Aldoleo

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Aldoleo uses

Aldoleo consists of Chlorthalidone, Spironolactone.

Chlorthalidone:


INDICATIONS AND USAGE:

Diuretics such as Aldoleo are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension.

Aldoleo (Chlorthalidone) is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

Aldoleo (Chlorthalidone) has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal 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 pathologic causes or from the physiologic and mechanical consequences of pregnancy. Aldoleo (Chlorthalidone) 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 that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that 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 that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.

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CONTRAINDICATIONS:

Anuria.

Known hypersensitivity to Aldoleo (Chlorthalidone) or other sulfonamide-derived drugs.

WARNINGS:

Aldoleo (Chlorthalidone) should be used with caution in severe renal disease. In patients with renal disease, Aldoleo (Chlorthalidone) or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Aldoleo (Chlorthalidone) should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to Aldoleo (Chlorthalidone). However, systemic lupus erythematosus has not been reported following Aldoleo (Chlorthalidone) administration.

PRECAUTIONS:

General

Hypokalemia may develop with Aldoleo (Chlorthalidone) as with any other diuretic, especially with brisk diuresis when severe cirrhosis is present or during concomitant use of corticosteroids or ACTH.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Digitalis therapy may exaggerate metabolic effects of hypokalemia especially with reference to myocardial activity.

Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather, appropriate therapy is water restriction, rather than administration of salt except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving Aldoleo (Chlorthalidone). Thiazide-like diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.

If progressive renal impairment becomes evident, as indicated by a rising nonprotein nitrogen or blood urea nitrogen, a careful reappraisal of therapy is necessary with consideration given to withholding or discontinuing diuretic therapy.

Calcium excretion is decreased by thiazide-like drugs. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in few patients on thiazide therapy. The common complications of hyperparathyroidism such as renal lithiasis, bone resorption and peptic ulceration have not been seen.

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Information for Patients

Patients should inform their physician if they have: (1) had an allergic reaction to Aldoleo (Chlorthalidone) or other diuretics or have asthma, (2) kidney disease, (3) liver disease, (4) gout, (5) systemic lupus erythematosus, or (6) been taking other drugs such as cortisone, digitalis, lithium carbonate, or drugs for diabetes.

Patients should be cautioned to contact their physician if they experience any of the following symptoms of potassium loss: excess thirst, tiredness, drowsiness, restlessness, muscle pains or cramps, nausea, vomiting, or increased heart rate or pulse.

Patients should also be cautioned that taking alcohol can increase the chance of dizziness occurring.

Laboratory Tests

Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

All patients receiving Aldoleo (Chlorthalidone) should be observed for clinical signs of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids.

Drug Interactions

Aldoleo (Chlorthalidone) may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic peripheral adrenergic blocking drugs.

Medication such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Insulin requirements in diabetic patients may be increased, decreased, or unchanged. Higher dosage of oral hypoglycemic agents may be required. Latent diabetes mellitus may become manifest during Aldoleo (Chlorthalidone) administration.

Aldoleo (Chlorthalidone) and related drugs may increase the responsiveness to tubocurarine.

Aldoleo (Chlorthalidone) and related drugs may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

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Drug/Laboratory Test Interactions

Aldoleo (Chlorthalidone) and related drugs may decrease serum PBI levels without signs of thyroid disturbance.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No information available.

Pregnancy

Teratogenic Effects. Pregnancy Category B

Reproduction studies have been performed in the rat and the rabbit at doses up to 420 times the human dose and have revealed no evidence of harm to the fetus due to Aldoleo. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects

Thiazides cross the placental barrier and appear in cord blood. The use of Aldoleo (Chlorthalidone) and related drugs in pregnant women requires that the anticipated benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.

Nursing Mothers

Thiazides are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Aldoleo (Chlorthalidone), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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Pediatric Use

Safety and effectiveness in children has not been established.

ADVERSE REACTIONS:

To report SUSPECTED ADVERSE REACTIONS, please call RiconPharma LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency.

Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis.

Central Nervous System Reactions: dizziness, vertigo, paresthesias, headache, xanthopsia.

Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia.

Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis).

Cardiovascular Reactions: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics.

Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence.

Whenever adverse reactions are moderate or severe, Aldoleo (Chlorthalidone) dosage should be reduced or therapy withdrawn.

OVERDOSAGE

Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

DOSAGE AND ADMINISTRATION:

Therapy should be initiated with the lowest possible dose. This dose should be titrated according to individual patient response to gain maximal therapeutic benefit while maintaining lowest dosage possible. A single dose given in the morning with food is recommended; divided daily doses are unnecessary.

