DRUGS & SUPPLEMENTS
When are you taking this medicine?
Eutens extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 Eutens.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Eutens extended-release tablets may be administered with other antihypertensive agents.
Eutens extended-release tablets are contraindicated in patients who are hypersensitive to this product.
Hypotension - Eutens, like other calcium antagonists, may occasionally precipitate significant hypotension and, rarely, syncope. It may lead to reflex tachycardia which in susceptible individuals may precipitate angina pectoris.
Heart Failure - Although acute hemodynamic studies in a small number of patients with NYHA Class II or III heart failure treated with Eutens have not demonstrated negative inotropic effects, safety in patients with heart failure has not been established. Caution, therefore, should be exercised when using Eutens extended-release tablets in patients with heart failure or compromised ventricular function, particularly in combination with a beta blocker.
Patients with Impaired Liver Function - Patients with impaired liver function may have elevated plasma concentrations of Eutens and may respond to lower doses of Eutens extended-release tablets; therefore, a starting dose of 2.5 mg once a day is recommended. These patients should have their blood pressure monitored closely during dosage adjustment of Eutens extended-release tablets. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION.)
Peripheral Edema - Peripheral edema, generally mild and not associated with generalized fluid retention, was the most common adverse event in the clinical trials. The incidence of peripheral edema was both dose and age dependent. Frequency of peripheral edema ranged from about 10% in patients under 50 years of age taking 5 mg daily to about 30% in those over 60 years of age taking 20 mg daily. This adverse effect generally occurs within 2–3 weeks of the initiation of treatment.
Patients should be instructed to take Eutens extended-release tablets whole and not to crush or chew the tablets. They should be told that mild gingival hyperplasia (gum swelling) has been reported. Good dental hygiene decreases its incidence and severity.
NOTE: As with many other drugs, certain advice to patients being treated with Eutens extended-release tablets is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
CYP3A4 Inhibitors - Eutens is metabolized by CYP3A4. Co-administration of CYP3A4 inhibitors with Eutens may lead to several-fold increases in the plasma levels of Eutens, either due to an increase in bioavailability or due to a decrease in metabolism. These increases in concentration may lead to increased effects, (lower blood pressure and increased heart rate). These effects have been observed with co-administration of itraconazole (a potent CYP3A4 inhibitor). Caution should be used when CYP3A4 inhibitors are co-administered with Eutens. A conservative approach to dosing Eutens should be taken. The following specific interactions have been reported:
Itraconazole - Co-administration of another extended release formulation of Eutens with itraconazole resulted in approximately 8-fold increase in the AUC, more than 6-fold increase in the Cmax, and 2-fold prolongation in the half-life of Eutens.
Erythromycin - Co-administration of Eutens extended-release tablets with erythromycin resulted in approximately 2.5-fold increase in the AUC and Cmax, and about 2-fold prolongation in the half-life of Eutens.
Grapefruit Juice - Co-administration of Eutens with grapefruit juice resulted in more than 2-fold increase in the AUC and Cmax, but no prolongation in the half-life of Eutens.
Cimetidine - Co-administration of Eutens with cimetidine (a non-specific CYP-450 inhibitor) resulted in an increase of approximately 50% in the AUC and the Cmax, of Eutens.
Beta-Blocking Agents - A pharmacokinetic study of Eutens in conjunction with metoprolol demonstrated no significant effects on the pharmacokinetics of Eutens. The AUC and Cmax of metoprolol, however, were increased approximately 31 and 38%, respectively. In controlled clinical trials, however, beta blockers including metoprolol were concurrently administered with Eutens and were well tolerated.
Digoxin - When given concomitantly with Eutens extended-release tablets the pharmacokinetics of digoxin in patients with heart failure were not significantly altered.
Anticonvulsants - In a pharmacokinetic study, maximum plasma concentrations of Eutens were considerably lower in epileptic patients on long-term anticonvulsant therapy (eg, phenytoin, carbamazepine, or phenobarbital) than in healthy volunteers. In such patients, the mean area under the Eutens plasma concentration-time curve was also reduced to approximately 6% of that observed in healthy volunteers. Since a clinically significant interaction may be anticipated, alternative antihypertensive therapy should be considered in these patients.
Tacrolimus - Eutens may increase the blood concentration of tacrolimus. When given concomitantly with Eutens, the tacrolimus blood concentration should be followed and the tacrolimus dose may need to be adjusted.
Other Concomitant Therapy - In healthy subjects there were no clinically significant interactions when Eutens was given concomitantly with indomethacin or spironolactone.
Interaction with Food - See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism.
In a 2-year carcinogenicity study in rats fed Eutens at doses of 7.7, 23.1 or 69.3 mg/kg/day (up to 61 times
In this same rat study a dose-related increase in the incidence of focal squamous cell hyperplasia compared to control was observed in the esophageal groove of male and female rats in all dose groups. No other drug-related esophageal or gastric pathology was observed in the rats or with chronic administration in mice and dogs. The latter species, like man, has no anatomical structure comparable to the esophageal groove.
