Possible benefits of using aspirin during pregnancy
Aspirin is one of the most commonly used over the counter drugs and is used for such diverse conditions as mild to moderate pain like headaches or menstrual cramps, mild to moderate arthritis and other inflammatory conditions, and as a blood thinner to prevent inappropriate clotting of blood that could cause thromboses, heart attacks and stroke. The use of aspirin during pregnancy is controversial and generally discouraged unless specific health conditions in the mother exist so that the benefits of using a low dose aspirin regimen outweigh possible risks that will be described in more detail below.
Studies have shown that low-does aspirin during pregnancy can reduce the risk for having a premature birth in women who have several risk factors for premature births, like having had a premature birth or preterm labor in the past or having diabetes or high blood pressure. A French study in women taking low dose aspirin during pregnancy to prevent premature birth showed that the children of these women had fewer problems five years after birth than the children of women who had not taken low-dose aspirin during the pregnancy.
Low dose aspirin during pregnancy is also often prescribed for women who have risk factors to develop a pregnancy associated disease that is called preeclampsia and that causes the blood pressure to rise to unsafe levels and also damages the kidney. This condition can advance to a potentially fatal disease for both mother and child that is called eclampsia. Risk factors for developing preeclampsia during pregnancy are having had preeclampsia in a prior pregnancy, diabetes, kidney disease, and chronic high blood pressure. Although studies have shown that some women at risk for preeclampsia can benefit from taking low dose aspirin during pregnancy, there is controversy about which women are the best candidates for this therapy, when it should start, and how long and how much aspirin should be taken.
Other health conditions for which low dose aspirin are prescribed are conditions that come with an increased risk for blood clotting or thrombosis. These conditions can include women who have lupus and produce a blood clot producing antibody that is called lupus coagulant or women with a related disease called antiphospholipid syndrome
Possible risk of using aspirin during pregnancy
Despite the fact that there are studies that show that low dose aspirin can be beneficial for certain conditions, use of aspirin, in particular at the regular adult strength is associated with considerable risk for both the mother and the baby. This is the reason why the U.S. Food and Drug Administration (FDA) issued a warning in 1990 that said the following about the use of aspirin during pregnancy: "It is especially important not to use aspirin during the last three months of pregnancy, unless specifically directed to do so by a physician because it may cause problems in the unborn child or complications during delivery."
Aspirin is also included on the list of the California Environmental Protection Agency (CAL/EPA) Proposition 65 of developmental toxins (CAL/EPA Proposition 65 List). This listing means that an expert panel of scientists agreed that there is enough evidence to believe that this substance can harm unborn babies. This does not necessarily mean that aspirin taken at a low dose for a specific health condition during the harms the baby in any case, but there are several mechanisms how aspirin can cause problems during pregnancy, especially in the last trimester. Aspirin and other non-steriodal anti-inflammatory drugs or NSAIDs work by inhibiting the synthesis of a certain family of inflammatory messenger molecules called prostaglandins. Prostaglandins, however, have also other functions in the body. One of the functions for example is the regulation of production of the mucus in the stomach that protects the stomach wall from the acid in the stomach. This is the reason why taking aspirin over a long time can cause stomach problems. In unborn babies, a drop in prostaglandin production happens during birth and is the signal to reroute the blood circulation to use the lung instead of the placenta as the source of oxygen. Taking a regular adult dose of aspirin during the last trimester of the pregnancy can cause a drop in prostaglandin production in the baby’s body and can thus cause the rerouting of the blood supply prematurely in the uterus. This can be fatal to the baby. There have also been studies that show that taking aspirin at the time of the conception or in the first weeks of the pregnancy is associated with an increased risk of miscarriages. Nevertheless, there have been other studies that did not find this result, and therefore it is still under debate whether aspirin can increase the risk of miscarriages. Since aspirin can inhibit blood clotting and works as a blood thinner, taking aspirin during pregnancy can increase the risk of bleeding problems during the delivery. However, taking low dose aspirin to decrease the risk of premature birth in women with risk factors for premature birth, did not increase the babies risk for bleeding in the brain in a French study. Bleeding in the brain is a condition premature babies often suffer from. Aspirin can also delay labor. This is one of the reasons why it is used for women with a high risk of premature birth, but this can cause problems in women that are full term. Aspirin is associated with a condition in children that is called Reye’s syndrome. This disease which causes are not entirely understood can damage many organs of the body, in particular the brain and the liver. It can be fatal and children taking aspirin have an increased risk of developing Reye’s syndrome. It is not known whether the risk for the baby of developing Reye’s syndrome after birth is increased, if the mother has taken aspirin during the pregnancy, but since aspirin is passed into the milk taking aspirin while breast feeding is strongly discouraged.
