gram positive and gram negative pathogenic ...
Pharmacokinetic properties
Tetracyclines are incompletely and irregularly absorbed from the gastrointestinal tract. Absorption is affected by the soluble salts of divalent and trivalent metals, milk and food. Plasma concentrations ...
Preclinical safety data
There are no other preclinical safety data of relevance to the prescriber apart from those already detailed in the SPC.
List of excipients
Cellulose (Elcema G250) Magnesium stearate Colloidal silicon dioxide (Aerosil 200) Capsule body and cap: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (El72) Erythrosine (El27) Gelatin ...
Incompatibilities
None.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C. Blister pack - Store in original package in order to protect from light and moisture. Container/Bottle - Keep the container/bottle tightly closed in the outer carton in order to ...
Nature and contents of container
Polypropylene containers - 20, 28 or 100 capsules. Screw capped glass bottles - 100 capsules. Blister pack - 20 capsules. HDPE ø 45 mm round 50 ml plastic container containing 28 capsules.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Mercury Pharmaceuticals Ltd No. 1 Croydon 12-16 Addiscombe Road Croydon CR0 0XT UK
Marketing authorization number(s)
PL 12762/0154
Date of first authorization / renewal of the authorization
8 March 2004
Date of revision of the text
03/09/2012