Eritel CH LS Overdose

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Consists of Chlorthalidone, Telmisartan

What happens if I overdose Chlorthalidone (Eritel CH LS)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dizziness; dry mouth; excessive urination followed by a decrease in amount of urine; muscle cramps; nausea; vomiting; weak or irregular heartbeat.

Proper storage of Chlorthalidone (Eritel CH LS):

Store Chlorthalidone (Eritel CH LS) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorthalidone (Eritel CH LS) out of the reach of children and away from pets.

Overdose of Chlorthalidone (Eritel CH LS) in details

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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.

What should I avoid while taking Chlorthalidone (Eritel CH LS)?

Avoid drinking alcohol, which can increase some of the side effects of Chlorthalidone (Eritel CH LS).

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Chlorthalidone (Eritel CH LS) can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Chlorthalidone (Eritel CH LS) warnings

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

Chlorthalidone (Eritel CH LS) 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 Chlorthalidone (Eritel CH LS). However, systemic lupus

erythematosus has not been reported following Chlorthalidone (Eritel CH LS) administration.

What should I discuss with my healthcare provider before taking Chlorthalidone (Eritel CH LS)?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Chlorthalidone (Eritel CH LS), the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Chlorthalidone (Eritel CH LS) or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Chlorthalidone (Eritel CH LS) in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of Chlorthalidone (Eritel CH LS) in geriatric patients. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose for patients receiving Chlorthalidone (Eritel CH LS).

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Chlorthalidone (Eritel CH LS), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Chlorthalidone (Eritel CH LS) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using Chlorthalidone (Eritel CH LS) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of Chlorthalidone (Eritel CH LS). Make sure you tell your doctor if you have any other medical problems, especially:

Chlorthalidone (Eritel CH LS) precautions

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GENERAL PRECAUTIONS

Hypokalemia may develop with Chlorthalidone (Eritel CH LS) 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 Chlorthalidone (Eritel CH LS). 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 postsympathectomy 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 Chlorthalidone (Eritel CH LS) 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 Chlorthalidone (Eritel CH LS) 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

Chlorthalidone (Eritel CH LS) may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic peripheraladrenergic 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 Chlorthalidone (Eritel CH LS) administration.

Chlorthalidone (Eritel CH LS) and related drugs may increase the responsiveness to tubocurarine.

Chlorthalidone (Eritel CH LS) 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 & OR LABORATORY TEST INTERACTIONS

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

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

No information is 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 Chlorthalidone (Eritel CH LS). 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 Chlorthalidone (Eritel CH LS) 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 Chlorthalidone (Eritel CH LS), 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 have not been established.

What happens if I miss a dose of Chlorthalidone (Eritel CH LS)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose Telmisartan (Eritel CH LS)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or slow heartbeat; severe dizziness or light-headedness.

Proper storage of Telmisartan (Eritel CH LS):

Store Telmisartan (Eritel CH LS) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Telmisartan (Eritel CH LS) out of the reach of children and away from pets.

Overdose of Telmisartan (Eritel CH LS) in details

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There is limited information available with regard to overdose in humans.

Symptoms: The most prominent manifestations of Telmisartan (Eritel CH LS) overdose were hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation, dizziness, increase in serum creatinine,and acute renal failure have also been reported.

Treatment: Telmisartan (Eritel CH LS) is not removed by hemodialysis. The patient should be closely monitored and the treatment should be symptomatic and supportive. Management depends on the time since ingestion and the severity of the symptoms. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacement given quickly.

What should I avoid while taking Telmisartan (Eritel CH LS)?

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of Telmisartan (Eritel CH LS).

Do not use potassium supplements or salt substitutes while you are taking Telmisartan (Eritel CH LS), unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Telmisartan (Eritel CH LS) warnings

Fetal Toxicity

Pregnancy Category D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Telmisartan (Eritel CH LS) as soon as possible.

Hypotension

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of therapy with Telmisartan (Eritel CH LS). Either correct this condition prior to administration of Telmisartan (Eritel CH LS), or start treatment under close medical supervision with a reduced dose.

If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Hyperkalemia

Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at risk.

Impaired Hepatic Function

As the majority of Telmisartan (Eritel CH LS) is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Initiate Telmisartan (Eritel CH LS) at low doses and titrate slowly in these patients.

Impaired Renal Function

As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal function in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal dysfunction), treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results have been reported with Telmisartan (Eritel CH LS).

