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Quinapril and Hydrochlorothiazide 20/25
Overview
What is Quinapril and Hydrochlorothiazide 10/12.5?
What does Quinapril and Hydrochlorothiazide 10/12.5 look like?
What are the available doses of Quinapril and Hydrochlorothiazide 10/12.5?
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What should I talk to my health care provider before I take Quinapril and Hydrochlorothiazide 10/12.5?
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How should I use Quinapril and Hydrochlorothiazide 10/12.5?
What interacts with Quinapril and Hydrochlorothiazide 10/12.5?
- 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.
- 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:
What are the warnings of Quinapril and Hydrochlorothiazide 10/12.5?
Anaphylactoid and Possibly Related Reactions:
Head and Neck Angioedema:
Where there is involvement of the tongue, glottis, or larynx likely to cause airway obstruction, emergency therapy including, but not limited to, subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL) should be promptly administered
Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.
Intestinal Angioedema:
Patients With a History of Angioedema:
Anaphylactoid Reactions During Desensitization:
Anaphylactoid Reactions During Membrane Exposure:
Hepatic Failure:
Hypotension:
Symptomatic hypotension sometimes associated with oliguria and/or progressive azotemia, and rarely acute renal failure and/or death, include patients with the following conditions or characteristics: heart failure, hyponatremia, high dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis or severe volume and/or salt depletion of any etiology. Volume and/or salt depletion should be corrected before initiating therapy with quinapril and hydrochlorothiazide tablets.
Quinapril and hydrochlorothiazide tablets should be used cautiously in patients receiving concomitant therapy with other antihypertensives. The thiazide component of quinapril and hydrochlorothiazide tablets may potentiate the action of other antihypertensive drugs, especially ganglionic or peripheral adrenergic-blocking drugs. The antihypertensive effects of the thiazide component may also be enhanced in the postsympathectomy patients.
In patients at risk of excessive hypotension, therapy with quinapril and hydrochlorothiazide tablets should be started under close medical supervision. Such patients should be followed closely for the first 2 weeks of treatment and whenever the dosage of quinapril or diuretic is increased. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in myocardial infarction or cerebrovascular accident.
If excessive hypotension occurs, the patient should be placed in a supine position and, if necessary, treated with intravenous infusion of normal saline. Quinapril and hydrochlorothiazide treatment usually can be continued following restoration of blood pressure and volume. If symptomatic hypotension develops, a dose reduction or discontinuation of quinapril and hydrochlorothiazide tablets may be necessary.
Impaired Renal Function:
When the renin-angiotensin-aldosterone system is inhibited by quinapril, changes in renal function may be anticipated in susceptible individuals. In patients with severe congestive heart failure, whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme inhibitors (including quinapril) may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death.
In clinical studies in hypertensive patients with unilateral renal artery stenosis, treatment with ACE inhibitors was associated with increases in blood urea nitrogen and serum creatinine; these increases were reversible upon discontinuation of ACE inhibitor, concomitant diuretic, or both. When such patients are treated with quinapril and hydrochlorothiazide tablets, renal function should be monitored during the first few weeks of therapy.
Some quinapril-treated hypertensive patients with no apparent preexisting renal vascular diseases have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient, especially when quinapril has been given concomitantly with a diuretic. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction of quinapril and hydrochlorothiazide tablets may be required. (see ).
Neutropenia/Agranulocytosis:
Fetal Toxicity
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue quinapril and hydrochlorothiazide tablets as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue quinapril and hydrochlorothiazide tablets, unless it is considered life-saving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of exposure to quinapril and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia (see ).
Intrauterine exposure to thiazide diuretics is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that occurred in adults.
