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Amoxicillin Capsules Instructions
Please read the instructions carefully and use under the guidance of a physician. =”font-family:Arial”>
[Drug Name]
Generic Name: Amoxicillin Capsules
English Name: Amoxicillin Capsules
Hanyu Pinyin: Amoxilin Jiaonang
[Ingredients
The main ingredient of this product is amoxicillin.
Chemical name: (2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2- (4-hydroxyphenyl)acetylamino] -7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid tri Hydrate.
Chemical structure formula.
Molecular formula: C16H19N3O5S-3H2O
Molecular weight: 419.46
[Properties
The content of this product is white to yellow powder or granule.
[Indications] Amoxicillin is indicated for the following infections in adults and children caused by sensitive bacteria (non-β-lactamase-producing strains):
1. Upper respiratory tract infections such as otitis media, sinusitis, pharyngitis and tonsillitis caused by Streptococcus haemolyticus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae.
2. Genitourinary tract infections due to Escherichia coli, Streptococcus oxysporum, or Enterococcus faecalis.
3. Soft tissue skin infections due to Streptococcus haemolyticus, Staphylococcus or Escherichia coli.
4. Lower respiratory tract infections such as acute bronchitis and pneumonia caused by Streptococcus haemolyticus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae.
5. Eradication of H. pylori in combination with other drugs.
Use with reference to the official guidelines for clinical use of antimicrobial drugs.
[Specification] 0.25g
According to C16H19N3O5S 0.25g
[Dosage and Administration].
Take orally, without opening the capsule, with water. Food does not affect the absorption of this product.
Adults and Children
Treatment should be continued beyond the time when the patient is asymptomatic or has obtained evidence of bacterial eradication48to72tohours.
A minimum of 10 days of treatment is recommended for any infection caused by Streptococcus pyogenes. days of treatment to prevent the onset of acute rheumatic fever.
In some infections, treatment may take several weeks. Continued clinical and/ or bacteriologic follow-up may be necessary for several months after discontinuation of treatment.
Children are advised to take the appropriate dosage form.
Infection siteSevere infection1
DegreeAdults and weight ≥40kgChildren’s usual dosageWeight40kgChildren (greater than3months) UsualDosageEar, Nose, Throat Infections
Skin soft tissue infection
Genitourinary tract infection
Mild to moderate infection
Severe infection500 mg once every 12 hours or 250 mg once every 8 hours
500 mg once every 8 hours
25 mg/kg/day in 2 divided doses (every 12 hours)or 20 mg/kg/day in 3 divided doses (every 8 hours)
45 mg/kg/day in 2 divided doses (1 dose every 12 hours)or 40 mg/kg/day in 3 divided doses (1 dose every 8 hours)Lower respiratory tract infectionMild to moderate or severe infection
500 mg once every 8 hours
45 mg/kg/day in 2 divided doses (every 12 hours)or 40 mg/kg/day in 3 divided doses (every 8 hours)Note:1. style=”font-family:equals”>Infections caused by bacteria with intermediate susceptibility to amoxicillin should refer to the recommended dose for administration in severe infections
Therapeutic Dose for Helicobacter pylori Infection
Recommended oral dose for adults is amoxicillin1g given twice daily (every12hours) 1times) in combination with other medications.
See instructions for other drugs used in combination and related guidelines.
Patients with renal impairment
Patients with renal impairment generally do not require dose reduction unless the impairment is severe.
Glomerular filtration rate of10to30ml/minute patients should receive 500 depending on the severity of the infectionmg or250mg per12hours1times.
Glomerular filtration rate less than10ml/minute patients should receive infusion according to the severity of the infection. span>500mg or250mg per 24hours1time.
Hemodialysis patients should receive 500mg or250mg per24hours1times. Additional doses should be received during and at the end of dialysis.
There are no dosing recommendations for pediatric patients with renal impairment.
Hepatic impairment
Cautious administration and regular monitoring of liver function is required (see [Precautions] and [Adverse Reactions]).
Elderly
Dose adjustment may be considered unnecessary. However, caution should be exercised in dose selection because of the greater likelihood of reduced renal function in the elderly (see [Geriatric Dosing]).
[Adverse Reactions].
The most common adverse drug reactions reported abroad are diarrhea, nausea, and rash.
The following table lists the adverse drug reactions in foreign clinical studies and post-marketing surveillance of amoxicillin according to the MedDRA Systematic Organ Classification.
