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HSA Approval

PULMOXYL DRY SYRUP 125 mg/5ml

SIN11300P

PULMOXYL DRY SYRUP 125 mg/5ml

PULMOXYL DRY SYRUP 125 mg/5ml

April 5, 2000

NAINA MOHAMED & SONS PRIVATE LIMITED

NAINA MOHAMED & SONS PRIVATE LIMITED

Regulatory Information

NAINA MOHAMED & SONS PRIVATE LIMITED

NAINA MOHAMED & SONS PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

SYRUP

**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: _Adults and Children over 40 kg:_Mild impairment (creatinine clearance greater than 30 mL/min)– No change in dosageModerate impairment (creatinine clearance 10 to 30 mL/min)– 500 mg twice a day maximumSevere impairment (creatinine clearance less than 10 mL/min)– 500 mg/day maximum _Children under 40 kg:_Mild impairment (creatinine clearance greater than 30 mL/min)– No change in dosageModerate impairment (creatinine clearance 10 to 30 mL/min)– 15 mg/kg twice a day (maximum 500mg/twice daily)Severe impairment (creatinine clearance less than 10 mL/min)– 15 mg/kg once a day (maximum 500 mg) 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. ![Pulmoxyl Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/25e5577ad2aa3fe18ac01491f6806e39.png) 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.

ORAL

Medical Information

**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:** Amoxicillin is penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalosporins).

J01CA04

amoxicillin

Manufacturer Information

NAINA MOHAMED & SONS PRIVATE LIMITED

MICRO LABS LTD

Active Ingredients

AMOXYCILLIN TRIHYDRATE EQV AMOXYCILLIN

125 mg/5ml

Amoxicillin

Documents

Package Inserts

Pulmoxyl Syrup 125 PI.pdf

Approved: January 17, 2023

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