Benazepril and hydrochlorothiazide

Name: Benazepril and hydrochlorothiazide

Benazepril and Hydrochlorothiazide Overview

Benazepril and hydrochlorothiazide is a prescription medication used to treat high blood pressure.

This medication is a single product containing 2 medications: benazepril and hydrochlorothiazide. Benazepril belongs to a group of drugs called angiotensin-converting enzyme (ACE) inhibitors. Benazepril works by blocking the ACE enzyme, which helps blood vessels to relax and lowers blood pressure. Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics, which work by stopping reabsorption of salt into your body. This prevents fluid from building up in the body.

This medication comes in tablet form. It is taken once daily, with or without food.

Common side effects include dizziness, tiredness (fatigue), and headache. Do not drive or operate heavy machinery until you know how benazepril and hydrochlorothiazide affects you. 

Benazepril and Hydrochlorothiazide Drug Class

Benazepril and Hydrochlorothiazide is part of the drug class:

  • ACE inhibitors and diuretics

Side Effects of Benazepril and Hydrochlorothiazide

Serious side effects have been reported with benazepril and hydrochlorothiazide. See the "Benazepril and hydrochlorothiazide Precautions" section. 

Common side effects of benazepril and hydrochlorothiazide include the following:

  • dizziness
  • tiredness (fatigue)
  • headache
  • cough
  • an abnormal increase in muscle tension and a reduced ability of a muscle to stretch (hypertonia)
  • feeling like your surroundings are spinning or moving (vertigo)
  • nausea
  • difficulty in getting or maintaing an erection (impotence)
  • sleepiness (somnolence)

This is not a complete list of benazepril and hydrochlorothiazide side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

Benazepril and Hydrochlorothiazide Overdose

If you take too much benazepril and hydrochlorothiazide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

Other Requirements

  • Do not store above 30ºC (86ºF). 
  • Protect from moisture and light. 
  • Dispense in tight, light-resistant container.
  • Keep this and all medicines out of the reach of children. 

What are some things I need to know or do while I take Benazepril and Hydrochlorothiazide?

  • Tell all of your health care providers that you take benazepril and hydrochlorothiazide. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take benazepril and hydrochlorothiazide.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
  • If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
  • Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • If you take cholestyramine or colestipol, talk with your pharmacist about how to take them with benazepril and hydrochlorothiazide.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Watch for gout attacks.
  • If you have lupus, this medicine can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
  • Low white blood cell counts have happened with captopril, a drug like this one. This may lead to more chance of getting an infection. Most of the time, this has happened in people with kidney problems, mainly if they have certain other health problems. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • A very bad reaction called angioedema has happened with benazepril and hydrochlorothiazide. Sometimes, this has been deadly. The chance of angioedema may be higher in black patients. Talk with the doctor.
  • If you are 65 or older, use this medicine with care. You could have more side effects.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Cough that does not go away.
  • Belly pain.
  • This medicine can cause certain eye problems. If left untreated, this can lead to lasting eyesight loss. If eye problems happen, signs like change in eyesight or eye pain most often happen within hours to weeks of starting this medicine. Call your doctor right away if you have these signs.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Benazepril and Hydrochlorothiazide - Clinical Pharmacology

Mechanism of Action

Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and in 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. The latter decrease may result in a small increase of serum potassium. Hypertensive patients treated with benazepril alone for up to 52 weeks had elevations of serum potassium of up to 0.2 mEq/L. Similar patients treated with Benazepril and Hydrochlorothiazide for up to 24 weeks had no consistent changes in their serum potassium (see PRECAUTIONS).

Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. In animal studies, benazepril had no inhibitory effect on the vasopressor response to angiotensin II and did not interfere with the hemodynamic effects of the autonomic neurotransmitters acetylcholine, epinephrine, and norepinephrine.

ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of benazepril hydrochloride and hydrochlorothiazide tablets remain to be elucidated.