The following terms are used to classify the incidence of adverse reactions.
very common (≥1/10)
Common (≥1/100 to <1/10)
Rare (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
unknown (cannot be estimated from available data)
Infections and Infectious DiseasesVery rareMucocutaneous candidiasisDiseases of the blood and lymphatic systemvery rarereversible leukopenia (including severe neutropenia or granulocyte deficiency), reversible thrombocytopenia, and hemolytic anemia.
Prolonged bleeding time and prothrombin time (see [Precautions]). Immune System DisordersVery rareSevere allergic reactions, including angioneurotic edema, anaphylaxis, serum sickness, and allergic vasculitis (see [Precautions]). unknownHirschsprung’s reaction (see [Precautions]). Neurological DisordersVery rareSpasms, vertigo, convulsions (see [Precautions]). Gastrointestinal DisordersForeign clinical trial data*CommonDiarrhea and nausea*rareVomitingForeign post-market datavery rareAntibiotic-associated colitis (including pseudomembranous enterocolitis and hemorrhagic colitis; see [Precautions]).
Black tongue diseaseDiseases of the hepatobiliary systemVery rareHepatitis and cholestatic jaundice. moderate AST and/or ALT ElevatedDermatologic and subcutaneous tissue disordersForeign clinical trial data*CommonRash*Rarely seenHives and itchingForeign post-market datavery rareDermal reactions such as erythema multiforme, Stevens Johnson syndrome, toxic necrolytic epidermolysis bullosa, exfoliative dermatitis herpetiformis, acute generalized eruptive pustulosis (AGEP), and drug reactions with eosinophilia and systemic symptoms (DRESS). (See [Precautions])Kidney and urinary tract disordersvery rareInterstitial nephritis
Crystalluria (see [Precautions] and [Drug Overdose]*These adverse event rates were derived from clinical studies of approximately 6000 adult and pediatric patients taking amoxicillin abroad. [Contraindications].
Penicillin allergy and positive penicillin skin test patients are contraindicated.
Severe tachyphylaxis (e.g., anaphylactic reaction) to other beta-lactams (e.g., cephalosporins, carbapenems, monocyclic beta-lactams) is contraindicated.
[Caution].
Allergic reactions
Before starting treatment with amoxicillin, carefully ask about previous history of allergy to penicillins, cephalosporins and other beta-lactams. A penicillin sodium skin test must be done before use and is contraindicated in positive reactions. Severe and occasionally fatal hypersensitivity reactions (including allergic reactions and severe cutaneous adverse reactions) have been reported in patients treated with penicillin. These reactions are more likely to occur in patients with a history of penicillin allergy as well as in allergic individuals. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate replacement therapy administered.
Non-sensitive microorganisms
Amoxicillin is not suitable for the treatment of certain types of infections unless the pathogen has been documented and is known to be highly sensitive to amoxicillin or the pathogen is likely to be suitable for treatment with amoxicillin. This is especially true in the treatment of urinary tract infections and in those with severe infections of the ear, nose, and throat.
Twitching
Convulsions may occur in patients with impaired renal function, in patients receiving high doses, or in patients with precipitating factors (e.g., history of seizures, epilepsy under treatment, or meningeal disease).
Renal impairment
Patients with renal impairment require dose adjustment based on the degree of impairment (see [Dosage]).
Dermal reactions
Pancytopenia with pustules at the start of treatment may be a symptom of acute generalized eruptive pustulosis (AGEP) (see [Adverse Reactions]). This reaction requires discontinuation of amoxicillin and prohibits any subsequent treatment.
Amoxicillin should be avoided if infectious mononucleosis is suspected, as the measles-like rash that occurs with amoxicillin may be associated with this condition.
Hirschsprung’s reaction
Hirschsprung’s reaction (see [Adverse Reactions]) has been reported overseas with amoxicillin for Lyme disease. It directly affects the bactericidal activity of amoxicillin against Lyme disease Burkholderia spirochetes. This is a common self-limiting outcome of antimicrobial therapy for Lyme disease.
Overgrowth of non-susceptible microorganisms
Long-term use of amoxicillin may lead to overgrowth of non-susceptible organisms.
