CINDOLIN

Posology The dosing recommendations depend on the severity and the type of infection, the age and the hepato-renal function of patients. International guidelines should be considered in addition to national or local guidance for some specific indications (e.

g. syphilis, prophylaxis of rheumatic fever). g. 4 Million IU If clinical symptoms recur or laboratory findings remain strongly positive, treatment should be repeated. 5 kg–30 kg body weight: 1 x 600,000 IU (½ vial) every 3–4 weeks Duration of treatment: a) without cardiac involvement: at least 5 years, or up to 21 years of age b) transient cardiac involvement: at least 10 years, or up to 21 years of age c) persistent cardiac involvement: at least 10 years or up to 40 years of age; life- long prophylaxis is sometimes necessary.

0 15 Proportion of the normal daily dose of benzathine benzylpenicillin 100% 75% 20–50% Dosage interval in 1 single administration in 1 single administration in 2–3 single administrations Haemodialysis patients Benzathine benzylpenicillin can be removed by hemodialysis.

There are no data available on the influence of dialysis on the plasma levels of benzylpenicillin. The decision to treat patients on dialysis with benzathine benzylpenicillin needs therefore to be taken on a case by case basis. Patients with impaired hepatic function In very severe cases of impaired hepatic and renal function, there may be a delay in the degradation and excretion of penicillins.

8) due to a reduced metabolism and elimination of lidocaine or its active metabolites. Paediatric population No adequate dosing data are available for children under 1 month of age. 5 kg in order to avoid exceeding the maximum dose for lidocaine.

In children less than 4 years of age, Cindolin should be used with special caution due to the content of lidocaine. 4). 4). 6. 90 mm), the injection of Cindolin must be made by deep intramuscular injection into the upper outer quadrant of the gluteal musculature in the direction of the iliac crest or by von Hochstetter’s technique.

The needle should be inserted as perpendicularly to the skin surface as possible, and the injection should be made as far away from larger vessels as possible. Always aspirate before injecting. If blood is aspirated or if the patient experiences pain during the injection, the injection must be stopped.

In children, the mid-lateral thigh muscles (m. quadriceps femoris) are recommended as an injection site. The deltoid muscle is only suitable if it is well formed; in this case, attention must be paid to the radial nerve. g. widespread burns), in order to avoid sciatic nerve lesions.

4). In case of repeated administration, the injection site should be changed. The injection should be made as slowly as possible and by applying only little pressure. “Rubbing” after the injection should be avoided. Severe local reactions may occur during intramuscular administration, especially in young children.

4). g. for the treatment of syphilis), repeated injections into a closely confined area in muscle tissue may lead to tissue injury and ingrowth […]

a) Summary of the safety profile Both benzathine benzylpenicillin and lidocaine are substances with an established safety profile. The most frequently reported adverse reactions associated with intramuscular injections of benzathine benzylpenicillin include infiltrates at the injection site, fever and allergic reactions, which predominantly comprise local skin reactions such as rash.

Anaphylactic reactions including life-threatening shock are, however, rare. The possible adverse reactions to lidocaine are essentially those reported for other acid amide-type local anaesthetics. g. after accidental intravenous injection.

Nervous system reactions may consist of dizziness, vomiting and lightheadedness. Apart from these, mild blood pressure increase is among the most frequent adverse reactions. b) Tabulated summary of adverse reactions The reported frequencies of adverse reactions are based on the following categories: 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) Possible adverse reactions to benazathine benzylpenicillin.

8 c) Description of selected adverse reactions Neurotoxic reactions, which are possible with high-dose penicillin therapy, do not occur because of the low plasma levels attained with this depot product.

Possible adverse reactions to lidocaine:

Because of the low lidocaine content and the low frequency of use of Cindolin, the risk of dose-related systemic adverse reactions to lidocaine is low when this product is used as intended. Nevertheless, patients should also be monitored for adverse reactions to lidocaine.

Possible adverse reactions are essentially those reported for other acid amide-type local anaesthetics. g. after accidental intravenous injection, in such cases, they can be very serious, in particular in terms of cardiac and neurologic function.

The undesirable effects are arranged according to body system. The frequency cannot be estimated from the available data. 4. This product contains phospholipids from the soya bean ((3-sn- phosphatidyl)choline), caution is warranted on the risk of allergic reactions.

It cannot be excluded that, in very rare cases and due to the povidone content, povidone may accumulate in the reticuloendothelial system (RES) or local deposits and foreign body granuloma may occur, which may be confused with tumors.

c) Description of selected adverse reactions Allergic reactions occur uncommonly to commonly, anaphylactic reactions including life-threatening shock occur rarely. The frequency of many individual symptoms of allergic reactions cannot be estimated with sufficient accuracy based on the available data.

