Phenytoin Sodium Tablets for The Treatment of Systemic Ankyotropic Seizures and Complex Partial Seizures

• Name: Phenytoin Sodium
• Transport Package: Carton
• Specification: 20x15x15cm
• Trademark: FUL
• Origin: China
• Model NO.: CF035
• Production Capacity: 100000/Month

Product Description

[Drug name]



General name: phenytoin sodium tablets



Product name: phenytoin sodium tablets



Phenytoin Sodium Tablets



Pinyin full code: BenTuoYingNaPian(OuYi)



[Main ingredients] phenytoin sodium chemical name: 5, 5-diphenylethyl urea sodium structure formula: molecular formula: C15H11N2NaO2 molecular weight: 274.25



"Into a"
 

Chemical name: 5, 5-diphenylacetonyl urea sodium



Molecular Weight: C15H11N2NaO2



The product is white sheet or thin film sheet.



It is suitable for the treatment of systemic ankyotropic seizures, complex partial seizures (psychomotor seizures, temporal lobe epilepsy), simple partial seizures (localized seizures) and continuous state of epilepsy. Can also be used in the treatment of trigeminal neuralgia, recessive nutrition not benign sexual epidermolysis bullosa (recessivedystrophicepidermolysisbullosa), ictal dance athetosis, seizure control disorders (include anger, anxiety and insomnia hyperexcitability of behavior disorder diseases), Myotonia and tricyclic antidepressant overdose of cardiac conduction disorders. This product is also applicable to digitalis poisoning caused by the ventricular and supraventricular arrhythmia, other various causes of arrhythmia caused by the effect is poor.



[Specification model] 50mg*100s



Usage and Dosage Normal dosage for adults with anti-epilepsy: 250-300mg daily, 100mg at the beginning, twice a day, increased to 250-300mg within 1 to 3 weeks, divided into three oral doses, maximum 300mg once, 500mg a day. Due to individual differences and pharmacokinetic characteristics of satiety, medication should be individualized. After the seizure is controlled and the blood concentration reaches steady state, the long-acting (controlled-release) preparation can be switched to a single dose. If the attack is frequent, 12~15mg/kg according to body weight can be taken in 2~3 times, once every 6 hours. 100mg (or 1.5~2mg/kg according to body weight) can be given from the second day, 3 times a day until the appropriate dose is adjusted. Usual dosage for children: start with 5mg/kg daily, divided into 2~3 times, adjusted as needed, no more than 250mg a day.



[Adverse Reactions] This product has few side effects and common gingival hyperplasia, which has a high incidence rate in children. Therefore, oral hygiene and gingival massage should be strengthened. After long-term use or blood concentration of 30& Mu; G /ml may cause nausea, vomiting and even gastritis, which can be relieved when taken after meals. The adverse reactions of the nervous system are dose-related, such as vertigo and headache, which can cause nystagmus, ataxia, slurred speech and blurred consciousness in severe cases, and can disappear when the dosage is adjusted or the drug is stopped. Less common adverse nervous system reactions include dizziness, insomnia, transient neuroticism, twitching, chorea, dystonia, tremor, flapping wing tremor, etc. Can affect the hematopoietic system, causing granulocyte and thrombocytopenia, rare aplastic; Common giant young erythrocyte sex anemia, usable folic acid adds vitamin B12 prevention and cure. It can cause allergic reactions, common rash with high fever, rare serious skin reactions, such as exfoliative dermatitis, polymorphic erosive erythema, systemic lupus erythematosus, fatal liver necrosis, Hodgkin's disease of the lymphatic system, etc. Once symptoms appear, discontinue the medication and take appropriate measures. Long-term use of vitamin D in children can accelerate the metabolism of rickets or bone abnormalities; Pregnant women take occasional teratogenic; It can inhibit the secretion of antidiuretic hormone and insulin to increase blood sugar, and has been reported to be carcinogenic.



It is contraindicated for patients with allergic history of acetonylurea drugs, Ass syndrome, ~ moderate degree of atrioventricular block, sinus node block, sinus bradycardia and other cardiac function impairment.



[Precautions] 1. People who are allergic to one of the acetonylurea drugs are also allergic to this product. 2. Enzyme induction can interfere with some diagnoses, such as dexamethasone test and thyroid function test, which can increase serum alkaline phosphatase, alanine aminotransferase and blood sugar concentration; 3. Blood, liver function, serum calcium, oral cavity, electroencephalogram and thyroid function should be checked during medication, and blood concentration should be followed up frequently to prevent toxic reactions; Blood concentrations were measured monthly during pregnancy and weekly postpartum to determine whether dose adjustment was necessary. 4. The following situations should be used with caution: alcoholism, so that the blood concentration of this product is reduced; Anaemia, which increases the risk of serious infection; Cardiovascular disease (especially in the elderly); Diabetes, which may raise blood sugar; Liver and kidney function damage, change the metabolism and excretion of this drug; Abnormal thyroid function. Please read the instructions carefully and follow the doctor's advice.



[Children's medication] Since the distribution volume and elimination half-life vary with age in children, blood drug concentration measurements should be made frequently. The pharmacokinetics of newborns or infants is special, and it is difficult to evaluate the symptoms of poisoning clinically, so it is generally not used first. The liver of preschool children should be monitored several times to determine the frequency and dosage of medication.



[Drug use for elderly patients] The incidence of chronic hypoproteinemia in the elderly is high, and there are many combined drugs in treatment, and the interaction between drugs is complex. Therefore, caution should be taken in the application of this product, the dosage should be low, and the blood drug concentration should be monitored frequently.



[Drug for pregnant women and lactating women] This product can pass through the placenta and may cause teratogenesis. However, it is considered that the risk of teratogenesis is greater than the risk of drug use due to poor seizure control, so the advantages and disadvantages should be weighed. Patients who can control their seizures with this product should continue to take it during pregnancy and maintain effective blood concentration, and then readjust after delivery. Vitamin K supplements should be taken one month before birth and given to newborns immediately after delivery to reduce the risk of bleeding. This product can be secreted into milk, it is generally recommended that mothers taking phenytoin avoid breastfeeding.



[Drug interaction] 1. The use of this product in patients with long-term use of acetaminophen can increase the risk of liver poisoning and reduce the efficacy. 2. Liver enzyme inducer. When used in combination with corticosteroids, digitalises (including digoxin), oral contraceptives, cyclosporine, estrogen, levodopa, quinidine, oxytetracycline, or tricyclic antidepressants, the effects of these drugs can be reduced. 3. Long-term drinking can reduce the concentration and efficacy of this product, but taking the drug while drinking a lot of alcohol can increase the blood drug concentration; When used together with chloramphenicol, isoniazid, butazone and sulfonamides, it may decrease the metabolism of the product, increase the blood drug concentration and increase the toxicity of the product. When combined with anticoagulants, the anticoagulant effect begins to increase, and continues to decrease. 4. The bioavailability of this product may be reduced when used in combination with magnesium, aluminum or calcium carbonate. The two should be taken at an interval of 2 to 3 hours. 5. When used together with hypoglycemic drugs or insulin, the dosage of the latter two should be adjusted because this product can increase blood sugar. 6. In principle, this product should not be used for patients who use dopamine. 7. This product may enhance cardiac inhibition when used in combination with lidocaine or propranolol. 8. Although this product consumes folic acid in the body, increasing folic acid can reduce the concentration and effect of this product. 9 phenobarbital or pourmitone on the effect of this product, change greatly, should be regularly monitored blood drug concentration; When used in combination with valproic acid, it has a protein binding competitive effect. Blood concentration should be monitored frequently and the dosage of this product should be adjusted. 10. When used in combination with carbamazepine, the latter reduces blood concentration. If combined with a large number of antipsychotics or tricyclic antidepressants may have seizures, the dosage of this product should be adjusted.



[Drug overdose] Blurred or double vision, clumsiness or unsteady walking and staggering gait, mental disorder, severe dizziness or drowsiness, hallucinations, nausea, and slurred speech.



[Pharmacological Toxicology] This product is an anti-epileptic and anti-arrhythmic drug. The therapeutic dose did not induce sedative hypnotic effects. 1. Animal experiments have proved that this product has a selective anti-epileptic effect on the tonic phase of super electroshock and convulsion, while it is ineffective or aggravated against the clonic phase. Therefore, it has a good effect on the major seizures of epilepsy, but has no effect on the seizures of absence. The mechanism of its anti-epileptic action has not yet been clarified. It is generally believed that it can increase the outflow of sodium ions from cells and reduce the inflow of sodium ions, stabilize the membrane of nerve cells, improve the excitation threshold and reduce the diffusion of high-frequency discharge of lesions. 2. In addition, this product can shorten the action potential interval and effective refractory period, but also inhibit calcium ion flow, reduce the automaticity of myocardium, inhibit the sympathetic center, inhibit the ectopic rhythm points of atrium and ventricle, and improve the threshold of atrial fibrillation and ventricular fibrillation. 3. It stabilizes cell membrane and reduces synaptic transmission, and has anti-neuralgia and skeletal muscle relaxation effect. 4. This product can inhibit the synthesis (or) secretion of collagenase by skin fibroblasts. It can also accelerate vitamin D metabolism, cause lymph node enlargement, have anti-folic acid effect, inhibit the hematopoietic system, cause allergic reaction, have enzyme induction effect, intravenous medication can dilate peripheral blood vessels.