While the mechanism through which benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, benazepril has an antihypertensive effect even in patients with low-renin hypertension.

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin, so coadministration of an ACE inhibitor tends to reverse the potassium loss associated with these diuretics.

The mechanism of the antihypertensive effect of thiazides is unknown.

Pharmacokinetics and Metabolism

Following oral administration of benazepril hydrochloride and hydrochlorothiazide tablets, peak plasma concentrations of benazepril are reached within 0.5 to 1.0 hour. As determined by urinary recovery, the extent of absorption is at least 37%. In fasting subjects, the rate and extent of absorption of Benazepril and Hydrochlorothiazide from benazepril hydrochloride and hydrochlorothiazide tablets are not different, respectively, from the rate and extent of absorption of Benazepril and Hydrochlorothiazide from immediate-release monotherapy formulations.

The estimated absolute bioavailability of hydrochlorothiazide after oral administration is about 70%. Peak plasma hydrochlorothiazide concentrations (Cmax) are reached within 2 to 5 hours after oral administration. Hydrochlorothiazide binds to albumin (40% - 70%) and distributes into erythrocytes.

The absorption of benazepril from benazepril hydrochloride tablets is not influenced by the presence of food in the gastrointestinal tract. There is no clinically significant effect of food on the bioavailability of hydrochlorothiazide.

Cleavage of the ester group (primarily in the liver) converts benazepril to its active metabolite, benazeprilat. Peak plasma concentrations of benazeprilat are reached 1 to 2 hours after drug intake in the fasting state and 2 to 4 hours after drug intake in the nonfasting state. The serum protein binding of benazepril is about 96.7% and that of benazeprilat about 95.3%, as measured by equilibrium dialysis; on the basis of in vitro studies, the degree of protein binding should be unaffected by age, hepatic dysfunction, or – over the concentration range of 0.24 - 23.6 µmol/L – concentration.

In studies of rats given 14C-benazepril, benazepril and its metabolites crossed the blood-brain barrier only to an extremely low extent. Multiple doses of benazepril did not result in accumulation in any tissue except the lung, where, as with other ACE inhibitors in similar studies, there was a slight increase in concentration due to slow elimination in that organ.

Benazepril is almost completely metabolized to benazeprilat, which has much greater ACE inhibitory activity than benazepril, and to the glucuronide conjugates of benazepril and benazeprilat. Only trace amounts of an administered dose of benazepril can be recovered unchanged in the urine; about 20% of the dose is excreted as benazeprilat, 4% as benazepril glucuronide, and 8% as benazeprilat glucuronide.

In patients with hepatic dysfunction due to cirrhosis, levels of benazeprilat are essentially unaltered. Similarly, the pharmacokinetics of benazepril and benazeprilat do not appear to be influenced by age.

The kinetics of benazepril are dose-proportional within the dosage range of 5 to 20 mg. Small deviations from dose proportionality were observed when the broader range of 2 to 80 mg was studied, possibly due to the saturable binding of the compound to ACE.

The effective half-life of accumulation of benazeprilat following multiple dosing of benazepril is 10 to 11 hours. Thus, steady-state concentrations of benazeprilat should be reached after 2 or 3 doses of benazepril given once daily.

During chronic administration (28 days) of once-daily doses of benazepril between 5 mg and 20 mg, the kinetics did not change, and there was no significant accumulation. Accumulation ratios based on AUC and urinary recovery of benazeprilat were 1.19 and 1.27, respectively.

When dialysis was started 2 hours after ingestion of 10 mg of benazepril, approximately 6% of benazeprilat was removed in 4 hours of dialysis. The parent compound, benazepril, was not detected in the dialysate.

Benazepril and benazeprilat are cleared predominantly by renal excretion in healthy subjects with normal renal function. Nonrenal (i.e., biliary) excretion accounts for approximately 11% - 12% of benazeprilat excretion in healthy subjects. In patients with renal failure, biliary clearance may compensate to an extent for deficient renal clearance.

