What happens if I overdose Pritoral?
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 Pritoral:
Store Pritoral 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 Pritoral out of the reach of children and away from pets.
Overdose of Pritoral in details
There is limited information available with regard to overdose in humans.
Symptoms: The most prominent manifestations of Pritoral 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: Pritoral 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 Pritoral?
Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of Pritoral.
Do not use potassium supplements or salt substitutes while you are taking Pritoral, 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.
Pritoral 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 Pritoral 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 Pritoral. Either correct this condition prior to administration of Pritoral, 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 Pritoral is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Initiate Pritoral 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 Pritoral.
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 Pritoral 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 Pritoral 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 Pritoral alone or ramipril alone.
Concomitant use of Pritoral 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 Pritoral and other agents that affect the RAS. Do not co-administer aliskiren with Pritoral in patients with diabetes. Avoid concomitant use of aliskiren with Pritoral in patients with renal impairment (GFR <60 mL/min/1.73 m2).
What should I discuss with my healthcare provider before taking Pritoral?
You should not use Pritoral if you are allergic to Pritoral.
If you have diabetes, do not use Pritoral together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).
You may also need to avoid taking Pritoral with aliskiren if you have kidney disease.
To make sure this medicine is safe for you, tell your doctor if you have:
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kidney disease (or if you are on dialysis);
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liver disease;
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heart disease;
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if you are dehydrated; or
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if you are on a low salt diet.
FDA pregnancy category D. Do not use Pritoral if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Pritoral 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 Pritoral passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Pritoral 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 Pritoral 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 Pritoral 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 Pritoral. Volume and/or sodium depletion should be corrected prior to administration of Pritoral.
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 Pritoral 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 Pritoral, 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 Pritoral.
Hepatic Impairment: Pritoral is eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Pritoral should be used with caution in these patients.
Note for Diabetics: The recommended daily dose of Pritoral 40-mg tab contains sorbitol 169 mg. Pritoral is therefore unsuitable for patients with hereditary fructose intolerance.
Others: As observed for angiotensin-converting enzyme inhibitors, Pritoral 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 Pritoral in children.
What happens if I miss a dose of Pritoral?
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
- 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).
- DrugBank. "Telmisartan". http://www.drugbank.ca/drugs/DB00966 (accessed September 17, 2018).
- MeSH. "Angiotensin II Type 1 Receptor Blockers". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
