Bioclan Tab (clindamycin)

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Description

 

 

BIOCLAN 150

Each uncoated tablet contains

Clindamycin Hydrochlonde IP

Equivalent to Clindamycin 150 mg

Excipients q.s.

 

CATEGORY: Anti-bacterial

PHARMACOLOGY PHARMACODYNAMICS:

Clindamycin inhibits bacterial protein synthesis at the ribosomal (50s sub-unit) level.

PHARMACOKINETICS:

Absorption:

Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal

tract following oral administration.

Effective

clindamycin antibacterial serum levels are reached within 30 minutes following administration of the therapeutic dose.

Serum values:

Therapeutic serum levels of clindamycin can be maintained by oral administration of 5.5 mg/kg body weight every 12 hours or 11 mg/kg body weight every 24 hours: peak serum concentrations are on average reached 75 minutes after oral administration. The biological plasma half-life of clindarycin in the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after several oral administrations.

Metabolism and Excretion:

Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent molecule as well as bioactive and bio-inactive metabolites is excreted via the urine and faeces. Nearty all bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).

INDICATIONS:

Clindamycin uncoated tablet are indicated for use in dogs as follows

  • For the treatment of infected wounds and abscesses, infected mouth cavity and dental infections caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis), 'Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens to help provide antimicrobial cover during dental procedures
  • For the treatment of superficial pyoderma associated with
  • Staphylococcus intermedius.
  • For the treatment of osteomyelitis caused by Staphylococcus aureus
  • Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to clindamycin established.

DOSAGE AND ADMINISTRATION:

For oral administration only.

For Cats:

The recommended daily therapeutic dose range for clindamycin hydrochloride is 11 to 33 mg/kg/day depending on the severity of the condition.

For the treatment of infected wounds and abscesses, infected mouth cavity and dental infections in cats, administer either:

• 5.5 mg/kg of body weight every 12 hours for 7 to 10 days, 11 mg/kg of body weight every 24 hours for 7 to 10 days

If no clinical response is seen within 4 days, redetermine the diagnosis.

To help provide anti-microbial cover during dental procedures, a 10 day course is recommended. This should be initated five days before dental therapy and continued for five days thereafter.

For Dogs:

1. For the treatment of infected wounds and abscesses, infected mouth cavity and dental infections in dogs, administer either:

5.5 mg/kg of body weight every 12 hours for 7-10 days, 11 mg/kg of body weight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis. To help provide antimicrobial cover during dental procedures, a 10 day course is recommended. This should be initiated five days before dental therapy and continued for five days thereafter. In dogs, treatment may be extended to a maximum of 28 days based on clinical judgment.

For the treatment of superficial pyoderma in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours,

11 mg/kg of body weight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy based on clinical judgment

3. For the treatment of osteomyetitis in dogs, administer:

11 mg/kg of body weight every 12 hours for a minimum of 28 days

It no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis redetermined.

contraindications, warnings :

Do not use in dogs and cats that are hypersensitive to preparations containing clindamycin or lincomycin.

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may result in severe gastrointestinal disturbance.

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolides antibiotics.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high dose clindamycin therapy.

Voriting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical situation.

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs has not been established.

Clindamycin hydrochloride has been shown to have neuromuscular enhance the action of neuromuscular blocking agents. Cindanycin uncoated tablets should be used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonize each other at their site of action at the

50S ribosomal subunit.

PREGNANCY AND LACTATION:

Safety in gestating female dogs or breeding male dogs has not been established.

INTERACTIONS

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Clindamycin uncoated tablets should be used with caution in animals recerving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonize each other at their site of action at the

50S ribosomal sub-unit.

ADVERSE DRUG REACTIONS:

Vomiting and diarrhoea have occasionally been observed.

Clindarycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical situation.


Dosage:

Dental Infections:
11mg/kg every day for 7 to 10 days

Osteomyelitis:
11mg/kg every 12 hours for 28 days

In Cats - 5mg/kg twice daily or 10mg/kg once daily 

Toxoplasmosis in Cats - 25mg/kg every day for 7 to 10 days 

Presentation:
1 x 10 Tablets

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