Actions of Amoxiclav Sandoz 250mg/62.5mg/5ml in details
Pharmacology: Clinical Studies: Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Amoxiclav Sandoz 250mg/62.5mg/5ml. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml).
While Amoxiclav Sandoz 250mg/62.5mg/5ml can be given without regard to meals, absorption of clavulanate potassium when taken with food is grater relative to the fasted state. In one study, the relative bioavailability of clavulanate was reduced when Amoxiclav Sandoz 250mg/62.5mg/5ml was dosed at 30 min and 150 min after the start of a high-fat breakfast. The safety and efficacy of Amoxiclav Sandoz 250mg/62.5mg/5ml have been established. In clinical trials where Amoxiclav Sandoz 250mg/62.5mg/5ml was taken without regard to meals.
Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) serum concebtrations achieved with Amoxiclav Sandoz 250mg/62.5mg/5ml are similar to those produced by the oral administration of equivalent doses of Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) alone. The t½ of Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) after the oral administration of Amoxiclav Sandoz 250mg/62.5mg/5ml is 1.3 hrs and that of Clavulanic Acid (Amoxiclav Sandoz 250mg/62.5mg/5ml) is 1 hr. Approximately 50-70% of the Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) and approximately 25-40% of the Clavulanic Acid (Amoxiclav Sandoz 250mg/62.5mg/5ml) are excreted unchanged in urine during the first 6 hours after administration of a single Amoxiclav Sandoz 250mg/62.5mg/5ml 625-mg tablet. Concurrent administration of probenecid delays Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) excretion but does not delay renal excretion of Clavulanic Acid (Amoxiclav Sandoz 250mg/62.5mg/5ml).
Neither component in Amoxiclav Sandoz 250mg/62.5mg/5ml is highly protein bound; Clavulanic Acid (Amoxiclav Sandoz 250mg/62.5mg/5ml) has been found to be approximately 25% bound to human serum and Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) approximately 18% bound. Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) diffuses readily into most body tissues and fluids with the excretion of the brain and spinal fluid. The results of experiments involving the administration of Clavulanic Acid (Amoxiclav Sandoz 250mg/62.5mg/5ml) to animals suggest that this compound, like Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml), is well distributed in body tissues.
Amoxiclav Sandoz 250mg/62.5mg/5ml administration
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
If you switch from one tablet form to another (regular, chewable, or extended-release tablet), take only the new tablet form and strength prescribed for you. The strength of clavulanate potassium is not the same among the different tablet forms, even though the amount of Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) may be the same as in the tablet you were using before. This medicine may not be as effective or could be harmful if you do not use the exact tablet form your doctor has prescribed.
Take this medicine with a full glass of water.
Take the medicine at the start of a meal to reduce stomach upset.
Take the medicine at the same time each day.
The Augmentin tablet should be swallowed whole.
The Augmentin Chewable tablet must be chewed before swallowing. Do not swallow a chewable tablet whole.
Do not crush or chew the Augmentin XR (extended-release) tablet. Swallow the pill whole, or break the pill in half and take both halves one at a time. If you have trouble swallowing a whole or half pill, talk with your doctor about using another form of Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) and clavulanate potassium.
Shake the liquid form of this medicine well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) and clavulanate potassium will not treat a viral infection such as the common cold or flu.
This medication can cause false results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) and clavulanate potassium.
Store the tablets at room temperature away from moisture and heat.
Store the liquid in the refrigerator. Throw away any unused liquid after 10 days.
Amoxiclav Sandoz 250mg/62.5mg/5ml pharmacology
The pharmacokinetics of Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) and clavulanate were determined in a study of 19 pediatric patients, 8 months to 11 years, given Amoxiclav Sandoz 250mg/62.5mg/5ml-600 at an Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) dose of 45 mg/kg every 12 hours with a snack or meal. The mean plasma Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) and clavulanate pharmacokinetic parameter values are listed in the following table.
Table 1: Mean (±SD) Plasma Amoxicillin (Amoxiclav Sandoz 250mg/62.5mg/5ml) and Clavulanate Pharmacokinetic Parameter Values Following Administration of 45 mg/kg of Amoxiclav Sandoz 250mg/62.5mg/5ml-600 Every 12 Hours to Pediatric Patients
| Parameter Clinical assessments at 15-18 days post-therapy may have been confounded by viral infections and new episodes of acute otitis media with time elapsed post-treatment. |
In the intent-to-treat analysis, overall clinical outcomes at 2-4 days and 15-18 days post-treatment in patients with S. pneumoniae with penicillin MIC = 2 mcg/mL and 4 mcg/mL were 29/41 (71%) and 17/41 (41.5%), respectively.
In the intent-to-treat population of 521 patients, the most frequently reported adverse events were vomiting (6.9%), fever (6.1%), contact dermatitis (i.e., diaper rash) (6.1%), upper respiratory tract infection (4.0%), and diarrhea (3.8%). Protocol-defined diarrhea (i.e., 3 or more watery stools in one day or 2 watery stools per day for 2 consecutive days as recorded on diary cards) occurred in 12.9% of patients.
A double-blind, randomized, clinical study compared Amoxiclav Sandoz 250mg/62.5mg/5ml-600 (90/6.4 mg/kg/day, divided every 12 hours) to AUGMENTIN (45/6.4 mg/kg/day, divided every 12 hours) for 10 days in 450 pediatric patients (3 months to 12 years) with acute otitis media. The primary objective of the study was to compare the safety of Amoxiclav Sandoz 250mg/62.5mg/5ml-600 to AUGMENTIN. There was no statistically significant difference between treatments in the proportion of patients with 1 or more adverse events. The most frequently reported adverse events for Amoxiclav Sandoz 250mg/62.5mg/5ml-600 and the comparator of AUGMENTIN were coughing (11.9% versus 6.8%), vomiting (6.5% versus 7.7%), contact dermatitis (i.e., diaper rash, 6.0% versus 4.8%), fever (5.5% versus 3.9%), and upper respiratory infection (3.0% versus 9.2%), respectively. The frequencies of protocol-defined diarrhea with Amoxiclav Sandoz 250mg/62.5mg/5ml-600 (11.1%) and AUGMENTIN (9.4%) were similar (95% confidence interval on difference: -4.2% to 7.7%). Only 2 patients in the group treated with Amoxiclav Sandoz 250mg/62.5mg/5ml-600 and 1 patient in the group treated with AUGMENTIN were withdrawn due to diarrhea.
REFERENCES
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing – 21st Informational Supplement. CSLI Document M100-S21. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2011.
1. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – Approved Standard 7th ed. CSLI Document M11-A7. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2007.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – 8th ed. CLSI Document M07-A8. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2009.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Test; Approved Standard – 10th ed. CLSI Document M02-A10. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2009.
References
- DailyMed. "AMOXICILLIN; CLAVULANATE POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- NCIt. "Amoxicillin Anhydrous: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- NCIt. "Clavulanic Acid: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
