PENICILLIN V POTASSIUM tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Blenheim Pharmacal, Inc.

DCI (Dénomination commune internationale):

PENICILLIN V POTASSIUM

Composition:

PENICILLIN V 250 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, 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 infect

Descriptif du produit:

Penicillin V Potassium Tablets, USP 250 mg (400,000 units) - White, oval, biconvex tablets engraved S20. NDC 67253-200-10 Bottles of 100 NDC 67253-200-11 Bottles of 1,000 Penicillin V Potassium Tablets, USP 500 mg (800,000 units) -White, oval, biconvex tablets engraved S21. NDC 67253-201-10 Bottles of 100 NDC 67253-201-50 Bottles of 500 NDC 67253-201-11 Bottles of 1,000 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep tightly closed. Protect from moisture. Penicillin V Potassium for Oral Solution, USP, is available as a powder which when reconstituted as directed yields a red color, fruit-flavored solution. NDC 67253-202-10                     125 mg/5 mL-                                                        100 mL individual bottles NDC 67253-202-20                     125 mg/5 mL-                                                        200 mL individual bottles When reconstituted according to the directions, each 5 mL contains Penicillin V Potassium equivalent to 125 mg (200,000 units) of Penicillin V. NDC 67253-203-10                     250 mg/5 mL-                                                        100 ml individual bottles NDC 67253-203-20                    250 mg/5 mL-                                                       200 mL individual bottles When reconstituted according to the directions, each 5 mL contains Penicillin V Potassium equivalent to 250 mg (400,000 units) of Penicillin V. Store the dry powder at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Keep bottle tightly closed. After reconstitution: Store in a refrigerator. Discard unused portion after 14 days.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET
BLENHEIM PHARMACAL, INC.
----------
PENICILLIN V POTASSIUM TABLETS, USP - 250 MG AND 500 MG
PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM FOR SOLUTION
R ONLY
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 cerebrospinal fluid. The drug is excreted as rapidly as it
i