Tosun Pharmaceutical Limited

27/02/2024

One Drug Knowledge per Day-Voclosporin

CAS：515814-01-4
chemical formula：C63H111N11O12
1. Specifications, usage, and dosage
Specification: Soft capsules: 7.9mg.
Usage and Dosage: For standard doses, one tablet should be taken twice a day.
2. Indications
Indications: An immunosuppressive calcineurin inhibitor used in combination with background immunosuppressive therapy for the treatment of adult patients with active lupus nephritis (LN).
3. Product advantages
A novel immunosuppressive agent for the treatment of adult systemic lupus nephritis (LN), developed by Aurinia Pharma in Canada and approved by the US FDA in January 2021, is the first drug targeting LN in the United States;
It is an improved cyclosporine analog, which has a similar structure and mechanism of action to cyclosporine A, but has higher efficacy and lower toxicity. Compared with cyclosporine, vocyclosporine also has the advantage of less impact on cholesterol and triglycerides, and lower risk of diabetes;
According to the 2020 disease guidelines, there are approximately one million patients with lupus erythematosus in China, of which 46% to 77% are complicated with lupus nephritis, and this disease is a controlled medication that requires long-term use;
The soft capsule formulation is the 66th batch reference, with no compound patent barriers. Currently, the original research has been clinically conducted in China, and it is highly likely to be declared as Class 4.

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26/02/2024

One Drug Knowledge per Day-daprodustat
CAS：960539-70-2
Chemical formula: C19H27N3O6

1.Specifications, usage, and dosage
Specifications:Tablets: 1mg, 2mg, 4mg, 6mg, 8mg;

Usage and dosage: Patients with conservative chronic kidney disease
The commonly used starting dose for adults without treatment with red blood cell hematopoietic stimulating factor preparations is 2mg or 4mg, taken orally once a day. Afterwards, the dosage can be adjusted according to the patient's condition, but the maximum dosage should be 24mg once a day.
When switching from red blood cell hematopoietic stimulating factor preparations, the usual adult dose is 4mg orally once a day. The dose can be adjusted according to the patient's condition, but the maximum dose should be 24mg once a day. Dialysis patients
The usual adult dose is 4mg orally once a day, and the dose can be adjusted according to the patient's condition, but the maximum dose should be 24mg once a day.
2.Indications
Indications: Used to treat anemia caused by chronic kidney disease in adults who have undergone dialysis for at least four months.
3.Product advantages
A novel oral hypoxia inducible factor proline hydroxylase inhibitor (HIF-PHI) is also the first FDA approved oral therapy for anemia caused by chronic kidney disease, used to treat non dialysis dependent (NDD) and dialysis dependent (DD) adult chronic kidney disease anemia;
The Phase III clinical results indicate that dapagliptin has shown positive efficacy in treating adult patients with non dialysis dependent (NDD) and dialysis dependent (DD) chronic kidney disease (CKD) anemia, without increasing cardiovascular risk;
This product benefits patients by stimulating the bone marrow to produce more red blood cells, and the oral dosage form is highly compliant, avoiding injection administration and refrigeration requirements;
The compound patent is about to expire in 2027, and it will first be listed in Japan in 2020. Currently, there are only original research applications in China, and our company can provide general agents for foreign raw materials. Please feel free to inquire.
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26/02/2024

New drugs for renal anemia! The results of the HIF-PHI Phase III study on Dapaglutide are being released with great weight!
As renal function declines, patients with chronic kidney disease (CKD) often develop anemia. Anemia patients do not have enough red blood cells or hemoglobin (Hb) in their bodies, so they cannot carry sufficient oxygen throughout the body. Due to insufficient oxygen supply to the body, individuals may experience fatigue, palpitations or increased heart rate, chest pain, shortness of breath, dizziness, headache, and weakness, leading to a decrease in the patient's quality of life. Previous studies have confirmed that hypoxia inducible factor proline hydroxylase inhibitors (HIF-PHI) can improve the quality of life in CKD patients with severe anemia. However, is HIF-PHI also effective for patients with mild to moderate anemia?

