PENICILLIN V POTASSIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Penicillin V Potassium Tablets, USP 500 mg (800,000 units) are white modified capsule shaped film coated tablets bisected from both sides and engraved with “W” on one side of the bisect and “112” on the other side. Bottles of 6 NDC 43063-780-06 Bottles of 15 NDC 43063-780-15 Bottles of 20 NDC 43063-780-20 Bottles of 28 NDC 43063-780-28 Bottles of 30 NDC 43063-780-30 Bottles of 40 NDC 43063-780-40 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Dispense in a tight, light-resistant container, as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
PENICILLIN V POTASSIUM TABLETS
250 MG (400,000 UNITS)
500 MG (800,000 UNITS)
Rx Only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
penicillin V potassium tablets and other antibacterial drugs,
penicillin V potassium tablets
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 V Potassium Tablets, USP for oral administration contain
penicillin V potassium
equivalent to 250 mg (400,000 units) or 500 mg (800,000 units)
penicillin V. In addition,
each tablet contains the following inactive ingredients: hydroxypropyl
methylcellulose,
magnesium stearate, polyethylene glycol, povidone, talc, titanium
dioxide and
microcrystalline cellulose.
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