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Oxcarbazepine tablets (qulai)

This product is suitable for the treatment of primary generalized tonic clonic seizures and partial seizures, with or without secondary generalized seizures. This product is suitable for adults and children aged 5 and over. More role
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Common name:
oxcarbazepine tablets
Product No.:
B14202012005
Approval No.:
H20171032 (original h20130016) (inquired by the State Drug Administration)
Jianke price:
¥228.85
Product specification:
0.3g * 10s * 5 board
Manufacturer:
Novartis Farma S.p.A (Italy)
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Product name Oxcarbazepine tablets (qulai)
Main raw materials Oxcarbazepine.
Main role This product is suitable for the treatment of primary generalized tonic clonic seizures and partial seizures, with or without secondary generalized seizures. This product is suitable for adults and children aged 5 and over.
Product specification 0.3g * 10s * 5 board
Usage and dosage usage This product is suitable for use alone or in combination with other antiepileptic drugs. In single drug treatment and combined drug use, this product can be administered from the clinical effective dose, which is divided into two times a day. Increase the dose according to the patient's clinical response; When trabeculae is used instead of other antiepileptic drugs, the dose of other antiepileptic drugs should be gradually reduced after the start of trabeculae treatment. If this product is used in combination with other antiepileptic drugs, due to the increase of the overall antiepileptic drug dose of the patient, it is necessary to reduce the dose of other antiepileptic drugs or / and increase the dose of this product more slowly. This product can be taken on an empty stomach or with food. There are nicks on the tablets. Each tablet can be divided into two equal parts to facilitate the patient's medication. consumption For patients without renal impairment, the recommended therapeutic doses are as follows. The pharmacokinetic characteristic of oxcarbazepine is that there is no need to monitor the blood concentration, which makes the treatment more convenient. adult Monotherapy For treatment with this product, the initial dose can be 600mg (8-10mg / kg / day) a day and administered twice. In order to obtain the ideal effect, the daily dose can be increased every other week, and the dose should not exceed 600mg each time. The daily maintenance dose range is 600-2400 mg, and most patients have an effect on the daily dose of 900 mg. The controlled study of monotherapy showed that the effective drug dose of patients who had not been treated with other antiepileptic drugs was 1200mg per day. Some patients with intractable epilepsy who are not well controlled with other antiepileptic drugs, but are treated with this product alone, the daily dose of 2400mg has proved to be effective. (see instructions for details)
manufacturing enterprise Novartis Farma S.p.A (Italy)
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[drug name] Oxcarbazepine tablets (qulai)

[common name] oxcarbazepine tablets

[specification and model] 0.3g * 10s * 5 board

[manufacturer] Novartis Farma S.p.A (Italy)

[drug type] Western medicine

[approval No.] H20171032 (original h20130016)

[validity period] 36 months

[functional indications] This product is suitable for the treatment of primary generalized tonic clonic seizures and partial seizures, with or without secondary generalized seizures. This product is suitable for adults and children aged 5 and over.

[usage and dosage] usage This product is suitable for use alone or in combination with other antiepileptic drugs. In single drug treatment and combined drug use, this product can be administered from the clinical effective dose, which is divided into two times a day. Increase the dose according to the patient's clinical response; When trabeculae is used instead of other antiepileptic drugs, the dose of other antiepileptic drugs should be gradually reduced after the start of trabeculae treatment. If this product is used in combination with other antiepileptic drugs, due to the increase of the overall antiepileptic drug dose of the patient, it is necessary to reduce the dose of other antiepileptic drugs or / and increase the dose of this product more slowly. This product can be taken on an empty stomach or with food. There are nicks on the tablets. Each tablet can be divided into two equal parts to facilitate the patient's medication. consumption For patients without renal impairment, the recommended therapeutic doses are as follows. The pharmacokinetic characteristic of oxcarbazepine is that there is no need to monitor the blood concentration, which makes the treatment more convenient. adult Monotherapy For treatment with this product, the initial dose can be 600mg (8-10mg / kg / day) a day and administered twice. In order to obtain the ideal effect, the daily dose can be increased every other week, and the dose should not exceed 600mg each time. The daily maintenance dose range is 600-2400 mg, and most patients have an effect on the daily dose of 900 mg. The controlled study of monotherapy showed that the effective drug dose of patients who had not been treated with other antiepileptic drugs was 1200mg per day. Some patients with intractable epilepsy who are not well controlled with other antiepileptic drugs, but are treated with this product alone, the daily dose of 2400mg has proved to be effective. (see instructions for details)

[adverse reactions] The most frequently reported adverse reactions include drowsiness, headache, dizziness, diplopia, nausea, vomiting and fatigue, which occur in more than 10% of patients. In clinical trials, most adverse reactions are mild to moderate and transient, mainly at the beginning of treatment. (see the inner packaging manual for details)