No teratogenic effects of quinapril were seen in studies of pregnant rats and rabbits. On a mg/kg basis, the doses used were up to 180 times (in rats) and one time (in rabbits) the maximum recommended human dose. No teratogenic effects of quinapril and hydrochlorothiazide tablets were seen in studies of pregnant rats and rabbits. On a mg/kg (quinapril/hydrochlorothiazide) basis, the doses used were up to 188/94 times (in rats) and 0.6/0.3 times (in rabbits) the maximum recommended human dose.
Impaired Hepatic Function:
Systemic Lupus Erythematosus:
Acute Myopia and Secondary Angle-Closure Glaucoma:
What are the precautions of Quinapril and Hydrochlorothiazide 10/12.5?
General
Serum Electrolyte Abnormalities:
Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. The risk of hyperkalemia may be increased in patients with renal insufficiency, diabetes mellitus or with concomitant use of drugs that raise serum potassium (see ). The risk of hypokalemia may be increased in patients with cirrhosis, brisk diuresis, or with concomitant use of drugs that lower serum potassium. Monitor serum electrolytes periodically.
Other Metabolic Disturbances:
Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving quinapril and hydrochlorothiazide tablets.
Cough:
Surgery/Anesthesia:
Information for Patients
Angioedema:
Pregnancy:
Symptomatic Hypotension:
Tell patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure because of reduction in fluid volume, with the same consequences of lightheadedness and possible syncope.
Tell patients planning to undergo major surgery and/ or general or spinal anesthesia to inform their physicians that they are taking an ACE inhibitor.
Hyperkalemia:
Neutropenia:
NOTE:
Laboratory Tests
The hydrochlorothiazide component of quinapril and hydrochlorothiazide tablets may decrease serum PBI levels without signs of thyroid disturbance.
Therapy with quinapril and hydrochlorothiazide tablets should be interrupted for a few days before carrying out tests of parathyroid function.
Drug Interactions
Agents Increasing Serum Potassium:
Lithium:
Dual Blockade of the Renin-Angiotensin System (RAS):
Do not co-administer aliskiren with quinapriland hydrochlorothiazide tablets in patients with diabetes. Avoid concomitant use of aliskiren with quinapril and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 mL/min/1.73 m).
Tetracycline and Other Drugs That Interact with Magnesium:
Gold:
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
The antihypertensive effect of ACE inhibitors, including quinapril may be attenuated by NSAIDs.
Agents that inhibit mTOR:
Other Agents:
Drug interaction studies of quinapril and other agents showed:
When administered concurrently, the following drugs may interact with thiazide diuretics.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity, and fertility studies have not been conducted in animals with quinapril and hydrochlorothiazide tablets.
Quinapril hydrochloride was not carcinogenic in mice or rats when given in doses up to 75 or 100 mg/kg/day (50 or 60 times the maximum human daily dose, respectively, on a mg/kg basis and 3.8 or 10 times the maximum human daily dose on a mg/mbasis) for 104 weeks. Female rats given the highest dose level had an increased incidence of mesenteric lymph node hemangiomas and skin/subcutaneous lipomas. Neither quinapril nor quinaprilat were mutagenic in the Ames bacterial assay with or without metabolic activation. Quinapril was also negative in the following genetic toxicology studies: mammalian cell point mutation, sister chromatid exchange in cultured mammalian cells, micronucleus test with mice, chromosome aberration with V79 cultured lung cells, and in an cytogenetic study with rat bone marrow. There were no adverse effects on fertility or reproduction in rats at doses up to 100 mg/kg/day (60 and 10 times the maximum daily human dose when based on mg/kg and mg/m, respectively).
Under the auspices of the National Toxicology Program, rats and mice received hydrochlorothiazide in their feed for 2 years, at doses up to 600 mg/kg/day in mice and up to 100 mg/kg/day in rats. These studies uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in rats or female mice, but there was "equivocal" evidence of hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in assays using strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of (the Ames test); in the Chinese hamster ovary (CHO) test for chromosomal aberrations; or assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the sex-linked recessive lethal trait gene. Positive test results were obtained in the CHO sister chromatid exchange (clastogenicity) test and in the mouse lymphoma cell (mutagenicity) assays, using concentrations of hydrochlorothiazide of 43 to 1300 μg/mL. Positive test results were also obtained in the nondisjunction assay, using an unspecified concentration of hydrochlorothiazide.
Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diets, to doses of up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation.
Nursing Mothers
Because quinapril and hydrochlorothiazide are secreted in human milk, caution should be exercised when quinapril and hydrochlorothiazide tablets are administered to a nursing woman.
Because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide and the unknown effects of quinapril in infants, a decision should be made whether to discontinue nursing or to discontinue quinapril and hydrochlorothiazide tablets, taking into account the importance of the drug to the mother.
Geriatric Use
Clinical studies of quinapril 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.
Pediatric Use
Neonates with a history of exposure to quinapril and hydrochlorothiazide tablets:
If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Removal of quinapril, which crosses the placenta, from the neonatal circulation is not significantly accelerated by these means.
Safety and effectiveness of quinapril and hydrochlorothiazide tablets in children have not been established.
What are the side effects of Quinapril and Hydrochlorothiazide 10/12.5?
Quinapril and hydrochlorothiazide tablets have been evaluated for safety in 1571 patients in controlled and uncontrolled studies. Of these, 498 were given quinapril plus hydrochlorothiazide for at least 1 year, with 153 patients extending combination therapy for over 2 years. In clinical trials with quinapril and hydrochlorothiazide tablets, no adverse experience specific to the combination has been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with quinapril or hydrochlorothiazide.
Adverse experiences were usually mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy because of adverse effects was required in 2.1% in patients in controlled studies. The most common reasons for discontinuation of therapy with quinapril and hydrochlorothiazide tablets were cough (1.0%; see ) and headache (0.7%).
Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 943 patients treated with quinapril plus hydrochlorothiazide in controlled trials are shown below.
Clinical adverse experiences probably, possibly, or definitely related or of uncertain relationship to therapy occurring in ≥0.5% to <1.0% (except as noted) of the patients treated with quinapril and HCTZ in controlled and uncontrolled trials (N=1571) and less frequent, clinically significant events seen in clinical trials or postmarketing experience (the rarer events are in italics) include (listed by body system):
Postmarketing Experience
The following serious nonfatal adverse events, regardless of their relationship to quinapril and HCTZ combination tablets, have been reported during extensive postmarketing experience:
BODY AS A WHOLE: Shock, accidental injury, neoplasm, cellulitis, ascites, generalized edema, hernia and anaphylactoid reaction.
CARDIOVASCULAR SYSTEM: Bradycardia, cor pulmonale, vasculitis, and deep thrombosis.
DIGESTIVE SYSTEM: Gastrointestinal carcinoma, cholestatic jaundice, hepatitis, esophagitis, vomiting, and diarrhea.
EYE DISORDERS: Acute myopia and acute angle closure glaucoma (see ).
HEMIC SYSTEM: Anemia.
METABOLIC AND NUTRITIONAL DISORDERS: Weight loss.
MUSCULOSKELETAL SYSTEM: Myopathy, myositis, and arthritis.
NERVOUS SYSTEM: Paralysis, hemiplegia, speech disorder, abnormal gait, meningism, and amnesia.
RESPIRATORY SYSTEM: Pneumonia, asthma, respiratory infiltration, and lung disorder.
SKIN AND APPENDAGES: Urticaria, macropapular rash, and petechiases.
SPECIAL SENSES: Abnormal vision.
UROGENITAL SYSTEM: Kidney function abnormal, albuminuria, pyuria, hematuria, and nephrosis.
Quinapril monotherapy has been evaluated for safety in 4960 patients. In clinical trials adverse events which occurred with quinapril were also seen with quinapril and hydrochlorothiazide tablets. In addition, the following were reported for quinapril at an incidence >0.5%: depression, back pain, constipation, syncope, and amblyopia.
