AMOXSAN 250 mg

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Category
Penicillin Antibiotic
Type
General Anaesthetic
Package
AMOXSAN® Dispersible Tablet Box of 10 strips @ 10 tablets. Lic. No. : DKL0732401281A1
Composition
Each tablet contains Amoxicillin Trihydrate USP equivalent to 250 mg of Amoxicillin. Specification: USP List of excipients: Mannitol DC, Crospovidone, Aspartame, Silicon Dioxide Colloidal, Strawberry Dry Flavor, Talc, Pigment Red No. 3 FDC E 127, Magnesium Stearate.
Indication
AMOXSAN Dispersible Tablet is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such a : • Upper respiratory tract infections e.g., tonsillitis, sinusitis, otitis media.
• Lower respiratory tract infections e.g., acute and chronic bronchitis, lobar and bronchopneumonia.
• Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis, septic abortion, puerperal sepsis.
• Skin and soft tissue infections.
• Bone infections.
• Gonorrhoea (non-penicillinase producing strains)
• Dental abscess (as an adjunct to surgical management).
• Strains of the following organisms are generally sensi®ti ve to the bactericidal action of AMOXSAN in vitro :
Gram-positive Aerobes :
Streptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, penicillin-sensitive Staphylococcus aureus, Coryne-bacterium species, Bacillus anthracis, Listeria monocytogenes. Anaerobes: Clostridium species. Gram-negave Aerobes: Haemophilus influenza, Eschericia coli, Proteus mirabilis, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae, Neisseria meningitides, Pasteurella septica, Vibrio cholera. Amoxicillin is susceptible to degradation by betalactamase and therefore the spectrum of activity of ®A MOXSAN does not include organisms which produce these enzymes, including resistant staphylococci and all strains of Pseudomonas, Klebsiella and Enterobacter.
Dossage
Posology and method of administration
AMOXSAN® Dispersible Tablet may be given without regard to meals. Dissolve one dispersible tablet in approximately one spoonful of drinking water, wait for about 50 seconds until the tablet is completely dispersed into small granules. The suspension may be directly given to patient, followed by drinking water. Usual dosage for the treatment of infection:
• Adults and children over 40 kg: for severe infections, 875 mg every 12 hours or 500 mg three times daily.
• Gonorrhoea: single 3 g dose.
• Children's dosage (Children under 40 kg) Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections. Note: Moderate infection are certain infection without complication such as septicemia or bactericemia. Severe infection are certain infection with complication such as septicemia or bactericemia.
Precaution
- Before initiating therapy with Amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillin.
- Periodic assessment of renal, hepatic and hematopoietic functions should be made during prolonged therapy. - Patient with renal disorder must be monitored for its plasma and urine level.
- Patient with renal disorder must be necessary to reduce the total daily unit amoxicillin dosage.
- As with other antibiotics, Amoxicillin administration may cause superinfection (the common causes are Pseudomonas, Enterobacterium, S. aureus and Candida). If it occurs, treatment should be discontinued and appropriate therapy should be instituted.
- Not for meningitis or body joint treatment (since oral Amoxicillin does not penetrate the cerebrospinal or sinovial liquid).
- Caution should be taken when this drug is administered to patients with lymphatic leukemia due to Amoxicillininduced skin rash susceptibility.
- It may be necessary to reduce the total daily unit amoxicillin dosage accordingly for patients with renal disorder.
- This product contains mannitol; it may cause osmotic diarrhea in some patients.
- Patients with infections mononucleosis (glandular fever), lymphatic leukaemia and possibly with HIV infection are particularly prone to developing erythematous rashes with amoxicillin. Amoxicillin should be discontinued if a skin rash occurs.
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CAPSINAT

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Category
Penicillin Antibiotic
Type
General Anaesthetic
Package
CAPSINAT® 500 Film-Coated caplet
Box of 5 strips @ 6 caplets.
Reg. No. : DKL0532400809A1

CAPSINAT® Dry Syrup
Bottle 60 ml.
Reg. No. : DKL0932402938A1

CAPSINAT® Forte Dry Syrup
Bottle 60 ml.
Reg. No. : DKL0932402938B1
Composition
CAPSINAT® 500 Film-Coated Caplet
Each film-coated caplet contains :
Amoxicillin Trihydrate equivalent to 500 mg of Amoxicillin and Clavulanate Potassium equivalent to 125 mg of Clavulanic Acid.
CAPSINAT® Dry Syrup
After reconstitution, each 5 ml contains :
Amoxicillin Trihydrate equivalent to 125 mg of Amoxicillin and Clavulanate Potassium equivalent to 31.25 mg of Clavulanic Acid.
CAPSINAT® Forte Dry Syrup
After reconstitution, each 5 ml contains :
Amoxicillin Trihydrate equivalent to 250 mg of Amoxicillin and Clavulanate Potassium equivalent to 62.5 mg of Clavulanic Acid.
Indication
- Upper respiratory tract infections e.g. tonsillitis, sinusitis, otitis media.
- Lower respiratory tract infections e.g. acute and chronic bronchitis, lobar and bronchopneumonia.
- Genito-urinary tract infections e.g. urethritis, cystitis, pyelonephritis.
- Skin and soft tissue infections e.g. abscesses, cellulitis, boils.
- Bone and joint infections e.g. osteomyelitis.
- Dental infections e.g. dentoalveolar abscess.
- Other infections e.g. septic abortion, purperal sepsis, intraabdominal sepsis.
Dossage
To minimize potential gastrointestinal intolerance, administer at the start of a meal. Treatment should not be extended beyond 14 days without review by a physician.

CAPSINAT® 500 Film-Coated Caplet
Adults and children > 12 years :
- In mild to moderate infections : 1 caplet 250/125 mg, 3 times daily.
- In severe infections : 1 caplet 500/125 mg, 3 times daily.
- Dental infections : 1 caplet 250/125 mg, 3 times daily for 5 days.
Children :
The usual recommended daily dosage is 25 mg/kg/day of body weight in the divided doses 8 hourly.
For renal impairment :
- Mild impairment (creatinine clearance > 30 ml/min) : not change in dosage.
- Moderate impairment (creatinine clearance 10 - 30 ml/min) : 1 tablet 250/125 mg or 1 caplet 500/125 mg 12 hourly.
- Severe impairment (creatinine clearance < 10 ml/min) : not more than 1 tablet 250/125 mg 12 hourly.

CAPSINAT® Dry Syrup
< 1 year (7.5 kg) : 2.5 ml, 3 times daily.
1 - 6 years (10 - 18 kg) : 5 ml, 3 times daily.

CAPSINAT® Forte Dry Syrup
> 6 years (18 - 40 kg) : 5 ml, 3 times daily.

In more serious infections the dosage may be increased up to 50 mg/kg/day in divided dose 8 hourly.
Precaution
- Cautiously in patients with severe hepatic impairment.
- In patients with moderate or severe renal impairment, dosage should be adjusted as recommended in the DOSAGES section.
- Not recommended to pregnant and nursing mother except on medical recommendation.
- In high dose or prolonged administration may induce superinfection (caused by Enterobacter, Pseudomonas, S. aureus, Candida) primarily in gastrointestinal tract.

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