What is tamoxifen?
Tamoxifen is a drug that inhibits the action of the female hormone estrogen. It was originally developed as a morning after pill in the early 1960s, but has failed in this indication. Even though it was known that certain cancers respond to estrogen with growth and increased survival, a clinical trial to explore tamoxifen’s activity in advanced breast cancer was not done until 1971. Since the results were very promising, ICI pharmaceuticals, the company who had first synthesized the drug in 1962, followed up with several new clinical trials for breast cancer. It was approved for the use in advance breast cancer in the United Kingdom in 1973, followed by its approval in the United States in 1977.
In the 1980s, several clinical trial were published that showed a major effect of tamoxifen in early breast cancer especially when given as an adjunct therapy together with surgery or radiation therapy. Since it has a relatively mild side effects like hot flashes, dryness in the vagina, an increased risk for blood clots and other menopausal type symptoms, it is now also used in women who are still healthy, but have a high risk to develop breast cancer because of mutations in certain genes (“breast cancer genes” like e.g. BRCA1 and BRCA2) to prevent the development of breast cancer. In women with early breast cancer it can prevent the formation metastases, it can stop the growth of the original tumor and thus prevent its re-growth and it can also inhibit the development of new tumors in the other breast.
How does tamoxifen fight breast cancer?
Tamoxifen is an inhibitor of the female hormone estrogen. Healthy mammary gland tissue and many breast cancers have a protein on their cell surface that is called the estrogen receptor. This protein can bind the hormone estrogen. The binding of the hormone gives the cell a powerful stimulus that can make the cell grow and can also induce changes in the cell that can enable the cell to better survive stressful situation like e.g. when the cell is bombarded with radiation or other cancer drugs.
Tamoxifen inhibits the binding of estrogen to its receptor by binding in its place. However, tamoxifen cannot induce the signals that the binding of the estrogen to the receptor induces. It therefore inhibits the actions of estrogen much like if a key that can fit in a lock, but does not open the lock, is broken in it. The real key that can turn the lock is now useless, as it will no longer be able to fit into the lock. Since tamoxifen does this in all cells of the body that have the estrogen receptor on their surface, tamoxifen can cause side effects similar to the hormonal changes that are associated with menopause. Sometimes bodybuilders who abuse steroids also abuse tamoxifen, as it can increase the efficacy of steroids.
Why does tamoxifen fail to work for certain breast cancers?
There are several different reasons why tamoxifen fails to work for certain breast cancers. Some cancers are never sensitive to it, and others develop resistance over time. Researchers are now starting to understand the reasons behind this.
Not all breast cancers express the estrogen receptor on their cell surface. These types of cancers which, in contrast to the estrogen-depended ones that are called hormone sensitive and that respond well to treatment with tamoxifen, are called hormone insensitive and do not respond to treatment with tamoxifen at all. Before the start of a treatment regimen with tamoxifen, the physician will therefore determine first whether this specific case of breast cancer is of the hormone sensitive or insensitive kind.
After taking tamoxifen, the drug needs to go to the liver, where it is converted into its active form, before it can do its job in the breast cancer cells. Some people have mutations in the genes for the machinery in the liver that does this conversion process. Tamoxifen’s activity will be greatly reduced in these people, so that these people either need to take a higher dose and risk more side effects, or in more severe cases, Tamoxifen might not work at all. Genetic tests can be done to determine before the start of the treatment whether somebody has these mutations.
Sometimes the cancer cells change over time, and tumors that used to be sensitive to tamoxifen, suddenly don’t respond anymore. A recent study done by researchers at the Institute of Cancer Research’s (ICR) Breakthrough Breast Cancer Research Centre in London shows a new mechanism, how cancer cells can develop this resistance to tamoxifen.
Tamoxifen shuts down the signaling pathway of the hormone estrogen on breast cancer cells. Estrogen acts as a so-called growth factor on the cells, which means it’s a hormone that tells a cell to grow and induces changes in the cells that help them survive. Healthy cells in the body will die automatically, if they do not receive signals from growth factors regularly. Cancer cells often don’t die under these conditions, but they still will survive and grow better, in the presence of growth factors.
In biological systems, it is very common that an important function can be taken over by another similar system at least in part as an insurance policy in the case that something goes wrong with the primary system. This is especially true for growth factors that signal cells to grow and help them to survive stressful situations. There are many different growth factors that provide similar stimuli for the cell that have receptors for them on their cell surface. They are named by the kind of cell that produces them and sometimes additionally the kind of tissue that usually responds to them e.g. VEGF stand for vascular epithelial growth factor as it is a growth factor produced in the vasculature that acts on epithelial cells.
