Use
Therapeutic indications
Amoxil 1 g, dispersible tablet is indicated for the oral treatment of the following bacterial infections caused by germs sensitive to amoxicillin (see section Pharmacodynamic properties):
- Upper respiratory tract infections including NCDs: Acute otitis media, acute sinusitis, and documented group A beta-hemolytic streptococcal angina.
- Lower respiratory tract infections: acute exacerbation of chronic bronchitis, community-acquired pneumonia.
- Lower urinary tract infections: cystitis
- Prevention of endocarditis.
- Lyme disease treatment at an early stage with migratory erythema (stage 1).
- Helicobacter pylori eradication: in appropriate combination with another antibacterial and a suitable anti-ulcer in adult patients also with H. pylori peptic ulcer.
Official recommendations on the proper use of antibacterials should be taken into account.
Dosage and method of administration
There are other presentations of amoxicillin that allow doses less than 2 g per day and forms more adapted to the child.
The dose of amoxicillin depends on the patient's age, weight, and kidney function, the severity and location of the infection, and the suspected or proven nature of the causative organism. The tablets can be used in two ways: you can disperse them in water and then drink the liquid, or take them directly with water. They can be broken to facilitate swallowing.
Amoxil 1 g, dispersible tablet can be taken before, during or after meals.
Dose:
In general, treatment should be continued for 2 to 3 days after symptoms disappear. In case of beta-hemolytic streptococcal infection, the treatment should last 10 days to guarantee the eradication of the germ.
Parenteral therapy is indicated if oral administration is considered impossible or inappropriate, particularly for the emergency treatment of serious infections.
Adults and kids older than 12 years old.
The usual daily dose is between 750 mg and 3 g of amoxicillin in 2 to 3 doses.
Special doses
Angina: 1 g twice a day. The duration of treatment is 6 days.
Acute exacerbation of chronic bronchitis in adults: 1 g twice daily.
Acute pneumonitis: 1 g three times a day (i.e. 1 g every 8 hours).
Lyme disease (strictly isolated chronic migraine erythema): 500 mg to 1 g three times a day, the duration of treatment is 14 to 21 days.
Helicobacter pylori eradication: amoxicillin 1 g twice daily, combined with clarithromycin 500 mg twice daily and omeprazole 20 mg or lansoprazole 30 mg twice daily, for 7 to 14 days. An alternative treatment should be considered for populations with more than 20% clarithromycin resistance.
Elderly patients
Same dose as in adults, except in case of kidney failure.
Dosage in case of kidney failure.
The dose should be reduced in severe kidney failure. When the renal clearance is less than 30 ml / min, it is recommended to lengthen the interval between doses or reduce the doses (see section Warnings and precautions for use).
In case of renal insufficiency, a brief treatment with a single dose of 3 g is not possible.
Adults (including elderly patients):
Creatinine clearance (ml / min)
Dose
Interval between captures
more than 30
No adjustment necessary
10 - 30
Half the usual dose
12 hours
minus 10
Half the usual dose
24 hours
In the case of hemodialysis, give 500 mg at the end of hemodialysis.
Endocarditis prevention
Administration of 2 to 3 g of amoxicillin orally in the hour prior to surgery.
For more details (postsurgical antibiotic coverage, for example) and a description of patients at risk, see the current official guidelines regarding the prevention of endocarditis.
Prescription and delivery conditions
List I
Duration and special precautions for conservation
Shelf life: 3 years.
Special precautions for storage: Store at a temperature not exceeding 25 ° C.
Preclinical safety data
Non-clinical data from conventional safety pharmacology, repeated-dose toxicology, genotoxicity, and reproductive toxicity studies have revealed no particular risk to humans.
Incompatibilities
Aimlessly.
Employment precautions
Contraindications
The use of Amoxil 1 g, dispersible tablet is contraindicated in the following cases:
- Hypersensitivity to penicillin; Consider the possibility of cross-allergy with beta-lactams such as cephalosporins.
- Hypersensitivity to any of the excipients in the product.
Pregnancy and lactation
Amoxicillin crosses the placental barrier and fetal plasma concentrations represent approximately 25-30% of maternal plasma concentrations.
The use of amoxicillin in a limited number of pregnancies has not shown any harmful effect of the product on pregnancy or the health of the fetus / newborn. To date, there are no other relevant epidemiological data. Animal studies show no direct or indirect harmful effects on pregnancy, embryonic / fetal development, delivery or postnatal development (see section Preclinical safety data).
Caution is required when prescribing for pregnant women.
Amoxicillin is excreted in milk (approximately 10% of the corresponding serum concentration). To date, no harmful effects have been observed in breastfed children after taking amoxicillin. Amoxicillin can be used during lactation.
However, breastfeeding should be discontinued in the case of gastrointestinal disorders (diarrhea, candidiasis, or skin rash) in the newborn.
