Farmabes is used alone or together with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). 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.
Farmabes is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, Farmabes relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.
Farmabes is available only with your doctor's prescription.
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.
Farmabes LA 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 this drug.
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.
Farmabes LA may be used alone or in combination with other antihypertensive medications.
Farmabes LA is indicated to improve exercise tolerance in patients with chronic stable angina.
DOSAGE AND ADMINISTRATION
Take Farmabes LA once a day at approximately the same time. Do not chew or crush the tablet.
Initiate dosing at 180 to 240 mg once daily, although some patients may respond to lower doses. Titrate according to blood pressure to a maximum of 540 mg daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy.
Initiate dosing at 180 mg once daily and increase dose at intervals of 7 to 14 days if adequate response is not obtained, to a maximum of 360 mg.
Switching To Farmabes LA Tablets
Patients controlled on Farmabes alone or in combination with other medications may be switched to Farmabes LA once-a-day at the nearest equivalent total daily dose. Higher doses of Farmabes LA may be needed in some patients based on clinical response.
How should I use Farmabes?
Use Farmabes 12-hour sustained-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Farmabes 12-hour sustained-release capsules by mouth with or without food. It is important to take it consistently with regard to meals. If you take it with food, try to always take it with food. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach.
Swallow Farmabes 12-hour sustained-release capsules whole. Do not break, crush, or chew before swallowing.
Take Farmabes 12-hour sustained-release capsules on a regular schedule to get the most benefit from it.
Taking Farmabes 12-hour sustained-release capsules at the same time each day will help you remember to take it.
Continue to take Farmabes 12-hour sustained-release capsules even if you feel well. Do not miss any doses.
If you miss a dose of Farmabes 12-hour sustained-release capsules, 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 Farmabes 12-hour sustained-release capsules.
Uses of Farmabes 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.
Farmabes 12-hour sustained-action capsules are used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Farmabes is called a calcium channel blocker. It works by relaxing blood vessels in the body and heart so blood can flow more easily. This effect lowers blood pressure. Farmabes may also lower your heart rate.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Farmabes is also used to prevent chest pain (angina). When used regularly, Farmabes can decrease the number and severity of episodes of chest pain from angina. Farmabes may also be used to control your heart rate if you have a fast/irregular heartbeat (such as atrial fibrillation).
How to use Farmabes SR
Take this medication by mouth with or without food, usually twice daily or as directed by your doctor. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once and may increase your risk of side effects.
Your doctor may gradually increase your dose. Follow your doctor's instructions carefully. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
If this medication is used for angina, this medication must be taken regularly to be effective. It should not be used to treat angina when it occurs. Use other medications (such as nitroglycerin placed under the tongue) to relieve an angina attack as directed by your doctor. Consult your doctor or pharmacist for details.
It may take up to 2 weeks before you get the full benefit of this drug. Tell your doctor if your condition persists or worsens (for example, your routine blood pressure readings remain high or increase).
Farmabes is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5[2-(dimethylamino)-ethyl]-2-3-dihydro-2-(4-methoxyphenyl),-monohydrochloride,(+)-cis-. It has an empirical formula of C22H26N2O4S·HCl and a molecular weight of 450.98.
Farmabes is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform.
Generic name: Farmabes 30mg
Dosage form: tablet, coated
Farmabes capsule, coated, extended release
Farmabes LA tablet, extended release
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Exertional Angina Pectoris Due to Atherosclerotic Coronary Artery Disease or Angina Pectoris at Rest Due to Coronary Artery Spasm
Dosage must be adjusted to each patient's needs. Starting with 30 mg four times daily, before meals and at bedtime, dosage should be increased gradually (given in divided doses three or four times daily) at 1- to 2-day intervals until optimum response is obtained. Although individual patients may respond to any dosage level, the average optimum dosage range appears to be 180 to 360 mg/day. There are no available data concerning dosage requirements in patients with impaired renal or hepatic function. If the drug must be used in such patients, titration should be carried out with particular caution.
Concomitant Use With Other Cardiovascular Agents
Sublingual NTG may be taken as required to abort acute anginal attacks during Farmabes (Farmabes) therapy.
Prophylactic Nitrate Therapy. Farmabes may be safely coadministered with short- and long-acting nitrates, but there have been no controlled studies to evaluate the antianginal effectiveness of this combination.
Swallow Farmabes tablets whole; do not split, crush or chew the tablets.
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Due to the potential for additive effects, caution and careful titration are warranted in patients receiving Farmabes concomitantly with any agents known to affect cardiac contractility and/or conduction.
Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with Farmabes.
As with all drugs, care should be exercised when treating patients with multiple medications. Farmabes is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of Farmabes. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered Farmabes in order to maintain optimum therapeutic blood levels.
The depression of cardiac contractility, conductivity, and automaticity, as well as the vascular dilation associated with anesthetics, may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium blockers should be titrated carefully.