On March 1, 2023, Kidney International released the HIF-PHI Daphpristal Quality of Life Measurement Study (ASCEND-NHQ), which showed that Daphpristal monotherapy significantly increased Hb levels in non dialysis CKD patients, improved fatigue symptoms in patients with mild to moderate anemia, and improved their quality of life!
The ASCEND-NHQ study is a multicenter, randomized, double-blind, placebo-controlled clinical study conducted in 142 medical institutions in 14 countries. This study includes a 4-week introduction period, a 28 week treatment period, and a 4-6 week follow-up period. The enrolled patients were divided into a dapulinastatin group and a placebo group in a 1:1 ratio.
The inclusion criteria for the study are: ① CKD stage 3-5 non dialysis patients; ② Anemia, Hb levels ranging from 8.5 to 10.5 g/dL, with transferrin saturation (TSAT) ≥ 15% and ferritin ≥ 50 ng/ml; ③ No red blood cell generation stimulants (ESAs) were used.
During the introduction period, the patient did not receive any ESAs or iron supplements. During the treatment period, the study did not restrict oral iron supplements, and intravenous iron supplements were only for emergency use. Titrate the dose of Dapaglutide to maintain the patient's Hb level between 11-12g/dL.

The main endpoint of the study is the change in patient Hb compared to baseline between weeks 24-28. The secondary endpoint is the proportion of patients with an increase in Hb ≥ 1g/dL, as well as changes in quality of life (assessed by the SF-36 scale). A total of 614 patients were included in the group, with 307 patients in each of the Dapaglutide and placebo groups. Most of the baseline characteristics of the two groups were similar, but there were still some intergroup differences, such as average age (intergroup difference of 1 year), C-reactive protein levels, and the proportion of patients with Hb

23/02/2024

Introduction to Four New Anti Schizophrenic Drugs
Schizophrenia is the most prevalent mental illness, and patients are prone to recurrent attacks, requiring long-term medication maintenance treatment. There are many drugs for treating schizophrenia, and the therapeutic effects of different drugs also vary. Today, I will take you through a list of four new anti schizophrenia drugs.
1. Lumepirone. It combines strong serotonin 2A receptor antagonists, glutamate modulators, and serotonin reuptake inhibitors, while also improving sleep quality and reducing negative symptoms of schizophrenia. It also has certain effects on depression, anxiety, and other symptoms related to impaired social function. Lumepirone will not lead to an increase in the risk of diabetes and cardiovascular disease. Therefore, compared with many existing antipsychotic drugs, it has significantly improved long-term safety and tolerance.
2. Amisulpiride is a sedative alternative to aniline and is currently a relatively new second-generation antipsychotic drug that can improve and control psychiatric symptoms. Clinically, it is mainly used to treat schizophrenia, and small doses can also treat the lazy and numb state of depression. The incidence of serious adverse reactions is less than 3%, indicating high safety.
3. Bretirasazin has a novel mechanism of multimodal regulation of the 5-hydroxytryptamine and dopamine signaling pathways. At present, it can not only treat schizophrenia, but also has certain therapeutic effects on bipolar disorder and depression.
ALKD3831, a double-layer tablet. The antipsychotic efficacy is comparable to that of olanzapine, and there are no side effects of weight gain. Overall, the tolerance and safety are good.
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Guangzhou TOSUN Pharmaceutical Co., Ltd:TOSUN Pharma provides professional services such as global APIs Sourcing, Reference listed drugs,Impurities and Excipients procurement,Research Chemicals,Chinese drug registration services, and Chinese regulatory consultation.

23/02/2024

One Drug Knowledge per Day-Lumateperone tosylate
CAS：313368-91-1
Chemical formula: C24H28FN3O

1. Dosage form specifications
Capsule: 42mg
2 Indications
Suitable for treating adult schizophrenia, depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults
3. Usage and dosage
The recommended dose is 42 mg, once a day
4. Variety advantages
A novel small molecule antipsychotic drug with a unique mechanism of action, which can synergistically regulate the transmission of serotonin, dopamine, and glutamine to exert therapeutic effects;
Approved by the FDA for marketing in December 2019 for the treatment of adult schizophrenia, with new indications added in December 2021 for the treatment of bipolar type I or type II related depressive episodes in adults;
It has the effect of improving sleep quality and reducing negative symptoms of schizophrenia. It also has a certain effect on depression, anxiety, and other symptoms related to impaired social function;
Compared with risperidone, the risk of weight gain is reduced by 13%, and research results show that switching to lumepirone can significantly improve the patient's weight gain. At the same time, this product will not increase the risk of diabetes and cardiovascular disease, so it has obvious advantages in long-term safety and tolerance compared with many existing antipsychotic drugs;
Capsules are the 60th batch of reference materials, without compound patents. The original research has not been imported into China. There is a domestic company that has applied for Class 3 capsules. Our company can provide general agents for foreign raw materials. Please feel free to inquire.

