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Amovin

Evans Medical PLC
Plot 6, Abimbola Way, Isolo, P.M.B. 1120, Apapa, Lagos, Nigeria., km 32, Lagos Bad, Exp/way, Agbara
Tel: 01-7901401 - 8 (8 lines)
Fax: 01-7912722, 01-7912732
Website: http://www.evansmedicalplc.com/

Brand Name

Amovin

Manufacturer

Bharat Parenterals Ltd., Village Haripura, Ta. Savli, Dist. Baroda, (Gujarat), India.

Therapeutic Class

Antibiotic, Aminopenicillins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet 375 mg (NRN: 04-2635): Amoxicillin 250 mg, Clavulanic acid 125 mg

Pack Size: 20’s

Tablet 625 mg (NRN: 04-8261): Amoxicillin 500 mg, Clavulanic acid 125 mg

Pack size: 14’s

Tablet 1g (NRN: A4-2780): Amoxicillin  875 mg, Clavulanic acid  125 mg

Pack size: 14’s; 

Suspension: (NRN: 04-8405): Amoxicillin 200 mg, Clavulanic acid 28.5 mg.

Pack size: Bottles containing powder for reconstitution to 100 mL

Suspension DS (NRN: A4-2779): Amoxicillin 400 mg, Clavulanic acid 57 mg

Pack size:  Bottles containing powder for reconstitution to 100 mL

Injection 600 mg (NRN: 04-8244): Amoxicillin 500 mg, Clavulanic acid 100 mg

Pack size: 600 mg in glass vials

Injection 1.2 g (NRN: A4-2339): Amoxicillin 1000 mg, Clavulanic acid 200 mg.

Pack size: 1.2 g in glass vials.

Pharmacology

Pharmacodynamics: Resistance to many antibiotics is caused by bacterial enzymes which destroy the antiobiotic before it can act on the pathogen. The Clavulanic acid in Amovin anticipates this defence mechanism by blocking beta-lactamase enzymes, thus rendering the organism sensitive to Amoxycillin’s rapid bactericidal effect at concentrations readily attainable in the body. Clavulanic acid by itself has little bacterial activity, however, in association with Amoxycillin as Amovin, it produces an antibiotic agent of broad spectrum. Amovin is bactericidal to a wide range of organisms including: Gram positive Aerobes and Anaerobes, Gram negative Aerobes and Anaerobes.

Infections caused by amoxycillin susceptible organisms are amenable to Amovin treatment due to its amoxycillin content. Mixed infections caused by amoxycillin-susceptible organism in conjunction with Amovin susceptible beta-lactamase producing organisms may therefore be treated with Amovin.

Pharmacokinetics: The Pharmacokinetics of the two components of Amovin are closely matched. Both Clavulanic acid and Amoxycillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of the Amovin approximately doubles the serum levels achieved.

Indications

Amovin is recommended for the treatment of susceptible bacterial infections of: Skin and soft tissue, Bone and joint, Upper and lower respiratory tract and Urinary/Genital tract.

Contra-indications

Amovin is contraindicated in patients who are hypersensitive to Penicillins. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g., Cephalosporins.

Precautions/Warnings

Changes in liver function tests have been observed in some patients receiving Amoxycillin/Clavulanic acid. The clinical significance of these changes is uncertain but Amovin should be used with caution in patients with evidence of hepatic dysfunction. Cholestatic jaundice, which may be severe, but usually reversible, has been reported rarely.

In patients with moderate or severe renal impairment, the dosage of Amovin should be adjusted.

Amovin should be avoided if glandular fever is suspected, as erythematous rashes have been associated with glandular fever in patients following the use of amoxycillin.

Interactions

Probenecid decreases the renal tubular secretion of amoxycillin. Concomitant use with Amovin may result in increased and prolonged blood levels of amoxycillin but not clavulanic acid.

Adverse Effects

Dosage & Administration

Unless prescribed otherwise, the following doses are recommended.

Tablets:

Adults and Children over 12 years

Mild to Moderate infections:

One Amovin 375 mg tablet thrice daily.

One Amovin 625 mg Tablet twice daily

One Amovin 1000 mg Tablet once daily

 Severe infections:                  

Two Amovin 375 mg Tablet thrice daily

One Amovin 625 mg Tablet thrice daily

One Amovin 1000 mg Tablet twice daily

Syrup:

The usual recommended daily dosage for children is 25 mg/kg/day in divided doses

 

 Infection

Amovin Suspension

Amovin-DS Suspension

Mild to moderate infections

 

 

Under 1 year: 2.5 mL twice daily

Under 1 year: 1.25 mL twice daily

1-6 years: 5 mL twice daily

1-6 years: 2.5 mL twice daily

6-12 years: 10 mL twice daily

6-12 years: 5 mL twice daily

Severe infections

The above dosage may be increased to thrice daily

The above dosage may be increased to thrice daily

 Injections:

Adults and Children over 12 years: usualy 1.2 g eight hourly.

In severe infections, the dosage may be increased to six hourly intervals.

Children (3 months – 12 years):

Usually 30 mg/kg eight hourly. In severe infections, the dosage may be increased to six hourly intervals.

Children (0-3 months):

30 mg/kg every 12 hours in premature infants and full term infants during the perinatal period, increasing to eight hourly thereafter.

Note: Each 30 mg Amovin contain 25 mg Amoxycillin and 5 mg Clavulanic acid.

Storage/Handling Recommendations

Amovin oral presentations should be stored in a dry place at 25oC.

Once reconstituted, Amovin suspension must be stored in a refrigerator (but not frozen) and used within 7 days.

Review Date

2013-10-07 18:40:11