DRUGS & SUPPLEMENTS

Logimax

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Logimax uses

Logimax consists of Felodipine, Metoprolol Succinate.

Felodipine:


INDICATIONS AND USAGE

Logimax (Felodipine) 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 Logimax (Felodipine).

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.

Logimax (Felodipine) extended-release tablets may be administered with other antihypertensive agents.

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CONTRAINDICATIONS

Logimax (Felodipine) extended-release tablets are contraindicated in patients who are hypersensitive to this product.

PRECAUTIONS

General

Hypotension - Logimax, 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. (See ADVERSE REACTIONS.)

Heart Failure - Although acute hemodynamic studies in a small number of patients with NYHA Class II or III heart failure treated with Logimax (Felodipine) have not demonstrated negative inotropic effects, safety in patients with heart failure has not been established. Caution, therefore, should be exercised when using Logimax (Felodipine) 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 Logimax (Felodipine) and may respond to lower doses of Logimax (Felodipine) 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 Logimax (Felodipine) 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.

Information for Patients

Patients should be instructed to take Logimax (Felodipine) 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 Logimax (Felodipine) 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.

Drug Interactions

CYP3A4 Inhibitors - Logimax is metabolized by CYP3A4. Co-administration of CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, grapefruit juice, cimetidine) with Logimax (Felodipine) may lead to several-fold increases in the plasma levels of Logimax (Felodipine), 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 Logimax (Felodipine). A conservative approach to dosing Logimax (Felodipine) should be taken. The following specific interactions have been reported:

Itraconazole - Co-administration of another extended release formulation of Logimax (Felodipine) 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 Logimax (Felodipine).

Erythromycin - Co-administration of Logimax (Felodipine) 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 Logimax (Felodipine).

Grapefruit Juice - Co-administration of Logimax (Felodipine) with grapefruit juice resulted in more than 2-fold increase in the AUC and Cmax, but no prolongation in the half-life of Logimax (Felodipine).

Cimetidine - Co-administration of Logimax (Felodipine) with cimetidine (a non-specific CYP-450 inhibitor) resulted in an increase of approximately 50% in the AUC and the Cmax, of Logimax (Felodipine).

Beta-Blocking Agents - A pharmacokinetic study of Logimax (Felodipine) in conjunction with metoprolol demonstrated no significant effects on the pharmacokinetics of Logimax (Felodipine). 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 Logimax (Felodipine) and were well tolerated.

Digoxin - When given concomitantly with Logimax (Felodipine) 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 Logimax (Felodipine) 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 Logimax (Felodipine) 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 - Logimax (Felodipine) may increase the blood concentration of tacrolimus. When given concomitantly with Logimax (Felodipine), 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 Logimax (Felodipine) was given concomitantly with indomethacin or spironolactone.

Interaction with Food - See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year carcinogenicity study in rats fed Logimax (Felodipine) at doses of 7.7, 23.1 or 69.3 mg/kg/day (up to 61 times the maximum recommended human dose on a mg/m2 basis), a dose-related increase in the incidence of benign interstitial cell tumors of the testes (Leydig cell tumors) was observed in treated male rats. These tumors were not observed in a similar study in mice at doses up to 138.6 mg/kg/day (61 times the maximum recommended human dose on a mg/m2 basis). Logimax (Felodipine), at the doses employed in the 2-year rat study, has been shown to lower testicular testosterone and to produce a corresponding increase in serum luteinizing hormone in rats. The Leydig cell tumor development is possibly secondary to these hormonal effects which have not been observed in man.

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.

Logimax (Felodipine) was not carcinogenic when fed to mice at doses up to 138.6 mg/kg/day (61 times the maximum recommended human dose on a mg/m2 basis) for periods of up to 80 weeks in males and 99 weeks in females.

Logimax (Felodipine) 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 the maximum recommended human dose on a mg/m2 basis) or in vitro in a human lymphocyte chromosome aberration assay.

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 the maximum recommended human dose on a mg/m2 basis) showed no significant effect of Logimax (Felodipine) on reproductive performance.

Pregnancy:

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 Logimax (Felodipine).

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 timesBased on patient weight of 50 kg the maximum human dose on a mg/m2 basis) and above.

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 Logimax (Felodipine) 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 Logimax (Felodipine) on labor and delivery and on the mammary glands of pregnant females.

Nursing Mothers

It is not known whether this drug is secreted in human milk and because of the potential for serious adverse reactions from Logimax (Felodipine) 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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Logimax (Felodipine) 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 Logimax (Felodipine) 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.

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ADVERSE REACTIONS

In controlled studies in the United States and overseas, approximately 3000 patients were treated with Logimax (Felodipine) as either the extended-release or the immediate-release formulation.

