Tolol AM is used alone or together with other medicines to treat angina (chest pain) and high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.
Tolol AM is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, Tolol AM relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.
Tolol AM is available only with your doctor's prescription.
Tolol AM indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Tolol AM is 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 Tolol AM.
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. Tolol AM may be used alone or in combination with other antihypertensive agents.
Coronary Artery Disease (CAD)
Chronic Stable Angina
Tolol AM is indicated for the symptomatic treatment of chronic stable angina. Tolol AM may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina)
Tolol AM is indicated for the treatment of confirmed or suspected vasospastic angina. Tolol AM may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, Tolol AM is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
How should I use Tolol AM?
Use Tolol AM as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Tolol AM. Talk to your pharmacist if you have questions about this information.
Take Tolol AM by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Taking Tolol AM at the same time each day will help you remember to take it.
Continue to take Tolol AM even if you feel well. Do not miss any doses.
If you miss a dose of Tolol AM, take it as soon as possible. If it has been more than 12 hours since you missed your last 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 Tolol AM.
Uses of Tolol AM in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
This medication is used along with other treatment for certain blood vessel diseases (e.g., arteriosclerosis obliterans, Raynaud's disease, Buerger's disease, cerebrovascular insufficiency). It works by widening blood vessels to help increase blood flow (improve circulation) to certain parts of the body (e.g., hands/feet, brain). This effect may help to decrease symptoms such as cold hands and feet, numbness, tingling, and decreased memory or judgment.
How to use Tolol AM
This medication is taken by mouth with or without food, usually 3 to 4 times daily or as directed by your doctor. Dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Tell your doctor if your condition persists or worsens.
Tolol AM description
Each 5-mg and 10-mg tablet contains Amlodipine besilate equivalent to Tolol AM 5 mg and 10 mg, respectively.
Tolol AM also contains the following excipients: Calcium hydrogen phosphate anhydrous, microcrystalline cellulose, magnesium stearate, sodium starch glycollate.
Tolol AM besilate is the besilate salt of Tolol AM, a long-acting calcium-channel blocker. It is 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulphonate. Its empirical formula is C20H25ClN2O5·C6H6O3S and has a molecular weight of 567.1.
Tolol AM besilate is a white crystalline powder and is slightly soluble in water and sparingly soluble in ethanol.
Tolol AM dosage
The usual initial antihypertensive oral dose of Tolol AM is 5 mg once daily, and the maximum dose is 10 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Tolol AM to other antihypertensive therapy.
Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
The recommended dose for chronic stable or vasospastic angina is 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.
Coronary Artery Disease
The recommended dose range for patients with coronary artery disease is 5–10 mg once daily. In clinical studies, the majority of patients required 10 mg.
The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
Dosage Forms And Strengths
2.5 mg white, diamond, flat-faced, beveled edged, with "Tolol AM" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, with "Tolol AM" on one side and "5" on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with "Tolol AM" on one side and "10" on the other
Storage And Handling
2.5 mg Tablets
Tolol AM – 2.5 mg Tablets (Tolol AM besylate equivalent to 2.5 mg of Tolol AM per tablet) are supplied as white, diamond, flat-faced, beveled edged engraved with "Tolol AM" on one side and "2.5" on the other side and supplied as follows:
NDC 0069-1520-68 Bottle of 90
5 mg Tablets
Tolol AM – 5 mg Tablets (Tolol AM besylate equivalent to 5 mg of Tolol AM per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both "Tolol AM" and "5" on one side and plain on the other side and supplied as follows:
NDC 0069-1530-68 Bottle of 90
NDC 0069-1530-41 Unit Dose package of 100
NDC 0069-1530-72 Bottle of 300
10 mg Tablets
Tolol AM – 10 mg Tablets (Tolol AM besylate equivalent to 10 mg of Tolol AM per tablet) are white, round, flat-faced, beveled edged engraved with both "Tolol AM" and "10" on one side and plain on the other side and supplied as follows:
NDC 0069-1540-68 Bottle of 90
NDC 0069-1540-41 Unit Dose package of 100
Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, lightresistant containers (USP).
