Penicillin V Potassium (Page 2 of 2)

PRECAUTIONS

Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.

General

Prescribing penicillin V potassium in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The oral route of administration should not be relied upon in patients with severe illness, or with nausea, vomiting, gastric dilatation, cardiospasm, or intestinal hypermotility. Occasionally patients will not absorb therapeutic amounts of orally administered penicillin.
In streptococcal infections, therapy must be sufficient to eliminate the organism (10-day minimum); otherwise the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated. Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken.

Information for Patients

Patients should be counseled that antibacterial drugs including penicillin V potassium should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When penicillin V potassium is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by penicillin V potassium or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

ADVERSE REACTIONS

Although the incidence of reactions to oral penicillins has been reported with much less frequency than following parenteral therapy, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been reported with oral penicillin.
The most common reactions to oral penicillin are nausea, vomiting, epigastric distress, diarrhea, and black hairy tongue. The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum-sickness like reactions, laryngeal edema, and anaphylaxis.
Fever and eosinophilia may frequently be the only reaction observed. Hemolytic anemia, leukopenia, thrombocytopenia, neuropathy, and nephropathy are infrequent reactions and usually associated with high doses of parenteral penicillin. To report SUSPECTED ADVERSE REACTIONS, contact Rising Health, LLC at 1-833-395-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

The dosage of Penicillin V should be determined according to the sensitivity of the causative microorganisms and the severity of infection, and adjusted to the clinical response of the patient.
The usual dosage recommendations for adults and children 12 years and over are as follows:
Streptococcal Infections
Mild to moderately severe — of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg (200,000 to 400,000 units) every 6 to 8 hours for 10 days.
Pneumococcal Infections
Mild to moderately severe — of the respiratory tract, including otitis media: 250 to 500 mg (400,000 to 800,000 units) every 6 hours until the patient has been afebrile for at least 2 days.
Staphylococcal Infections
Mild infections of skin and soft tissue (culture and sensitive tests should be performed): 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.
Fusospirochetosis (Vincent’s infection) of the oropharynx. Mild to moderately severe infections: 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.
For the prevention of recurrence following rheumatic fever and/or chorea: 125 mg to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis.
For prophylaxis against bacterial endocarditis 1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract: 2 gram of penicillin V (1 gram for children under 60 lbs.) 1 hour before the procedure, and then, 1 gram (500 mg for children under 60 lbs.) 6 hours later.

HOW SUPPLIED

Penicillin V Potassium Tablets USP, 500 mg (800,000 units) are white to off-white, capsule shaped, film-coated tablets, debossed with E and a break line on one side and 8 and 5 separated with a break line on the other side.


NDC 68071-4838-8 BOTTLES OF 28

NDC 68071-4838-3 BOTTLES OF 30
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Dispense in a tight container, as defined in the USP.
Keep tightly closed.
Keep out of reach of children.

REFERENCES

1. American Heart Association.1984. Prevention of bacterial endocarditis. Circulation 70(6):1123A – 1127A.


Distributed by:
Rising Health, LLC
Saddle Brook, NJ 07663
Made in India
Code: TS/DRUGS/57/2003 Revised: 09/2018

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg

PDP
(click image for full-size original)

PENICILLIN V POTASSIUM penicillin v potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4838(NDC:57237-041)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN V POTASSIUM (PENICILLIN V) PENICILLIN V 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K90
MICROCRYSTALLINE CELLULOSE
TALC
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white (White to Off-white) Score 2 pieces
Shape CAPSULE Size 17mm
Flavor Imprint Code E;8;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-4838-8 28 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68071-4838-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065435 04/29/2008
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-4838)

Revised: 06/2022 NuCare Pharmaceuticals,Inc.

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