The most common clinical adverse events reported with Logimax (Felodipine) 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 Logimax (Felodipine) 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 Logimax (Felodipine) 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 Logimax (Felodipine) 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
Adverse Events N=334 N=255 N=581 N=408
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)
Cardiovascular
Palpitation 2.4 (0.0) 0.4 (0.0) 1.4 (0.3) 2.5 (0.5)
Digestive
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)
Nervous
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)
Respiratory
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)
Skin
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 Logimax (Felodipine) 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 Logimax (Felodipine) 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;

Endocrine: Gynecomastia;

Hematologic: Anemia;

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 Logimax (Felodipine) 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.

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OVERDOSAGE

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 Logimax (Felodipine) 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 Logimax (Felodipine) 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.

DOSAGE AND ADMINISTRATION

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.

Logimax (Felodipine) extended-release tablets should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism ). Logimax (Felodipine) 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 Logimax (Felodipine) (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 Logimax (Felodipine) and may respond to lower doses of Logimax (Felodipine) extended-release tablets; therefore, patients should have their blood pressure monitored closely during dosage adjustment of Logimax (Felodipine) extended-release tablets (see CLINICAL PHARMACOLOGY ).

HOW SUPPLIED

Logimax (Felodipine) extended-release tablets are supplied as follows:

Logimax (Felodipine) 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

Logimax (Felodipine) 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

Logimax (Felodipine) 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.

Manufactured by:

MUTUAL PHARMACEUTICAL COMPANY, INC.

Philadelphia, PA 19124 USA

Rev 06, November 2012

Logimax (Felodipine) ER 5mg Tablet

Chemical Structure

Metoprolol Succinate:


Pharmacological action

Logimax is a cardioselective beta1-blocker without intrinsic sympathomimetic activity. This medication has antihypertensive, antianginal and antiarrhythmic effect. Logimax (Metoprolol Succinate) decreases automaticity of sinus node, reducing heart rate, slows AV-conduction, decreases myocardial contractility and excitability, reduces cardiac output, reduces myocardial oxygen demand. This drug inhibits the stimulatory effect of catecholamines on the heart during physical and psycho-emotional stress.

Logimax (Metoprolol Succinate) causes a hypotensive effect which is stabilized by the end of the second week of a course. With angina Logimax (Metoprolol Succinate) reduces the frequency and severity of attacks.

This medicine also normalizes the heart rate during supraventricular tachycardia and atrial fibrillation; when myocardial infarction it contributes to limit the zone of ischemia of the heart muscle and reduces the risk of developing fatal arrhythmias, reduces the risk of recurrence of myocardial infarction. When Logimax (Metoprolol Succinate) is used in the medium therapeutic doses it has a less pronounced effect on smooth muscles of the bronchi and peripheral arteries than non-selective beta-blockers.

Pharmacokinetics

After oral administration Logimax (Metoprolol Succinate) is rapidly and almost completely absorbed from the gastrointestinal tract, Cmax of the active substance in the blood plasma is reached after 1-2 hours. This medication intensively metabolized in the liver to form inactive metabolites. T1/2 of Logimax (Metoprolol Succinate) from plasma is 3-4 h and during the course of treatment it does not change. More than 95% of the dose excreted by the kidneys of which only 3% is in unchanged form.

Why is Logimax prescribed?

Hypertension, prevention of angina, cardiac arrhythmias (supraventricular tachycardia, extrasystoles), secondary prevention after myocardial infarction, cardiac hyperkinetic syndrome (including in hyperthyroidism, NDCs). Prophylaxis of migraine.

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Dosage and administration

For oral administration the average dose of Logimax is 100 mg / day in 1-2 reception. If necessary the daily dose gradually increased up to 200 mg. For IV injections a single dose is 2.5 mg, with no effect a re-introduction is possible in 5 minutes.

Maximum daily dose for oral administration is 400 mg, for IV injections a single dose is 15-20 mg.

Logimax (Metoprolol Succinate) side effects, adverse reactions

Cardiovascular system: possible bradycardia, hypotension, AV-conduction disturbances, symptoms of heart failure.

Digestive system: at the beginning of therapy may include dry mouth, nausea, vomiting, diarrhea, constipation, and in some cases - liver function abnormalities.

CNS and peripheral nervous system: at the beginning of therapy may be weakness, fatigue, dizziness, headache, muscle cramps, coldness and paresthesia in the extremities; possible reduction in the secretion of tear fluid, conjunctivitis, rhinitis, depression, sleep disturbances, nightmares.

Hemopoietic system: in some cases - thrombocytopenia.

Endocrine: hypoglycemic state in patients with diabetes.

Respiratory system: in predisposed patients may cause symptoms of bronchial obstruction.

Allergic reactions: skin rash, itching.

Logimax contraindications

AV-block II and III degree, sinoatrial block, bradycardia (heart rate below 50 beats / min), SSS, hypotension, chronic heart failure IIB-III stages, acute heart failure, cardiogenic shock, metabolic acidosis, pronounced disturbances of peripheral circulation, increased sensitivity to Logimax (Metoprolol Succinate).

