Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet Breastfeeding

For most of the drugs advantages of taking medications overweighs the potential risks however some drugs could be really dangerous for breastfed baby hence every medication shall be considered separately. In this page we will discuss about purpose of Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet and its risk associated with lactation. We will also discuss the usage of Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet and some common side effects associated with Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet.

What is Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet ?


Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Tribenzor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension. Tribenzor is a combination of an angiotensin II receptor blocker, a dihydropyridine calcium channel blocker, and a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1). Limitations of Use Tribenzor is not indicated for initial therapy.

Can I use Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet while breastfeeding?

Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet low risk for breastfeeding
There are 3 ingredients used in manufacturing of Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet .Based on our analysis of Olmesartan medoxomil, Amlodipine, Hydrochlorothiazide i.e. all 3 ingredients we can conclude that Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet has low risk associated with breastfeeding. Below is the summarized detail of breastfeeding effects associated with all 3 ingredients.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers It is not known whether amlodipine or olmesartan are excreted in human milk, but thiazides appear in human milk and olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet Breastfeeding Analsys


Olmesartan medoxomil while Breastfeeding

Low Risk

CAS Number: 144689-63-4

At latest update, relevant published data on excretion into breast milk were not found. A high protein-binding capacity makes excretion into breast milk unlikely. In addition, a low oral bioavailability makes difficult the absorption towards the infant's plasma from ingested milk, except in prematures or newborns who may show an increased absorption. Case report of kidney function impairment of a baby whose mother had taken Telmisartan in pregnancy. Until more data on this medication is available, safer alternative drugs are preferred, especially in premature babies or during the neonatal period. Should an ARA-II medication (Sartan type) be necessary, the associated risk may be decreased by choosing the one with a favorable pharmacokinetics (shorter half-life elimination time and lower bioavailability) like Eprosartan and Losartan

Amlodipine while Breastfeeding

Low Risk

CAS Number: 111470-99-6

It is excreted into breast milk in small amount (less than 10% of relative dose) without problems observed in infants whose mothers were on treatment with this drug. (Naito 2015, Ahn 2007)When measured, the plasma levels of drug in these infants were undetectable (Vasa 2013). Because its drug elimination period is very prolonged, an alternative drug known to be safer should be used, especially during the neonatal period and in case of premature infant.

Hydrochlorothiazide while Breastfeeding

Safe

CAS Number: 58-93-5

Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet and breastfeeding

Thiazide diuretic drug. Excretion into breast milk is clinically non-significant. No side-effects were observed in a one-month old breastfed baby whose mother was treated with this medication. Drug level in the plasma of this child was undetectable. Long-term treatment with diuretic drugs (particularly Thiazide type ones with long-lasting effect and loop-acting mechanism) may inhibit lactation, mostly if lactation is not well-established yet. Use as lower dose as possible, especially during the first postnatal month. American Academy of Pediatrics 2013: Maternal Medication Usually Compatible With Breastfeeding. WHO Model List of Essential Drugs 2002: Compatible with breastfeeding.


Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet Breastfeeding Analsys - 2


Olmesartan medoxomil while Breastfeeding

CAS Number: 144689-24-7

Because no information is available on the use of olmesartan during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Amlodipine while Breastfeeding

CAS Number: 88150-42-9

Limited information indicates that milk levels of amlodipine are usually low and plasma levels in breastfed infants are undetectable. Maternal use of amlodipine during breastfeeding has not caused any adverse effects in breastfed infants. If amlodipine is required by the mother, it is not a reason to discontinue breastfeeding.

Hydrochlorothiazide while Breastfeeding

CAS Number: 58-93-5

Hydrochlorothiazide doses of 50 mg daily or less are acceptable during lactation. Intense diuresis with large doses may decrease breastmilk production.


Is Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet safe while breastfeeding

What should I do if I am breastfeeding mother and I am already exposed to Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet?

During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet then you shall inform your doctor, But you should not be worried too much as Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet comes in category of low risk drug.


My doctor has prescribed me Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet, what should I do?

Though Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.


If I am using Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Tribenzor | Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week

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