Lomir SRO

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Lomir SRO uses


DESCRIPTION

Lomir SRO is a calcium antagonist available for oral administration in capsules containing 2.5 mg or 5 mg. The structural formula of Lomir SRO is:

Chemically, Lomir SRO is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-,methyl 1-methylethyl ester. Lomir SRO is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor. Lomir SRO is practically insoluble in water (<10 mg/L at 37°C), but is soluble in ethanol and freely soluble in acetone, chloroform and methylene chloride.

Active Ingredient: Lomir SRO

Inactive Ingredients: colloidal silicon dioxide, corn starch, gelatin, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, red iron oxide (5 mg), sodium lauryl sulfate, and titanium dioxide.

Black ink contains the following ingredients: Black Iron Oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, n-Butyl Alcohol, Propylene Glycol, and Shellac Glaze in SD-45 Alcohol.

Structural formula of Lomir SRO

CLINICAL PHARMACOLOGY

Mechanism of Action

Lomir SRO is a dihydropyridine calcium channel blocker. It binds to calcium channels with high affinity and specificity and inhibits calcium flux into cardiac and smooth muscle. The effects observed in mechanistic experiments in vitro and studied in intact animals and man are compatible with this mechanism of action and are typical of the class.

Except for diuretic activity, the mechanism of which is not clearly understood, the pharmacodynamic effects of Lomir SRO observed in whole animals can also be explained by calcium channel blocking activity, especially dilating effects in arterioles which reduce systemic resistance and lower blood pressure, with a small increase in resting heart rate. Although like other dihydropyridine calcium channel blockers, Lomir SRO has negative inotropic effects in vitro, studies conducted in intact anesthetized animals have shown that the vasodilating effect occurs at doses lower than those which affect contractility. In patients with normal ventricular function, isradipine's afterload reducing properties lead to some increase in cardiac output.

Effects in patients with impaired ventricular function have not been fully studied.

Clinical Effects

Dose-related reductions in supine and standing blood pressure are achieved within 2-3 hours following single oral doses of 2.5 mg, 5 mg, 10 mg, and 20 mg Lomir SRO, with a duration of action of more than 12 hours following administration of the highest dose.

Lomir SRO has been shown in controlled, double-blind clinical trials to be an effective antihypertensive agent when used as monotherapy, or when added to therapy with thiazide-type diuretics. During chronic administration, divided doses (b.i.d.) in the range of 5-20 mg daily have been shown to be effective, with response at trough (prior to next dose) over 50% of the peak blood pressure effect. The response is dose-related between 5-10 mg daily. Lomir SRO is equally effective in reducing supine, sitting, and standing blood pressure.

On chronic administration, increases in resting pulse rate averaged about 3-5 beats/min. These increases were not dose-related.

Hemodynamics

In man, peripheral vasodilation produced by Lomir SRO is reflected by decreased systemic vascular resistance and increased cardiac output. Hemodynamic studies conducted in patients with normal left ventricular function produced, following intravenous Lomir SRO administration, increases in cardiac index, stroke volume index, coronary sinus blood flow, heart rate, and peak positive left ventricular dP/dt. Systemic, coronary, and pulmonary vascular resistance was decreased. These studies were conducted with doses of Lomir SRO which produced clinically significant decreases in blood pressure. The clinical consequences of these hemodynamic effects, if any, have not been evaluated.

Effects on heart rate are variable, dependent upon rate of administration and presence of underlying cardiac condition. While increases in both peak positive dP/dt and LV ejection fraction are seen when intravenous Lomir SRO is given, it is impossible to conclude that these represent a positive inotropic effect due to simultaneous changes in preload and afterload. In patients with coronary artery disease undergoing atrial pacing during cardiac catheterization, intravenous Lomir SRO diminished abnormalities of systolic performance. In patients with moderate left ventricular dysfunction, oral and intravenous Lomir SRO in doses which reduce blood pressure by 12%-30%, resulted in improvement in cardiac index without increase in heart rate, and with no change or reduction in pulmonary capillary wedge pressure. Combination of Lomir SRO and propranolol did not significantly affect left ventricular dP/dtmax. The clinical consequences of these effects have not been evaluated.

Electrophysiologic Effects

In general, no detrimental effects on the cardiac conduction system were seen with the use of Lomir SRO. Electrophysiologic studies were conducted on patients with normal sinus and atrioventricular node function. Intravenous Lomir SRO in doses which reduce systolic blood pressure did not affect PR, QRS, AH* or HV* intervals.

No changes were seen in Wenckebach cycle length, atrial, and ventricular refractory periods. Slight prolongation of QTc interval of 3% was seen in one study. Effects on sinus node recovery time were mild or not seen.

