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LISINOPRIL AND HYDROCHLOROTHIAZIDE

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Overview

What is LISINOPRIL AND HYDROCHLOROTHIAZIDE?

Lisinopril and hydrochlorothiazide tablets combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide.

Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as ()-1-[ -(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is CHNO•2HO and its structural formula is:

Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is CHClNOS and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

Lisinopril and hydrochlorothiazide tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide.

Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch. Lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg also contain red iron oxide.



What does LISINOPRIL AND HYDROCHLOROTHIAZIDE look like?



What are the available doses of LISINOPRIL AND HYDROCHLOROTHIAZIDE?

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What should I talk to my health care provider before I take LISINOPRIL AND HYDROCHLOROTHIAZIDE?

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How should I use LISINOPRIL AND HYDROCHLOROTHIAZIDE?

Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension.

These fixed-dose combinations are not indicated for initial therapy (see ).

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 .)

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 .)

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 ) of lisinopril 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 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.


What interacts with LISINOPRIL AND HYDROCHLOROTHIAZIDE?

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 angiotensin converting 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.



What are the warnings of LISINOPRIL AND HYDROCHLOROTHIAZIDE?

General

Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

Lithium generally should not be given with thiazides (see , and ).

Pregnancy

Teratogenicity studies were conducted in mice and rats with up to 90 mg/kg/day of lisinopril in combination with 10 mg/kg/day of hydrochlorothiazide. This dose of lisinopril is 5 times (in mice) and 10 times (in rats) the maximum recommended human daily dose (MRHDD) when compared on a body surface area basis (mg/m); the dose of hydrochlorothiazide is 0.9 times (in mice) and 1.8 times (in rats) the MRHDD. Maternal or fetotoxic effects were not seen in mice with the combination. In rats decreased maternal weight gain and decreased fetal weight occurred down to 3/10 mg/kg/day (the lowest dose tested). Associated with the decreased fetal weight was a delay in fetal ossification. The decreased fetal weight and delay in fetal ossification were not seen in saline-supplemented animals given 90/10 mg/kg/day.

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, lisinopril and hydrochlorothiazide should be discontinued as soon as possible. (See , below.)

Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg/kg/day, respectively, provided no evidence of harm to the fetus. These doses are more than 150 times the MRHDD on a body surface area basis. Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia and possibly other adverse reactions that have occurred in adults.


What are the precautions of LISINOPRIL AND HYDROCHLOROTHIAZIDE?

General

Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may cause cardiac arrhythmia and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability). Because lisinopril reduces the production of aldosterone, concomitant therapy with lisinopril attenuates the diuretic-induced potassium loss (see ).

Although any chloride deficit is generally mild and usually does not require specific treatment, except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis.

Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required.

Hyperglycemia may occur with thiazide diuretics. Thus latent diabetes mellitus may become manifest during thiazide therapy.

The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient.

If progressive renal impairment becomes evident consider withholding or discontinuing diuretic therapy. Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Thiazides may decrease urinary calcium excretion. Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.

Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.

Information for Patients

Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril. Patients should be so advised and told to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.

Patients should be cautioned to report lightheadedness especially during the first few days of therapy. If actual syncope occurs, the patients should be told to discontinue the drug until they have consulted with the prescribing physician.

All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; patients should be advised to consult with their physician.

Patients should be told not to use salt substitutes containing potassium without consulting their physician.

Patients should be told to report promptly any indication of infection (e.g., sore throat, fever) which may be a sign of neutropenia.

Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors during pregnancy. These patients should be asked to report pregnancies to their physicians as soon as possible.

NOTE: As with many other drugs, certain advice to patients being treated with lisinopril and hydrochlorothiazide is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Drug Interactions

When administered concurrently the following drugs may interact with thiazide diuretics.

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Carcinogenesis, Mutagenesis, Impairment of Fertility

Lisinopril in combination with hydrochlorothiazide was not mutagenic in a microbial mutagen test using (Ames test) or with or without metabolic activation or in a forward mutation assay using Chinese hamster lung cells.

Lisinopril-hydrochlorothiazide did not produce DNA single strand breaks in an alkaline elution rat hepatocyte assay. In addition, it did not produce increases in chromosomal aberrations in an test in Chinese hamster ovary cells or in an study in mouse bone marrow.

There was no evidence of a tumorigenic effect when lisinopril was administered orally for 105 weeks to male and female rats at doses up to 90 mg/kg/day or for 92 weeks to male and female mice at doses up to 135 mg/kg/day. These doses are 10 times and 7 times, respectively, the maximum recommended human daily dose (MRHDD) when compared on a body surface area basis.

