Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin converting enzyme inhibitors, including Iperton. Patients should be so advised and told to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.
Iperton can cause a severe allergic reaction. Symptoms include:
- trouble breathing
- swelling of your face, lips, tongue, or throat
Call 911 or go to the nearest emergency room if you develop these symptoms.
Don’t take this drug again if you’ve ever had an allergic reaction to it before. Taking it again could be fatal (cause death).
VASOTEC® (Iperton Maleate) is the maleate salt of Iperton, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, Ipertonat. Iperton maleate is chemically described as (S)-1-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5•C4H4O4, and its structural formula is:
Iperton maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.
Iperton is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to Ipertonat, which is the active angiotensin converting enzyme inhibitor.
Iperton maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient Iperton maleate, each tablet contains the following inactive ingredients: lactose, magnesium stearate, sodium bicarbonate, and starch. The 10 mg and 20 mg tablets also contain iron oxides.
Conversion from IV to oral dosage form
If not concurrently receiving diuretics, initiate Iperton 5 mg PO qDay; if concurrently receiving diuretics and responding to 0.625 mg IV q6hr, initiate at 2.5 mg PO qDay; titrate upwards as necessary
How to take Iperton
- Before you start the treatment, read the manufacturer's printed information leaflet from ins >
Q: About two weeks ago, while undergoing tests for allergies, I had an allergic reaction - swelling in my lips. I usually take Iperton and I took 20 mg doing that time. It didn't seem to work to help lower my blood pressure, which rose to 183/121. Anyhow, since then I've been careful to avoid anything with any type of nuts since the reaction was caused by almonds. However, I noticed yesterday under my lower lip a funny feeling and I eventually looked in the mirror. I saw redness and one small spot of swelling on the skin. I was baffled as to what could have caused it. I later remember it hadn't been long since I'd taken a dose of Iperton. Could this now be causing the angioedema? I never had problems like this with the Iperton and I've been taking it at least five years. I do feel I have "plateaued" on it. I've been taking the maximum dose for more than a year and it doesn't seem to have the same effects as before. Second question - I can only take ACE Inhibitors and ARBs to lower my BP because of other medical conditions, including CHF. Should I get another ACE Inhibitor? My BP is around 140/90 when I take Iperton only, and I was supposed to have a second med, but which one? I've had trouble with some of the others including clonidine, Nifedipine, Norvasc, metoprolol and propanolol, and they all had to be stopped.
A: Angioedema is an uncommon side effect with Iperton and usually occurs in the first month of treatment. Although it is possible to have this condition occur later in treatment, it is more common in African-American patients, women and people who have a history of drug or seasonal allergies. The exact prevalence and incidence of ARB-induced angioedema are not known, but are thought to be significantly lower than the ACE inhibitors. For patients who cannot take any other alternatives, ARBs seem the way to go for people who have had this issue with ACE inhibitors, although careful monitoring is recommended for the physician. There are no clear cut ways to distinguish which medication would be best in this case for your condition, but it has been shown that losartan (Cozaar) seems to show the most cases with angioedema, if it happens at all, with the ARBs. Lori Mendoza, PharmD Poulin, PharmD
Immediate action required: Call 999 or go to A&E if:
- you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
- you're wheezing
- you get tightness in the chest or throat
- you have trouble breathing or talking
- your mouth, face, lips, tongue or throat start swelling
You could be having a serious allergic reaction and may need immediate treatment in hospital.
These are not all the side effects of Iperton. For a full list see the leaflet inside your medicines packet.
You can report any suspected side effect to the UK safety scheme.
For hypertension patients on diuretics, if possible discontinue diuretics 2-3 days before starting Iperton.
Excessive hypotension if concomitant diuretics, hypovolemia, or hyponatremia.
Risk of high blood potassium (hyperkalemia), especially in patients with renal impairment or diabetes mellitus or in those taking concomitant potassium-elevating drugs.
Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy.
Injection contains benzyl alcohol preservative (linked to potentially fatal "gasping syndrome" in preemies).
ACE inhibition also causes an increase in bradykinin levels, which putatively mediates angioedema.
Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors.
If laryngeal stridor or angioedema of the face, tongue, or glottis occurs discontinue therapy and institute appropriate therapy immediately.
Patients receiving co-administration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema Intestinal angioedema has been reported in patients treated with ACE inhibitors.
Dry hacking nonproductive cough may occur within few months of treatment; consider other causes of cough prior to discontinuation.
Agranulocytosis, neutropenia, or leukopenia with myeloid hypoplasia reported with other ACE inhibitor; patients with renal impairment are at high risk; monitor CBC with differential in these patients.
Discontinue immediately if patient becomes pregnant.
Less effective in people of African ethnicity.
Drugs called neprilysin inhibitors
These drugs are used to treat heart failure. They should not be used with Iperton. Do not use Iperton within 36 hours of switching to or from a neprilysin inhibitor. Using these drugs together raises your risk of angioedema (sudden swelling of your face, arms, legs, lips, tongue, throat, and intestines).
An example of this drug class includes:
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
Iperton oral tablet comes with several warnings.
In trials in patients treated with digitalis and diuretics, treatment with Iperton resulted in decreased systemic vascular resistance, blood pressure, pulmonary capillary wedge pressure and heart size, and increased cardiac output and exercise tolerance. Heart rate was unchanged or slightly reduced, and mean ejection fraction was unchanged or increased. There was a beneficial effect on severity of heart failure as measured by the New York Heart Association (NYHA) classification and on symptoms of dyspnea and fatigue. Hemodynamic effects were observed after the first dose and appeared to be maintained in uncontrolled studies lasting as long as four months. Effects on exercise tolerance, heart size, and severity and symptoms of heart failure were observed in placebo-controlled studies lasting from eight weeks to over one year.
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 VASOTEC as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the reninangiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue VASOTEC, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to VASOTEC for hypotension, oliguria, and hyperkalemia (see PRECAUTIONS, Pediatric use).
No teratogenic effects of Iperton were seen in studies of pregnant rats and rabbits. On a body surface area basis, the doses used were 57 times and 12 times, respectively, the maximum recommended human daily dose (MRHDD).
Iperton oral tablet is a prescription drug that’s available as the brand-name drug Vasotec. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.
Iperton also comes as a prescription oral solution.
What other drugs will affect Iperton?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Iperton, especially:
a diuretic or "water pill";
gold injections to treat arthritis; or
NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may interact with Iperton, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
1. About Iperton
Iperton is a medicine used to reduce high blood pressure and to prevent or treat heart failure.
If you have high blood pressure, taking Iperton will help prevent a future heart attack or stroke.
This medicine is only available on prescription. It comes as tablets. It also comes as a liquid for people who find it hard to swallow tablets but your pharmacist will have to order this for you.
Iperton is also available mixed with another blood pressure medicine called hydrocholorothiazide.