Description

TOXO-MOX 300/ 600 Injection

Amoxycillin and Potassium Clavulanate Injection

Manufactured / Marketed by: SAVA VET / SAVA Healthcare Ltd.

Dosage form: Injection

Presentation: 

TOXO-MOX 300

300mg/Vial with WFI 5ml

TOXO-MOX 600

600mg/Vial with WFI 10ml

Ingredients & Composition:

TOXO-MOX 300
Each Combi pack Contains:
(A) One Vial of Amoxycillin and Potassium Calvulanate Injection IP 300 mg
Each Vial Contains:
Amoxycillin Sodium IP (Sterile) Eq. to Anhydrous Amoxycillin          250 mg
Potassium Clavulanate IP (Sterile)
Eq. to Clavulanic Acid                  50 mg
(B) 1 Ampoule of Sterile Water for Injections IP – Contains:             5ml

TOXO-MOX 600
Each Combi pack Contains:
(A) One Vial of Amoxycillin and Potassium Calvulanate Injection IP   600 mg
Each Vial Contains:
Amoxycillin Sodium IP (Sterile) Eq. to Anhydrous Amoxycillin                     500 mg
Potassium Clavulanate IP (Sterile)
Eq. to Clavulanic Acid                 100 mg
(B) 1 Ampoule of Sterile Water for Injections IP – Contains:             10 ml

Description / Action: 

TOXO-MOX (Amoxycillin trihydrate and Potassium clavulanate) is the broad-spectrum antibiotic Amoxycillin trihydrate and the Beta-lactamase inhibitor, Potassium clavulanate (the potassium salt of clavulanic acid).

Amoxycillin trihydrate is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative, aerobic and anaerobic microorganisms. It does not resist destruction by B-lactamases; therefore, it is not effective against B-lactamase producing bacteria. Chemically, it is D (-)-α-amino-p-hydroxybenzyl penicillin trihydrate. Clavulanic acid, an inhibitor of B-lactamase enzymes, is produced by the fermentation of Streptomyces clavuligerus but by itself has only weak antibacterial activity. Chemically, Clavulanate potassium is potassium z-(3R,5R)-2-β-hydroxyethylidene clavam-3-carboxylate.

Clinical Pharmacology:

Amoxycillin acts through the inhibition of biosynthesis of cell wall mucopeptide of susceptible organisms and is bactericidal in action. The action of clavulanic acid extends the antimicrobial spectrum of Amoxycillin to include organisms resistant to Amoxycillin and other β-lactam antibiotics.

Rapidly absorbed Amoxycillin and clavulanic acid concentrations are similar in serum, urine, and tissues to those produced when each is administered alone. Amoxycillin and clavulanic acid diffuse readily into most body tissues and fluids with the exception of brain and spinal fluid, which Amoxycillin penetrates adequately when meninges are inflamed.

Maximum fraction of Amoxicillin administered is excreted unchanged in the urine. Clavulanic acid’s penetration into spinal fluid is unknown but approximately 15% of the administered dose is excreted in the urine within the first 6 hours. TOXO-MOX combines the distinctive properties of a broad spectrum antibiotic and a ß-lactamase inhibitor to effectively extend the antibacterial spectrum of Amoxycillin to include B lactamase producing as well as non-ß-lactamase producing aerobic and anaerobic organisms.

Microbiology:

Amoxycillin/Clavulanate has been shown to have a wide range of activity which includes ß-lactamase producing strains of both gram positive and gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following organisms, including ß-lactamase producing strains, isolated from veterinary sources, were found to be susceptible to Amoxycillin/Clavulanate in vitro but the clinical significance has not been demonstrated for some of these organisms. Aerobic bacteria, including Staphylococcus aureus, ß-lactamase producing Staphylococcus aureus (penicillin resistant), Staphylococcus species, Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus species, Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathiae, Proteus species, Proteus mirabilis, Bordefella bronchiseptica, Enterobacter species, Escherichia coli, Salmonella dublin, Klebsiella pneumoniae, Pasteurella multocida, Salmonella typhimurium, Pasteurella haemolytica, Pasteurella species.

Studies have demonstrated those both aerobic and anaerobic floras are isolated from gingival cultures of dogs with clinical evidence of periodontal disease. Both gram-positive and gram negative aerobic and anaerobic subgingival isolates indicate sensitivity to Amoxycillin/Clavulanic acid during antimicrobial susceptibility testing.

Class: Antibiotics / Aminopenicillin   

Indication / Uses:

TOXO-MOX Injection is indicated in the treatment of:

Dogs

• • Skin and soft tissue infections – cellulitis, abscesses, wounds, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: ß-lactamase producing Staphylococcus aureus, non-ß-lactamase producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and coli
  • Peridontal infections – TOXO-MOX has been shown to be clinically effective for treating cases of canine periodontal disease caused by susceptible strains of aerobic and anaerobic bacteria.

Cats

• • Skin and soft tissue infections – abscesses, wounds, and cellulitis/dermatitis due to susceptible strains of the following organisms: ß-lactamase producing Staphylococcus aureus, non-ß lactamase producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. coli, Pasteurella multocida, and Pasteurella spp.
  • UTI or Urinary tract infections /cystitis due to susceptible strains of coli. Therapy may be initiated with TOXO-MOX prior to obtaining results from bacteriological and susceptibility studies.

A culture should be obtained prior to treatment to determine the susceptibility of the organisms to TOXO-MOX. Following determination of susceptibility results and clinical response to medication, therapy may be re-evaluated.

Dosage and administration:

Dogs and Cats: The recommended dosage is 8.75 mg/kg of body weight through IV administration at intervals of 8 hours or through IM administration at intervals of 24 hours. As directed by the Veterinarian.

Reconstitution Instructions-Dissolve the contents of the vial using sterile water for injections IP. Use the reconstituted solution immediately after preparation.  Constitute with requisite quantity from the Sterile Water for Injections IP 10 ml or 5 ml provided with the pack. Do not allow to freeze.

Warning: If any foreign matter is visible in the vial after dissolving the contents, please do not use the solution.

Route of administration: For IM/IV Use

Overdoses / Side effects / Contraindications /Warnings:

Contraindicated in animals with a history of hypersensitivity or an allergic reaction to any of the penicillin or cephalosporins. TOXO-MOX contains a semisynthetic penicillin (Amoxycillin) and has the potential for producing allergic reactions. In case of hypersensitivity or allergic reaction administer epinephrine and/or steroids.

Pharmaceutical precautions / Instructions: 

Store in a cool and dry place at room temperature below 25°C. Protect from light. For Veterinary Use. Not for human use. For treatment of Dogs & Cats Only. Keep out of reach of children. Details of Sterile Water for Injections IP printed on the ampoule label. Schedule H Prescription Drug.

Safety: Age / Pregnancy/ Withdrawal:

Safety regarding use in breeding or pregnant animals has not been determined. Always follow the recommended dose.

Substitute: Amoxyrum forte Injection, Inimox Forte Injection, Moxikind SB,