INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LEN V.K. 250 mg TABLETS
LEN V.K. 500 mg TABLETS
LEN V.K. 250 SYRUP

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

LEN V.K. 250 mg TABLETS
LEN V.K. 500 mg TABLETS
LEN V.K. 250 SYRUP

COMPOSITION:
Each tablet contains the equivalent of 250 mg or 500 mg
Phenoxymethylpenicillin as the potassium salt.
When dispensed as directed each 5 mL contains the equivalent of 250 mg Phenoxymethylpenicillin as the potassium salt
Preservative: Sodium Benzoate 0,1% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Phenoxymethylpenicillin is a narrow spectrum penicillin, inhibited by penicillinase. It has an antimicrobial spectrum similar to benzylpenicillin for aerobic Gram + organisms. Itis more stable in acidic medium than benzylpenicillin and is therefore better absorbed from the gastro-intestinal tract.
Once absorbed it is widely distributed throughout the body, and normally rapidly eliminated from the body, mainly by the kidneys.

INDICATIONS:
Prophylactic: Recurrence of rheumatic fever. Treatment of mild to moderate infections caused by sensitive organisms: Pneumococcal infections of the middle ear; Streptococcal otitis media and sinusitis; Streptococcal pharyngitis caused by Strep pyogenes; mild to moderate pulmonary and periodontal anaerobic infections; gingivostomatitis; early Lyme disease.

CONTRA-INDICATIONS:
Phenoxymethylpenicillin should not be given to patients known to be allergic to penicillin and should be given with care to patients with a history of allergy to cephalosporins. Cases of cross sensitivity have been reported. It should not be given to babies, in the neonatal period, born of hypersensitive mothers. It is not recommended for chronic, severe or deep-seated infections such as subacute bacterial endocarditis, meningitis or syphilis.

WARNINGS:
When Len V.K. is administered to a patient with penicillin sensitivity, anaphylactic shock may occur. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis.
Use with caution in patients with known history of allergy.

DOSAGE AND DIRECTIONS FOR USE:
Len V.K. should be taken 1 hour before or at least 2 hours after meals.
Prophylactic use: 125-250 mg twice a day.
Adult therapeutic dose: 250 mg-500 mg every six hours, depending on the severity of the infection.
Children up to 1 year: 62,5 mg every six hours. 1 to 5 years: 125 mg every six hours. 6 to 12 years: 250 mg every six hours. Streptococcal pharyngitis must be treated for a minimum of 10 days.
Directions for reconstitution: 100 mL syrup:        Add 54 mL water and shake well to dissolve. Shake the bottle well before use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Phenoxymethylpenicillin may produce diarrhoea, nausea and heartburn. Allergic reactions which may include exfoliative dermatitis, other skin rashes, interstitial nephritis and vasculitis, may occur.
A generalised sensitivity reaction with urticaria, fever, joint pains and eosinophilia can develop within a few hours to several weeks after starting treatment. Superinfection by resistant species, such as Pseudomonas or Candida, which do not respond to penicillin therapy may occur. A sore mouth and a black hairy tongue have been reported.
Increases in liver enzyme values have been reported. Care should be taken when high doses are given to patients with renal impairment (because of the risk of neurotoxicity) or congestive heart failure.
Renal and haematological systems should be monitored during prolonged and high dose therapy.
Care should be taken when treating patients with syphilis, as the Jarisch-Herxheimer reaction may occur shortly after starting treatment. This reaction, manifesting as fever, chills, headache and reactions at the site of the lesion, can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy.
Haemolytic anaemia and leucopenia, prolongation of bleeding time and defective platelet function have been observed. Convulsions and other signs of toxicity to the CNS may occur particularly in patients with renal failure.
Disturbances of blood electrolytes may follow the administrations of large doses of Len V.K.
High doses should be used with caution in patients receiving potassium containing medicines or potassium-sparing diuretics.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects. Treatment is symptomatic and supportive.

IDENTIFICATION:
250 mg Tablets: White, bisected, biconvex tablets.
500 mg Tablets: Flat, white, bisected tablets with a bevelled edge, 13 mm in diameter.
250 mg/5 mL Powder for Syrup: A pale pink free-flowing powder, which when reconstituted as directed, forms an orange-coloured syrup.

PRESENTATION:
250 mg Tablets: Packs of 100, 500 or 5000 tablets.
500 mg Tablets: Packs of 24 or 100 tablets.
250 mg/5 mL Powder for Syrup: Bottles of powder to make 100 mL of syrup.

STORAGE INSTRUCTIONS:
Tablets: Store in a cool, dry place (below 25°C). Keep the bottle tightly closed.
Powder for Syrup: Store in a cool, dry place (below 25°C). Keep the bottle tightly closed
Use within 7 days of preparation if stored at room temperature (25°C) or within 14 days if stored in a refrigerator.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
250 mg Tablets: A/20.1.2/315 –500 mg Tablets: N/20.1.1/27
250 mg/5 mL Powder for Syrup: J/20.1.2.301

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited –(Co. Reg. No. 04/00252/06) –7 Fairclough Road, PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 June 1996

Code 308249        A205 LH&SEL-K21154 K97

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