In patients with sick sinus syndrome, at doses which significantly reduced blood pressure, intravenous Lomir SRO resulted in no depressant effect on sinus and atrioventricular node function.

*AH = conduction time from low right atrium to His bundle deflection, or AV nodal conduction

time;

HV = conduction time through His bundle and the bundle branch-Purkinje system.

Pharmacokinetics and Metabolism

Lomir SRO is 90%-95% absorbed and is subject to extensive first-pass metabolism, resulting in a bioavailability of about 15%-24%. Lomir SRO is detectable in plasma within 20 minutes after administration of single oral doses of 2.5-20 mg, and peak concentrations of approximately 1ng/mL/mg dosed occur about 1.5 hours after drug administration. Administration of Lomir SRO with food significantly increases the time to peak by about an hour, but has no effect on the total bioavailability (area under the curve) of the drug. Lomir SRO is 95% bound to plasma proteins. Both peak plasma concentration and AUC exhibit a linear relationship to dose over the 0-20 mg dose range. The elimination of Lomir SRO is biphasic with an early half-life of 1½-2 hours, and a terminal half-life of about 8 hours. The total body clearance of Lomir SRO is 1.4 L/min and the apparent volume of distribution is 3 L/kg.

Lomir SRO is completely metabolized prior to excretion, and no unchanged drug is detected in the urine. Six metabolites have been characterized in blood and urine, with the mono acids of the pyridine derivative and a cyclic lactone product accounting for >75% of the material identified. Approximately 60%-65% of an administered dose is excreted in the urine and 25%-30% in the feces. Mild renal impairment (creatinine clearance 30-80 mL/min) increases the bioavailability (AUC) of Lomir SRO by 45%. Progressive deterioration reverses this trend, and patients with severe renal failure (creatinine clearance <10 mL/min) who have been on hemodialysis show a 20%-50% lower AUC than healthy volunteers. No pharmacokinetic information is available on drug therapy during hemodialysis. In elderly patients, Cmax and AUC are increased by 13% and 40%, respectively; in patients with hepatic impairment, Cmax and AUC are increased by 32% and 52%, respectively (see DOSAGE AND ADMINISTRATION ).

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INDICATIONS AND USAGE

Hypertension

Lomir SRO capsules are indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.

CONTRAINDICATIONS

Lomir SRO is contraindicated in individuals who have shown hypersensitivity to any of the ingredients in the formulation.

WARNINGS

None

PRECAUTIONS

General

Blood Pressure: Because Lomir SRO decreases peripheral resistance, like other calcium blockers Lomir SRO may occasionally produce symptomatic hypotension. However, symptoms like syncope and severe dizziness have rarely been reported in hypertensive patients administered Lomir SRO, particularly at the initial recommended doses.

Use in Patients with Congestive Heart Failure: Although acute hemodynamic studies in patients with congestive heart failure have shown that Lomir SRO reduced afterload without impairing myocardial contractility, it has a negative inotropic effect at high doses in vitro, and possibly in some patients. Caution should be exercised when using the drug in congestive heart failure patients, particularly in combination with a beta-blocker.

Drug Interactions

Nitroglycerin: Lomir SRO has been safely coadministered with nitroglycerin.

Hydrochlorothiazide: A study in normal healthy volunteers has shown that concomitant administration of Lomir SRO and hydrochlorothiazide does not result in altered pharmacokinetics of either drug. In a study in hypertensive patients, addition of Lomir SRO to existing hydrochlorothiazide therapy did not result in any unexpected adverse effects, and Lomir SRO had an additional antihypertensive effect.

Propranolol: In a single dose study in normal volunteers, co-administration of propranolol had a small effect on the rate but no effect on the extent of Lomir SRO bioavailability. Significant increases in AUC (27%) and Cmax (58%) and decreases in tmax (23%) of propranolol were noted in this study. However, concomitant administration of 5 mg b.i.d. Lomir SRO and 40 mg b.i.d. propranolol to healthy volunteers under steady-state conditions had no relevant effect on either drug's bioavailability. AUC and Cmax differences were <20% between Lomir SRO given singly and in combination with propranolol, and between propranolol given singly and in combination with Lomir SRO.

Cimetidine: In a study in healthy volunteers, a one-week course of cimetidine at 400 mg b.i.d. with a single 5 mg dose of Lomir SRO on the sixth day showed an increase in Lomir SRO mean peak plasma concentrations (36%) and significant increase in area under the curve (50%). If Lomir SRO therapy is initiated in a patient currently receiving cimetidine, careful monitoring for adverse reactions is advised and downward dose adjustment may be required.