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22/02/2024

Eye drops commonly used for glaucoma and their side effects

The commonly used eye drops for glaucoma patients, the principle of blood pressure reduction, and their corresponding side effects.
When using medication, everyone must read the instructions to understand these side effects, so as not to panic and stop taking the medication the next day.
Dry and astringent eyes are common and can be relieved with artificial tears. I will write a detailed article on how to alleviate these side effects.

1. Prostaglandins generally have the greatest antihypertensive effect and the longest duration, typically ranging from 24 to 48 hours
Such as Latan, Travus, Beimei, and Tafu

2 β Adrenergic receptor blockers, inhibiting aqueous humor generation
Ru Tiao Ma Xin An, Bei Ta Gen, Mei Kai Lang, Bei Te Shu

3. Choline like drugs that increase aqueous humor outflow
Rucine from Fructus pilosula

4. Carbonic anhydrase inhibitors treat glaucoma CAIs and inhibit aqueous humor generation
Examples include doxorubicin, pyrimidine, as well as oral medications such as acetaminophen and nimex

5. Combination therapy
When single drug treatment fails to achieve the target intraocular pressure, consideration should be given to switching to a different single drug.If a single medication cannot achieve the target intraocular pressure, additional medication should be considered for treatment.In principle, only one type of medication with different antihypertensive mechanisms can be used.Compared to single drug combination therapy, fixed compound formulations are more convenient and require less medication administration，Like paracetamol and ceftazide.

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Guangzhou TOSUN Pharmaceutical Co., Ltd:TOSUN Pharma provides professional services such as global APIs Sourcing, Reference listed drugs,Impurities and Excipients procurement,Research Chemicals,Chinese drug registration services, and Chinese regulatory consultation.

22/02/2024

One Drug Knowledge per Day-Travoprost
1.Dosage form specifications
Chemical structural formula: C26H35F3O6
Dosage form specifications:
Eye drops: 0.004% (2.5ml: 0.1mg);
Compound eye drops of timolol maleate: 2.5ml: travoprost 0.1mg and timolol maleate 12.5mg (calculated as timolol)

2.Applicability
Reduce the elevated pressure limit in patients with open angle glaucoma or high intraocular pressure

3.Usage and dosage
Recommended dosage: once per night, 1 drop per time, drop into the affected eye.

4.Product advantages
Travoprost is a prostaglandin analogue developed by Alcon in the United States. It was launched in the United States in 2001 and has been sold in dozens of countries worldwide. It is currently one of the first-line drugs for treating glaucoma. Prostaglandin analogues can increase the excretion of aqueous humor, thereby reducing intraocular pressure.
Clinical trials have shown that travoprost significantly improves vision, astigmatism, and intraocular pressure at different times after treatment compared to timolol maleate; The incidence of adverse reactions is significantly lower than that of timolol maleate.
Glaucoma is a common chronic ophthalmic disease and the second leading cause of blindness worldwide. Its main characteristics include elevated intraocular pressure, damage to the optic nerve, and in severe cases, even loss of vision. This treatment market has great potential for development.
Travoprost eye drops are included in the reference catalog for the 22nd and 27th batches, and our company can provide A-state general agent foreign raw materials at a competitive price.

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21/02/2024

One Drug Knowledge per Day-Tafluprost

CAS: 209860-87-7
Chemical formula: C25H34F2O5

1.Specifications, usage, and dosage
Specifications:0.0015% (0.3ml: 4.5) μ g) ;0.0015% (2.5ml: 37.5) μ g) ;
Usage and dosage:Once a day, one drop each time.

2.Indications
Indications:A therapeutic agent for glaucoma and high intraocular pressure.

