Drug: Altace Capsules

Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester; its structural formula is: Its empiric formula is C23H32N2O5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. ALTACE (ramipril) is supplied as hard shell capsules for oral administration containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains yellow iron oxide, the 2.5 mg capsule shell contains D&C yellow #10 and FD&C red #40, the 5 mg capsule shell contains FD&C blue #1 and FD&C red #40, and the 10 mg capsule shell contains FD&C blue #1.

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Hypertension ALTACE (ramipril capsules) has been evaluated for safety in over 4,000 patients with hypertension; of these, 1,230 patients were studied in US controlled trials, and 1,107 were studied in foreign controlled trials. Almost 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in ALTACE (ramipril capsules) and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ALTACE (ramipril capsules) in US placebo-controlled trials were: headache (5.4%), "dizziness" (2.2%) and fatigue or asthenia (2.0%), but only the last was more common in ALTACE (ramipril capsules) patients than in patients given placebo. Generally, the side effects were mild and transient, and there was no relation to total dosage within the range of 1.25 to 20 mg. Discontinuation of therapy because of a side effect was required in approximately 3% of US patients treated with ALTACE (ramipril capsules) . The most common reasons for discontinuation were: cough (1.0%), "dizziness" (0.5%), and impotence (0.4%). Of observed side effects considered possibly or probably related to study drug that occurred in US placebo-controlled trials in more than 1% of patients treated with ALTACE (ramipril capsules) , only asthenia (fatigue) was more common on Altace (ramipril capsules) than placebo (2% vs. 1%). PATIENTS IN US PLACEBO CONTROLLED STUDIES
  ALTACE Placebo (n=651) (n=286) n % n % Asthenia (Fatigue) 13 2 2 1 In placebo-controlled trials, there was also an excess of upper respiratory infection and flu syndrome in the ramipril group, not attributed at that time to ramipril. As these studies were carried out before the relationship of cough to ACE inhibitors was recognized, some of these events may represent ramipril-induced cough. In a later 1-year study, increased cough was seen in almost 12% of ramipril patients, with about 4% of patients requiring discontinuation of treatment. Heart Failure Post Myocardial Infarction Adverse reactions (except laboratory abnormalities) considered possibly/probably related to study drug that occurred in more than one percent of patients and more frequently on ramipril are shown below. The incidences represent the experiences from the AIRE study. The follow-up time was between 6 and 46 months for this study. Percentage of Patients with Adverse Events Possibly/ Probably Related to Study Drug
Placebo-Controlled (AIRE) Mortality Study
Adverse Event Ramipril Placebo (n=1004) (n=982) Hypotension 11 5 Cough Increased 8 4 Dizziness 4 3 Angina Pectoris 3 2 Nausea 2 1 Postural Hypotension 2 1 Syncope 2 1 Vomiting 2 0.5 Vertigo 2 0.7 Abnormal Kidney Function 1 0.5 Diarrhea 1 0.4 HOPE Study: Safety data in the HOPE trial were collected as reasons for discontinuation or temporary interruption of treatment. The incidence of cough was similar to that seen in the AIRE trial. The rate of angioedema was the same as in previous clinical trials (see WARNINGS).   RAMIPRIL PLACEBO (N=4645) (N=4652) % % Discontinuation at any time 34 32 Permanent discontinuation 29 28 Reasons for stopping Cough 7 2 Hypotension or Dizziness 1.9 1.5 Angioedema 0.3 0.1 Other adverse experiences reported in controlled clinical trials (in less than 1% of ramipril patients), or rarer events seen in postmarketing experience, include the following (in some, a causal relationship to drug use is uncertain): Body As a Whole: Anaphylactoid reactions. (See WARNINGS.) Cardiovascular: Symptomatic hypotension (reported in 0.5% of patients in US trials) (See WARNINGS and PRECAUTIONS ), syncope and palpitations. Hematologic: Pancytopenia, hemolytic anemia and thrombocytopenia. Renal: Some hypertensive patients with no apparent pre-existing renal disease have developed minor, usually transient, increases in blood urea nitrogen and serum creatinine when taking ALTACE (ramipril capsules) , particularly when ALTACE (ramipril capsules) was given concomitantly with a diuretic. (See WARNINGS.) Acute renal failure. Angioneurotic Edema: Angioneurotic edema has been reported in 0.3% of patients in US clinical trials. (See WARNINGS.) Gastrointestinal: Hepatic failure, hepatitis, jaundice, pancreatitis, abdominal pain (sometimes with enzyme changes suggesting pancreatitis), anorexia, constipation, diarrhea, dry mouth, dyspepsia, dysphagia, gastroenteritis, increased salivation and taste disturbance. Dermatologic: Apparent hypersensitivity reactions (manifested by urticaria, pruritus, or rash, with or without fever), photosensitivity, purpura, onycholysis, pemphigus, pemphigoid, erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome. Neurologic and Psychiatric: Anxiety, amnesia, convulsions, depression, hearing loss, insomnia, nervousness, neuralgia, neuropathy, paresthesia, somnolence, tinnitus, tremor, vertigo, and vision disturbances. Miscellaneous: As with other ACE inhibitors, a symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, photosensitivity, rash and other dermatologic manifestations. Additionally, as with other ACE inhibitors, eosinophilic pneumonitis has been reported. Fetal/Neonatal Morbidity and Mortality. See WARNINGS : Fetal/Neonatal Morbidity and Mortality . Other: arthralgia, arthritis, dyspnea, edema, epistaxis, impotence, increased sweating, malaise, myalgia, and weight gain. Post-Marketing Experience: In addition to adverse events reported from clinical trials, there have been rare reports of hypoglycemia reported during ALTACE (ramipril capsules) therapy when given to patients concomitantly taking oral hypoglycemic agents or insulin. The causal relationship is unknown. Clinical Laboratory Test Findings Creatinine and Blood Urea Nitrogen: Increases in creatinine levels occurred in 1.2% of patients receiving ALTACE (ramipril capsules) alone, and in 1.5% of patients receiving ALTACE (ramipril capsules) and a diuretic. Increases in blood urea nitrogen levels occurred in 0.5% of patients receiving ALTACE (ramipril capsules) alone and in 3% of patients receiving ALTACE (ramipril capsules) with a diuretic. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis. (See WARNINGS and PRECAUTIONS.) Since ramipril decreases aldosterone secretion, elevation of serum potassium can occur. Potassium supplements and potassium-sparing diuretics should be given with caution, and the patient's serum potassium should be monitored frequently. (See WARNINGS and PRECAUTIONS.) Hemoglobin and Hematocrit: Decreases in hemoglobin or hematocrit (a low value and a decrease of 5 g/dl or 5% respectively) were rare, occurring in 0.4% of patients receiving ALTACE (ramipril capsules) alone and in 1.5% of patients receiving ALTACE (ramipril capsules) plus a diuretic. No US patients discontinued treatment because of decreases in hemoglobin or hematocrit. Other (causal relationships unknown): Clinically important changes in standard laboratory tests were rarely associated with ALTACE (ramipril capsules) administration. Elevations of liver enzymes, serum bilirubin, uric acid, and blood glucose have been reported, as have cases of hyponatremia and scattered incidents of leukopenia, eosinophilia, and proteinuria. In US trials, less than 0.2% of patients discontinued treatment for laboratory abnormalities; all of these were cases of proteinuria or abnormal liver-function tests. Read the Altace Capsules (ramipril capsules) Side Effects Center for a complete guide to possible side effectsLearn More »