A very common growth factor that is truly an entire family of slightly different growth factors that all have very similar functions, is the family of FGF, which stands for fibroblast growth factor. There are more than 20 slightly different fibroblast growth factors known today. Fibroblast growth factors can induce cell growth and survival in a number of different tissues and they have an important role in the body. Lack of certain FGF’s can lead to conditions like e.g. an increased susceptibility for diabetes.
In cancerous tissue however, they can make cells less sensitive to certain cancer drugs and increase growth of the tumor. The recent study reported in the journal Cancer by the Institute of Cancer Research’s (ICR) Breakthrough Breast Cancer Research Centre in London showed that breast cancers that are resistant to tamoxifen treatment despite the fact that they express the estrogen receptor, often have multiple copies of an FGF-receptor called FGFR1. This enables the cells to produce much more of this receptor than healthy cells. The cells become hypersensitive to the actions of FGF’s, so that they need very little FGF to be able to survive. In the presence of FGF’s these cells no longer need to rely on estrogen for survival and growth, and thus tamoxifen is useless in the fight against these cancer cells.
Some cancer cells employed an even more deviant way to become independent of the estrogen survival signal. They acquired a mutation in the FGFR1 that enables this receptor to give the growth and survival signal even in the absence of the growth factor. Cancers that have this kind of short circuit in their signaling pathways are very hard to treat with chemotherapy of any kind and have a very poor prognosis.
Generic Name: atenolol (ah TEN oh lol)
Brand Names: Tenormin
What is atenolol?
Atenolol (Tenormin) is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).
Atenolol is used to treat angina (chest pain) and hypertension (high blood pressure). It is also used to treat or prevent heart attack.
Atenolol may also be used for purposes other than those listed in this medication guide.
Important information about atenolol
Do not stop taking atenolol without first talking to your doctor. Stopping suddenly may make your condition worse.
If you need to have any type of surgery, you may need to temporarily stop using atenolol. Be sure the surgeon knows ahead of time that you are using atenolol.
Atenolol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which could increase drowsiness and dizziness while you are taking atenolol.
Atenolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.
If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Store atenolol at room temperature away from moisture and heat.
What should I discuss with my healthcare provider before taking atenolol?
You should not use this medication if you are allergic to atenolol, or if you have certain heart conditions such as slow heartbeats, or heart block.
Before taking atenolol, tell your doctor if you have:
asthma, bronchitis, emphysema;
diabetes;
low blood pressure;
a heart problem such as heart block, sick sinus syndrome, slow heart rate, or congestive heart failure;
depression;
liver or kidney disease;
a thyroid disorder;
myasthenia gravis;
pheochromocytoma; or
problems with circulation (such as Raynaud's syndrome).
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use atenolol if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Atenolol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take atenolol?
Take atenolol exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.
Take this medication with a full glass of water.
Take atenolol at the same time every day.
Do not skip doses or stop taking atenolol without first talking to your doctor. Stopping suddenly may make your condition worse.
To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any visits to your doctor.
If you need to have any type of surgery, tell the surgeon that you are using atenolol. You may need to briefly stop using atenolol before having surgery.
Atenolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.
If you are being treated for high blood pressure, keep using atenolol even if you feel fine. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Store atenolol at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include uneven heartbeats, shortness of breath, bluish-colored fingernails, dizziness, weakness, fainting, or seizure (convulsions).
What should I avoid while taking atenolol?
Atenolol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which could increase drowsiness and dizziness while you are taking atenolol.
Atenolol side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
slow or uneven heartbeats;
feeling light-headed, fainting;
feeling short of breath, even with mild exertion;
swelling of your ankles or feet;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
depression; or
cold feeling in your hands and feet.
Less serious atenolol side effects may include:
decreased sex drive, impotence, or difficulty having an orgasm;
sleep problems (insomnia);
tired feeling; or
anxiety, nervousness.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect atenolol?
Before taking atenolol, tell your doctor if you are using:
allergy treatments (or if you are undergoing allergy skin-testing);
amiodarone (Cordarone, Pacerone);
clonidine (Catapres);
digoxin (digitalis, Lanoxin);
disopyramide (Norpace);
guanabenz (Wytensin);
an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam);
a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), or metformin (Glucophage);
a heart medication such as nifedipine (Procardia, Adalat), reserpine (Serpasil), verapamil (Calan, Verelan, Isoptin), diltiazem (Cartia, Cardizem);
medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), bitolterol (Tornalate), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair); or
cold medicines, stimulant medicines, or diet pills.
