Indications:

Treatment of hypertension.

Contraindications:

Patients with a history of angioedema related to previous treatment with an ACE inhibitor; patients with anuria; hypersensitivity to sulfonamide-derived drugs or any component of the product.

Adverse reactions:

Cardiovascular Bradycardia; cor pulmonale; vasculitis; deep thrombosis; vasodilatation; chest pain. Quinapril Syncope. Hydrochlorothiazide Orthostatic hypotension. CNS Dizziness; somnolence; paralysis; hemiplegia; speech disorder; abnormal gait; meningism; amnesia; headache; fatigue; insomnia; vertigo; asthenia. Quinapril Depression. Hydrochlorothiazide Lightheadedness; paresthesia; weakness; restlessness. Dermatologic Urticaria; macropapular rash; petechiases. EENT Esophagitis; abnormal vision; rhinitis. Quinapril Amblyopia. Hydrochlorothiazide Transient blurred vision; xanthopsia. GI GI carcinoma; vomiting; diarrhea; nausea; abdominal pain; constipation; dyspepsia. Hydrochlorothiazide Pancreatitis; sialadenitis; diarrhea; cramping; gastric irritation; anorexia. Genitourinary Abnormal kidney function; albuminuria; pyuria; hematuria; nephrosis. Hydrochlorothiazide Renal failure; renal function impairment; interstitial nephritis. Hematologic Anemia. Hydrochlorothiazide Aplastic anemia; agranulocytosis; leukopenia; thrombocytopenia; hemolytic anemia. Hepatic Cholestatic jaundice; hepatitis. Hydrochlorothiazide Jaundice (intrahepatic cholestatic). Metabolic Weight loss. Hydrochlorothiazide Hyperglycemia; glucosuria; hyperuricemia; hypokalemia; hyponatremia; hypochloremic alkalosis. Respiratory Coughing; pneumonia; asthma; respiratory infiltration; lung disorder; upper respiratory tract infection; bronchitis. Miscellaneous Shock; accidental injury; neoplasm; cellulitis; ascites; generalized edema; hernia; myopathy; myositis; arthritis; myalgia; viral infection; angioedema. Quinapril Back pain; anaphylactoid reactions. Hydrochlorothiazide Muscle spasm; hypersensitivity (including necrotizing angiitis, Stevens-Johnson syndrome, respiratory distress [including pneumonia and pulmonary edema], purpura, urticaria, rash, and photosensitivity).

Interactions:

ACTH, corticosteroids Electrolyte depletion may be intensified, especially hypokalemia. Alcohol, barbiturates (eg, phenobarbital), narcotics Orthostatic hypotension may be potentiated. Anticoagulants (eg, warfarin) Anticoagulant effect may be decreased. Antidiabetic agents (eg, insulin, sulfonylureas), antigout agents (eg, probenecid) Dosage adjustment may be necessary because of possible hydrochlorothiazide-induced elevation in blood glucose levels. Cardiac glycosides (eg, digoxin) Possible digitalis toxicity associated with hypokalemia. Cholestyramine, colestipol May impair the absorption of hydrochlorothiazide. Insulin In diabetic patients, requirements of insulin may be increased, decreased, or unchanged. Lithium Plasma levels of lithium may be elevated, increasing the risk of toxicity. NSAIDs May reduce the natriuretic and antihypertensive effect of hydrochlorothiazide. Potassium supplements, potassium-sparing diuretics (eg, spironolactone) Increased risk of hyperkalemia. Nondepolarizing muscle relaxants (eg, tubocurarine) Effects may be increased. Pressor amines (eg, norepinephrine) Response to pressor amines may be decreased. Tetracycline and other drugs that interact with magnesium Because of the magnesium content in quinapril, absorption of tetracycline may be reduced, decreasing the therapeutic effect. Laboratory Test Interactions Hydrochlorothiazide May decrease serum protein-bound iodine levels without signs of thyroid disturbances.

Warnings:

Warnings 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, discontinue therapy as soon as possible. Monitor Monitor blood sugar in diabetic patient when drug is started or dose is changed. Pregnancy Category D (second and third trimester); Category C (first trimester). ACE inhibitors (eg, quinapril) can cause injury or death to fetus if used during second or third trimester. When pregnancy is detected, discontinue as soon as possible. Lactation Excreted in breast milk. Children Safety and efficacy not established. Elderly Select dose with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function and comorbidity. Renal Function Use with caution. Hepatic Function Use with caution. Anaphylactoid reactions Reported in patients with a history of angioedema, undergoing desensitizing treatment with Hymenoptera venom, and in patients dialyzed with high-flux membranes. Angioedema Use with extreme caution in patients with a history of angioedema. Angioedema associated with laryngeal edema may be fatal. Angioedema may occur more frequently in black patients receiving an ACE inhibitor compared with non-black patients. Cough Chronic cough may occur during treatment. Electrolyte imbalance Treatment with thiazide diuretics has been associated with hypokalemia, hyponatremia, hypochloremic alkalosis, hypercalcemia, and hypomagnesemia. Do not initiate therapy prior to correction of imbalance. Hepatic failure Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and death. Hypotension Decreases in BP may occur, especially in salt- or volume-depleted patients as a result of dialysis, prolonged diuretic therapy, dietary salt restriction, diarrhea, or vomiting. Volume and salt depletion should be corrected before initiating therapy with quinapril/hydrochlorothiazide. Metabolic disturbances Thiazide diuretics tend to reduce glucose tolerance, raise cholesterol, triglycerides, and uric acid levels. Neutropenia/Agranulocytosis Has occurred with other ACE inhibitors. Surgery/Anesthesia In patients undergoing surgery or during anesthesia with agents that produce hypotension, angiotensin II formation, secondary to compensatory renal release, may be blocked. Systemic Lupus Erythematosus (SLE) Hydrochlorothiazide may exacerbate or activate SLE.

Form:

SOLUTION FOR INJECTION