PENICILLIN V POTASSIUM tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Αγόρασέ το τώρα

Κατεβάστε Αρχείο Π.Χ.Π. (SPC)
09-02-2011

Δραστική ουσία:

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

Διαθέσιμο από:

Rebel Distributors Corp

INN (Διεθνής Όνομα):

PENICILLIN V POTASSIUM

Σύνθεση:

PENICILLIN V POTASSIUM 500 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 bacteriological 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 should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal infections – Mild to moderately severe infections of the respiratory tract. Staphylococcal infections – penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE:

Περίληψη προϊόντος:

Penicillin - VK Tablets (Penicillin V Potassium Tablets USP), 500 mg (800,000 units) are oval, biconvex white tablets, engraved S21. NDC 21695-318-12 .......bottles of 12 NDC 21695-318-20 .......bottles of 20 NDC 21695-318-28 .......bottles of 28 NDC 21695-318-40 .......bottles of 40 Store at 20° - 25°C (68° - 77°F) (see USP Controlled Room Temperature). Keep tightly closed. Dispense in a tight container, as defined in the USP. Manufactured for: Dava Pharmaceuticals, Inc. Fort Lee, NJ 07024 USA by: Stada Production Ireland Ltd. Clonmel, Ireland Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

                                PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET
REBEL DISTRIBUTORS CORP
----------
PENICILLIN-VK
PENICILLIN V POTASSIUM TABLETS, USP500 MG (800,000 UNITS)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of penicillin-VK
and other antibacterial drugs, penicillin-VK should be used only to
treat or prevent infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION
_Penicillin V is the phenoxymethyl analog of penicillin G._
_Penicillin V potassium is the potassium salt of penicillin V._
Penicillin -VK (Penicillin V Potassium Tablets USP), for oral
administration, contain 250 mg (400,000
units) or 500mg (800,000 units) penicillin V potassium. In addition,
each tablet contains the following
inactive ingredients: hydroxypropyl methylcellulose, magnesium
stearate, polyethylene glycol,
povidone, talc, and titanium dioxide.
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 
                                
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