If you are using any of these drugs, you may not be able to take atenolol, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect atenolol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about atenolol.
What does my medication look like?
Atenolol is available with a prescription under the brand name Tenormin. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Tenormin 25 mg - round, flat, white, uncoated
Tenormin 50 mg - round, flat, white, uncoated
Tenormin 100 mg - round, flat, white, uncoated
- Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
Atenolol Pregnancy and Breastfeeding Warnings
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Atenolol Pregnancy Warnings
Atenolol crosses the placental barrier and appears in cord blood. Administration of atenolol in the second trimester of pregnancy has been associated with the birth of infants that are small for their gestational age. In addition, some data have shown a significantly decreased fetal heart rate and significantly decreased mean birth weight of infants whose mothers were taking atenolol relative to those taking acebutolol or pindolol. Case reports of profound beta-blockade in neonates of mothers who were taking atenolol are reported. Because of this, observation of affected neonates for bradycardia and hypotension is recommended for 48 hours postpartum. The results of one study indicate that maternal renal function, mean cardiac output, and heart rate are significantly increased, while mean total peripheral resistance is significantly decreased during the second and third trimesters as compared to 3 months postpartum.
Atenolol has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of dose-related embryotoxicity and fetotoxicity. Atenolol has been used during human pregnancy (starting in the second trimester) with evidence of lower birth weight and preterm (less than 37 weeks) delivery. Neonates born to mothers who are receiving atenolol at parturition may be at risk for hypoglycemia and bradycardia. Atenolol should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
Atenolol Breastfeeding Warnings
Atenolol is excreted into human breast milk at a ratio of 1.5 to 6.8 when compared to the concentration in plasma. Neonates born to mothers who are receiving atenolol and are breast-feeding may be at risk for hypoglycemia and bradycardia. The manufacturer recommends that caution be used when administering atenolol to nursing women.
Milk atenolol levels may be four times higher than maternal serum levels. One case of bradycardia, peripheral cyanosis, and hypothermia is reported in a nursing infant whose mother was taking atenolol 50 mg orally every 12 hours. The authors calculated that the atenolol exposure to the nursing infant was 9% of the mother's daily dose. Because of this, observation of nursing infants for bradycardia and hypotension is recommended during breast-feeding. In addition, neonates born to mothers who are breast-feeding may be at an increase risk for hypoglycemia. Premature infants or infants with impaired renal function may be more at risk to develop side effects.
Atenolol Dosage
Usual Adult Dose for Hypertension
Initial dose: 50 mg orally once a day. The full effect of this dose will usually be seen within 1 to 2 weeks. If an optimal response is not achieved, the dosage should be increased to 100 mg orally once a day.
Usual Adult Dose for Angina Pectoris Prophylaxis
Initial dose: 50 mg orally once a day. If an optimal response is not achieved within one week, the dosage should be increased to 100 mg orally once a day. Some patients may require a dosage of 200 mg once a day for optimal effect.
Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.
Usual Adult Dose for Angina Pectoris
Initial dose: 50 mg orally once a day. If an optimal response is not achieved within one week, the dosage should be increased to 100 mg orally once a day. Some patients may require a dosage of 200 mg once a day for optimal effect.
Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.
Usual Adult Dose for Myocardial Infarction
IV: 5 mg over 5 minutes followed by another 5 mg injection 10 minutes later.
Oral: In patients who tolerate the full IV dose (10 mg), atenolol tablets 50 mg should be initiated 10 minutes after the last IV dose followed by another 50 mg dose 12 hours later. Thereafter, either 100 mg once a day or 50 mg twice a day for 6 to 9 days.
Usual Adult Dose for Anxiety
Initial dose: 50 mg orally once a day.
Maintenance dose: In most cases data have shown no benefit and an increased risk of fatigue with daily doses greater than 100 mg.
Usual Adult Dose for Esophageal Variceal Hemorrhage Prophylaxis
Initial dose: 50 mg orally once a day.
Maintenance dose: In most cases data have shown no benefit and an increased risk of fatigue with daily doses greater than 100 mg.
Usual Adult Dose for Migraine Prophylaxis
Initial dose: 50 mg orally once a day.
Maintenance dose: In most cases data have shown no benefit and an increased risk of fatigue with daily doses greater than 100 mg.
Usual Adult Dose for Alcohol Withdrawal
Initial dose: 50 mg orally once a day.
