Aprovel review Uses, Dosage, Side Effects, Precautions &Warnings
active ingredients: Irbesartan
- 1 What is Aprovel 300mg used for and indication?
- 2 ِِAprovel 150 mg | 300 mg dosage
- 3 Contraindications
- 4 How it works Aprovel
- 5 aprovel side effects
- 6 aprovel drug interactions
- 7 Warnings and Precautions
- 8 Drive and use machines
- 9 PREGNANCY / BREAST FEEDING / FERTILITY:
- 10 What happens if I overdose from Aprovel ?
- 11 What is Forms and Composition?
What is Aprovel 300mg used for and indication?
Aprovel is indicated in adults for the treatment of essential hypertension.
It is also indicated for the treatment of renal impairment in adult hypertensive patients with type 2 diabetes, in the context of management with an antihypertensive drug (see sections Contraindications , Warnings and precautions for use , Interactions with other medicinal products and other forms of interaction andpharmacodynamic properties ).
ِِAprovel 150 mg | 300 mg dosage
Dosage The recommended starting and usual maintenance dose is 150 mg given as a single dose daily during or after meals. Aprovel at a dose of 150 mg once a day usually provides better control of blood pressure over 24 hours than the 75 mg dose. However, initiation of treatment with 75 mg daily may be considered particularly in hemodialysis patients or patients over 75 years of age.
In patients inadequately controlled at 150 mg once daily, the dosage may be increased to 300 mg or another antihypertensive agent may be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Aprovel (see section Interactions with other medicinal products and other forms of interaction ).
In hypertensive patients with type 2 diabetes, treatment should be initiated at a dose of 150 mg irbesartan once daily and increased to 300 mg once daily, a preferable maintenance dose for the treatment of renal impairment. . The demonstration of the renal benefit of Aprovel in hypertensive patients with type 2 diabetes is based on studies in which irbesartan was used, if necessary, in addition to other antihypertensive agents to achieve a blood pressure goal . Pharmacodynamic properties). Special populations
- Renal Insufficiency: No dose adjustment is required in patients with renal impairment. A lower starting dose (75 mg) should be considered in patients undergoing hemodialysis (see section 4.4 Special warnings and precautions for use ).
- Hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
- Elderly: Apart from subjects over 75 years of age, in whom treatment may be initiated at a dose of 75 mg / day, no dose adjustment is usually necessary in the elderly.
- Pediatric population: The efficacy and safety of Aprovel in children aged 0 to 18 years has not been established. The available data are described in the Adverse Reactions, Pharmacodynamic Properties and Pharmacokinetic Properties sections, but no dosage recommendations can be made.
- Hypersensitivity to one of the components of the product (see composition section).
- Second and third trimesters of pregnancy: Aprovel is contraindicated during the second and third trimesters of pregnancy. During the second and third trimesters, substances that act directly on the renin-angiotensin system can lead to fetal or neonatal renal failure, fetal cranial hypoplasia or even fetal death. If pregnancy is diagnosed, irbesartan should be stopped as soon as possible, the skull and renal function should be checked by ultrasound if the treatment has been inadvertently taken for a long time.
- Breast-feeding: Aprovel is contraindicated during breast-feeding. It is not known whether irbesartan is excreted in human breast milk. Irbesartan is excreted in the milk of lactating rats.
- Due to the presence of lactose , this medication is contraindicated in cases of congenital galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency.
- Children: the use of irbesartan in children and adolescents is not recommended due to a lack of efficacy and safety data.
- Primary hyperaldosteronism: patients with primary hyperaldosteronism generally do not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Aprovel is not recommended.
- Hepatic impairment: there is no clinical experience in patients with severe hepatic impairment.
- Pregnancy: as a precaution, irbesartan should preferably not be used during the first trimester of pregnancy. A change to an appropriate alternative treatment should be made before considering pregnancy.
- Lithium : the combination of lithium and Aprovel is not recommended.
- Co- administration of Aprovel with potassium-sparing diuretics, potassium supplementation, potassium-containing diet salts or other drugs which may increase serum potassium levels (eg heparin) is not recommended.
How it works Aprovel
Pharmacotherapeutic group: Antagonists of angiotensin-II receptors, ATC code C09C A04.