Warnings and precautions for use
Before starting amoxicillin treatment, care should be taken to look for a history of hypersensitivity reactions to penicillins and cephalosporins. Consider the possibility of a cross allergy to cephalosporins (10% - 15%).
Serious (sometimes fatal) allergic reactions (anaphylactoid reactions) have been reported in patients receiving penicillin. The probability of these reactions increases in patients with a history of hypersensitivity to beta-lactam antibiotics.
In renal insufficiency, the excretion of amoxicillin is delayed and the total daily dose may need to be reduced, depending on the degree of renal insufficiency (see section 4.2).
Long-term use of amoxicillin sometimes leads to overgrowth of resistant germs or yeasts. Therefore, it is necessary to closely monitor the possible appearance of secondary infections.
Anaphylactic shock and other serious allergic reactions are rare after oral administration of amoxicillin. However, if such reactions do occur, appropriate emergency measures should be taken: for example, administration of adrenaline, followed by administration of antihistamines, vascular filling, and administration of corticosteroids. Patients should be closely monitored and other therapeutic measures (artificial respiration, oxygen) should be taken if the situation requires it.
The presence of high concentrations of amoxicillin in the urine can cause the precipitation of the product in the urinary catheters. Therefore, the probes must be examined periodically.
Under high-dose treatment, it is necessary to ensure adequate fluid intake and urine output to reduce the risk of crystalluria due to amoxicillin.
Amoxil 1 g, dispersible tablet should be used with caution in case of viral infection, acute lymphoblastic leukemia or infectious mononucleosis (due to an increased risk of cutaneous erythema).
In the case of persistent severe diarrhea, the possibility of pseudomembranous colitis (usually due to Clostridium difficile) should always be considered. In this case, administration of Amoxil 1 g, dispersible tablet should be discontinued and appropriate therapy initiated (eg, 250 mg vancomycin 4 times daily orally).
As with other beta-lactams, blood counts should be checked regularly when treated with large doses.
Administration of high doses of beta-lactams in patients with a history of renal failure or comitiality, or treated for epilepsy or meningeal involvement can, in exceptional cases, cause seizures.
The appearance of a generalized erythema with fever and pustules at the start of treatment should point to the possibility of generalized acute exanthematous pustulosis; treatment should be discontinued and any subsequent administration of amoxicillin is contraindicated.
Amoxil 1 g, dispersible tablet contains aspartame (E951) and should therefore be used with caution in case of phenylketonuria. In the case of homozygous phenylketonuria, the amount of phenylalanine provided by aspartame must be taken into account when calculating the diet.
The dose of anticoagulants may need to be adjusted during co-administration of amoxicillin (see section Interactions with other medicinal products and other forms of interaction).
Serum methotrexate levels should be closely monitored during co-administration of amoxicillin (see section Interactions with other medicinal products and other forms of interaction).
Interaction with other medicinal products and other forms of interaction
Associations not recommended
+ Alopurinol
Co-administration of allopurinol may promote the appearance of allergic skin reactions and is therefore not recommended.
+ Digoxin
Digoxin absorption may increase with concomitant administration of amoxicillin. The dose of digoxin may need to be adjusted (see section 4.4).
+ Anticoagulants
Co-administration of amoxicillin and coumarin anticoagulants may cause longer bleeding times. The dose of anticoagulants may need to be adjusted (see section 4.4). Numerous cases of increased oral anticoagulant activity have been reported in patients receiving concurrent antibiotic therapy. The infectious and inflammatory context, the age and the general condition of the patient seem to be risk factors. In such circumstances, it is difficult to distinguish the part of responsibility for the infection and that of its treatment in the appearance of changes in the INR. However, certain classes of antibiotics are more associated with such events, in particular fluoroquinolones, macrolides, cyclins, cotrimoxazole, and certain cephalosporins.
+ Methotrexate
Increased effects and hematological toxicity of methotrexate by inhibition of renal tubular secretion by penicillins. Serum methotrexate levels should be closely monitored during concurrent amoxicillin treatment (see section 4.4).
+ Hormonal oral contraceptives
Administration of amoxicillin may cause a transient decrease in plasma estrogen and progestin levels and may reduce the effectiveness of oral contraceptives. Therefore, it is recommended to take additional, non-hormonal contraceptive measures.
+ Other forms of interactions:
- Forced diuresis causes a decrease in blood concentrations of amoxicillin through an increase in its elimination.
- For the detection of glucosuria during treatment with amoxicillin, it is recommended to use enzymatic methods with glucose oxidase. In fact, in the presence of high urinary concentrations of amoxicillin, chemical methods often give false positive results.
- At high concentrations, amoxicillin can lower the blood glucose test result.
- Amoxicillin can interfere with protein determination by colorimetric methods.
