Carbamazepine Tablets

1. Carbamazepine is an anticonvulsant and specific analgesic for trigeminal neuralgia. Carbamazepine shows anticonvulsant effects in rat and rabbit epilepsy models induced by electrical and chemical stimulation, which may be exerted by inhibiting polysynaptic responses and blocking post-tetanic potentiation. Carbamazepine can significantly reduce or eliminate the pain caused by stimulation of the infraorbital nerve in rats and cats, and reduce the thalamic potential, medulla oblongata and polysynaptic reflexes in cats, including the lingual mandibular reflex. The chemical structure of carbamazepine is not related to other anticonvulsant and trigeminal neuralgia drugs, and its mechanism of action is still unclear. 2. The main metabolite of carbamazepine is carbamazepine-10,11 epoxide, which shows anticonvulsant effects in some animal models of epilepsy. Although it is inferred that the epoxide has clinical activity, the impact of its activity on the safety and efficacy of carbamazepine is still unclear.

Active ingredient: Carbamazepine Chemical name: 5H-dibenzo[b,f]azepine-5-carboxamide.

This product is a white tablet and is an anticonvulsant and analgesic.

1. Partial epileptic seizures: - Complex partial seizures; - Simple partial seizures. Primary or secondary generalized tonic-clonic seizures. Mixed seizures. Can be taken alone or in combination with other anticonvulsants. Ineffective for absence seizures and myoclonic seizures. 2. Trigeminal neuralgia: Trigeminal neuralgia caused by multiple sclerosis. Primary trigeminal neuralgia. Primary glossopharyngeal neuralgia.

1. This product can be taken with a small amount of liquid during meals, after meals, or between meals. 2. For elderly patients, the dose of carbamazepine should be carefully selected. 3. Carbamazepine should be used as a single drug for epilepsy as much as possible. Treatment should start with a small dose and slowly increase to achieve the best effect. When the seizure is controlled, it can be slowly reduced to the lowest effective dose. Measuring blood drug concentration can help determine the appropriate dose. If carbamazepine is added to other antiepileptic drugs, the dose of carbamazepine should be gradually increased while maintaining the original dose. If necessary, the dose of other antiepileptic drugs can be adjusted (see [Drug Interactions]). 4. Adults: The initial dose is 100-200 mg each time, 1-2 times a day; gradually increase the dose until the best effect is achieved (usually 400 mg each time, 2-3 times a day). Some patients rarely need to increase to 1600 mg per day. 5. Children: 10-20 mg/kg body weight per day. Under 12 months old, 100-200 mg/day. 1-5 years old, 200-400 mg/day. 6-10 years old, 400-600 mg/day. 11-15 years old, 600-1000 mg/day, taken in divided doses. Recommended: For children 4 years old or younger, the initial dose is 20-60 mg/day, then increase by 20-60 mg every other day. For children over 4 years old, the initial dose can be 100 mg/day, then increase by 100 mg every week. 6. The initial dose for trigeminal neuralgia is 200-400 mg/day, gradually increase until the pain is relieved (usually 200 mg each time, 3-4 times a day), and then the dose is gradually reduced to the lowest sustainable dose. The recommended initial dose for elderly patients is 100 mg each time, twice a day.

1. Particularly in the early stages of treatment with carbamazepine, or when the initial dose is too high or when it is taken by elderly patients, some adverse reactions may occur occasionally or frequently, such as: adverse reactions of the central nervous system (dizziness, headache, ataxia, drowsiness, fatigue, diplopia); gastrointestinal discomfort (such as nausea, vomiting) and skin allergic reactions. 2. Adverse reactions related to dose usually subside on their own within a few days or after reducing the dose. Adverse reactions of the central nervous system may be a manifestation of excessive dose or significant fluctuations in blood drug concentration. In this case, blood drug concentration monitoring should be performed, the daily dose should be reduced and it should be taken in 3-4 times. 3. Adverse reactions are listed in the table below (Table 1) according to the frequency of occurrence, using the following expressions: very common (ge; 1/10); common (ge; 1/100, 1/10); uncommon (ge; 1/1,000; 1/100); rare (ge; 1/10,000; 1/1,000); very rare (1/10,000), including individual case reports. *There are also rare reports in some Asian countries, please refer to [Precautions] Adverse drug reactions from spontaneous reports and literature (frequency unknown) 4. The following adverse drug reactions have been reported in spontaneous case reports and literature after the marketing of Deleto. Because the size of the patient population from which these spontaneous reports came is unclear, the incidence cannot be reliably estimated and is therefore listed as unknown frequency. Adverse drug reactions are listed according to the system organ class of MedDRA. Within each system organ class, they are listed in descending order of severity. 5. Immune system abnormalities Drug rash with eosinophilia and systemic symptoms (DRESS). 6. Skin and subcutaneous tissue abnormalities Acute generalized exanthematous pustulosis (AGEP).

