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Flunarizine hydrochloride capsules

Product description
Approved date: March 16, 2007
 
Date of revision: October 1, 2010
 
         November 30, 2015
 
 
Flunarizine hydrochloride capsule instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Common name: Flunarizine hydrochloride capsules
 
English name: Flunauzine Hydrochloride Capsules
 
Chinese Pinyin: Yansuan Fuguiliqin Jiaonang
 
[Ingredients] The main component of this product is: flunarizine hydrochloride. Its chemical name is: (E)-1-[bis-(4-fluorophenyl)methyl]-4-(2-propenyl-3-phenyl)piperazine dihydrochloride.
 
 
 
Molecular formula: C26H26F2N2·2HCl
 
Molecular weight: 477.42
 
【Properties】 This product is a capsule, the content of which is white or off-white granular powder.
 
[indications]
 
 (1) Insufficient blood supply to the brain, vertebral artery ischemia, and post-cerebral thrombosis.
 
 (2) tinnitus, brain dizziness.
 
 (3) Migraine prevention.
 
 (4) adjuvant treatment of epilepsy.
 
[Specification] 5mg (according to C26H26F2N2)
 
[Usage and Dosage] Oral: (1) Central vertigo and peripheral vertigo including blood supply to the base of the vertebral base, 10 to 20 mg (2 to 4 capsules) per day, 2 to 8 weeks for 1 course of treatment.
 
(2) Idiopathic tinnitus, 10mg (2 capsules), once a night, 10 days for a course of treatment.
 
(3) Intermittent claudication, 10 to 20 mg per day (2 to 4 capsules).
 
(4) migraine prevention, 5 ~ 10mg (1 ~ 2), 2 times a day.
 
(5) cerebral arteriosclerosis, cerebral infarction recovery period; flunarizine daily 5 ~ 10mg (1 ~ 2).
 
【Adverse reactions】
 
(1) Adverse reactions of the central nervous system are: 1 sleepiness and fatigue are the most common. 2 Long-term users can have depression, which is more common in female patients. 3 extrapyramidal symptoms, manifested as involuntary movement, squat dyskinesia, rigidity and so on. Most of the medications appeared after 3 weeks and disappeared after stopping the drug. It is easy to happen in the elderly. 4 a small number of patients may have symptoms such as insomnia and anxiety.
 
(2) Symptoms of the digestive tract are: a burning sensation in the stomach, an increase in appetite, an increase in food intake, and an increase in body weight.
 
(3) Others: A small number of patients may have symptoms such as rash, dry mouth, galactorrhea, muscle soreness, etc., but most of them are transient, and withdrawal can be relieved.
 
[Contraindications] There is a history of allergies to the drug, or a history of depression and acute cerebral hemorrhagic disease.
 
【Notes】 (1) If the symptoms of fatigue are gradually worsened after medication, the dose should be reduced or discontinued.
 
(2) Strictly control the dosage of the drug to be applied. When the application of the maintenance dose does not achieve the therapeutic effect or the extra-pyramidal symptoms appear in the long-term application, the drug should be reduced or stopped.
 
(3) This preparation should be used with caution when suffering from extrapyramidal diseases such as Parkinson's disease.
 
(4) Drivers and machinery operators should be used with caution to avoid accidents.
 
[Pregnant women and lactating women] Because this drug can pass through the placental barrier and can be secreted with milk, although there is no report of teratogenicity and impact on embryonic development, in principle, pregnant women and lactating women do not need this medicine.
 
[Children's medication] Because the drug can pass through the blood-brain barrier, there are clear central nervous system adverse reactions and the child's central nervous system is sensitive to drug reactions; metabolic function is relatively weak, although there is no detailed research data on children's medication, principles Children should be used with caution or avoid this medicine.
 
[Geriatric Use] Because elderly patients have a more sensitive nervous system and a weaker metabolic capacity, they should be reduced as appropriate.
 
[Drug interactions] (1) When combined with alcohol, hypnotics or sedatives, the effect of sedation is aggravated.
 
(2) When combined with phenytoin and carbamazepine, the blood concentration of flunarizine can be reduced.
 
(3) Radiation therapy patients with flunarizine can increase the lethality of tumor cells.
 
(4) On the basis of the application of antiepileptic drugs, the addition of flunarizine can improve the antiepileptic effect.
 
[Drug overdose] is not clear.
 
[Pharmacology and Toxicology] This product is a calcium channel blocker. It can prevent cell damage caused by intracellular pathological calcium overload caused by ischemia and the like. This product has:
 
(1) relieve vasospasm, and have a long-lasting inhibitory effect on persistent vasospasm caused by vasoconstrictor substances, especially for basilar artery and internal carotid artery, which is 15 times stronger than brain azine;
 
(2) vestibular inhibition, can increase the blood flow of the cochlear small artery and improve the circulation of the vestibular organs;
 
(3) anti-epileptic effect, this product can block the pathological calcium overload of nerve cells and prevent paroxysmal depolarization, cell discharge, thereby avoiding seizures;
 
(4) protect the myocardium and significantly reduce ischemic myocardial damage;
 
(5) Flunarizine has the effect of improving renal function and can be used for chronic renal failure; in addition, this product has antihistamine effect.
 
[Pharmacokinetics] This product takes 2 to 4 hours to reach the peak plasma, T1/2 is 2.4 to 5.5 hours, the body is mainly distributed in the liver, lung, pancreas, and accumulated in bone marrow and fat. Even after 5 to 6 weeks of steady-state blood concentration, 90% combined with plasma protein, can pass the blood-brain barrier, and can be secreted with milk. Most of it is metabolized by the liver and excreted by the digestive tract. Enter the intestine through bile and excrete through the feces.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Packing] aluminum plastic packaging, 20 capsules per box.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44021377
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348 400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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