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:

Hikma Pharmaceuticals USA Inc.

INN (Nome Internazionale):

PENICILLIN V POTASSIUM

Composizione:

PENICILLIN V 250 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis) Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract1 . Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts).  Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association1 . 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 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. A previous hypersensitivity reaction to any penicillin is a contraindication.

Dettagli prodotto:

Penicillin V Potassium Tablets, USP 250 mg (400,000 units) are white round film coated tablets bisected from one side and engraved with “W” on the upper side of the bisect and with “111” on the lower side. Bottles of 100 Bottles of 1000 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 100 Bottles of 1000 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET, FILM COATED
HIKMA PHARMACEUTICALS USA INC.
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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 f