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    PTF >>Anti Bacterial>>Respiclav 100,200


Composition
Respiclav 200
Each Film coated tablet contains:
Cefixime USP as trihydrate equivalent anhydrous cefixime - 200 mg
Potassium Clavulanate Diluted IP equivalent to clavulanic acid - 125 mg
Respiclav 100
Each Film coated tablet contains:
Cefixime USP as trihydrate equivalent anhydrous cefixime - 100 mg
Potassium Clavulanate Diluted IP equivalent to clavulanic acid - 62.5 mg

Product Description
 Cefixime Is An antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes
 Cefixime is an effective treatment to stop the spread of several bacterial infections. It is often used as a treatment for gonorrhea, pharyngitis , Typhoid Fever , and tonsillitis.
 Clavulanic acid is a beta-lactamase inhibitor combined with penicillin group antibiotics to overcome certain types of antibiotic resistance.

Pharmacology
Pharmacodynamics
Cefixime, is an orally active third generation bactericidal cephalosporin ( beta lactam antibiotic ) with broad spectrum of coverage .
Cefixime has been shown to be active against most strains of the following
organisms both in vitro and in clinical infections.
Gram-positive Organisms.
Streptococcus pneumoniae,
Streptococcus pyogenes.

Gram-negative Organisms
Haemophilus influenzae
(beta-lactamase positive and negative strains)
Moraxella (Branhamella) catarrhalis
(most of which are beta-lactamase positive),
Escherichia coli,
Proteus mirabilis.

Gram-positive Organisms
Streptococcus agalactiae
Cefixime are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins) but are less susceptible to penicillinases. Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs). PBPs bind to the D-Ala-D-Ala at the end of muropeptides (peptidoglycan precursors) to crosslink the peptidoglycan. Beta-lactam antibiotics mimic this site and competitively inhibit PBP crosslinking of peptidoglycan
However, cefixime was found to be ineffective against bacteria which produces ESBL enzyme and resistance is seen in such types of bacteria
Clavulanic acid has negligible intrinsic antimicrobial activity, despite sharing the β-lactam ring that is characteristic of beta-lactam antibiotics. However, the similarity in chemical structure allows the molecule to act as a competitive inhibitor of beta-lactamases secreted by certain bacteria to confer resistance to beta-lactam antibiotics. This inhibition restores the antimicrobial activity of beta-lactam antibiotics against lactamase-secreting-resistant bacteria. Despite this, some bacterial strains that are even resistant to such combinations have emerged.


Features
Orally active cephalosporin with a Broad spectrum of antibacterial coverage Offers 100 % clinical cure rates
• Effective against resistant organisms
• Reduced chance of β Lactamse induction
• Ideal Switch over from 3 rd generation IV Cephalosporin
• Its Effective against ESBL RESISTANCE.

Indications
Respiratory tract infections – Bronchitis, Bronchiectasis, Pneumonia
ENT Infections – Chronic Maxillary Sinusitis, Chronic Otitis Media
Urinary tract infections – Acute uncomplicated and complicated urinary tract Infection
Multi Drug Resistant Fever

Dosage
Adults and Children over 10 Years :one tablet twice daily Course of treatement seven Days.

Contra Indication
Patients with known hypersensitivity to cephalosporin antibiotics.

Drug Interactions
In common with other Cephalosporins, increases in Prothrombin times have been noted in a few patients Care should therefore be taken in patients receiving Anticoagulation therapy.
A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognised that a positive Coombs test may be due to the drug.

Undesirable Effects
Generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature.
o Gastrointestinal Disturbances : Diarrhoea and stool changes;
o Central Nervous System: Headache and dizziness.
o Hypersensitivity Reactions
o Hematological and Clinical Chemistry
o Hepatic Disorders

Warnings and Precautions
Should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporin should be given with caution to penicillin-sensitive patients, as there is some evidence of partial crossallergenicity between the penicillins and cephalosporin.

Overdose
Adverse reactions seen at dose levels up to 2 g in normal subjects did not differ from the profile seen in patients treated at the recommended doses.
Gastric lavage may be indicated in overdosage.

Pregnancy & Lactation
There are no adequate and well-controlled studies in pregnant women. Therefore this combination not be used in pregnancy or in nursing mothers Unless considered essential by the physician.

Packing
Alu Alu Blister pack.
Each pack contains 6 Tablets.
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