PULMOXYL DRY SYRUP 125 MG/5ML

MICRO LABS LTD (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Apr 5, 2000
Approval ID: b18b9eaa06373339
Company: MICRO LABS LTD (INDIA)
Type: Therapeutic

Approval Details

Approval Id: b18b9eaa06373339
Drug Name: PULMOXYL DRY SYRUP 125 MG/5ML
Product Name: PULMOXYL DRY SYRUP 125 MG/5ML
Approval Number: SIN11300P
Approval Date: 2000-04-05
Registrant: NAINA MOHAMED & SONS PRIVATE LIMITED
Licence Holder: NAINA MOHAMED & SONS PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: SYRUP
Dosage: DOSAGE: Adult dosage (including elderly patients): Standard adult dosage: 250 mg 3 times daily, increasing to 500 mg 3 times daily for more severe infections. High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract. Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10 to 12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose. Helicobacter eradication in peptic (duodenal and gastric) ulcer disease: Amoxicillin is recommended at a dose of twice daily in association with a proton pump inhibitor and antimicrobial agents as detailed below: Omeprazole 40 mg daily, Amoxicillin 1 g twice a day, Clarithromycin 500 mg twice a day for 7 days. or Omeprazole 40 mg daily, Amoxicillin 750 mg to 1 g twice a day, Metronidazole 400 mg 3 times a day for 7 days. Children's dosage (up to 10 years of age): Standard children's dosage: 125 mg 3 times daily, increasing to 250 mg 3 times daily for more severe infections. Amoxicillin Paediatric Suspension is recommended for children under 6 months of age. Patients with renal impairment: In renal impairment, the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage according to the following scheme: <table class="borderless-100"> <tbody> <tr> <td colspan="2">Adults and Children over 40 kg:</td> </tr> <tr> <td>Mild impairment (creatinine clearance greater than 30 mL/min)</td> <td>– No change in dosage</td> </tr> <tr> <td>Moderate impairment (creatinine clearance 10 to 30 mL/min)</td> <td>– 500 mg twice a day maximum</td> </tr> <tr> <td>Severe impairment (creatinine clearance less than 10 mL/min)</td> <td>– 500 mg/day maximum </td> </tr> <tr> <td colspan="2">Children under 40 kg:</td> </tr> <tr> <td>Mild impairment (creatinine clearance greater than 30 mL/min)</td> <td>– No change in dosage</td> </tr> <tr> <td>Moderate impairment (creatinine clearance 10 to 30 mL/min)</td> <td>– 15 mg/kg twice a day (maximum 500mg/twice daily)</td> </tr> <tr> <td>Severe impairment (creatinine clearance less than 10 mL/min)</td> <td>– 15 mg/kg once a day (maximum 500 mg)</td> </tr> </tbody> </table> Patients receiving peritoneal dialysis: Dosing as for patients with severe renal impairment (creatinine clearance less than 10 mL/min). Amoxicillin is not removed by peritoneal dialysis. Patients receiving haemodialysis: Dosing as for patients with severe renal impairment (creatinine clearance less than 10 mL/min) Amoxicillin is removed from the circulation by haemodialysis. Therefore, 1 additional dose (500 mg for adults or 15 mg/kg for children under 40 kg) may be administered during dialysis and at the end of each dialysis. Prophylaxis of endocarditis: see table below. <img src="/TGIF/Pulmoxyl-Table1.png" alt="Pulmoxyl Dosage Table 1" /> Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection. In renal impairment the excretion of the antibiotic will be delayed and depending on the degree of impairment, it may be necessary to reduce the total daily dosage.
Route Of Administration: ORAL
Indication Info: INDICATIONS: Amoxicillin should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. Amoxicillin is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as: Upper respiratory tract infections e.g. ear, nose and throat infections, otitis media. Lower respiratory tract infections e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia Gastrointestinal tract infections e.g. typhoid and paratyphoid fever. Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, septic abortion, puerperal sepsis Skin and soft tissue infections. Biliary tract infections Bone infections Pelvic infections Gonorrhoea (non-penicillinase producing strains) Septicaemia Endocarditis Meningitis Peritonitis Dental abscess (as an adjunct to surgical management) Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease Infections such as septicaemia, endocarditis and meningitis due to susceptible organisms should be treated initially with high doses of a parenteral therapy and, where appropriate, in combination with another antibiotic. Prophylaxis of endocarditis: Amoxicillin may be used for the prevention of bacteraemia associated with procedures such as dental extraction, in patients at risk of developing endocarditis. Susceptibility to amoxicillin will vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing performed where necessary.
Contraindications: CONTRAINDICATIONS: Amoxicillin is penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalosporins).
Atc Code: J01CA04
Atc Item Name: amoxicillin
Pharma Manufacturer Name: NAINA MOHAMED & SONS PRIVATE LIMITED

Active Ingredients

AMOXYCILLIN TRIHYDRATE EQV AMOXYCILLIN

125 mg/5ml

AMOXYCILLIN TRIHYDRATE EQV AMOXYCILLIN

125 MG/5 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 5, 2000

Approval ID

b18b9eaa06373339

Type

Therapeutic

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