BETAMOX Capsule, Suspension Ref.[50348] Active ingredients: Amoxicillin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext. 1, Roodepoort 1724, South Africa

4.1. Therapeutic indications

BETAMOX is indicated for the treatment of iInfections caused by susceptible, non-penicillinase-producing organisms including:

  • Upper and lower respiratory tract infections: sinusitis, pharyngitis, epiglottitis, acute and chronic bronchitis and acute typical pneumonia
  • Otitis media
  • Upper and lower urinary tract infections
  • Uncomplicated gonococcal infections
  • Non-specific urethritis
  • Meningitis (sensitivity tests must be performed)
  • Gastrointestinal tract infections including salmonella and typhoid
  • Uncomplicated gastro enteritis and enteric fever
  • Miscellaneous: Skin and soft tissue infections, bacteremia and as adjunct in the treatment of sepsis caused by gram-negative bacteria

4.2. Posology and method of administration

The average adult dose for BETAMOX is 750 mg to 1,5 g per day.

General dosages

Adults: 250 mg (1 × 250 mg capsule or 5 ml of 250 mg/5 ml suspension) three times a day.

Children 2 to 10 years: 125 mg (5 ml of 125 mg/5 ml suspension) three times a day.

Children 6 months to 2 years: 125 mg (5 ml of 125 mg/5 ml suspension) three times a day.

Infants 0 to 6 months: 62,5 mg (2,5 ml of 125 mg/5 ml suspension) three times a day.

To reconstitute 75 ml suspension, add 44 ml of water, invert the bottle and shake well until all the powder is dispersed.

To reconstitute 100 ml suspension, add 57 ml of water, invert the bottle and shake well until all the powder is dispersed.

Specific dosages

Gastrointestinal tract infections

Adults: 1 to 2 g daily for 4 to 5 days.

Acute typhoid fever

Adults: 4 g daily for 14 days.

Children: 100 mg/kg daily for 21 days.

Gonorrhoea

Adults: 2 to 3 g stat.

4.9. Overdose

See section 4.4 and 4.8.

Treatment is symptomatic and supportive.

Should a serious anaphylactic reaction occur, BETAMOX should be discontinued and the patient treated with adrenalin, corticosteroids and antihistamines.

6.3. Shelf life

BETAMOX 250:

36 months
15 months (for Patient Ready Packs)

BETAMOX 500:

48 months (for the 500’s pack size packed in amber PVC bottle)
60 months (for 15’s and 100’s packed a in white polypropylene securitainer and 500’s packed in an opaque white HDPE jar with a white HDPE screw on cap)
15 months (Patient Ready Packs)

BETAMOX S:

60 months (for powder packed in a glass bottle)
24 months (for powder packed in a HDPE bottle)

BETAMOX SF:

60 months (for powder packed in a glass bottle)

6.4. Special precautions for storage

Store at or below 25°C, in a dry place.

The reconstituted suspension must be used within 14 days if stored in a refrigerator or within 7 days if stored below 25°C.

6.5. Nature and contents of container

BETAMOX 250: Canisters containing 15, 100 or 500 × 250 mg amoxycillin capsules.

Patient ready packs of different pack sizes.

BETAMOX 500: Canisters containing 15, 100 or 500 × 500 mg amoxycillin capsules.

Patient ready packs of different pack sizes.

BETAMOX S: Bottles containing powder for reconstitution to 75 ml and to 100 ml of 125 mg/5 ml suspension.

BETAMOX SF: Bottles containing powder for reconstitution to 100 ml of 250 mg/5 ml suspension.

6.6. Special precautions for disposal and other handling

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

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