PENICILLIN V POTASSIUM powder, for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Physicians Total Care, Inc.

INN (Διεθνής Όνομα):

PENICILLIN V POTASSIUM

Σύνθεση:

PENICILLIN V 125 mg in 5 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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. 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, meningi

Περίληψη προϊόντος:

Penicillin V potassium for oral solution, USP is available as follows: 125 mg (200,000 Units) per 5 mL: bottles of 100 mL [NDC 54868-4125-1] and 200 mL [NDC 54868-4125-2]. 250 mg (400,000 Units) per 5 mL: bottles of 100 mL [NDC 54868-1780-1] and 200 mL [NDC 54868-1780-2]. 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PENICILLIN V POTASSIUM - PENICILLIN V POTASSIUM POWDER, FOR SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
PENICILLIN V POTASSIUM TABLETS, USP / PENICILLIN V POTASSIUM FOR ORAL
SOLUTION, USP
1172
1174
4125
4127
RX 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.
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 PHARM