Rifampicin: In a study in healthy volunteers, a six-day course of rifampicin at 600 mg/day followed by a single 5 mg dose of Lomir SRO resulted in a reduction in Lomir SRO levels to below detectable limits. If rifampicin therapy is required, Lomir SRO concentrations and therapeutic effects are likely to be markedly reduced or abolished as a consequence of increased metabolism and higher clearance of Lomir SRO.

Warfarin: In a study in healthy volunteers, no clinically relevant pharmacokinetic or pharmacodynamic interaction between Lomir SRO and racemic warfarin was seen when two single oral doses of warfarin(0.7 mg/kg body weight) were administered during11 days of multiple-dose treatment with 5 mg b.i.d. Lomir SRO. Neither racemic warfarin nor Lomir SRO binding to plasma proteins in vitro was altered by the addition of the other drug.

Digoxin: The concomitant administration of Lomir SRO and digoxin in a single-dose pharmacokinetic study did not affect renal, nonrenal and total body clearance of digoxin.

Fentanyl Anesthesia: Severe hypotension has been reported during fentanyl anesthesia with concomitant use of a beta blocker and a calcium channel blocker. Even though such interactions have not been seen in clinical studies with Lomir SRO, an increased volume of circulating fluids might be required if such an interaction were to occur.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Treatment of male rats for 2 years with 2.5, 12.5, or 62.5 mg/kg/day Lomir SRO admixed with the diet resulted in dose dependent increases in the incidence of benign Leydig cell tumors and testicular hyperplasia relative to untreated control animals. These findings, which were replicated in a subsequent experiment, may have been indirectly related to an effect of Lomir SRO on circulating gonadotropin levels in the rats; a comparable endocrine effect was not evident in male patients receiving therapeutic doses of the drug on a chronic basis. Treatment of mice for two years with 2.5, 15, or 80 mg/kg/day Lomir SRO in the diet (approximately 6, 38, and 200 times the maximum recommended daily dose based on a 50 kg man) showed no evidence of oncogenicity. There was no evidence of mutagenic potential based on the results of a battery of mutagenic tests. No effect on fertility was observed in male and female rats treated with up to 60 mg/kg/day Lomir SRO.

Pregnancy

Pregnancy Category C: Lomir SRO was administered orally to rats and rabbits during organogenesis. Treatment of pregnant rats with doses of 6, 20, or 60 mg/kg/day produced a significant reduction in maternal weight gain during treatment with the highest dose (150 times the maximum recommended human daily dose) but with no lasting effects on the mother or the offspring. Treatment of pregnant rabbits with doses of 1, 3, or 10 mg/kg/day (2.5, 7.5, and 25 times the maximum recommended human daily dose) produced decrements in maternal body weight gain and increased fetal resorption at the two higher doses. There was no evidence of embryotoxicity at doses which were not maternotoxic and no evidence of teratogenicity at any dose tested. In a peri/postnatal administration study in rats, reduced maternal body weight gain during late pregnancy at oral doses of 20 and 60 mg/kg/day Lomir SRO was associated with reduced birth weights and decreased peri and postnatal pup survival.

There are no adequate and well controlled studies in pregnant women. The use of Lomir SRO during pregnancy should only be considered if the potential benefit outweighs potential risks.

Nursing Mothers

It is not known whether Lomir SRO is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for adverse effects of Lomir SRO on nursing infants, a decision should be made as to whether to discontinue nursing or 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.

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ADVERSE REACTIONS

In multiple dose U.S. studies in hypertension, 1228 patients received Lomir SRO alone or in combination with other agents, principally a thiazide diuretic, 934 of them in controlled comparisons with placebo or active agents. An additional 652 patients (which includes 374 normal volunteers) received Lomir SRO in U.S. studies of conditions other than hypertension, and 1321 patients received Lomir SRO in non-U.S. studies. About 500 patients received Lomir SRO in long-term hypertension studies, 410 of them for at least 6 months. The adverse reaction rates given below are principally based on controlled hypertension studies, but rarer serious events are derived from all exposures to Lomir SRO, including foreign marketing experience.

Most adverse reactions were mild and related to the vasodilatory effects of Lomir SRO (dizziness, edema, palpitations, flushing, tachycardia), and many were transient. About 5% of Lomir SRO patients left studies prematurely because of adverse reactions (vs. 3% of placebo patients and 6% of active control patients), principally due to headache, edema, dizziness, palpitations, and gastrointestinal disturbances.

