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Amoxicillin Capsules Instructions
Please read the instructions carefully and use under the guidance of a physician
[Medication Name]
Generic Name: Amoxicillin Capsules
English Name:Amoxicillin Capsules
Hanyu Pinyin:Amoxilin Jiaonang
[Composition]
The main ingredient of this product is amoxicillin.
Chemical name:(2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)acetamido]-7-oxo-4-thia-1-azabicycloazabicyclo[3.2.0]heptane-2-Formic acid trihydrate.
chemical structure formula:
Molecular Formula:C16H19N3 O5S-3H2O
Molecular weight:419.46
[Properties] The contents of this product are white to yellow powder or granules.
[Indications] Amoxicillin is indicated for sensitive bacteria (not producingββ span>lactamase strains) in adults and children due to the following infections:
1. Upper respiratory tract infections such as otitis media, sinusitis, pharyngitis, tonsillitis due to Streptococcus haemolyticus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae.
2. Genitourinary tract infection due to Escherichia coli, Aspergillus chimaera, 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 official guidelines for clinical use of antimicrobial drugs.
[Specifications] byC16H19N3O5SAccount0.125g
[Dosage]
Take by mouth, without opening the capsule, with water. Food does not affect the absorption of this product.
Adults and Children
After the patient is asymptomatic or has obtained evidence of bacterial eradication, treatment should be continued for at least 48to72 hours.
A minimum of 10hours is recommended for any infection caused by Streptococcus pyogenes. family:Arial”>day treatment to prevent the development 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 treatment is discontinued.
Children are advised to take the appropriate dosage form.
Site of infectionSevere infection1
DegreeAdults and weight≥40kgChildren usual dosageWeight 40kgchildren (>3months) usually doseEar, nose, and throat infections
Skin and soft tissue infections
Genitourinary tract infection
Mild to moderate infection
Severe infection500 mg every12hours1time or250 mgper8 hour1time
500 mg per8hours1times
25 mg/kg/day in2doses (each12hours11times)or20 mg/kg/day inminutes. 3doses (every3days) Roman”>8hours1times)
45 mg/kg/day, divided2doses (every12 hourly1time). strong>or40 mg/kg/day indoses “font-family:Times New Roman”>3doses (every8hourly1time)Lower respiratory tract infectionmild to moderate or severe infection
500 mg Every8hours1time
45 mg/kg/day in2doses (each12hours11times)or40 mg/kg/day inminutes. 3doses (every3days) Roman”>8hours1times)to Infections caused by bacteria with moderate susceptibility to amoxicillin should refer to the recommended dosing for serious infections
Therapeutic Dose for Helicobacter pylori Infection
Recommended oral dose for adults is amoxicillin1ggiven twice daily (every12hours) 1time) in combination with other medications.
See the instructions for the other drugs used in combination and related guidelines.
Patients with renal impairment
Patients with impaired renal function generally do not require dose reduction unless the impairment is severe.
Glomerular filtration rate is10 to :Arial”>to30ml/minute patients should receive500mg or250mg per12hours1. /span>times.
Glomerular filtration rate less than10ml/minute should receive depending on the severity of the infection style=”font-family:Times New Roman”>500mg or250. span>mg every24hours1time.
Hemodialysis patients should receive 500 depending on the severity of the infection. “font-family:Arial”>mg or250mg per24hours1 times. 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 periodic 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 shows the results by MedDRAsystematic organ classification lists foreign clinical studies and postmarketing surveillance of amoxicillin for adverse drug reactions.
The following terms are used to classify the incidence of adverse reactions.
Very common (≥1/10)
Common (≥1/100 to <1/10))
Rare (≥1/1,000to<1/100)
Rare (≥1/10,000to<1/1,000)
Very rare (<1/10,000)
unknown (cannot be estimated from available data)
Infectious and Infectious Diseasesvery rareMucocutaneous candidiasisMucocutaneous 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 rare Antibiotic-associated colitis (including pseudomembranous enterocolitis and hemorrhagic colitis; see [Precautions]).
Black tongue diseaseDiseases of the hepatobiliary systemVery rareHepatitis and cholestatic jaundice. ASTand/orALTModerately elevatedskin and subcutaneous tissue disordersForeign Clinical trial data*CommonRash*Rarely seenHives and itchingForeign post-market datavery rareskin reactions such as erythema multiforme,Stevens Johnson syndrome, neutrophilic toxic epidermolysis bullosa, exfoliative dermatitis herpetiformis, acute generalized eruptive pustulosis (AGEP), and drug reactions with eosinophilia () and systemic symptoms of drug reactions (DRESS). (See [Note])Kidney and urinary tract disordersVery rare:Interstitial nephritis
Crystalluria (see [Precautions] and [Drug Overdose]*The incidence of these adverse events originates from foreign countries about6000 clinical studies of adult and pediatric patients taking amoxicillin. [Contraindication]
Penicillin allergy and positive penicillin skin test patients are contraindicated.
