PENICILLIN V POTASSIUM- penicillin v potassium tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Hikma Pharmaceutical

INN (Међународно име):

PENICILLIN V POTASSIUM

Састав:

PENICILLIN V 250 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Penicillin V Potassium Tablets, USP 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 tiss

Резиме производа:

Penicillin V Potassium Tablets, USP 250 mg (400,000 units) are white round film coated tablets bisected from one side and imprinted 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 imprinted 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 tightly closed. Dispense in a tight container, as defined in the USP using a child-resistant closure. REFERENCES 1. American Heart Association.1984. Prevention of bacterial endocarditis. Circulation 70(6):1123A –1127A. 2. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Test; Approved Standard-Eleventh Edition. CLSI document M02-A11. Clinical and Laboratory Standards Institute, 950West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012. 3. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Test for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition . CLSI document M07-A9. Clinical and Laboratory Standards Institute,950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012. 4. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement .CLSI document M100-S22. Clinical and Laboratory Standards Institute, 950West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012. Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724  USA Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400 Amman 11118 - Jordan Issued August 2013

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET, FILM COATED
HIKMA PHARMACEUTICAL
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PENICILLIN V POTASSIUM TABLETS, USP
250 MG (400,000 UNITS)
500 MG (800,000 UNITS)
RX ONLY
Iss. 08/13
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