Logroton Retard

Chlorthalidone:

• Indications and usage:
• Contraindications:
• Warnings:
• Precautions:
• Information for patients
• Laboratory tests
• Drug interactions
• Drug/laboratory test interactions
• Carcinogenesis, mutagenesis, impairment of fertility
• Pregnancy
• Nursing mothers
• Pediatric use
• Adverse reactions:
• Overdosage
• Dosage and administration:
• How supplied:
• Animal pharmacology:
• Logroton Retard (Chlorthalidone) reviews

INDICATIONS AND USAGE:

Diuretics such as Logroton Retard 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.

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

Logroton Retard (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. Logroton Retard (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.

CONTRAINDICATIONS:

Anuria.

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

WARNINGS:

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

Logroton Retard (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 Logroton Retard (Chlorthalidone). However, systemic lupus erythematosus has not been reported following Logroton Retard (Chlorthalidone) administration.

PRECAUTIONS:

General

Hypokalemia may develop with Logroton Retard (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 Logroton Retard (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.

Information for Patients

Patients should inform their physician if they have: (1) had an allergic reaction to Logroton Retard (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 Logroton Retard (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

Logroton Retard (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 Logroton Retard (Chlorthalidone) administration.

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

Logroton Retard (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.

Drug/Laboratory Test Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

No information available.

Pregnancy

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 Logroton Retard. 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 Logroton Retard (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 Logroton Retard (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.

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, Logroton Retard (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 Logroton Retard (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:

Logroton Retard (Chlorthalidone) Tablets, USP are available containing 25 mg or 50 mg of Logroton Retard (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 Logroton Retard (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

Metoprolol Tartrate:

• Pharmacological action
• Pharmacokinetics
• Why is Logroton Retard prescribed?
• Dosage and administration
• Logroton Retard (Metoprolol Tartrate) side effects, adverse reactions
• Logroton Retard contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Logroton Retard drug interactions
• Logroton Retard in case of emergency / overdose
• Logroton Retard (Metoprolol Tartrate) reviews

Pharmacological action

Logroton Retard is a cardioselective beta1-blocker without intrinsic sympathomimetic activity. This medication has antihypertensive, antianginal and antiarrhythmic effect. Logroton Retard (Metoprolol Tartrate) decreases automaticity of sinus node, reducing heart rate, slows AV-conduction, decreases myocardial contractility and excitability, reduces cardiac output, reduces myocardial oxygen demand. This drug inhibits the stimulatory effect of catecholamines on the heart during physical and psycho-emotional stress.

Logroton Retard (Metoprolol Tartrate) causes a hypotensive effect which is stabilized by the end of the second week of a course. With angina Logroton Retard (Metoprolol Tartrate) reduces the frequency and severity of attacks.

This medicine also normalizes the heart rate during supraventricular tachycardia and atrial fibrillation; when myocardial infarction it contributes to limit the zone of ischemia of the heart muscle and reduces the risk of developing fatal arrhythmias, reduces the risk of recurrence of myocardial infarction. When Logroton Retard (Metoprolol Tartrate) is used in the medium therapeutic doses it has a less pronounced effect on smooth muscles of the bronchi and peripheral arteries than non-selective beta-blockers.

Pharmacokinetics

After oral administration Logroton Retard (Metoprolol Tartrate) is rapidly and almost completely absorbed from the gastrointestinal tract, C_max of the active substance in the blood plasma is reached after 1-2 hours. This medication intensively metabolized in the liver to form inactive metabolites. T_1/2 of Logroton Retard (Metoprolol Tartrate) from plasma is 3-4 h and during the course of treatment it does not change. More than 95% of the dose excreted by the kidneys of which only 3% is in unchanged form.

Why is Logroton Retard prescribed?

Hypertension, prevention of angina, cardiac arrhythmias (supraventricular tachycardia, extrasystoles), secondary prevention after myocardial infarction, cardiac hyperkinetic syndrome (including in hyperthyroidism, NDCs). Prophylaxis of migraine.

Dosage and administration

For oral administration the average dose of Logroton Retard is 100 mg / day in 1-2 reception. If necessary the daily dose gradually increased up to 200 mg. For IV injections a single dose is 2.5 mg, with no effect a re-introduction is possible in 5 minutes.

Maximum daily dose for oral administration is 400 mg, for IV injections a single dose is 15-20 mg.

Logroton Retard (Metoprolol Tartrate) side effects, adverse reactions

Cardiovascular system: possible bradycardia, hypotension, AV-conduction disturbances, symptoms of heart failure.

Digestive system: at the beginning of therapy may include dry mouth, nausea, vomiting, diarrhea, constipation, and in some cases - liver function abnormalities.