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Blood pressure decreases associated with any dose of ALTACE (ramipril capsules) depend, in part, on the presence or absence of volume depletion (e.g., past and current diuretic use) or the presence or absence of renal artery stenosis. If such circumstances are suspected to be present, the initial starting dose should be 1.25 mg once daily. Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes ALTACE (ramipril capsules) should be given at an initial dose of 2.5 mg, once a day for 1 week, 5 mg, once a day for the next 3 weeks, and then increased as tolerated, to a maintenance dose of 10 mg, once a day. If the patient is hypertensive or recently post myocardial infarction, it can also be given as a divided dose. Hypertension The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Dosage should be adjusted according to the blood pressure response. The usual maintenance dosage range is 2.5 to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with ALTACE (ramipril capsules) alone, a diuretic can be added. Heart Failure Post Myocardial Infarction For the treatment of post-infarction patients who have shown signs of congestive failure, the recommended starting dose of ALTACE (ramipril capsules) is 2.5 mg twice daily (5 mg per day). A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily, and after one week at the starting dose, patients should then be titrated (if tolerated) toward a target dose of 5 mg twice daily, with dosage increases being about 3 weeks apart. After the initial dose of ALTACE (ramipril capsules) , the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS: DRUG INTERACTIONS.) If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of ALTACE (ramipril capsules) does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension. The ALTACE (ramipril capsules) Capsule is usually swallowed whole. The ALTACE (ramipril capsules) Capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of apple sauce or mixed in 4 oz. (120 ml) of water or apple juice. To be sure that ramipril is not lost when such a mixture is used, the mixture should be consumed in its entirety. The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration. Concomitant administration of ALTACE (ramipril capsules) with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium. (See PRECAUTIONS.) In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of ALTACE (ramipril capsules) . To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with ALTACE. (See WARNINGS.) Then, if blood pressure is not controlled with ALTACE (ramipril capsules) alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 1.25 mg ALTACE (ramipril capsules) should be used to avoid excess hypotension. Dosage Adjustment in Renal Impairment In patients with creatinine clearance < 40 ml/min/1.73m2 (serum creatinine approximately > 2.5 mg/dl) doses only 25% of those normally used should be expected to induce full therapeutic levels of ramiprilat. (See CLINICAL PHARMACOLOGY.) Hypertension: For patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg ALTACE (ramipril capsules) once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 5 mg. Heart Failure Post Myocardial Infarction: For patients with heart failure and renal impairment, the recommended initial dose is 1.25 mg ALTACE (ramipril capsules) once daily. The dose may be increased to 1.25 mg b.i.d. and up to a maximum dose of 2.5 mg b.i.d. depending upon clinical response and tolerability.

