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Flunarizine hydrochloride capsule

Product description

Approval date: 16 March 2007

 

Modified date: 01 October 2010

 

November 30, 2015

 

Instructions for flunarizine hydrochloride capsules

 

Please read the instructions carefully and use them under the guidance of your physician.

 

[name of drug]

 

General name: flunarizine hydrochloride capsule

 

English name: Flunarizine Hydrochloride Capsules

 

Yansuan Fuguiliqin Jiaonang

 

The main ingredient of this product is flunarizine hydrochloride. Its chemical name is (E)-1- (bis -(4- fluorophenyl) methyl)- 4-(2- allyl -3- phenyl) piperazine dihydrochloride.

 

Molecular formula: C26H26F2N2·2HCl

 

Molecular weight: 477.42

 

[properties] this product is capsule, the content is white or white granular powder.

 

[indications]

 

(1) insufficient cerebral blood supply, vertebral artery ischemia, cerebral thrombosis, etc.

 

(2) tinnitus and halo.

 

(3) migraine prevention.

 

(4) adjuvant therapy for epilepsy.

 

Specification: 5mg (C26H26F2N2)

 

[usage and dosage] oral administration :(1) central vertigo and peripheral vertigo including incomplete blood supply to the base of vertebral artery, 10 ~ 20mg(2 ~ 4 pills) per day, 2-8 weeks for a course of treatment.

 

(2) for idiopathic tinnitus, 10mg(2 pills), once every night, 10 days for a course of treatment.

 

(3) intermittent claudication, 10-20mg (2-4 pills) per day.

 

(4) prevention of migraine, 5 ~ 10mg(1 ~ 2 pills), twice a day.

 

(5) cerebral arteriosclerosis, cerebral infarction recovery period; Flunarizine 5 ~ 10mg(1 ~ 2 tablets) per day.

 

[adverse reactions]

 

(1) adverse reactions of the central nervous system: (1) drowsiness and fatigue are the most common. (2) long-term users can appear depression, to female patients more common. (3) extrapyramidal symptoms, performance for involuntary movement, mandible movement disorders, ankylosis, and so on. Most medications appear after 3 weeks and disappear after withdrawal. It happens in old people. (4) a few patients can appear insomnia, anxiety and other symptoms.

 

(2) gastrointestinal symptoms include: burning sensation in the stomach, hyperactivity in stomach, increased food intake and weight gain.

 

(3) others: a few patients may have rash, dry mouth, breast overflow, muscle pain and other symptoms, but most of them are transient, which can be relieved by stopping the medicine.

 

[contraindications] if there is a history of allergy to this drug, a history of depression, and acute cerebral hemorrhage.

 

(1) after the use of the drug, fatigue symptoms gradually aggravated should reduce or stop.

 

(2) strictly control the dosage of drugs. When the maintenance dosage fails to achieve the therapeutic effect or the long-term application of extrapyramidal symptoms, the dosage should be reduced or stopped.

 

(3) caution should be exercised in patients with extrapyramidal diseases such as Parkinson's disease.

 

(4) careful use by drivers and mechanical operators to avoid accidents.

 

[drug for pregnant and lactating women] because this drug can cross the placental barrier and can be secreted with milk, although there are no reports on teratogenic and effects on embryo development, pregnant and lactating women should not use this drug in principle.

 

[children's drug] because this drug can cross the blood-brain barrier, it has clear adverse reactions of the central nervous system, and children's central nervous system is sensitive to the reaction of the drug; Metabolic function is relatively weak, although there is no detailed children's drug research data at present, in principle children with caution or avoid using this drug.

 

[medication for the elderly] due to the sensitivity of the nervous system and weak metabolic capacity of elderly patients, the dosage should be reduced as appropriate.

 

(1) when combined with alcohol, hypnotics, or sedatives, the sedative effect is aggravated.

 

(2) when combined with phenytoin sodium and carbamazepine, the plasma concentration of flunarizine can be reduced.

 

(3) flunarizine combined with radiotherapy can improve the lethality of tumor cells.

 

(4) in addition to antiepileptic drugs, flunarizine can improve the antiepileptic effect.

 

[drug overdose] is unclear.

 

[pharmacology and toxicology] this product is a calcium channel blocker. It can prevent cell damage caused by intracellular pathological calcium overload caused by ischemia. This product has:

 

(1) relieve vasospasm, and have a long-lasting inhibitory effect on continuous vasospasm caused by vasoconstrictor substances, especially on basilar artery and internal carotid artery, which are 15 times stronger than cerebral iperazine;

 

(2) vestibular inhibition can increase the blood flow of cochlea arteries and improve vestibular circulation;

 

(3) antiepileptic effect, this product can block the pathological calcium overload of nerve cells and prevent paroxysmal depolarization, cell discharge, so as to avoid seizures;

 

(4) protect myocardium and significantly reduce ischemic myocardial damage;

 

(5) flunarizine can improve renal function and be used in chronic renal failure; In addition this article still has antihistamine action.

 

[pharmacokinetics] this product was taken orally for 2-4 hours to reach the plasma peak, and t1/2 for 2.4-5.5 hours. It was mainly distributed in liver, lung and pancreas, and accumulated in bone marrow and fat. After 5 ~ 6 weeks of continuous administration, the stable blood concentration is reached, 90% of which can bind with plasma protein, and can pass the blood-brain barrier and be secreted with milk. Most are metabolized by the liver and excreted by the digestive tract. It enters the intestine through bile and is excreted through feces.

[storage] shading, sealed (10 ~ 30℃) storage.

 

[packaging] aluminum and plastic packaging, 20 pieces per box.

 

[validity period] 24 months

 

[executive standard] the second edition of Chinese pharmacopoeia in 2015

 

[approval document no.] Chinese medicine approval number H44021377

 

[production enterprise]

 

Company name: guangdong peidi pharmaceutical co., LTD

 

Production address: 66 peidi avenue, yueshan town, kaiping city, guangdong province

 

Zip: 529331

 

Telephone number :(0750)2789348 400-8899-328 (national service number)

 

Fax number :(0750)2789348

 

Web site: http://www.pdpharm.com

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