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen were observed. There has been no long term use of Telmisartan (Eritel CH LS) in patients with unilateral or bilateral renal artery stenosis, but anticipate an effect similar to that seen with ACE inhibitors.

Dual Blockade of the Renin-Angiotensin-Aldosterone System

Dual blockade of the RAS with angiotensin-receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

Patients receiving the combination of Telmisartan (Eritel CH LS) and ramipril (in ONTARGET trial that enrolled 25,620 patients ≥55 years old with atherosclerotic disease or diabetes with endorgan damage – added for clarification) did not obtain any additional benefit compared to monotherapy, but experienced an increase incidence of renal dysfunction (e.g., acute renal failure) compared with groups receiving Telmisartan (Eritel CH LS) alone or ramipril alone.

Concomitant use of Telmisartan (Eritel CH LS) and ramipril is not recommended.

In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on Telmisartan (Eritel CH LS) and other agents that affect the RAS. Do not co-administer aliskiren with Telmisartan (Eritel CH LS) in patients with diabetes. Avoid concomitant use of aliskiren with Telmisartan (Eritel CH LS) in patients with renal impairment (GFR <60 mL/min/1.73 m2).

What should I discuss with my healthcare provider before taking Telmisartan (Eritel CH LS)?

You should not use Telmisartan (Eritel CH LS) if you are allergic to Telmisartan (Eritel CH LS).

If you have diabetes, do not use Telmisartan (Eritel CH LS) together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

You may also need to avoid taking Telmisartan (Eritel CH LS) with aliskiren if you have kidney disease.

To make sure this medicine is safe for you, tell your doctor if you have:

FDA pregnancy category D. Do not use Telmisartan (Eritel CH LS) if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Telmisartan (Eritel CH LS) can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether Telmisartan (Eritel CH LS) passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Telmisartan (Eritel CH LS) precautions

Renovascular Hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.

Renal Impairment and Kidney Transplant: When Telmisartan (Eritel CH LS) is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Telmisartan (Eritel CH LS) in patients with a recent kidney transplant.

Intravascular Volume Depletion: Symptomatic hypotension, especially after the 1st dose, may occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting. Such conditions should be corrected before the administration of Telmisartan (Eritel CH LS). Volume and/or sodium depletion should be corrected prior to administration of Telmisartan (Eritel CH LS).

Dual Blockade of the Renin-Angiotensin-Aldosterone System: As a consequence of inhibiting the renin-angiotensin-aldosterone system changes in renal function (including renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system. Dual blockade of the renin-angiotensin-aldosterone system (eg, by adding an ACE inhibitor or the direct renin-inhibitor aliskiren to an angiotensin II receptor antagonist) should therefore be limited to individually defined cases with close monitoring of renal function.

Other Conditions with Stimulation of the Renin-Angiotensin-Aldosterone System: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (eg, patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system has been associated with acute hypotension, hyperazotemia, oliguria or rarely, acute renal failure.

Primary Aldosteronism: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of Telmisartan (Eritel CH LS) is not recommended.

Aortic and Mitral Valve Stenosis, Obstructive Hypertrophic Cardiomyopathy: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy.

Hyperkalemia: During treatment with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur, especially in the presence of renal impairment and/or heart failure. While this is not documented with Telmisartan (Eritel CH LS), adequate monitoring of serum potassium in patients at risk is recommended.

Based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase the potassium level (heparin, etc) may lead to an increase in serum potassium and should, therefore, be co-administered cautiously with Telmisartan (Eritel CH LS).

Hepatic Impairment: Telmisartan (Eritel CH LS) is eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Telmisartan (Eritel CH LS) should be used with caution in these patients.

Note for Diabetics: The recommended daily dose of Telmisartan (Eritel CH LS) 40-mg tab contains sorbitol 169 mg. Telmisartan (Eritel CH LS) is therefore unsuitable for patients with hereditary fructose intolerance.

Others: As observed for angiotensin-converting enzyme inhibitors, Telmisartan (Eritel CH LS) and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.

As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

Use in children: There are no data on the safety and efficacy of Telmisartan (Eritel CH LS) in children.

What happens if I miss a dose of Telmisartan (Eritel CH LS)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.



References

  1. DailyMed. "AMLODIPINE BESYLATE; TELMISARTAN: 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).
  2. 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/dailyme... (accessed September 17, 2018).
  3. DrugBank. "Telmisartan". http://www.drugbank.ca/drugs/DB00966 (accessed September 17, 2018).

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