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Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including ALTACE (ramipril capsules) . With nonsteroidal anti-inflammatory agents: Rarely, concomitant treatment with ACE inhibitors and nonsteroidal anti-inflammatory agents have been associated with worsening of renal failure and an increase in serum potassium. With diuretics: Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with ALTACE (ramipril capsules) . The possibility of hypotensive effects with ALTACE (ramipril capsules) can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with ALTACE (ramipril capsules) . If this is not possible, the starting dose should be reduced. (See DOSAGE AND ADMINISTRATION.) With potassium supplements and potassium-sparing diuretics: ALTACE (ramipril capsules) can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, they should be given with caution, and the patient's serum potassium should be monitored frequently. With lithium: Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased. Other: Neither ALTACE (ramipril capsules) nor its metabolites have been found to interact with food, digoxin, antacid, furosemide, cimetidine, indomethacin, and simvastatin. The combination of ALTACE (ramipril capsules) and propranolol showed no adverse effects on dynamic parameters (blood pressure and heart rate). The co-administration of ALTACE (ramipril capsules) and warfarin did not adversely affect the anticoagulant effects of the latter drug. Additionally, co-administration of ALTACE (ramipril capsules) with phenprocoumon did not affect minimum phenprocoumon levels or interfere with the subjects' state of anti-coagulation. Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of a tumorigenic effect was found when ramipril was given by gavage to rats for up to 24 months at doses of up to 500 mg/kg/day or to mice for up to 18 months at doses of up to 1000 mg/kg/day. (For either species, these doses are about 200 times the maximum recommended human dose when compared on the basis of body surface area.) No mutagenic activity was detected in the Ames test in bacteria, the micronucleus test in mice, unscheduled DNA synthesis in a human cell line, or a forward gene-mutation assay in a Chinese hamster ovary cell line. Several metabolites and degradation products of ramipril were also negative in the Ames test. A study in rats with dosages as great as 500 mg/kg/day did not produce adverse effects on fertility. Pregnancy Pregnancy Categories C (first trimester) and D (second and third trimesters). See WARNINGS : Fetal/Neonatal Morbidity and Mortality . Nursing Mothers Ingestion of single 10 mg oral dose of ALTACE resulted in undetectable amounts of ramipril and its metabolites in breast milk. However, because multiple doses may produce low milk concentrations that are not predictable from single doses, women receiving ALTACE (ramipril capsules) should not breast feed. Geriatric Use Of the total number of patients who received ramipril in US clinical studies of ALTACE (ramipril capsules) 11.0% were 65 and over while 0.2% were 75 and over. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. One pharmacokinetic study conducted in hospitalized elderly patients indicated that peak ramiprilat levels and area under the plasma concentration time curve (AUC) for ramiprilat are higher in older patients. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Irreversible kidney damage has been observed in very young rats given a single dose of ramipril. Last reviewed on RxList: 6/12/2009
This monograph has been modified to include the generic and brand name in many instances.