Hydrochlorothiazide has been extensively prescribed for many years, but there has not been enough systematic collection of data to support an estimate of the frequency of the observed adverse reactions. Within organ-system groups, the reported reactions are listed here in decreasing order of severity, without regard to frequency.
Clinical Laboratory Test Findings
Serum Electrolytes:
Creatinine, Blood Urea Nitrogen:
PBI and Tests of Parathyroid Function:
Hematology:
Other
What should I look out for while using Quinapril and Hydrochlorothiazide 10/12.5?
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.
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:
What might happen if I take too much Quinapril and Hydrochlorothiazide 10/12.5?
How should I store and handle Quinapril and Hydrochlorothiazide 10/12.5?
Caution should be exercised in handling and preparing carboplatin injection. Several guidelines on this subject have been published. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing carboplatin injection. If carboplatin injection contacts the skin, immediately wash the skin thoroughly with soap and water. If carboplatin injection contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.Caution should be exercised in handling and preparing carboplatin injection. Several guidelines on this subject have been published. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing carboplatin injection. If carboplatin injection contacts the skin, immediately wash the skin thoroughly with soap and water. If carboplatin injection contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.Silver sulfadiazine cream, USP 1% - white to off-white cream 67877-124-20 20g tube 67877-124-25 25g tube 67877-124-05 50g tube 67877-124-85 85g tube 67877-124-50 50g jar 67877-124-40 400g jar 67877-124-10 1000g jar Store at room temperature. 15°-30°C (56°-86°F).Manufactured for:Manufactured by:Product information: 1-877-272-7901Silver sulfadiazine cream, USP 1% - white to off-white cream 67877-124-20 20g tube 67877-124-25 25g tube 67877-124-05 50g tube 67877-124-85 85g tube 67877-124-50 50g jar 67877-124-40 400g jar 67877-124-10 1000g jar Store at room temperature. 15°-30°C (56°-86°F).Manufactured for:Manufactured by:Product information: 1-877-272-7901Silver sulfadiazine cream, USP 1% - white to off-white cream 67877-124-20 20g tube 67877-124-25 25g tube 67877-124-05 50g tube 67877-124-85 85g tube 67877-124-50 50g jar 67877-124-40 400g jar 67877-124-10 1000g jar Store at room temperature. 15°-30°C (56°-86°F).Manufactured for:Manufactured by:Product information: 1-877-272-7901Silver sulfadiazine cream, USP 1% - white to off-white cream 67877-124-20 20g tube 67877-124-25 25g tube 67877-124-05 50g tube 67877-124-85 85g tube 67877-124-50 50g jar 67877-124-40 400g jar 67877-124-10 1000g jar Store at room temperature. 15°-30°C (56°-86°F).Manufactured for:Manufactured by:Product information: 1-877-272-7901Silver sulfadiazine cream, USP 1% - white to off-white cream 67877-124-20 20g tube 67877-124-25 25g tube 67877-124-05 50g tube 67877-124-85 85g tube 67877-124-50 50g jar 67877-124-40 400g jar 67877-124-10 1000g jar Store at room temperature. 15°-30°C (56°-86°F).Manufactured for:Manufactured by:Product information: 1-877-272-7901
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
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.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:
Specific interaction studies between diclofenac sodium gel and other topical or oral agents were not performed.
General
Serum Electrolyte Abnormalities:
Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. The risk of hyperkalemia may be increased in patients with renal insufficiency, diabetes mellitus or with concomitant use of drugs that raise serum potassium (see ). The risk of hypokalemia may be increased in patients with cirrhosis, brisk diuresis, or with concomitant use of drugs that lower serum potassium. Monitor serum electrolytes periodically.
Other Metabolic Disturbances:
Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving quinapril and hydrochlorothiazide tablets.