To otherβ-lactams (e.g. cephalosporins, carbapenems, monocyclicβ-lactams) with severe tachyphylaxis (e.g. Lactams are contraindicated in individuals with severe tachyphylaxis (e.g., allergic reaction).
[Caution]
Allergic reactions
Before starting treatment with amoxicillin, carefully ask about previous reactions to penicillins, cephalosporins, and otherβ- lactams for a history of allergy. 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.
Convulsions
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 beginning of treatment may be a symptom of acute generalized eruptive pustulosis (AGEP) (see [Adverse Reactions]). This reaction requires discontinuation of amoxicillin and prohibition of any subsequent therapy.
Amoxicillin should be avoided if infectious mononucleosis is suspected, because the measles-like rash that occurs with amoxicillin may be associated with this condition.
Hirschsprung’s reaction
Hirschsprung’s reaction has been reported abroad with amoxicillin for Lyme disease (see [Adverse Reactions]). 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-sensitive microorganisms
Long-term use of amoxicillin may lead to overgrowth of non-susceptible organisms.
Antibiotic-associated colitis has been reported with almost all antibacterial 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 present with decreased urine output and small amounts of urine crystals are 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
Amoxicillin in serum and urine may interfere with certain laboratory tests. Due to the high concentration of amoxicillin in the 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 estriol assay results in pregnant women.
Formation of drug-resistant bacteria
Prescribing amoxicillin to patients in cases of undiagnosed or not highly suspected bacterial infection 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 the benefit/risk.
Fertility
There are no data on the effect of amoxicillin on human fertility. Reproduction studies in animals have shown no effect on fertility.
[Pediatric use]See [Dosage].
[Drug Interactions]
Probenecid
Co-administration 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 increased international normalized ratios. 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 reduce methotrexate excretion, 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 cause 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 poisoning:
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 spp. such as Streptococcus pneumoniae and Streptococcus haemolyticus, aerobic gram-positive cocci such as Staphylococcus faecalis and Enterococcus faecalis, and aerobic gram-positive cocci such as Escherichia coli, Acinetobacter chimaera, Salmonella spp. The non-aerobic Gram-negative strains of aerobic Gram-negative bacteria such as β-lactamase strains and Helicobacter pylori have good antibacterial activity.
Amoxicillin has good antibacterial activity by binding to bacterial penicillin-binding proteins (PBPs. “font-family:Arial”>) binds to inhibit bacterial cell wall synthesis and exerts bactericidal effects, which can cause bacteria to rapidly become globular and lyse and rupture.
[Pharmacokinetics]
Absorption
Amoxicillin in physiologicalpHcompletely dissolved in 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 approximately1h.
250 mg three times daily in healthy volunteers on an empty stomach =”font-family:Arial”>The results of the pharmacokinetic study of amoxicillin 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 250-3000mgdose range (measuredCmaxandAUCvalues).
Absorption is not affected by eating.
Hemodialysis clears amoxicillin.
Distribution
The protein binding rate of amoxicillin is about 18%, with an apparent volume of distribution of about0.3 to0.4 L/ kg.
After intravenous administration, amoxicillin is 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 the drug derivative. 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% of the initial dose10%to25% of the initial dose. .
Clear
Amoxicillin is primarily cleared by the kidneys.
In healthy subjects, the mean clearance half-life of amoxicillin is approximately1hand a mean total clearance of approximately25L/h. A single administration of 250mgor500mgamoxicillin,6in 6hours approximately60-70%of amoxicillin is excreted in the urine as a prototype drug. Several studies have shown that during 24hcycles,50-85% of amoxicillin is excreted from the urine.
The combination of probenecid delays the excretion of amoxicillin (see [Drug Interactions]).
Age
For3months to2years, older children, and adults, the elimination half-life of amoxicillin is similar. In very young children (including premature neonates), dosing intervals during the first1week of life, due to immature renal elimination pathways, should not more than twice daily. Because of the greater potential for decreased renal function in elderly patients, care should be taken in dose selection and possible 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 reduced renal function (see)
[Dosage] and [Precautions]).
Hepatic impairment
Patients with hepatic impairment should take with caution and monitor liver function regularly.
[Storage] 25 below 25C.
[Package]
Pharmaceutical aluminum foil and polyvinyl chloride/polyvinylidene chloride solid pharmaceutical laminate rigid sheets. 10capsules//plate,2board/box,5boards//box.
[Executive Standard]
[Approval number]
[Marketing Authorization Holder]
Name of the holder of the marketing authorization for the drug: Shih Pharma Group Zhongnuo Pharmaceutical (Shijiazhuang) Co. Roman”>
Registered address: Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei Province88No.
Postal Code:052165
Phone Number:80091118868009111886(please call from a landline),4006128666
Fax number:0311-67809458
[Manufacturer]
Company Name: Shih Pharma Group Zhongnuo Pharmaceutical (Shijiazhuang) Co.
Manufacturing Address: Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei Province88No.
Postal Code:052165
Phone Number:80091118868009111886(please call from a landline),4006128666
Fax number:0311-67809458
Web
Address:www.cspczhongnuo.com