Product Overview
[Drug name]
Generic name: Doxazosin mesylate extended-release tablets
Trade name: Cube doxazosin mesylate sustained-release tablets 4mg*10 tablets
Pinyin full code: LiFang JiaHuangSuanDuoShaZuoZuoHuanShiPian 4mg*10Pian
[Main ingredients]
Doxazosin mesylate.
[Properties]
This product is a white film-coated tablet with laser holes on the coating layer. It is white or off-white after removing the coating.
[Indications/Main functions]
Suitable for symptomatic treatment of benign prostatic hyperplasia; hypertension.
[Specifications]
4mg*10 tablets (cubic)
[Usage and dosage]
When taking this sustained-release tablet, swallow the tablet completely with enough water. Do not chew, break or crush it before taking. It is not affected by eating or not. The interval between dose adjustments should be 1-2 weeks. The most commonly used dose is 4mg once a day. The maximum dose used clinically abroad is 8mg once a day. There is no such clinical experience in China. Common doses of doxazosin can be used in patients with renal insufficiency and elderly patients. For patients with liver insufficiency, please refer to [Precautions].
[Adverse Reactions]
1. Adverse reactions with an incidence of more than 10%: dizziness, headache, fatigue and discomfort. 2. Adverse reactions with an incidence of 2% to 10%: drowsiness, edema, nausea, rhinitis, dyspnea, postural hypotension, palpitations, dizziness, dry mouth, visual abnormalities, nervousness, sexual dysfunction, diarrhea, polyuria, chest pain and body pain. Postural hypotension, edema and dyspnea are often dose-dependent. 3. Adverse reactions with an incidence of about 1%: arrhythmia, hypotension, rash, itching, joint pain/arthritis, muscle weakness, myalgia, paresthesia, movement disorders, ataxia, hypertonia, muscle spasm, flushing, conjunctivitis, tinnitus, depression, insomnia, constipation, indigestion, gastrointestinal flatulence, epistaxis, urinary incontinence, weakness and facial edema. 4. Adverse reactions with an incidence of about 0.3%: tachycardia, peripheral ischemia.
[Contraindications]
It is contraindicated for patients who are known to be allergic to any component of quinazolines or cordova. It is contraindicated for patients who have recently had a myocardial infarction. If a myocardial infarction occurs in patients who have been treated with doxazosin, the treatment after the infarction should be determined based on individual circumstances. This product is contraindicated for patients with a history of gastrointestinal obstruction, esophageal obstruction, or any degree of gastrointestinal tract stenosis.
[Drug Interactions]
1. The use of indomethacin or other non-steroidal anti-inflammatory drugs with this product can weaken the antihypertensive effect. It may be due to the inhibition of renal prostaglandin synthesis and (or) the retention of water and sodium. 2. Cimetidine can slightly increase the blood concentration and half-life of doxazosin, but its clinical significance is unknown. 3. The antihypertensive effect of other antihypertensive drugs is enhanced when used with this product, and the dose needs to be adjusted. 4. When estrogen is used in combination with this product, blood pressure increases due to fluid retention. 5. The combination of sympathomimetic amines and this product can weaken both the pressor effect of the former and the hypotensive effect of the latter. 6. In vitro plasma studies have shown that doxazosin has no effect on the protein binding rate of digoxin, warfarin, phenytoin, and indomethacin.
[Precautions]
1. In order to reduce the first dose effect and postural hypotension, the first dose of treatment should be 1 mg, and the dose should be increased as needed every 1 to 2 weeks. The first dose and the first dose after each increase should be taken before bedtime. 2. Patients should avoid sudden changes in body position and actions when starting treatment and increasing the dose during treatment, and pay attention to the possible harm to the body. 3. If other antihypertensive drugs are added to the treatment of this product, the dose of this product should be reduced; if this product is added to the existing antihypertensive drug treatment, special caution should be taken. 4. If syncope occurs, the patient should be placed in a supine position and supportive treatment should be given if necessary. 5. Patients with impaired liver function or who are taking any drugs that affect liver metabolism should be very cautious when using doxazosin. 6. Penile spasm is a very rare adverse reaction in the treatment of this product, which can cause persistent erectile dysfunction and requires immediate treatment once it occurs. 7. Prostate cancer and prostate hyperplasia have many of the same symptoms, and the two often coexist. Therefore, before starting doxazosin to treat benign prostatic hyperplasia, prostate cancer should be ruled out first.
[Drug Use in Children]
The effectiveness and safety of this product in children have not yet been confirmed.
[Drug Use in Elderly Patients]
1. This product may cause obvious hypotension in elderly hypertensive patients, and the daily maintenance dose must be reduced. 2. In the treatment of benign prostatic hyperplasia, the safety and effectiveness of this product in the elderly and non-elderly are consistent.
[Drug Overdose]
Drug overdose can occur due to accidental ingestion or suicidal behavior. It is often manifested as postural hypotension, dizziness, headache, fatigue, drowsiness, and severe shock or death. In mild cases, the patient is placed in a supine position, and those with low blood pressure are given fluid replacement and pressor therapy; in severe cases, activated carbon gastric lavage should be used immediately, and anti-shock treatment should be given at the same time. Due to the high protein binding rate of doxazosin, hemodialysis cannot excrete it from the body.
[Pharmacology and toxicology]
It is not clear yet.
