GMP Certified / Irbesartan and Hydrochlorothiazide Tablets 175mg

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 175mg
• Model NO.: injection
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Irbesartan and Hydrochlorothiazide Tablets
Strength	175mg
Packing	28 tablets /box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Irbesartan and Hydrochlorothiazide Tablets 175mg

Character:
150mg/12.5mg: Light pink double convex oval film coating, notched. One side is engraved with a heart, the other with 2875.

Indications:
It is used to treat essential hypertension. This fixed-dose combination is indicated for the treatment of patients whose blood pressure is not effectively controlled by irbesartan or hydrochlorothiazide alone.

Adverse reactions:
The incidence of adverse reactions listed below are defined by the following conventions:
Very common (≥1/10); Common (≥1/100); Occasionally (≥1/1000, < 1/100); Rare (≥1/10000, < 1/1000); Very rare (< 1/10000).
Irbesartan/hydrochlorothiazide compound tablets
In placebo-controlled trials of hypertensive patients, the overall incidence of adverse events was not different between the irbesartan/hydrochlorothiazide and placebo groups. The incidence of treatment discontinuation due to clinical or laboratory adverse events was lower in the irbesartan/hydrochlorothiazide group than in the placebo group. Adverse events occurred regardless of dose (within the recommended dose range), gender, age, race, or treatment cycle. In the placebo-controlled trial, 898 hypertensive patients received various doses of irbesartan/hydrochlorothiazide (ranging from 37.5mg/6.25mg to 300mg/25mg of irbesartan/hydrochlorothiazide).
The following are reports of adverse reactions:
Neurological abnormalities are common: vertigo; Uncommon: Postural vertigo
Cardiac abnormalities: Occasionally - hypertension, edema, syncope, tachycardia
Vascular abnormalities: Occasional - blushing
Gastrointestinal abnormalities: Common - nausea/vomiting; I see. - Diarrhea, dry mouth
Skeletal muscle, connective tissue, and bone abnormalities: uncommon; Distal limb edema, muscle/bone pain
Skin and subcutaneous tissue abnormalities: Rare - rash
Kidney and urethral abnormalities: Common - abnormal urination
Reproductive system and breast abnormalities: Rare - changes in sexual desire, sexual dysfunction
Systemic abnormalities and dosing points: Common - fatigue: occasionally - weakness
Check:
Few patients in the irbesartan/hydrochlorothiazide group had clinically significant changes in laboratory parameters. Common: Increased BUN (urea chlorine), creatinine and creatine kinase; Occasionally: serum potassium and sodium levels decreased.
In addition, since the launch of the Irbesartan/hydrochlorothiazide combination, the following adverse reactions have been reported:
Immune system abnormalities: Rare - as with other angiotensin-II receptor antagonists, hypersensitivity reactions such as rash, urticaria, and angioneurotic edema may occur in a few cases
Metabolic and nutritional abnormalities: Very rare - hyperkalemia
Neurological abnormalities: Very rare - headache
Ear and labyrinth abnormalities: Very rare - tinnitus
Respiratory, chest, diaphragmatic abnormalities: Occasionally - cough
Gastrointestinal abnormalities: Very rare - loss of taste, indigestion
Hepatobiliary abnormalities: Very rare - abnormal liver function, hepatitis
Skeletal muscle, connective tissue and bone abnormalities: Very rare - arthralgia, myalgia;
Renal and urethral abnormalities: Very rare - renal impairment, including renal failure in individual high-risk patients.
Additional information about single ingredients: In addition to the adverse reactions in combination products listed above, previously reported adverse reactions in the application of one of the single ingredients are also potential adverse reactions to be aware of.
Irbesartan
Cardiac abnormalities: Rare - Abnormal electrocardiogram
Gastrointestinal abnormalities: Occasional - abdominal pain
Skin and subcutaneous tissue abnormalities: Occasional - pruritus
Systemic disease and point of administration: Uncommon - chest pain, extreme weakness
The post-marketing experience of a single ingredient is listed below:
Irbesartan:
Similar to other angiotensin-II receptor antagonists, very rare hypersensitivity reactions (angioedema, urticaria) have been reported since irbesartan monotherapy was introduced. In postmarketing surveillance, the following very rare adverse events have been reported, however, not necessarily causally associated with irbesartan: vertigo, weakness, hyperkalemia, jaundice, myalgia, elevated liver function test levels, hepatitis, and impaired kidney function, including occasional renal failure in at-risk populations.
Hydrochlorothiazide
Adverse events that have been reported for hydrochlorothiazide alone, whether or not related to taking the drug, include:
Blood and lymphatic system: hypoplastic anemia, myelosuppression, hemolytic anemia, leukopenia, neutrophil/granulocytopenia, thrombocytopenia
Psychiatric disorders: depression, sleep disorders
Nervous system abnormalities: dizziness, paresthesia, restlessness, lightheadedness
Eye abnormalities: temporary blurred vision, yellow vision
Heart abnormality: arrhythmia
Vascular abnormalities: postural hypotension
Respiratory, chest, diaphragmatic abnormalities: difficulty breathing (including pneumonia, pulmonary edema)
Gastrointestinal abnormalities: pancreatitis, anorexia, constipation, diarrhea, gastric irritation, anorexia, salivary gland inflammation
Hepatobiliary abnormalities: jaundice (jaundice due to intrahepatic sweat)
Skin and subcutaneous tissue abnormalities: allergic reactions, toxic subcutaneous necrosis lysis, cutaneous lupus-like reactions, necrotizing vasculature (phlebitis, cutaneous phlebitis), photoallergic reactions, rashes, urticaria
Skeletal muscle, connective tissue, and bone abnormalities: muscle spasms, weakness
Renal and urethral abnormalities: interstitial nephritis, renal dysfunction
Systemic abnormalities and point of administration: fever
Check:
Electrolyte disturbances (including hypokalemia and hyponatremia), glycosuria, hyperglycemia, elevated blood uric acid, elevated cholesterol and triglycerides.

