Amlodipine And Valsartan Tablet Breastfeeding

Breast milk is superior in nutrition, It provides resistance against infections and allergies, It is naturally sterile. Despite all the advantages of breastfeeding some mothers choose to pause the breastfeeding in fear of harmful effects of medicines passing in breast milk. Are you wondering about breastfeeding and using Amlodipine And Valsartan Tablet ? Know what is Amlodipine And Valsartan Tablet and how it can affect your breast milk and whether Amlodipine And Valsartan Tablet is safe for your kid or not.

What is Amlodipine And Valsartan Tablet used for?


Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled on monotherapy ( 1) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension Amlodipine and valsartan tablets are 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and valsartan tablets. 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 1 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. Amlodipine and valsartan tablets are indicated for the treatment of hypertension. Amlodipine and valsartan tablets may be used in patients whose blood pressure is not adequately controlled on either monotherapy. Amlodipine and valsartan tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of amlodipine and valsartan tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of amlodipine and valsartan tablets. Patients with stage 2 hypertension (moderate or severe) are at a relatively higher risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high-dose multifactorial study [see CLINICAL STUDIES (14)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and valsartan tablets compared to amlodipine or valsartan monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with amlodipine and valsartan tablets 10/320 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8 Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8 Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8 Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8 For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 67% likelihood of achieving a goal of <140 mmHg (systolic) and 80% likelihood of achieving <90 mmHg (diastolic) on amlodipine alone, and the likelihood of achieving these goals on valsartan alone is about 47% (systolic) or 62% (diastolic). The likelihood of achieving these goals on amlodipine and valsartan tablets rises to about 80% (systolic) or 85% (diastolic). The likelihood of achieving these goals on placebo is about 28% (systolic) or 37% (diastolic). image-01 image-02 image-03 image-04

Amlodipine And Valsartan Tablet while breastfeeding safe or not? Can there be any side effects for infant while using it during breastfeeding?

Amlodipine And Valsartan Tablet low risk for breastfeeding
Amlodipine and Valsartan are the two main ingredients of Amlodipine And Valsartan Tablet. Based on our individual analysis of Amlodipine and Valsartan we can safely say that Amlodipine And Valsartan Tablet has low risk while breastfeeding. Below we have summarized the usage of Amlodipine and Valsartan while breastfeeding, we recommend you to go through it for better understanding of your usage.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while amlodipine is administered. It is not known whether valsartan is excreted in human milk. Valsartan was excreted into the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from amlodipine and valsartan tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Amlodipine And Valsartan Tablet Breastfeeding Analsys


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.

Valsartan while Breastfeeding

Low Risk

CAS Number: 137862-53-4

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 And Valsartan Tablet Breastfeeding Analsys - 2


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.

Valsartan while Breastfeeding

CAS Number: 137862-53-4

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



What if I already have used Amlodipine And Valsartan Tablet?

Amlodipine And Valsartan Tablet is in the category of low risk, if you have already used it then its not a big deal if health and behavior of baby is good. However your health care provider shall be aware of the fact that you have used Amlodipine And Valsartan Tablet so you should inform him based on your convenience.


I am nursing mother and my doctor has suggested me to use Amlodipine And Valsartan Tablet, is it safe?

Though Amlodipine And Valsartan 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 Amlodipine And Valsartan Tablet, will my baby need extra monitoring?

Not much monitoring required while using Amlodipine And Valsartan Tablet


Who can I talk to if I have questions about usage of Amlodipine And Valsartan 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