150 mg vial : To reconstitute dissolve contents in 2.5 mL of Water for Injection I.P. (final volume 2.

625 mL)
A transient pink colouration may appear during reconstitution. Reconstituted solutions are normally a pale, straw colour.
Intravenous injection
The stability of LACTOCLAAV intravenous solution is concentration dependent, thus LACTOCLAAV intravenous should be used immediately upon reconstitution and given by slow intravenous injection over a period of 3-4 minutes.
LACTOCLAAV intravenous solutions should be used within 20 minutes of reconstitution. LACTOCLAAV may be injected directly into a vein or via a drip tube.

Amoxicillin and Clavulanate potassium USP Injection / Tablets / Syrup/ DT /Drops

Intravenous infusion
LACTOCLAAV intravenous may be infused in water for injection I.P. or sodium chloride intravenous injection I.P. (0.9% w/v). Add without delay*, 1.2 g reconstituted solution to 100 mL infusion fluid. Infuse over 30-40 minutes and complete
within 4 hours of reconstitution.

COMPOSITION :
LACTOCLAAV 1.2 gm Injection
Each vial contains
Amoxycillin Sodium IP sterile equivalent to Amoxycillin ......
Clavulanate potassium USP sterile Clavulanic acid .......

*Solutions should be made up to full infusion volume immediately after reconstitution. Any residual antibiotic solutions should be discarded.

1000 mg
200 mg

LACTOCLAAV 300 mg Injection

Each vial contains
Amoxycillin Sodium IP sterile equivalent to Amoxycillin......................................
Clavulanate potassium USP sterile Clavulanic acid..............................................

Stability and Compatibility

Intravenous infusions of LACTOCLAAV may be given in a range of different intravenous fluids. Satisfactory antibiotic concentrations are retained at 5C and at room temperature (25C) in the recommended volumes of the following
infusions fluids. If reconstituted and maintained at room temperature, infusions should be completed within the time stated.

250 mg
50 mg

LACTOCLAAV 150 mg Injection

Each vial contains
Amoxycillin Sodium IP sterile equivalent to Amoxycillin.......................................
Clavulanate potassium USP sterile Clavulanic acid..............................................
LACTOCLAAV 625 mg Tablets
Each film-coated tablet contains
Amoxycillin trihydrate IP equivalent to Amoxycillin.............................................
Clavulanic acid....................................................................................................
(Present as clavulanate potassium USP)

Reconstituted solutions should not be frozen.

125 mg
25 mg
500 mg
125 mg

LACTOCLAAV 375 mg DT
Each uncoated dispersible tablet contains
Amoxycillin trihydrate IP equivalent to Amoxycillin..............................................
Clavulanic acid.....................................................................................................
(Present as clavulanate potassium USP)

250 mg
125mg

LACTOCLAAV 228.5 mg DT
Each uncoated dispersible tablet contains
Amoxycillin trihydrate IP equivalent to Amoxycillin............................................
Clavulanic acid....................................................................................................
(Present as clavulanate potassium USP)

Intravenous infusion fluids

Stability period 25C

Water for Injections I.P.

4 hours

Sodium chloride Intravenous Infusion I.P. (0.9% w/v)

4 hours

Sodium Lactate Intravenous Infusion I.P. ( one sixth molar)

4 hours

Compound Sodium Chloride Intravenous Infusion I.P.

(Ringers solution)

3 hours

Compound Sodium Lactate Intravenous Infusion I.P.

(Ringer-Lactate Solution; Hartmann`s Solution )

3 hours

Potassium Chloride and Sodium Chloride Intravenous

infusion B.P.

3 hours

LACTOCLAAV is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solutions of LACTOCLAAV should therefore, not be added to such infusions but may be injected into the drip tubing, over a period of 3-4
minutes.For storage at 5C, the reconstituted solution should be added to pre-refrigerated infusion bags which can be stored for up to 8 hours. Thereafter, the infusion should be administered immediately after reaching room
temperatures.
Oral Administration
Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing. Dispersible tablets should be dissolved in 30-60 ml of water before administration. To minimize potential
gastrointestinal intolerance, administer at the start of a meal. The absorption of LACTOCLAAV is optimized when taken at the start of a meal. Treatment should not be extended beyond 14 days without review.