Maintenance dose: Initial oral doses may be titrated upward as needed and tolerated approximately every 7 days. The maximum recommended daily dose is 200 mg.
Usual Adult Dose for Supraventricular Tachycardia
Initial dose: 50 mg orally once a day.
Maintenance dose: Initial oral doses may be titrated upward as needed and tolerated approximately every 7 days. The maximum recommended daily dose is 200 mg.
Usual Adult Dose for Ventricular Tachycardia
Initial dose: 50 mg orally once a day.
Maintenance dose: Initial oral doses may be titrated upward as needed and tolerated approximately every 7 days. The maximum recommended daily dose is 200 mg.
Renal Dose Adjustments
CrCl less than 15 mL/min: Maximum dose: 25 mg orally once a day.
CrCl 15 to 35 mL/min: Maximum dose: 50 mg orally once a day.
Liver Dose Adjustments
Data not available
Dose Adjustments
Data from other beta blocker trials suggest that if there is any question concerning the use of IV beta blocker or clinical estimate that there is a contraindication, the IV beta blocker may be eliminated and patients fulfilling the safety criteria may be given atenolol tablets 50 mg twice daily or 100 mg once a day for at least 7 days (if the IV dosing is excluded).
During the second and third trimesters of pregnancy a dose adjustment may be required in order to maintain an adequate therapeutic effect because of a significant increase in atenolol renal clearance and a shorter half-life. A generalized dosage recommendation for pregnancy is not possible due to the variability in bioavailability.
Renally impaired or elderly patients being treated for hypertension may require a lower starting dose of atenolol, usually 25 mg once daily. If this lower dose is used, assessment of efficacy should be made carefully. This should include measurement of blood pressure just prior to the next dose ("trough" blood pressure) to ensure that the treatment effect is present for a full 24 hours. Although a similar dosage reduction may be considered for renally impaired or elderly patients being treated for indications other than hypertension, data are not available for these patient populations.
Precautions
Patients with coronary artery disease receiving atenolol should be advised to avoid abrupt discontinuation of the drug, as severe exacerbation of angina and occurrence of myocardial infarction and ventricular arrhythmias have occurred. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of atenolol is planned, the patients should be carefully monitored and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is advised that atenolol be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue atenolol treatment abruptly even in patients treated only for hypertension.
Atenolol is contraindicated in patients with sinus bradycardia, second- or third-degree atrioventricular heart block, cardiogenic shock, untreated pheochromocytoma, and overt congestive heart failure.
Atenolol should be used with caution in patients with heart failure, a history of heart failure, bronchospastic disease, diabetes and hypoglycemia.
Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Abrupt discontinuation of beta-blockade might precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom atenolol treatment is to be withdrawn should be closely monitored.
Withdrawal of beta-blocker therapy prior to major surgery is controversial, as the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
Atenolol therapy may aggravate peripheral arterial circulatory disorders.
Atenolol therapy should be used with caution in patients with impaired renal function.
If bradycardia or hypotension requiring treatment or any other untoward effects occur, atenolol should be discontinued.
Safety and effectiveness in pediatric patients have not been established.
Dialysis
Atenolol is moderately hemodialyzable (20% to 50%). Patients should be given 25 to 50 mg after each hemodialysis.
Elimination is not enhanced via peritoneal dialysis. A supplemental dose is not needed with peritoneal dialysis.
Other Comments
Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit when treating hypertension.
Atenolol may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa.
Compared with Caucasian patients, Black patients have a reduced blood pressure response to monotherapy with beta-blockers; however, the reduced response is largely eliminated if combination therapy that includes an adequate dose of a diuretic is instituted.
Brand Name: Augmentin.
Amoxicillin/Clavulanate Chewable Tablets are used for:
Treating infections caused by certain bacteria.
Amoxicillin/Clavulanate Chewable Tablets are a penicillin antibiotic. It works by killing sensitive bacteria.