1. Patients with known allergies to carbamazepine and related structural drugs (such as tricyclic antidepressants) or other ingredients of the preparation. 2. Patients with atrioventricular conduction block. 3. Severe abnormalities in serum iron. 4. Patients with a history of bone marrow suppression. 5. Patients with a history of hepatic porphyria (such as acute intermittent porphyria, variant porphyria, porphyria cutanea tarda), severe hepatic insufficiency, etc. 6. Theoretically, carbamazepine (which has a similar structure to tricyclic antidepressants) should be avoided in combination with monoamine oxidase inhibitors (MAOIs) (see [Drug Interactions]). Before taking carbamazepine, stop taking monoamine oxidase inhibitors for at least two weeks, and longer if clinical conditions permit.

Precautions for children: This product can be used for children of all ages, please refer to [Usage and Dosage] for details. Precautions for pregnancy and lactation: This product can pass through the placenta, and it is not clear whether it is teratogenic. It should be used with caution in early pregnancy; this product can be secreted into breast milk, with a blood concentration of about 60%, and it should not be used by lactating women. Precautions for the elderly: Elderly patients are more sensitive to this product, which can often cause cognitive dysfunction, agitation, restlessness, anxiety, mental confusion, atrioventricular block or bradycardia, and can also cause aplastic anemia.

