PENICILLIN V POTASSIUM- penicillin v potassium powder, for solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

NuCare Pharmaceuticals, Inc.

Designació comuna internacional (DCI):

PENICILLIN V POTASSIUM

Composición:

PENICILLIN V 125 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Penicillin V potassium tablets, USP are available as follows: 125 mg (200,000 Units) per 5 mL: bottles of 100 mL NDC 68071-1806-1 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.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM POWDER, FOR SOLUTION
NUCARE PHARMACEUTICALS, 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.
DESCRIPTION
Penicillin V is the phenoxymethyl analog of penicillin G.
Penicillin V potassium is the potassium salt of penicillin V.
Each penicillin V potassium tablet, USP contains penicillin V
potassium equivalent to 250 mg (400,000
units) or 500 mg (800,000 units) penicillin V. The inactive
ingredients present are dibasic calcium
phosphate, magnesium stearate, microcrystalline cellulose, and sodium
citrate.
Each penicillin V potassium tablet, USP, 250 mg contains 0.71 mEq
(27.9 mg) of potassium and each
penicillin V potassium tablet, USP, 500 mg contains 1.43 mEq (55.8 mg)
of potassium.
Penicillin V potassium for oral solution, USP is an off-white to
pinkish colored powder, which when
reconstituted as directed, yields a red colored solution with cherry
flavor in which each 5 mL contains
penicillin V potassium equivalent to 125 mg (200,000 units) or 250 mg
(400,000 units) penicillin V.
The inactive ingredients present are cherry flavor, FD&C Red #40,
saccharin sodium, sodium benzoate,
and sugar.
Each 5 mL of reconstituted penicillin V potassium for oral solution,
USP, 125 mg (200,000 units) per 5
mL contains 0.36 mEq (13.9 mg) of potassium. Each 5 mL of
reconstituted penicillin V potassium for
oral solution, USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq
(27.9 mg) of potassium.
Monopotassium (2 _S,_5 _R,_6
_R_)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylate.
CLINICAL PHARMACOLOGY