Mechanism of action: Irbesartan is a potent selective angiotensin-II receptor antagonist (type AT 1 ), active orally. Irbesartan blocks all the effects of angiotensin-II, involving AT 1 receptors , regardless of the origin or route of synthesis of angiotensin-II. Selective antagonism of angiotensin-II receptors (AT 1) causes elevated renin plasma levels and angiotensin-II levels and a decrease in plasma aldosterone concentration.
Serum potassium is not significantly affected by irbesartan alone at the recommended doses. Irbesartan does not inhibit ACE (kininase-II), an enzyme that generates angiotensin-II formation and also degrades bradykinin into inactive metabolites. Irbesartan does not require metabolic activation to be active.
- Irbesartan lowers blood pressure by causing minimal changes in heart rate. The drop in blood pressure is dose-dependent with a tendency to plateau at doses greater than 300 mg once a day. Daily doses of 150 to 300 mg lower the blood pressure values, supine or sitting, by an average of 8-13 / 5-8 mm Hg (PAS / PAD) at the 24th hour after catch (valley). This decrease is greater than that observed with placebo.
- The maximum drop in blood pressure is achieved within 3 to 6 hours after administration of the product. The antihypertensive effect is maintained for at least 24 hours. At 24 hours, the drop in blood pressure is still 60 to 70% of the diastolic and systolic peak, at the recommended doses. A dose of 150 mg, taken once a day, produces similar effects on blood pressure 24 hours after dosing (valley) and on 24-hour average blood pressure than the same dose divided into 2 doses per day.
- The antihypertensive effect of Aprovel occurs within one to two weeks, with peak effect occurring four to six weeks after the start of treatment. Antihypertensive effects are maintained during long-term treatments. The blood pressure gradually returns to its initial state after stopping treatment. Stopping the treatment does not result in a rebound effect.
- The antihypertensive effects of irbesartan and thiazide diuretics are additive. In patients who are not adequately controlled with irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily produces a greater decrease in BP. , adjusted to placebo, 24 hours after setting (valley), 7-10 / 3-6 mm Hg (PAS / PAD).
- The efficacy of Aprovel is independent of age or sex. As with other drugs that work on the renin-angiotensin system, black hypertensive patients have a significantly lower response to irbesartan alone. When irbesartan is administered in combination with a low dose of hydrochlorothiazide (eg 12.5 mg daily), the antihypertensive response of black patients is similar to that of white patients.
- There is no clinically significant effect on serum uricemia or uricuria.
- The reduction in blood pressure obtained after titration with irbesartan target doses of 0.5 mg / kg (low), 1.5 mg / kg (mean) and 4.5 mg / kg (high) was evaluated in 318 hypertensive or at risk children and adolescents (diabetic, family history of hypertension) aged 6 to 16 years over a three-week period.
- At the end of the three weeks, the mean decrease from baseline in the primary efficacy endpoint, systolic systolic systolic systolic systolic systolic systolic systolic systolic systolic systolic systolic systolic systolic systolic , 3 mmHg (medium dose) and 13.2 mmHg (high dose).
- No significant difference was found between these doses. The adjusted mean fall in diastolic blood pressure while sitting in the valley (PAD ass) was: 3.8 mm Hg (low dose), 3, 2 mm Hg (medium dose), 5.6 mm Hg (high dose). Over a further two-week period during which patients were re-randomized to the active drug or placebo, placebo-treated patients experienced an increase in SBP of 2.4 mm Hg and a PAD of 2; 0 mm Hg compared with a change of +0.1 and – 0.3 mm Hg respectively for patients taking irbesartan at all doses (see sectionDosage and method of administration ).
Hypertension and type 2 diabetes with kidney involvement
The Irbesartan Diabetic Nephropathy Trial (IDNT) study shows that irbesartan slows the progression of renal impairment in patients with chronic renal failure and proven proteinuria. IDNT is a double-blind, controlled morbidity-mortality study comparing Aprovel, amlodipine and placebo.
