Description

Inimox Forte Injection

Amoxycillin Sulbactam Injection

Mfd/Mktd by: Indian Immunologicals Limited

Dosage form:  Injection (Dry Powder with WFI)

Presentation: 

4.5 g, 3000 mg & 300 mg vial along with sterile WFI (water for injection)

Ingredients & Composition:

Inimox forte 4.5 g:
Each vial contains:
Amoxycillin Sodium (Sterile) IP Eq. to Anhydrous Amoxycillin 3000 mg
Sulbactam Sodium (Sterile) USP Eq. to Sulbactam 1500 mg.

Inimox forte 3000 mg:
Each vial contains:
Amoxycillin Sodium (Sterile) IP Eq. to Anhydrous Amoxycillin 2000 mg
Sulbactam Sodium (Sterile) USP Eq. to Sulbactam 1000 mg.

Inimox forte 300 mg:
Each vial contains:
Amoxycillin Sodium (Sterile) IP Eq. to Anhydrous Amoxycillin 200 mg
Sulbactam Sodium (Sterile) USP Eq. to Sulbactam 100 mg.

Description / Action: 

Inimox forte is an effective combination of Amoxycillin Sodium, a bactericidal broad-spectrum Penicillin group, and Sulbactam Sodium, an irreversible inhibitor of ß-lactamase enzymes. The class of bacteria which produce ß-lactamase enzyme will act on the ß-lactam ring of the susceptible antibiotics and thus makes them ineffective. Sulbactam inhibits the destruction of Amoxycillin Sodium by binding the ß-lactamase enzyme, thus enhancing the spectrum of activity of Amoxycillin including the ß -lactamase producing bacteria.

Spectrum of Activity:

Inimox forte is bactericidal to a wide range of Gram-positive and Gram-negative bacteria including many clinically important B-lactamase producing, penicillin-resistant organisms like:

Gram-positive:
Staphylococcus aureus
Streptococcus agalactiae
Streptococcus dysgalactiae
Staphylococcus aureus (B-lactamase+ Ve)
Corynebacterium pyogenes
Coagulase negative Staphylococcus
Streptococcus pyogenes
Clostridium species
Streptococcus pneumoniae
Staphylococcus epidermidis
Enterococcus faecalis
Listeria monocytogenese
Bacillus anthracis
Streptococcus vindans
Peptococcus species
Peptostreptococcus species

Gram-negative:
Escherichia coli
Klebsiella species
Pseudomonas aeruginosa
Bordetella bronchiseptica
Bacteroides species
Brucella species (B-lactamase+ Ve)
Salmonella species
Haemophilus species
Pasteurella species
Treponema hyodysenteriae

Class: Amino-penicillin /Antibiotics

Indication / Uses / Benefits:

Inimox forte is indicated for the treatment of common bacterial infections where antibiotic therapy is indicated, including:

• • Skin and soft tissue infections e.g. Mastitis, Abscesses, Cellulitis, Wound infections
  • Upper respiratory tract infections e.g. Sinusitis, Tonsillitis, Otitis media
  • Lower respiratory tract infections e.g. Acute and chronic bronchitis and Bronchopneumonia
  • Genito-urinary tract infections e.g. Cystitis, Urethritis, Pyelonephritis, Metritis, Endometritis, Cervicitis & Pyometra
  • Bone and joint infection e.g. Osteomyelitis
  • Other infections e.g. Septicaemia, Peritonitis, Post-operative infections, Intra-abdominal sepsis, Septic abortion

Dosage and administration:

Large animals
Usually 3000 mg or 4.5 g. (7 mg/kg body weight). 24 hourly by I.V. or I.M. route. In more serious infections, increase frequency 12 hourly intervals. In case of Mastitis infuse 300 mg in each infected quarter.

Small animals
Usually 300 mg, 24 hourly by IV. or I.M. route. In more serious infections, increase frequency 12 h intervals.

Inimox forte may be administered either by Intravenous, Intramuscular or Intramammary route.

I.V., I.M. Injection: Inimox forte may be given by slow Intravenous injection over a period of 3-4 minutes or can be given by Intramuscular route. Inimox forte may be injected directly into a vein or via drip tube.

Intramammary Infusion: “For better efficiency Inimox forte may be used at the rate of 300 mg per infected quarter along with systemic treatment.”

Dosage for surgical prophylaxis: Surgical prophylaxis with Inimox forte aims to protect the patient for the period of the risk of infection. Accordingly, surgical procedures lasting for less than 1 hour are covered in large animals by 4.5 g Inimox forte given at induction of anaesthesia. Longer surgical operations require subsequent doses of 4.5 g Inimox forte (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 Inimox forte therapy post-operatively.

Direction For Preparation:

Inimox forte 4.5 g: To reconstitute, dissolve the contents in 20 mL of sterile water for injection provided along with this pack.

Inimox forte 3000 mg: To reconstitute, dissolve the contents in 15 mL of sterile water for injection provided along with this pack

Inimox forte 300 mg: To reconstitute, dissolve the contents in 5 mL of sterile water for injection provided along with this pack.

The reconstituted solution should be used immediately or use within 20 minutes of reconstitution.

Pharmaceutical precautions / Instructions: 

The solution should be used within 20 minutes of reconstitution. It may be given along with intra venous fluids at recommended volumes of the infusion fluids. It should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates or with intra venous lipid, emulsions. If prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe or intravenous fluid container because inactivation of the aminoglycoside can occur under these conditions.

Store in a cool, dark and dry place.

Do not use if any particulate matter is observed after reconstitution.

Not to be sold by retail without the prescription of a Registered Veterinary Practitioner.

Not For Human Use. For Animal Treatment or Veterinary use Only.

Safety / Contraindications / Side-Effects:

While Amoxycillin possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic and hemopoietic system function is advisable if therapy is longer than approved for administration.

Serious and occasionally fatal hypersensitivity (anaphylactic) reaction have been reported in animals after penicillin therapy. These reactions are more likely to occur in animals with a history of penicillin hypersensitivity.

A high percentage of animals with mononucleosis who receive Amoxycillin developed erythematous skin rash. During administration of high doses adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.

Inimox forte should be used cautiously in animals on anticoagulation therapy.

Reproduction studies in animals (mice and rats) with orally and parenterally administered ‘Amoxycillin’ have shown no teratogenic effects.

Withdrawal Period:

Milk from treated cows must not be used for consumption during and after 96 hours (8 milking) from the last treatment date. Treatment with Inimox forte should not exceed 5 days without review.

Problems of overdosage with Inimox forte are unlikely to occur.

Substitute: Amoxyrum forte Injection, Toxo mox Injection,