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

Logo IPCAMOX Capsules

IJVR02

SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME
(and dosage form):

IPCAMOX Capsules

COMPOSITION:
Each capsule contains
amoxycillin trihydrate equivalent to amoxycillin 250 mg.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Amoxycillin is a penicillinase-susceptible penicillin. Amoxycillin exhibits in vitro, bactericidal activity against a wide range of Gram-negative and Gram positive organisms including:
Gram-positive bacteria: Staphylococcus aureus* (penicillin-sensitive) Streptococcus pyogenes Streptococcus viridans* Streptococcus faecalis* Streptococcus pneumoniae* Corynebacterium species* Clostridium species* Bacillus anthracis*
* Sensitivity tests must be performed
Gram-negative bacteria: Neisseria gonorrhoeae Neisseria meningitidis Haemophilis influenzae** Bordetella pertussis Escherichia coli* Salmonella typhi Salmonella species Shigella species Brucella species Proteus mirabilis
** Except type b-strains causing meningitis in children
(in vitro sensitivity does not necessarily imply in vivo efficacy)
Amoxycillin is well absorbed orally. After oral administration, there is no significant difference between the peak serum levels in fasting and non-fasting subjects. The presence of food does not interfere with the absorption of amoxycillin. Amoxycillin may, therefore, be taken with meals. There is a linear dose response in peak serum levels after oral administration.
There is insufficient evidence at present to show that IPCAMOX penetrates into me cerebro-spinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebro-spinal infections.
Approximately 60% of an oral dose of amoxycillin is excreted unchanged in the active form, into the urine within six hours,

INDICATIONS:
Infections caused by susceptible, non penicillinase-producing organisms including:
• Upper respiratory tract infections • Lower respiratory tract infections
• Otitis media • Upper urinary tract infections • Lower urinary tract infections • Skin and soft tissue infections • Gonorrhoea • Non-specific urethritis • Typhoid fever • Gastro-intestinal tract infections

DOSAGE AND DIRECTIONS FOR USE:
a) The average adult dose for Ipcamox is 750 mg - 1.5 g per day taken in three divided doses.
b) Specific Dosages:

Indications         Daily dosages 
  Adults Children Duration
Gastro Intestinal tract infections         1-2g         -         4-5 days
Acute typhoid fever         4g         -         14 days
          - 100 mg/kg         21 days
Gonorrhoea         2-3g         -         Stat

c) In the treatment of beta-haemolytic streptococcal infections a therapeutic dose must be administered for at least 10 days.

CONTRA-INDICATIONS:
Allergy to penicillins or any of the cephalosporins.
Patients with infectious mononucleosis since they are especially susceptible to amoxycillin induced skin rashes. Patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may also be at increased risk of developing skin rashes.
Safety in pregnancy and lactation has not been established.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances, including diarrhoea, nausea and vomiting occur frequently. Allergic reactions may occur, presenting as a pruritic skin rash, an erythematous skin reaction or urticaria. In this event withdrawal of IPCAMOX is necessary.
Should a serious anaphylactic reaction occur, IPCAMOX should be discontinued and the patient treated with Adrenalin, corticosteroids and antihistamines. Treatment with IPCAMOX may give rise to a maculopapular rash during therapy or within a few days after completion thereof The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
Pseudomembranous colitis has been reported. Super - infections with non - susceptible organisms may occur.
Caution must be exercised in treating patients with dehydration or oliguria because of the possibility of crystalluria.
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity testing should; therefore, be carried out wherever possible, to ensure !he appropriateness of the therapy.
Special precautions:
The dose should be reduced in patients with renal failure, Caution is needed when administering IPCAMOX to. patients with syphilis, as the Jarisch-Herxheimer reaction may occur in these patients. IPCAMOX may decrease the efficacy of oestrogen-containing oral contraceptives. Due to IPCAMOX's effect on intestinal flora the absorption of other medicines may be affected.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects and special precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
A hard gelatin capsule with an orange body and grey cap containing a white to almost white powder.

PRESENTATION:
Carton containing 10 blister strips each containing 10 capsules.
Carton containing 1 blister strip containing 15 capsules.
Securipac container containing 500 capsules in LOPE bags.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
27/20.1.2/0415

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
NATIONAL DRUGGISTS (PTY) LTD., R.S.A.
30 Pariet street, Amalgam, Johannesburg 2092
P.O. Box 3253, Durban 4000

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
08 August 2002.

IJVR02

Updated on this site: January 2005
Source: Community Pharmacy

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