Digoksino 0.25 mg Sanitas is derived from the leaves of a digitalis plant. Digoksino 0.25 mg Sanitas helps make the heart beat stronger and with a more regular rhythm.
Digoksino 0.25 mg Sanitas is used to treat heart failure.
Digoksino 0.25 mg Sanitas is also used to treat atrial fibrillation, a heart rhythm disorder of the atria (the upper chambers of the heart that allow blood to flow into the heart).
Digoksino 0.25 mg Sanitas may also be used for purposes not listed in this medication guide.
Digoksino 0.25 mg Sanitas 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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Heart Failure in Adults
Digoksino 0.25 mg Sanitas® (Digoksino 0.25 mg Sanitas tablets) is indicated for the treatment of mild to moderate heart failure in adults. Digoksino 0.25 mg Sanitas® (Digoksino 0.25 mg Sanitas tablets) increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, Digoksino 0.25 mg Sanitas® (Digoksino 0.25 mg Sanitas tablets) should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
Heart Failure in Pediatric Patients
Digoksino 0.25 mg Sanitas® (Digoksino 0.25 mg Sanitas tablets) increases myocardial contractility in pediatric patients with heart failure.
Atrial Fibrillation in Adults
Digoksino 0.25 mg Sanitas® (Digoksino 0.25 mg Sanitas tablets) is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
How should I use Digoksino 0.25 mg Sanitas?
Use Digoksino 0.25 mg Sanitas solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Digoksino 0.25 mg Sanitas solution by mouth. Do not take it within 30 to 60 minutes of food high in fiber.
If you take an antacid, cholestyramine, or colestipol, ask your doctor or pharmacist how to take it with Digoksino 0.25 mg Sanitas solution.
Use the dropper that comes with Digoksino 0.25 mg Sanitas solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you miss a dose of Digoksino 0.25 mg Sanitas solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Digoksino 0.25 mg Sanitas solution.
Uses of Digoksino 0.25 mg Sanitas 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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Digoksino 0.25 mg Sanitas is used to treat heart failure, usually along with other medications. It is also used to treat a certain type of irregular heartbeat (chronic atrial fibrillation). Treating heart failure may help maintain your ability to walk and exercise and may improve the strength of your heart. Treating an irregular heartbeat can decrease the risk for blood clots, an effect that may reduce your risk for a heart attack or stroke.
Digoksino 0.25 mg Sanitas belongs to a class of medications called cardiac glycosides. It works by affecting certain minerals (sodium and potassium) inside heart cells. This reduces strain on the heart and helps it maintain a normal, steady, and strong heartbeat.
How to use Digoksino 0.25 mg Sanitas
Take this medication by mouth with or without food, usually once daily or as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using the dropper provided by the manufacturer. Do not use a household spoon because you may not get the correct dose.
Your body may not absorb this drug as well if you also eat foods that are high in fiber or if you take certain medications. Therefore, take this medication at least 2 hours before or after eating food products that are high in fiber (such as bran). If you are also taking cholestyramine, colestipol, or psyllium, wait at least 2 hours after taking your Digoksino 0.25 mg Sanitas dose before taking any of these products. If you are taking antacids, kaolin-pectin, milk of magnesia, metoclopramide, sulfasalazine, or aminosalicylic acid, take them as far apart from your Digoksino 0.25 mg Sanitas dose as possible. Ask your pharmacist if you are not sure when to take any of your medications.
The dosage of this medication is based on your medical condition, age, body weight, laboratory tests, and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped.
Tell your doctor if your condition does not improve or if it worsens.
Digoksino 0.25 mg Sanitas description
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A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone digoxigenin. Digoksino 0.25 mg Sanitas Pediatric has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in atrial fibrillation and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Digoksino 0.25 mg Sanitas dosage
Important Dosing and Administration Information
In selecting a Digoksino 0.25 mg Sanitas dosing regimen, it is important to consider factors that affect Digoksino 0.25 mg Sanitas blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of Digoksino 0.25 mg Sanitas are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.
Parenteral administration of Digoksino 0.25 mg Sanitas should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orally.
Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred. If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage. For adults, no more than 500 mcg of Digoksino 0.25 mg Sanitas Injection should be injected into a single site. For pediatric patients, no more than 200 mcg of Digoksino 0.25 mg Sanitas Injection Pediatric should be injected into a single site.
