INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
INCIL VK T 125 tablets
INCIL VK T 250 tablets
INCIL VK S 125 powder for elixir

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

INCIL VK T 125 tablets
INCIL VK T 250 tablets
INCIL VK S 125 powder for elixir

COMPOSITION:

Incil VK T 125 tablets	Each tablet contains Phenoxymethylpenicillin potassium equivalent to Phenoxymethylpenicillin 125 mg
Incil VK T 250 tablets:	Each tablet contains Phenoxymethylpenicillin potassium equivalent to Phenoxymethylpenicillin 250 mg
Incil VK S 125 powder for elixir:	Each 5 mL of reconstituted elixir contains Phenoxymethylpenicillin potassium equivalent to Phenoxymethylpenicillin 125 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 PENICILLINS

PHARMACOLOGICAL ACTION:
A narrow spectrum penicillin, inhibited by penicillinase. It has an antimicrobial spectrum similar to benzylpenicillin for aerobic Gram positive organisms. It is 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 Streptococcus pyogenes; mild to moderate pulmonary and periodontal anaerobic infections; gingivostomatitis; early Lyme disease.

CONTRA-INDICATIONS:
Known sensitivity to penicillin or cephalosporins. Cases of cross sensitivity have been reported.
Babies born of hypersensitive mothers in the neonatal period. Phenoxymethylpenicillin is not recommended for chronic, severe, or deep-seated infections such as subacute bacterial endocarditis, meningitis or syphilis.

WARNINGS:
When 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:
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 to 500 mg every 6 hours depending on the severity of the infection.
Children up to one year:	60 mg every 6 hours
1-5 years:	125 mg every 6 hours
6-12 years:	250 mg every 6 hours

RECONSTITUTION:
Incil VK 125 mg/5 mL: Add 70 mL of distilled water , in two portions, to the bottle and shake well.
Once reconstituted, the elixir must be used within 7 days when stored below 25°C or within 14 days when stored in a refrigerator.
SHAKE THE BOTTLE BEFORE USE

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
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 or tongue 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 usually following high intravenous doses. Convulsions and other signs of toxicity to the CNS may occur particularly with intravenous administration or in patients with renal failure.
Disturbances of blood electrolytes may follow the administration of large doses of potassium.
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:
Incil VK T 125 tablets: White round tablets.
Incil VK T 250 tablets: White round tablets.
Incil VK S 125 powder for elixir: Pinkish white powder.

PRESENTATION:
Incil VK T 125 tablets: 100 and 1000 tablets in a HDPE Jar.
Incil VK T 250 tablets: 100 and 1000 tablets in a HDPE Jar.
Incil VK S 125 powder for elixir: HDPE bottle containing 48 g powder for elixir.

STORAGE DIRECTIONS:
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Incil VK T 125 tablets: G/20.1.2/145
Incil VK T 250 tablets: G/20.1.2/146
Incil VK S 125 powder for elixir: G/20.1.2/144

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alliance Pharma (Pty) Ltd
17 Faraday Street,
Village Main,
JOHANNESBURG 2001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1975

PM 0503 - 8/99

Updated on this site: November 2005
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