3.Product advantages
Due to rigid market demand and a large patient population, glaucoma ranks second among global blinding eye diseases and first among irreversible blinding eye diseases. At present, there are about 67 million patients worldwide, and in 2020, the number of patients in China may reach 21.8 million, with over 25% of them being blind. The incidence rate of glaucoma in the general population is 1%, 1-2% after 40 years old, and 3-4% above 50 years old.

Lowering intraocular pressure is the only proven effective treatment strategy for glaucoma, and drug therapy runs through the entire process, with prostaglandin drugs having the strongest effect on lowering intraocular pressure; The European Guidelines for Glaucoma (EGS Guidelines) emphasize the priority and importance of glaucoma drug therapy.

High selectivity: Tafluprost has high selectivity for prostaglandin receptor FP and has almost no effect on other receptors; High affinity: Tafluprost has a 12 fold affinity for prostaglandin receptor FP compared to latanoprost;
Efficiency: Effectively reduces intraocular pressure by 37.2%; The 24-hour fluctuation of intraocular pressure is also significantly lower than that of latanoprost; Replacing other prostaglandin drugs with tafluoroprostaglandin can reduce average intraocular pressure by 1mm Hg.

High safety and similar clinical effects to latanoprost, but tafluprost has a more favorable distribution of certain confocal parameters in the cornea; Compared with travoprost, tafluprost may have improved corneal safety while maintaining an effective effect in reducing intraocular pressure; In addition, preparations without preservatives can improve patient subjective satisfaction and tear time.

Clinical urgent and market scarce varieties, Class B medical insurance, the domestic hospital terminal market in 2022 was 75.3 million yuan, a year-on-year increase of 57.83%. Currently, there are few domestic listed companies, and the market competition is good. Our company can supply high-quality imported raw materials (excluding preservatives).

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20/02/2024

One Drug Knowledge per Day-pemafibrate
CAS: 848259-27-8
Chemical formula: C28H30N2O6

1.Specifications, usage, and dosage
Specifications:Tablets: 0.1mg;
Usage and dosage:Usually, adults take 0.2mg orally once a day, and depending on the degree of high triglyceride levels, 0.4mg once can be increased to once a day.

02.Indications
Indications:Hyperlipidemia (including familial).

3.Product advantages
Pemabet is a new, highly selective PPAR developed by Kowa Company α The regulator was launched in Japan in July 2017 and a new formulation of sustained-release tablets was launched in June 2023;

High safety, it can improve the problem of low serum triglyceride levels by regulating liver lipid metabolism, and its safety is superior to other beta lipid-lowering drugs;

Compared to Fenobert, Pemabert's PPAR α The active form of activated fenofibrate, fenofibrate, is more than 2500 times stronger than that of fenofibrate. According to experimental results in Japan, the incidence of adverse events in Pemabet is much lower than that of fenofibrate, similar to placebo. In Japan, Pemabet tablets exceed the market share of fenofibrate after three years of marketing;

Improving liver function measurements, mainstream beta drugs such as fenofibrate can cause alanine aminotransferase (ALT) and γ- Glutamyltransferase（ γ- GT) and other liver function test values deteriorate, but using Pemabet will actually reduce these values. After treatment, these changes in renal and liver function test values are caused by Pemabet as SPPARM α One of the characteristics of;

It can be used in combination with statins because of the risk of rhabdomyolysis, beta drugs cannot be used in combination with statins, and Pemabet tablets are a high choice PPAR- α The lower dosage is safer, so it can be used in combination with statins, especially in patients with impaired kidney function, which can also improve liver function test values;

The reduction of triglycerides by statins is not significant (10-30%), but there is a lack of drugs that can reduce triglycerides on the basis of statins. Only omega-3 can reduce triglyceride levels (20%), and Pemabet tablets can reduce triglyceride levels by 50%;

The world's first peroxisome proliferator activated receptor α (PPAR) α） It is estimated that the regulator can be applied for exemption from major clinical trials according to four categories, and the tablet is the 30th batch of reference. In addition, three indications (non-alcoholic fatty liver disease, type 2 diabetes, and hypercholesterolemia) are still in the clinical research stage. Our company can supply the general agent of foreign raw materials, and the price is favorable. You are welcome to consult.