The long-term (on average 2.6 years) effects of Aprovel on progression of renal impairment and all-cause mortality were studied in 1,715 hypertensive diabetic type 2 patients with proteinuria ≥ 900 mg / day and serum creatinine between 1.0 and 3.0 mg / dl. Patients received progressive doses, depending on the tolerability, of 75 mg up to a maintenance dose of 300 mg irbesartan, 2.5 mg up to a dose of 10 mg amlodipine, or a placebo. In all treatment groups, patients generally received 2 to 4 antihypertensives (eg, diuretics, beta-blockers, alpha-blockers) to achieve a predefined blood pressure goal ≤ 135/85 mm Hg or a reduction of 10 mm Hg.
systolic blood pressure if it was> 160 mm Hg in the basal state. Sixty percent (60%) of patients in the placebo group achieved this blood pressure goal and 76% and 78%, respectively, in the irbesartan and amlodipine groups.Irbesartan significantly reduced the relative risk of the combined primary endpoint:
doubling of serum creatinine, end-stage renal disease (ESRD) or all-cause mortality. Approximately 33% of patients in the irbesartan group achieved this primary combined renal outcome compared to 39% and 41% in the placebo and amlodipine groups [relative risk reduction of 20% versus placebo (p = 0.024) and relative risk reduction of 23%). % relative to amlodipine (p = 0.006)]. In the individual analysis of the components of the primary endpoint, no effect on all-cause mortality was observed, while a positive trend in IRT reduction and a significant reduction in serum creatinine doubling were observed. .
The effect of treatment was assessed in subgroups that included gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and baseline. albuminuria. In women and the black patient subgroup, which accounted for 32% and 26% of the total study population respectively, renal benefit was not evident, although confidence intervals did not exclude it. . Similarly for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference between the three groups in the total population, whereas an increase in the incidence of nonfatal myocardial infarction was observed in women and that a decrease in the incidence of Nonfatal myocardial infarction was observed in men in the irbesartan group versus placebo treatment. An increase in the incidence of nonfatal myocardial infarction and stroke was observed in women in the irbesartan treatment group versus the amlodipine treatment group, while hospitalizations for heart failure were reduced on the global population. However, no particular explanation for these findings in women has been identified. Stroke was observed in women in the irbesartan treatment group versus the amlodipine treatment group, while hospitalizations for heart failure were reduced in the overall population. However, no particular explanation for these findings in women has been identified.Stroke was observed in women in the irbesartan treatment group versus the amlodipine treatment group, while hospitalizations for heart failure were reduced in the overall population. However, no particular explanation for these findings in women has been identified.
The study “Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with Type 2 Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to proven proteinuria in patients with microalbuminuria. IRMA 2 is a double-blind, placebo-controlled, morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg / day) and normal renal function (serum creatinine ≤ 1.5 mg / day). dl in men and <1.1 mg / dl in women). The study evaluated the long-term (2 years) effects of Aprovel on progression to clinical (proven) proteinuria (urinary albumin excretion rate> 300 mg / day and increased TEUA from minus 30% of the basal value). The predefined voltage target was ≤ 135/85 mm Hg. other antihypertensives (with the exception of ACE inhibitors, angiotensin II receptor antagonists, and dihydropyridine calcium channel blockers) were added as needed to achieve the blood pressure goal. While comparable blood pressure was achieved in all treatment groups, fewer patients achieved the proteinuria criterion in the irbesartan 300 mg group (5.2%) than in the placebo groups (14.9%). or irbesartan 150 mg (9.7%), demonstrating for the highest dose a 70% relative risk reduction versus placebo (p = 0.0004). A concomitant improvement in glomerular filtration rate (GFR) was not observed during the first three months of treatment. The slowdown in progression to clinical proteinuria was evident as early as the third month and continued over a 2-year period. Regression to normal albuminuria (<30 mg / day) was more common in the Aprovel 300 mg (34%) group than in the placebo group (21%).
Double blockade of the renin-angiotensin-aldosterone system (RAAS)
- The use of a combination of a converting enzyme inhibitor (ACE) with an angiotensin II receptor antagonist (ARB II) was analyzed in two large randomized controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes).
- The ONTARGET study was conducted in patients with a history of cardiovascular disease or cerebrovascular disease, or type 2 diabetes with target organ involvement. The VA NEPHRON-D study was conducted in type 2 diabetic patients with diabetic nephropathy.
- In comparison with monotherapy, these studies did not show any significant beneficial effect on renal and / or cardiovascular outcomes and mortality, whereas an increased risk of hyperkalemia was observed. , acute renal failure and / or hypotension.
- These results are also applicable to other IEC and ARA II, given the similarity of their pharmacodynamic properties.
- ACE inhibitors and ARBs should not be used in patients with diabetic nephropathy.
aprovel side effects
- In placebo-controlled trials in hypertensive patients, the overall incidence of adverse events was not different between the irbesartan group (56.2%) and the placebo group (56.5%). .
- Treatment interruptions due to clinical or laboratory adverse events were less frequent in patients treated with irbesartan (3.3%) than in placebo-treated patients (4.5%).