The disposition of benazepril and benazeprilat in patients with mild-to-moderate renal insufficiency (creatinine clearance > 30 mL/min) is similar to that in patients with normal renal function. In patients with creatinine clearance ≤ 30 mL/min, peak benazeprilat levels and the initial (alpha phase) half-life increase, and time to steady-state may be delayed (see DOSAGE AND ADMINISTRATION).

Following oral administration, plasma hydrochlorothiazide concentrations decline bi-exponentially, with a mean distribution half-life of about 2 hours and an elimination half-life of about 10 hours. About 70% of an orally administered dose of hydrochlorothiazide is eliminated in the urine as unchanged drug. In a study in individuals with impaired renal function, the mean elimination half-life of hydrochlorothiazide was increased to 2 fold in individuals with mild/moderate renal impairment (30 < CLcr < 90 mL/min) and 3 fold and severe renal impairment (≤ 30 mL/min), when compared to individuals with normal renal function (CLcr > 90 mL/min).

Pharmacodynamics

Benazepril

Single and multiple doses of 10 mg or more of benazepril cause inhibition of plasma ACE activity by at least 80% - 90% for at least 24 hours after dosing. For up to 4 hours after a 10 mg dose, pressor responses to exogenous angiotensin I were inhibited by 60% - 90%.

In normal human volunteers, single doses of benazepril caused an increase in renal blood flow but had no effect on glomerular filtration rate.

Hydrochlorothiazide

After oral administration of hydrochlorothiazide, diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours.

Drug Interactions

Benazepril hydrochloride and hydrochlorothiazide tablets potentiate the antihypertensive action of other antihypertensive drugs (e.g., curare derivatives, guanethidine, methyldopa, beta-blockers, vasodilators, calcium channel blockers ACE inhibitors and ARBs and DRIs).

Overdosage

No specific information is available on the treatment of overdosage with benazepril hydrochloride and hydrochlorothiazide tablets; treatment should be symptomatic and supportive. Therapy with benazepril hydrochloride and hydrochlorothiazide tablets should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance, and hypotension should be treated by established procedures.

Single oral doses of 1 g/kg of benazepril caused reduced activity in mice, and doses of 3 g/kg were associated with significant lethality. Reduction of activity in rats was not seen until they had received doses of 5 g/kg, and doses of 6 g/kg were not lethal. In single-dose studies of hydrochlorothiazide, most rats survived doses up to 2.75 g/kg.

Data from human overdoses of benazepril are scanty, but the most common manifestation of human benazepril overdosage is likely to be hypotension. In human hydrochlorothiazide overdose, the most common signs and symptoms observed have been those of dehydration and electrolyte depletion (hypokalemia, hypochloremia, hyponatremia). If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

Laboratory determinations of serum levels of benazepril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of benazepril overdose.

No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of benazepril and its metabolites. Benazeprilat is only slightly dialyzable, but dialysis might be considered in overdosed patients with severely impaired renal function (see WARNINGS).

Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of benazepril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of benazepril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat benazepril overdose by infusion of normal saline solution.

How is Benazepril and Hydrochlorothiazide Supplied

Benazepril Hydrochloride and Hydrochlorothiazide Tablets are available containing benazepril hydrochloride USP, 5 mg and hydrochlorothiazide USP, 6.25 mg; benazepril hydrochloride USP, 10 mg and hydrochlorothiazide USP, 12.5 mg; benazepril hydrochloride USP, 20 mg and hydrochlorothiazide USP, 12.5 mg; or benazepril hydrochloride USP, 20 mg and hydrochlorothiazide USP, 25 mg.