Do NOT use Amoxicillin/Clavulanate Chewable Tablets if:
- you are allergic to any ingredient in Amoxicillin/Clavulanate Chewable Tablets or another penicillin antibiotic (eg, ampicillin)
- you have a history of liver problems or yellowing of the eyes or skin caused by Amoxicillin/Clavulanate Chewable Tablets
- you have infectious mononucleosis (mono)
- you have recently received or will be receiving live oral typhoid vaccine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Amoxicillin/Clavulanate Chewable Tablets:
Some medical conditions may interact with Amoxicillin/Clavulanate Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of allergies, asthma, hay fever, or hives
- if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to a cephalosporin (eg, cephalexin) or another beta-lactam antibiotic (eg, imipenem)
- if you have kidney problems or gonorrhea
- if you have a history of liver problems or yellowing of the eyes or skin
Some MEDICINES MAY INTERACT with Amoxicillin/Clavulanate Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
- Probenecid because it may increase the amount of Amoxicillin/Clavulanate Chewable Tablets in your blood
- Chloramphenicol, macrolide antibiotics (eg, erythromycin), sulfonamides (eg, sulfamethoxazole), or tetracycline antibiotics (eg, doxycycline) because they may decrease Amoxicillin/Clavulanate Chewable Tablets's effectiveness
- Methotrexate because the risk of its side effects may be increased by Amoxicillin/Clavulanate Chewable Tablets
- Live oral typhoid vaccine or hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Amoxicillin/Clavulanate Chewable Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Amoxicillin/Clavulanate Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Amoxicillin/Clavulanate Chewable Tablets:
Use Amoxicillin/Clavulanate Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Amoxicillin/Clavulanate Chewable Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Chew Amoxicillin/Clavulanate Chewable Tablets well before swallowing.
- To clear up your infection completely, take Amoxicillin/Clavulanate Chewable Tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Amoxicillin/Clavulanate Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Amoxicillin/Clavulanate Chewable Tablets.
Important safety information:
- Amoxicillin/Clavulanate Chewable Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Amoxicillin/Clavulanate Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Amoxicillin/Clavulanate Chewable Tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
- Be sure to use Amoxicillin/Clavulanate Chewable Tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Long-term or repeated use of Amoxicillin/Clavulanate Chewable Tablets may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Amoxicillin/Clavulanate Chewable Tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Brown, yellow, or gray tooth discoloration has occurred rarely in some patients taking Amoxicillin/Clavulanate Chewable Tablets. It occurred most often in children. The discoloration was reduced or removed by brushing or dental cleaning in most cases. Contact your doctor if you experience this effect.
- Diabetes patients - Amoxicillin/Clavulanate Chewable Tablets may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
- Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed if you use Amoxicillin/Clavulanate Chewable Tablets for a long period of time. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Amoxicillin/Clavulanate Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially patients with kidney problems.
- Use Amoxicillin/Clavulanate Chewable Tablets with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.
- Amoxicillin/Clavulanate Chewable Tablets should be used with extreme caution in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amoxicillin/Clavulanate Chewable Tablets while you are pregnant. Amoxicillin/Clavulanate Chewable Tablets are found in breast milk. If you are or will be breast-feeding while you use Amoxicillin/Clavulanate Chewable Tablets, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Amoxicillin/Clavulanate Chewable Tablets:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:Diarrhea; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; stomach pain or cramps; unusual bruising or bleeding; vaginal discharge or irritation; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased urination; severe nausea, vomiting, or diarrhea; stomach pain; unusual drowsiness.
Proper storage of Amoxicillin/Clavulanate Chewable Tablets:Store Amoxicillin/Clavulanate Chewable Tablets at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amoxicillin/Clavulanate Chewable Tablets out of the reach of children and away from pets.
General information:
- If you have any questions about Amoxicillin/Clavulanate Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Amoxicillin/Clavulanate Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Amoxicillin/Clavulanate Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Brand names: Augmentin XR, Augmentin
Why is Amoxicillin, Clavulanate potassium prescribed?
Augmentin is used in the treatment of lower respiratory, middle ear, sinus, skin, and urinary tract infections that are caused by certain specific bacteria. These bacteria produce a chemical enzyme called beta lactamase that makes some infections particularly difficult to treat.
Augmentin ES-600, a stronger, oral-suspension form of the drug, is prescribed for certain stubborn ear infections that previous treatment has failed to clear up in children two and under, or those attending day care.
Augmentin XR is an extended-release form of the drug used to treat pneumonia and sinus infections.
Most important fact about Amoxicillin, Clavulanate potassium
If you are allergic to either penicillin or cephalosporin antibiotics in any form, consult your doctor before taking Augmentin. You may be allergic to it, and if a reaction occurs, it could be extremely severe. If you take the drug and feel signs of a reaction, seek medical attention immediately.
How should you take Amoxicillin, Clavulanate potassium?
Augmentin should be taken every 8 or 12 hours, depending on the dosage strength. It may be taken with or without food, but taking it with meals or snacks will help prevent stomach upset. However, the extended-release form, Augmentin XR, should always be taken with food to improve absorption.
Your doctor will only prescribe Augmentin to treat a bacterial infection; it will not cure a viral infection, such as the common cold. It's important to take the full dosage schedule of Augmentin, even if you're feeling better in a few days. Not completing the full dosage schedule may decrease the drug's effectiveness and increase the chances that the bacteria may become resistant to Augmentin and similar antibiotics.
