Irbesartan (Tablets) Instructions for Use
ATC Code
C09CA04 (Irbesartan)
Active Substance
Irbesartan (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Angiotensin II receptor antagonist
Pharmacotherapeutic Group
Angiotensin II receptor antagonist
Pharmacological Action
Antihypertensive agent, angiotensin II (type AT1) receptor blocker.
It reduces plasma aldosterone concentration (does not suppress kinase II, which destroys bradykinin); eliminates the vasoconstrictive effect of angiotensin II; reduces total peripheral vascular resistance, decreases afterload, systemic blood pressure and pressure in the pulmonary circulation. It does not affect the concentration of triglycerides, cholesterol, glucose, uric acid in plasma and the excretion of uric acid.
The maximum reduction in blood pressure is achieved 3-6 hours after oral administration of the drug, and the antihypertensive effect persists for at least 24 hours. Twenty-four hours after administration in recommended doses, the reduction in blood pressure is 60-70% compared to the maximum reduction in diastolic and systolic blood pressure in response to the drug’s use. When taken once daily at a dose of 150-300 mg, the degree of blood pressure reduction (systolic/diastolic) at the end of the dosing interval (i.e., 24 hours after drug administration) in the patient’s lying or sitting position is on average 8-13/5-8 mm Hg greater than with placebo, respectively. Administration of the drug at a dose of 150 mg once daily produces the same antihypertensive response (reduction in blood pressure before the next dose and average 24-hour blood pressure reduction) as administration of the same dose divided into two doses.
The antihypertensive effect of irbesartan develops within 1-2 weeks, and the maximum therapeutic effect is achieved 4-6 weeks after the start of treatment. The antihypertensive effect is maintained during long-term treatment. After discontinuation of treatment, blood pressure gradually returns to baseline values; no withdrawal syndrome was observed.
The drug’s efficacy does not depend on age and sex.
Patients of Black race respond less well to irbesartan monotherapy (as with all other drugs affecting the renin-angiotensin-aldosterone system (RAAS)).
Pharmacokinetics
After oral administration, Irbesartan is well absorbed from the gastrointestinal tract. Cmax of irbesartan in blood plasma is reached 1.5-2 hours after oral administration. The absolute bioavailability is 60-80%. Concurrent food intake does not significantly affect the bioavailability of the drug.
Irbesartan has linear and dose-proportional pharmacokinetics in the dose range from 10 to 600 mg; at doses above 600 mg (twice the recommended maximum dose), the kinetics of irbesartan become non-linear (decreased absorption). Plasma protein binding is approximately 96%. Binding to blood cellular components is insignificant. Vd is 53-93 L. With daily once-daily administration, the equilibrium concentration is reached in 3 days. With repeated once-daily administration, limited accumulation of irbesartan in plasma (less than 20%) is noted. After oral administration or intravenous administration of 14C-irbesartan, 80-85% of the radioactivity in the circulating blood is accounted for by unchanged Irbesartan.
Irbesartan is biotransformed in the liver by oxidation and conjugation with glucuronic acid. Irbesartan is oxidized mainly by the isoenzyme CYP2C9; the involvement of the isoenzyme CYP3A4 in the metabolism of irbesartan is insignificant. The main metabolite in the systemic bloodstream is irbesartan glucuronide (about 6%).
Total clearance and renal clearance are 157-176 ml/min and 3-3.5 ml/min, respectively. The terminal T1/2 is 11-15 hours. Irbesartan and its metabolites are excreted by the kidneys in the urine and through the intestines in the bile. After oral administration of 14C-irbesartan, about 20% of the radioactivity is found in the urine, the rest in the feces. Less than 2% of the administered dose is excreted by the kidneys in the urine as unchanged irbesartan. Slightly higher plasma concentrations of irbesartan are noted in women (compared to men). However, no differences in the T1/2 value and accumulation of irbesartan were identified. Dose adjustment of irbesartan in women is not required. The AUC and Cmax values of irbesartan were somewhat higher in elderly patients (> 65 years) than in younger patients, but the terminal T1/2 values did not differ significantly. Dose adjustment of irbesartan in elderly patients is not required.
In patients with impaired renal function or patients undergoing hemodialysis, the pharmacokinetic parameters of irbesartan do not change significantly. Irbesartan is not removed from the body during hemodialysis.
