Ampicillin + Cloxacillin for Oral usage

INTRODUCTION

Compi–clox^® is a combination of Ampicillin as Trihydrate and Penicillinase resistant Cloxacillin as Sodium Salt to form a broad spectrum antibiotic preparation. Compi–clox^® exhibits bactericidal activity against a broad range of Gram-positive and Gram-negative organisms such as Streptococcus species, Staphylococcus species, Salmonella species, Haemophilus influenzae, Escherichia coli, Proteus mirabilis, and Neisseria species.

ABSORPTION AND EXCRETION

Ampicillin and Cloxacillin are both acid stable and are easily absorbed, producing good serum and urine concentrations.

Compi-clox^® is mainly excreted by glomerular filtration and renal tubular secretion.

INDICATIONS

Compi-clox^® is effective in the treatment of respiratory tract infections, ear, nose and throat Infections, urinary tract infections, gastro-intestinal infections, skin and soft tissue infections, pelvic Infections, septicaemia, endocarditis, orthopaedic infections.

Compi-clox^® Neonatal Oral Drops is indicated for the prophylaxis or treatment of bacterial infections in premature babies or neonates.

 

DOSAGE AND ADMINISTRATION

Administer Compi-clox^® ½ – 1 hour before meals of feeding

DROPS:  Neonates: –   0.5ml (90mg)-4 times daily or as directed by Physician.

See 0.5ml mark on the dropper.

SYRUP:                       Children: –                 1 month – 2years:                      ½ – 1 teaspoonful (2.5-5) ml 4 times daily

2-10 years:                                  1-2 teaspoonful (5-10) ml 4 times daily

CAPSULES:                Adult: –                       One or Two capsules 4 times daily or as directed by the physician.

CONTRAINDICATIONS

Hypersensitivity to penicillin

SIDE EFFECTS

The side effects of Compi-clox^® as with other penicillins are usually of a mild and transitory nature. They may include diarrhea, indigestion or occasionally rash-either urticarial which suggests penicillin hypersensitivity or erythematous. An erythematous rash may be caused in patients with glandular fever. In either case, it is advisable to discontinue treatment.

PREPARATION OF THE SUSPENSION

To make 100ml of the suspension, add 80ml of boiled and cooled water, while 10 ml (two teaspoonfuls) of the water is added to Neonatal Oral drops to make 12ml Suspension. Invert and shake the bottle until all powder is dispersed. Alternatively for 100ml suspension, add boiled and cooled water to half of the bottle, shake well and slowly add more water up to the mark on the bottle.

SHAKE WELL BEFORE TAKING EACH DOSE.

STORAGE

The Suspension should be stored below 30⁰C before and after reconstitution. Neonatal Drop should used within 5 days and Dry syrup within 7 days of reconstitution. The Capsule should be stored below 30⁰C.

All Compi-clox^® containers should be tightly closed.

PRECAUTION

Reduced dosage is required in patients with impaired renal functions e.g. renal failure, neonates, and premature infants.

KEEP OUT OF THE REACH OF CHILDREN

COMPOSITION AND AVAILABILITY

NEONATAL ORAL DROPS:     90mg Drops:  When reconstituted, each 0.5ml contains 60mg Ampicillin as Ampicillin Trihydrate BP        and 30mg Cloxacillin as the Sodium Salt BP.

SUSPENSION:  250mg Dry Syrup: When reconstituted, each 5ml contains 125mg Ampicillin as the Trihydrate BP plus 125mg Cloxacillin as the Sodium salt BP.

CAPSULES:  500mg: 250mg Ampicillin       Trihydrate BP and    250mg Cloxacillin as Cloxacillin Sodium BP in Blister and 500’s packs.