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20/02/2024

KOWA TO DISCONTINUE K-877 (PEMAFIBRATE) "PROMINENT" CARDIOVASCULAR OUTCOMES STUDY

RESEARCH TRIANGLE PARK, N.C., April 8, 2022 /PRNewswire/ -- Kowa Research Institute, Inc. announces the decision not to continue the Phase 3 PROMINENT study, taking into consideration the recommendations of the Data Safety Monitoring Board (DSMB). Based on the review of a planned interim analysis, the DSMB concluded that the primary endpoint was unlikely to be met. Notable safety concerns were not raised. Kowa Research Institute, Inc. will continue to pursue the potential of K-877 in new therapeutic areas, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), as encouraging data was revealed during the analysis of PROMINENT results.

Full data from the trial will be presented as soon as possible at a future conference.

About K-877 (pemafibrate)
Pemafibrate is a highly potent and selective peroxisome proliferator activator receptor-alpha modulator (SPPARMα). Kowa launched pemafibrate for treatment of hyperlipidemia in Japan under the brand name PARMODIA®.

About the PROMINENT study
The PROMINENT study is an international, multi-center, double-blinded, placebo-controlled, randomized trial which included approximately 850 clinical sites in 24 countries. The trial is registered to ClinicalTrials.gov (NCT03071692). Its primary objective is to investigate whether K-877 reduced the risk of cardiovascular events in high-risk patients with type 2 diabetes, mild-to-moderate hypertriglyceridaemia and low levels of HDL-C treated with statins. The primary endpoint is a composite of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization and cardiovascular death.

06/02/2024

One Drug Knowledge per Day-Cinitapride Hydrogen Tartrate
CAS: 66564-14-5
Chemical formula: C21H30N4O4

1. Specifications, usage, and dosage
Specification: Tablets: 1mg;
Usage and dosage:
Adults (over 20 years old): Take 1mg (1 tablet) once, 3 times a day, 15 minutes before meals.

2. Indications
Indications: Improve symptoms of early satiety, postprandial fullness and discomfort, and abdominal distension in mild to moderate functional dyspepsia.

3. Product advantages
Xinibili has better efficacy than metoclopramide and domperidone in treating gastrointestinal dysfunction, FD, and GERD, and has good safety;
This product is not only metabolized by cytochrome P450 (CYP) 3A4 in the liver, but also by CYP2C8, resulting in a lower risk of drug interaction;
The free blood drug concentration is much lower than that of cisapride and domperidone, resulting in a lower risk of cardiac toxicity, and the effect of this drug on the QT interval of the heart has not been found yet;

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02/02/2024

One Drug Knowledge per Day - fosphenytoin sediment
CAS: 92134-98-0
Chemical formula: C16H16N2NaO6P
1. Specifications, usage, and dosage
Specification: Injection: 50mg/ml (C15H11N2NaO2) (2ml, 10ml)
Usage and Dosage: Before intravenous infusion, dilute Sesquient with 5% glucose or 0.9% injectable saline to 1.5mg phenytoin equivalent/mL to 25mg phenytoin equivalent/mL. The maximum concentration of Sesquient in any solution should be 25mg sodium phenytoin equivalent/mL. When Sesquient is administered intravenously, it needs to be diluted and should be administered at a rate not exceeding 150mg of phenytoin equivalent per minute in adults or 0.4mg of phenytoin equivalent per kilogram per minute in pediatric patients aged 2 to 17.
2. Indications: Used to treat generalized tonic clonic epileptic status, prevent and treat epileptic seizures caused by neurosurgical perioperative and intraoperative conditions.
3. Product advantages
In November 2020, it was approved by the US FDA as the only type of medication approved by the FDA for optimal on-site storage and rapid distribution in emergency rooms, intensive care units, emergency vehicles, and long-term medical institutions for timely treatment of continuous epileptic seizures;
Phosphophenyl phenytoin sodium is a prodrug of phenytoin sodium, which can be completely converted into phenytoin in the body, overcoming the adverse reactions caused by phenytoin sodium. It has higher efficacy and safety, and less irritation. It can be injected intramuscularly and intravenously, and does not require cardiac monitoring during intramuscular injection;
Injectable concentrated solution is the first standard treatment drug in China used to prevent and treat epileptic seizures caused by neurosurgery during the perioperative and intraoperative periods;
High clinical application value, the concentrated solution retains the advantages of phosphophenytoin sodium injection, overcomes its shortcomings of only being stored and transported at low temperatures, and has better safety.

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01/02/2024

Neostigmine Methylsulfate
Chemical structural formula: C12H19N2O2CH3O4S
1. Applicability
Anticholinesterase drugs. It is used to antagonize the residual muscle relaxation of non depolarizing muscle relaxants at the end of the operation, for myasthenia gravis, functional flatulence and urinary retention after the operation, etc.
Gelong ammonium bromide compound injection: reversing residual non depolarizing (competitive) neuromuscular blockade
2. Usage and dosage
Commonly used dosage, inject 0.25-1mg subcutaneously or intramuscularly once (1ml: 0.5mg specification half to 2 tubes; 2ml: 1mg specification 1/4 to 1 tube), 1-3 times a day.
Extreme dosage, subcutaneous or intramuscular injection of 1mg (1ml: 0.5mg, 2 tubes; 2ml: 1mg, 1 tube), 5mg per day (1ml: 0.5mg, 10 tubes; 2ml: 1mg, 5 tubes).
3. Product advantages
A cholinesterase inhibitor, approved by the FDA in 2013, for reversing the effects of non depolarizing neuromuscular blockers after surgery;
It has the strongest effect on skeletal muscles and also has a strong stimulating effect on the smooth muscles of the gastrointestinal tract, bladder, and uterus;
Reversible binding with cholinesterase, with fewer side effects and difficulty in crossing the blood-brain barrier. The plasma protein binding rate is low (15% to 25%), and some drugs in the body are hydrolyzed by plasma cholinesterase and excreted from urine in the form of quaternary ammonium alcohol and its original form. The metabolized portion through the liver is excreted from the biliary tract;
More effective recovery of patient's autonomous urination. Clinical studies have shown that this product combined with intermittent catheterization technology can shorten the establishment of autonomous urination time, reduce the number of catheterization times, and lower the risk of urinary tract infections compared to intermittent catheterization technology treatment for neurogenic bladder. Patients are more receptive to this treatment;
Class A varieties, mainstream muscle relaxant antagonists, with significant sales growth. In 2020, the domestic sales exceeded 300 million yuan, a year-on-year increase of 446.81%. In the first half of 2021, it exceeded the full year of 2020, a year-on-year increase of 190.09%;
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31/01/2024

One Drug Knowledge per Day - Articaine Hydrochloride
1. Dosage form specifications
Chemical structural formula: C18H24Fe2O248047-67-4)
1.7ml: Articaine hydrochloride 68mg and adrenaline 0.017mg

2. Applicability
Local anesthetics for oral use are particularly suitable for surgical procedures involving osteotomy and mucosal incision.

3. Usage and dosage
Administration method: Local infiltration or nerve block anesthesia, oral submucosal injection for administration. Before injection, please draw back blood to check for accidental entry into the blood vessels, especially during nerve block anesthesia. The injection rate should not exceed 1ml/minute.

4. Dosage
Suitable for adults and children over 4 years old, this anesthesia technique is not suitable for the age group under 4 years old.
Adults: The appropriate dosage must be injected according to the surgical needs. For general surgery, the usual dosage is 1-2 ml. The maximum dosage of Articaine Hydrochloride shall not exceed 7mg/kg body weight.
Children over 4 years old: Different doses must be used according to the child's age, weight, and type of surgery. The maximum dosage of Articaine Hydrochloride shall not exceed 5mg/kg body weight.
The average dosage of Articaine Hydrochloride used in children, measured in mg, can be calculated as follows: Children's weight (kg) × one point three three
Elderly: Use half of the adult dose.

5. Product advantages
The commonly used local infiltration anesthesia drugs in clinical practice can block the nerve conduction of the injected nerve fibers. Due to the presence of adrenaline in the preparation, it usually has a hemostatic effect when used;
Quick onset, long duration of efficacy, and generally fast anesthesia effect. It takes effect immediately after basic injection and has a relatively long duration. It can be used for children over 4 years old and adults;
Low toxicity, its toxicity is lower than that of lidocaine, and it avoids the occurrence of complications of conduction block anesthesia. Studies have shown that articaine has a positive anesthetic effect in the treatment of molars and pulp in the elderly, especially in mandibular anesthesia, and its effect is better than mepivacaine;

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