Dyna Teicoplanin 400 Mg Oral Solution

DYNA TEICOPLANIN is indicated for the treatment of a wide variety of serious Gram-positive infections, including those Gram-positive infections which cannot be treated with other antimicrobial medicines.

DYNA TEICOPLANIN is indicated for the treatment of the following infections caused by teicoplanin sensitive bacteria:

• Blood infections: Septicaemia due to Staphylococcus aureus, Listeria monocytogenes, Clostridium difficile, coagulase negative staphylococci (sensitive or resistant to methicillin), streptococci and enterococci.
• Respiratory infections caused by methicillin-resistant Staphylococcus aureus, streptococci and Gram-positive anaerobes including peptococci.
• Cardiac infections: Endocarditis due to Staphylococcus aureus, Corynebacterium jeikeium, Listeria monocytogenes, coagulase negative staphylococci (sensitive or resistant to methicillin), streptococci and enterococci.
• Skin and soft tissue infections caused by Staphylococcus aureus, coagulase negative staphylococci (sensitive or resistant to methicillin), streptococci, micrococci and Gram-positive anaerobes including peptococci.
• Urinary tract infections caused by enterococci.
• Bone infections: Osteomyelitis due to staphylococcus aureus, coagulase negative staphylococci (sensitive or resistant to methicillin), streptococci, enterococci and Gram-positive anaerobes.
• Peritonitis associated with chronic ambulatory peritoneal dialysis (CAPD) due to Staphylococcus aureus and enterococci.

DYNA TEICOPLANIN may be used as prophylaxis in high risk patients unable to receive penicillin in orthopaedic and vascular surgery at risk of Gram-positive infection.

DYNA TEICOPLANIN 200 may be used orally for the treatment of antibiotic-associated diarrhoea, including pseudomembranous colitis, caused by Clostridium difficile.

The majority of patients, with infections caused by organisms sensitive to DYNA TEICOPLANIN, show a therapeutic response within 2 to 3 days. The duration of therapy is determined by the type and severity of the infection, and the clinical response of the patient. In endocarditis and osteomyelitis, treatment for three weeks or longer is recommended.

Determination of DYNA TEICOPLANIN serum concentrations may optimise therapy. In severe infections, trough serum concentrations should not be less than 10 mg per litre. Peak concentrations measured one hour after a 400 mg intravenous dose are usually in the range of 20 to 50 mg per litre; peak serum concentrations of up to 250 mg per litre have been reported after intravenous doses of 25 mg/kg. No relationship has yet been established between plasma concentration and toxicity.

Adults and elderly patients with normal renal function:

Moderate infections: Skin and soft tissue infections, urinary tract infections, lower respiratory tract infections.

• Loading dose: One single IV injection of 400 mg on the first day.
• Maintenance dose: A single IV or IM injection of 200 mg daily.

Severe infections: Joint and bone infections, septicaemia, endocarditis.

• Loading dose: 400 mg IV injection every 12 hours for the first three doses.
• Maintenance dose: A single IV or IM injection of 400 mg daily.

In some clinical situations, such as infected, severely burned patients or Staphylococcus aureus endocarditis, unit maintenance doses of up to 12 mg/kg may be required.

Note: Standard doses of 200 mg and 400 mg are equivalent to mean doses of 3 mg/kg and 6 mg/kg respectively. In overweight patients it is recommended that the dose be adapted to the weight of the patient as follows: moderate infections 3 mg/kg; severe infections 6 mg/kg.

Prophylaxis in orthopaedic and vascular surgery at risk of Gram-positive infection: 400 mg intravenously as a single dose at induction of anaesthesia.

DYNA TEICOPLANIN 200 mg: Oral treatment of antibiotic-associated diarrhoea, including pseudomembranous colitis, caused by Clostridium difficile: After reconstitution, the contents of the vial may be administered as an oral solution. The DYNA TEICOPLANIN solution is tasteless.

Dosage: 200 mg orally twice a day for 10 days.

Monitoring the plasma concentrations: If checks are carried out on the DYNA TEICOPLANIN serum level in patients with severe infections, then the minimum serum level should not be below 10 mg per litre (measured just before the following dose).

