Phenoxymethylpenicillin potassium BP

PEN-V

Presentation

PEN-V Tablets: White, scored, circular, tablet; each tablets; contains phenoxymethylpenicillin potassium BP equivalent to 250 mg phenoxymethylpenicillin. PEN-V Syrup: Bottles containing powder to produce 50 ml of red coloured, raspberry flavoured syrup; when reconstituted each 5 ml contains phenoxymethylpenicillin potassium BP equivalent to 125 mg phenoxymethylpenicillin.

Uses

PEN-V is highly active in a wide variety of infectious diseases caused by phenoxymethylpenicillin susceptible Gram-positive organisms. It is used in the management of infections due to phenoxymethylpenicillin-sensitive organisms in particular streptococci and staphylococci but also including pneumococci, treponema pallidum, clostridia and some strains of neisseria. It is recommended for the therapeutic use in the following conditions: Pneumococcal infections: Respiratory tract infection of mild to moderate severity and infection in the middle ear and paranasal sinuses. Streptococcal infections: Pharyngitis including scarlet fever, otitis media and sinusitis. Staphylococcal infections (except penicillinase- producing strains): Mild infections of the skin and soft tissue sensitive to penicillin. Fusospirochetal infections: Gingivitis and Pharyngitis. Prophylactic uses: It is found to be effective in preventing streptococcal infection in susceptible hosts. Also it has proved effective in preventing the recurrence of rheumatic fever and chorea.

Dosage and administration

Adults: 125 mg to 500 mg every four to six hours depending on the severity of the condition. Children: 5 to 12 years: 125 mg to 250 mg every four to six hours. 1 to 5 years: 125 mg every six hours. Infants: (upto 1 year): 62.5 mg every six hours. To prevent the recurrence of rheumatic fever doses of 125 mg every twelve hours may be given for a period as suggested by the physician. Ideally, each dose should be given half an hour before or at least three hours after a meal.

Contra-indications, warnings, etc

Contra-indications: Contra-indicated in patients known to be hypersensitive to any penicillin. Use in pregnancy and lactation: It is secreted in the breast milk and should be used with caution in nursing mothers as it may provoke allergic reactions in the offspring. PEN-V has been used during human pregnancy for many years with no evidence of any teratogenic effect. However, as with all drugs it should not be used during the first trimester unless essential. Warnings: Hypersensitivity reactions are likely to occur in patients with a history of sensitivity to multiple allergens and enquiry of such history should be made before the treatment is started. Treatment should be continued for at least 10 days in cases of streptococcal infections and to confirm eradication of the organism, post-therapy cultures should be performed. Precautions: It should be used with caution in patients with known history of allergy. It is not recommended for chronic, severe, or deep-seated infections such as subacute bacterial endocarditis, meningitis, or syphillis. It should not be used as adjunctive prophylactic therapy prior to genito- urinary instrumentation or surgery, childbirth, etc. Side-effects: It is usually well tolerated but may occasionally cause transient nausea and diarrhea. Hypersensitivity reactions may include skin rashes, chills, fever, oedema, arthralgia, laryngeal oedema and anaphylaxis. The only reactions frequently observed may be fever and eosinophilia.

Pharmaceutical precautions

PEN-V syrup should be freshly prepared, stored in a cool place, preferably in a refrigerator. Reconstituted syrup should be used within 5 days if kept at room temperature or within 7 days if kept in a refrigerator. Containers should be tightly closed. Storage: PEN-V tablets and syrup should be stored in a cool dry place.

Package quantities

PEN-V Tablets: Cartons of 100 tablets in strip. PEN-V Syrup: Bottles containing powder to produce 50 ml of syrup when reconstituted.

Ref: FISONS (BANGLADESH) LIMITED