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Eprosartan Generic Teveten Hct 600-25 Mg Tabs 30 By Mylan Pharma

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Eprosartan Generic Teveten Hct 600-25 Mg Tabs 30 By Mylan Pharma

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Eprosartan Generic Teveten Hct 600-25 Mg Tabs 30 By Mylan Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4549309/RXB10102081/RXA320224
Size : 30
Selling UoM : EA
NDC: 00378-6629-93
UPC Barcode : 303786629930
Supplier: 0050000337 MYLAN PHARM
Supplier Material : 662993
Generic Code : 043063 EPROSARTAN MESYLATE ORAL TABLET 600 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GR

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Product Description.:

M EN3
tablet , film-coated , white , oblong oblong
Black inkWhite to off-white

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, TEVETEN? should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

DESCRIPTION
TEVETEN? (eprosartan mesylate) is a non-biphenyl non-tetrazole angiotensin II receptor (AT1) antagonist. A selective non-peptide molecule, TEVETEN? is chemically described as the monomethanesulfonate of (E)-2-butyl-1-(p-carboxybenzyl)-α-2-thienylmethylimidazole-5-acrylic acid.

Eprosartan mesylate is a white to off-white free-flowing crystalline powder that is insoluble in water, freely soluble in ethanol, and melts between 248?C and 250?C.

TEVETEN? is available as aqueous film-coated tablets containing eprosartan mesylate equivalent to 400 mg or 600 mg eprosartan zwitterion (pink, oval, non-scored tablets or white, non-scored, capsule-shaped tablets, respectively).
Inactive Ingredients

The 400 mg tablet contains the following: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, and titanium dioxide. The 600 mg tablet contains crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, and titanium dioxide.

INDICATIONS

TEVETEN? is indicated for the treatment of hypertension. It may be used alone or in combination with other anti hypertensives such as diuretics and calcium channel blockers.

SIDE EFFECTS

TEVETEN? (eprosartan mesylate) has been evaluated for safety in more than 3,300 healthy volunteers and patients worldwide, including more than 1,460 patients treated for more than 6 months, and more than 980 patients treated for 1 year or longer. TEVETEN? was well tolerated at doses up to 1200 mg daily. Most adverse events were of mild or moderate severity and did not require discontinuation of therapy. The overall incidence of adverse experiences and the incidences of specific adverse events reported with eprosartan were similar to placebo.

Adverse experiences were similar in patients regardless of age, gender, or race. Adverse experiences were not dose-related. In placebo-controlled clinical trials, about 4% of 1,202 patients treated with TEVETEN? discontinued therapy due to clinical adverse experiences, compared to 6.5% of 352 patients given placebo.
Adverse Events Occurring at an Incidence of 1% or More Among Eprosartan-treated Patients

The following table lists adverse events that occurred at an incidence of 1% or more among eprosartan-treated patients who participated in placebo-controlled trials of 8 to 13 weeks' duration, using doses of 25 mg to 400 mg twice daily, and 400 mg to 1200 mg once daily. The overall incidence of adverse events reported with TEVETEN? (54.4%) was similar to placebo (52.8%).

WARNINGS
Fetal/Neonatal Morbidity and Mortality

Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature in patients who were taking angiotensin-converting enzyme inhibitors. When pregnancy is detected, TEVETEN? should be discontinued as soon as possible.

The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypo plastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug.

These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should advise the patient to discontinue the use of eprosartan as soon as possible.

Rarely (probably less often than once in every thousand pregnancies), no alternative to a drug acting on the renin-angiotensin system will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and seri