Manufactured by: Pfizer, Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised: March 2015
Tolol AM has been safely administered with thiazide diuretics, alpha-blockers, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerine, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
In vitro data from studies with human plasma indicate that Tolol AM has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).
Simvastatin: Co-administration of multiple doses of 10 mg Tolol AM with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on Tolol AM to 20 mg daily.
Grapefruit Juice: Co-administration of 240 mL grapefruit juice with a single oral dose of 10 mg Tolol AM in 20 healthy volunteers had no significant effect on the pharmacokinetics of Tolol AM. The study did not allow examination of the effect of genetic polymorphism in CYP3A4, the primary enzyme responsible for metabolism of Tolol AM; therefore, administration of Tolol AM with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
CYP3A4 Inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg Tolol AM in elderly hypertensive patients (69 to 87 years of age) resulted in a 57% increase in Tolol AM systemic exposure. Co-administration of erythromycin in healthy volunteers (18 to 43 years of age) did not significantly change Tolol AM systemic exposure (22% increase in area under the concentration versus time curve [AUC]). Although the clinical relevance of these findings is uncertain, pharmacokinetic variations may be more pronounced in the elderly.
Strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of Tolol AM to a greater extent than diltiazem. Tolol AM should be used with caution when administered with CYP3A4 inhibitors.
Clarithromycin: Clarithromycin is an inhibitor of CYP3A4. There is an increased risk of hypotension in patients receiving clarithromycin with Tolol AM. Close observation of patients is recommended when Tolol AM is co-administered with clarithromycin.
CYP3A4 Inducers: There is no data available regarding the effect of CYP3A4 inducers on Tolol AM. Concomitant use of CYP3A4 inducers (e.g., rifampicin, Hypericum perforatum) may decrease the plasma concentrations of Tolol AM. Tolol AM should be used with caution when administered with CYP3A4 inducers.
In the following studies, there were no significant changes in the pharmacokinetics of either Tolol AM or another drug within the study, when co-administered.
Special Studies: Effect of Other Agents on Tolol AM: Cimetidine: Co-administration of Tolol AM with cimetidine did not alter the pharmacokinetics of Tolol AM.
Aluminum/Magnesium (Antacid): Co-administration of aluminum/magnesium (antacid) with a single dose of Tolol AM had no significant effect on the pharmacokinetics of Tolol AM.
Sildenafil: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of Tolol AM. When Tolol AM and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Special Studies: Effect of Tolol AM on Other Agents: Atorvastatin: Co-administration of multiple 10 mg doses of Tolol AM with 80 mg atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.
Digoxin: Co-administration of Tolol AM with digoxin did not change serum digoxin levels or digoxin renal clearance in healthy volunteers.
Ethanol (Alcohol): Single and multiple 10 mg doses of Tolol AM had no significant effect on the pharmacokinetics of ethanol.
Warfarin: Co-administration of Tolol AM with warfarin did not change the warfarin prothrombin response time.
Cyclosporin: Pharmacokinetic studies with cyclosporin have demonstrated that Tolol AM does not significantly alter the pharmacokinetics of cyclosporin.
Tacrolimus: There is a risk of increased tacrolimus blood levels when co-administered with Tolol AM. In order to avoid toxicity of tacrolimus, administration of Tolol AM in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tolol AM has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with Tolol AM was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Tolol AM were of mild or moderate severity. In controlled clinical trials directly comparing Tolol AM (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Tolol AM because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:
Tolol AM 5 mg
Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:
Tolol AM (%)
For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Tolol AM treatment as shown in the following table:
The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Before taking Tolol AM, tell your doctor if you have congestive heart failure or liver disease.
Drinking alcohol can further lower your blood pressure and may increase certain side effects of Tolol AM.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Tolol AM is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.
Tell your doctor about all other heart or blood pressure medications you are taking.
Your chest pain may become worse when you first start taking Tolol AM or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.
DailyMed. "METOPROLOL FUMARATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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