Studies showed that Farmabes increased the AUC of midazolam and triazolam by 3-to 4-fold and the Cmax by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5-to 2.5-fold) during coadministration with Farmabes. These pharmacokinetic effects seen during Farmabes coadministration can result in increased clinical effects (e.g., prolonged sedation) of both midazolam and triazolam.
Controlled and uncontrolled domestic studies suggest that concomitant use of Farmabes and beta-blockers is usually well tolerated. Available data are not sufficient, however, to predict the effects of concomitant treatment, particularly in patients with left ventricular dysfunction or cardiac conduction abnormalities.
Administration of Farmabes (Farmabes) concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects, and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by Farmabes. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted.
In nine healthy subjects, Farmabes significantly increased the mean buspirone AUC 5.5-fold and Cmax 4.1-fold compared to placebo. The T½ and Tmax of buspirone were not significantly affected by Farmabes. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with Farmabes. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.
Concomitant administration of Farmabes with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase) resulting in toxicity in some cases. Patients receiving these drugs concurrently should be monitored for a potential drug interaction.
A study in six healthy volunteers has shown a significant increase in peak Farmabes plasma levels (58%) and area-under-the-curve (53%) after a 1-week course of cimetidine at 1200 mg per day and a single dose of Farmabes 60 mg. Ranitidine produced smaller, nonsignificant increases. The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of Farmabes. Patients currently receiving Farmabes therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. An adjustment in the Farmabes dose may be warranted.
Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with Farmabes. Monitor heart rate in patients receiving concomitant Farmabes and clonidine.
A pharmacokinetic interaction between Farmabes and cyclosporine has been observed during studies involving renal and cardiac transplant patients. In renal and cardiac transplant recipients, a reduction of cyclosporine trough dose ranging from 15% to 48% was necessary to maintain concentrations similar to those seen prior to the addition of Farmabes. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when Farmabes therapy is initiated, adjusted, or discontinued. The effect of cyclosporine on Farmabes plasma concentrations has not been evaluated.
Administration of Farmabes with digoxin in 24 healthy male subjects increased plasma digoxin concentrations approximately 20%. Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease. Since there have been conflicting results regarding the effect of digoxin levels, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing Farmabes therapy to avoid possible over-or under-digitalization.
Farmabes significantly increases the AUC (0→infin;) of quinidine by 51%, T½ by 36%, and decreases its CLoral by 33%. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly.
Coadministration of rifampin with Farmabes lowered the Farmabes plasma concentrations to undetectable levels. Coadministration of Farmabes with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered.
Farmabes is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of Farmabes. When possible, use a non-CYP3A4-metabolized statin together with Farmabes; otherwise, dose adjustments for both Farmabes and the statin should be considered along with close monitoring for signs and symptoms of any statin related adverse events.
In a healthy volunteer cross-over study (N=10), co-administration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID Farmabes SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of Farmabes showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of Farmabes, an 8-to 9-fold mean increase in simvastatin AUC can be expected. If co-administration of simvastatin with Farmabes is required, limit the daily doses of simvastatin to 10 mg and Farmabes to 240 mg.
In a ten-subject randomized, open label, 4-way cross-over study, co-administration of Farmabes (120 mg BID Farmabes SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3-to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during Farmabes coadministration. Farmabes plasma levels were not significantly affected by lovastatin or pravastatin.
Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.
In the hypertension study, the following table presents adverse reactions more common on Farmabes than on placebo (but excluding events with no plausible relationship to treatment), as reported in placebo-controlled hypertension trials in patients receiving a Farmabes extended-release formulation (once-a-day dosing) up to 540 mg.
# pts (%)
# pts (%)
# pts (%)
Edema lower limb
In the angina study, the adverse event profile of Farmabes extended-release tablets was consistent with what has been previously described for Farmabes extended-release tablets and other formulations of Farmabes HCl. The most frequent adverse effects experienced by Farmabes extended-release tablets-treated patients were edema lower-limb (6.8%), dizziness (6.4%), fatigue (4.8%), bradycardia (3.6%), first-degree atrioventricular block (3.2%), and cough (2%).
In clinical trials of other Farmabes formulations involving over 3200 patients, the most common events (i.e. greater than 1%) were edema (4.6%), headache (4.6%), dizziness (3.5%), asthenia (2.6%), first-degree AV block (2.4%), bradycardia (1.7%), flushing (1.4%), nausea (1.4%), and rash (1.2%).
In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials:
The following postmarketing events have been reported infrequently in patients receiving Farmabes: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and Farmabes therapy is yet to be established.
To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Do not use this medication if you have certain heart conditions such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), low blood pressure, or if you have recently had a heart attack.
Before taking Farmabes, tell your doctor if you have kidney disease, liver disease, or congestive heart failure.
Farmabes may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Do not stop taking this medication without first talking to your doctor. If you stop taking Farmabes suddenly, your condition may become worse.
Farmabes may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely.
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.
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