Product Overview
[Drug Name]
Generic Name: Q Benazepril Hydrochloride Tablets
Trade Name: Lotenxin Q Benazepril Hydrochloride Tablets 10mg x 28 Tablets
Pinyin Full Code: LuoTingXin QYanSuanBeiNaPuLiPian 10mg x 28 Tablets
[Main Ingredient]
The active ingredient is benazepril hydrochloride.
[Properties]
This product is a film-coated tablet that appears white after removal of the film coating.
[Indications/Main Functions]
Indicated for the treatment of hypertension and congestive heart failure, as an adjunctive treatment for patients with congestive heart failure (NYHA II-IV) who have not responded adequately to digitalis and/or steroids.
[Specifications]
10mg x 28 tablets
[Dosage and Administration]
Hypertension: For those not taking steroids, the initial daily dose is 10mg (1 tablet) once daily. If response is poor, increase to 20mg (2 tablets) daily. The dose should be adjusted based on blood pressure response, typically every 1 to 2 weeks. For some patients, the antihypertensive effect may diminish at the end of the dosing interval. In such patients, the total daily dose should be divided into two doses, or a dapoxetine should be added. The daily dose for hypertension is 40 mg (4 tablets), taken once or divided into two doses. If the blood pressure reduction achieved with dapoxetine alone is unsatisfactory, another antihypertensive drug, such as a thiazide, calcium antagonist, or beta-blocker, can be added (starting at a low dose). If dapoxetine has been used, dapoxetine should be discontinued for 2 to 3 days before starting lotensin, but can be continued thereafter if necessary. If discontinuation of dapoxetine is not possible, the initial dose of lotensin should be reduced (5 mg instead of 10 mg) to avoid hypotension (see [Precautions]). Patients with a creatinine rate ≥30 mL/min can take the usual dose. For patients with a creatinine rate ≥30 mL/min, the initial daily dose is 5 mg (5 mg per tablet), and the dose can be increased to 10 mg (one tablet) per day if necessary. If further blood pressure reduction is still required, dapoxetine or another antihypertensive drug can be added. Congestive Heart Failure: This product is indicated for use as an adjunctive therapy for patients with congestive heart failure. The initial dose is 2.5 mg (5 mg, half a tablet) once. Due to the risk of a sharp drop in blood pressure after the first dose, patients should be closely monitored when taking this product for the first time (see Precautions). If heart failure symptoms are not effectively relieved, the dose can be increased to 5 mg (5 mg, one tablet) once every 2-4 weeks, provided the patient does not experience symptomatic hypotension or other unacceptable side effects. Depending on the patient's response, the dose can be increased to 10 mg (one tablet) or even 20 mg (two tablets) once every 2-4 weeks. This product is effective with a single dose. Some patients may respond better if the dose is divided into two doses. Controlled studies have shown that patients with severe heart failure (NYHA score IV) require a lower dose than those with mild or moderate heart failure (NYHA score III). When the creatinine level in heart failure patients is less than 30 mL/min, the daily dose can be increased to 10 mg (one tablet), but a lower initial dose, such as 2.5 mg (5 mg, half a tablet), may be more ideal. For patients with progressive chronic renal insufficiency (CRI) with or without hypertension, the recommended long-term dose is 10 mg (one tablet) once daily. If additional antihypertensive agents are needed to further lower blood pressure, it can be used in combination with other antihypertensives.
