PENICILLIN V POTASSIUM tablet PENICILLIN V POTASSIUM for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical

INN (International Name):

PENICILLIN V POTASSIUM

Composition:

PENICILLIN V 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 infections - penicillin G sensi

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM TABLET
PENICILLIN V POTASSIUM- PENICILLIN V POTASSIUM FOR SOLUTION
PAR PHARMACEUTICAL
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PENICILLIN V POTASSIUM TABLETS, USP - 250 MG AND 500 MG
PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP - 125 MG/5 ML AND 250
MG/5 ML
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.
DESCRIPTION
Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V
potassium is the potassium salt of
penicillin V. Penicillin V Potassium is designated chemically as
4-Thia-1-azabicyclo [3.2.0] heptane-2-
carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-,
monopotassium salt, [2S-(2α,5α,6β)]-.
It has the following chemical structure:
The molecular formula is C
H KN O S, and the molecular weight is 388.48.
Each tablet contains Penicillin V Potassium equivalent to 250 mg or
500 mg (400,000 or 800,000 units)
of penicillin V.
Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq
(28.2 mg) of Potassium and each
Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg)
of Potassium.
Each tablet also contains the following inactive ingredients: lactose,
NF; magnesium stearate, NF;
microcrystalline cellulose, NF; polyethylene glycol, NF; povidone,
USP; sodium laurel sulfate, NF.
Each 5 mL when reconstituted as directed contains Penicillin V
Potassium equivalent to 125 mg or 250
mg (200,000 or 400,000 units) of Penicillin V.
Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution,
USP, 125 mg per 5 mL contains
0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin
V Potassium for Oral Solution,
USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium.
Each 5 mL of reconstituted sus