In patients with mild liver cirrhosis (5-6 points on the Child-Pugh scale) or moderate severity (7-9 points on the Child-Pugh scale), the pharmacokinetic parameters of irbesartan do not change significantly. Pharmacokinetic studies have not been conducted in patients with severe (more than 9 points on the Child-Pugh scale) hepatic insufficiency.
Indications
- Essential hypertension;
- Nephropathy in arterial hypertension and type 2 diabetes mellitus (as part of combined antihypertensive therapy).
ICD codes
| ICD-10 code | Indication |
| I10 | Essential [primary] hypertension |
| N08.3 | Glomerular disorders in diabetes mellitus |
| ICD-11 code | Indication |
| BA00.Z | Essential hypertension, unspecified |
| MF83 | Diabetic glomerular changes |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets
The drug should be taken orally; the tablet should be swallowed whole with water. The initial and maintenance dose is 150 mg once daily, regardless of food intake. Use of the drug at this dose provides more optimal 24-hour blood pressure control than at a dose of 75 mg/day. However, in some cases, especially in patients on hemodialysis or in patients over 75 years of age, the initial dose should be 75 mg.
If the therapeutic effect is insufficient when using the drug at a dose of 150 mg once daily, the dose can be increased to 300 mg, or another antihypertensive agent should be prescribed. In particular, it has been shown that the administration of a diuretic, such as hydrochlorothiazide, enhanced the effect of Irbesartan.
In patients with arterial hypertension and type 2 diabetes mellitus, treatment should be started at a dose of 150 mg once daily and gradually increased to 300 mg – the dose that is the preferred maintenance dose for the treatment of nephropathy.
In patients with water-electrolyte imbalance, blood volume and/or hyponatremia should be corrected before starting Irbesartan.
In patients with impaired renal function, no dosage adjustment is required. For patients on hemodialysis, the initial dose should be 75 mg/day.
In patients with mild (5-6 points on the Child-Pugh scale) or moderate (7-9 points on the Child-Pugh scale) hepatic impairment, no dosage adjustment is required. There is no clinical experience with the drug in patients with severe (more than 9 points on the Child-Pugh scale) hepatic impairment.
Although it is recommended to start treatment for patients over 75 years of age with a dose of 75 mg, usually no dosage adjustment is required for elderly patients.
The safety and efficacy of the drug in patients under 18 years of age have not been established.
Adverse Reactions
Definition of adverse reaction frequency: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000, < 1/100), rare (≥1/10,000, < 1/1000), very rare (≥1/10,000), including isolated cases.
Arterial hypertension
From the central nervous system common – dizziness; very rare – headache.
From the cardiovascular system uncommon – tachycardia, skin flushing.
From the respiratory system: uncommon – cough.
From the digestive system common – nausea, vomiting; uncommon – diarrhea, dyspepsia, heartburn; very rare – dysgeusia (taste disturbance), impaired liver function, hepatitis.
From the reproductive system uncommon – sexual dysfunction.
From the urinary system very rare – impaired renal function, including isolated cases of renal failure in at-risk patients.
From the body as a whole common – increased fatigue; uncommon – chest pain.
From laboratory parameters common – significant increase in creatine phosphokinase (CPK) activity (1.7%), not accompanied by clinical manifestations from the musculoskeletal system.
Allergic reactions rare – skin rash, urticaria, angioedema.
From metabolism very rare – hyperkalemia.
From the hearing organ: very rare – tinnitus.
From the musculoskeletal system very rare – myalgia, arthralgia (sometimes in combination with increased CPK activity), muscle cramps.
Arterial hypertension and type 2 diabetes mellitus with renal impairment
In addition to the adverse reactions indicated in patients with arterial hypertension, in patients with arterial hypertension and type 2 diabetes mellitus with microalbuminuria without impaired renal function, orthostatic dizziness and orthostatic hypotension were observed in 6.5% of patients when taking irbesartan (compared to the frequency of these adverse reactions when taking placebo).
In patients with arterial hypertension, type 2 diabetes mellitus with severe proteinuria and chronic renal failure, the adverse reactions listed below were observed in >2% of patients (compared to the frequency of their occurrence when taking placebo).