The 5 mg/6.25 mg tablets are beige, film-coated, oval, scored tablets debossed with M 725 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-4725-01
bottles of 100 tablets

The 10 mg/12.5 mg tablets are beige, film-coated, round, scored tablets debossed with M above the score and 735 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-4735-01
bottles of 100 tablets

The 20 mg/12.5 mg tablets are beige, film-coated, capsule-shaped, scored tablets debossed with M to the left of the score and 745 to the right of the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-4745-01
bottles of 100 tablets

The 20 mg/25 mg tablets are beige, film-coated, oval, scored tablets debossed with M to the left of the score and 775 to the right of the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-4775-01
bottles of 100 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from moisture and light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 8/2017
BZHCTZ:R6

PRINCIPAL DISPLAY PANEL - 5 mg/6.25 mg

NDC 0378-4725-01

Benazepril HCl and
Hydrochlorothiazide
Tablets
5 mg/
6.25 mg

Rx only    100 Tablets

Each film-coated tablet contains:
Benazepril hydrochloride, USP 5 mg
Hydrochlorothiazide, USP 6.25 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from moisture and light.

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM4725A2

PRINCIPAL DISPLAY PANEL - 20 mg/25 mg

NDC 0378-4775-01

Benazepril HCl and
Hydrochlorothiazide
Tablets
20 mg/
25 mg

Rx only    100 Tablets

Each film-coated tablet contains:
Benazepril hydrochloride, USP 20 mg
Hydrochlorothiazide, USP 25 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from moisture and light.

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM4775A2

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 
benazepril hydrochloride and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0378-4725
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
FERROSOFERRIC OXIDE  
SILICON DIOXIDE  
CROSPOVIDONE, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
POLYDEXTROSE  
POLYETHYLENE GLYCOL, UNSPECIFIED  
STARCH, CORN  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
FERRIC OXIDE YELLOW  
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code M;725
Contains     
Packaging
# Item Code Package Description
1 NDC:0378-4725-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076688 02/11/2004
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 
benazepril hydrochloride and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0378-4735
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
FERROSOFERRIC OXIDE  
SILICON DIOXIDE  
CROSPOVIDONE, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
POLYDEXTROSE  
POLYETHYLENE GLYCOL, UNSPECIFIED  
STARCH, CORN  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
FERRIC OXIDE YELLOW  
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code M;735
Contains     
Packaging
# Item Code Package Description
1 NDC:0378-4735-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076688 02/11/2004
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 
benazepril hydrochloride and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0378-4745
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
FERROSOFERRIC OXIDE  
SILICON DIOXIDE  
CROSPOVIDONE, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
POLYDEXTROSE  
POLYETHYLENE GLYCOL, UNSPECIFIED  
STARCH, CORN  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
FERRIC OXIDE YELLOW  
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape OVAL (capsule-shaped) Size 16mm
Flavor Imprint Code M;745
Contains     
Packaging
# Item Code Package Description
1 NDC:0378-4745-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076688 02/11/2004
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 
benazepril hydrochloride and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0378-4775
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
FERROSOFERRIC OXIDE  
SILICON DIOXIDE  
CROSPOVIDONE, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
POLYDEXTROSE  
POLYETHYLENE GLYCOL, UNSPECIFIED  
STARCH, CORN  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
FERRIC OXIDE YELLOW  
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code M;775
Contains     
Packaging
# Item Code Package Description
1 NDC:0378-4775-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076688 02/11/2004
Labeler - Mylan Pharmaceuticals Inc. (059295980)
Revised: 08/2017   Mylan Pharmaceuticals Inc.

Contraindications

Hypersensitivity to benazepril, any other ACE inhibitor, hydrochlorothiazide, sulfonamide-derived drugs, or any component of the formulation; patients with a history of angioedema (with or without prior ACE inhibitor therapy); concomitant use with aliskiren in patients with diabetes mellitus; coadministration with or within 36 hours of switching to or from a neprilysin inhibitor (eg, sacubitril); anuria.

Note: Although the FDA approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See “Warnings/Precautions” for more detail.

Dosing Adult

Note: Not for initial therapy; dose should be individualized.

