Penicillin V Potassium (Penicillin V Potassium)

Trade Name : Penicillin V Potassium

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 250 mg/1

PENICILLIN V POTASSIUM Penicillins [CS],Penicillin-class Antibacterial [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Penicillin V Potassium (Penicillin V Potassium) which is also known as Penicillin V Potassium and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 250 mg/1 per ml. Read more

Penicillin V Potassium (Penicillin V Potassium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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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.

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 (256)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.

Penicillin V exerts a bactericidal action against penicillin-sensitive microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall mucopeptide. It is not active against the penicillinase-producing bacteria, which include many strains of staphylococci. The drug exerts high activity against staphylococci (except penicillinase-producing strains), streptococci (groups A, C, G, H, L, and M), and pneumococci. Other organisms sensitive to penicillin V are , , , , , , , and is extremely sensitive.
The potassium salt of penicillin V has the distinct advantage over penicillin G in resistance to inactivation by gastric acid. It may be given with meals; however, blood levels are slightly higher when the drug is given on an empty stomach. Average blood levels are two to five times higher than the levels following the same dose of oral penicillin G and also show much less individual variation.
Once absorbed, penicillin V is about 80% bound to serum protein. Tissue levels are highest in the kidneys, with lesser amounts in the liver, skin, and intestines. Small amounts are found in all other body tissues and the cerebrospinal fluid. The drug is excreted as rapidly as it is absorbed in individuals with normal kidney function; however, recovery of the drug from the urine indicates that only about 25% of the dose given is absorbed. In neonates, young infants, and individuals with impaired kidney function, excretion is considerably delayed.

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

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
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.
Staphylococcal infections
NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections.
Fusospirochetosis
NOTE: Necessary dental care should be accomplished in infections involving the gum tissue.
Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions.
Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen.
NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.n
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 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.

A previous hypersensitivity reaction to any penicillin is a contraindication.

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, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PENICILLIN V POTASSIUM SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. n
Clostridium difficilen- C. difficile
C. difficilen- C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

No data

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-sicknesslike 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.

The dosage of penicillin V potassium tablets and penicillin V potassium for oral solution 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
Pneumococcal infections
Staphylococcal infections
Fusospirochetosis (Vincentu2019s infection)
For the prevention of recurrence following rheumatic fever and/or chorea: 125 to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis.
For prophylaxis against bacterial endocarditis 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.
Do not add water until you dispense. When dispensing, tap bottle until all powder flows freely, slowly add the total amount of water for reconstitution (see table below). After partially filling bottle, replace cap and shake vigorously. Add remaining water and repeat shaking. n

Penicillin V Potassium Tablets USP are available as follows:
250 mg (400,000 units): biconvex, oval, mottled, white to off-white, uncoated, scored tablets, debossed u201c93u201d on one side and u201c1172u201d on the other side in bottles of 100 (NDC 0093-1171-01) and 1000 (NDC 0093-1172-10).
500 mg (800,000 units): biconvex, oval, mottled, white to off-white, uncoated, scored tablets, debossed u201c9u201d to the left of partial bisect and u201c3u201d to the right on one side and u201c1174u201d on the other side in bottles of 100 (NDC 0093-1174-01) u00a0and 1000 (NDC 0093-1174-10).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [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 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [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.

Manufactured In Canada By:
Teva Canada Limited
Toronto, Canada M1B 2K9
Manufactured For:
Teva Pharmaceuticals USA,u00a0INC.
North Wales, PA 19454
Rev. N 10/2018

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Penicillin V Potassium (Penicillin V Potassium)

Trade Name : Penicillin V Potassium

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Penicillin V Potassium (Penicillin V Potassium)

Trade Name : Penicillin V Potassium

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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