Cough:
Surgery/Anesthesia:
Information for Patients
Angioedema:
Pregnancy:
Symptomatic Hypotension:
Tell patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure because of reduction in fluid volume, with the same consequences of lightheadedness and possible syncope.
Tell patients planning to undergo major surgery and/ or general or spinal anesthesia to inform their physicians that they are taking an ACE inhibitor.
Hyperkalemia:
Neutropenia:
NOTE:
Laboratory Tests
The hydrochlorothiazide component of quinapril and hydrochlorothiazide tablets may decrease serum PBI levels without signs of thyroid disturbance.
Therapy with quinapril and hydrochlorothiazide tablets should be interrupted for a few days before carrying out tests of parathyroid function.
Drug Interactions
Agents Increasing Serum Potassium:
Lithium:
Dual Blockade of the Renin-Angiotensin System (RAS):
Do not co-administer aliskiren with quinapriland hydrochlorothiazide tablets in patients with diabetes. Avoid concomitant use of aliskiren with quinapril and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 mL/min/1.73 m).
Tetracycline and Other Drugs That Interact with Magnesium:
Gold:
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
The antihypertensive effect of ACE inhibitors, including quinapril may be attenuated by NSAIDs.
Agents that inhibit mTOR:
Other Agents:
Drug interaction studies of quinapril and other agents showed:
When administered concurrently, the following drugs may interact with thiazide diuretics.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity, and fertility studies have not been conducted in animals with quinapril and hydrochlorothiazide tablets.
Quinapril hydrochloride was not carcinogenic in mice or rats when given in doses up to 75 or 100 mg/kg/day (50 or 60 times the maximum human daily dose, respectively, on a mg/kg basis and 3.8 or 10 times the maximum human daily dose on a mg/mbasis) for 104 weeks. Female rats given the highest dose level had an increased incidence of mesenteric lymph node hemangiomas and skin/subcutaneous lipomas. Neither quinapril nor quinaprilat were mutagenic in the Ames bacterial assay with or without metabolic activation. Quinapril was also negative in the following genetic toxicology studies: mammalian cell point mutation, sister chromatid exchange in cultured mammalian cells, micronucleus test with mice, chromosome aberration with V79 cultured lung cells, and in an cytogenetic study with rat bone marrow. There were no adverse effects on fertility or reproduction in rats at doses up to 100 mg/kg/day (60 and 10 times the maximum daily human dose when based on mg/kg and mg/m, respectively).
Under the auspices of the National Toxicology Program, rats and mice received hydrochlorothiazide in their feed for 2 years, at doses up to 600 mg/kg/day in mice and up to 100 mg/kg/day in rats. These studies uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in rats or female mice, but there was "equivocal" evidence of hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in assays using strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of (the Ames test); in the Chinese hamster ovary (CHO) test for chromosomal aberrations; or assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the sex-linked recessive lethal trait gene. Positive test results were obtained in the CHO sister chromatid exchange (clastogenicity) test and in the mouse lymphoma cell (mutagenicity) assays, using concentrations of hydrochlorothiazide of 43 to 1300 μg/mL. Positive test results were also obtained in the nondisjunction assay, using an unspecified concentration of hydrochlorothiazide.
Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diets, to doses of up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation.
Nursing Mothers
Because quinapril and hydrochlorothiazide are secreted in human milk, caution should be exercised when quinapril and hydrochlorothiazide tablets are administered to a nursing woman.
Because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide and the unknown effects of quinapril in infants, a decision should be made whether to discontinue nursing or to discontinue quinapril and hydrochlorothiazide tablets, taking into account the importance of the drug to the mother.
Geriatric Use
Clinical studies of quinapril 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.
Pediatric Use
Neonates with a history of exposure to quinapril and hydrochlorothiazide tablets:
If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Removal of quinapril, which crosses the placenta, from the neonatal circulation is not significantly accelerated by these means.
Safety and effectiveness of quinapril and hydrochlorothiazide tablets in children have not been established.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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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. 315.72Tips
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