Special populations

Adults and elderly patients with renal insufficiency: For patients with impaired renal function, reduction of the dose is not required until the fourth day of treatment. From the fourth day of treatment:

• In mild renal insufficiency: Creatinine clearance between 40 mL and 60 mL per minute: The dose of DYNA TEICOPLANIN should be halved; either by administering the initial unit dose every two days or by administering half the initial unit dose once a day.
• In severe renal insufficiency: Creatinine clearance less than 40 mL per minute and in haemodialysed patients: The dose of DYNA TEICOPLANIN should be one third of the normal dose; either by administering the initial unit dose every third day, or by administering one third of the unit dose once a day.

DYNA TEICOPLANIN is not removed by dialysis. Unless measurement of the serum concentrations can be guaranteed to accompany the therapy, patients with a creatinine clearance lower than or equal to 20 mL per minute must be excluded from therapy with DYNA TEICOPLANIN.

In continuous ambulatory peritoneal dialysis: After a single intravenous loading dose of 400 mg, if the patient is febrile, the recommended dosage is 20 mg per litre, per bag, in the first week; 20 mg per litre in alternate bags in the second week; and 20 mg per litre in the overnight dwell bag only, in the third week. Do not keep mixed solutions for longer than 24 hours.

Paediatric population: DYNA TEICOPLANIN can be used to treat Gram-positive infections in children and infants older than three years. For severe infections and neutropenic patients, the recommended dose is 10 mg/kg every 12 hours, by intravenous injection, for the first three doses. Thereafter a dose of 10 mg/kg should be administered by either intravenous or intramuscular injection as a single dose each day. For moderate infections the recommended dose is 10 mg/kg, by intravenous injection, every 12 hours for the first three doses. Thereafter a dose of 6 mg/kg should be administered by either intravenous or intramuscular injection as a single dose each day.

Method of administration: The reconstituted DYNA TEICOPLANIN injection is given intravenously as a bolus or by 30 minute infusion or by intramuscular injection. A once daily dosage regime is usually followed but, in cases of severe infection, a second injection should be administered on the first day in order to reach the required serum concentrations more rapidly.

Administration: The entire contents (3,2 mL water for injection) of DYNA TEICOPLANIN SOLVENT in the accompanying ampoule is used to reconstitute the lyophilised teicoplanin to produce the ready-to-use solution by slowly injecting the solvent into the vial with the dry substance. The vial is then rolled, not shaken, until the lyophilised powder is completely dissolved. Care must be taken to avoid the formation of foam. The solution must be left to stand for approximately 15 minutes if foam develops during the preparation of the injection solution, to allow for the foam to disappear.

For intravenous injection, DYNA TEICOPLANIN is injected either directly intravenously; or into the proximal end of a drip line after clamping the line. DYNA TEICOPLANIN can be injected as a bolus within one minute. DYNA TEICOPLANIN can be administered by infusion, it is dissolved in 20 mL to 50 mL of infusion solution and administered over 20 to 30 minutes by the infusion route. DYNA TEICOPLANIN can also be injected intramuscularly.

For the purposes of infusion, the following infusion solutions are suitable for mixing with DYNA TEICOPLANIN:

• 0,9 % sodium chloride solution (saline)
• Ringeru2019s Lactate solution
• Hartman solution
• 5 % glucose solution
• 0,18 % sodium chloride and 4 % dextrose solution.

Reconstituted solutions of DYNA TEICOPLANIN should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 u2013 8 u00b0C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions. Incompatibilities: Solutions of DYNA TEICOPLANIN and aminoglycosides are incompatible and should not be mixed before injection.

Duration of DYNA TEICOPLANIN treatment: With infections caused by DYNA TEICOPLANIN-sensitive pathogens, a therapeutic result is shown in the majority of cases within 48 to 72 hours. The duration of treatment with DYNA TEICOPLANIN depends on the severity of the infection as well as upon the bacteriological and clinical progress. DYNA TEICOPLANIN treatment should be continued for at least three days after the disappearance of clinical symptoms and after the patient has become afebrile. In cases of endocarditis or osteomyelitis at least three weeks of DYNA TEICOPLANIN treatment is recommended. DYNA TEICOPLANIN should not be administered for longer than four months.

• Hypersensitivity to teicoplanin or to any of the ingredients of DYNA TEICOPLANIN (see section 6.1).
• Safety and efficacy have not been established in children less than three years of age.
• Pregnancy and lactation (see section 4.6).
• DYNA TEICOPLANIN must not be injected into the subarachnoid space (see section 4.4).

