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Irbesartan And Hydrochlorothiazide (Irbesartan And Hydrochlorothiazide)

Trade Name : Irbesartan and Hydrochlorothiazide

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 30012.5 mg/1mg/1

IRBESARTAN; HYDROCHLOROTHIAZIDE Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Irbesartan And Hydrochlorothiazide (Irbesartan And Hydrochlorothiazide) which is also known as Irbesartan and Hydrochlorothiazide and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 300; 12.5 mg/1; mg/1 per ml. Read more

Irbesartan And Hydrochlorothiazide (Irbesartan And Hydrochlorothiazide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warning
  • When pregnancy is detected, discontinue irbesartan and hydrochlorothiazide tablets as soon as possible. ()
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()
  • No data
  • Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
  • Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy.
  • Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
  • The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
  • Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
  • Data from Studies V and VI [] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP < 140 or < 130 mmHg or SeDBP < 90 or < 80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.
  • Figure 1a: Probability of Achieving SBP < 140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)n
  • Figure 1b: Probability of Achieving SBP < 130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)n
  • Figure 2a: Probability of Achieving DBP < 90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)n
  • Figure 2b: Probability of Achieving DBP < 80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)n
  • The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure u2264 140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.
  • For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of < 140 mmHg (systolic) and 50% likelihood of achieving < 90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).
  • The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).
  • Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension:
  • In patients not adequately controlled with monotherapy. ()
  • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. ()
  • General Considerations
  • Hypertension
  • Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg are light pink to pink film-coated, capsule-shaped, unscored tablets, debossed with u201cTEVAu201d on one side of the tablet and u201c7238u201d on the other side.
  • Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg are light pink to pink film-coated, capsule-shaped, unscored tablets, debossed with u201cTEVAu201d on one side of the tablet and u201c7239u201d on the other side.
  • 150 mg irbesartan/12.5 mg hydrochlorothiazide tablets ()
  • 300 mg irbesartan/12.5 mg hydrochlorothiazide tablets ()
  • No data
  • Hypersensitivity to any component of this product ()
  • Anuria ()
  • Hypersensitivity to sulfonamide-derived drugs ()
  • Do not coadminister aliskiren with irbesartan and hydrochlorothiazide tablets in patients with diabetes. ()
  • No data
  • Hypotension: Correct volume-depletion prior to administration. ()
  • Impaired renal function. ()
  • Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus. ()
  • Secondary acute angle-closure glaucoma and/or acute myopia. ()
  • Most common adverse events (u2265 5% on irbesartan and hydrochlorothiazide tablets and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • NSAIDs and selective COX-2 inhibitors: Can reduce diuretic, natriuretic of diuretic, may lead to increased risk of renal impairment and reduced antihypertensive effect. Monitor renal function periodically. ()
  • Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ()
  • Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. ()
  • Cholestyramine and colestipol: Reduced absorption of thiazides. ()
  • Lithium: Increases in serum lithium concentrations and lithium toxicity. ()
  • Carbamazepine: Increased risk of hyponatremia. ()
  • No data
  • Nursing Mothers: Potential for adverse effects in infant. (8.3)
  • Irbesartan
  • No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.
  • To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.
  • Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.
  • Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25-fold and 50-fold the MRHD (300 mg) on a mg/m basis, respectively.
  • Hydrochlorothiazide
  • The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
  • Irbesartan and Hydrochlorothiazide Tablets USP are a combination of an angiotensin II receptor antagonist (AT subtype), irbesartan, USP and a thiazide diuretic, hydrochlorothiazide (HCTZ), USP.
  • Irbesartan, USP is a non-peptide compound, chemically described as a 2-Butyl-3-[-(-1-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its structural formula is:
  • CHNO M.W. 428.5
  • Irbesartan, USP is a white to off-white crystalline powder. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan, USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water.
  • Hydrochlorothiazide, USP is 6-Chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its structural formula is:
  • CHClNOS M.W. 297.7
  • Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. Hydrochlorothiazide, USP is very slightly soluble in water and freely soluble in sodium hydroxide solution.
  • Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan, USP combined with 12.5 mg of hydrochlorothiazide, USP. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, povidone, pregelatinized corn starch and titanium dioxide.
  • No data
  • No data
  • No data
  • No data
  • Pregnancy
  • Tell female patients of childbearing age about the consequences of exposure to irbesartan and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physician as soon as possible.
  • Symptomatic Hypotension
  • Tell patients using irbesartan and hydrochlorothiazide tablets that they may feel lightheaded, especially during the first days of use. Tell patients to inform their physician if they feel lightheaded or faint. Tell the patient, if fainting occurs, stop using irbesartan and hydrochlorothiazide tablets and contact the prescribing doctor.
  • Tell patients using irbesartan and hydrochlorothiazide tablets that getting dehydrated can lower their blood pressure too much and lead to lightheadedness and possible fainting. Dehydration may occur with excessive sweating, diarrhea, or vomiting and with not drinking enough liquids.
  • Potassium Supplements
  • Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [].
  • Acute Myopia and Secondary Angle-Closure Glaucoma
  • Advise patients to discontinue irbesartan and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of Acute Myopia or Secondary Angle-Closure Glaucoma [].
  • Manufactured In Croatia By:n Zagreb, Croatia
  • Manufactured For:n North Wales, PA 19454
  • Rev. M 8/2018
  • No data
  • No data

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