Description

Amoxirum Forte Injection

Amoxycillin Sodium and Sulbactam Sodium for Injection

Manufactured / Mktd by: Virbac

Dosage form: Injection

Presentation: 4500 mg, 3000 mg and 300 mg

Ingredients & Composition:

Amoxirum Forte 4500 mg

Amoxycillin Sodium IP equivalent to Amoxycillin         3000 mg

Sulbactam Sodium IP equivalent to Sulbactam               1500 mg

Amoxirum Forte 3000 mg

Amoxycillin Sodium IP equivalent to Amoxycillin         2000 mg

Sulbactam Sodium IP equivalent to Sulbactam     1000 mg

Amoxirum Forte 300 mg

Amoxycillin Sodium IP equivalent to Amoxycillin         200 mg

Sulbactam Sodium IP equivalent to Sulbactam     100 mg

All these packs contain Sterile Water for Injections IP for reconstitution.

Description / MOA:

‘Amoxirum Forte’ is a formulation of Amoxycillin Sodium, a bactericidal broad-spectrum Penicillin and Sulbactam Sodium, a progressive and irreversible inhibitor of beta-lactamase enzymes. The presence of Sulbactam Sodium protects Amoxycillin Sodium from destruction and subsequent loss of antibacterial activity by the B-lactamase enzymes produced by many Gram-ve and Gram+ve bacteria. The spectrum of Amoxycillin is thus widened to include organisms normally by virtue of their ability to produce Beta-lactamase. ‘Amoxycillin’ will not only eliminate primary pathogens but also not get inactivated by non-pathogenic beta-lactamase-producing organisms at the site of infection.

Resistance to many antibiotics is caused by bacterial enzymes such as ß- lactamase, which destroy the antibiotic before it can act on the pathogens. The Sulbactam Sodium anticipates this defence mechanism by blocking the ß-lactamase enzymes, thus rendering the organisms sensitive to Amoxycillin Sodium’s rapid bactericidal effect at concentrations readily attainable in the body.

Sulbactam by itself has little antibacterial activity; however, in association with Amoxycillin it produces an antibiotic agent of broad spectrum activity with wide applications.

The pharmacokinetics of the two components of ‘Amoxirum Forte ‘ is closely matched. Both Sulbactam and Amoxycillin Sodium have low levels of serum binding; about 70 % remain free in the serum. Doubling the dosage of amoxycillin approximately doubles the serum levels achieved.

Category: Anti-biotics (penicillin)

Indication / Uses:

As safe, broad-spectrum penicillin, Amoxycillin has been found of value in a wide variety of bacterial infections in animals. In farm animals, infections treated include those of respiratory, alimentary, genito-urinary, skin and soft tissue, and mammary glands.

In dogs and cats, the indications include respiratory infections, skin and soft tissue infections, enteric infections, and infections of the genito-urinary tract. It is indicated for the treatment of common bacterial infections where antibiotic therapy is indicated, including

• Upper Respiratory Upper Respiratory Tract Infections – e.g. Sinusitis, Tonsilitis, Otitis media, Lower Respiratory Tract Infections, Acute and chronic bronchitis and Bronchopneumonia.
• Genito-urinary Infections – e.g. Cystitis, Urethritis, Pyelonephritis, Female genital infections like Metritis, Endometritis, Cervicitis & Pyometra.
• Skin and Soft Tissue Infections – e.g. Mastitis, Abscesses, Cellulitis, Wound infections.
•  Bone and Joint Infections– e.g. Osteomyelitis.
• Other Infections – e.g. Septicaemia, Peritonitis, Post-operative infections, Intra-Abdominal sepsis, Septic abortion

Bacteriology:

‘Amoxirum Forte’ is bactericidal to a wide range of Gram+ve and Gram-ve bacteria including many clinically important beta-lactamase-producing penicillin-resistant organisms, like:

Gram-Positive:

Staphylococcus aureus, Streptococcus agalactiae, Corynebacterium pyogenes, Coagulase-negative

Streptococcus pyogenes, Enterococcus faecalis, Listeria monocytogenes, Streptococcus spp.

