What happens if I overdose Prestarium neo?
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; severe dizziness or light-headedness; weakness.
Proper storage of Prestarium neo:
Store Prestarium neo at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, light, and moisture. Do not store in the bathroom. Keep Prestarium neo out of the reach of children and away from pets.
Overdose of Prestarium neo in details
In animals, doses of Prestarium neo up to 2500 mg/kg in mice, 3000 mg/kg in rats and 1600 mg/kg in dogs were non-lethal. Past experiences were scant but suggested that overdosage with other ACE inhibitors was also fairly well tolerated by humans. The most likely manifestation is hypotension, and treatment should be symptomatic and supportive. Therapy with the ACE inhibitor should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance and hypotension should be treated by established procedures.
However, of the reported cases of Prestarium neo overdosage, 1 (dosage unknown) required assisted ventilation and the other developed hypothermia, circulatory arrest and died following ingestion of up to 180 mg of Prestarium neo. The intervention for Prestarium neo overdose may require vigorous support.
Laboratory determinations of serum levels of Prestarium neo and its metabolites are not widely available and such determinations have, in any event, no established role in the management of Prestarium neo overdose.
No data are available to suggest physiological maneuvers (eg, maneuvers to change the pH of the urine) that might accelerate elimination of Prestarium neo and its metabolites. Prestarium neo can be removedby hemodialysis, with clearance of 52 mL/min for Prestarium neo and 67 mL/min for perindoprilat.
Angiotensin II could presumably serve as a specific antagonist-antidote in the settling of Prestarium neo overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of Prestarium neo is achieved through vasodilation and effective hypovolemia, it is reasonable to treat Prestarium neo overdose by infusion of normal saline solution.
What should I avoid while taking Prestarium neo?
Drinking alcohol can further lower your blood pressure and may increase certain side effects of Prestarium neo.
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.
Do not use salt substitutes or potassium supplements while taking Prestarium neo, unless your doctor has told you to.
Prestarium neo warnings
Anaphylactoid and Possibly Related Reactions
Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including Prestarium neo) may be subject to a variety of adverse events, some of them serious. Black patients receiving ACE inhibitors have a higher incidence of angioedema compared to nonblacks.
Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, or larynx has been reported in patients treated with ACE inhibitors, including Prestarium neo (0.1% of patients treated with Prestarium neo in U.S. clinical trials). Angioedema associated with involvement of the tongue, glottis or larynx may be fatal. In such cases, discontinue Prestarium neo treatment immediately and observe until the swelling disappears. When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, administer appropriate therapy, such as subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL), promptly.
Intestinal Angioedema: Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Hypotension
Prestarium neo can cause symptomatic hypotension. Prestarium neo has been associated with hypotension in 0.3% of uncomplicated hypertensive patients in U.S. placebo-controlled trials. Symptoms related to orthostatic hypotension were reported in another 0.8% of patients.
Symptomatic hypotension is most likely to occur in patients who have been volume or salt-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting.
ACE inhibitors may cause excessive hypotension, and may be associated with oliguria or azotemia, and rarely with acute renal failure and death. In patients with ischemic heart disease or cerebrovascular disease, an excessive fall in blood pressure could result in a myocardial infarction or a cerebrovascular accident.
In patients at risk of excessive hypotension, Prestarium neo therapy should be started under very close medical supervision. Patients should be followed closely for the first two weeks of treatment and whenever the dose of Prestarium neo and/or diuretic is increased.
If excessive hypotension occurs, the patient should be placed immediately in a supine position and, if necessary, treated with an intravenous infusion of physiological saline. Prestarium neo treatment can usually be continued following restoration of volume and blood pressure.
Neutropenia/Agranulocytosis
ACE inhibitors have been associated with agranulocytosis and bone marrow depression, most frequently in patients with renal impairment, especially patients with a collagen vascular disease such as systemic lupus erythematosus or scleroderma.
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 Prestarium neo as soon as possible.
Impaired Renal Function
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. Renal function should be monitored periodically in patients receiving Prestarium neo,.
In patients with severe congestive heart failure, where renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including Prestarium neo, may be associated with oliguria, progressive azotemia, and, rarely, acute renal failure and death.
In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur; usually reversible upon discontinuation of the ACE inhibitor. In such patients, renal function should be monitored during the first few weeks of therapy.
Some Prestarium neo-treated patients have developed minor and transient increases in blood urea nitrogen and serum creatinine especially in those concomitantly treated with a diuretic.
Hyperkalemia
Elevations of serum potassium have been observed in some patients treated with ACE inhibitors, including Prestarium neo. Most cases were isolated single values that did not appear clinically relevant and were rarely a cause for withdrawal. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus and the concomitant use of agents such as potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes.
Serum potassium should be monitored periodically in patients receiving Prestarium neo.
Cough
Presumably because of the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, generally resolving after discontinuation of therapy. Consider ACE inhibitor-induced cough in the differential diagnosis of cough.