Pharmacology and toxicology:
This drug is a combination of the angiotension-II receptor antagonist irbesartan and the thiazide diuretic hydrochlorothiazide. The compound has a blood pressure lowering synergistic effect, which is more effective than any single drug ingredient in it.
Irbesartan is a potent, orally effective and selective angiotensin-II receptor (AT1 subtype) antagonist. It blocks all the effects of angiotensin-II mediated by AT1 receptors, regardless of its source or synthetic pathway. Its selective antagonism to angiotensin-II receptor (AT1) resulted in increased plasma renin and angiotensin-II levels and decreased plasma aldosterone levels. Serum potassium is not significantly affected when the recommended dose of irbesartan is given to patients without electrolyte disturbances alone (see [Precautions] and [Drug interactions]). Irbesartan does not inhibit angiotensin-converting enzyme (ACE kininase II), which produces angiotensin-II and degrades bradykinin into inactive metabolites. Irbesartan activity does not require metabolic activation. Hydrochlorothiazide is a thiazide diuretic. The antihypertensive mechanism of thiazide diuretics has not been fully defined. It can affect the mechanism of electrolyte reabsorption by renal tubules, directly increasing the excretion of sodium and chlorine (roughly equal amounts). Hydrochlorothiazide reduces blood volume, increases plasma renin activity, increases aldosterone secretion and thereby increases urine potassium and bicarbonate excretion and decreases serum potassium levels. The combination of irbesartan reverses the loss of potassium associated with diuretics by blocking the renin-angiotensin-aldosterone system. The diuretic effects of hydrochlorothiazide begin about 2 hours after administration, with peak effects occurring about 4 hours and lasting about 6-12 hours.
Hydrochlorothiazide and irbesartan compounds produce dose-dependent synergistic hypotensive effects within their recommended therapeutic dose ranges. In patients whose blood pressure was not effectively controlled by irbesartan 300mg alone, the addition of hydrochlorothiazide 12.5mg once daily resulted in an additional 6.1mmHg reduction in placebo-adjusted diastolic trough (24 hours after administration). The combination of irbesartan 300mg and hydrochlorothiazide 12.5mg resulted in an additional 13.6/11.5mmHg reduction in total systolic/diastolic blood pressure after deducting the placebo effect.
In patients with mild to moderate essential hypertension, irbesartan 150mg and hydrochlorothiazide 12.5mg once daily reduced the average placebo-adjusted systolic/diastolic trough (24 hours after administration) by 12.9/6.9mmHg. The peak effect occurs at 3-6 hours. Once daily administration of irbesartan 150mg and hydrochlorothiazide 12.5mg resulted in a sustained 24-hour hypertensive effect with a placebo-adjusted mean systolic/diastolic blood pressure reduction of 15.8/10.0mmHg at 24 hours. Ambonol (150/12.5mg) and Ambonol (300/12.5mg) were measured by ambulator-based blood pressure monitoring (AMbulator-based blood pressure monitoring) to 100%. Ambonol (150/12.5mg) and Ambonol (300/12.5mg) were measured by cuff blood pressure calculation at the clinic at 68% and 76%, respectively. When taken once a day, blood pressure is not excessively reduced to produce a peak blood pressure lowering, so the blood pressure lowering effect is safe and effective for 24 hours.
In patients whose blood pressure was not effectively controlled by hydrochlorothiazide 25mg alone, the addition of irbesartan resulted in an additional average reduction of 11.1/7.2mmHg in the systolic/diastolic blood pressure after the placebo effect.
The antihypertensive effect of the combination of irbesartan and hydrochlorothiazide appeared after the first dose, and the effect was significant within 1-2 weeks. The greatest effect was at 6-8 weeks, and in long-term follow-up studies, the antihypertensive effect of irbesartan/hydrochlorothiazide lasted for more than one year. Although there have been no specific studies of Ambonol, no rebound increase in blood pressure was observed with either irbesartan or hydrochlorothiazide.
The effects of irbesartan and hydrochlorothiazide on cardiovascular morbidity and mortality have not been studied. Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of vascular morbidity and death.
There was no difference in response to Ambonol among patients of different ages and genders. When irbesartan was combined with a small dose of hydrochlorothiazide (e.g. 12.5mg daily), the antihypertensive effect was similar in blacks and non-blacks.

Storage:
Do not store in a place above 30ºC, store in the original packaging.