Antibiotic-associated colitis has been reported with almost all antimicrobial drugs and may range in severity from mild to life-threatening (see [Adverse Reactions]). Therefore, the most important thing is to diagnose whether the patient has pre-existing diarrhea or diarrhea resulting from antibiotic use. If antibiotic-associated colitis occurs, amoxicillin should be discontinued immediately, a physician should be consulted, and appropriate therapy should be initiated. Anti-peristaltic agents are contraindicated in this situation.
Long-term treatment
Organ system function, including renal, hepatic, and hematopoietic function, should be evaluated regularly during long-term treatment. Elevated liver enzymes and changes in blood cell counts have been reported (see [Adverse Reactions]).
Anticoagulants
Prolongation of prothrombin time has rarely been reported in patients treated with amoxicillin. Appropriate monitoring should be performed when administered concomitantly with anticoagulants. Dose adjustment of oral anticoagulants may be necessary to achieve the desired level of anticoagulation. (See [Drug Interactions] and [Adverse Reactions])
Crystalluria
Predominantly in amoxicillin injection therapy, patients experienced decreased urine output and small amounts of urine crystals were observed. When high doses of amoxicillin are given, it is best to maintain adequate fluid intake and urine volume in order to reduce the likelihood of amoxicillin crystalluria. Patients with bladder cannulation should have their catheters checked periodically (see [Adverse Reactions] and [Drug Overdose]).
Interference with diagnostic testing
Serum and urine amoxicillin may interfere with certain laboratory tests. Because of the high concentration of amoxicillin in urine, false positives are often seen using chemical methods.
The glucose oxidase method is recommended for testing urine glucose during amoxicillin therapy.
The presence of amoxicillin may affect the results of estriol measurements in pregnant women.
Formation of drug-resistant bacteria
Prescribing amoxicillin to patients with undiagnosed or not highly suspected bacterial infections may not benefit the patient and increase the formation of drug-resistant bacteria.
Impact on ability to drive and use machines
No studies have been conducted on the effects on the ability to drive and use machines. However, adverse reactions (e.g., allergic reactions, dizziness, seizures) may occur, which may affect the ability to drive and use the machine (see [ADVERSE REACTIONS]).
[Medication for Pregnant and Lactating Women].
Pregnancy
Animal studies have not shown direct or indirect reproductive toxicity. Limited data suggest that human use of amoxicillin during gestation does not increase the risk of congenital malformations. Amoxicillin may be used in pregnancy when the potential therapeutic benefit outweighs the potential risk associated with treatment.
Lactation
Amoxicillin can be secreted into breast milk in small amounts and may be a risk for sensitization. As a result, breastfed infants may develop diarrhea and mucosal fungal infections and may have to be terminated from breastfeeding. Amoxicillin should only be used during breastfeeding after a physician’s assessment of benefit/risk.
Fertility
There are no data to suggest that amoxicillin has an effect on human fertility. Reproduction studies in animals have shown no effect on fertility.
[Pediatric use]See [Dosage].
[Drug Interactions
Probenecid
Combination with probenecid is not recommended. Probenecid reduces renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased blood levels and prolonged retention of amoxicillin.
Allopurinol
The combination of allopurinol with amoxicillin during treatment may increase the likelihood of allergic skin reactions.
Tetracyclines
Tetracyclines and other antibacterial drugs may interfere with the bactericidal effect of amoxicillin.
Oral anticoagulants
Oral anticoagulants and penicillin-based antibiotics are widely used in practice, and no interactions have been reported. However, according to the literature, patients using vinblastine or warfarin in combination with a course of amoxicillin have had an increased international normalized ratio. If a combination is necessary, prothrombin time and international normalized ratio should be carefully monitored as amoxicillin is added and withdrawn. In addition, the dose of oral anticoagulant may need to be adjusted (see [Precautions] and [Adverse Reactions]).
Methotrexate
Penicillins can decrease the excretion of methotrexate, leading to an increase in potential toxicity.
[Drug overdose].
Signs and symptoms of overdose.
Gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea), and disturbances in water-electrolyte balance may be evident. Amoxicillin crystalluria has been observed to lead to renal failure in some cases. Convulsions may occur in patients with impaired renal function or those receiving high doses (see [Precautions] and [Adverse Reactions]).
Treatment of toxicity.
Gastrointestinal symptoms can be treated symptomatically, with attention to water and electrolyte balance. Amoxicillin can be cleared from the circulation by hemodialysis.
[Pharmacology and Toxicology].