1. Cytochrome P4503A4 (CYP3A4) is the enzyme that plays the main catalytic role in the active metabolite 10,11-epoxycarbamazepine. Taking CYP3A4 inhibitors at the same time can lead to an increase in the plasma concentration of carbamazepine, thereby inducing adverse reactions. If CYP3A4 inducers are taken at the same time, the metabolic rate of carbamazepine may be increased, resulting in a potential decrease in the plasma level and efficacy of carbamazepine. Similarly, if CYP3A4 inducers are discontinued, the metabolic rate of carbamazepine will decrease, causing an increase in the plasma level of carbamazepine. 2. Carbamazepine is a potent inducer of CYP3A4 and other phase I and phase II enzyme systems in the liver, and therefore can reduce the plasma concentration of drugs that are mainly metabolized by CYP3A4. 3. Human microsomal epoxide hydrolase was found to be the main enzyme responsible for the formation of 10,11-trans diol from carbamazepine-10,11 epoxide. Coadministration with human microsomal epoxide hydrolase may result in increased plasma concentrations of carbamazepine-10,11-epoxide. 4. Preparations that can increase the plasma levels of carbamazepine and/or carbamazepine-10,11 epoxide 5. Since increased plasma levels of carbamazepine and/or carbamazepine-10,11 epoxide can lead to adverse reactions (such as dizziness, drowsiness, ataxia, diplopia), the dose of Delevofloxacin should be adjusted accordingly based on the monitored plasma levels when the following drugs are used concomitantly: Analgesics, anti-inflammatory drugs: dextropropoxyphene, ibuprofen Androgens: danazol Antibiotics: macrolide antibiotics (such as erythromycin, troleandomycin, josamycin, clarithromycin) Antidepressants: may include desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine Antiepileptic preparations: stiripentol, vigabatrin Antifungal drugs: azoles (such as itraconazole, ketoconazole, fluconazole, voriconazole) Antihistamines: loratadine, terfenadine Antipsychotics: olanzapine Anti-tuberculosis drugs: isoniazid Antiviral drugs: protease inhibitors used for HIV treatment (such as ritonavir) Carbonic anhydrase inhibitors: acetazolamide Cardiovascular drugs: diltiazem, verapamil Gastrointestinal drugs: possibly cimetidine, omeprazole Muscle relaxants: oxybutynin, dantrolene Platelet aggregation inhibitors: ticlopidine Other interactions: grapefruit, niacinamide (only in high doses in adults) 6. Preparations that can increase the plasma levels of the active metabolite carbamazepine-10,11-epoxide 7. Because increased plasma levels of carbamazepine-10,11-epoxide may cause adverse reactions (such as dizziness, drowsiness, ataxia, diplopia), the dose of Delevo should be adjusted accordingly based on the monitored plasma levels when the following drugs are used simultaneously: 8. It has been reported that loxapine, quetiapine, primidone, progamide, valproic acid and valproamide can increase the concentration of the active metabolite 10,11-epoxide carbamazepine. 9. Preparations that can reduce the plasma level of carbamazepine 10. The dose of Deletox must be adjusted when the following drugs are used in combination: Antiepileptic preparations: Felbamate, methsuximide, oxcarbazepine, phenobarbital, phensuximide, phenytoin and fosphenytoin, primidone, although the data may be somewhat contradictory, it is generally believed that clonazepam is also included. Antineoplastic drugs: Cisplatin or doxorubicin Antituberculosis drugs: Rifampicin Bronchodilators or antiasthmatic drugs: Theophylline, aminophylline Dermatological drugs: Isotretinoin Other interactions: Chinese herbal preparations containing Hypericum perforatum (Hypericum) 0 11. The effect of Deletox on the plasma level of concomitantly used preparations 12. Carbamazepine can reduce the plasma levels of certain specific drugs, or weaken or even eliminate the active effects of these drugs. The doses of the following drugs must be adjusted according to clinical requirements: Analgesics, anti-inflammatory drugs: Buprenorphine, methadone, acetaminophen, phenazone (antipyrine), tramadol. Antibiotics: doxycycline Anticoagulants: Oral anticoagulants (such as warfarin, phenprocoumon, dicoumarol and acenocoumarol) Antidepressants: aminopropion, citalopram, mianserin, nefazodone, sertraline, trazodone, tricyclic antidepressants (such as imipramine, amitriptyline, nortriptyline, clomipramine). It is not recommended to use Deliduo in combination with monoamine oxidase inhibitors (MAOI); before taking Deliduo, if the clinical situation allows, MAOIs should be stopped at least two weeks in advance or more (see [Contraindications]) Antiepileptic preparations: clobazam, clonazepam, ethosuximide, felbamate, lamotrigine, oxcarbazepine, primidone, tiagabine, topiramate, valproic acid, zonisamide. It has been reported that plasma phenytoin levels can be both increased and decreased under the action of carbamazepine, but there are rare case reports of increased plasma levels of mephenytoin. Antifungal drugs: itraconazole Anthelmintics: praziquantel Antineoplastic drugs: imatinib Antipsychotics: clozapine, haloperidol and bromperidol, olanzapine, quetiapine, risperidone, ziprasidone Antiviral drugs: protease inhibitors used for HIV treatment (such as indinavir, ritonavir, saquinavir). Antianxiety drugs: alprazolam, midazolam Bronchodilators or antiasthmatic drugs: theophylline Contraceptives: hormonal contraceptives (other alternative contraceptive methods should be considered) Cardiovascular drugs: calcium channel blockers (dihydropyridine series), such as felodipine, digoxin Corticosteroids: corticosteroids (such as prednisolone, dexamethasone) Immunosuppressants: cyclosporine, everolimus Thyroxine: levothyroxine. Other drug interactions: Drugs containing estrogen and/or progesterone. 13. Co-administration of drugs that require special attention It has been reported that the combined use of carbamazepine and levetiracetam can increase carbamazepine-induced toxicity. It has been reported that the combined use of carbamazepine and isoniazid can increase the incidence of isoniazid-induced liver toxicity. The combined use of carbamazepine with lithium salts or metoclopramide, or with neuroleptics (such as haloperidol, thioridazine), can increase the adverse effects of the nervous system (and the latter method of administration will increase neurological adverse reactions even at therapeutic blood drug concentrations). The combined use of carbamazepine and acetaminophen, especially a single overdose or long-term large amounts, increases the risk of liver poisoning and may reduce the efficacy of the latter. The combined use of carbonic anhydrase inhibitors increases the risk of osteoporosis. 14. Due to the hepatic enzyme induction effect of this product, the antidiuretic effect can be enhanced when used in combination with chlorpropamide, clofibrate (clofibrate), desmopressin, lypressin, vasopressin, vasopressin, etc., and the dose of each drug used in combination needs to be reduced. 15. Phenobarbital, phenytoin, primidone, progabin, and theophylline can reduce the blood concentration of carbamazepine, and clonazepam, valproic acid, and valproamide also have the same effect, although the experimental data are somewhat contradictory. In addition, it has been reported that valproic acid, valproamide, and primidone can increase the blood concentration of the active metabolite 10,11-epoxycarbamazepine, so the dose of carbamazepine needs to be adjusted accordingly. 16. Combination with some diuretics (such as hydrochlorothiazide, furosemide) may cause hyponatremia. 17. Lithium salts can reduce the antidiuretic effect of carbamazepine. 18. Carbamazepine has an antagonistic effect on non-depolarizing muscle relaxants (such as pancuronium); if necessary, the dose can be increased and the patient should be closely monitored because the recovery of neuromuscular blockade may be faster than expected. 19. Carbamazepine can reduce the absorption of nomifensine and accelerate its elimination. 20. It has been reported that isotretinoin changes the bioavailability and/or clearance of carbamazepine and 10,11-epoxycarbamazepine, so the blood concentration of carbamazepine should be monitored. 21. Like other psychotropic drugs, carbamazepine can reduce alcohol tolerance, so during treatment, advise patients to abstain from alcohol. 22. Vaginal bleeding may occur when used in combination with oral contraceptives. 23. Carbamazepine has been reported to reduce or increase the blood concentration of phenytoin. There are very few reports of increased plasma concentrations of mephenytoin.

Keep away from light and store in sealed container.

0.1g

60 months.

Shanghai Sine WANXIANG Pharmaceuticals Co., Ltd.

• Founded in:

  1999-01-25

• Address:

  No. 217, Zhaozhong Road, Qingpu District, Shanghai

• Tax NO.:

  91310000631358877Y

• Registered Funds:

  100 million yuan

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