PENICILLIN V POTASSIUM tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

即購入

ダウンロード 製品の特徴 (SPC)
19-03-2015

有効成分:

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

から入手可能:

Blenheim Pharmacal, Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Penicillin V potassium tablets and penicillin V potassium for oral solution 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 infec

製品概要:

Penicillin V potassium tablets, USP are available as follows: 250 mg (400,000 units): biconvex, oval, mottled, white to off-white, uncoated tablets, debossed “93” on one side and “1172” on the other side in bottles of 100 and 1000. 500 mg (800,000 units): biconvex, oval, mottled, white to off-white, uncoated, scored tablets, debossed “9” to the left of partial bisect and “3” to the right on one side and “1174” on the other side in bottles of 100 and 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, with a child-resistant closure as required. Penicillin V potassium for oral solution, USP is available as follows: 125 mg (200,000 Units) per 5 mL: bottles of 100 mL and 200 mL. 250 mg (400,000 Units) per 5 mL: bottles of 100 mL and 200 mL. Keep tightly closed. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. After reconstitution, solution must be stored in a refrigerator. Discard any unused portion after 14 days. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

                                PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET
BLENHEIM PHARMACAL, INC.
----------
PENICILLIN V POTASSIUM TABLETS, USP PENICILLIN V POTASSIUM FOR ORAL
SOLUTION, USP
1172
1174
4125
4127
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of penicillin V
potassium tablets, penicillin V potassium for oral solution, and other
antibacterial drugs, penicillin V
potassium tablets and penicillin V potassium for oral solution 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 abs
                                
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