• DYNA TEICOPLANIN should be administered with caution in patients known to be hypersensitive to vancomycin since cross hypersensitivity including fatal anaphylactic shock, may occur.
• Infusion related reactions such as red man syndrome (a complex of symptoms including pruritus, urticaria, erythema, angioedema, tachycardia, hypotension, dyspnoea) has been observed with DYNA TEICOPLANIN. Stopping or slowing the infusion may result in cessation of these reactions. Infusion related reactions can be limited if the daily dose is not given via bolus injection but infused over a 30 minute period.
• Life-threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with the use of DYNA TEICOPLANIN. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present DYNA TEICOPLANIN, treatment should be discontinued immediately.
• Since data on safety are limited on loading dose regimen, patients should be carefully monitored for adverse reactions when DYNA TEICOPLANIN doses of 12 mg/kg body weight twice a day are administered. Under this regimen blood creatinine values should be monitored in addition to the recommended periodic haematological examination. DYNA TEICOPLANIN should not be administered by intraventricular route, due to the risk of seizure.
• Thrombocytopenia has been reported especially with higher than recommended doses. Periodic haematological examinations are recommended during treatment, including complete cell blood count.
• Renal failure has been reported with DYNA TEICOPLANIN. Patients with renal insufficiency should be carefully monitored by carrying out regular checks on serum level as well as on kidney and auditory function. Dosage adjustments are required in renal impairment.
• DYNA TEICOPLANIN is not recommended in patients with a creatinine clearance lower than or equal to 20 mL per minute.
• Liver function tests are advised during treatment with DYNA TEICOPLANIN.
• Ototoxicity (deafness and tinnitus) has been reported in patients treated with DYNA TEICOPLANIN (see section 4.8). Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with DYNA TEICOPLANIN should be carefully evaluated and monitored, especially in case of prolonged treatment and in patients with renal insufficiency.
• The use of DYNA TEICOPLANIN, especially if prolonged, may result in overgrowth of non-susceptible organisms. Continued evaluation of the patientu2019s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

In general, periodic blood counts, and renal, liver and auditory function tests are advised in the following cases:

• prolonged treatment in patients with pre-existing renal insufficiency
• in patients receiving other neurotoxic and/or nephrotoxic medicines such as the aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and ethacrynic acid. However, there is no evidence of synergistic toxicity when DYNA TEICOPLANIN is used in combination with the above medicines
• DYNA TEICOPLANIN may not be administered into the subarachnoid space (see section 4.3).

Spectrum of antibacterial activity

Teicoplanin has a limited spectrum of antibacterial activity (Gram-positive). It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin. The rational use of teicoplanin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient. On this basis it is expected that in most instances DYNA TEICOPLANIN will be used to treat severe infections in patients for whom standard antibacterial activity is considered to be unsuitable.

• DYNA TEICOPLANIN and aminoglycoside solutions are incompatible and must not be mixed for injection; however, they are compatible in dialysis fluid and may be freely used in the treatment of CAPD-related peritonitis.
• Concomitant or sequential use of DYNA TEICOPLANIN with medicines known for their ototoxic and/or nephrotoxic properties including aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and ethacrynic acid, should be used with caution. The required patient monitoring is to be followed (see section 4.4).
• There is no evidence of synergistic toxicity in combinations with DYNA TEICOPLANIN.
• Studies indicate no evidence of adverse interaction in patients administered DYNA TEICOPLANIN who are already receiving various medications, including other antibiotics, antihypertensives, anaesthetics, cardiac medicinal products and antidiabetic medicines.

Pregnancy

The safety of DYNA TEICOPLANIN has not been established and it should not be used during pregnancy (see section 4.3).

Breastfeeding

It is not known whether DYNA TEICOPLANIN passes into breast milk. The safety of DYNA TEICOPLANIN has not been established and it should not be used during lactation (see section 4.3).

Fertility

Animal reproduction studies have not shown evidence of impairment of fertility.

DYNA TEICOPLANIN has minor influence on the ability to drive and use machines. DYNA TEICOPLANIN can lead to dizziness and patients should be aware how they react to DYNA TEICOPLANIN and exercise caution before driving, operating hazardous machinery or performing hazardous tasks.

Tabulated summary of adverse reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8. An email can be sent directly to the company, [email protected] to ensure safety of the product.

Signs and symptoms: Available information on two children with agranulocytosis to whom several doses of 100 mg per kg body weight per day were administered in error, shows that despite very high serum concentrations of 300 mg per litre, no intoxication phenomena appeared.

Management of overdose: General symptomatic and supportive measures are recommended for the management of an overdose. DYNA TEICOPLANIN is not removed by haemodialysis or peritoneal dialysis.