Lisinopril was not mutagenic in the Ames microbial mutagen test with or without metabolic activation. It was also negative in a forward mutation assay using Chinese hamster lung cells. Lisinopril did not produce single strand DNA breaks in an alkaline elution rat hepatocyte assay. In addition, lisinopril did not produce increases in chromosomal aberrations in an test in Chinese hamster ovary cells or in an study in mouse bone marrow.

There were no adverse effects on reproductive performance in male and female rats treated with up to 300 mg/kg/day of lisinopril (33 times the MRHDD when compared on a body surface area basis).

Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice at doses of up to approximately 600 mg/kg/day (53 times the MRHDD when compared on a body surface area basis) or in male and female rats at doses of up to approximately 100 mg/kg/day (18 times the MRHDD when compared on a body surface area basis). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.

Hydrochlorothiazide was not genotoxic in the Ames mutagenicity assay of strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the sex-linked recessive lethal trait gene. Positive test results were obtained only in the CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 µg/mL, and in the non-disjunction assay at an unspecified concentration.

Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation. In mice and rats these doses are 9 times and 0.7 times, respectively, the MRHDD when compared on a body surface area basis.

Pregnancy

Pregnancy Categories C

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Nursing Mothers

It is not known whether lisinopril is secreted in human milk. However, milk of lactating rats contains radioactivity following administration of C lisinopril. In another study, lisinopril was present in rat milk at levels similar to plasma levels in the dams. Thiazides do appear in human milk. Because of the potential for serious reactions in nursing infants from ACE inhibitors and hydrochlorothiazide, a decision should be made whether to discontinue nursing or to discontinue lisinopril and hydrochlorothiazide, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of lisinopril and hydrochlorothiazide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In a multiple-dose pharmacokinetic study in elderly versus young hypertensive patients using the lisinopril/hydrochlorothiazide combination, area under the plasma concentration time curve (AUC) increased approximately 120% for lisinopril and approximately 80% for hydrochlorothiazide in older patients.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Evaluation of the hypertensive patient should always include assessment of renal function. (See .)


What are the side effects of LISINOPRIL AND HYDROCHLOROTHIAZIDE?

Lisinopril and hydrochlorothiazide has been evaluated for safety in 930 patients, including 100 patients treated for 50 weeks or more.

In clinical trials with lisinopril and hydrochlorothiazide no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide.

The most frequent clinical adverse experiences in controlled trials (including open label extensions) with any combination of lisinopril and hydrochlorothiazide were: dizziness (7.5 percent), headache (5.2 percent), cough (3.9 percent), fatigue (3.7 percent) and orthostatic effects (3.2 percent), all of which were more common than in placebo-treated patients. Generally, adverse experiences were mild and transient in nature; but see regarding angioedema and excessive hypotension or syncope. Discontinuation of therapy due to adverse effects was required in 4.4 percent of patients, principally because of dizziness, cough, fatigue and muscle cramps.

Adverse experiences occurring in greater than one percent of patients treated with lisinopril plus hydrochlorothiazide in controlled clinical trials are shown below.

Clinical adverse experiences occurring in 0.3 to 1.0 percent of patients in controlled trials included: Chest pain, abdominal pain, syncope, chest discomfort, fever, trauma, virus infection. Palpitation, orthostatic hypotension. Gastrointestinal cramps, dry mouth, constipation, heartburn. Back pain, shoulder pain, knee pain, back strain, myalgia, foot pain. Decreased libido, vertigo, depression, somnolence. Common cold, nasal congestion, influenza, bronchitis, pharyngeal pain, dyspnea, pulmonary congestion, chronic sinusitis, allergic rhinitis, pharyngeal discomfort. Flushing, pruritus, skin inflammation, diaphoresis. Blurred vision, tinnitus, otalgia. Urinary tract infection.

Angioedema:

Hypotension:

Cough:

Clinical Laboratory Test Findings

Hemoglobin and Hematocrit:

Other adverse reactions that have been reported with the individual components are listed below:

Lisinopril

Body as a Whole:

Cardiovascular:

Digestive:

Hematologic:

Metabolic:

Musculoskeletal:

Nervous System/Psychiatric:

Respiratory:

Skin:

Special Senses:

Urogenital:

Miscellaneous:

Hydrochlorothiazide

Body as a Whole:

Digestive:

Hematologic:

Musculoskeletal:

Nervous System/Psychiatric:

Renal:

Skin:

Special Senses:

Hypersensitivity:

Percent of Patients in Controlled Studies
Lisinopril-Hydrochlorothiazide (n=930) Incidence (discontinuation)Placebo(n=207)Incidence
Dizziness7.5 (0.8)1.9
Headache5.2 (0.3)19
Cough3.9 (0.6)1.0
Fatigue3.7 (0.4)1.0
Orthostatic Effects3.2 (0.1)1.0
Diarrhea2.5 (0.2)2.4
Nausea2.2 (0.1)2.4
Upper Respiratory Infection2.2 (0.0)0.0
Muscle Cramps2.0 (0.4)0.5
Asthenia1.8 (0.2)1.0
Paresthesia1.5 (0.1)0.0
Hypotension1.4 (0.3)0.5
Vomiting1.4 (0.1)0.5
Dyspepsia1.3 (0.0)0.0
Rash1.2 (0.1)0.5
Impotence1.2 (0.3)0.0



What should I look out for while using LISINOPRIL AND HYDROCHLOROTHIAZIDE?

