Indacard belongs to the group of medicines known as diuretics. It is commonly used to treat high blood pressure (hypertension).
High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.
Indacard is also used to help reduce the amount of water in the body by increasing the flow of urine.
Indacard is available only with your doctor's prescription.
Indacard indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Indacard (Indacard) is indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs.
Indacard (Indacard) is also indicated for the treatment of salt and fluid retention associated with congestive heart failure.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard.
Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Indacard is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
How should I use Indacard?
Use Indacard as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Indacard by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Indacard may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
If you miss a dose of Indacard and you are taking 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Indacard.
Uses of Indacard in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Heart failure: Treatment of edema in heart failure
Hypertension: Management of mild to moderate hypertension
Guideline recommendations: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults recommends if monotherapy is warranted, in the absence of comorbidities (eg, cerebrovascular disease, chronic kidney disease, diabetes, heart failure, ischemic heart disease, etc), that thiazide-like diuretics or dihydropyridine calcium channel blockers may be preferred options due to improved cardiovascular endpoints (eg, prevention of heart failure and stroke). ACE inhibitors and ARBs are also acceptable for monotherapy. Combination therapy may be required to achieve blood pressure goals and is initially preferred in patients at high risk (stage 2 hypertension or atherosclerotic cardiovascular disease [ASCVD] risk ≥10%) (ACC/AHA [Whelton 2017]).
Off Label Uses
Calcium nephrolithiasis
Data from a prospective, randomized, study supports the use of Indacard for the prevention of recurrent calcium nephrolithiasis. Additional trials may be necessary to further define the role of Indacard in the treatment of this condition.
Based on the American Urologic Association (AUA) guidelines for the medical management of kidney stones, Indacard is effective and recommended for the prevention of recurrent calcium stones in patients with high or relatively high urine calcium concentrations.
Indacard description
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Indacard also contains the following excipients: Tablet: Lactose monohydrate 124.5 mg, anhydrous colloidal silica, hypromellose, magnesium stearate, povidone. Film-coating: Glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide.
Indacard dosage
Indacard Dosage
Generic name: Indacard
Dosage form: Tablets
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Hypertension
The adult starting Indacard dose for hypertension is 1.25 mg as a single daily dose taken in the morning. If the response to 1.25 mg is not satisfactory after four weeks, the daily dose may be increased to 2.5 mg taken once daily. If the response to 2.5 mg is not satisfactory after four weeks, the daily dose may be increased to 5.0 mg taken once daily, but adding another antihypertensive should be considered.
Edema of Congestive Heart Failure
The adult starting Indacard dose for edema of congestive heart failure is 2.5 mg as a single daily dose taken in the morning. If the response to 2.5 mg is not satisfactory after one week, the daily dose may be increased to 5.0 mg taken once daily.
If the antihypertensive response to Indacard is insufficient, Indacard may be combined with other antihypertensive drugs, with careful monitoring of blood pressure. It is recommended that the usual dose of other agents be reduced by 50% during initial combination therapy. As the blood pressure response becomes evident, further dosage adjustments may be necessary.
In general, doses of 5.0 mg and larger have not appeared to provide additional effects on blood pressure or heart failure, but are associated with a greater degree of hypokalemia. There is minimal clinical trial experience in patients with doses greater than 5.0 mg once a day.
Indacard (Indacard) may add to or potentiate the action of other antihypertensive drugs. In limited controlled trials that compared the effect of Indacard combined with other antihypertensive drugs with the effect of the other drugs administered alone, there was no notable change in the nature or frequency of adverse reactions associated with the combined therapy.
Lithium
Post-Sympathectomy Patient
The antihypertensive effect of the drug may be enhanced in the post-sympathectomized patient.
Norepinephrine
Indacard, like the thiazides, may decrease arterial responsiveness to norepinephrine, but this diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.
Most adverse effects have been mild and transient.
The Clinical Adverse Reactions listed in Table 1 represent data from Phase II/III placebo-controlled studies (306 patients given Indacard 1.25 mg). The Clinical Adverse Reactions listed in Table 2 represent data from Phase II placebo-controlled studies and long-term controlled clinical trials (426 patients given Indacard (Indacard) 2.5 mg or 5.0 mg). The reactions are arranged into two groups: 1) a cumulative incidence equal to or greater than 5%; 2) a cumulative incidence less than 5%. Reactions are counted regardless of relation to drug.
TABLE 1: Adverse Reactions from Studies of 1.25 mg
Incidence ≥ 5%
Incidence < 5%*
BODY AS A WHOLE
Headache
Asthenia
Infection
Flu Syndrome
Pain
Abdominal Pain
Back Pain
Chest Pain
GASTROINTESTINAL SYSTEM
Constipation
Diarrhea
Dyspepsia
Nausea
METABOLIC SYSTEM
Peripheral Edema
CENTRAL NERVOUS SYSTEM
Nervousness
Dizziness
Hypertonia
RESPIRATORY SYSTEM
Cough
Rhinitis
Pharyngitis
Sinusitis
SPECIAL SENSES
Conjunctivitis
*OTHER
All other clinical adverse reactions occurred at an incidence of < 1%.