From the nervous system common – orthostatic dizziness.
From the cardiovascular system: common – orthostatic hypotension.
From the musculoskeletal system common – muscle and bone pain.
From laboratory parameters hyperkalemia when taking irbesartan in diabetes occurred more often than when taking placebo. In diabetic patients with elevated blood pressure and microalbuminuria with normal renal function, hyperkalemia (≥5.5 mmol/L) when taking irbesartan at a dose of 300 mg was observed in 29.4% of patients (very common), and in the placebo group – in 22% of patients. In diabetic patients with elevated blood pressure, chronic renal failure and severe proteinuria, hyperkalemia (≥ 5.5 mmol/L) when taking irbesartan was noted in 46.3% of patients (very common), and in the placebo group – in 26.3% of patients.
In patients with elevated blood pressure and diabetic nephropathy receiving Irbesartan, a clinically insignificant decrease in hemoglobin was observed in 1.7% of patients (common).
Contraindications
- Pregnancy;
- Lactation period;
- Childhood and adolescence under 18 years (efficacy and safety not established);
- Lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome;
- Hypersensitivity to the drug components.
With caution the drug should be used for aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy, dehydration, hyponatremia, diarrhea, vomiting, adherence to a diet with limited salt intake, diuretic therapy, bilateral renal artery stenosis, unilateral stenosis of the artery of a solitary kidney, chronic heart failure of functional class III-IV according to the NYHA classification, coronary artery disease and/or atherosclerotic cerebrovascular disease, hyperkalemia, renal failure, hemodialysis, recent kidney transplantation (no clinical experience of use), severe (more than 9 points on the Child-Pugh scale) hepatic insufficiency (no clinical experience of use), age over 75 years.
Use in Pregnancy and Lactation
Irbesartan (like any other drug that directly affects the RAAS) is contraindicated for use during pregnancy. If pregnancy occurs during treatment, the drug should be discontinued immediately.
Transition to appropriate alternative therapy should be carried out before planning pregnancy.
It is not known whether Irbesartan is excreted in breast milk. The drug is contraindicated during lactation (breastfeeding).
Use in Hepatic Impairment
In patients with mild (5-6 points on the Child-Pugh scale) or moderate (7-9 points on the Child-Pugh scale) hepatic impairment, no dosage adjustment is required. There is no clinical experience with the drug in patients with severe (more than 9 points on the Child-Pugh scale) hepatic impairment.
Use in Renal Impairment
In patients with impaired renal function, no dosage adjustment is required. For patients on hemodialysis, the initial dose should be 75 mg/day.
Pediatric Use
The safety and efficacy of the drug in patients under 18 years of age have not been established.
Geriatric Use
Although it is recommended to start treatment for patients over 75 years of age with a dose of 75 mg, usually no dosage adjustment is required for elderly patients.
Special Precautions
Treatment should be carried out under blood pressure monitoring.
In dehydrated patients, as well as in sodium deficiency (due to intensive diuretic therapy, diarrhea or vomiting, limited salt intake with food) and in patients on hemodialysis, symptomatic arterial hypotension may develop, especially after taking the first dose of the drug.
In case of water-electrolyte imbalance, circulating blood volume should be restored before starting the drug.
In patients with renal failure, periodic monitoring of plasma potassium and creatinine concentrations should be performed.
In severe heart failure, kidney disease (including renal artery stenosis) the risk of excessive blood pressure reduction, azotemia, oliguria, up to renal failure increases; in ischemic cardiomyopathy – the risk of angina and myocardial infarction.
Patients with primary aldosteronism usually do not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of the drug Irbesartan in such cases is not advisable.
Effect on ability to drive vehicles and mechanisms
During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions (dizziness and increased fatigue are possible).
Overdose
No toxicity was identified when irbesartan was used in adult patients at doses up to 900 mg/day for 8 weeks.
Symptoms: most likely pronounced decrease in blood pressure, tachycardia, bradycardia.
Treatment in case of accidental ingestion of the drug in high doses, induced vomiting and/or gastric lavage, activated charcoal, symptomatic and supportive therapy are indicated. Hemodialysis is ineffective. There is no specific information on the treatment of irbesartan overdose.