200 mg
28.5 mg

LACTOCLAAV Tablets
Adults and Children over 12 years

LACTOCLAAV 228.5 mg Syrup

Each 5 ml (on reconstitution) contains
Amoxycillin trihydrate IP equivalent to Amoxycillin..............................................
Clavulanate Potassium USP equivalent to Clavulanic acid................................

200 mg
28.5 mg

Usual dosages for the treatment of infection.

INDICATIONS

Mild to Moderate Infections

One 625 mg tablet twice a day.

Severe Infections

One 1 g tablet twice a day.

LACTOCLAAV is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Dentoalveolar abscess one LACTOCLAAV 625 mg tablet twice a day for five days.

Lower Respiratory Tract Infections - caused by (beta)-lactamase producing strains of H. influenzae and M. catarrhalis .

Renal Impairment

Otitis Media - caused by (beta)-lactamase producing strains of H. influenzae and M. catarrhalis.

Adults

Sinusitis - caused by (beta)-lactamase producing strains of H. influenzae and M. catarrhalis .

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 1g tablet

Skin and Skin Structure Infections - caused by (beta)-lactamase producing strains of S. aureus, E. coli and Klebsiella spp.

Mild impairment
( Creatinine clearance > 30 mL/min)

No change in dosage.

Urinary Tract Infections - caused by (beta)-lactamase producing strains of E. coli, Klebsiella spp. and Enterobacter spp.

Moderate impairment
( Creatinine clearance 10-30 mL/min)

One 625 mg tablet twice a day.

1 g tablet should not be administered.

Severe impairment
( Creatinine clearance <10 - 30 mL/min)

Not more than one 625 mg tablet every 24 hours.

Prophylaxis of wound infection associated with surgical procedures in particular gastrointestinal, pelvic, major head and neck surgery and after limb amputation for infection.While LACTOCLAAV is indicated only for the conditions
listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with LACTOCLAAV due to its amoxycillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and (beta)lactamase producing organisms susceptible to LACTOCLAAV should not require the addition of another antibiotic. Because amoxycillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S.
pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxycillin and LACTOCLAAV .
DOSAGE AND ADMINISTRATION
LACTOCLAAV Injection
LACTOCLAAV Intravenous may be administered either by intravenous injection or intermittent infusion. It is not suitable for intramuscular administration.
Usual dosages for the treatment of infection
Usual dosages
treatment of infection
Children 3 months-12 years
Childrenfor
0-3the
months
30 mg/kg* LACTOCLAAV every 12
hourly in premature infants and in
full term infants during perinatal
period, increasing to 8 hours
thereafter.

Hemodialysis patients should receive 625 mg tablet every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals.
LACTOCLAAV 625mg and 1g tablets are not recommended in children of 12 years and under.
LACTOCLAAV DT
Usual dosages for the treatment of infection.

Adults and Children over 12 years

Usually 30* mg/kg LACTOCLAAV 8 Usually 1.2 g thrice daily. In more

hourly. In more serious infections, serious infections, increase
frequency to 6 hourly intervals.
increase frequency to 6 hourly.

Children over 6 years upto 12 years

One LACTOCLAAV 228.5 mg DT three times a day.
.
Renal Impairment
For children with GFR of > 30 mL/min no adjustment in dosage is required. For children with a GFR of < 30 mL/min LACTOCLAAV 228.5 mg DT is not recommended.

*Each 30 mg of LACTOCLAAV injection provides 5 mg clavulanic acid and 25 mg amoxycillin. Therapy can be
started parenterally and continued with the oral preparation.

Hepatic impairment
Dose with caution; monitor hepatic function at regular intervals. There are, as yet, insufficient data on which to base a dosage recommendation.

Treatment with LACTOCLAAV should not extend beyond 14 days without review .

LACTOCLAAV Syrup
Usual dosages for the treatment of infection.