CNS and peripheral nervous system: at the beginning of therapy may be weakness, fatigue, dizziness, headache, muscle cramps, coldness and paresthesia in the extremities; possible reduction in the secretion of tear fluid, conjunctivitis, rhinitis, depression, sleep disturbances, nightmares.

Hemopoietic system: in some cases - thrombocytopenia.

Endocrine: hypoglycemic state in patients with diabetes.

Respiratory system: in predisposed patients may cause symptoms of bronchial obstruction.

Allergic reactions: skin rash, itching.

Logroton Retard contraindications

AV-block II and III degree, sinoatrial block, bradycardia (heart rate below 50 beats / min), SSS, hypotension, chronic heart failure IIB-III stages, acute heart failure, cardiogenic shock, metabolic acidosis, pronounced disturbances of peripheral circulation, increased sensitivity to Logroton Retard (Metoprolol Tartrate).

Using during pregnancy and breastfeeding

Taking of Logroton Retard during pregnancy is only possible if the intended benefits to the mother outweighs the potential risk to the fetus. This medication crosses the placental barrier. In connection with the possible development of a newborn bradycardia, hypotension, hypoglycemia, and respiratory failure, Logroton Retard (Metoprolol Tartrate) should be abolished for 48-72 hours before the scheduled date of delivery. After delivery it is necessary to ensure strict monitoring of the newborn within 48-72 hours.

Logroton Retard (Metoprolol Tartrate) in small amounts excreted in breast milk. The using during lactation is not recommended.

Special instructions

With careful use in patients with chronic obstructive airways disease, diabetes (especially during labile), Raynaud's disease and obliterative peripheral arterial disease, pheochromocytoma (to be used in combination with alpha-blockers), pronounced renal and liver functions impairment.

During treatment with Logroton Retard (Metoprolol Tartrate) a production of lacrimal fluid may decreases, which is important for patients who use contact lenses.

Completion of a long course of treatment with Logroton Retard (Metoprolol Tartrate) should be gradual (at least 10 days) under the supervision of a physician.

There is not recommended for concurrent use of Logroton Retard (Metoprolol Tartrate) with MAO inhibitors.

Combined therapy with clonidine should receive the later stop in a few days after discontinuation of Logroton Retard (Metoprolol Tartrate), in order to avoid a hypertensive crisis. Simultaneous administration of Logroton Retard (Metoprolol Tartrate) with hypoglycemic agents require correction of their dosing regimen.

A few days before the anesthesia it is necessary to stop taking this drug or find any anesthesia medication with minimal negative inotropic effects.

Patients whose work requires more attention, the application of Logroton Retard (Metoprolol Tartrate) outpatients should be addressed only after the evaluation of individual patient response.

Logroton Retard drug interactions

Sympatholytics, nifedipine, nitroglycerin, diuretics, hydralazine and other antihypertensive drugs potentiate hypotension.

Antiarrhythmic and anesthetic medications increase the risk of bradycardia, arrhythmia, hypotension.

Digitalis drugs potentiate slowing AV conduction.

Simultaneously intravenous injection of verapamil and diltiazem may cause cardiac arrest.

Beta-adrenoceptor agonists, aminophylline, cocaine, estrogens, indomethacin and other NSAIDs impair antihypertensive effect.

Logroton Retard (Metoprolol Tartrate) enhances and prolongs the action of anti depolarizing muscle relaxants.

Combination with alcohol leads to mutual reinforcement of inhibitory effects on the CNS.

Allergens increased the risk of severe systemic allergic reactions or anaphylaxis.

Logroton Retard (Metoprolol Tartrate) edits the effectiveness of insulin and oral antidiabetic drugs and increases the risk of hypoglycemia.

Oral contraceptives, cimetidine, ranitidine, phenothiazines raise the level of this drug in the blood, rifampicin decreases it.

Logroton Retard (Metoprolol Tartrate) reduces the clearance of lidocaine, the effectiveness of beta 2-agonists (it is necessary to increase the dose of the latter).

This medicine is incompatible with MAO inhibitors of type A.

Logroton Retard in case of emergency / overdose

Symptoms: hypotension, acute heart failure, bradycardia, heart block, AV block, cardiogenic shock, bronchospasm, trouble breathing and consciousness, coma, nausea, vomiting, generalized convulsions, cyanosis (manifest in 20 minutes - 2 hours after taking of Logroton Retard (Metoprolol Tartrate)).

Treatment: gastric lavage, the symptomatic therapy: atropine sulfate injection (IV fast 0.5-2 mg) if bradycardia and a violation of AV conduction; glucagon (1-10 mg IV, then IV infusion 2-2.5 mg / h) and dobutamine in the case of reduction of myocardial contractility; agonists (noradrenaline, adrenaline, etc.) when arterial hypotension; diazepam (IV slowly) to eliminate seizures; beta-agonists inhalation or IV jet injection of aminophylline to relieve broncho spastic reactions; cardioacceleration.