Drugplain

Penicillin V Potassium 250 mg/1

Penicillin V Potassium · TABLET · NuCare Pharmaceuticals,Inc.

3 Recalls on RecordCurrently in Shortage
Plain English

Penicillin V Potassium is a tablet containing penicillin v potassium at 250 mg/1, taken oral. Manufactured by NuCare Pharmaceuticals,Inc..

Key Facts

Brand Name
Penicillin V Potassium
Generic Name
Penicillin V Potassium
NDC Code (Product)
68071-2244
Manufacturer
NuCare Pharmaceuticals,Inc.
Strength
250 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA060711
Marketing Start
09/30/1990

Recall History

3 Recalls on Record
Class III02/24/2017

Citron Pharma Llc

Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg

TerminatedVoluntary: Firm initiated
Class II12/16/2021

Teva Pharmaceuticals USA

Subpotent

TerminatedVoluntary: Firm initiated
Class III11/28/2017

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug hypersensitivity460 reports
dyspnoea212 reports
anxiety178 reports
hypersensitivity151 reports
asthma144 reports
condition aggravated144 reports
fatigue136 reports
rash132 reports
pain in extremity122 reports
therapeutic product effect incomplete122 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium 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 are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic 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 re…

Dosage & Administration

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 con…

Warnings

WARNINGS SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (anaphylactic) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH PENICILLIN V POTASSIUM TABLETS, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PENICILLIN V POTASSIUM TABLETS SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including penicillin V potassium tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with…

Contraindications

CONTRAINDICATIONS A previous hypersensitivity reaction to any penicillin is a contraindication.

Adverse Reactions

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.

Frequently Asked Questions

What is Penicillin V Potassium used for?

Penicillin V Potassium contains Penicillin V Potassium. It is a tablet taken oral. Consult your doctor for specific uses.

Is Penicillin V Potassium a controlled substance?

Penicillin V Potassium is not classified as a controlled substance by the DEA.

What is the generic name for Penicillin V Potassium?

The generic name for Penicillin V Potassium is Penicillin V Potassium. There are no other listed brand versions of Penicillin V Potassium.

What is the NDC code for Penicillin V Potassium 250 mg/1?

The NDC (National Drug Code) for Penicillin V Potassium 250 mg/1 is 68071-2244, listed by NuCare Pharmaceuticals,Inc..

Product NDC

68071-2244

Package NDC

68071-2244-6

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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