Amoxicillin is a penicillin antibiotic that is effective against Streptococcus pneumoniae, Streptococcus haemolyticus and other streptococci, non-penicillinase producing Staphylococcus, Enterococcus faecalis and other aerobic gram-positive cocci, Escherichia coli, E. coli and E. oxytoca. It has good antibacterial activity against Streptococcus spp. such as Streptococcus pneumoniae, Streptococcus haemolyticus, Staphylococcus nonpenicillinase-producing, Enterococcus faecalis and other aerobic Gram-positive cocci, Escherichia coli, Aspergillus chimaera, Salmonella spp. antibacterial activity.
Amoxicillin showed good antibacterial activity by binding to bacterial penicillin-binding proteins (PBPs) binding to inhibit bacterial cell wall synthesis and exert bactericidal effects, which can cause bacteria to rapidly become spheroplasts and lyse and rupture.
[Pharmacokinetics].
Absorption
Amoxicillin is completely dissolved in physiological pH aqueous solution. It is rapidly absorbed after oral administration. After oral administration, the bioavailability of amoxicillin is approximately 70%. The time to peak blood concentration (Tmax) is approximately 1 h.
The results of a pharmacokinetic study of 250 mg amoxicillin administered three times daily to healthy volunteers in the fasted state are as follows.
CmaxTmax *AUC (0-24h)T ½(μg/ml)(h)(μg.h/ml)(h)3.3 ± 1.121.5 (1.0-2.0)26.7 ± 4.561.36 ± 0.56*Median value (range)Bioavailability is linear with dose in the 250-3000 mg dose range (measuring Cmaxand AUC values). Absorption is not affected by feeding.
Hemodialysis clears amoxicillin.
Distribution
Amoxicillin has a protein binding rate of about 18% and an apparent volume of distribution of about 0.3 to 0.4 L/ kg.
After intravenous administration, amoxicillin was distributed in the gallbladder, abdominal tissue, skin, fat, muscle tissue, synovial and peritoneal fluid, bile, and pus. Amoxicillin is not adequately distributed into the cerebrospinal fluid.
In animal studies, there was no evidence of significant tissue retention of drug derivatives. As with most penicillins, amoxicillin can be detected in breast milk (see [Dosage for Pregnant and Lactating Women]).
Amoxicillin has been shown to cross the placental barrier (see [Dosage for Pregnant and Lactating Women]).
Biotransformation
Part of amoxicillin is excreted in the urine as inactive penicillin-thiazolic acid, equivalent to 10% to 25% of the initial dose.
Clearance
Amoxicillin is primarily cleared by the kidneys.
In healthy subjects, the mean clearance half-life of amoxicillin is approximately 1 h, and the mean total clearance is approximately 25 L/h. With a single administration of 250 mg or 500 mg of amoxicillin, approximately 60-70% of amoxicillin is excreted in the urine within 6 h as a prototype drug. . Several studies have shown that 50-85% of amoxicillin is excreted in the urine during a 24-h cycle.
The combination of probenecid delays the excretion of amoxicillin (see [Drug Interactions]).
Age
For children 3 months to 2 years of age, older children, and adults, the elimination half-life of amoxicillin is similar. In very young children (including premature neonates), dosing intervals should not exceed twice daily during the first week of life due to immature renal elimination pathways. Because of the greater potential for decreased renal function in older patients, care should be taken in dose selection and possibly monitoring of renal function.
Gender
Gender did not significantly affect the pharmacokinetics of amoxicillin in healthy male and female subjects following oral administration of amoxicillin.
Renal impairment
Total serum clearance of amoxicillin decreases proportionally with decreased renal function (see [Dosage] and [Precautions]).
Hepatic impairment
Patients with hepatic impairment should take with caution and monitor liver function regularly.
[Storage] Not to exceed 25°C.
[Package] Aluminum blister plate, (1) 2×10 capsules/plate/box, 5×10 capsules/plate/box, 20×10 capsules/plate/box, 3×10 capsules/plate/box, 4×10 capsules/plate/box, 10×10 capsules/plate/box, (2) 2×12 capsules/plate/box.
[Expiration date] 18 months
[Executive Standard
[Approval Number
[Manufacturer
Company Name: North China Pharmaceutical Co.
Manufacturing Address: No. 282, Guanghua Road, Shijiazhuang, China
Postal Code: 050015
Customer Service Tel: 4006128588, 4006128585
Website: www.ncpc.com.cn