Administer the dose over a period of 5 minutes or longer and avoid bolus administration to prevent systemic and coronary vasoconstriction. Mixing of Digoksino 0.25 mg Sanitas Injection and Injection Pediatric with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.
Digoksino 0.25 mg Sanitas Injection and Injection Pediatric can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. The use of less than a 4-fold volume of diluent could lead to precipitation of the Digoksino 0.25 mg Sanitas. Immediate use of the diluted product is recommended.
If tuberculin syringes are used to measure very small doses do not flush with the parenteral solution after its contents are expelled into an indwelling vascular catheter to avoid overadministration of Digoksino 0.25 mg Sanitas.
Consider interruption or reduction in Digoksino 0.25 mg Sanitas dose prior to electrical cardioversion.
Loading Dosing Regimen in Adults and Pediatric Patients
Total IV Loading Dose (mcg/kg) Administer half the total loading dose initially, then 1/4 the loading dose every 6-8 hours twice
Premature
15-25
Full-Term
20-30
1-24 Months
30-50
2-5 Years
25-35
5-10 Years
15-30
Adults and pediatric patients over 10 years
8-12
mcg = microgram
Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old
The maintenance dose is based on lean body weight, renal function, age, and concomitant products.
The recommended starting maintenance doses in adults and pediatric patients over 10 years old with normal renal function are given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.
Table 2: Recommended Starting Digoksino 0.25 mg Sanitas Injection Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old
Age
Total
Intravenous Maintenance Dose, mcg/kg/day (given once daily)
Adults and pediatric patients over 10 years
2.4-3.6
mcg = microgram
Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over 10 years old (to be given once daily) according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):
Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100 (% Daily Loss = 14 + Creatinine clearance/5)
Reduce the dose of Digoksino 0.25 mg Sanitas in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.
Table 3: Recommended Maintenance Dose (in micrograms given once daily) of Digoksino 0.25 mg Sanitas Injection in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Function
Corrected Creatinine Clearance If no loading dose administered.
Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels
Monitor for signs and symptoms of Digoksino 0.25 mg Sanitas toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.
Serum Digoksino 0.25 mg Sanitas levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.
Interpret the serum Digoksino 0.25 mg Sanitas concentration in the overall clinical context, and do not use an isolated measurement of serum Digoksino 0.25 mg Sanitas concentration as the basis for increasing or decreasing the Digoksino 0.25 mg Sanitas dose. Serum Digoksino 0.25 mg Sanitas concentrations may be falsely elevated by endogenous Digoksino 0.25 mg Sanitas-like substances. If the assay is sensitive to these substances, consider obtaining a baseline Digoksino 0.25 mg Sanitas level before starting Digoksino 0.25 mg Sanitas and correct post-treatment values by the reported baseline level.
Obtain serum Digoksino 0.25 mg Sanitas concentrations just before the next scheduled Digoksino 0.25 mg Sanitas dose or at least 6 hours after the last dose. The Digoksino 0.25 mg Sanitas concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in Digoksino 0.25 mg Sanitas concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.
Switching from
Intravenous Digoksino 0.25 mg Sanitas to
Oral Digoksino 0.25 mg Sanitas
When switching from intravenous to oral Digoksino 0.25 mg Sanitas formulations, make allowances for differences in bioavailability when calculating maintenance dosages.
Table 6: Comparison of the Systemic Availability and Equivalent Doses of
Oral and
Intravenous Digoksino 0.25 mg Sanitas
Absolute Bioavailability
Equivalent Doses (mcg)
Digoksino 0.25 mg Sanitas Tablets
60-80%
62.5
125
250
500
Digoksino 0.25 mg Sanitas
Intravenous Injection
100%
50
100
200
400
How supplied
Dosage Forms And Strengths
Digoksino 0.25 mg Sanitas Injection: Ampules of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL).
Digoksino 0.25 mg Sanitas Injection Pediatric: Ampules of 100 mcg (0.1 mg) in 1 mL.
Storage And Handling
Digoksino 0.25 mg Sanitas (Digoksino 0.25 mg Sanitas) Injection, 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL); box of 10 ampules (NDC 24987 260 10)
Digoksino 0.25 mg Sanitas (Digoksino 0.25 mg Sanitas) Injection Pediatric, 100 mcg (0.1 mg) in 1 mL; box of 10 ampules (NDC 24987 262 10)
Store at 25 °C (77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) and protect from light.