- The incidence of adverse events was independent of dosage (within recommended dose range), sex, age, race or duration of treatment.
- In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic vertigo and orthostatic hypotension were reported in 0.5% (ie, infrequently) patients, but in excess of placebo.
- The following adverse events have been reported in placebo-controlled clinical studies in which 1965 patients received irbesartan. In diabetic hypertensive patients with chronic renal failure and overt proteinuria, the marked adverse effects of (*) were reported in more than 2% of patients and in excess of placebo.
- The frequency of adverse reactions listed below is defined according to the following convention: very common (≥ 1/10); frequent (≥ 1/100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥ 1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000). In each frequency group, adverse effects are presented in order of decreasing severity.
- Additional adverse reactions reported after marketing are also listed. These side effects come from spontaneous reports.
Immune system disorders:
- Not known: hypersensitivity reactions, such as angioedema, rash, urticaria
Metabolism and nutrition disorders:
- Not known: hyperkalemia
Nervous system disorders
- Common: dizziness, orthostatic vertigo *
- Not known: dizziness, headache
Affections of the ear and labyrinth:
- Not known: tinnitus
- Uncommon: tachycardia
- Common: orthostatic hypotension *
- Uncommon: Vasomotor flush
Respiratory, thoracic and mediastinal disorders
- Uncommon: cough
- Common: nausea / vomiting
- Uncommon: diarrhea, dyspepsia / heartburn
- Not known: dysgeusia
- Uncommon: jaundice
- Not known: hepatitis, abnormal liver function
Skin and subcutaneous tissue disorders:
- Not known: leukocytoclastic vasculitis
Musculoskeletal and systemic disorders
- Frequent: musculoskeletal pain *
- Not known: arthralgia, myalgia (associated in some cases with increased creatine kinase levels), muscle cramp
Renal and urinary disorders:
- Not known: alteration of renal function, including renal failure in patients at risk (see Warnings and Precautions section )
Disorders of reproductive organs and breast
- Uncommon: Sexual dysfunction
General disorders and administration site conditions
- Frequency: tiredness
- Uncommon: chest pain\
- Very common: hyperkalemia * occurred more often in diabetic patients treated with irbesartan than in those treated with placebo. In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalemia (≥ 5.5 mEq / l) occurred in 29.4% (ie, very frequently) patients in the irbesartan 300 mg group. and in 22% of patients in the placebo group. In diabetic hypertensive patients with chronic renal failure and overt proteinuria, hyperkalemia (≥ 5.5 mEq / l) occurred in 46.3% of patients in the irbesartan group and 26.3% of patients in the placebo group.
- Frequent: Significant increases in plasma creatine kinase have been observed frequently (1.7%) in subjects treated with irbesartan. None of these increases were associated with clinically identifiable musculoskeletal events.
- In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a non-clinically significant decrease in hemoglobin * was observed.
- In a randomized study that included 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse events were reported during the 3-week double-blind phase: headache (7.9%), hypotension (2.2%) , vertigo (1.9%), cough (0.9%).
- In the 26-week open-label period of this study, the most frequently observed laboratory abnormalities were increases in creatinine (6.5%) and increased CK values in 2% of children receiving the product.
aprovel drug interactions
- Diuretics and other antihypertensives : Other antihypertensive agents may increase the hypotensive effects of irbesartan. However, Aprovel has been safely associated with other antihypertensives such as beta-blockers, long-acting calcium antagonists and thiazide diuretics. Previous treatment with high dose diuretics may cause hypovolemia and a risk of hypotension when treatment with Aprovel is started (see Warnings and Precautions ).
- Products containing aliskirenor an IEC: Data from clinical trials have shown that double blockade of the renin-angiotensin-aldosterone system (RAAS) by the concomitant use of angiotensin-converting enzyme inhibitors, antagonists Angiotensin II or aliskiren receptors are associated with a higher incidence of adverse events such as hypotension, hyperkalemia, and impaired renal function (including acute renal failure) compared with the use of a single drug acting on the RAAS (see sections Contraindications , Warnings and Precautions for Use and Pharmacodynamic Properties ).
- Potassium-sparing potassium supplementation or diuretics: Based on experience with other substances in the renin-angiotensin system, co-administration of Aprovel with potassium-sparing diuretics, potassium supplementation, A diet containing potassium or other drugs that can increase serum potassium levels (eg heparin) may cause elevated serum potassium, and therefore is not recommended (see Warnings and Precautions section ).