Hypertension

Initiation: Therapy, in most patients, should be initiated with a single daily dose of 25 mg. If the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 50 mg. If additional control is required, the dosage of Aldoleo (Chlorthalidone) may be increased to 100 mg once daily or a second antihypertensive drug (step 2 therapy) may be added. Dosage above 100 mg daily usually does not increase effectiveness. Increases in serum uric acid and decreases in serum potassium are dose-related over the 25 to 100 mg/day range.

Maintenance: Maintenance doses may be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.

Edema

Initiation: Adults, initially 50 to 100 mg daily, or 100 mg on alternate days. Some patients may require 150 to 200 mg at these intervals or up to 200 mg daily. Dosages above this level, however, do not usually produce a greater response.

Maintenance: Maintenance doses may often be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.

HOW SUPPLIED:

Aldoleo (Chlorthalidone) Tablets, USP are available containing 25 mg or 50 mg of Aldoleo (Chlorthalidone), USP.

The 25 mg tablets are green colored, biconvex, round shaped tablets debossed with ‘010’ on one side, and plain on the other side. They are available as follows:

NDC 51125-010-06

Bottles of 100 tablets

NDC 51125-010-09

Bottles of 1000 tablets

The 50 mg tablets are green colored, capsule shaped tablets debossed with ‘011’ on one side, and a break-line on the other side. They are available as follows:

NDC 51125-011-06

Bottles of 100 tablets

NDC 51125-011-09

Bottles of 1000 tablets

Store at 20ºC to 25º C (68º to 77º F).

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

ANIMAL

Pharmacology:

Biochemical studies in animals have suggested reasons for the prolonged effect of Aldoleo (Chlorthalidone). Absorption from the gastrointestinal tract is slow due to its low solubility. After passage to the liver, some of the drug enters the general circulation, while some is excreted in the bile, to be reabsorbed later. In the general circulation, it is distributed widely to the tissue, but is taken up in highest concentrations by the kidneys, where amounts have been found 72 hours after ingestion, long after it has disappeared from other tissues. The drug is excreted unchanged in the urine.

Manufactured for:

RiconPharma LLC.

Denville, NJ, 07834

Made in U.S.A

PC143 Revised: 03/17

Spironolactone:


Pharmacological action

Aldoleo is a potassium, magnesium sparing diuretic. This medication is a competitive antagonist of aldosterone on the effect on distal nephron (competes for binding sites on cytoplasmic protein receptors, reduces the synthesis of permeases in the aldosterone-sensitive part of collecting tubules and distal tubules), increases the excretion of Na+, Cl- and water and reduces the excretion of K+ and urea, reduces the titratable acidity of urine. Increased diuresis causes a hypotensive effect, which is unstable. The hypotensive effect is not dependent on the level of renin in the blood plasma and is not revealed in normal blood pressure.

The diuretic effect is seen at 2-5 days of treatment.

Pharmacokinetics

After oral administration Aldoleo (Spironolactone) absorbed from the gastrointestinal tract, the absorption is 90%. This drug metabolized in the liver, the major active metabolite is canrenone. T1/2 is 13-24 hours. This medicine derived primarily by the kidneys, some is excreted in the bile.

Why is Aldoleo prescribed?

Edema in congestive heart failure, cirrhosis of the liver (especially in the simultaneous presence of hypokalemia and hyperaldosteronism), in the nephrotic syndrome.

Swelling in the II and III trimester of pregnancy.

Hypertension, including with aldosterone producing adrenal adenoma (in combination therapy).

Primary hyperaldosteronism. Aldosterone produced adrenal adenoma (long-term maintenance therapy with contraindications to surgery or in case of refusal from it). Diagnosis of hyperaldosteronism.

Hypokalemia and its prevention in the treatment of saluretics.

Polycystic ovary syndrome, premenstrual syndrome.

Dosage and administration

The dosage regimen is set individually depending on the severity of violations of water-electrolyte metabolism and hormonal status.

In cases of edema - 100-200 mg / day in 2-3 recepts (usually in combination with the "loop" and / or thiazide diuretic) daily for 14-21 days. The correction of dose should be based on the values of potassium in the plasma. If necessary, repeat it every 10-14 days. In marked hyperaldosteronism and a reduced content of plasma potassium - 300 mg in 2-3 recepts.

Aldoleo (Spironolactone) side effects, adverse reactions

Digestive system: nausea, vomiting, abdominal pain, gastritis, ulcers and bleeding in the gastrointestinal tract, intestinal colic, diarrhea or constipation.

CNS: dizziness, drowsiness, lethargy, headache, lethargy, ataxia.

Metabolism: increased concentrations of urea, hypercreatininemia, hyperuricemia, impaired water-salt metabolism and KSCHR (metabolic acidosis or hypochloremic alkalosis).