Drug Interactions
Diuretics and other antihypertensive agents
With simultaneous use of irbesartan with other antihypertensive agents, an enhancement of the antihypertensive effect is possible. The antihypertensive effects of irbesartan and thiazide diuretics are additive.
In patients with uncontrolled blood pressure on irbesartan monotherapy, the administration of small doses of hydrochlorothiazide (12.5 mg/day) leads to an additional reduction (compared to the placebo effect) in blood pressure by 7-10/3-6 mm Hg (systolic/diastolic blood pressure at the end of the dosing interval). When using irbesartan with small doses of hydrochlorothiazide (12.5 mg/day), the antihypertensive effect of this combination in Black patients approaches that in Caucasian patients.
Prior treatment with high doses of diuretics can lead to dehydration and an increased risk of arterial hypotension at the beginning of treatment with irbesartan.
Potassium preparations and potassium-sparing diuretics, heparin
Based on experience with the use of other drugs affecting the RAAS, with simultaneous use of potassium preparations, electrolyte solutions containing potassium, potassium-sparing diuretics or other drugs that can increase blood potassium levels, including heparin, an increase in serum potassium levels is possible.
Lithium
Reversible increases in serum lithium concentrations or its toxicity have been noted with the simultaneous use of lithium with ACE inhibitors. To date, such effects have been observed very rarely with the use of irbesartan.
If it is necessary to use this combination, serum lithium concentrations should be carefully monitored during treatment.
NSAIDs
With simultaneous use of angiotensin II receptor antagonists and NSAIDs (including selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), a weakening of the antihypertensive effect is possible. As with the simultaneous use of ACE inhibitors and NSAIDs, with the combined use of angiotensin II antagonists and NSAIDs, the risk of impaired renal function, including the possibility of acute renal failure, and an increase in serum potassium levels may increase, especially in patients with already impaired renal function. This combination should be used with caution, especially in elderly patients. It is necessary to restore circulating blood volume and monitor renal function throughout the period of combined therapy, as well as periodically after its completion.
Other interactions
With simultaneous use of irbesartan with hydrochlorothiazide, the pharmacokinetics of irbesartan do not change.
Irbesartan is mainly metabolized with the participation of the isoenzyme CYP2C9 and to a lesser extent undergoes glucuronidation. No significant pharmacokinetic or pharmacodynamic interaction was observed when irbesartan was combined with warfarin, drugs metabolized by the isoenzyme CYP2C9. Studies on the effect of inducers of the activity of the isoenzyme CYP2C9 (including rifampicin) on the pharmacokinetics of irbesartan have not been conducted.
Irbesartan does not alter the pharmacokinetics of digoxin.
Storage Conditions
In a dry, light-protected place, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.
Shelf Life
The shelf life is 2 years.
Do not use after the expiration date printed on the package.
Dispensing Status
The drug is dispensed by prescription.
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets, 75 mg: 28, 500, 1000, 1400, 2000, 2800, 5000, 7000, or 14000 pcs.
Film-coated tablets, 150 mg: 28, 500, 1000, 1400, 2000, 2800, 5000, 7000, or 14000 pcs.
Film-coated tablets, 300 mg: 28, 500, 1000, 1400, 2000, 2800, 5000, 7000, or 14000 pcs.
Marketing Authorization Holder
Kern Pharma S.L. (Spain)
Manufactured By
Kern Pharma S.L. (Spain)
Labeled By
DEKO COMPANY, LLC (Russia)
Or
SINTEZ, JSC (Russia)
Dosage Forms
 |
Irbesartan | Film-coated tablets, 75 mg: 28, 500, 1000, 1400, 2000, 2800, 5000, 7000, or 14000 pcs. |
| Film-coated tablets, 150 mg: 28, 500, 1000, 1400, 2000, 2800, 5000, 7000, or 14000 pcs. | ||
| Film-coated tablets, 300 mg: 28, 500, 1000, 1400, 2000, 2800, 5000, 7000, or 14000 pcs. |
Dosage Form, Packaging, and Composition
| Film-coated tablets | 1 tab. |
| Irbesartan (as hydrochloride) | 150 mg |
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (2) – cardboard packs.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (100) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (200) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (500) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (1000) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
1000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
2000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
5000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
| Film-coated tablets | 1 tab. |
| Irbesartan (as hydrochloride) | 150 mg |
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (2) – cardboard packs.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (100) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (200) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (500) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (1000) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
1000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
2000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
5000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
| Film-coated tablets | 1 tab. |
| Irbesartan (as hydrochloride) | 300 mg |
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (2) – cardboard packs.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (100) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (200) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (500) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (1000) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
1000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
2000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
5000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
| Film-coated tablets | 1 tab. |
| Irbesartan (as hydrochloride) | 300 mg |
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (2) – cardboard packs.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (100) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (200) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (500) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (1000) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
1000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
2000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
5000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
| Film-coated tablets | 1 tab. |
| Irbesartan (as hydrochloride) | 75 mg |
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (2) – cardboard packs.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (100) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (200) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (500) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (1000) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
1000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
2000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
5000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
| Film-coated tablets | 1 tab. |
| Irbesartan (as hydrochloride) | 75 mg |
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (2) – cardboard packs.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (100) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (200) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (500) – cardboard boxes.
