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Advent.

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Advent Structure

Advent 1.2 gm Injection:
- 1000 mg - Amoxycillin Sodium IP
- 200 mg - Clavulanate potassium USP

Advent 600 mg Injection:
- 500 mg - Amoxycillin Sodium IP
- 100 mg - Clavulanate potassium USP

Advent 300 mg Injection:
- 250 mg - Amoxycillin Sodium IP
- 50 mg - Clavulanate potassium USP

Advent 150 mg Injection:
- 125 mg - Amoxycillin Sodium IP
- 25 mg - Clavulanate potassium USP

Advent 1000 mg Tablets:
- 875 mg - Amoxycillin trihydrate IP
- 125 mg - Clavulanic acid
Colour: Titanium dioxide

Advent 625 mg Tablets:
- 500 mg - Amoxycillin trihydrate IP
- 125 mg - Clavulanic acid
Colour: Titanium dioxide

Advent 457 mg DT
- 400 mg - Amoxycillin trihydrate IP
- 57 mg - Clavulanic acid
Colour : Lake Erythrosine

Advent 228.5 mg DT:
- 200 mg - Amoxycillin trihydrate IP
- 28.5 mg - Clavulanic acid
Colour: Sunset yellow FCF

Advent Forte Syrup:
Each 5 ml contains:
- 400 mg - Amoxycillin trihydrate IP
- 57 mg - Clavulanate Potassium USP

Advent 228.5 mg Syrup:
Each 5 ml contains:
- 200 mg - Amoxycillin trihydrate IP
- 28.5 mg - Clavulanate Potassium USP

Advent 91.4 mg Drops:
Each 1 ml contains:
- 80 mg - Amoxycillin trihydrate IP
- 11.4 mg - Clavulanate Potassium USP

Advent Indications

Advent is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
- Urinary Tract Infections;
- Skin and Skin Structure Infections;
- Sinusitis;
- Prophylaxis of wound infection associated with surgical procedures in particular gastrointestinal pelvic major head and neck surgery and after limb amputation for infection;
- Otitis Media;
- Lower Respiratory Tract Infections;

Advent Dosage

Advent Injection

1. Children 0-3 months:
30 mg/kg* Advent every 12 hourly in premature infants and in full term infants during perinatal period, increasing to 8 hours thereafter.

2. Children 3 months-12 years:
Usually 30* mg/kg Advent 8 hourly. In more serious infections, increase frequency to 6 hourly.

3. Adults and Children over 12 years:
Usually 1.2 g thrice daily. In more serious infections, increase frequency to 6 hourly intervals.

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

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

Dosage for Surgical Prophylaxis:
The usual dose is 1.2 g Advent 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 Advent 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 Advent therapy post-operatively.

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)
600 mg vial: To reconstitute dissolve contents in 10 mL of Water for Injection I.P. (final volume 10.5 mL)
300 mg vial : To reconstitute dissolve contents in 5 mL of Water for Injection I.P. (final volume 5.25 mL)
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 Advent intravenous solution is concentration dependent, thus Advent intravenous should be used immediately upon reconstitution and given by slow intravenous injection over a period of 3-4 minutes. Advent intravenous solutions should be used within 20 minutes of reconstitution. Advent may be injected directly into a vein or via a drip tube.

Intravenous infusion
Advent 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.

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

Reconstituted solutions should not be frozen.
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

Advent is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solutions of Advent should therefore, not be added to such infusions but may be injected into the drip tubing, over a period of 3-4 minutes.

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 Advent is optimized when taken at the start of a meal. Treatment should not be extended beyond 14 days without review.

Advent Tablets
Adults and Children over 12 years
Usual dosages for the treatment of infection.

Mild to Moderate Infections
One 625 mg tablet twice a day.

Severe Infections
One 1 g tablet twice a day.
Dentoalveolar abscess one Advent 625 mg tablet twice a day for five days.

Renal Impairment
Adults
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

Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals.

Advent 625mg and 1g tablets are not recommended in children of 12 years and under.

Advent DT
Usual dosages for the treatment of infection.
Children over 6 years upto 12 years
One Advent 228.5 mg DT three times a day.

Adults and children over 12 years:
One Advent 457 mg DT three times a day. 457 mg DT is not recommended in children of 12 years and under.

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 Advent 228.5 mg DT is not recommended.

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

Infants with immature kidney function:
For infants with immature renal function Advent 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 Advent 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 ( Advent Forte syrup and Advent Drops) and 10 days ( Advent 228.5 mg syrup).

Advent Contraindications

Advent 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 (cephalosporins). Advent is contraindicated in patients with a
previous history of cholestatic jaundice/hepatic dysfunction associated with amoxycillin- clavulanate.

Advent Form

Vial of 20mL - Advent 1.2 gm Injection
Vial of 10mL - Advent 600 mg Injection
Vial of 5mL - Advent 300/150 mg Injection

Blister of 6 tablets - Advent 625mg tablets
Blister of 4 tablets - Advent 1000mg tablets

Alu-Alu of 6 tablets - Advent 457 mg DT
Alu-Alu of 10 tablets - Advent 228.5 mg DT

Bottle of 30mL - Advent Forte Syrup
Bottle of 30mL - Advent 228.5 mg Syrup
Bottle of 10 mL - Advent 91.4 mg Drops


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