PENICILLIN V POTASSIUM tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

PENICILLIN V POTASSIUM (UNII: 146T0TU1JB) (PENICILLIN V - UNII:Z61I075U2W)

Commercializzato da:

Blenheim Pharmacal, Inc.

INN (Nome Internazionale):

PENICILLIN V POTASSIUM

Composizione:

PENICILLIN V 500 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures shou

Dettagli prodotto:

Penicillin V Potassium Tablets USP, 250 mg (400,000 units) are white to off-white, round shaped, biconvex, film-coated tablets debossed with ‘E’ and ‘84’ on one side and break line on the other side.                            Bottles of 100                           NDC 16714-234-01                            Bottles of 1000                         NDC 16714-234-02 Penicillin V Potassium Tablets USP, 500 mg (800,000 units) are white to off-white, capsule shaped, film-coated tablets, debossed with ‘E’ and a breakline on one side and ‘8’ and ‘5’ separated with a breakline on the other side.                            Bottles of 100                           NDC 16714-235-01                            Bottles of 1000                         NDC 16714-235-02 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container, as defined in the USP. Keep tightly closed. Keep out of reach of children.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
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PENICILLIN V POTASSIUM TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of penicillin V
potassium and other antibacterial drugs, penicillin V potassium should
be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
CLINICAL PHARMACOLOGY
Penicillin V exerts a bactericidal action against penicillin-sensitive
microorganisms during the stage of
active multiplication. It acts through the inhibition of biosynthesis
of cell-wall mucopeptide. It is not
active against the penicillinase-producing bacteria, which include
many strains of staphylococci. The
drug exerts high _in vitro_ activity against staphylococci (except
penicillinase-producing strains),
streptococci (groups A, C, G, H, L and M), and pneumococci. Other
organisms sensitive _in vitro_ to
penicillin V are _Corynebacterium diphtheriae_, _Bacillus
anthracis,Clostridia, Actinomyces bovis_,
_Streptobacillus moniliformis_, _Listeria monocytogenes, Leptospira,_
and _Neisseria gonorrhoeae_. _Treponema_
_pallidum_ is extremely sensitive.
The potassium salt of penicillin V has the distinct advantage over
penicillin G in resistance to
inactivation by gastric acid. It may be given with meals; however,
blood levels are slightly higher when
the drug is given on an empty stomach. Average blood levels are two to
five times higher than the
levels following the same dose of oral penicillin G and also show much
less individual variation.
Once absorbed, penicillin V is about 80% bound to serum protein.
Tissue levels are highest in the
kidneys, with lesser amounts in the liver, skin, and intestines. Small
amounts are found in all other body
tissues and the cerebrospinal fluid. The drug is excreted as rapidly
as it is absorbed in individuals with
normal kidney function; however, recovery of the drug from the urine
indicates that only about 25% of
the dose given is absorbed.