The following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related. The results for the Lomir SRO treated patients are presented for all doses pooled together (reported by 1% or greater of patients receiving any dose of Lomir SRO), and also for the two treatment regimens most applicable to the treatment of hypertension with Lomir SRO: (1) initial and maintenance dose of 2.5 mg b.i.d., and (2) initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5 mg b.i.d.


Lomir SRO


All Doses

N=934


2.5 mg b.i.d.

199


5 mg b.i.d.

150


10 mg b.i.d.††

59


Placebo

297


Active Controls*

414


Adverse

Experience


%


%


%


%


%


%


Headache


13.7


12.6


10.7


22.0


14.1


9.4


Dizziness


7.3


8.0


5.3


3.4


4.4


8.2


Edema


7.2


3.5


8.7


8.5


3.0


2.9


Palpitations


4.0


1.0


4.7


5.1


1.4


1.5


Fatigue


3.9


2.5


2.0


8.5


0.3


6.3


Flushing


2.6


3.0


2.0


5.1


0.0


1.2


Chest Pain


2.4


2.5


2.7


1.7


2.4


2.9


Nausea


1.8


1.0


2.7


5.1


1.7


3.1


Dyspnea


1.8


0.5


2.7


3.4


1.0


2.2


Abdominal

Discomfort


1.7


0.0


3.3


1.7


1.7


3.9


Tachycardia


1.5


1.0


1.3


3.4


0.3


0.5


Rash


1.5


1.5


2.0


1.7


0.3


0.7


Pollakiuria


1.5


2.0


1.3


3.4


0.0


<1.0


Weakness


1.2


0.0


0.7


0.0


0.0


1.2


Vomiting


1.1


1.0


1.3


0.0


0.3


0.2


Diarrhea


1.1


0.0


2.7


3.4


2.0


1.9


Initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5 mg b.i.d.

†† Initial dose of 2.5 mg b.i.d. followed by sequential titration to 5 mg b.i.d., 7.5 mg

b.i.d., and maintenance dose of 10 mg b.i.d.

* Propranolol, prazosin, hydrochlorothiazide, enalapril, captopril.

Except for headache, which is not clearly drug-related, the more frequent adverse reactions listed show little change, or increase slightly, in frequency over time, as shown in the following table:


Incidence Rates for Lomir SRO

(All Doses) by Week (%)


Week

N


1

694


2

906


3

649


4

847


5

432


6

494


Adverse Reaction


Headache


6.5


6.1


5.2


5.2


5.8


4.5


Dizziness


1.6


1.9


1.7


2.2


2.3


2.0


Edema


1.2


2.5


3.2


3.2


5.3


5.5


Palpitations


1.2


1.3


1.4


1.9


2.1


1.4


Fatigue


0.4


1.0


1.4


1.2


1.2


1.6


Flushing


1.2


1.3


2.0


1.4


2.1


1.4


Week

N


7

153


8

377


9

261


10

362


11

107


12

105


Adverse Reaction


Headache


2.0


2.7


1.9


2.8


2.8


3.8


Dizziness


2.0


1.9


2.3


3.9


4.7


3.8


Edema


5.9


5.0


4.6


4.7


3.8


3.8


Palpitations


1.3


0.8


0.8


1.7


1.9


2.9


Fatigue


2.0


2.7


1.5


1.4


0.9


1.9


Flushing


3.3


1.3


1.1


0.8


0.0


0.0



Edema, palpitations, fatigue, and flushing appear to be dose-related, especially at the higher doses of 15-20 mg/day.

In open-label, long-term studies of up to two years in duration, the adverse events reported were generally the same as those reported in the short-term controlled trials. The overall frequencies of these adverse events were slightly higher in the long-term than in the controlled studies, but as in the controlled trials most adverse reactions were mild and transient.

The following adverse experiences were reported in 0.5%-1.0% of the isradipine-treated patients in hypertension studies, or are rare. More serious events from this and other data sources, including postmarketing exposure, are shown in italics. The relationship of these adverse events to Lomir SRO administration is uncertain.

Skin: pruritus, urticaria

Musculoskeletal: cramps of legs/feet

Respiratory: cough

Cardiovascular: shortness of breath, hypotension, atrial fibrillation, ventricular fibrillation, myocardial infarction, heart failure

Gastrointestinal: abdominal discomfort, constipation, diarrhea

Urogenital: nocturia

Nervous System: drowsiness, insomnia, lethargy, nervousness, impotence, decreased libido, depression, syncope, paresthesia (which includes numbness and tingling), transient ischemic attack, stroke

Autonomic: hyperhidrosis, visual disturbance, dry mouth, numbness

Miscellaneous: throat discomfort, leukopenia, elevated liver function tests

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OVERDOSAGE

Minimal empirical data are available on Lomir SRO overdosage. Three individual suicide attempts with dosages of Lomir SRO reported to be from 20 mg up to 100 mg resulted in lethargy, sinus tachycardia and, in the case of the person ingesting 100 mg, transient hypotension which responded to fluid therapy. A foreign report of the ingestion of 200 mg of Lomir SRO with ethanol resulted only in flushing, tachycardia with ST depression on ECG, and hypotension, all of which were reversible. The ingestion of 5 mg of Lomir SRO by a 22-month old child and the accidental ingestion of 100 mg of Lomir SRO by a 58-year old female did not result in any sequelae.