- Lithium : reversible increases in serum concentrations and lithium toxicity have been reported with angiotensin converting enzyme inhibitors. To date, similar effects have been reported very rarely with irbesartan. Therefore, this association is not recommended (see section Warnings and precautions for use ).If association is needed, strict monitoring of lithemia is recommended.
- Non-steroidal anti-inflammatory drugs : When angiotensin II antagonists are administered concomitantly with nonsteroidal anti-inflammatory drugs (ie, selective cyclooxygenase type 2 (COX-2) inhibitors, acetylsalicylic acid (> 3 g / day) and nonselective nonsteroidal anti-inflammatory drugs, an attenuation of the antihypertensive effect of irbesartan may occur.
- As with angiotensin converting enzyme inhibitors, the concomitant use of angiotensin II antagonists and nonselective nonsteroidal anti-inflammatory drugs may increase the risk of deterioration of renal function, with the possibility of acute renal failure, and an increase in serum potassium especially in patients with previously impaired renal function. The combination should be administered with caution, especially in the elderly. Patients should be properly hydrated and monitoring of renal function should be considered after initiation of the combination, then periodically.
- Other information on irbesartan interactions: In clinical studies, the pharmacokinetics of irbesartan have not been modified by concomitant administration of hydrochlorothiazide. Irbesartan is mainly metabolized by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic and pharmacodynamic interactions were observed when irbesartan was administered concomitantly with warfarin, a drug metabolized by CYP2C9. The effects of CYP2C9 inducers, such as rifampicin, on the pharmacokinetics of irbesartan have not been evaluated. The pharmacokinetics of digoxin were not impaired by simultaneous administration of irbesartan.
Warnings and Precautions
- Hypovolemia: Symptomatic hypotension, particularly after the first dose, may occur in patients with sodium depletion and / or hypovolemia secondary to intensive diuretic therapy, low sodium diet, diarrhea or vomiting. These abnormalities should be corrected prior to administration of Aprovel.
- Renovascular Hypertension : There is an increased risk of severe hypotension and renal failure when patients with bilateral renal artery stenosis or renal arterial stenosis on a single functional kidney receive drugs that act on the renin-renal system. angiotensin-aldosterone. Although this has not been documented with Aprovel, a similar phenomenon is to be expected with angiotensin-II receptor antagonists.
- Renal Impairment and Renal Transplantation : When Aprovel is used in patients with impaired renal function, periodic serum potassium and serum creatinine monitoring is recommended. No experience is available regarding the use of Aprovel in patients with recent kidney transplantation.
- Type 2 diabetic hypertensive patients with renal impairment : In an analysis of a study in patients with advanced renal impairment, the effects of irbesartan on both renal and cardiovascular events were not uniform at all. across all subgroups. In particular, they appeared less favorable in women and in non-white patients (see section 5.1 Pharmacodynamic properties ).
- Hyperkalemia : As with other drugs acting on the renin-angiotensin-aldosterone system, hyperkalaemia may occur during treatment with Aprovel, particularly in the presence of renal insufficiency, proven proteinuria related to renal impairment due to diabetes, and / or heart failure. Close control of serum potassium in these patients at risk is recommended (see section Interactions with other medicinal products and other forms of interaction ).
- Lithium : the combination of lithium and Aprovel is not recommended (see section Interactions with other medicinal products and other forms of interaction ).
- Stenosis of the aortic and mitral valve, obstructive hypertrophic cardiomyopathy : as with other vasodilators, particular caution is indicated in patients with aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy.
- Primary Hyperaldosteronism : Patients with primary hyperaldosteronism do not generally respond to antihypertensive medications acting through inhibition of the renin-angiotensin system. As a result, the use of Aprovel is not recommended.
General : in patients whose vascular tone and renal function are predominantly dependent on renin-angiotensin-aldosterone system activity (eg patients with severe congestive heart failure or underlying renal disease, including stenosis renal arteries), treatment with ACE inhibitors or angiotensin-II receptor antagonists acting on this system has been associated with acute hypotension, azotemia, oliguria or, rarely, renal failure. acute. As with any antihypertensive agents, a sudden drop in blood pressure in patients with ischemic heart disease or
As observed with angiotensin converting enzyme inhibitors, irbesartan and other angiotensin antagonists appear to be less effective in lowering blood pressure in black subjects compared to non-black subjects, probably because of a greater high prevalence of low renin in the black hypertensive population.
