RETARPEN. 1 vial
Retarpen is a depot preparation of penicillin G, intended for deep intramuscular injection. In appropriate concentrations acting bactericidal against sensitive to penicillin proliferating microorganisms by inhibiting the biosynthesis of cell walls.
Due to its specific pharmacokinetic data spectrum of activity is limited to microorganisms, highly sensitive to penicillin as streptococci of groups A, C, G, H, L and M, Streptococcus pneumoniae, penicillinase-non producing staphylococci and neyserii; Erysipelothrix rhusiopathiae, Listeria, corynebacteria, Bacillus anthracis, actinomycetes, streptobatsili, Pasteurella multocida, Spirillum minus and spirochetes as Leptospira, treponema, Borrelia, etc .; sensitive are also a number of anaerobes as peptokoki, peptostreptokoki, fuzobakterii, clostridia. Only some of enterococcal strains (streptococcus group D) are sensitive.
What is Retarpen?
Retarpen be used in the treatment and prevention of infections caused by highly penicillin microorganisms:
Retarpen used alone for the treatment of:
- Acute tonsillitis
- Erysipelas (chronic) erizipeloid
- Infected wounds and wounds from bites
- Syphilis (in cases of primary syphilis is a sufficient dose)
- Other treponemal infections (frambeziya, Beja, pint).
Retarpen be used alone to prevent:
- Rheumatism (chorea, rheumatic heart damage)
- Poststreptokokov glomerulonephritis
- Scarlet (contact)
- Syphilis (contact)
When not to apply Retarpen?
- Known hypersensitivity to penicillin or any of the excipients of the medicinal product. Be considered possible cross allergy in case of hypersensitivity to cephalosporins.
- In diseases such as severe pneumonia, empyema, sepsis, pericarditis, meningitis, peritonitis or arthritis, which require high concentration of penicillin in serum, treatment should be initiated with fast water soluble salt of benzylpenicillin.
- In the event that, in patients with congenital syphilis neurological changes can not be ruled out, should be used formulations whose dosage provides higher concentrations of the penicillin in the cerebrospinal fluid.
- Special attention should be paid in patients with allergic diathesis or with bronchial asthma.
When necessary precautions when applying Retarpen?
- Patients should be informed of the possible occurrence of allergic reactions and instructed to report them. Before starting treatment, patients should be screened for hypersensitivity. Special attention should be paid to patients with allergic diathesis or with bronchial asthma. Patients should be monitored 30 minutes after administration of the product ready for injection of epinephrine as needed. In the event of an allergic reaction to drug administration should be discontinued immediately and begin usual treatment with epinephrine, antihistamines and corticosteroids.
- For suppression or amelioration of reactions Jariscn-Herxheimer (see "side effects") during the administration of the first dose of the antibiotic may be administered 50 mg prednisolone or the like steroid. In patients with cardiovascular syphilis or meningovaskularen reactions Jarisch-Herxheimer can be prevented by administration of prednisolone 50 rng I day or another similar steroid for 1-2 weeks.
- In patients with diabetes should be considered delayed absorption of intramuscular depot.
- Validation of blood and study of kidney function during prolonged treatment. With prolonged treatment should be given to the possibility for the development of resistant organisms. Patients developed secondary infections should be treated appropriately.
- In patients treated for venereal diseases, if there is suspicion of concomitant syphilis should be made microscopic and serological tests before starting treatment and then for at least 4 months. In patients with congenital syphilis CSF should be examined before commencement of treatment.
- Severe and persistent diarrhea should arouse suspicion of pseudomembranous colitis provoked by antibiotics (watery diarrhea with blood and mucus diffuse dull or cramping abdominal pain, fever and sometimes painful colic), which can be life-threatening. In these cases the application of Retarpen should be discontinued immediately and to appoint a specific treatment according to the results of bacteriological testing (eg. Oral vancomycin 250 mg four times daily).
Adoption of antiperistaltichni products is contraindicated.
- To avoid damage to the sciatic nerve in infants and young children the drug should not be injected into the upper outer quadrant of the buttock with the exception of some specific cases, eg. with extensive burns.
- Retarpen should be injected subcutaneously, intravenously or intrathecally, or in body cavities. Subcutaneous injection (inadvertently) can cause painful uppatnenie. The pain disappeared after putting ice on the area. Inadequate intravascular injection can cause syndrome Hoigne (symptoms of shock, a real threat to life, confusion, hallucinations, sometimes also cyanosis, tachycardia and motor abnormalities, but without circulatory collapse). Propensity to mikroembolizam suspension causing these symptoms disappear spontaneously after 1 hour. In severe cases, patients must be administered by injection sedative medications. Especially in children inadequate arterial injection can cause severe complications such as blockage of the blood vessel thrombosis and gangrene. They are preceded by blanching of the skin of the buttock. If injected under pressure, fluid injection may fall in the flow of large iliac arteries, aorta or spinal artery.
What other products influence the effect of Retarpen or may be affected by product?
As penicillins act only against proliferating microorganisms Retarpen should not be combined with bacteriostatic antibiotics. Combination treatment with other antibiotics should be performed only if expected synergistic or at least additive effect. Except in cases of proven synergistic effect doses of participating in the combination drugs must comply with their therapeutic doses.