[Adverse Reactions]
Observed in hypertensive patients: Side effects of this drug are mild and transient. Daily doses range from 2.5 to 80 mg. The overall frequency of adverse reactions is unrelated to dose, gender, age, race, or route of administration. Doses exceeding 80 mg have not been evaluated. In a double-blind clinical trial of 2004 hypertensive patients, the overall incidence of adverse reactions was similar to that of placebo, regardless of causal relationship. Common adverse reactions are as follows: Lotensin Placebo (n=2004) (n=525) Headache 204 (10.2%) 75 (14.3%) Upper respiratory symptoms 108 (5.1%) 23 (4.4%) Dizziness 84 (4.2%) 21 (4.0%) Fatigue 73 (3.6%) 26 (4.9%) Increased cough68 (3.4%) 7 (1.3%) Myalgia 53 (2.6%) 18 (3.4%) Nausea 50 (2.5%) 11 (2.1%) Rhinitis 48 (2.4%) 15 (2.9%) Diarrhea 40 (2.0%) 6 (1.1%) Sore throat 35 (1.7%) 4 (0.7%) Back pain34 (1.7%) 8 (1.5%) Abdominal pain 28 (1.4%) 4 (0.7%) The following adverse reactions were also observed in double-blind clinical trials, with an incidence similar to placebo: Incidence 1-2%: pruritus, rash, flushing, dizziness, drowsiness, insomnia, nervousness, palpitations, chest pain, peripheral edema, dyspepsia, sinusitis, flu-like symptoms, urinary tract symptoms, and weakness. Incidence <1%: excessive decrease in blood pressure, lip and facial edema, gastritis, flatulence, vomiting, constipation, anxiety, depression, decreased sensation, ataxia, dyspnea, generalized edema, decreased libido, impotence, sweating, arthritis, tinnitus, cardiovascular dysfunction, and skin reactions. Laboratory Studies: Similar to other ACE inhibitors, even with monotherapy, some patients with essential hypertension (<0.1%) may experience mild elevations in blood urea nitrogen and serum creatinine, which resolve upon discontinuation of therapy. Elevations are more likely with concomitant use of diuretics or in patients with renal artery stenosis (see Precautions). In controlled clinical trials, discontinuation of therapy due to reasons unrelated to the medication occurred in 4% of the lotensin group and 3% of the placebo group. In Patients with Heart Failure: In controlled clinical trials, 180 patients with heart failure were treated with lotensin at doses of 2-20 mg daily. The incidence of common adverse reactions in patients taking lotensin was comparable to that in patients taking placebo, with the only exception being dizziness, which occurred more frequently in the lotensin group than in the placebo group. The following symptoms occurred more frequently in the lotensin group than in the placebo group: muscle cramps, abdominal pain, fatigue, malaise, and postural dizziness. The incidence of upper respiratory symptoms was higher in the placebo group than in the lotensin group. No clinically significant changes were observed in laboratory tests.
[Contraindications]
1. Known allergies to benazepril, related compounds, or any of the excipients of this product. 2. History of angioedema caused by angiotensin-converting enzyme (ACE) agents. 3. Pregnant women (see [Use in Pregnant and Lactating Women]). 4. Concomitant use of ACE agents or angiotensin receptor blockers with aliskiren in patients with type 1 diabetes.
[Precautions]
This product is well tolerated. The following are adverse reactions associated with benazepril and other ACE inhibitors: Cardiovascular Common: Palpitations, orthostatic intolerance; Rare: Symptomatic hypotension, chest pain, angina, arrhythmias; Very rare: Myocardial infarction; Gastrointestinal Common: Nonspecific gastrointestinal disturbances; Rare: Diarrhea, constipation, nausea, vomiting, abdominal pain; Very rare: Pancreatitis; Skin Common: Rash, flushing, itching, photosensitivity; Rare: Rare reports of pemphigus in patients taking ACE inhibitors. Very rare: severe erythema multiforme (also known as Stevens-Johnson syndrome). Liver and bile duct. Rare: hepatitis (mainly cholestatic hepatitis), cholestatic jaundice (see "Precautions"). Genitourinary system. Common: urinary frequency. Rare: increased blood urea nitrogen level, increased serum creatinine level. Very rare: impaired renal function (see "Precautions"). Respiratory system. Common: cough, respiratory syndrome. Central nervous system. Common: headache, dizziness, fatigue. Rare: drowsiness, insomnia, nervousness, paresthesia. Blood. Very rare: hemolytic anemia, thrombocytopenia (see "Precautions"). Sense organs. Very rare: tinnitus and taste disturbance. Allergic and immune reactions. Rare: angioedema, lip and facial edema (see "Precautions"). Musculoskeletal system. Rare: arthralgia, arthritis, myalgia.
