PENICILLIN V POTASSIUM powder, for solution

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)
15-02-2012

有効成分:

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

から入手可能:

Physicians Total Care, Inc.

INN(国際名):

PENICILLIN V POTASSIUM

構図:

PENICILLIN V 125 mg in 5 mL

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

                                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
                                
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