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Recommendations of Expert Committee Meeting held on 6.03.2014 The expert committee deliberated the following proposals on 06.03.14 and recommended the following: Agenda No. Name of FDC 1 Amoxicillin Trihydrate IP eq. to Amoxicillin 125mg +Cloxacillin Sodium IP eq. to Cloxacillin 125mg Dispersible Tablets Although the firm claimed that the proposed FDC is superior than individual drugs, it could not produce any data in this regard. The committee opined that superiority of FDC over individual drugs needs to be proven in current scenario and accordingly, protocol shall be submitted within 3 months and data shall be generated within next one and half year. Non- compliance of this instruction may lead to suspension/cancellation of license. Amoxicillin trihydrate 250 mg + cloxacillin sodium 250 mg capsule Firm could not produce any data in respect of superiority of FDC over individual drugs. The committee opined that superiority of FDC over individual drugs needs to be proven in current scenario and accordingly, protocol shall be submitted within 3 months and data shall be generated within next one and half year. Noncompliance of this instruction may lead to suspension/cancellation of license. Amoxicillin Trihydrate IP 250mg +Cloxacillin Sodium 250mg +Saccharomyces Boulardii 40 million spores Hard Gelatin Capsules Firm did not produce any data with respect to use of Saccharomyces Boulardii in the treatment of antibiotic associated diarrhea. The committee opined that currently there is no data/ evidence to suggest the rationality of the FDC. However, if the firm generates safety and efficacy data, same may be re-examined. Accordingly, protocol shall be submitted within 3 months and data shall be generated within next one and half year. Noncompliance of this instruction may lead to suspension/cancellation of license. 2 3 4 Recommendations Amoxicillin Trihydrate IP Eq. to Amoxicillin 125mg/500mg +Dicloxacillin Sodium USP Eq. to Dicloxacillin 125mg/500mgTablets/Sachet The committee reviewed following FDC (i) Amoxicillin 250mg + Dicloxacillin 250mg (ii)Amoxicillin 125mg + Dicloxacillin 125mg (iii)Amoxicillin 500mg + Dicloxacillin 500mg It was noted that Amoxicillin 250mg + Dicloxacillin 250mg was approved by CDSCO in 2006 and the FDC at (ii) and (iii) are nowbeingrequested by the company. Committee opined that : (a) Since, 2006 the scenario of antimicrobial resistance pattern has changed significantly, majority of isolates of Staph. aureus have become resistance to the amoxicillin &cloxacillin including dicloxacillin (b) Better efficacious antibiotic andare now available and used for staph. aureus infections. In light of these, the rationality of combination in current scenario is questionable. It is also noted that this combination is not available anywhere in the world as per information provided by the firm and also the fact that there is only one study presently by the firm showing better efficacy was published in journal “Pharmazie” Sept. 40(9), 650-1, 1984. However after 30 years, this has lost its relevance in today’s scenario of drug resistance. Committee therefore doesn’t recommended the new strengths of the FDC and also recommended that the superiority of such FDC over the individual drug andneed to be proven in current scenario. Accordingly, Protocol should be submitted within 3 months and data shall be generated within next one and half year. Noncompliance of this instruction may lead to suspension/cancellation of license. 5 6 AmoxycillinTrihydrate IP 250mg +Dicloxacillin Sodium IP 250mg +Serratiopeptidase IP 10mg Hard gelatin capsules Committee opined that combination of serratiopeptidase with antibiotics has no rationale. Hence Committee didn’t recommend for manufacturing and marketing of the proposed FDC Regarding amoxicillin 200 mg + Clavulanic acid (i) Amoxycillin 875mg + Clavulanic 28.5mg Tablet/dispersible tablet, committee observed that original data needs to be generated acid 125 mg Film coated tablets on their own formulation of the firms in respect of (ii) Amoxycillin 250 mg+ Bioavailability, Acceptability/ palatability, in Clavulanic acid 125 Film coated pediatric population. Accordingly, protocol shall tablets be submitted within 3 months and data shall be generated within next one and half year. Non(iii) Amoxycillin 200mg + compliance of this instruction may lead to Clavulanic acid 28.5 mg dispersible suspension/cancellation of license. tablets Committee noted that other strengths apart from the above mentioned strengths are approved by DCG(I) as claimed by the firm. DCG(I) may take action accordingly with respect to these strengths. 