PENICILLIN V POTASSIUM powder, for solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
11-02-2021

Viambatanisho vya kazi:

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

Inapatikana kutoka:

NuCare Pharmaceuticals,Inc.

INN (Jina la Kimataifa):

PENICILLIN V POTASSIUM

Tungo:

PENICILLIN V 250 mg in 5 mL

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

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 and 1000. 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 and 1000. 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 and 200 mL. 250 mg (400,000 Units) per 5 mL: bottles of 100 mL and 200 mL. 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                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

                                
                                Soma hati kamili
                                
                            

Tafuta arifu zinazohusiana na bidhaa hii