14 pcs. – blister packs (PVC/PVDX/aluminum foil) (1000) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
1000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
2000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
5000 pcs. – polyethylene bags (1) – polymer jars or cardboard drums.
Film-coated tablets, 75 mg: 3, 4, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 28, 30, 32, 35, 40, 42, 45, 49, 50, 56, 60, 70, 75, 80, 84, 90, 98, 100, 105, 108, 120, 125, 140, 150, 160, 175, 180, 200, 210, 240, 250, or 300 pcs.
Film-coated tablets, 150 mg: 3, 4, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 28, 30, 32, 35, 40, 42, 45, 49, 50, 56, 60, 70, 75, 80, 84, 90, 98, 100, 105, 108, 120, 125, 140, 150, 160, 175, 180, 200, 210, 240, 250, or 300 pcs.
Film-coated tablets, 300 mg: 3, 4, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 28, 30, 32, 35, 40, 42, 45, 49, 50, 56, 60, 70, 75, 80, 84, 90, 98, 100, 105, 108, 120, 125, 140, 150, 160, 175, 180, 200, 210, 240, 250, or 300 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Forms
|
Irbesartan | Film-coated tablets, 75 mg: 3, 4, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 28, 30, 32, 35, 40, 42, 45, 49, 50, 56, 60, 70, 75, 80, 84, 90, 98, 100, 105, 108, 120, 125, 140, 150, 160, 175, 180, 200, 210, 240, 250, or 300 pcs. |
| Film-coated tablets, 150 mg: 3, 4, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 28, 30, 32, 35, 40, 42, 45, 49, 50, 56, 60, 70, 75, 80, 84, 90, 98, 100, 105, 108, 120, 125, 140, 150, 160, 175, 180, 200, 210, 240, 250, or 300 pcs. | ||
| Film-coated tablets, 300 mg: 3, 4, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 28, 30, 32, 35, 40, 42, 45, 49, 50, 56, 60, 70, 75, 80, 84, 90, 98, 100, 105, 108, 120, 125, 140, 150, 160, 175, 180, 200, 210, 240, 250, or 300 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; a cross-section shows two layers: a white or almost white core and a film coating.
| 1 tab. | |
| Irbesartan | 75 mg |
Excipients : lactose monohydrate (milk sugar) – 46.6 mg, microcrystalline cellulose – 24 mg, croscarmellose sodium – 7.2 mg, povidone K25 – 4.8 mg, magnesium stearate – 1.6 mg, colloidal silicon dioxide – 0.8 mg.
Excipients (coating) hypromellose – 2.2 mg, macrogol-4000 – 0.6 mg, titanium dioxide – 1.2 mg.
3 pcs. – contour blister packs (1) – cardboard packs.
3 pcs. – contour blister packs (2) – cardboard packs.
3 pcs. – contour blister packs (3) – cardboard packs.
3 pcs. – contour blister packs (4) – cardboard packs.
3 pcs. – contour blister packs (5) – cardboard packs.
3 pcs. – contour blister packs (6) – cardboard packs.
3 pcs. – contour blister packs (7) – cardboard packs.
3 pcs. – contour blister packs (8) – cardboard packs.
3 pcs. – contour blister packs (10) – cardboard packs.
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4 pcs. – contour blister packs (8) – cardboard packs.