7 (i) Amoxicillin trihydrate IP 80mg + Potassium Clavulanate IP 11.4mg Oral Suspension (ii) Amoxicillin 80mg/200mg/400mg + Clavulanic Acid 11.4mg/28.4mg/28.5mg/ 57mg Suspension (iii)Amoxicillin 875mg/200mg/400mg/200 mg + Potassium Clavulanic Acid 125mg/28.5mg/57mg /28.5mg per 5ml-Suspension (i) The firm presented that FDC of Amoxycillin 200mg + potassium Clavulanate 28.5mg per 5ml is already approved by US FDA. The committee recommended that the combination of amoxicillin 200 mg+ clavulanic Acid 28.5mg in children less that 20 kg body weight and 400mg + clavulanate potassium57.5 mg per 5 ml in children more than 20 kg body weight may be approved for manufacturing and marketing as there have been no safety concerns with respect to these strength. (ii) Regarding amoxicillin 200 mg + Clavulanic acid 28.5mg Tablet/dispersible tablet, committee observed that original data needs to be generated on their own formulation of the firms in respect of (iv) Amoxicillin trihydrate 400mg + Bioavailability, acceptability/palatability, in potassium clavulanate diluted paediatric population. Accordingly, protocol shall 57 mg- reconstituted suspension be submitted within 3 months and data shall be generated within next one and half year. Non(v) Amoxycillin Trihydrate compliance of this instruction may lead to 875/200mg/400 mg/200mg30ml suspension/cancellation of license. +Potassium Clavulanate 125mg/28.5mg/57.7mg+28.5mg (iii) As regard to Combipack, it was noted by the Tablet/ Dispersible tablet/Oral committee that mentioning of Sterile water for Suspension/ injection on the label for the purpose of reconstitution is not appropriate as it could lead to (vi) Amoxicillin other confusions. Firm should revise the label and 400mg/200mg/250mg + other promotional literature appropriately and Potassium Clavulanate Diluted should submit the same to the office of DCG(I) 57mg/28.5mg/62.5mg Dry for further approval. Syrup (vii) Amoxycillin Trihydrate 400mg + Potassium clavulanate diluted 57mg Oral suspension (viii) Amoxicillin trihydrate 200mg + clavulanate potassium 28.5mg dry syrup 8 (i) (iv) Regarding Amoxycillin 250 mg + clauvulanic Acid 62.5 mg per 5 ml, committee opined that the proposed strength is not recommendable as too many strength will lead to confusion in prescribing for the physician. Hence the committee did not recommend for the proposed strength The committee noted that the pharmacokinetics of A Amoxicillin require dosing frequency 6-8 hourly. moxycillintrihydrate 500 In contradiction Tinidazole dosing is twice a day. mg + tinidazole 300 mg- Further the proposed indications are not as per the film coated tablet (ii) moxycillin 500mg + 300mg) clinical indication of these two individual drugs A such as Amoebiasis. Tinidazole is good enough Trihydrate for the treatment of amoebiasis and Amoxicillin tinidazole does not have any role and therefore the FDC does not have any rationale. Even for H. pylori infection the proposed FDC is not rationale. The proposed FDC is also not approved anywhere in the world. Hence the committee didn’t recommend the FDC for manufacturing and marketing. 9 Amoxicillin Trihydrate IP Eq. to Amoxicillin 500mg + Cefixime IP as Trihydrate Eq. to Anhydrous Cefixime 200mg +Potassium Clavulanic Acid 125mg Tablets Committee noted that Cefixime requires 12 hourly dosing. Whereas, Amoxicillin dosing schedule is 6-8 hrs. When these two drugs are given in combination, it will have a pharmacokinetic mismatch. As claimed by the firm the dosing of FDC is 12 hourly, which will lead to under dosing of Amoxicillin and may increase possibility of drug resistance. Further the FDC is not approved anywhere in the world. The committee did not recommend for the manufacturing and marketing of the FDC