Description

BEETAPET Dry Syrup and Tablets

Amoxycillin Trihydrate and Potassium Clavulanate Oral Suspension and Tablets

Amoxicillin oral suspension and tablets for dogs and cats

Manufactured by: SkyEc Pharma

Dosage form: Oral Suspension and Tablets

Presentation: 

Oral Suspension:         3 gm/ 30 ml with 30 ml Sterile Water for Reconstitution and Calibrated Dropper of 1 ml

Tablets:     62.5 mg, 250 mg, 375 mg and 625 mg

Ingredients & Composition:

Oral Suspension:
Each Combipack contains:
(a) One bottle of Amoxicillin and Potassium Clavulanate Power
Each 5 ml of reconstituted suspension contains:
Amoxycillin Trihydrate equivalent to Amoxycillin IP     200mg
Diluted Potassium Clavulanate IP equivalent to Clavulanic Acid 50mg
Excipients          q.s.
(b) One Ampoule (FFS) of sterile water for reconstitution 30ml.

Each film coated 62.5 mg tablet contains:
Amoxycillin Trihydrate
Equivalent to Amoxycillin           50 mg
Clavulanic acid as the Potassium Clavulanate          12.5 mg

Each film coated 250 mg tablet contains:
Equivalent to Amoxycillin           200 mg
Clavulanic acid as the Potassium Clavulanate          50 mg

Each film coated 375 mg tablet contains:
Equivalent to Amoxycillin           300 mg
Clavulanic acid as the Potassium Clavulanate         75 mg

Each film coated 625 mg tablet contains:
Equivalent to Amoxycillin           500 mg
Clavulanic acid as the Potassium Clavulanate         125 mg

Description / Action: 

Beetapet Oral Suspension and Tablets contain broad-spectrum antibiotic Amoxicillin trihydrate and the β-lactamase inhibitor, Potassium clavulanate (the potassium salt of clavulanic acid) for dogs and cats.

Amoxicillin trihydrate is a semisynthetic aminopenicillin with a broad spectrum of antibacterial activity (bactericidal) against many gram positive and gram-negative, aerobic and anaerobic microorganisms. Amoxicillin is not effective against β-lactamase-producing bacteria because it does not resist destruction by β -lactamases. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

Clavulanic acid which is a β-lactamase enzyme inhibitor, is produced by the fermentation of Streptomyces clavuligerus. Clavulanic acid by itself has only weak antibacterial activity. Chemically, Potassium clavulanate in potassium z-(3R,5R)-2- β-hydroxyethylidene clavam-3-carboxylate broad-spectrum antibiotic Amoxycillin trihydrate and the β-lactamase inhibitor, Potassium clavulanate (the potassium salt of clavulanic acid).

Clinical Pharmacology:

Amoxycillin trihydrate has bactericidal activity against a variety of gram-positive and gram-negative, aerobic and anaerobic bacteria. However, the antibiotic can be inactivated by B-lactamases, so it isn’t effective against bacteria that produce these enzymes.

Clavulanic acid inhibits ß-lactamase enzymes. Clavulanic acid has weak bactericidal activity, but when combined with amoxicillin trihydrate, it prevents bacteria that produce β-lactamases from destroying the amoxicillin, thereby broadening the spectrum of activity against susceptible microbes.

Amoxycillin and Clavulanic Acid diffuse readily into most body tissues and fluids with the exception of brain and spinal fluid which amoxycillin penetrated adequately when meninges are inflamed. Most of the amoxycillin is excreted unchanged in the urine Clavulanic Acid’s penetration into spinal fluid is unknown at this time. Approximately 15% of the administered dose of clavulanic acid is excreted in the urine within the first 6 hours.

Microbiology:

Amoxycillin/Clavulanate has been shown to have a wide range of activity which includes β-lactamase producing strains of gram-positive and gram-negative aerobes, facultative and obligate anaerobes. Many strains of the following organisms including β-lactamase-producing strains isolated from veterinary sources were found to be susceptible to Amoxycillin Clavulanate in vitro but the clinical significance of this activity has not been demonstrated for some of these organisms in animals Aerobic bacteria including Staphylococcus aureus, & lactamase producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus species, Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathie, Bordetella bronchiseptica. E. coli, Proteus mirabilis, Proteus species, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasturella multocida, Pasturella spp and infections due to susceptible strains of both aerobic and anaerobic bacteria.

Class: Potentiated Aminopenicillin Antibiotic – Amoxycillin trihydrate / Clavulanate potassium

Indication / Uses:

Dogs

• Infections of the skin and soft tissue like Abscesses, Cellulitis, Wounds, Superficial/Juvenile and Deep Pyoderma

Caused by susceptible strains of the following micro-organisms:

β-lactamase-producing Staphylococcus aureus, non- β-lactamase producing Staphylococcus aureus, Staphylococcus spp.,

Streptococcus spp., and E. coli.

• Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria.

Cats

• Infections of skin and soft tissue like abscesses, wounds, and cellulitis/dermatitis

Caused by susceptible strains of the following micro-organisms:

β-lactamase-producing Staphylococcus aureus, non- β-lactamase-producing Staphylococcus aureus, Staphylococcus spp..

Streptococcus spp. E coli, and Pasteurella spp.

• Urinary tract infections (cystitis) due to susceptible strains of E. coli.

Dosage and administration:

Dogs & Cats:

The recommended dosage is 12.5 mg/kg body weight twice a day Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5-7 days or for 48 hours after all symptoms have subsided.

If there is no response after 5 days of treatment, then discontinue the treatment and re-evaluate the case. In case of deep bacterial pyoderma treatment for 21 days may be required and the maximum duration of treatment should not exceed 30 days.

Can be given with or without food, but gastrointestinal side effects (eg, vomiting, diarrhoea, lack of appetite) might be prevented if given with food.

NOTE: The ratio of amoxycillin-clavulanic acid is not equivalent in different formulations of Beetapet (tablets, and suspension). Do not interchange the dosage forms until it is noted.

Directions for reconstitution of oral suspension:

Shake bottle to loosen powder.
Twist and open the vial of sterile water given with the pack.
Slowly add sterile water upto ring mark on the bottle.
Put the cap and shake the bottle vigorously.
Adjust the volume upto the ring mark by adding more sterile water, if necessary & shake again, discard the excess water.
Store the reconstituted suspension in the refrigerator. Content to be consumed within 7 days, any extra portion left to be thrown away.

After reconstitution, Each 5ml of suspension will contain 200 mg of amoxicillin activity as the trihydrate and 50 mg of clavulanic acid activity as the potassium salt.

Over-dosage / Side effects / Contraindications /Warnings:

Do not give to rabbits, guinea pigs, chinchillas, hamsters, rodents or other pocket pets since life-threatening diarrhea may occur.

It has the potential for producing allergic reactions because it contains a semisynthetic penicillin (amoxicillin).

Pharmaceutical precautions / Instructions: 

Store in a cool and dry place below 25°C. Protect from direct sunlight and moisture.
Do not use the product if the seal is missing or not intact.
Do Not Use If Powder / Reconstituted Suspension Turns Pale Yellow to Brown Colour.  Shake the suspension well before each use.
Keep the medicine out of reach of children.
Not For Human Use. For Animal Treatment Only.

Safety: Age / Pregnancy/ Withdrawal:

The safety of use in Pregnant or breeding animals has not been determined.

Substitute: Toxo-mox Tablets, Biomox Amoxicillin Oral Suspension and Tablet, Mentin Duo Tablets,