Hematopoietic system: megaloblastosis, agranulocytosis, thrombocytopenia.

Endocrine system: in long-term use - gynecomastia, erectile dysfunction in men; women - dysmenorrhea, amenorrhea, metrorrhagia, menopause, hirsutism, deepening voice, breast tenderness, breast carcinoma.

Allergic reactions: urticaria, papular makulopapular and erythematous rash, drug fever, pruritus.

Other: muscle cramps, reduced potency.

Aldoleo contraindications

Addison's disease, hyperkalemia, hypercalcemia, hyponatremia, chronic renal failure, anuria, hepatic failure, diabetes mellitus with confirmed or suspected renal disease, diabetic nephropathy, I trimester of pregnancy, metabolic acidosis, menstrual disorders or breast enlargement, hypersensitivity to Aldoleo (Spironolactone).

Using during pregnancy and breastfeeding

There is no data on adverse effects of Aldoleo on pregnancy and fetal development.

However, in the I trimester of pregnancy this medication is contraindicated, in II and III trimester can be used for prescription. If necessary to use during lactation it should be considered that with breast milk in small amounts canrenone (metabolite of Aldoleo (Spironolactone)) excretes.

Category of the fetus by FDA - C.

Special instructions

Use Aldoleo (Spironolactone) cautiously in AV block (the possibility of strengthening due to the development of hyperkalemia), decompensated cirrhosis, surgery, taking drugs that cause gynecomastia, while taking local and general anesthetics in elderly patients.

Against the background of Aldoleo (Spironolactone) it should not be given medications containing potassium and other diuretics that cause potassium retention in the body. Patients should avoid using this drug with carbenoxolone, causing sodium retention.

In the period of treatment should be periodic determination of electrolytes and urea in the blood.

If taking of Aldoleo (Spironolactone) in combination with other diuretics or antihypertensive the dose of latters is recommended to be reduced.

In the application of this medicatio in conjunction with digoxin it may be necessary to reduce both the saturation and maintenance dose of the latter.

Aldoleo drug interactions

When this drug applied simultaneously with:

- antihypertensive drugs potentiated the hypotensive effect of Aldoleo (Spironolactone).

- ACE inhibitors may develop hyperkalemia (especially in patients with impaired renal function), as ACE inhibitors reduce the content of aldosterone, resulting in a delay of potassium in the body against the removal of potassium restriction.

- preparations of potassium and other potassium-sparing diuretics, salt substitutes and food supplements containing potassium may develop hyperkalemia.

- salicylates decreases the diuretic effect of Aldoleo (Spironolactone) due to blockade of canrenone excretion by the kidneys.

- decreases hypoprothrombinemic effect of oral anticoagulants.

- digitoxin may gain as well as reducing the effects of digitoxin.

- Aldoleo (Spironolactone) inhibits the excretion of digoxin by the kidneys, and probably reduce its volume of distribution. This may cause an increased concentration of digoxin in plasma.

- candesartan, losartan, eprosartan is a risk of hyperkalemia.

- cholestyramine it been described a case of hypochloremic alkalosis.

- lithium carbonate may increase the concentration of lithium in blood plasma.

- norepinephrine may decrease the sensitivity of vessels to noradrenaline.

- amplified effect triptorelin, buserelin, gonadorelin. Indomethacin and mefenamic acid inhibit the excretion of canrenone by kidneys.

Aldoleo in case of emergency / overdose

Symptoms: nausea, vomiting, drowsiness, dizziness, confusion, leg cramps, skin rash, diarrhea, dehydration may, disruption of water and electrolyte balance.

Treatment: discontinuation of the drug, induction of vomiting, gastric lavage, symptomatic treatment of dehydration and disorders of water and electrolyte balance, arterial hypotension, maintenance of vital functions; in the case of hyperkalemia - fast IV injection of 20-50% solution of glucose and insulin - 0.25-0.5 units / g of glucose. Used diuretics, and potassium carve ion exchange resins. Perhaps hemodialysis. There is no specific antidote for Aldoleo (Spironolactone) Quality Pharmaceutical Laboratory.

Aldoleo pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Aldoleo available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Aldoleo destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Aldoleo Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Aldoleo pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CHLORTHALIDONE TABLET [RICONPHARMA LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."ATENOLOL; CHLORTHALIDONE: 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/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Aldoleo?

Depending on the reaction of the Aldoleo after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Aldoleo not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Aldoleo addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Aldoleo, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Aldoleo consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Aldoleo drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Aldoleo is mentioned below.
Visitors%
Once in a day1
100.0%

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

One visitor reported age

Visitors%
> 601
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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