Using during pregnancy and breastfeeding

Taking of Logimax during pregnancy is only possible if the intended benefits to the mother outweighs the potential risk to the fetus. This medication crosses the placental barrier. In connection with the possible development of a newborn bradycardia, hypotension, hypoglycemia, and respiratory failure, Logimax (Metoprolol Succinate) should be abolished for 48-72 hours before the scheduled date of delivery. After delivery it is necessary to ensure strict monitoring of the newborn within 48-72 hours.

Logimax (Metoprolol Succinate) in small amounts excreted in breast milk. The using during lactation is not recommended.

Special instructions

With careful use in patients with chronic obstructive airways disease, diabetes (especially during labile), Raynaud's disease and obliterative peripheral arterial disease, pheochromocytoma (to be used in combination with alpha-blockers), pronounced renal and liver functions impairment.

During treatment with Logimax (Metoprolol Succinate) a production of lacrimal fluid may decreases, which is important for patients who use contact lenses.

Completion of a long course of treatment with Logimax (Metoprolol Succinate) should be gradual (at least 10 days) under the supervision of a physician.

There is not recommended for concurrent use of Logimax (Metoprolol Succinate) with MAO inhibitors.

Combined therapy with clonidine should receive the later stop in a few days after discontinuation of Logimax (Metoprolol Succinate), in order to avoid a hypertensive crisis. Simultaneous administration of Logimax (Metoprolol Succinate) with hypoglycemic agents require correction of their dosing regimen.

A few days before the anesthesia it is necessary to stop taking this drug or find any anesthesia medication with minimal negative inotropic effects.

Patients whose work requires more attention, the application of Logimax (Metoprolol Succinate) outpatients should be addressed only after the evaluation of individual patient response.

Logimax drug interactions

Sympatholytics, nifedipine, nitroglycerin, diuretics, hydralazine and other antihypertensive drugs potentiate hypotension.

Antiarrhythmic and anesthetic medications increase the risk of bradycardia, arrhythmia, hypotension.

Digitalis drugs potentiate slowing AV conduction.

Simultaneously intravenous injection of verapamil and diltiazem may cause cardiac arrest.

Beta-adrenoceptor agonists, aminophylline, cocaine, estrogens, indomethacin and other NSAIDs impair antihypertensive effect.

Logimax (Metoprolol Succinate) enhances and prolongs the action of anti depolarizing muscle relaxants.

Combination with alcohol leads to mutual reinforcement of inhibitory effects on the CNS.

Allergens increased the risk of severe systemic allergic reactions or anaphylaxis.

Logimax (Metoprolol Succinate) edits the effectiveness of insulin and oral antidiabetic drugs and increases the risk of hypoglycemia.

Oral contraceptives, cimetidine, ranitidine, phenothiazines raise the level of this drug in the blood, rifampicin decreases it.

Logimax (Metoprolol Succinate) reduces the clearance of lidocaine, the effectiveness of beta 2-agonists (it is necessary to increase the dose of the latter).

This medicine is incompatible with MAO inhibitors of type A.

Logimax in case of emergency / overdose

Symptoms: hypotension, acute heart failure, bradycardia, heart block, AV block, cardiogenic shock, bronchospasm, trouble breathing and consciousness, coma, nausea, vomiting, generalized convulsions, cyanosis (manifest in 20 minutes - 2 hours after taking of Logimax (Metoprolol Succinate)).

Treatment: gastric lavage, the symptomatic therapy: atropine sulfate injection (IV fast 0.5-2 mg) if bradycardia and a violation of AV conduction; glucagon (1-10 mg IV, then IV infusion 2-2.5 mg / h) and dobutamine in the case of reduction of myocardial contractility; agonists (noradrenaline, adrenaline, etc.) when arterial hypotension; diazepam (IV slowly) to eliminate seizures; beta-agonists inhalation or IV jet injection of aminophylline to relieve broncho spastic reactions; cardioacceleration.

Logimax pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Logimax available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Logimax destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Logimax Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Logimax pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. 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/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Logimax?

Depending on the reaction of the Logimax after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Logimax 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 Logimax 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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Review

sDrugs.com conducted a study on Logimax, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Logimax consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported side effects

Did you get side effects while taking the Logimax drug, or were there no side effects?
According to the survey conducted by website sDrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Logimax medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects1
100.0%

Two visitors reported frequency of use

How often in a day do you take the medicine?
Are you taking the Logimax drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sDrugs.com website users about the frequency of taking the drug Logimax is mentioned below.
Visitors%
Once in a day2
100.0%

Two visitors reported doses

What is the dose of Logimax drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg1
50.0%
11-50mg1
50.0%

Two visitors reported time for results

What is the time duration Logimax drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sDrugs.com website users needed 1 month to notice the result from using Logimax drug. The time needed to show improvement in health condition after using the medicine Logimax need not be same for all the users. It varies based on other factors.
Visitors%
1 month1
50.0%
> 3 month1
50.0%

One visitor reported administration

The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Logimax drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
Visitors%
Empty stomach1
100.0%

Four visitors reported age

Visitors%
30-451
25.0%
1-51
25.0%
> 601
25.0%
46-601
25.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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