Shake the suspension well. Use a dosing spoon or medicine dropper to give a child the medication; rinse the spoon or dropper after each use.
- If you miss a dose...
Take it as soon as you remember. If it is almost time for the next dose, and you take 2 doses a day, take the one you missed and the next dose 5 to 6 hours later. If you take 3 doses a day, take the one you missed and the next dose 2 to 4 hours later. Then go back to your regular schedule.
- Storage instructions...
Store the suspension under refrigeration and discard after 10 days. Store tablets away from heat, light, and moisture.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Augmentin.
- Side effects may include:
Diarrhea/loose stools, nausea, skin rashes and hives
Why should Amoxicillin, Clavulanate potassium not be prescribed?
If you are sensitive to or have ever had an allergic reaction to any penicillin medication, do not take Amoxicillin, Clavulanate potassium.
Also avoid taking Augmentin if it has ever given you liver problems or yellowing of the skin and eyes. Additionally, do not take Augmentin XR if you have severe kidney problems or need dialysis.
Special warnings about Amoxicillin, Clavulanate potassium
Augmentin and other penicillin-like medicines are generally safe; however, anyone with liver, kidney, or blood disorders is at increased risk when using Amoxicillin, Clavulanate potassium. Alternative choices may be available to your doctor.
If you have diabetes and test your urine for the presence of sugar, you should ask your doctor or pharmacist if Amoxicillin, Clavulanate potassium will interfere with the type of test you use.
Allergic reactions to Amoxicillin, Clavulanate potassium can be serious and possibly fatal. Let your doctor know about previous allergic reactions to medicines, food, or other substances before using Augmentin. If you experience a reaction, report it to your doctor immediately and seek medical treatment.
If you develop diarrhea while taking Augmentin, inform your doctor. It could be a sign of a potentially dangerous form of bowel inflammation.
Some formulations of Augmentin contain phenylalanine. If you have the hereditary disease phenylketonuria, check with your doctor or pharmacist before taking Amoxicillin, Clavulanate potassium.
Possible food and drug interactions when taking Amoxicillin, Clavulanate potassium
Augmentin may react with the antigout medication probenecid, resulting in changes in blood levels. A reaction with another antigout drug, allopurinol, may cause a rash. Notify your doctor if you are taking either of these drugs.
Like many antibiotics, Augmentin may reduce the effectiveness of birth control pills. You may want to take additional measures while taking Augmentin.
Special information if you are pregnant or breastfeeding
The effects of Augmentin during pregnancy have not been adequately studied. Because there may be risk to the developing baby, doctors usually recommend Augmentin to pregnant women only when the benefits of therapy outweigh any potential danger. Augmentin appears in breast milk and could affect a nursing infant. If Augmentin is essential to your health, your doctor may advise you to stop nursing your baby until your treatment with Amoxicillin, Clavulanate potassium is finished.
Recommended dosage for Amoxicillin, Clavulanate potassium
ADULTS
The usual adult dose is one 500-milligram tablet every 12 hours or one 250-milligram tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-milligram tablet every 12 hours or one 500-milligram tablet every 8 hours. It is essential that you take this medicine according to your doctor's directions.
The total daily dose of Augmentin XR is 4,000 milligrams of amoxicillin and 250 milligrams of clavulanate potassium, given in divided doses every 12 hours for 10 days (for sinus infections) or for 7 to 10 days (for pneumonia).
CHILDREN
Older than 3 months
For middle ear infections, sinus inflammation, lower respiratory tract infections, and more severe infections, the usual dose of the 200- or 400-milligram suspension is 45 milligrams per 2.2 pounds per day, in 2 doses, every 12 hours, and of the 125- or 250-milligram suspension, 40 milligrams per 2.2 pounds per day, in 3 doses, every 8 hours.
For less severe infections, the usual dose is 25 milligrams of the 200- or 400-milligram suspension for each 2.2 pounds of weight per day, divided into 2 doses, every 12 hours, or 20 milligrams of the 125- or 250-milligram suspension per 2.2 pounds per day, divided into 3 doses, every 8 hours.
The usual dosage of Augmentin ES-600 oral suspension is 90 milligrams per 2.2 pounds of body weight per day, divided into 2 doses taken every 12 hours. Treatment lasts 10 days.
Children weighing 88 pounds or more will take the adult dosage of standard Augmentin.
Less than 3 months
Children in this age group take 30 milligrams per 2.2 pounds of body weight per day, divided into 2 doses and taken every 12 hours.