Digoksino 0.25 mg Sanitas Injection manufactured by Jubilant Hollister. Kirkland, Canada H9H 4J4. Digoksino 0.25 mg Sanitas Injection Pediatric manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27834. Distributed by Covis Pharmaceuticals, Inc. Cary, NC 27511
Potassium-depleting diuretics are a major contributing factor to digitalis toxicity. Calcium, particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients. Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone raise the serum Digoksino 0.25 mg Sanitas concentration due to a reduction in clearance and/or in volume of distribution of the drug, with the implication that digitalis intoxication may result. Erythromycin and clarithromycin (and possibly other macrolide antibiotics) and tetracycline may increase Digoksino 0.25 mg Sanitas absorption in patients who inactivate Digoksino 0.25 mg Sanitas by bacterial metabolism in the lower intestine, so that digitalis intoxication may result. The risk of this interaction may be reduced if Digoksino 0.25 mg Sanitas is given as capsules. Propantheline and diphenoxylate, by decreasing gut motility, may increase Digoksino 0.25 mg Sanitas absorption. Antacids, kaolin-pectin, sulfasalazine, neomycin, cholestyramine, certain anticancer drugs, and metoclopramide may interfere with intestinal Digoksino 0.25 mg Sanitas absorption, resulting in unexpectedly low serum concentrations. Rifampin may decrease serum Digoksino 0.25 mg Sanitas concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of Digoksino 0.25 mg Sanitas. There have been inconsistent reports regarding the effects of other drugs (e.g.,quinine,penicillamine) on serum Digoksino 0.25 mg Sanitas concentration. Thyroid administration to a digitalized, hypothyroid patient may increase the dose requirement of Digoksino 0.25 mg Sanitas. Concomitant use of Digoksino 0.25 mg Sanitas and sympathomimetics increases the risk of cardiac arrhythmias. Succinylcholine may cause a sudden extrusion of potassium from muscle cells, and may thereby cause arrhythmias in digitalized patients. Although beta-adrenergic blockers or calcium channel blockers and Digoksino 0.25 mg Sanitas may be useful in combination to control atrial fibrillation, their additive effects on AV node conduction can result in advanced or complete heart block.
Due to the considerable variability of these interactions, the dosage of Digoksino 0.25 mg Sanitas should be individualized when patients receive these medications concurrently. Furthermore, caution should be exercised when combining Digoksino 0.25 mg Sanitas with any drug that may cause a significant deterioration in renal function, since a decline in glomerular filtration or tubular secretion may impair the excretion of Digoksino 0.25 mg Sanitas.
In general, the adverse reactions of Digoksino 0.25 mg Sanitas are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when Digoksino 0.25 mg Sanitas is used within the recommended dose range or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.
Because some patients may be particularly susceptible to side effects with Digoksino 0.25 mg Sanitas, the dosage of the drug should always be selected carefully and adjusted as the clinical condition of the patient warrants. In the past, when high doses of Digoksino 0.25 mg Sanitas were used and little attention was paid to clinical status or concurrent medications, adverse reactions to Digoksino 0.25 mg Sanitas were more frequent and severe. Cardiac adverse reactions accounted for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse reactions. However, available evidence suggests that the incidence and severity of Digoksino 0.25 mg Sanitas toxicity has decreased substantially in recent years. In recent controlled clinical trials, in patients with predominantly mild to moderate heart failure, the incidence of adverse experiences was comparable in patients taking Digoksino 0.25 mg Sanitas and in those taking placebo. In a large mortality trial, the incidence of hospitalization for suspected Digoksino 0.25 mg Sanitas toxicity was 2% in patients taking Digoksino 0.25 mg Sanitas compared to 0.9% in patients taking placebo. In this trial, the most common manifestations of Digoksino 0.25 mg Sanitas toxicity included gastrointestinal and cardiac disturbances; CNS manifestations were less common.
Adults: Cardiac: Therapeutic doses of Digoksino 0.25 mg Sanitas may cause heart block in patients with pre-existing sinoatrial or AV conduction disorders; heart block can be avoided by adjusting the dose of Digoksino 0.25 mg Sanitas. Prophylactic use of a cardiac pacemaker may be considered if the risk of heart block is considered unacceptable. High doses of Digoksino 0.25 mg Sanitas may produce a variety of rhythm disturbances, such as first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation. Digoksino 0.25 mg Sanitas produces PR prolongation and ST segment depression which should not by themselves be considered Digoksino 0.25 mg Sanitas toxicity. Cardiac toxicity can also occur at therapeutic doses in patients who have conditions which may alter their sensitivity to Digoksino 0.25 mg Sanitas.