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 angiotensin converting 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.


What might happen if I take too much LISINOPRIL AND HYDROCHLOROTHIAZIDE?

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.


How should I store and handle LISINOPRIL AND HYDROCHLOROTHIAZIDE?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.They are supplied as follows:NDC 68180-518-01 – 100’s bottleNDC 68180-518-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.They are supplied as follows:NDC 68180-519-01 – 100’s bottleNDC 68180-519-02 – 500’s bottleLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.They are supplied as follows:NDC 68180-520-01 – 100’s bottleNDC 68180-520-02 – 500’s bottleStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.Manufactured for: Baltimore, Maryland 21202United StatesManufactured by: Goa 403 722INDIARevised: May 2010ID#: 222016


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Clinical Information

Chemical Structure

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Clinical Pharmacology

As a result of its diuretic effects, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, and decreases serum potassium. Administration of lisinopril 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 lisinopril and hydrochlorothiazide was approximately additive. The lisinopril and hydrochlorothiazide 10 mg/12.5 mg combination worked equally well in Black and Caucasian patients. The lisinopril and hydrochlorothiazide 20 mg/12.5 mg and lisinopril and hydrochlorothiazide 20 mg/25 mg combinations appeared somewhat less effective in Black patients, but relatively few Black patients were studied. In most patients, the antihypertensive effect of lisinopril and hydrochlorothiazide was sustained for at least 24 hours.

In a randomized, controlled comparison, the mean antihypertensive effects of lisinopril and hydrochlorothiazide 20 mg/12.5 mg and lisinopril and hydrochlorothiazide 20 mg/25 mg were similar, suggesting that many patients who respond adequately to the latter combination may be controlled with lisinopril and hydrochlorothiazide 20-12.5. (See .)

Concomitant administration of lisinopril 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.

Non-Clinical Toxicology
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 angiotensin converting 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.

Lisinopril and hydrochlorothiazide has been evaluated for safety in 930 patients, including 100 patients treated for 50 weeks or more.

In clinical trials with lisinopril and hydrochlorothiazide no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide.

The most frequent clinical adverse experiences in controlled trials (including open label extensions) with any combination of lisinopril and hydrochlorothiazide were: dizziness (7.5 percent), headache (5.2 percent), cough (3.9 percent), fatigue (3.7 percent) and orthostatic effects (3.2 percent), all of which were more common than in placebo-treated patients. Generally, adverse experiences were mild and transient in nature; but see regarding angioedema and excessive hypotension or syncope. Discontinuation of therapy due to adverse effects was required in 4.4 percent of patients, principally because of dizziness, cough, fatigue and muscle cramps.

Adverse experiences occurring in greater than one percent of patients treated with lisinopril plus hydrochlorothiazide in controlled clinical trials are shown below.

Clinical adverse experiences occurring in 0.3 to 1.0 percent of patients in controlled trials included: Chest pain, abdominal pain, syncope, chest discomfort, fever, trauma, virus infection. Palpitation, orthostatic hypotension. Gastrointestinal cramps, dry mouth, constipation, heartburn. Back pain, shoulder pain, knee pain, back strain, myalgia, foot pain. Decreased libido, vertigo, depression, somnolence. Common cold, nasal congestion, influenza, bronchitis, pharyngeal pain, dyspnea, pulmonary congestion, chronic sinusitis, allergic rhinitis, pharyngeal discomfort. Flushing, pruritus, skin inflammation, diaphoresis. Blurred vision, tinnitus, otalgia. Urinary tract infection.

Angioedema:

Hypotension:

Cough:

Clinical Laboratory Test Findings

Hemoglobin and Hematocrit:

Other adverse reactions that have been reported with the individual components are listed below:

Lisinopril

Body as a Whole:

Cardiovascular:

Digestive:

Hematologic:

Metabolic:

Musculoskeletal:

Nervous System/Psychiatric:

Respiratory:

Skin:

Special Senses:

Urogenital:

Miscellaneous:

Hydrochlorothiazide

Body as a Whole:

Digestive:

Hematologic:

Musculoskeletal:

Nervous System/Psychiatric:

Renal:

Skin:

Special Senses:

Hypersensitivity:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).