4 pcs. – contour blister packs (10) – cardboard packs.
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10 pcs. – contour blister packs (10) – cardboard packs.
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15 pcs. – contour blister packs (10) – cardboard packs.
20 pcs. – contour blister packs (1) – cardboard packs.
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20 pcs. – contour blister packs (5) – cardboard packs.
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20 pcs. – contour blister packs (8) – cardboard packs.
20 pcs. – contour blister packs (10) – cardboard packs.
25 pcs. – contour blister packs (1) – cardboard packs.
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25 pcs. – contour blister packs (4) – cardboard packs.
25 pcs. – contour blister packs (5) – cardboard packs.
25 pcs. – contour blister packs (6) – cardboard packs.
25 pcs. – contour blister packs (7) – cardboard packs.
25 pcs. – contour blister packs (8) – cardboard packs.
25 pcs. – contour blister packs (10) – cardboard packs.
30 pcs. – contour blister packs (1) – cardboard packs.
30 pcs. – contour blister packs (2) – cardboard packs.
30 pcs. – contour blister packs (3) – cardboard packs.
30 pcs. – contour blister packs (4) – cardboard packs.
30 pcs. – contour blister packs (5) – cardboard packs.
30 pcs. – contour blister packs (6) – cardboard packs.
30 pcs. – contour blister packs (7) – cardboard packs.
30 pcs. – contour blister packs (8) – cardboard packs.
30 pcs. – contour blister packs (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
60 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; a cross-section shows two layers: a white or almost white core and a film coating.
| 1 tab. | |
| Irbesartan | 150 mg |
Excipients : lactose monohydrate (milk sugar) – 93.2 mg, microcrystalline cellulose – 48 mg, croscarmellose sodium – 14.4 mg, povidone K25 – 9.6 mg, magnesium stearate – 3.2 mg, colloidal silicon dioxide – 1.6 mg.
Excipients (coating) hypromellose – 4.4 mg, macrogol-4000 – 1.2 mg, titanium dioxide – 2.4 mg.
3 pcs. – contour blister packs (1) – cardboard packs.
3 pcs. – contour blister packs (2) – cardboard packs.
3 pcs. – contour blister packs (3) – cardboard packs.
3 pcs. – contour blister packs (4) – cardboard packs.
3 pcs. – contour blister packs (5) – cardboard packs.
3 pcs. – contour blister packs (6) – cardboard packs.
3 pcs. – contour blister packs (7) – cardboard packs.
3 pcs. – contour blister packs (8) – cardboard packs.
3 pcs. – contour blister packs (10) – cardboard packs.
4 pcs. – contour blister packs (1) – cardboard packs.
4 pcs. – contour blister packs (2) – cardboard packs.
4 pcs. – contour blister packs (3) – cardboard packs.
4 pcs. – contour blister packs (4) – cardboard packs.
4 pcs. – contour blister packs (5) – cardboard packs.
4 pcs. – contour blister packs (6) – cardboard packs.
4 pcs. – contour blister packs (7) – cardboard packs.
4 pcs. – contour blister packs (8) – cardboard packs.
4 pcs. – contour blister packs (10) – cardboard packs.
7 pcs. – contour blister packs (1) – cardboard packs.
7 pcs. – contour blister packs (2) – cardboard packs.
7 pcs. – contour blister packs (3) – cardboard packs.
7 pcs. – contour blister packs (4) – cardboard packs.
7 pcs. – contour blister packs (5) – cardboard packs.
7 pcs. – contour blister packs (6) – cardboard packs.
7 pcs. – contour blister packs (7) – cardboard packs.
7 pcs. – contour blister packs (8) – cardboard packs.
7 pcs. – contour blister packs (10) – cardboard packs.
10 pcs. – contour blister packs (1) – cardboard packs.
10 pcs. – contour blister packs (2) – cardboard packs.
10 pcs. – contour blister packs (3) – cardboard packs.
10 pcs. – contour blister packs (4) – cardboard packs.
10 pcs. – contour blister packs (5) – cardboard packs.
10 pcs. – contour blister packs (6) – cardboard packs.
10 pcs. – contour blister packs (7) – cardboard packs.
10 pcs. – contour blister packs (8) – cardboard packs.
10 pcs. – contour blister packs (10) – cardboard packs.
