hit upon [60:<0.1) 0.0 Impotence 2.2 (0.5) 0.5 Diarrhea 2.1 (> <0.1) 1.7 Clinical adverse experiences occurring in 0.5 to 2.0 percent of patients in controlled trials included: Body As A Whole: Syncope, chest pain, abdominal pain Cardiovascular: Orthostatic hypotension, palpitation, tachycardia Digestive: Vomiting, dyspepsia, constipation, flatulence, dry mouth Nervous/Psychiatric: Insomnia, nervousness, paresthesia, somnolence, vertigo Skin: Pruritus, rash Other: Dyspnea, gout, back pain, arthralgia, diaphoresis, decreased libido, tinnitus, urinary tract infection Angioedema: Angioedema has been reported in patients receiving enalapril maleate and hydrochlorothiazide, with an incidence higher in black than in non-black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with enalapril maleate and hydrochlorothiazide should be discontinued and appropriate therapy instituted immediately (see WARNINGS ). Hypotension: In clinical trials, adverse effects relating to hypotension occurred as follows: hypotension (0.9 percent), orthostatic hypotension (1.5 percent), other orthostatic effects (2.3 percent). In addition syncope occurred in 1.3 percent of patients (see WARNINGS ). Cough: See PRECAUTIONS, Cough . Clinical Laboratory Test Findings Serum Electrolytes: See PRECAUTIONS . Creatinine, Blood Urea Nitrogen: In controlled clinical trials minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 0.6 percent of patients with essential hypertension treated with enalapril maleate and hydrochlorothiazide. More marked increases have been reported in other enalapril experience. Increases are more likely to occur in patients with renal artery stenosis (see PRECAUTIONS ). Serum Uric Acid, Glucose, Magnesium, and Calcium: See PRECAUTIONS . Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g percent and 1.0 vol percent, respectively) occur frequently in hypertensive patients treated with enalapril maleate and hydrochlorothiazide but are rarely of clinical importance unless another cause of anemia coexists. In clinical trials, less than 0.1 percent of patients discontinued therapy due to anemia. Liver Function Tests: Rarely, elevations of liver enzymes and/or serum bilirubin have occurred (see WARNINGS, Hepatic Failure ). Other adverse reactions that have been reported with the individual components are listed below and, within each category, are in order of decreasing severity. Enalapril Maleate Enalapril has been evaluated for safety in more than 10,000 patients. In clinical trials adverse reactions which occurred with enalapril were also seen with enalapril maleate and hydrochlorothiazide. However, since enalapril has been marketed, the following adverse reactions have been reported: Body As A Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure ); Cardiovascular: Cardiac arrest; myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension ); pulmonary embolism and infarction; pulmonary edema; rhythm disturbances including atrial tachycardia and bradycardia; atrial fibrillation; hypotension; angina pectoris, Raynaud's phenomenon; Digestive: Ileus, pancreatitis, hepatic failure, hepatitis (hepatocellular [proven on rechallenge] or cholestatic jaundice) (see WARNINGS, Hepatic Failure ), melena, anorexia, glossitis, stomatitis, dry mouth; Hematologic: Rare cases of neutropenia, thrombocytopenia and bone marrow depression. Hemolytic anemia, including cases of hemolysis in patients with G6PD deficiency, has been reported; a causal relationship to enalapril cannot be excluded. Nervous System/Psychiatric: Depression, confusion, ataxia, peripheral neuropathy (e.g., paresthesia, dysesthesia), dream abnormality; Urogenital: Renal failure, oliguria, renal dysfunction, (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ), flank pain, gynecomastia; Respiratory: Pulmonary infiltrates, eosinophilic pneumonitis, bronchospasm, pneumonia, bronchitis, rhinorrhea, sore throat and hoarseness, asthma, upper respiratory infection; Skin: Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, herpes zoster, erythema multiforme, urticaria, pemphigus, alopecia, flushing, photosensitivity; Special Senses: Blurred vision, taste alteration, anosmia, conjunctivitis, dry eyes, tearing. Miscellaneous: A symptom complex has been reported which may include some or all of the following: a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, rash and other dermatologic manifestations. Hydrochlorothiazide Body as a Whole: Weakness; Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation, anorexia; Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions; Musculoskeletal: Muscle spasm; Nervous System/Psychiatric: Restlessness; Renal: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS ); Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia; Special Senses: Transient blurred vision, xanthopsia. To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Overdosage No specific information is available on the treatment of overdosage with enalapril maleate and hydrochlorothiazide. Treatment is symptomatic and supportive. Therapy with enalapril maleate 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. Enalapril Maleate Single oral doses of enalapril above 1,000 mg/kg and ≥ 1,775 mg/kg were associated with lethality in mice and rats, respectively. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Enalaprilat may be removed from general circulation by hemodialysis and has been removed from neonatal circulation by peritoneal dialysis (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure ). Hydrochlorothiazide Lethality was not observed after administration of an oral dose of 10 g/kg to mice and rats. The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. Enalapril and Hydrochlorothiazide Dosage and Administration Enalapril and Hydrochlorothiazide are effective treatments for hypertension. The usual dosage range of enalapril is 10 to 40 mg per day administered in a single or two divided doses; hydrochlorothiazide is effective in doses of 12.5 to 50 mg daily. The side effects (see WARNINGS ) of enalapril 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 Enalapril and Hydrochlorothiazide will be associated with both sets of dose-independent side effects but the addition of enalapril 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. Dose Titration Guided by Clinical Effect A patient whose blood pressure is not adequately controlled with either enalapril or hydrochlorothiazide monotherapy may be given enalapril maleate and hydrochlorothiazide 5/12.5 mg or enalapril maleate and hydrochlorothiazide 10/25 mg. Further increases of enalapril, hydrochlorothiazide or both depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. In general, patients do not require doses in excess of 20 mg of enalapril or 50 mg of hydrochlorothiazide. The daily dosage should not exceed four tablets of enalapril maleate and hydrochlorothiazide 5/12.5 mg or two tablets of enalapril maleate and hydrochlorothiazide 10/25 mg. Replacement Therapy The combination may be substituted for the titrated components. Use in Renal Impairment The usual regimens of therapy with enalapril maleate and hydrochlorothiazide need not be adjusted as long as the patient's creatinine clearance is greater than 30 mL/min/1.73m 2 (serum creatinine approximately less than or equal to 3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so enalapril maleate and hydrochlorothiazide is not recommended (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure ). How is Enalapril and Hydrochlorothiazide Supplied Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5/12.5 mg , are ivory, caplet-shaped compressed tablets, engraved on one side with T4. Each tablet contains 5 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide. They are supplied as follows: NDC 51672-4045-1 bottles of 100 (with desiccant). NDC 51672-4045-3 bottles of 1,000 (with desiccant). Enalapril Maleate and Hydrochlorothiazide Tablets USP, 10/25 mg , are peach colored, capsule shaped, tablets. One side scored and engraved "T" to the left of the score and "3" to the right of the score. Other side scored. Each tablet contains 10 mg of enalapril maleate and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 51672-4046-1 bottles of 100 (with desiccant). NDC 51672-4046-3 bottles of 1,000 (with desiccant). Storage Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture. Dispense in a tight container as per USP, if product package is subdivided. Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: August 2017 89610-0817-8 PRINCIPAL DISPLAY PANEL - 5/12.5 mg Tablet Bottle Label NDC 51672- 4045 -1 100 Tablets Enalapril Maleate and Hydrochlorothiazide Tablets USP 5/12.5 mg TARO Rx only PRINCIPAL DISPLAY PANEL - 10/25 mg Tablet Bottle Label NDC 51672- 4046 -1 100 Tablets Enalapril Maleate and Hydrochlorothiazide Tablets USP 10/25 mg Rx only TARO ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate and hydrochlorothiazide tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51672-4045 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Enalapril Maleate (Enalaprilat Anhydrous) Enalapril Maleate 5 mg Hydrochlorothiazide (Hydrochlorothiazide) Hydrochlorothiazide 12.5 mg Inactive Ingredients Ingredient Name Strength lactose monohydrate starch, corn ferrosoferric oxide ferric oxide yellow sodium bicarbonate magnesium stearate water Product Characteristics Color WHITE (Ivory) Score no score Shape OVAL (Caplet shape) Size 8mm Flavor Imprint Code T4 Contains Packaging # Item Code Package Description 1 NDC:51672-4045-1 100 TABLET in 1 BOTTLE 2 NDC:51672-4045-3 1000 TABLET in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075788 09/18/2001 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate and hydrochlorothiazide tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51672-4046 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Enalapril Maleate (Enalaprilat Anhydrous) Enalapril Maleate 10 mg Hydrochlorothiazide (Hydrochlorothiazide) Hydrochlorothiazide 25 mg Inactive Ingredients Ingredient Name Strength lactose monohydrate starch, corn ferric oxide red ferric oxide yellow sodium bicarbonate magnesium stearate water Product Characteristics Color PINK (peach) Score 2 pieces Shape OVAL (Caplet shape) Size 10mm Flavor Imprint Code T;3 Contains Packaging # Item Code Package Description 1 NDC:51672-4046-1 100 TABLET in 1 BOTTLE 2 NDC:51672-4046-3 1000 TABLET in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075788 09/18/2001 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Operations Taro Pharmaceutical Industries, Ltd. 600072078 MANUFACTURE(51672-4045, 51672-4046) Revised: 09/2017 Taro Pharmaceuticals U.S.A., Inc. Next Interactions Print this page Add to My Med List More about enalapril/hydrochlorothiazide Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: ACE inhibitors with thiazides Consumer resources Hydrochlorothiazide and enalapril Enalapril and Hydrochlorothiazide Enalapril and hydrochlorothiazide (Advanced Reading) Professional resources Enalapril and Hydrochlorothiazide (Wolters Kluwer) Other brands: Vaseretic Related treatment guides Heart Failure High Blood Pressure> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA WADA Class Anti-Doping Classification Manufacturers Apotex Corp. Dr. Reddy's Laboratories, Inc. 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make sure that Enalapril and Hydrochlorothiazide every body
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