Augmentin XR has not been studied in children younger than 16 years old and should not be used in this group.
Overdosage
Augmentin is generally safe; however, large amounts may cause overdose symptoms. Suspected overdoses of Augmentin must be treated immediately; contact your physician or an emergency room.
- Symptoms of Augmentin overdose may include:
Diarrhea, drowsiness, kidney problems, overactivity, rash, stomach and abdominal pain, vomiting
Generic Name: pioglitazone (oral) (PYE o GLIT a zone) Actos is an oral diabetes medicine that helps control blood sugar levels. Actos is for people with type 2 (non-insulin-dependent) diabetes. It is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes. Actos may also be used for purposes other than those listed in this medication guide. Do not use Actos if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Before taking Actos, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, or liver disease. Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar. Some women using Actos have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Actos. Talk with your doctor if you are concerned about this possibility. Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Actos. Do not use Actos if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). If you have any of these other conditions, you may need to adjust your dose of Actos or have special tests: congestive heart failure or heart disease; a history of heart attack or stroke; or liver disease. Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Actos. Some women using Actos have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Actos. Talk with your doctor if you are concerned about this possibility. FDA pregnancy category C. It is not known whether Actos is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby. Do not take Actos without first talking to your doctor if you are breast-feeding a baby. Take Actos exactly as it was prescribed by your doctor. Do not take in larger or smaller amounts, or take it for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from Actos. This medicine is usually taken once daily. You may take Actos with or without food. Actos is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your doctor may also recommend other medicines to treat your diabetes. It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. To be sure Actos is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested, and you may need regular eye exams. It is important that you not miss any scheduled visits to your doctor. Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking Actos for a short time if any of these situations affect you. Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress. Know the signs of low blood sugar (hypoglycemia) and how to recognize them: hunger, headache, confusion, irritability; drowsiness, weakness, dizziness, tremors; sweating, fast heartbeat; seizure (convulsions); or fainting, coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection. Store Actos at room temperature away from moisture, heat, and light. See also: Actos dosage in more detail 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. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma. Avoid drinking alcohol while taking Actos. Alcohol lowers blood sugar and may increase the risk of hypoglycemia while you are taking this medicine. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Actos and call your doctor at once if you have any of these serious side effects: feeling short of breath, even with mild exertion; swelling or rapid weight gain; chest pain, general ill feeling; nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); blurred vision; increased thirst or hunger, urinating more than usual; or pale skin, easy bruising or bleeding, weakness. Less serious Actos side effects may include: sneezing, runny nose, cough or other signs of a cold; headache; gradual weight gain; muscle pain; or tooth problems. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. See also: Actos side effects in more detail You may be more likely to have hyperglycemia (high blood sugar) if you take Actos with other drugs that raise blood sugar, such as: isoniazid; diuretics (water pills); steroids (prednisone and others); phenothiazines (Compazine and others); thyroid medicine (Synthroid and others); birth control pills and other hormones; seizure medicines (Dilantin and others); and diet pills or medicines to treat asthma, colds or allergies. You may be more likely to have hypoglycemia (low blood sugar) if you take Actos with other drugs that lower blood sugar, such as: aspirin or other salicylates (including Pepto-Bismol); sulfa drugs (Bactrim and others); a monoamine oxidase inhibitor (MAOI); probenecid (Benemid). The following drugs can interact with Actos: midazolam (Versed); gemfibrozil (Lopid); rifampin (Rifadin); furosemide (Lasix); or nifedipine (Adalat, Procardia). This list is not complete and other drugs may interact with Actos. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Pioglitazone is available with a prescription under the brand name Actos. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about Actos, especially if it is new to you. Actos 15 mg - white, round tablets Actos 30 mg - white, round tablets Actos 45 mg - white, round tablets Pioglitazone has been assigned to pregnancy category C by the FDA. Animal studies have not revealed evidence of teratogenicity. Delayed parturition and embryotoxicity were observed in both rats and rabbits. There are no controlled data in human pregnancy. Pioglitazone is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of pioglitazone into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking in to account the importance of the drug to the mother.
Brand Names: ActosImportant information about Actos
Before taking Actos
How should I take Actos?
What happens if I miss a dose?
What happens if I overdose?
What should I avoid while taking Actos?
Actos side effects
What other drugs will affect Actos?
Where can I get more information?
What does my medication look like?
Pioglitazone Pregnancy and Breastfeeding Warnings
Overview
.Pioglitazone Pregnancy Warnings
Pioglitazone Breastfeeding Warnings