14 pcs. – contour blister packs (1) – cardboard packs.
14 pcs. – contour blister packs (2) – cardboard packs.
14 pcs. – contour blister packs (3) – cardboard packs.
14 pcs. – contour blister packs (4) – cardboard packs.
14 pcs. – contour blister packs (5) – cardboard packs.
14 pcs. – contour blister packs (6) – cardboard packs.
14 pcs. – contour blister packs (7) – cardboard packs.
14 pcs. – contour blister packs (8) – cardboard packs.
14 pcs. – contour blister packs (10) – cardboard packs.
15 pcs. – contour blister packs (1) – cardboard packs.
15 pcs. – contour blister packs (2) – cardboard packs.
15 pcs. – contour blister packs (3) – cardboard packs.
15 pcs. – contour blister packs (4) – cardboard packs.
15 pcs. – contour blister packs (5) – cardboard packs.
15 pcs. – contour blister packs (6) – cardboard packs.
15 pcs. – contour blister packs (7) – cardboard packs.
15 pcs. – contour blister packs (8) – cardboard packs.
15 pcs. – contour blister packs (10) – cardboard packs.
20 pcs. – contour blister packs (1) – cardboard packs.
20 pcs. – contour blister packs (2) – cardboard packs.
20 pcs. – contour blister packs (3) – cardboard packs.
20 pcs. – contour blister packs (4) – cardboard packs.
20 pcs. – contour blister packs (5) – cardboard packs.
20 pcs. – contour blister packs (6) – cardboard packs.
20 pcs. – contour blister packs (7) – cardboard packs.
20 pcs. – contour blister packs (8) – cardboard packs.
20 pcs. – contour blister packs (10) – cardboard packs.
25 pcs. – contour blister packs (1) – cardboard packs.
25 pcs. – contour blister packs (2) – cardboard packs.
25 pcs. – contour blister packs (3) – cardboard packs.
25 pcs. – contour blister packs (4) – cardboard packs.
25 pcs. – contour blister packs (5) – cardboard packs.
25 pcs. – contour blister packs (6) – cardboard packs.
25 pcs. – contour blister packs (7) – cardboard packs.
25 pcs. – contour blister packs (8) – cardboard packs.
25 pcs. – contour blister packs (10) – cardboard packs.
30 pcs. – contour blister packs (1) – cardboard packs.
30 pcs. – contour blister packs (2) – cardboard packs.
30 pcs. – contour blister packs (3) – cardboard packs.
30 pcs. – contour blister packs (4) – cardboard packs.
30 pcs. – contour blister packs (5) – cardboard packs.
30 pcs. – contour blister packs (6) – cardboard packs.
30 pcs. – contour blister packs (7) – cardboard packs.
30 pcs. – contour blister packs (8) – cardboard packs.
30 pcs. – contour blister packs (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
60 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; the cross-section shows two layers: a core of white or almost white color and a film coating.
| 1 tab. | |
| Irbesartan | 300 mg |
Excipients: lactose monohydrate (milk sugar) – 186.4 mg, microcrystalline cellulose – 96 mg, croscarmellose sodium – 28.8 mg, povidone K25 – 19.2 mg, magnesium stearate – 6.4 mg, colloidal silicon dioxide – 3.2 mg.
Excipients (coating): hypromellose – 8.8 mg, macrogol-4000 – 2.4 mg, titanium dioxide – 4.8 mg.
3 pcs. – contour cell packaging (1) – cardboard packs.
3 pcs. – contour cell packaging (2) – cardboard packs.
3 pcs. – contour cell packaging (3) – cardboard packs.
3 pcs. – contour cell packaging (4) – cardboard packs.
3 pcs. – contour cell packaging (5) – cardboard packs.
3 pcs. – contour cell packaging (6) – cardboard packs.
3 pcs. – contour cell packaging (7) – cardboard packs.
3 pcs. – contour cell packaging (8) – cardboard packs.
3 pcs. – contour cell packaging (10) – cardboard packs.
4 pcs. – contour cell packaging (1) – cardboard packs.
4 pcs. – contour cell packaging (2) – cardboard packs.
4 pcs. – contour cell packaging (3) – cardboard packs.
4 pcs. – contour cell packaging (4) – cardboard packs.
