Quinapril And Hydrochlorothiazide Tablets, Usp

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue quinapril 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. See Warnings: Fetal Toxicity

Quinapril and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to quinapril or hydrochlorothiazide and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.

Quinapril and hydrochlorothiazide tablets is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Quinapril and hydrochlorothiazide tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS).

Because of the hydrochlorothiazide components, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Do not co-administer quinapril and hydrochlorothiazide with aliskiren:

• in patients with diabetes.

Quinapril and hydrochlorothiazide tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide.

Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C₂₅H₃₀N₂O₅. HCl and its structural formula is:

Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents.

Hydrochlorothiazide, USP is chemically described as: 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C₇H₈CIN₃O₄S₂ and its structural formula is:

Hydrochlorothiazide, USP is a white to off-white, crystalline powder which is slightly soluble in water but freely soluble in sodium hydroxide solution.

Quinapril and hydrochlorothiazide tablets, USP are available for oral use as fixed combination tablets in three strengths of quinapril with hydrochlorothiazide: 10 mg with 12.5 mg (quinapril and hydrochlorothiazide 10/12.5), 20 mg with 12.5 mg (quinapril and hydrochlorothiazide 20/12.5), and 20 mg with 25 mg (quinapril and hydrochlorothiazide 20/25). Inactive ingredients: lactose, magnesium carbonate, crospovidone, povidone, magnesium stearate and opadry pink 03B14436 (hypromellose, titanium dioxide, polyethylene glycol and iron oxide red).

NDC 69097-828-05                  R_x Only

Quinapril and

Hydrochlorothiazide

Tablets, USP

10 mg/12.5 mg*

90 Tablets

Cipla

NDC 69097-829-05              R_x Only

Quinapril and

Hydrochlorothiazide

Tablets, USP

20 mg/12.5 mg*

90 Tablets

Cipla

NDC 69097-831-05              R_x Only

Quinapril and

Hydrochlorothiazide

Tablets, USP

20 mg/25 mg*

90 Tablets

Cipla

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue quinapril 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. See Warnings: Fetal Toxicity

Quinapril and hydrochlorothiazide tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide.

Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C₂₅H₃₀N₂O₅. HCl and its structural formula is:

Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents.

Hydrochlorothiazide, USP is chemically described as: 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C₇H₈CIN₃O₄S₂ and its structural formula is:

Hydrochlorothiazide, USP is a white to off-white, crystalline powder which is slightly soluble in water but freely soluble in sodium hydroxide solution.

Quinapril and hydrochlorothiazide tablets, USP are available for oral use as fixed combination tablets in three strengths of quinapril with hydrochlorothiazide: 10 mg with 12.5 mg (quinapril and hydrochlorothiazide 10/12.5), 20 mg with 12.5 mg (quinapril and hydrochlorothiazide 20/12.5), and 20 mg with 25 mg (quinapril and hydrochlorothiazide 20/25). Inactive ingredients: lactose, magnesium carbonate, crospovidone, povidone, magnesium stearate and opadry pink 03B14436 (hypromellose, titanium dioxide, polyethylene glycol and iron oxide red).

Quinapril and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to quinapril or hydrochlorothiazide and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.

Quinapril and hydrochlorothiazide tablets is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Quinapril and hydrochlorothiazide tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS).

Because of the hydrochlorothiazide components, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Do not co-administer quinapril and hydrochlorothiazide with aliskiren:

• in patients with diabetes.

NDC 69097-828-05                  R_x Only

Quinapril and

Hydrochlorothiazide

Tablets, USP

10 mg/12.5 mg*

90 Tablets

Cipla

NDC 69097-829-05              R_x Only

Quinapril and

Hydrochlorothiazide

Tablets, USP

20 mg/12.5 mg*

90 Tablets

Cipla

NDC 69097-831-05              R_x Only

Quinapril and

Hydrochlorothiazide

Tablets, USP

20 mg/25 mg*

90 Tablets

Cipla