Available data suggest that, as with other dihydropyridines, overdosage with Lomir SRO might result in excessive peripheral vasodilatation with subsequent marked and probably prolonged systemic hypotension, and tachycardia. Emesis, gastric lavage, administration of activated charcoal followed in 30 minutes by a saline cathartic would be reasonable therapy. Lomir SRO is highly protein-bound and not removed by hemodialysis. Overdosage characterized by clinically significant hypotension should be treated with active cardiovascular support including monitoring of cardiac and respiratory function, elevation of lower extremities, and attention to circulating fluid volume and urine output. A vasoconstrictor (such as epinephrine, norepinephrine, or levarterenol) may be helpful in restoring a normotensive state, provided that there is no contraindication to its use.

Refractory hypotension or AV conduction disturbances may be treated with intravenous calcium salts, or glucagon. Cimetidine should be withheld in such instances due to the risk of further increasing plasma Lomir SRO levels.

Significant lethality was observed in mice given oral doses of over 200 mg/kg and rabbits given about 50 mg/kg of Lomir SRO. Rats tolerated doses of over 2000 mg/kg without effects on survival.

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DOSAGE AND ADMINISTRATION

The dosage of Lomir SRO should be individualized. The recommended initial dose of Lomir SRO is 2.5 mg b.i.d. alone or in combination with a thiazide diuretic. An antihypertensive response usually occurs within 2-3 hours. Maximal response may require 2-4 weeks. If a satisfactory reduction in blood pressure does not occur after this period, the dose may be adjusted in increments of 5 mg/day at 2-4 week intervals up to a maximum of 20 mg/day. Most patients, however, show no additional response to doses above 10 mg/day, and adverse effects are increased in frequency above 10 mg/day.

The bioavailability of Lomir SRO (increased AUC) is increased in elderly patients (above 65 years of age), patients with hepatic functional impairment, and patients with mild renal impairment. Ordinarily, the starting dose should still be 2.5 mg b.i.d. in these patients.

HOW SUPPLIED

Lomir SRO Capsules, USP 2.5 mg are Filled Gelatin Capsules Size #3, Cap: White Opaque/Body: White Opaque with Imprint "A-263" on cap and body. Available in bottles of 100's and 500's.

Lomir SRO Capsules, USP 5 mg are Filled Gelatin Capsules Size #3, Cap: Flesh Opaque/Body: Flesh Opaque with Imprint "A-264" on cap and body. Available in bottles of 100's and 500's.

Store 20°- 25°C (68°- 77°F). Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required.


Manufactured By:

Elite Laboratories, Inc.

Northvale, NJ 07647


Distributed By:

Epic Pharma, LLC.

Laurelton, NY 11413

Manufactured in USA

Issued November 2014

MF263REV11/14

OE1511

Lomir SRO Capsules USP, 2.5 mg

Rx Only

100 Capsules

Lomir SRO Capsules USP, 2.5 mg, 100 Count -- Revised 11/14

Lomir SRO Capsules USP, 2.5 mg

Rx Only

500 Capsules

Lomir SRO Capsules USP, 2.5 mg, 500 Count -- Revised 11/14

Lomir SRO Capsules USP, 5 mg

Rx Only

100 Capsules

Lomir SRO Capsules USP, 5 mg, 100 Count -- Revised 11/14

Lomir SRO Capsules USP, 5 mg

Rx Only

500 Capsules

Lomir SRO Capsules USP, 5 mg, 500 Count -- Revised 11/14

Lomir SRO pharmaceutical active ingredients containing related brand and generic drugs:

Active 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.


Lomir SRO available forms, composition, doses:

Form 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.


Lomir SRO destination | category:

Destination 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.


Lomir SRO Anatomical Therapeutic Chemical codes:

A 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.


Lomir SRO pharmaceutical companies:

Pharmaceutical 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."ISRADIPINE CAPSULE [EPIC PHARMA, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."ISRADIPINE: 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).
  3. "isradipine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lomir SRO?

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

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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