4 pcs. – contour cell packaging (5) – cardboard packs.
4 pcs. – contour cell packaging (6) – cardboard packs.
4 pcs. – contour cell packaging (7) – cardboard packs.
4 pcs. – contour cell packaging (8) – cardboard packs.
4 pcs. – contour cell packaging (10) – cardboard packs.
7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (5) – cardboard packs.
7 pcs. – contour cell packaging (6) – cardboard packs.
7 pcs. – contour cell packaging (7) – cardboard packs.
7 pcs. – contour cell packaging (8) – cardboard packs.
7 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (6) – cardboard packs.
14 pcs. – contour cell packaging (7) – cardboard packs.
14 pcs. – contour cell packaging (8) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
15 pcs. – contour cell packaging (1) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (5) – cardboard packs.
15 pcs. – contour cell packaging (6) – cardboard packs.
15 pcs. – contour cell packaging (7) – cardboard packs.
15 pcs. – contour cell packaging (8) – cardboard packs.
15 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (6) – cardboard packs.
20 pcs. – contour cell packaging (7) – cardboard packs.
20 pcs. – contour cell packaging (8) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
25 pcs. – contour cell packaging (1) – cardboard packs.
25 pcs. – contour cell packaging (2) – cardboard packs.
25 pcs. – contour cell packaging (3) – cardboard packs.
25 pcs. – contour cell packaging (4) – cardboard packs.
25 pcs. – contour cell packaging (5) – cardboard packs.
25 pcs. – contour cell packaging (6) – cardboard packs.
25 pcs. – contour cell packaging (7) – cardboard packs.
25 pcs. – contour cell packaging (8) – cardboard packs.
25 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (7) – cardboard packs.
30 pcs. – contour cell packaging (8) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
60 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Film-coated tablets, 75 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90, or 100 pcs.
Film-coated tablets, 150 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90, or 100 pcs.
Film-coated tablets, 300 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.
Marketing Authorization Holder
Pranapharm, LLC (Russia)
Dosage Forms
|
Irbesartan | Film-coated tablets, 75 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90, or 100 pcs. |
| Film-coated tablets, 150 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90, or 100 pcs. | ||
| Film-coated tablets, 300 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light orange to dark orange, round, biconvex, without a score; the cross-section shows two layers, the inner layer is white or almost white.
| 1 tab. | |
| Irbesartan | 75 mg |
Excipients: lactose monohydrate – 40 mg, microcrystalline cellulose (type 102) – 31.2 mg, croscarmellose sodium – 7.2 mg, povidone K-25 – 5 mg, magnesium stearate – 1.6 mg.
Film coating composition: hypromellose – 3.35 mg, macrogol 400 – 0.613 mg, dimethicone 100 – 0.23 mg, titanium dioxide – 0.682 mg, iron oxide yellow dye – 0.093 mg, iron oxide red dye – 0.032 mg.
7 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
10 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
Film-coated tablets from light orange to dark orange, round, biconvex, with a score; the cross-section shows two layers, the inner layer is white or almost white.
| 1 tab. | |
| Irbesartan | 150 mg |
Excipients: lactose monohydrate – 80 mg, microcrystalline cellulose (type 102) – 62.4 mg, croscarmellose sodium – 14.4 mg, povidone K-25 – 10 mg, magnesium stearate – 3.2 mg.
Film coating composition: hypromellose – 6.7 mg, macrogol 400 – 1.226 mg, dimethicone 100 – 0.46 mg, titanium dioxide – 1.364 mg, iron oxide yellow dye – 0.186 mg, iron oxide red dye – 0.064 mg.
7 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
10 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
Film-coated tablets white, round, biconvex, with a score; the cross-section of the tablet is white or almost white.
| 1 tab. | |
| Irbesartan | 300 mg |
Excipients: lactose monohydrate – 136 mg, microcrystalline cellulose (type 102) – 108 mg, croscarmellose sodium – 30 mg, povidone K-25 – 20 mg, magnesium stearate – 6 mg.
Film coating composition: hypromellose – 6.768 mg, macrogol 400 – 1.288 mg, dimethicone 100 – 0.52 mg, titanium dioxide – 1.424 mg.
7 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
10 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
![Irbesartan [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Irbesartan [Tablets] 2")