In order to exclude unwanted chemical interactions applying Retarpen with other substances in the syringe should be avoided. Found compatibility of benzylpenicillin with alcohols, glycerol, polyethylene glycol, sugars, acids, amines, aminoacridine hydrochloride, ephedrine, procaine, metal ions (in particular those of copper, zinc, mercury), the rubber stopper of the infusion bag, thiamine hydrochloride, zinc oxide, oxidants, oxidized cellulose, iodides, thiols, thiomersal, chlorocresol and resorcinol.
What special precautions should be taken during pregnancy and lactation?
So far, no evidence of embryotoxic, teratogenic or mutagenic effects in the application of benzathine benzylpenicillin during pregnancy. It must be borne in mind that benzatinbenzilpenitsilin can pass into breast milk.
What to be aware when driving, operating machinery or insecure (eg. Climbing stairs)?
No data Retarpen influence on the ability to drive or operate machinery.
Dosage, method and duration of administration:
Retarpen dosage depends on the severity of the infection and is determined only by the doctor!
How much and how often you can apply Retarpen?
Treatment of syphilis:
1) Congenital syphilis in neonates and infants (without neurological symptoms) - half dose Retarpen
2.4 injected in two places.
2) Primary, secondary, latent syphilis
1 dose Retarpen2.4, injected in two places
2 doses Retarpen 2.4, injected in two places.
Treatment should be repeated if relapse or if laboratory tests have lasting positive.
c) late (tertiary HIV-positive):
1-2 doses Retarpen2.4 weekly for 3 to 5 weeks.
Treatment of frambeziya:
Adults and children over 12 years: LA 1 dose of Retarpen® 2.4.
Persons who are in contact and those with latent infections are appointed
reduced by half doses.
Treatment of pint: Children: LA dose of Retarpen® 2.4. Adults: 1 dose of Retarpen2.4
Prevention of scarlet fever in contact:
Children under 12 years: 1/2 dose Retarpen 2.4 per week.
Adults: 1 dose Retarpen2.4.
For the prevention of complications, patients with streptococcal infection must be treated for at least 10 days. This can be achieved with a dose of 14 Retarpen 2.4 in children over 12 years and 1 dose Retarpen 2.4 in adults.
Dosage in patients with renal insufficiency
In these patients dosing is determined by the creatinine clearance.
Administration: Deep intramuscular injection.
For intramuscular injection, the vial contents dissolve in less than 5 ml water for injections.
Shake vigorously for 20 seconds and apply immediately using needle size at least 0.9 mm. Get no more than one dose. Use only freshly prepared suspensions. Before the dose aspirate to ensure that the needle has entered a blood vessel. Repeated dose vary the injection.
Administer by deep intramuscular injection into the upper outer quadrant of the buttock or ventrikuloglutealnata area Hochstetter. Children preferred application srednostranichno thigh (musculus quadriceps femoris). Use only the deltoid muscle injection, if well developed; keep radial nerve.
Maximum tolerable volume at the injection site was 5 ml. Therefore should not apply more than 5 ml.
Do not apply more than 50 mg povidone (equivalent to 1 dose Retarpen 2.4) of one single injection site. If necessary, inject a high unit dose (eg. 2 doses Retarpen® 2.4) in two different places.
What should I do if Retarpen was administered in very large amounts (intentional or inadvertent overdose)?
Symptoms of overdose largely overlap profile of adverse reactions. Possible gastrointestinal complaints and disorders of fluid and electrolyte balance.
There is no specific antidote for overdose. Treatment consists of
hemodialysis, gastric lavage or symptomatic measures while maintaining fluid and electrolyte balance.
Children under 12 years old: 1/2 dose Retarpen 2.4 at intervals of 2 to 4 weeks. Adults: 1 1/2 IME Retarpen2.4 dose once a week.
Dosage for prophylaxis
Prevention of recurrent rheumatic fever, rheumatic endocarditis. chorea, poststreptokokov glomerulonephritis and erysipelas: Children under 12 years: 1/2 dose Retarpen 2.4 at intervals of 4 weeks. Adults: 1/2 to 1 dose Retarpen 2.4 at intervals of 4 weeks.
What side effects can cause the application of Retarpen?
Allergic reactions are common. Possible allergic reactions include urticaria, angioneurotic edema, erythema multiforme, exfoliative dermatitis, fever, joint pain or anaphylactic shock with collapse and anaphylactoid reactions (asthma, purpura, gastrointestinal symptoms).
Gastrointestinal side effects
Rarely observed inflammation of the mouth and tongue. In patients who develop diarrhea during treatment must be considered likely to pseudomembranous colitis (see. Special warnings and precautions for use).
Haematological adverse reactions
A positive direct test of Coombs, hemolytic anemia, leukopenia, thrombocytopenia and agranulocytosis have been reported, but extremely rare.
Other side effects
Patients treated for syphilis can develop secondary Jarisch-Herxheimer reaction to bakterioliza.
In infants may show local reactions.
Although very rare, accumulation of povidone in the reticuloendothelial system, or topical injections and granuloma-like tumors can not be excluded.
What measures should be taken in relation to side effects?
If you notice any of these side effects, please inform your doctor. He / she will decide, depending on their weight, what measures to take.
Please tell your doctor if you notice any side effects not listed in this leaflet.
Keep out of reach of children!
The product should be stored in the original container in the dark at a temperature below 25 ° C.
The shelf life of the product is printed on the packaging. Do not use after the expiry date!