Hypertension: Oral:

Add-on therapy:

Patients not adequately controlled on benazepril or hydrochlorothiazide monotherapy: Initial: Benazepril 10 mg/hydrochlorothiazide 12.5 mg once daily; titrate based on blood pressure response at 2- to 3-week intervals (maximum: benazepril 20 mg/hydrochlorothiazide 25 mg per day)

Replacement therapy: Substitute for the individually titrated components

For Healthcare Professionals

Applies to benazepril / hydrochlorothiazide: oral tablet

General

The most common side effects were dizziness, fatigue, headache, and cough.[Ref]

Nervous system

Common (1% to 10%): Dizziness, postural dizziness, headache, hypertonia, somnolence
Uncommon (0.1% to 1%): Paresthesia, taste perversion, tinnitus, syncope, hypesthesia

Hydrochlorothiazide:
Postmarketing reports: Lightheadedness, headache, paresthesia[Ref]

Respiratory

Common (1% to 10%): Cough, upper respiratory infection, rhinitis, sinusitis
Uncommon (0.1% to 1%): Epistaxis, bronchitis, voice alteration

Benazepril:
Postmarketing reports: Eosinophilic pneumonitis

Hydrochlorothiazide:
Postmarketing reports: Respiratory distress, pneumonitis, pulmonary edema[Ref]

Other

Common (1% to 10%): Fatigue, vertigo, flu syndrome
Uncommon (0.1% to 1%): Asthenia, chest pain, fever, chills

Hydrochlorothiazide:
Postmarketing reports: Vertigo, weakness, pyrexia, asthenia[Ref]

Genitourinary

Common (1% to 10%): Impotence, urinary frequency
Uncommon (0.1% to 1%): Urinary tract infection[Ref]

Gastrointestinal

Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Vomiting, diarrhea, dyspepsia, constipation, dry mouth, abdominal pain, gastroenteritis, flatulence, tooth disorder

Hydrochlorothiazide:
Postmarketing reports: Pancreatitis, small bowel angioedema, sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Arthralgia, myalgia, neck pain, arthritis

Hydrochlorothiazide:
Postmarketing reports: Muscle spasm[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, sweating, photosensitivity, pruritus, alopecia

Benazepril:
Postmarketing reports: Stevens-Johnson syndrome, pemphigus

Hydrochlorothiazide:
Postmarketing reports: Purpura, urticaria, rash, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia, nervousness, libido decreased, abnormal dreams

Hydrochlorothiazide:
Postmarketing reports: Restlessness[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations, flushing, peripheral vascular disorder, tachycardia

Hydrochlorothiazide:
Postmarketing reports: Necrotizing angiitis[Ref]

Ocular

Uncommon (0.1% to 1%): Abnormal vision, retinal disorder, conjunctivitis

Hydrochlorothiazide:
Postmarketing reports: Transient blurred vision, xanthopsia[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Hydrochlorothiazide:
Postmarketing reports: Anorexia, hyperglycemia, glycosuria, hyperuricemia[Ref]

Immunologic

Uncommon (0.1% to 1%): Infection

Hydrochlorothiazide:
Postmarketing reports: Anaphylactoid reactions[Ref]

Renal

Frequency not reported: Serum creatinine increased, BUN increased[Ref]

Hematologic

Benazepril:
Postmarketing reports: Hemolytic anemia, thrombocytopenia

Hydrochlorothiazide:
Postmarketing reports: Aplastic anemia, agranulocytosis, leukopenia, neutropenia, thrombocytopenia[Ref]

Hepatic

Benazepril:
Postmarketing reports: Pancreatitis

Hydrochlorothiazide:
Postmarketing reports: Intrahepatic cholestatic jaundice[Ref]

Endocrine

Hydrochlorothiazide:
Postmarketing reports: Parathyroid gland changes with hypercalcemia and hypophosphatemia[Ref]

Some side effects of benazepril / hydrochlorothiazide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Precautions

US BOXED WARNING:
-FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

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