[precautions] 1. Patients allergic to carbamazepine may also have allergic reactions (such as severe skin reactions) during the treatment of this product. The cross allergic reaction rate of carbamazepine and oxcarbazepine was 25-30%. 2. Allergic reactions can also occur in patients without a history of allergy to carbamazepine. As a principle, this product should be stopped immediately when there are signs of allergic reaction for the first time. 3. When up to 2.7% of patients are treated with this product, the serum sodium will drop below 125 mmol / L, but there are often no clinical symptoms and there is no need to change the treatment. If clinical intervention is considered, experience from clinical trials shows that the serum sodium level will return to above the normal baseline by reducing or stopping the product, or taking conservative treatment for patients (such as reducing fluid intake). Attention should be paid to the following situations: Patients with kidney disease and need to ingest a large amount of liquid; Patients with hyponatremia; For patients who are treated with drugs that can reduce blood sodium level (such as diuretics and desmopressin) or non steroidal anti-inflammatory drugs (such as indomethacin), the serum sodium level should be measured before using this product, and about 2 weeks after starting treatment. Then, the serum sodium level was measured every 1 month or according to clinical needs in the first 3 months of treatment. More attention should be paid to the above-mentioned risk factors in elderly patients. Patients who are treated with drugs to reduce blood sodium level and treated with this product should also be monitored for serum sodium. As a principle, if there is clinical manifestation of hyponatremia when treated with this product, the determination of serum sodium level should be considered. In addition, the determination of serum sodium level can be used as a part of routine indicators for laboratory monitoring. * 4. heart failure patients should be regularly monitored for weight to determine whether there is fluid retention. * if there is fluid retention or deterioration of cardiac function, serum sodium levels should be determined. If hyponatremia is clear, limiting fluid intake is an important treatment. 5. Although clinical trials do not suggest that oxcarbazepine treatment can lead to heart block, theoretically, patients with heart conduction diseases (such as atrioventricular block and arrhythmia) should be carefully monitored. (cardiac arrhythmia refers to any abnormality in the origin of heart rhythm, heart beat frequency and rhythm, impulse conduction, etc. "arrhythmia" or "arrhythmia" focuses on the arrhythmia indicating rhythm. Arrhythmia includes both rhythm and frequency abnormalities, which is more accurate and appropriate. Normal heart rhythm originates from sinoatrial node, with a frequency of 60 ~ 100 times / min (adults), relatively regular. The conduction time of sinoatrial node impulse sequentially activates atrium and ventricle through normal atrioventricular conduction system is constant (0.12 ~ 1.21 seconds in adults); the conduction time of impulse from bundle branch and its branches and Purkinje fiber to ventricular muscle is also constant(<0.10秒)。) 6.有关肝炎的病例报道非常罕见,且在大多数病例中,疾病的自然病程良好。如果有理由怀疑肝功能有损害,应进行检查,考虑终止本品的治疗。 和其它抗癫痫药一样,本品应避免突然停药。应该逐渐地减少剂量,以避免诱发痫性发作(发作加重或癫痫持续状态)。如果不得不突然停药,例如由于严重的不良反应,应该在合适的抗癫痫药(如安定静脉或直肠给药,苯妥英静脉给药)发挥作用的情况下换用另外一种抗癫痫药,并在严格的观察下进行。 7.奥卡西平的酶诱导能力低于卡马西平。在某些情况下,同时使用的其它抗癫痫药的剂量应该降低。 应告知育龄期的女性,本品和激素类避孕药同时使用能够导致避孕效果的丧失。对于使用本品的育龄女性,建议使用其它非激素类避孕药。 8.接受本品治疗的病人,应避免饮酒以免发生附加的镇静作用。 9.对驾驶和操纵机器能力的影响:本品能够产生眩晕和嗜睡,导致反应能力受损。因此,驾驶和操纵机器时,应该特别小心。 (详见内包装说明书)请仔细阅读说明书并遵医嘱使用。

[taboo] 1. Patients who are known to be allergic to any component of this product. 2. Atrioventricular block.

[listing Permit Holder] Novartis Armas. P.A (Italy)

[packaging unit] box

[main ingredients] Oxcarbazepine.

[character] The product is light grayish green (0.15g), yellow (0.3g) or light pink (0.6g) oval film coated tablets. The film coated tablets are white or off white.

[applicable population] adult

[medication for pregnant and lactating women] 1、 Pregnancy: 1. There is definite evidence that oxcarbazepine tablets (tralai) are dangerous to human embryos, but the benefits of drugs to mothers with epilepsy may outweigh their risks. 2. There is not enough evidence and clinical human control study of oxcarbazepine tablets (Trasylol) to evaluate the safety of taking this product during treatment. For women during treatment or women treated with this product during pregnancy, the advantages and disadvantages of using drugs must be carefully weighed. 3. Oxcarbazepine and its active metabolite MHD can pass through the placental barrier. 4. During the last few weeks of pregnancy, the mother should take vitamin K1 and the newborn should also take it. 5. Vitamin B12 deficiency should be excluded or treated. 2、 Lactation: 1. During lactation, the advantages and disadvantages of using this product should be carefully considered. 2. Breastfeeding mothers shall not be treated with oxcarbazepine tablets (Trile).

[medication for children] See usage and dosage, or follow the doctor's advice.

[medication for elderly patients] See usage and dosage, or follow the doctor's advice.

[storage] Shading, sealed storage.

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    Oxcarbazepine tablets (qulai)

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