Caution
Undesirable effects
In this section, the frequency of side effects is defined as follows:
Common: (≥1 / 100, minus 1/10)
Uncommon: (≥1 / 1,000, minus 1/100)
Rare: (≥1 / 10,000, minus 1/1000)
Very rare: (less than 1 / 10,000)
frequency not known (cannot be estimated from the available data)
Infections and infestations.
Infrequent
Superinfections and colonization by resistant germs or yeasts, for example, oral or vaginal yeast infections after prolonged and repeated use of amoxicillin.
Blood and lymphatic system disorders.
Rare
Eosinophilia and hemolytic anemia.
Very rare
Leukopenia, neutropenia, granulopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, longer bleeding time and longer prothrombin time. All these phenomena were reversible after stopping treatment.
Immune system disorders.
Rare
Laryngeal edema, serum sickness, allergic vasculitis, and anaphylactic shock.
Nervous system disorders
Rare
CNS effects, including hyperkinesia, dizziness, and seizures. Seizures are possible in case of kidney failure, epilepsy, meningitis, or under high-dose treatment.
Gastrointestinal disorders.
Frequent
Gastric disorders, nausea, anorexia, vomiting, flatulence, loose stools, diarrhea, enanthemas (especially in the mouth region), dry mouth, abnormal taste. These gastrointestinal effects are usually mild and often disappear during treatment or very quickly after treatment has ended. Taking amoxicillin with meals generally helps reduce the frequency of these side effects.
Rare
Abnormal superficial staining of the teeth (especially with the suspension) is possible, but rare. In general, brushing your teeth helps to remove this abnormal discoloration.
Very rare
If severe and persistent diarrhea occurs, the very rare possibility of pseudomembranous colitis should be considered. Medications that inhibit peristalsis are contraindicated.
Appearance of a black tongue.
Hepatobiliary disorders.
Rare
Moderate and transitory increase in the level of liver enzymes.
Rare
Hepatitis and cholestatic jaundice.
Skin and subcutaneous tissue disorders.
Frequent
Skin reactions like skin rash, itching, hives; The typical morbilliform rash occurs 5 to 11 days after the start of treatment. The immediate appearance of hives indicates an allergic reaction to amoxicillin and requires that treatment be discontinued.
Rare (see also Warnings and precautions for use)
Angioneurotic edema (angioedema), erythema multiforme, generalized exanthematous pustulosis, Lyell syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), and bullous and exfoliative dermatitis.
Kidney conditions
Rare
Acute interstitial nephritis. Crystalluria.
General disorders and administration site conditions.
Rare
Medicated fever.
Overdose
Overdose symptoms:
In general, amoxicillin does not induce acute toxic effects, even in the case of accidentally taking high doses. An overdose can cause symptoms such as digestive disorders, kidney disorders, neuropsychical disorders, and electrolyte disorders. In the event of severe disruption of kidney function, massive overdoses may induce signs of nephrotoxicity; Crystalluria is possible.
Overdose treatment:
There is no specific antidote for amoxicillin overdose.
The treatment is mainly based on the administration of activated carbon (a stomach lavage is generally not necessary) and symptomatic measures. It is particularly important to control the hydro-electrolyte balance.
Amoxicillin can be removed by hemodialysis.
| Package | Price |
|---|---|
| 250 mg 270 caps | AUD 158.84 |
| 250 mg 180 caps | AUD 116.48 |
| 250 mg 120 caps | AUD 84.71 |
| 250 mg 90 caps | AUD 74.12 |
| 250 mg 60 caps | AUD 57.48 |
| 250 mg 40 caps | AUD 42.35 |
| 250 mg 20 caps | AUD 25.70 |
| 500 mg 180 caps | AUD 207.25 |
| 500 mg 120 caps | AUD 163.38 |
| 500 mg 90 caps | AUD 136.15 |
| 500 mg 60 caps | AUD 99.84 |
| 500 mg 30 caps | AUD 55.96 |
| 500 mg 10 caps | AUD 19.65 |
| 625 mg 270 pills | AUD 612.71 |
| 625 mg 180 pills | AUD 435.70 |
| 625 mg 120 pills | AUD 326.77 |
| 625 mg 90 pills | AUD 272.31 |
| 625 mg 60 pills | AUD 226.92 |
| 625 mg 30 pills | AUD 127.07 |
| 625 mg 10 pills | AUD 45.37 |
| 1000 mg 270 pills | AUD 612.71 |
| 1000 mg 180 pills | AUD 599.09 |
| 1000 mg 120 pills | AUD 472.01 |
| 1000 mg 90 pills | AUD 408.47 |
| 1000 mg 60 pills | AUD 317.69 |
| 1000 mg 30 pills | AUD 181.53 |
| 1000 mg 20 pills | AUD 136.15 |
| 1000 mg 10 pills | AUD 75.63 |