- Pregnancy: Angiotensin II Receptor Inhibitors (AIIRAs) should not be started during pregnancy. Unless AIIRA treatment is considered essential, it is recommended that the antihypertensive therapy be modified in patients who are planning pregnancy for a drug with an established safety profile during pregnancy. If pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately and if necessary alternative treatment should be started (see sections Contraindications and Pregnancy and breast-feeding ).
- Lactose : Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency.
- Pediatric population : irbesartan has been studied in pediatric populations of 6 to 16 years of age, but current data are insufficient to support an extension of use in children until additional data are available , Pharmacodynamic properties and Pharmacokinetic properties ).
Drive and use machines
- Effects on the ability to drive and use machines have not been studied. Based on its pharmacodynamic properties, it is unlikely that irbesartan will affect this ability.
- When driving vehicles or using machines, it should be taken into account that vertigo or fatigue may occur during treatment.
PREGNANCY / BREAST FEEDING / FERTILITY:
aprovel for pregnancy
- The use of AIIRAs is not recommended during the 1 st trimester of pregnancy ( see Warnings and Precautions ). The use of AIIRAs is against-indicated to 2 eand 3 e trimesters of pregnancy ( see Contraindications , Warnings and Precautions ).
- Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the 1 st trimester of pregnancy does not suggest. However, a small increase in the risk of congenital malformation can not be ruled out. There are no epidemiological studies available on the use of AIIRAs at 1 st trimester of pregnancy, however a similar risk to IEC could exist for this class. Unless AIIRA treatment is considered essential, it is recommended that antihypertensive therapy be modified in patients who are planning pregnancy for a drug with an established safety profile during pregnancy. If pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately and, if necessary, alternative treatment should be initiated.
- Exposure to AIIRA therapy during the 2 e and 3 e trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of the skull) and toxicity in the newborn ( renal insufficiency, hypotension, hyperkalemia): see Preclinical safety .
- If exposure to angiotensin II receptor antagonists from 2 th trimester of pregnancy, it is recommended to do a fetal ultrasound check of renal function and the bones of the skull.
- Infants born to mothers treated with AIIRAs should be monitored for blood pressure ( see Contraindications , Warnings and Precautions ).
- No information is available regarding the use of Aprovel during breastfeeding, so Aprovel is not recommended.
- It is advisable to use alternative treatments with a better established safety profile during breastfeeding, especially for breastfeeding newborns and premature infants.
- It is not known whether irbesartan and its metabolites are excreted in milk in women.
- Available pharmacodynamic and toxicological data in rats have shown that irbesartan and its metabolites are excreted in milk ( see Preclinical Safety).
- Irbesartan did not show any effects on the fertility of the treated rats and their progeny up to the doses leading to the first signs of parental toxicity ( see Preclinical safety ).
What happens if I overdose from Aprovel ?
- No toxicity has been reported following exposure of adults at doses up to 900 mg / day for 8 weeks. In case of overdose, the most likely clinical signs would be hypotension and tachycardia. Bradycardia may also occur.
- No specific information is available on treatment for overdosage with irbesartan.
- The patient should be under close supervision and symptomatic and supportive treatment should be instituted. Measures such as inducing vomiting and / or gastric lavage are suggested.
- Activated charcoal may be useful in the treatment of overdose. Irbesartan is not hemodialysable.
What is Forms and Composition?
|FORMS and PRESENTATIONS|
75 mg film-coated tablet (biconvex, oval, with a heart on one side, and number 2871 on the other side, white to cream-white): Boxes of 30 and 90, in blister packs of 15. Film-coated tablet 150 mg (biconvex, oval, with a heart on one side, and the number 2872 engraved on the other side, white to cream-white): Boxes of 30 and 90, in blister packs of 15. 300 mg film-coated tablet ( biconvex, oval, with a heart on one side, and the number 2873 engraved on the other side, white to cream-white): Boxes of 30 and 90, under blister packs of 10. Hospital models (all dosages): Boxes of 56 × 1 tablet under blister packs of 8 for single delivery.
|Irbesartan (DCI)||75 mg|
Excipients (common): lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate. Film coating:
- lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 3000, carnauba wax.
- Lactose content monohydrate: 25.50 mg / cw at 75 mg, 51 mg / cw at 150 mg, 102 mg / cw at 300 mg.
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