PROCA-PEN 400.000 

Penicillin G Procaine

Vial 400.000 IU

Proca-pen^®(Penicillin Procaine)

Description

Proca-pen^® is a bactericide antibiotic, with a broad spectrum of bactericidal activity.

Clinical pharmacology

Proca-pen^® inhibits the biosynthesis of cell wall mucopeptide. It is not active against the penicillinase-producing bacteria, which include many strains of staphylococci.

Antibacterial activity

Aerobic and anaerobes Gram-Positive Microorganisms such as:

Bacillus anthracis, clostridium perfringens, Corynebacterium diphteriae, Erysipelothrix rhusiopathiae, Listeria monocytogenes, staphylococci (except penicillinase-producing strains, streptococci Groups A, C, G, H, L, and M, and pneumococci).

Aerobic and anaerobes Gram-Negative Microorganisms such as:

Neisseria meningitides, Neisseria gonorrhoeae although beta - lactamase-producing strains are common. Proteus mirabilis, Eschericha coli, pasteurella multocida, streptobacillus moniliformis, pseudomonas spp., prevotella (non – fragilis bacteroides and Fusobacterium spp).

Pharmacokinetics

Oral absorption ----

Presystemic metabolism ----

Plasma half – life range 30 min

Volume of distribution 0.31.kg^-1

Plasma protein binding ~ 60%

Indication

1- Streptococcal infections

2- Respiratory tract infection

3- Skin and soft tissue infection

4- Fusospirochetosis

5- Syphilis

6- Yaws, bejel, and pinta

7- Diphtheria

8- Anthrax

9- Rat-bite fever

10-Erysipeloid

11-Endocarditis

Contraindication

A previous hypersensitivity reaction to any penicillin or to procaine is a contraindication

Precaution

· Proca-pen^® should be used with caution in individuals with histories of significant allergies and /or asthma

· If renal impairment is known or suspected, reduce the total dosage and monitor blood levels to avoid possible neurotoxic reactions.

· Therapy must be sufficient to eliminate the organism 9 a minimum of 10 days); otherwise, sequelae (eg, endocardities, rheumatic fever) may occur. Take cultures after treatment to confirm that streptococci have been eradicated.

· All cases of penicillin-treated syphilis should receive clinical and serological examinations every 6 months for 2 to 3 years. Test all syphilis patients for HIV infection.

· Proca-pen^® should not be used in the treatment of beta-lactamase producing organisms that include most strains of Nesseria gonorrhea.

· The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. Such overgrowth may lead to a secondary infction. Take appropriate measures if this occurs.

· Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

· If sensitivity to the procaine in penicillin G procaine is suspected, inject 0.1 ml of a 1% to 2% procaine solution intradermally. Development of erythma, wheal, flare, or eruption indicates procaine sensitivity; treat by the usual methods. Do not use procaine penicillin preparations.

Pregnancy

Pregnancy category is B.

Adequate and well-controlled studies in humans have not been done; Penicillins cross the placenta. This drug should be used during pregnancy only if clearly needed.

Breast feeding

Proca-pen^® is excreted in human milk in low concentrations; use may cause diarrhea, candidiasis, or allergic response in the nursing infant, therefore, decide whether to discontinue breast-feeding or Penicillin, taking in to account the importance of the drug to the mother.

Dosage

Usual adult and adolescent dose

· Pneumonia (pneumococcal), moderately severe (uncomplicated):600,000 to1,000,000 units/day.

· Streptococcal infections (group A): moderately severe to severe tonsillitis, erysipelas, scarlet fever, upper respiratory tract, skin and soft tissue: 600,000 to 1,000,000 units/day for 10-day minimum.

· Staphylococcal infections, moderately severe to severe:600,000 to 1,000,000 units/day

· Bacterial endocarditis (group A streptococci) only in extremely sensitive infections: 600,000 to 1,000,000 units/day

· Syphilis: primary , secondary, and latent with a negative spinal fluid :600,000 units/day for 8 days; total 4,800,000 units

- Late (tertiary, neurosyphilis, and latent syphilis with positive spinal-fluid examination or no spinal-fluid examination) 600,000 units/ day for 10 to 15 days; total 6 to 9 million units

- Congenital syphilis under 70 lb body weight: 50,000 units/ kg/day for 10 days

Yaws, bejel, and pinta: Treatment as for syphilis in corresponding stage of disease

· Diphtheria:

- Adjunctive therapy with antitoxin: 300,000 to 600,000 units/day

- Diphtheria carrier state: 300,000 units/day for 10 days

· Fusospirochetosis:

Vincent’s infection: 600,000 to 1,000,000 units/day

· Etysipeloid: 600,000 TO 1,000,000 units/day

· Anthrax:

Anthrax, cutaneous- 600,000 to 1,000,000 units/day