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Rx Item-Enalapril-HCTZ 5Mg 12.5Mg Tab 100 By Mylan Pharma

NDC 00378-0712-01 UPC/GTIN No.3-03780-71201-2 Mfg.Part No.71201BRAND: ENALAPRIL-HCTZ NDC: 00378-0712-01,378071201 UPC: 3-03780-71201-2,303780712012 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Enalapril-HCTZ 5Mg 12.5Mg Tab 100 By Mylan Pharma

$107.10$122.40

Item No.:RX118690 NDC No.378071201 UPC No.:303780712012 NDC No. 00378-0712-01 UPC/GTIN No. 3-03780-71201-2 MPN 71201 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx118690 Enalapril-HCTZ 5mg/12.5mg Tab 100 by Mylan Pharma Item No. 3118690 NDC No. 00378071201 UPC No. 303780712012 Other Name Vasere

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VASERETIC- enalapril maleate and hydrochlorothiazide tablet
Valeant Pharmaceuticals North America LLC
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.


When pregnancy is detected, discontinue Vaseretic� as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
DESCRIPTION



VASERETIC� (Enalapril Maleate-Hydrochlorothiazide) combines an angiotensin converting enzyme inhibitor, enalapril maleate, and a diuretic, hydrochlorothiazide.

Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N -[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20 H28 N2 O5 �C4 H4 O4
Enalapril maleate is a white to off-white crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.

Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7 H8 ClN3 O4 S2
VASERETIC is available in the tablet combination of enalapril maleate with hydrochlorothiazide: VASERETIC 10-25, containing 10 mg enalapril maleate and 25 mg hydrochlorothiazide. Inactive ingredients are: iron oxide, lactose, magnesium stearate, sodium bicarbonate, and starch.

CLINICAL PHARMACOLOGY

As a result of its diuretic effects, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, and decreases serum potassium. Administration of enalapril maleate blocks the renin-angiotensin-aldosterone axis and tends to reverse the potassium loss associated with the diuretic.

In clinical studies, the extent of blood pressure reduction seen with the combination of enalapril maleate and hydrochlorothiazide was approximately additive. The antihypertensive effect of VASERETIC was usually sustained for at least 24 hours.
Concomitant administration of enalapril maleate and hydrochlorothiazide has little, or no effect on the bioavailability of either drug. The combination tablet is bioequivalent to concomitant administration of the separate entities.

Enalapril Maleate

Mechanism of Action: Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. Although the latter decrease is small, it results in small increases of serum potassium. In hypertensive patients treated with enalapril maleate alone for up to 48 weeks, mean increases in serum potassium of approximately 0.2 mEq/L were observed. In patients treated with enalapril maleate plus a thiazide diuretic, there was essentially no change in serum potassium
INDICATIONS AND USAGE

VASERETIC is indicated for the treatment of hypertension.

This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION).

In using VASERETIC, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril does not have a similar risk (see WARNINGS).

In considering use of VASERETIC, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema).
DOSAGE AND ADMINISTRATION

Enalapril and hydrochlorothiazide are effective treatments for hypertension. The usual dosage range of enalapril is 10 to 40 mg per day administered in a single or two divided doses; hydrochlorothiazide is effective in doses of 12.5 to 50 mg daily. The side effects (see WARNINGS) of enalapril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of enalapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects but the addition of enalapril in clinical trials blunted the hypokalemia normally seen with diuretics. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

NDC 00378-0712-01 UPC/GTIN No.3-03780-71201-2 Mfg.Part No.71201
RX ITEM-Enalapril-HCTZ 5Mg 12.5Mg Tab 10
NDC 00378-0712-01 UPC/GTIN No.3-03780-71201-2 Mfg.Part No.71201

BRAND: ENALAPRIL-HCTZ NDC: 00378-0712-01,378071201 UPC: 3-03780-71201-2,303780712012
Enalapril-HCTZ 5Mg 12.5Mg Tab 100 By Myl
BRAND: ENALAPRIL-HCTZ NDC: 00378-0712-01,378071201 UPC: 3-03780-71201-2,303780712012

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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