Each capsule contains:
Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg
Each caplet contains :
Amoxicillin Trihydrate equivalent to Amoxicillin 500 mg
Each 5 ml of the suspension contains:
Amoxicillin Trihydrate equivalent to Amoxicillin 125 mg
Each 5 ml of the suspension contains :
Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg
Each vial contains:
Sodium Amoxicillin equivalent to Amoxicillin 1000 mg
Pharmacology
Amoxicillin is a semi synthetic derivative of penicillin which is active against Gram-positive and Gram-negative microorganisms.
Excretion is inhibited when is administered with probenecid, which cause prolonged
therapeutic effect.
Capsules, Caplets and Dry Syrup
Amoxicillin is stable in acid gastrointestinal. Amoxicillin is rapidly and welt absorbed through digestive tract, not depend on food availability.
Amoxicillin especially is excreted in unchanged form in urine.
Injection
Administration of 250 mg or 500 mg amoxicillin injection intramuscular, produces serum level about 5.5-10 ug/ml for 60 minutes.
The major route of excretion for amoxicillin injection is through the kidney. In normal renal function about 70 of amoxicillin will be excreted in unchanged form (rapid i.m. and i.v. administration) after 6 hours.
Indications
Amoxicillin injection is given if the oral administration is not possible.
Amoxicillin is indicated for the infections therapy caused by sensitive bactena strain :
- Skin and soft tissue Infections : Slaphylococcus sp. nonpeniclllinase-producing strains, Streptococcus sp., E. coli,
- Respiratory tract Infections: Haemophilus intluenzae. Streptococcus sp. including Streptococcus pneumoniae, Slaphylococcus sp. nonpenicillinase-producing strains, E. coli.
- Urogenital tract infections : E co//, P. mirabilis and Streptococcus faecalis.
- Gonorrhoea : N. gononrrhoea (nonpenicillinase-producing strains).
Capsules, Caplets and Dry Syrup
- Adult and Children › 20 kg : 250 - 500 mg every 8 hours.
- Children ‹ 20 kg : 20 - 40 mg/kg body weight/day in divided dose, every 8 hours.
- Patient with renal dysfunction, necessary to reduce the dosage, The maximum recommended dose for patient with peritoneal dialysis is 500 mg/day.
- Gonococcus urethritis : 3 g as a single dose.
Patients with normal renal function:
- Upper respiratory tract infections, urogenital tract infections, skin and soft tissue infections:
- Adult: 250 mg every 6-8 hours, depends on patient's condition.
- Children (‹ 20 kg): 20 mg/kg/day In divided dose every 6-8 hours.
- In severe infection, dosage can be increased up to 500 mg every 6 - 8 hours
- (adult) and 40 mg/kg/day in divided dose every 6-8 hours (children).
- Lower respiratory tract infections :
- Adult: 500 mg every 6-8 hours.
- Children (‹ 20 kg); 40 mg/kg/day in divided dose every 6-8 hours.
- Bacterial septicemia:
- Adult: for more serious infections : 1 gram every 6 hours with intermittent i.v.
- injection or i.v. infuse for 30-60 minutes.
- Children (‹ 20 kg): 20 - 40 nig/kg every 6 hours.
| Creatinine clearance › 30ml/minute | No dose adjustment is needed. |
| Moderate impairment (Creatinine clearance 10-30ml/minute) | 1g injection amoxicillin followed by 500 mg injection amoxicillin 12 hourly. |
| Severe impairment (Creatinine clearance ‹ 10ml/minute) | 1g injection amoxicillin followed by 500 mg injection amoxicillin 24 hourly. |
Warnings and Precautions
- Careful inquiry should be made in patient with lymphatic leukemia because it can cause hypersensitivity reaction such as skin rash.
- Severe colitis can be occurred.
- Before initiating therapy with amoxicillin, sensitivity reaction with penicillin should be tested.
- Amoxicillin should be used by caution when administered to pregnant and nursing women.
- Prolonged therapy with amoxicillin should be accompanied with renal, hepatic and hematopoietic function assessment.
- Superinfection can be occured (usually caused by Enlerobacterium, Pseudomonas, Staphylococcus auraus, Candida). If this case is happened, treatment should be discontinued and others alternative antimicroba is given.
- Patient with renal dysfunction, plasma and urine level monitoring should be maintained. Dosage adjustment should be taken.
- Oral amoxicillin is not recommended for meningitis and bone and joint infections because the amoxicillin oral cannot penetrate In cerebrospinal and sinovial liquid.
- Injection amoxicillin should not be mixed with blood products or other proteinaceous fluids, e.g. protein hydrolysates or with intravena lipid emulsion.
- Prescribed concurrently with an aminoglycoside, should not be mixed In the same syringe/infuse fluid container because the activity of the aminoglycoside will decrease.
- During treatment with high doses of amoxicillin, particularly by bolus Injection, an adequate fluid intake and urinary output must be maintained.
- Amoxicillin injection is stable with commonly used intravena fluids at 23°C, if Infused over a period not exceeding 6 hours.
- Solutions should be changed after 1 hour if amoxicillin injection is administered in fluids containing dextrose or other carbohydrates, or within 3 hours in solutions containing sodium lactate.
- Hypersensitivity reaction such as erythemalous maculopapular rashes, urticaria, serum sickness.
- Serious and fatal hypersensitivity reaction : anaphylaxis especially occurs In patient with hypersensitivity to penicillin.
- Gastrointestinal tract disturbance such as : vomiting, nausea, diarrhoea.
- Haematological reactions (usually reversible).
- Especially for injection administration can cause phlebitis and pain at injection site.
Patient with hypersensitivity or with known history of hypersensitivity to beta ladam
antibiotics (penicillin, cephalosphorin).
Drug Interactions
- Probenecide can increase and prolong amoxicillin concentration in plasma.
- It may increase skin reaction when amoxicillin is administered with allopurinol
| Capsule 250 mg | : | Box of 10 strips x 10 capsules | Reg. No. DKL7411607301A1 |
| Caplet 500 mg | : | Box of 3 strips x 10 Caplets | Reg, No. DKL7811607404A1 |
| : | Box of 10 strips x 10 caplets | Reg. No. DKL7811607404A1 | |
| Dry syrup 125 mg/5 ml | : | Box of bottle 60 ml | Reg. No. DKL9911629538A1 |
| Dry syrup 250 mg/5 ml | : | Box of bottle 60 ml | Reg.No.DKL7611600638A1 |
| Injection 1000 mg | : | Box of 10 vials @ 1000 mg | Reg. No. DKL9611600644A1 |
Should be administered Immediately after reconstruction.
After reconstruction :
- Store at room temperature maximal 1 hour.
- Store at refrigerator maximal 3 hours.
| Capsules, Caplets and Dry Syrup Store below 30°C. | Injection Store below 25°C. |
On medical Prescription only
| Injection Manufactured by: PT Bernofarm Pharmaceutical Surabaya - Indonesia For: PT. KALBEFARMA Tbk. Bekasi - Indonesia | Capsules, Caplets and Dry Syrup Manufactured by: PT DANKOS FARMA Jakarta - Indonesia For: PT. KALBEFARMA Tbk. Bekasi - Indonesia |
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