View Drug - Lentocilin
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Lentocilin

Generic: PENICILLIN G BENZATHIN

100%
Basic Information
Manufacturer
LABORATRIOS ATRAL, S.A.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
1a4e5124-618b-ce44-e063-6394a90a43e3
Indications & Usage
Lentocilin S is indicated for the treatment of the following infections in adults and children: - Upper respiratory tract infections, namely group A streptococcal infections - Primary and secondary syphilis - Latent syphilis - Tertiary syphilis (in adults) - Congenital syphilis (in children) - Yaws - Bejel - Pinta Lentocilin S is also indicated prophylactically in the following situations: - Rheumatic fever - Diphtheria (including elimination of the asymptomatic carrier state) Consideration should be given to official guidelines for appropriate use of antimicrobial agents.

indications&usage section
Adverse Reactions
The most common undesirable effects of benzylpenicillin are hypersensitivity reactions, especially skin rashes.

Anaphylactic reactions occurred occasionally, which have sometimes been fatal.

The overall incidence of allergic reactions to penicillin ranges between 1 and 10%.

Anaphylactic reactions occur in approximately 0.05% of patients, usually after parenteral administration.

The following undesirable effects were observed with benzylpenicillin: Blood and lymphatic system disorders - Eosinophilia and hemolytic anemia (both with immunological basis), leukopenia and thrombocytopenia.

These effects are usually reversible after discontinuation of treatment.

Immune system disorders - Hypersensitivity reactions to penicillin cause a wide variety of clinical syndromes.

Immediate reactions include anaphylaxis, laryngeal edema, angioedema, urticaria and maculopapular rashes.

Late reactions include hemolytic anemia and immune complex self-limited sickness-like reactions, characterized by fever, malaise, urticaria, arthralgia, myalgia, lymphadenopathy and splenomegaly.

In order to determine which patients will probably develop severe allergic reactions, hypersensitivity skin tests may be used.

Jarisch – Herxheimer reaction.

Nervous system disorders - Benzylpenicillin is very irritating to the central and peripheral nervous systems.

Neurotoxic reactions include anxiety, asthenia, cerebrovascular accident (CVA), confusion, dizziness, euphoria, nervousness, hallucinations, headache, neuropathy, neurovascular injury, localized or generalized seizures, coma, tremor and vasospasm at the administration site, and occur after parenteral administration of benzylpenicillin potassium.

These reactions are most common when the benzylpenicillin is given daily in doses of more than 20,000,000 IU intravenously to renal impaired patients.

The accidental injection of preparations of benzylpenicillin into or near by the nerves may produce neuromuscular damage, which rarely may be permanent.

Rarely, inadvertent intravascular administration of benzathine benzylpenicillin or procaine benzylpenicillin, including direct administration into an artery - or adjacent to an artery - causes occlusion, thrombosis and severe neurovascular injury, especially in children.

Deep injection in the glutes gluteal muscles can cause paralysis, dysfunction and painful irritation of the sciatic nerve.

Repeated intramuscular injection of benzylpenicillin preparations in the anterolateral side of the thigh of newborns has rarely caused generalized muscular contractions, as well as atrophy and fibrosis of the quadriceps femoris muscle.

After intramuscular administration of benzathine benzylpenicillin may occurs Hoigné syndrome may occur, characterized by agitation accompanied by symptoms such as fear of impending death and visual and auditory hallucinations.

Transversal myelitis with permanent paralysis, gangrene requiring amputation of fingers and the more proximal regions of the extremities, and necrosis with formation of scars surrounding the site of injection, have occurred after injections in the buttocks, thighs and deltoid muscle.

Eye disorders - Blurred vision, transient blindness.

Cardiac disorders - Hypotension, palpitations, syncope, tachycardia, vasodilation and vasovagal syndrome characterized by anxiety, sweating, hypotension, peripheral arterial vasodilation and bradycardia.

Cardiopulmonary arrest and death due to inadvertent IV administration.

Respiratory, thoracic and mediastinal disorders - Apnea, dyspnea, hypoxia, pulmonary embolism and pulmonary hypertension.

Gastro-intestinal disorders - Intestinal necrosis, melena, nausea, vomiting, and pseudomembranous colitis, which can arise during or after treatment.

Hepatobiliary disorders - Transient increases in SGOT, hepatitis and cholestatic jaundice.

Skin and subcutaneous tissue disorders - Diaphoresis, pruritus and urticaria.

Musculo-skeletal, connective tissue and bone disorders - Arthritis, arthropathy, myoglobinuria, periostitis and rhabdomyolysis.

Renal and urinary disorders - Hematuria, neurogenic bladder, renal impairment, proteinuria and increased serum BUN and creatinine.

Reproductive system and breast disorders - Impotence and priapism General disorders and administration site conditions - Parenteral administration of benzylpenicillin preparations may cause dose-related injection site reactions dose-related and are the result of a direct toxic effect of the drug.

IM administration of high doses of benzylpenicillin benzathine (in particular more than 600,000 IU of benzylpenicillin) in a single injection site can result in painful tumefaction and endothelial injury on site.

IM administration of benzylpenicillin has been associated with the occurrence of the following side effects at the administration site: inflammation, pain, abscess, edema, hemorrhage, cellulitis, atrophy and cutaneous ulceration.

It has also been reported cases of fever and fatigue associated with the use of benzylpenicillin.