Eutens was not carcinogenic when fed to mice at doses up to 138.6 mg/kg/day (61 times
Eutens did not display any mutagenic activity in vitro in the Ames microbial mutagenicity test or in the mouse lymphoma forward mutation assay. No clastogenic potential was seen in vivo in the mouse micronucleus test at oral doses up to 2500 mg/kg (1100 times
A fertility study in which male and female rats were administered doses of 3.8, 9.6 or 26.9 mg/kg/day (up to 24 times
Pregnancy Category C.
Teratogenic Effects:- Studies in pregnant rabbits administered doses of 0.46, 1.2, 2.3, and 4.6 mg/kg/day showed digital anomalies consisting of reduction in size and degree of ossification of the terminal phalanges in the fetuses. The frequency and severity of the changes appeared dose related and were noted even at the lowest dose. These changes have been shown to occur with other members of the dihydropyridine class and are possibly a result of compromised uterine blood flow. Similar fetal anomalies were not observed in rats given Eutens.
In a teratology study in cynomolgus monkeys, no reduction in the size of the terminal phalanges was observed, but an abnormal position of the distal phalanges was noted in about 40% of the fetuses.
Nonteratogenic Effects - A prolongation of parturition with difficult labor and an increased frequency of fetal and early postnatal deaths were observed in rats administered doses of 9.6 mg/kg/day (8 times
Significant enlargement of the mammary glands, in excess of the normal enlargement for pregnant rabbits, was found with doses greater than or equal to 1.2 mg/kg/day (2.1 times the maximum human dose on a mg/m2 basis). This effect occurred only in pregnant rabbits and regressed during lactation.
Similar changes in the mammary glands were not observed in rats or monkeys.
There are no adequate and well-controlled studies in pregnant women. If Eutens is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus, possible digital anomalies of the infant, and the potential effects of Eutens on labor and delivery and on the mammary glands of pregnant females.
It is not known whether this drug is secreted in human milk and because of the potential for serious adverse reactions from Eutens in the infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Eutens did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Pharmacokinetics, however, indicate that the availability of Eutens is increased in older patients (see CLINICAL PHARMACOLOGY, Geriatric Use ). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
In controlled studies in the United States and overseas, approximately 3000 patients were treated with Eutens as either the extended-release or the immediate-release formulation.
The most common clinical adverse events reported with Eutens extended-release tablets administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache. Peripheral edema was generally mild, but it was age and dose related and resulted in discontinuation of therapy in about 3% of the enrolled patients. Discontinuation of therapy due to any clinical adverse event occurred in about 6% of the patients receiving Eutens extended-release tablets, principally for peripheral edema, headache, or flushing.
Adverse events that occurred with an incidence of 1.5% or greater at any of the recommended doses of 2.5 mg to 10 mg once a day (felodipine extended-release tablets, N = 861; Placebo, N = 334), without regard to causality, are compared to placebo and are listed by dose in the table below. These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of Eutens extended-release tablets or titrated from an initial dose of 2.5 mg or 5 mg once a day. A dose of 20 mg once a day has been evaluated in some clinical studies. Although the antihypertensive effect of Eutens extended-release tablets is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see DOSAGE AND ADMINISTRATION ).
|Body System||Placebo||2.5 mg||5 mg||10 mg|
|Body as a Whole|
|Peripheral Edema||3.3 (0.0)||2.0 (0.0)||8.8 (2.2)||17.4 (2.5)|
|Asthenia||3.3 (0.0)||3.9 (0.0)||3.3 (0.0)||2.2 (0.0)|
|Warm Sensation||0.0 (0.0)||0.0 (0.0)||0.9 (0.2)||1.5 (0.0)|
|Palpitation||2.4 (0.0)||0.4 (0.0)||1.4 (0.3)||2.5 (0.5)|
|Nausea||1.5 (0.9)||1.2 (0.0)||1.7 (0.3)||1.0 (0.7)|
|Dyspepsia||1.2 (0.0)||3.9 (0.0)||0.7 (0.0)||0.5 (0.0)|
|Constipation||0.9 (0.0)||1.2 (0.0)||0.3 (0.0)||1.5 (0.2)|
|Headache||10.2 (0.9)||10.6 (0.4)||11.0 (1.7)||14.7 (2.0)|
|Dizziness||2.7 (0.3)||2.7 (0.0)||3.6 (0.5)||3.7 (0.5)|
|Paresthesia||1.5 (0.3)||1.6 (0.0)||1.2 (0.0)||1.2 (0.2)|
|Upper Respiratory Infection||1.8 (0.0)||3.9 (0.0)||1.9 (0.0)||0.7 (0.0)|
|Cough||0.3 (0.0)||0.8 (0.0)||1.2 (0.0)||1.7 (0.0)|
|Rhinorrhea||0.0 (0.0)||1.6 (0.0)||0.2 (0.0)||0.2 (0.0)|
|Sneezing||0.0 (0.0)||1.6 (0.0)||0.0 (0.0)||0.0 (0.0)|
|Rash||0.9 (0.0)||2.0 (0.0)||0.2 (0.0)||0.2 (0.0)|
|Flushing||0.9 (0.3)||3.9 (0.0)||5.3 (0.7)||6.9 (1.2)|
Adverse events that occurred in 0.5 up to 1.5% of patients who received Eutens extended-release tablets in all controlled clinical trials at the recommended dosage range of 2.5 mg to 10 mg once a day, and serious adverse events that occurred at a lower rate, or events reported during marketing experience (those lower rate events are in italics) are listed below. These events are listed in order of decreasing severity within each category, and the relationship of these events to administration of Eutens extended-release tablets is uncertain:
Body as a Whole: Chest pain, facial edema, flu-like illness;
Cardiovascular: Myocardial infarction, hypotension, syncope, angina pectoris, arrhythmia, tachycardia, premature beats;
Digestive: Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation;
Metabolic: ALT (SGPT) increased;
Musculoskeletal: Arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, hip pain;
Nervous/Psychiatric: Insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decreased libido;
Respiratory: Dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, respiratory infection;
Skin: Angioedema, contusion, erythema, urticaria, leukocytoclastic vasculitis;
Special Senses: Visual disturbances;
Urogenital: Impotence, urinary frequency, urinary urgency, dysuria, polyuria.