[Pharmacokinetics] Oral absorption is slow, 85-90% is absorbed by the small intestine, and the absorption rate varies greatly among individuals and is affected by food. Neonatal absorption is very poor. The oral bioavailability was about 79%, distributed in extracellular fluid, perhaps more intracellular than extracellular, and the apparent volume of distribution was 0.6L/kg. Plasma protein binding rate is 88~92%, mainly binding to albumin, and may be higher in brain tissue. Blood concentration reached peak 4 to 12 hours after oral administration. The metabolites were mainly metabolized in the liver and had no pharmacological activity. Hydroxyphenytoin was the main metabolite (about 50~70%). There were genetic polymorphisms and ethnic differences in this metabolism. There is enterohepatic circulation, mainly through the kidney excretion, alkaline urine excretion is faster. T1/2 is 7 to 42 hours, and patients taking phenytoin sodium for a long time can be 15 to 95 hours, or even longer. After the application of a certain dose of drugs, the liver metabolism (hydroxylation) capacity reaches saturation. At this time, even if the dose is increased very small, the blood drug concentration will increase non-linearly and sharply, and there is a risk of poisoning, so the blood drug concentration should be monitored. The effective plasma concentration was 10-20mg /L, taken orally 300mg daily, and reached steady state concentration in 7-10 days. When the blood concentration exceeds 20mg/L, it is easy to produce toxic reactions and nystagmus. When more than 30mg/L, ataxia appeared; Severe toxic effects often occur when more than 40mg/L. It can pass through the placenta, it can be secreted into milk.



Storage: Keep away from light and sealed.



[Packed] 100 tablets/bottle



[Effective period] 24 months



[Approval Number] National medicine approval H13020977



FAQ
1.who are we?
We are based in Fujian, China, start from 2000,sell to North America(40.00%),Southeast Asia(25.00%),Western Europe(25.00%),Africa(10.00%).There are total about 50 people in our office.

2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;

3.what can you buy from us?
Pharmaceutical production lines,Intermediates,APIs,Finished Drug Preparations & Vaccines.

4. why should you buy from us not from other suppliers?
We have our own manufacture factories and one professional sales team working for the clients all over the world.

5. what services can we provide?
Accepted Delivery Terms: FOB,CIF,EXW,DDP,Express Delivery;
Accepted Payment Currency:USD,EUR,CAD,AUD,GBP,CNY;
Accepted Payment Type: T/T,L/C,PayPal,Western Union;
Language Spoken:English,Chinese,Japanese

Our Ddvantage:
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2. Online payment
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4. Welcome big order
5. After-sales service 24 hours
6. Competitive advantage products
7. Our value information is "Quality is our culture"
8. Work with us to provide you with secure funds, your business is securely protected, our advantages

Our Service
a)  Free amples can be provided.
b) Guide customers through professional technology and teach them how to use our products after sale
c) Determine the lowest price of high-quality products
1. Skilled experience: Our company is a leading manufacturer of professional production in China pharmaceutical field for many years.
2. The highest quality: to ensure high quality, once any problems are found, the package will be re-shipped for you.
3. Safe transportation: by air express (FedEx, UPS, DHL, EMS). It is recommended that you choose the most professional freight forwarder.
4. Fast delivery: We have stock, so once payment is received, we can deliver quickly.
5. Quality service: We will provide you with enthusiastic after-sales service. If you have any questions, we will reply to youwithin 24 hours.
6. Competitive price: discounts will be obtained when making large orders.

Our Manufacture Factory
Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd business radiates to all levels, including direct supply cooperation with government departments and industry representatives, as well as establishing supply cooperation relationship with retail industry. We supply high quality, safe and effective medicines and medical equipment to governments, hospitals, clinics and licensed pharmacies in different countries with timely and effective services at reasonable prices.

At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.


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