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LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP - PACKAGE LABELS | Lisinopril and Hydrochlorothiazide

05:46 EDT 27th August 2014 | BioPortfolio
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IMAGE Lisinopril HCTZ - Chemical Structure  - 1.jpgIMAGE Lisinopril HCTZ - Chemical Structure  - 2.jpg

Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an 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 lisinopril does not have a similar risk. (See WARNINGS.) In considering use of lisinopril and hydrochlorothiazide tablets, 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.)

Lisinopril and hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an angiotensinconverting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. 

Percent of Patients in Controlled Studies

Lisinopril-Hydrochlorothiazide (n=930)
Incidence(discontinuation)
Placebo(n=207)
Incidence
Dizziness
7.5(0.8)
1.9
Headache
5.2(0.3)
19
Cough
3.9(0.6)
1.0
Fatigue
3.7(0.4)
1.0
Orthostatic Effects
3.2(0.1)
1.0
Diarrhea
2.5(0.2)
2.4
Nausea
2.2(0.1)
2.4
Upper Respiratory Infection
2.2(0.0)
0.0
Muscle Cramps
2.0(0.4)
0.5
Asthenia
1.8(0.2)
1.0
Paresthesia
1.5(0.1)
0.0
Hypotension
1.4(0.1)
0.5
Vomiting
1.4(0.1)
0.5
Dyspepsia
1.3(0.0)
0.0
Rash
1.2(0.1)
0.5
Impotence
1.2(0.3)
0.0

No specific information is available on the treatment of overdosage with lisinopril and hydrochlorothiazide. Treatment is symptomatic and supportive. Therapy with lisinopril and hydrochlorothiazide should be discontinued and the patient observed closely. Suggested measures include induction of emesis and/ or gastric lavage, and correction of dehydration, electrolyte imbalance and hypotension by established procedures. Lisinopril Following a single oral dose of 20 mg/kg, no lethality occurred in rats and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Lisinopril can be removed by hemodialysis. (See WARNINGS, Anaphylactoid reactions during membrane exposure.) Hydrochlorothiazide Oral administration of a single oral dose of 10 mg/kg to mice and rats was not lethal. The most common signs and symptoms observed 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.

Lisinopril is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 to 80 mg and hydrochlorothiazide doses of 6.25 to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component. The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and doseindependent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but addition of lisinopril 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. Dose Titration Guided by Clinical Effect A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar or greater blood pressure control with less potassium loss if they are switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg. Dosage higher than lisinopril 80 mg and hydrochlorothiazide 50 mg should not be used. Replacement Therapy The combination may be substituted for the titrated individual components. Use in Renal Impairment The usual regimens of therapy with lisinopril and hydrochlorothiazide tablets need not be adjusted as long as the patient’s creatinine clearance is >30 mL/min/1.73 m2 (serum creatinine approximately ≤3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablets are not recommended (see WARNINGS, Anaphylactoid reactions during membrane exposure).

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injuryand even death to the developing fetus. When pregnancy is detected, lisinopril and hydrochlorothiazidetablets should be discontinued as soon as possible. See WARNINGS, Pregnancy, Lisinopril, Fetal/Neonatal Morbidity and Mortality.

LB0010 - Lisinopril HCTZ Tablets USP 10 12.5 mg

LB0011 Lisinopril HCTZ Tablets USP 20 12.5 mg

LB0012 Lisinopril HCTZ Tablets USP 20 25 mg

Manufacturer

International Labs, Inc.

Active Ingredients

Source

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LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP - PACKAGE LABELS

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Clinical Trials [223 Associated Clinical Trials listed on BioPortfolio]

The Vascular Effects of Carvedilol CR Plus Lisinopril Versus Lisinopril Plus Hydrochlorothiazide in Abdominally Obese Hypertensive Patients

The purpose of this study is to compare the effects of two different combination therapies for high blood pressure on vascular health.

Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence betwee...

Antialbuminuric Effects of Valsartan and Lisinopril

Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 wee...

A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of ...

Fasting Study of Hydrochlorothiazide Tablets 50 mg to Hydrochlorothiazide Tablets 50 mg

The objective of this study was to investigate the bioequivalence of Mylan's hydrochlorothiazide 50 mg tablets to Ivax's Hydrochlorothiazide 50 mg tablets following a single, oral 50 mg (1...

PubMed Articles [30 Associated PubMed Articles listed on BioPortfolio]

An innovative validated spectrofluorimetric method for determination of Lisinopril in presence of hydrochlorothiazide; application to content uniformity testing.

A new sensitive and discriminating spectrofluorimetric method has been developed and validated for determination of Lisinopril, one of the angiotensin converting enzyme inhibitors, in its pure bulk fo...

Green micellar HPLC analysis of three angiotensin-converting enzyme inhibitors in their mixtures with hydrochlorothiazide and modeling of their retention behavior by fitting to Foley's model.

We present an environmentally friendly method for the analysis of three angiotensin-converting enzyme inhibitors and hydrochlorothiazide simultaneously using a green micellar eluent for the first time...

The effect of swimming exercise on adenine-induced kidney disease in rats, and the influence of curcumin or lisinopril thereon.

Patients with chronic kidney disease (CKD) have been reported to benefit from different types of exercises. It has also been shown that the ACE inhibitor lisinopril, and the natural product curcumin a...

Multicriteria Optimization Methodology in Stability-Indicating Method Development of Cilazapril and Hydrochlorothiazide.

Multicriteria optimization methodology was applied in development of UHPLC-UV-MS method for separation of cilazapril, hydrochlorothiazide and their degradation products. This method is also applicable...

Ablation of the Cl-/HCO3- Exchanger Pendrin Enhances Hydrochlorothiazide-Induced Diuresis.

The Cl-/HCO3- exchanger pendrin and the thiazide-sensitive Na-Cl cotransporter NCC are expressed in the kidney distal nephron and mediate salt absorption. We hypothesized that deletion of pendrin leav...

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