Pemapen Crystalline Penicillin Injection 1 Mega

Pemapen

Crystalline Penicillin Injection 1 Mega

 

COMPOSITION/ACTIVE INGREDIENT

Each vial contains Benzyl penicillin Sodium B.P. 1,000,000 IU (600mg) powder for reconstitution to be dissolved in 2ml water for injection.

 

CHEMICAL NAME

4-Thia-1-azabicyclo(3.2.0)-heptane-2-carboxylic acid, 2, 3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-[2s-(2α,5a,6β)]-mono sodium

 

MOLECULAR FORMULA

C16H17N2O4S

 

MOLECULAR WEIGHT

356.37g/mol

 

PHARMACOLOGY

Penicillin G. is the semi-synthetic antibiotic derived from the fungi, ‘penicillium notatum’. It is bactericidal against most strains of bacteria susceptible to it (except the penicillinase producing strains). It acts by inhibiting the biosynthesis of cell wall mucopeptide during the stage of active multiplication.

Peak serum concentration is attained immediately after completion of IV infusion, with a serum half life range of 31-50 minutes. There is an inverse relationship of serum half-life with age and creatinine clearance (T½ =3.2 hours in infants 0-6 days; 1.4 hours in infants 14 days and over).

Penicillin G is wildly distributed in the body including lungs, liver, kidney, muscles, bones, placenta, etc. However, penetration into the eye, brain, cerebral-spinal fluid (CSF) or prostrate is poor, but may improve with inflammation. It is predominantly cleared via the kidney and excreted in urine.

 

INDICATION

PEMAPEN injection is used for the treatment of serious infections like Septicemiempyema, pneumonia, pericarditis, endocarditis, meningitis, etc caused by penicillin-sensitive organisms. E.g. Strep. pyrogeus, Bacillus Antracis, Clostridum Species, Nesseria spp., E. coli etc.

 

DOSAGE

The dose of PEMAPEN and duration of treatment usually depend on the infecting organism and severity of the infection.

 

FOR ADULTS (16years and above)

150,000 IU (90mg)/kg body weight per day in 4 divided doses given every 4-6 hours.

In more severe infections, up to 250,000 IU (150mg) /kg body weight/day in 4 divided doses may be used.

Most infections will resolve between 7 to 14-day therapy except in rat-bite fever/Haverhill fever (with endocartis caused by S. moniliformis) when the treatment may extend to 4 weeks.

 

IN CHILDREN WEIGHING LESS THAN 45kg

Half the adult dose or 100,000IU (60mg) /kg body weight/day should be used and increased according to the severity of the infection.

Incomplete development of renal function in newborns may delay the elimination of penicillin. Reduction in dose and frequency is therefore advised in this category of patients with close monitoring even when the treatment is initiated. Doses should be individualized and calculated using body weight.

 

METHOD OF RECONSTITUTION

Tap vial to loosen powder. Dissolve powder with 3ml of water for injection or normal saline. Shake to produce a homogeneous solution reedy for administration.

 

ADVERSE EFFECTS

Adverse effects include phlebitis and thrombophlebitis at IV administration sites, renal tubular damage and interstitial nephritis, neuro-toxic reactions, twitches, seizures, coma, congestive heart failure, high sodium electrolyte disturbance, neurophenia, pseudo membrenous colitis, immediate and delayed hypersensitive reactions, Jarisoh-hexheimer reactions. These, however, are more associated with very high dosages of Penicillin G.

 

CONTRA-INDICATION

PEMAPEN is contra-indicated in persons sensitive to penicillin.

 

SIDE-EFFECTS

Side effects include diarrhoea, urticaria, erythema, dermatitis, vomiting, fever, nausea, rash and super infections (candiditis).

 

INTERACTIONS

Aspirin, Sulphonamides, indometacin and diuretics compete with Penicillin G for renal-tubular secretions, and when given together may prolong serum half-life of penicillin.

Probenicid also blocks tubular excretion of Penicillin G and may increase serum level when given together.

Bacteriostatic antibiotics like chloramphenicol, erythromycin, tetracycline, etc may antagonize the bactericidal effects.

 

PREGNANCY/LACTATION

Studies in rats and rabbits have not shown any adverse effects on the foetus. There is need, for caution, however, since the studies are not exhaustive.

 

PRECAUTIONS

Extra caution required in patients with asthma and a history of allergy. High doses should be administered slowly, considering the electrolyte imbalance of the sodium content. Withdraw therapy if allergy occurs, and seek physician’s advice/initiate appropriate measures. Excessive use of antibiotics may promote overgrowth and super infections of non-susceptible strains including fungi.

 

SHELF-LIFE

Three (3) years.

 

STORAGE

Store in a cool, dry place, below 30°C, away from light.

 

PACKAGE

In 7m1 vials; 10 vials in a pack; 10 packs in a carton.

 

NAFDAC REG NO.: A4-5115

 

Manufactured by

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

NO. 47 Fengshou Road, Shijiazhuang City, China

 

Marketed by

Pemason Pharmaceuticals Ltd.

7, Agege Motor Rd, Alakara Mushin, Lagos.

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Omogo

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