Hepatic Failure
Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
Surgery/Anesthesia
In patients undergoing surgery or during anesthesia with agents that produce hypotension, Prestarium neo may block angiotensin II formation that would otherwise occur secondary to compensatory renin release. Hypotension attributable to this mechanism can be corrected by volume expansion.
What should I discuss with my healthcare provider before taking Prestarium neo?
Do not use this medication if you are allergic to Prestarium neo or to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, or trandolapril.
If you have diabetes, do not use Prestarium neo together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).
You may also need to avoid taking Prestarium neo with aliskiren if you have kidney disease.
You should not use Prestarium neo if you have hereditary angioedema.
To make sure you can safely take Prestarium neo, tell your doctor if you have any of these other conditions:
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kidney disease (or if you are on dialysis);
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liver disease;
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heart disease or congestive heart failure;
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diabetes; or
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a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis.
FDA pregnancy category D. Do not use Prestarium neo if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Prestarium neo can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking Prestarium neo.
It is not known whether Prestarium neo passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Prestarium neo precautions
General: Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Hypertensive Patients with Congestive Heart Failure: In patients with severe congestive heart failure, where renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including Prestarium neo, may be associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death.
Hypertensive Patients with Renal Artery Stenosis: In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur. Experience with ACE inhibitors suggests that these increases are usually reversible upon discontinuation of the drug. In such patients, renal function should be monitored during the first few weeks of therapy.
Some hypertensive patients without apparent preexisting renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient. These increases are more likely to occur in patients treated concomitantly with a diuretic and in patients with preexisting renal impairment. Reduction of dosages of Prestarium neo, diuretic or both may be required. In some cases, discontinuation of either or both drugs may be necessary.
Evaluation of hypertensive patients should always include an assessment of renal function.
Hyperkalemia: Elevations of serum potassium have been observed in some patients treated with ACE inhibitors, including Prestarium neo. In U.S. controlled clinical trials, 1.4% of the patients receiving Prestarium neo and 2.3% of patients receiving placebo showed increased serum potassium levels to >5.7 mEq/L. Most cases were isolated single values that did not appear clinically relevant and were rarely a cause for withdrawal. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus and the concomitant use of agents eg, potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes. Drugs associated with increases in serum potassium should be used cautiously, if at all, with Prestarium neo.
Cough: Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. Angiotensin-converting enzyme inhibitor-induced cough should be considered in the differential diagnosis of cough. In controlled trials with Prestarium neo, cough was present in 12% of Prestarium neo patients and 4.5% of patients given placebo.
Surgery/Anesthesia: In patients undergoing surgery or during anesthesia with agents that produce hypotension, Prestarium neo may block angiotensin II formation secondary to compensatory renin release. Hypotension attributable to this mechanism can be corrected by volume expansion.
Information on Excipients: This product contains 29.1925 mg of lactose monohydrate/Prestarium neo tert-butylamine 4-mg tablets. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take Prestarium neo.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis: No evidence of carcinogenic effect was observed in studies in rats and mice when Prestarium neo was administered at dosages up to 20 times (mg/kg) or 2-4 times (mg/m2) the maximum proposed clinical doses (16 mg/day) for 104 weeks.
Mutagenesis: No genotoxic potential was detected for Prestarium neo, perindoprilat and other metabolites in various in vitro and in vivo investigations, including the Ames test, the Saccharomyces cerevisiae D4 test, cultured human lymphocytes, TK ± mouse lymphoma assay, mouse and rat micronucleus tests and Chinese hamster bone marrow assay.
Use in pregnancy: Pregnancy Category D : When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Prestarium neo tert-butylamine should be discontinued as soon as possible.
Use in lactation: Milk of lactating rats contained radioactivity following administration 14C-Prestarium neo. lt is not known whether Prestarium neo is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Prestarium neo is given to nursing mothers.
Use in children: Safety and effectiveness of Prestarium neo in pediatric patients have not been established.
Use in the
Elderly: The mean blood pressure effect of Prestarium neo was somewhat smaller in patients >60 than in younger patients, although the difference was not significant. Plasma concentrations of both Prestarium neo and perindoprilat were increased in elderly patients compared to concentrations in younger patients. No adverse effects were clearly increased in older patients with the exception of dizziness and possibly rash.
Prestarium neo should be used with caution when administered to elderly patients who are at an increased risk for falls due to age, their underlying disease and/or their concurrent use of medication(s) associated with falls. Falls and fall-related events may be exacerbated by the central nervous system effects of dizziness and syncope as well as the symptomatic hypotension, including orthostatic, associated with Prestarium neo. Experience with Prestarium neo in elderly patients at daily doses exceeding 8 mg is limited.
What happens if I miss a dose of Prestarium neo?
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
- DrugBank. "PERINDOPRIL". http://www.drugbank.ca/drugs/DB00790 (accessed September 17, 2018).
- MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