Approximately 4% of patients given Indacard 1.25 mg compared to 5% of the patients given placebo discontinued treatment in the trials of up to eight weeks because of adverse reactions. In controlled clinical trials of six to eight weeks in duration, 20% of patients receiving Indacard 1.25 mg, 61% of patients receiving Indacard 5.0 mg, and 80% of patients receiving Indacard 10.0 mg had at least one potassium value below 3.4 mEq/L. In the Indacard 1.25 mg group, about 40% of those patients who reported hypokalemia as a laboratory adverse event returned to normal serum potassium values without intervention. Hypokalemia with concomitant clinical signs or symptoms occurred in 2% of patients receiving Indacard 1.25 mg.
TABLE 2: Adverse Reactions from Studies of 2.5 mg and 5.0 mg
table 2
Incidence ≥ 5%
Incidence < 5%
CENTRAL NERVOUS SYSTEM/NEUROMUSCULAR
Headache
Lightheadedness
Dizziness
Drowsiness
Fatigue, weakness, loss of energy, lethargy, tiredness, or malaise
Vertigo
Insomnia
Muscle cramps or spasm, or numbness of the extremities
Depression
Blurred Vision
Nervousness, tension, anxiety, irritability, or agitation
GASTROINTESTINAL SYSTEM
Constipation
Nausea
Vomiting
Diarrhea
Gastric irritation
Abdominal pain or cramps
Anorexia
CARDIOVASCULAR SYSTEM
Orthostatic hypotension
Premature ventricular contractions
Irregular heart beat
Palpitations
GENITOURINARY SYSTEM
Frequency of urination
Nocturia
Polyuria
DERMATOLOGIC/ HYPERSENSITIVITY
Rash
Hives
Pruritus
Vasculitis
OTHER
Impotence or reduced libido
Rhinorrhea
Flushing
Hyperuricemia
Hyperglycemia
Hyponatremia
Hypochloremia
Increase in serum urea nitrogen
(BUN) or creatinine
Glycosuria
Weight loss
Dry mouth
Tingling of extremities
Because most of these data are from long-term studies (up to 40 weeks of treatment), it is probable that many of the adverse experiences reported are due to causes other than the drug. Approximately 10% of patients given Indacard discontinued treatment in long-term trials because of reactions either related or unrelated to the drug.
Hypokalemia with concomitant clinical signs or symptoms occurred in 3% of patients receiving Indacard 2.5 mg q.d. and 7% of patients receiving Indacard 5 mg q.d. In long-term controlled clinical trials comparing the hypokalemic effects of daily doses of Indacard and hydrochlorothiazide, however, 47% of patients receiving Indacard 2.5 mg, 72% of patients receiving Indacard 5 mg, and 44% of patients receiving hydrochlorothiazide 50 mg had at least one potassium value (out of a total of 11 taken during the study) below 3.5 mEq/L. In the Indacard 2.5 mg group, over 50% of those patients returned to normal serum potassium values without intervention.
In clinical trials of six to eight weeks, the mean changes in selected values were as shown in the tables below.
Mean Changes from Baseline after 8 Weeks of Treatment – 1.25 mg
No patients receiving Indacard 1.25 mg experienced hyponatremia considered possibly clinically significant ( < 125 mEq/L). Indacard had no adverse effects on lipids.
Mean Changes from Baseline after 40 Weeks of Treatment – 2.5 mg and 5.0 mg
The following reactions have been reported with clinical usage of Indacard (Indacard) : jaundice (intrahepatic cholestatic jaundice), hepatitis, pancreatitis and abnormal liver function tests. These reactions were reversible with discontinuance of the drug.
Also reported are erythema multiforme, Stevens-Johnson Syndrome, bullous eruptions, purpura, photosensitivity, fever, pneumonitis, anaphylactic reactions, agranulocytosis, leukopenia, thrombocytopenia and aplastic anemia. Other adverse reactions reported with antihypertensive/diuretics are necrotizing angiitis, respiratory distress, sialadenitis, xanthopsia.
Hypersensitivity to Indacard or any component of the formulation or sulfonamide-derived drugs; 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.
Canadian labeling: Additional contraindications (not in US labeling): Severe renal failure (CrCl <30 mL/minute); hepatic encephalopathy; severe hepatic impairment; hypokalemia; concomitant use with antiarrhythmic agents causing torsade de pointes; pregnancy; breast-feeding; hereditary problems of galactose intolerance, glucose-galactose malabsorption, or Lapp lactase deficiency
DailyMed. "INDAPAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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