Staphylococcus aureus (ß Lactamase + ve), Streptococcus dysgalactiae, Clostridium spp.,

Streptococcus pneumonia, Staphylococcus epidermidis, Bacillius anthracis, Streptococcus viridians

Gram Negative:

Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa, Bordetella bronchiseptica,

Bacteroides spp., Mycoplasma, Brucella spp. (ß Lactamase + ve), Salmonella spp.,

Haemophilus spp., Pasteurella spp., Treponema hyodysenteriae

Dosage:

Large Animals

For Cows & Buffalos

7-10 mg/kg body weight by I/M or I/V

Usually 3000 mg-4500 mg, 24 hourly by IV or IM route. In more serious infections, increase the frequency and repeat at 12-hour intervals. In case of Mastitis infuse 300 mg in each infected quarter.

Small Animals:

For Dogs

10-20mg/kg body weight every 8-12 hours

Usually 300 mg. 24 hourly by IV or IM route. In more serious infections, increase frequency -12 hourly intervals

Treatment with ‘Amoxirum Forte’ should not extend beyond 14 days without review.

Dosage for surgical prophylaxis:

Surgical prophylaxis should aim to protect the patient for the period of risk of infection. Accordingly, procedures lasting for less than 1 hour are covered in large animals by 3000 mg-4500 mg, given at induction of anesthesia. Longer operations require subsequent doses of 3000 mg-4500 mg (up to 4 doses in 24 hours), and this regime can be continued for several days if the procedure has significantly increased the risk of infection. Clear clinical signs of infection at operation will require a normal course of ‘Amoxirum Forte’ therapy post-operatively.

Preparation & Route of Administration:

4500 mg vial:- To reconstitute, dissolve contents in 15 ml of Sterile Water for Injections IP provided in the pack.

3000 mg vial:- To reconstitute, dissolve contents in 15 ml of Sterile Water for Injections IP provided in the pack.

300 mg vial:- To reconstitute, dissolve contents in 5 ml of Sterile Water for Injections IP provided in the pack.

Amoxirum Forte may be administered either by intravenous, intramuscular or by the intramammary route.

Intramammary Infusion: It is also indicated for prophylaxis against Mastitis.

In case of contagious and Environmental Mastitis add 5 ml Water for injections IP in Amoxirum Forte 300 mg and infuse the solution in the infected quarter with the help of a special blunt-headed teat needle.

Overdoses / Side effects / Contraindications /Warnings:

Problems of overdosage are unlikely to occur. The safety of Amoxycillin is typical of that of other penicillins. It has a very low intrinsic toxicity, except in animals with a specific allergy to beta-lactams (seems rare in animals). Diarrhoea as a side effect is uncommon in animals.

Anaphylaxis or Serious and occasionally fatal hypersensitivity reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in animals with a history of penicillin hypersensitivity.

Erythematous rashes have been associated with glandular fever in patients receiving Amoxycillin Sodium. During the administration of high doses of ‘Amoxirum Forte’ adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria. Amoxycillin Sodium may precipitate in bladder catheters when present at high concentrations in urine at room temperature. It should be used with care in patients on anticoagulation therapy.

Stability & Compatibility:

The stability of reconstituted Amoxirum Forte is concentration-dependent; so it should be used immediately (within 20 minutes) after reconstitution. It should be given by slow intravenous injection (directly into a vein or via a drip tube) over a period of 3-4 minutes or can be given by intramuscular route.

Intravenous infusions may be given in a range of different intravenous fluids. It should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates or with intravenous lipid emulsions. If it is prescribed or used concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of the aminoglycoside can occur under these conditions.

Pharmaceutical precautions / Instructions: 

Store at a temperature not exceeding 30°C. Protect from direct light. For the use only of registered veterinary practitioners or a hospital or a laboratory

Not for human use. For animal treatment only.

Safety / Age / Pregnancy/ Withdrawal:

Reproduction studies in animals (mice and rats) with orally and parenterally administered ‘Amoxycillin’ have shown no teratogenic effects. Amoxirum Forte may be administered during the period of lactation.

Meat: 28 days after last administration

Milk: 7 days after last administration

Habit-forming: No

Substitute: Moxikind SB, Inimox Forte Injection, Toxo mox Injection,