Dosage for Surgical Prophylaxis

The usual dose is 1.2 g LACTOCLAAV Intravenous injection given at the induction of anaesthesia. Operations where there is a high risk of infection, e.g. colorectal surgery, may require three, and up to four, doses of 1.2 g LACTOCLAAV
Intravenous in a 24-hour period. These doses are usually given at 0, 8, 16 (and 24) hours. This regimen can be continued for several days if the procedure has a significantly increased risk of infection. Clear clinical signs of infection at
operation will require a normal course of intravenous or oral LACTOCLAAV therapy post-operatively.
Renal Impairment
Adults
Mild impairment

No change in dosage

Moderate impairment

1.2 g I.V stat. followed by 600 mg I.V. q 12 hourly

Severe impairment

1.2 g I.V stat. followed by 600 mg I.V. q 24 hourly.

bid

45/6.4 mg/kg/day

bid

6
Children 3 months-12 years

Children over 12 years

30 mg/kg* LACTOCLAAV every 12 hourly in

Usually 30* mg/kg LACTOCLAAV 8 hourly. In
premature infants and in full term infants during more serious infections, increase frequency to 6
perinatal period, increasing to 8 hours thereafter. hourly.

Usually 1.2 g thrice daily. In more serious

infections, increase frequency to 6 hourly
intervals. Maximum daily dose should not exceed
7.2 g by IV route. Maximum single dose is 1.2 g.

No change in dosage

No change in dosage

No change in dosage

Moderate impairment (creatinine 30* mg/kg I.V stat. followed by 15 mg I.V. q 12

clearance 10-30 ml/min)
hourly

30* mg/kg I.V stat. followed by 15 mg I.V. q 12

hourly

1.2 g I.V stat. followed by 600 mg I.V. q 12

hourly

Moderate impairment (creatinine 30* mg/kg I.V stat. followed by 15 mg I.V. q 24

clearance 10-30 ml/min)
hourly

30* mg/kg I.V stat. followed by 15 mg I.V. q 24

hourly

1.2 g I.V stat. followed by 600 mg I.V. q 24 hourly.

An additional 600 mg IV dose may need to be
given during dialysis and at the end of dialysis.

Mild impairment (creatinine

clearance > 30 ml/min

25/3.6 mg/kg/day

Weight (kg)
5

Recommended dosage for pediatric patients with renal impairment

Children 0-3 months

Mild to Moderate infections

Severe Infections and Otitis media,
sinusitis, lower respiratory infections

LACTOCLAAV Drops
Dose of LACTOCLAAV Drops (in mL) to be given every 12 hours to children aged 3 to 24 months (based on body weight)

Pediatrics
Similar reductions in dosage should be made for pediatric patients as follows:
Renal impairment

Patients aged 12 weeks (3 months) and older.

*Each 30 mg of LACTOCLAAV I.V. provides 5 mg clavulanic acid and 25 mg amoxycillin. Therapy can be started parenterally and continued with the oral preparation.

Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals.
Preparation
1.2 g vial
: To reconstitute dissolve contents in 20 mL of Water for Injection I.P. (final volume 20.9 mL)
300 mg vial : To reconstitute dissolve contents in 5 mL of Water for Injection I.P. (final volume 5.25 mL)

7
8
9
10
11
12
13
14
15

25/3.6 mg/kg/day (ml/b.i.d)

45/6.4 mg/kg/day (ml/b.i.d)

0.8
0.9
1.1
1.3
1.4

1.4
1.7
2.0
2.3
2.5

1.6
1.7
1.9
2.0
2.2
2.3

2.8
3.1
3.4
3.7
3.9
4.2

Infants with immature kidney function For infants with immature renal function LACTOCLAAV Syrup 228 mg/5 mL is not recommended.
Renal Impairment For children with GFR of > 30 mL/min no adjustment in dosage is required. For children with a GFR of < 30 mL/min LACTOCLAAV Syrup 228/5 mL is not recommended.
Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals. There is, as yet, insufficient evidence on which to base a dosage recommendation.
Instructions for use/handling
At the time of dispending, the dry powder should be reconstituted to form an oral suspension. First shake the bottle to loosen powder. Add water to 2/3 of fill-mark on bottle. Replace the cap, and shake the bottle until all of the powder is
suspended. Add more water until the level of the fill line is attained, and shake again. When first reconstituted, allow to stand for 5 minutes to ensure full dispersion. After reconstitution, keep in a refrigerator when not in use. Use the
reconstituted syrup within 7 days.
CONTRAINDICATIONS
LACTOCLAAV is contraindicated in patients with a history of allergic reactions to any penicillin. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics , e.g. cephalosporins. It is also contraindicated in
patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxycillin- clavulanate.