The usual emergency procedures should be instituted for the management of anaphylactic reactions. Serum sickness may be accompanied by, but is not limited to, fever, joint swelling and allergic rash. g. syphilis) may (usually 2−12 hours after the first dose) be associated with the development of a Jarisch-Herxheimer reaction, characterised by fever, rigors, general and focal symptoms.

Any immediate urticarial reaction must always be considered a serious sign and strictly mandates discontinuation of […]

Benzathine benzylpenicillin Benzathine benzylpenicillin should not be used in tissues with reduced perfusion. 8). Serious and occasionally fatal hypersensitivity reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals.

If an allergic reaction occurs, benzathine benzylpenicillin must be discontinued and appropriate therapy instituted. 2); Adequate post-injection monitoring and the availability of shock management interventions should be ensured whenever using benzathine benzylpenicillin.

If there is evidence of penicillin allergy from earlier treatment, prescribers are expressly warned against the use of depot products. Medical monitoring or on-call availability for at least 1 hour should be ensured because of the possibility of severe immediate-type allergic reactions even with first-time use.

When treating syphilis, a Jarisch-Herxheimer reaction may occur as a result of the bactericidal action of penicillin on pathogens. 2 to 12 hours after administration headaches, fever, sweating, shivering, myalgia, arthralgia, nausea, tachycardia, increased blood pressure followed by hypotension may occur.

These symptoms resolve after 10 to 12 hours. Patients should be informed that this is a usual, transient sequela of antibiotic therapy. 8). In long-term treatment, blood count monitoring and renal function tests are recommended. 8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics.

Should antibiotic-associated colitis occur, benzathine benzylpenicillin should immediately be discontinued, a physician be consulted and an appropriate therapy initiated. Anti-peristaltic drugs are contra-indicated in this situation.

Long-term and repeated use may lead to superinfections with resistant bacteria and yeasts. If neurological involvement cannot be excluded in patients with congenital syphilis, forms of penicillin that reach a higher level in cerebrospinal fluid should be used.

In patients with dermatomycosis, para-allergic reactions may occur when first dosed with benzathine benzylpenicillin because of shared antigenicity between penicillin and dermatophytes. Painful induration may occur in the event of accidental subcutaneous administration.

Ice packs help in such cases. g. tingling, numbness) or tachycardia (accelerated pulse). These symptoms usually resolve completely within 30 minutes, but there have also been reports of death. Accidental intra-arterial or paravascular injection may cause Nicolau’s syndrome.

Apart from signs related to local ischaemia such as pain, pallor, oedema and blistering followed by necrosis, severe forms with shock and disseminated intravascular coagulation as well as disseminated ischaemic and neurological complications including hypaesthesia, paraplegia and sphincter incompetence are possible.

Lidocaine:

Hoigné’s syndrome and Nicolau’s syndrome may be exacerbated by the lidocaine contained in this medicinal product. g. in epilepsy): Also low doses of lidocaine can cause increased convulsive readiness. • cardiac insufficiency • cardiac impulse conduction disorders • bradycardia • respiratory depression Cindolin should be used with particular caution in elderly and generally debilitated patients.

Lidocaine has been shown to be porphyrinogenic in animals and should be avoided in people with porphyria. Inadvertent intravascular administration or overdoses may cause high lidocaine blood concentrations responsible for acute central nervous and cardiovascular toxic symptoms.

Symptoms caused by lidocaine may occur especially after accidental intravascular administration of Cindolin. Inadvertent intravenous administration may trigger systemic reactions immediately (within seconds to a few minutes). In case of an overdose, onset of systemic toxicity is later (15 to 60 minutes after injection) as result of the slower increase in the concentration of the local anaesthetic in the blood.

g. heparin), non-steroidal anti-inflammatory drugs or plasma substitutes as accidental injury of blood vessels may lead to serious bleedings. Effect on diagnostic laboratory procedures: - A positive direct Coombs’ test often develops (≥ 1% to < 10%) in patients receiving 10 Million IU (equivalent to 6 g) benzylpenicillin or more per day.

8). - Determination of urinary protein using […]

1. g. cephalosporin, carbapenem or monobactam). Lidocaine Hypersensitivity to amide-type local anaesthetics. Cindolin is contraindicated in neonates with congenital syphilis. Cindolin is contraindicated in patients with complete heart block.