VANCOCIN MATRIGEL

Posology:

Adults and adolescents aged 12 to less than 18 years old The recommended vancomycin dose is 125 mg every 6 hours for 10 days for the first episode of non-severe CDI. This dose can be increased to 500 mg every 6 hours for 10 days in case of severe or complicated disease.

The maximum daily dose should not exceed 2 g. , 125–500 mg/day every 2–3 days for at least 3 weeks. Treatment duration with vancomycin may need to be tailored to the clinical course of individual patients. Whenever possible the antibacterial suspected to have caused CDI should be discontinued.

Adequate replacement of fluid and electrolytes should be instituted. 4). 4). Paediatric population Vancomycin capsules are not appropriate for the treatment of children under the age of 12 years or for adolescents unable to swallow them.

Below 12 years, age- appropriate formulation should be used. Method of administration For oral use. The capsule should not be open and should be taken with plenty of water.

Summary of the safety profile The absorption of vancomycin from the gastrointestinal tract is negligible. However, in severe inflammation of the intestinal mucosa, especially in combination with renal insufficiency, side effects that occur when vancomycin is administered parenterally may appear.

Therefore, the below mentioned adverse reactions and frequencies related to parenteral vancomycin administration are included. When vancomycin is administered parenterally, the most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (“red-neck syndrome”) in connection with too rapid intravenous infusion of vancomycin.

4). Tabulated List of Adverse reactions Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The adverse reactions listed below are defined using the following MedDRA convention and system organ class database: 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), not known (cannot be estimated from the available data).

System organ class Frequency Adverse reaction Blood and the lymphatic system disorders: Rare Reversible neutropenia, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia.

Not known Haemolytic anaemia Immune system disorders:

Rare Hypersensitivity reactions, anaphylactic reactions Ear and labyrinth disorders: Uncommon Transient or permanent loss of hearing Rare Vertigo, tinnitus, dizziness Cardiac disorders Very rare Cardiac arrest Not known Kounis syndrome Vascular disorders: Common Decrease in blood pressure Rare Vasculitis Respiratory, thoracic and mediastinal disorders: Common Dyspnoea, stridor Gastrointestinal disorders: Rare Nausea Very rare Pseudomembranous enterocolitis Not known Vomiting, diarrhoea Hepatobiliary disorders: Common Alanine aminotransferase increased, aspartate aminotransferase increased Skin and subcutaneous tissue disorders: Common Flushing of the upper body (“red man syndrome”), exanthema and mucosal inflammation, pruritus, urticaria Very rare Exfoliative dermatitis, Stevens-Johnson syndrome, Toxic epidermal necrolysis (TEN), Linear IgA bullous dermatosis Not known Eosinophilia and systemic symptoms (DRESS syndrome), AGEP (Acute Generalized Exanthematous Pustulosis) Renal and urinary disorders: Common Renal insufficiency manifested primarily by increased serum creatinine and serum urea Rare Interstitial nephritis, acute renal failure Not known Acute tubular necrosis General disorders and administration site conditions: Common Phlebitis, redness of the upper body and face Rare Drug fever, shivering, pain and muscle spasm of the chest and back muscles Description of selected adverse drug reactions Reversible neutropenia usually starting one week or more after onset of intravenous therapy or after total dose of more than 25 g.

for use Oral use only This preparation is for oral use only and is not systemically absorbed. Orally administered Vancomycin capsules are not effective for other types of infections. Potential for systemic absorption Absorption may be enhanced in patients with inflammatory disorders of the intestinal mucosa or Clostridium difficile-induced pseudomembranous colitis.

These patients may be at risk for the development of adverse reactions, especially if there is a concomitant renal impairment. The greater the renal impairment, the greater the risk of developing the adverse reactions associated with the parenteral administration of vancomycin.

Monitoring of serum vancomycin concentrations of patients with inflammatory disorders of the intestinal mucosa should be performed. Nephrotoxicity Serial monitoring of renal function should be performed when treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside or other nephrotoxic drugs.

Ototoxicity Serial tests of auditory function may be helpful in order to minimise the risk of ototoxicity in patients with an underlying hearing loss, or who are receiving concomitant therapy with an ototoxic agent such as an aminoglycoside.

Cardiovascular and cerebrovascular effects Cases of Kounis syndrome have been reported in patients treated with vancomycin. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.

Drug interactions with anti-motility agents and proton pump inhibitors Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered. 8). Most of these reactions occurred within a few days and up to eight weeks after commencing treatment with vancomycin.

At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, vancomycin should be withdrawn immediately and an alternative treatment considered.

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