Gingival Hyperplasia - Gingival hyperplasia, usually mild, occurred in < 0.5% of patients in controlled studies. This condition may be avoided or may regress with improved dental hygiene. (See PRECAUTIONS, Information for Patients.)
Clinical Laboratory Test Findings
Serum Electrolytes - No significant effects on serum electrolytes were observed during short- and long-term therapy (see CLINICAL PHARMACOLOGY, Renal/Endocrine Effects ).
Serum Glucose - No significant effects on fasting serum glucose were observed in patients treated with Eutens extended-release tablets in the U.S. controlled study.
Liver Enzymes - 1 of 2 episodes of elevated serum transaminases decreased once drug was discontinued in clinical studies; no follow-up was available for the other patient.
Oral doses of 240 mg/kg and 264 mg/kg in male and female mice, respectively, and 2390 mg/kg and 2250 mg/kg in male and female rats, respectively, caused significant lethality.
In a suicide attempt, one patient took 150 mg Eutens together with 15 tablets each of atenolol and spironolactone and 20 tablets of nitrazepam. The patient's blood pressure and heart rate were normal on admission to hospital; he subsequently recovered without significant sequelae.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly bradycardia.
If severe hypotension occurs, symptomatic treatment should be instituted. The patient should be placed supine with the legs elevated. The administration of intravenous fluids may be useful to treat hypotension due to overdosage with calcium antagonists. In case of accompanying bradycardia, atropine (0.5–1 mg) should be administered intravenously. Sympathomimetic drugs may also be given if the physician feels they are warranted.
It has not been established whether Eutens can be removed from the circulation by hemodialysis.
To obtain up-to-date information about the treatment of overdose, consult your Regional Poison-Control Center. Telephone numbers of certified poison-control centers are listed in the Physicians' Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.
The recommended starting dose is 5 mg once a day. Depending on the patient's response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5–10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS ). Modification of the recommended dosage is usually not required in patients with renal impairment.
Eutens extended-release tablets should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism ). Eutens extended-release tablets should be swallowed whole and not crushed or chewed.
Geriatric Use - Patients over 65 years of age are likely to develop higher plasma concentrations of Eutens (see CLINICAL PHARMACOLOGY ). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment.
Patients with Impaired Liver Function - Patients with impaired liver function may have elevated plasma concentrations of Eutens and may respond to lower doses of Eutens extended-release tablets; therefore, patients should have their blood pressure monitored closely during dosage adjustment of Eutens extended-release tablets (see CLINICAL PHARMACOLOGY ).
Eutens extended-release tablets are supplied as follows:
Eutens extended-release tablets, 2.5 mg, are round, light green, film-coated, unscored, debossed MP 771
|Bottles of 30||NDC 53489-368-07|
|Bottles of 90||NDC 53489-368-90|
|Bottles of 100||NDC 53489-368-01|
|Bottles of 250||NDC 53489-368-03|
|Bottles of 500||NDC 53489-368-05|
|Bottles of 1000||NDC 53489-368-10|
Eutens extended-release tablets, 5 mg, are round, light orange, film-coated, unscored, debossed MP 772
|Bottles of 30||NDC 53489-369-07|
|Bottles of 90||NDC 53489-369-90|
|Bottles of 100||NDC 53489-369-01|
|Bottles of 250||NDC 53489-369-03|
|Bottles of 500||NDC 53489-369-05|
|Bottles of 1000||NDC 53489-369-10|
Eutens extended-release tablets, 10 mg, are round, brown, film-coated, unscored, debossed MP 773
|Bottles of 30||NDC 53489-370-07|
|Bottles of 90||NDC 53489-370-90|
|Bottles of 100||NDC 53489-370-01|
|Bottles of 250||NDC 53489-370-03|
|Bottles of 500||NDC 53489-370-05|
|Bottles of 1000||NDC 53489-370-10|
Store at 20° to 25°C (68° to 77°F).
PROTECT FROM LIGHT.
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA
Rev 06, November 2012
Eutens ER 5mg Tablet
Depending on the reaction of the Eutens after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Eutens not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Eutens addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology