Phenytoin Sodium Tablets product summary

Please use it under the guidance of a doctor.

[drug name]

Generic name: Phenytoin Sodium Tablets

Sodium Tablets Phenytoin

[character] this product is a white film or film coated tablets.

[indications]

Control athetoid dance can also be applicable in the treatment of generalized tonic - RUF twin seizures and complex partial seizures (psychomotor seizures in temporal lobe epilepsy), simple partial seizures (limited to seizures and epileptic state. For the treatment of trigeminal neuralgia, recessive nutrition not benign bullous epidermal lysis (recessive dystrophic epidermolysis major episodes of hand foot syndrome, paroxysmal disorder (including anger, anxiety and insomnia excited over the behavior disorders), myotonia and tricyclic antidepressant overdose of cardiac conduction disorders. This product is also applicable to digitalis poisoning caused by ventricular and supraventricular arrhythmia of various other reasons induced arrhythmia effect is poor.

[Specification] 100mg 50mg

[usage and dosage]

1 anti epileptic adults used amount: a day at the beginning of 250 ~ 300mg, 100 mg, 2 times a day, 1 ~ 3 weeks increased to 250 ~ 300 mg, three times a day, after a 300mg, a 500mg. on the dynamic characteristics due to the individual differences and the saturation of drugs, medication should be individualized. To attack and control of blood concentration reached a steady state, can use long-acting (controlled-release) preparations, one ton service. Such as frequent attacks, according to the weight of 12 to 15 mg/kg, 2 ~ 3 times a day, 6 hours, 1 times, second days to 100mg (or according to the weight of 1.5 ~ 2mg/kg), 1 it was not until the 3 time adjustment to the appropriate dose. The amount used in children: one day 5mg/kg, 2 ~ 3 times a day, adjusted according to the need, to a day not more than 250 mg. To maintain the volume of 4 to 8 mg/kg or according to the surface area of 250 mg/m2, 2 ~ 3 times a day, if possible can the blood concentration monitoring.

Antiarrhythmic. Adults are commonly used: 100 ~ 300 mg, a service or 2 ~ 3 times to take, or first, 10 ~ 15mg / kg, 2 ~ 4, 7.5 ~ 10mg / kg, to maintain the volume 2 ~ 6mg/kg. amount used in children: start by 5 mg / kg, 2 ~ 3 times a day orally. According to the condition of adjustment of daily dose does not exceed 300 mg, maintenance dose of 4 to 8 mg / kg, or according to the surface area of 250mg / m2, 2 ~ 3 times a day orally.

3. Collagenase synthesis inhibitor, the usual adult dosage a day 2 ~ 3 mg / kg divided into 2 doses, within 2 to 3 weeks, increased to patients can tolerate the amount, blood drug concentration of at least $8 µ g / ml. the general, 100 ~ 300 mg.

[adverse reactions]

This product has little side effect, common gingival hyperplasia, high incidence of children, should strengthen oral hygiene and massage gums. After long-term use or blood concentration up to 30 g/ml may cause nausea, vomiting and gastritis, after meals can alleviate the nervous system. Adverse reactions associated with the dose, vertigo, headache, severe cases can cause nystagmus, ataxia, slurred speech and confusion, dose adjustment or withdrawal may disappear; adverse reaction of nervous system is rare dizziness, insomnia, a nervous twitch, chorea, dystonia, tremor, asterixis. Effect of hematopoietic system, and induced by granulocyte thrombocytopenia, rare aplastic anemia; common megaloblastic anemia, available folic acid and vitamin B12. Prevention can cause allergic reactions and common rash with fever, rare serious skin reactions, such as exfoliative dermatitis, erythema multiforme, systemic lupus Lupus erythematosus and fatal liver necrosis, lymphatic system Hodgkin's disease. Once the symptoms stop the medicine immediately and take corresponding measures. Children with long-term use can accelerate vitamin D metabolism causing rickets or osseous abnormalities; pregnant women taking even teratogenic. Can inhibit anti diuretic hormone and insulin secretion to hyperglycemia and carcinogenic reports.

[taboo]

Disable: of ethylene in the sulfonylurea drug allergy history or Aspen syndrome, II ~ III degree atrioventricular block, sinus arrest, sinus tachycardia slow the deterioration of heart function.

[note] [note]

1 a drug allergy to the class B is also allergic to this product.

2 there is an enzyme inducing effect, which can interfere with some diagnosis, such as dexamethasone test, thyroid function test, serum alkaline phosphatase, alanine aminotransferase, and blood glucose concentration;

3. During the treatment need to inspect hemogram, liver function, calcium, oral, EEG, thyroid function and regular follow-up blood drug concentration to prevent toxicity; pregnancy were determined monthly time, postpartum week determination of blood drug concentration to determine if there is a need to adjust the dose.

4. The following conditions should be caution: alcohol, so that the product of blood drug concentration reduced; anemia, increased the risk of severe infection; cardiovascular disease (especially) for the elderly; diabetes may increase blood sugar; damage to liver and kidney function, change the metabolism and excretion of the drug; thyroid function abnormalities.

[pregnant women and breastfeeding women medication]

This product can pass through the placenta and may be teratogenic, but that seizures poorly controlled teratogenic risk is greater than the risk of medication, you should weigh the pros and cons. Where this product can control seizures in patients with during pregnancy should be continued to take, and maintain effective blood concentration, delivery and re adjust. Prenatal a month should be supplemented with vitamin K, immediately postpartum to neonatal injection of vitamin K to reduce bleeding risk. This product can be secreted into the milk advocate general taking phenytoin mothers avoid breastfeeding.

[children's drug use]

In children due to the volume of distribution and elimination half-life varies with age, so we should often make blood drug concentration determination. Neonatal or infantile period for the drugs moving more special, clinical symptom rating of toxic have difficulty, generally no first use. Preschool children liver on behalf of the TSE, much time monitoring of blood drug concentration to determine the number of drugs and dosage.

[old age medication]

The incidence of chronic low protein in the elderly is high, the treatment of the combined medication is more, the interaction between drugs is complex, the application of this product should be careful, dosage should be low, and often monitor blood drug concentration.

[drug overdose]

Can appear blurred vision or diplopia, clumsy or walking instability and staggering gait, mental disorders, severe vertigo, dizziness, drowsiness, hallucinations, nausea, language is not clear. Treatment: no solution of poison, only symptomatic therapy and supportive therapy, emetic, gastric lavage, oxygen, boost, assisted respiration, hemodialysis.

[pharmacological and toxicological]

This product is antiepileptic drugs, anti arrhythmic drugs. The therapeutic dose does not cause sedative and hypnotic effects.

1. Animal experiment proved that the product of strong electric shock, convulsion tonic phase selective antagonism, and the clonic phase is invalid or aggravated, so the epilepsy of grand mal has good effect, and on absence of exacerbations. Its antiepileptic mechanism has not been clarified. It is generally believed that the increased cell sodium ion efflux and decreased sodium ion influx, and make neural cell membrane stability, improve the excitability threshold, the diffusion lesion high frequency discharge is reduced.

2. In addition the relationship action potential duration and effective refractory period, also can inhibit calcium influx, reduce myocardial autorhythmicity, inhibition of central sympathetic, on atrial, ventricular ectopic rhythm point inhibitory effect, improve the atrial fibrillation and ventricular fibrillation threshold.

3 its stable cell membrane function and reduce the role of synaptic transmission, and has the role of anti nerve pain and skeletal muscle relaxation.

4. This product can inhibit skin fibroblasts and (or) secretion of collagenase. Also can accelerate the metabolism of vitamin D can cause lymph nodes and has the effect of anti folic acid, on the hematopoietic system have inhibitory effect, can cause allergic reactions, enzyme induction and intravenous medication can be peripheral vasodilation.

[storage] light shading, sealed preservation.

[packing] plastic bottle packaging, 100 / bottle.

[Effective] 24 months

[executive standard] < Chinese Pharmacopoeia >2015 version two

[50mg] approval number: Zhunzi H32020046

100mg: national drug standard word H32022528