PENICILLIN V POTASSIUM tablet 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:

Teva Pharmaceuticals USA, Inc.

INN (Διεθνής Όνομα):

PENICILLIN V POTASSIUM

Σύνθεση:

PENICILLIN V 250 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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 (NDC 0093-1172-01) and 1000 (NDC 0093-1172-10). 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 (NDC 0093-1174-01) and 1000 (NDC 0093-1174-10). 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 (NDC 0093-4125-73) and 200 mL (NDC 0093-4125-74). 250 mg (400,000 Units) per 5 mL: bottles of 100 mL (NDC 0093-4127-73) and 200 mL (NDC 0093-4127-74). 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET
PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM POWDER, FOR SOLUTION
TEVA PHARMACEUTICALS USA, INC.
----------
PENICILLIN V POTASSIUM TABLETS, USP
PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP
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 sucrose.
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]hepta