Gastrointestinal: Digoksino 0.25 mg Sanitas may cause anorexia, nausea, vomiting, and diarrhea. Rarely, the use of Digoksino 0.25 mg Sanitas has been associated with abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.
CNS: Digoksino 0.25 mg Sanitas can produce visual disturbances (blurred or yellow vision), headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).
Other: Gynecomastia has been occasionally observed following the prolonged use of Digoksino 0.25 mg Sanitas. Thrombocytopenia and maculopapular rash
and other skin reactions have been rarely observed.
Table 4 summarizes the incidence of those adverse experiences listed above for patients treated with Digoksino 0.25 mg Sanitas tablets or placebo from two randomized, double-blind, placebo-controlled withdrawal trials. Patients in these trials were also receiving diuretics with or without angiotensin-converting enzyme inhibitors. These patients had been stable on Digoksino 0.25 mg Sanitas, and were randomized to Digoksino 0.25 mg Sanitas or placebo. The results shown in Table 4 reflect the experience in patients following dosage titration with the use of serum Digoksino 0.25 mg Sanitas concentrations and careful follow-up. These adverse experiences are consistent with results from a large, placebo-controlled mortality trial (DIG trial) wherein over half the patients were not receiving Digoksino 0.25 mg Sanitas prior to enrollment.
Table 4: Adverse Experiences in Two Parallel, Double-Blind, Placebo-Controlled Withdrawal Trials (Number of Patients Reporting)
Adverse Experience
Digoksino 0.25 mg Sanitas Patients
(n = 123)
Placebo Patients
(n = 125)
Cardiac
Palpitation
Ventricular extrasystole
Tachycardia
Heart arrest
1
1
2
1
4
1
1
1
Gastrointestinal
Anorexia
Nausea
Vomiting
Diarrhea
Abdominal pain
1
4
2
4
0
4
2
1
1
6
CNS
Headache
Dizziness
Mental disturbances
4
6
5
4
5
1
Other
Rash
Death
2
4
1
3
Infants and Children: The side effects of Digoksino 0.25 mg Sanitas in infants and children differ from those seen in adults in several respects. Although Digoksino 0.25 mg Sanitas may produce anorexia, nausea, vomiting, diarrhea, and CNS disturbances in young patients, these are rarely the initial symptoms of overdosage. Rather, the earliest and most frequent manifestation of excessive dosing with Digoksino 0.25 mg Sanitas in infants and children is the appearance of cardiac arrhythmias, including sinus bradycardia. In children, the use of Digoksino 0.25 mg Sanitas may produce any arrhythmia. The most common are conduction disturbances or supraventricular tachyarrhythmias, such as atrial tachycardia (with or without block) and junctional (nodal) tachycardia. Ventricular arrhythmias are less common. Sinus bradycardia may be a sign of impending Digoksino 0.25 mg Sanitas intoxication, especially in infants, even in the absence of first-degree heart block. Any arrhythmia or alteration in cardiac conduction that develops in a child taking Digoksino 0.25 mg Sanitas should be assumed to be caused by Digoksino 0.25 mg Sanitas, until further evaluation proves otherwise.
You should not use this medication if you are allergic to Digoksino 0.25 mg Sanitas, or if you have ventricular fibrillation (a heart rhythm disorder of the ventricles, or lower chambers of the heart that allow blood to flow out of the heart).
Before using Digoksino 0.25 mg Sanitas, tell your doctor if you have certain heart conditions, especially "AV block" (unless you have a pacemaker), or a recent history of heart attack. Also tell your doctor if you have kidney disease, a thyroid disorder, an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood), or if you are malnourished or have recently been sick with vomiting or diarrhea.
Keep taking Digoksino 0.25 mg Sanitas as directed, even if you feel well. Get your prescription refilled before you run out of medicine completely.
Do not stop taking Digoksino 0.25 mg Sanitas without first talking to your doctor. Stopping suddenly may make your condition worse.
Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Digoksino 0.25 mg Sanitas overdose can occur more easily if you are dehydrated.
There are many other drugs that can interact with Digoksino 0.25 mg Sanitas. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
Active ingredient matches for Digoksino 0.25 mg Sanitas:
Digoxin (Argentina, Australia, Bahrain, Bangladesh, Belgium, Canada, Ethiopia, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Romania, Singapore, South Africa, Sweden, Taiwan, Thailand, United Kingdom, United States)
DailyMed. "DIGOXIN: 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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