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Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes Altace (ramipril capsules) is indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Altace (ramipril capsules) can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy). Hypertension ALTACE (ramipril capsules) is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using ALTACE (ramipril capsules) , consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that ALTACE does not have a similar risk. (See WARNINGS .) In considering use of ALTACE (ramipril capsules) , it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (See WARNINGS , Angioedema.) Heart Failure Post Myocardial Infarction Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure. (See CLINICAL PHARMACOLOGY , Heart Failure Post Myocardial Infarction for details and limitations of the survival trial.)

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ALTACE (ramipril capsules) is contraindicated in patients who are hypersensitive to this product or any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Last reviewed on RxList: 6/12/2009
This monograph has been modified to include the generic and brand name in many instances.

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Single oral doses in rats and mice of 10-11 g/kg resulted in significant lethality. In dogs, oral doses as high as 1 g/kg induced only mild gastrointestinal distress. Limited data on human overdosage are available. The most likely clinical manifestations would be symptoms attributable to hypotension. Laboratory determinations of serum levels of ramipril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of ramipril overdose. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of ramipril and its metabolites. Similarly, it is not known which, if any, of these substances can be usefully removed from the body by hemodialysis. Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of ramipril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of ramipril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat ramipril overdose by infusion of normal saline solution.

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ALTACE (ramipril capsules) is available in potencies of 1.25 mg, 2.5 mg, 5 mg, and 10 mg in hard gelatin capsules. ALTACE (ramipril capsules) 1.25 mg capsules are supplied as yellow, hard gelatin capsules in bottles of 100 (NDC 61570-110-01). ALTACE (ramipril capsules) 2.5 mg capsules are supplied as orange, hard gelatin capsules in bottles of 100 (NDC 61570-111-01), 500 (NDC 61570-111-05), Unit Dose packs of 100 (NDC 61570-111-56), and Bulk pack of 5000's (NDC 61570-111-50). ALTACE (ramipril capsules) 5 mg capsules are supplied as red, hard gelatin capsules in bottles of 100 (NDC 61570-112-01), 500 (NDC 61570-112-05), Unit Dose packs of 100 (NDC 61570-112-56), and Bulk pack of 5000's (NDC 61570-112-50). ALTACE (ramipril capsules) 10 mg capsules are supplied as Process Blue, hard gelatin capsules in bottles of 100 (NDC 61570-120-01), and 500 (NDC 61570-120-05). Dispense in well-closed container with safety closure. Store at controlled room temperature (59° to 86°F). Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: King Pharmaceuticals, Inc., Bristol, TN 37620. Prescribing Information as of July 2008. Last reviewed on RxList: 6/12/2009
This monograph has been modified to include the generic and brand name in many instances.

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Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, 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 ALTACE (ramipril capsules) , may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur. Experience with another angiotensin converting enzyme inhibitor suggests that these increases are usually reversible upon discontinuation of ALTACE (ramipril capsules) and/or diuretic therapy. In such patients renal function should be monitored during the first few weeks of therapy. Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient, especially when ALTACE (ramipril capsules) has been given concomitantly with a diuretic. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction of ALTACE (ramipril capsules) and/or discontinuation of the diuretic may be required. Evaluation of the hypertensive patient should always include assessment of renal function. (See DOSAGE AND ADMINISTRATION.) Hyperkalemia: In clinical trials, hyperkalemia (serum potassium greater than 5.7 mEq/L) occurred in approximately 1% of hypertensive patients receiving ALTACE (ramipril). In most cases, these were isolated values, which resolved despite continued therapy. None of these patients was discontinued from the trials because of hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes, which should be used cautiously, if at all, with ALTACE. (See DRUG INTERACTIONS.) Cough: Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough. Impaired Liver Function: Since ramipril is primarily metabolized by hepatic esterases to its active moiety, ramiprilat, patients with impaired liver function could develop markedly elevated plasma levels of ramipril. No formal pharmacokinetic studies have been carried out in hypertensive patients with impaired liver function. However, since the renin-angiotensin system may be activated in patients with severe liver cirrhosis and/or ascites, particular caution should be exercised in treating these patients. Surgery/Anesthesia: In patients undergoing surgery or during anesthesia with agents that produce hypotension, ramipril may block angiotensin II formation that would otherwise occur secondary to compensatory renin release. Hypotension that occurs as a result of this mechanism can be corrected by volume expansion. Last reviewed on RxList: 6/12/2009
This monograph has been modified to include the generic and brand name in many instances.

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