What is Lopracil?
Lopracil (Lopracil) is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).
Lopracil is used to treat depression.
Lopracil may also be used for purposes not listed in this medication guide.
Lopracil (Lopracil HBr) is indicated for the treatment of depression.
The efficacy of Lopracil in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder.
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The antidepressant action of Lopracil in hospitalized depressed patients has not been adequately studied.
The efficacy of Lopracil in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials. Nevertheless, the physician who elects to use Lopracil for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
How should I use Lopracil?
Use Lopracil solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Lopracil solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lopracil solution refilled.
- Take Lopracil solution by mouth with or without food.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Taking Lopracil solution at the same time each day will help you remember to take it.
- Do not suddenly stop taking Lopracil solution without checking with your doctor. You may have an increased risk of side effects (eg, mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, unusual tiredness). If you need to stop Lopracil solution, your doctor may need to gradually lower your dose.
- Continue to take Lopracil solution even if you feel well. Do not miss any doses.
- If you miss a dose of Lopracil solution, 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 Lopracil solution.
Uses of Lopracil in details
Lopracil is used in the treatment of depression and panic disorder.
Lopracil hydrobromide belongs to a class of antidepressant agents known as selective serotonin-reuptake inhibitors (SSRIs). Lopracil and its N-demethylated metabolites exist as a racemic mixture but its effects are largely due to the S-enantiomer, S-Lopracil and S-demthylcitalopram. Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Chronic use leads to desensitization of somatodendritic 5-HT1A and terminal autoreceptors. The overall clinical effect of increased mood and decreased anxiety is thought to be due to adaptive changes in neuronal function that leads to enhanced serotonergic neurotransmission. Side effects include dry mouth, nausea, dizziness, drowsiness, sexual dysfunction and headache. Side effects generally occur within the first two weeks of therapy and are usually less severe and frequent than those observed with tricyclic antidepressants. Lopracil is approved for treatment of depression. Unlabeled indications include mild dementia-associated agitation in nonpsychotic patients, smoking cessation, ethanol abuse, obsessive-compulsive disorder (OCD) in children, and diabetic neuropathy. Lopracil has the fewest drug-drug interactions of the SSRIs.
Lopracil should be administered once daily, in the morning or evening, with or without food.
Lopracil (Lopracil HBr) should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.
20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor.
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Lopracil should be used with caution in patients with severe renal impairment.
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to Lopracil and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with Lopracil during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of Lopracil in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of Lopracil (20-60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of Lopracil 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups. Based on these limited data, it is not known whether the dose of Lopracil needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.
Discontinuation of Treatment with Lopracil
Symptoms associated with discontinuation of Lopracil and other SSRIs and SNRIs have been reported. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Lopracil. Conversely, at least 14 days should be allowed after stopping Lopracil before starting an MAOI intended to treat psychiatric disorders.
Use of Lopracil with Other MAOIs, Such as Linezolid or Methylene Blue
Do not start Lopracil in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered.
In some cases, a patient already receiving Lopracil therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Lopracil should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Lopracil may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Lopracil is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.
There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of Lopracil with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
CNS Drugs - Given the primary CNS effects of Lopracil, caution should be used when it is taken in combination with other centrally acting drugs.
Alcohol - Although Lopracil did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking Lopracil is not recommended.
Monoamine Oxidase Inhibitors (MAOIs) - See CONTRAINDICATIONS, WARNINGS and DOSAGE AND ADMINISTRATION.
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) - Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when Lopracil is initiated or discontinued.
Cimetidine - In subjects who had received 21 days of 40 mg/day Lopracil, combined administration of 400 mg twice a day cimetidine for 8 days resulted in an increase in Lopracil AUC and Cmax of 43% and 39%, respectively.
Lopracil 20 mg/day is the maximum recommended dose for patients taking concomitant cimetidine because of the risk of QT prolongation.
Digoxin - In subjects who had received 21 days of 40 mg/day Lopracil, combined administration of Lopracil and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either Lopracil or digoxin.
Lithium - Coadministration of Lopracil (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of Lopracil or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of Lopracil, caution should be exercised when Lopracil and lithium are coadministered.
Pimozide - In a controlled study, a single dose of pimozide 2 mg co-administered with Lopracil 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Lopracil did not alter the mean AUC or Cmax of pimozide. The mechanism of this pharmacodynamic interaction is not known.
Theophylline - Combined administration of Lopracil (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of Lopracil was not evaluated.
Sumatriptan - There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, Lopracil) is clinically warranted, appropriate observation of the patient is advised.
Warfarin - Administration of 40 mg/day Lopracil for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.
Carbamazepine - Combined administration of Lopracil (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough Lopracil plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of Lopracil should be considered if the two drugs are coadministered.
Triazolam - Combined administration of Lopracil (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either Lopracil or triazolam.
Ketoconazole - Combined administration of Lopracil (40 mg) and ketoconazole (200 mg) decreased the Cmax and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of Lopracil.
CYP2C19 Inhibitors - Lopracil 20 mg/day is the maximum recommended dose for patients taking concomitant CYP2C19 inhibitors because of the risk of QT prolongation.
Metoprolol - Administration of 40 mg/day Lopracil for 22 days resulted in a two-fold increase in the plasma levels of the beta-adrenergic blocker metoprolol. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of Lopracil and metoprolol had no clinically significant effects on blood pressure or heart rate.
Imipramine and Other Tricyclic Antidepressants (TCAs) - In vitro studies suggest that Lopracil is a relatively weak inhibitor of CYP2D6. Coadministration of Lopracil (40 mg/day for 10 days) with the TCA imipramine (single dose of 100 mg), a substrate for CYP2D6, did not significantly affect the plasma concentrations of imipramine or Lopracil. However, the concentration of the imipramine metabolite desipramine was increased by approximately 50%. The clinical significance of the desipramine change is unknown. Nevertheless, caution is indicated in the coadministration of TCAs with Lopracil.
Electroconvulsive Therapy (ECT) - There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and Lopracil.
Lopracil side effects
The premarketing development program for Lopracil included Lopracil exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with Lopracil varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.
The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Adverse Findings Observed In Short-Term, Placebo-Controlled Trials
Adverse Events Associated with Discontinuation of Treatment
Among 1063 depressed patients who received Lopracil at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration, 16% discontinued treatment due to an adverse event, as compared to 8% of 446 patients receiving placebo. The adverse events associated with discontinuation and considered drug-related (i.e., associated with discontinuation in at least 1% of Lopracil-treated patients at a rate at least twice that of placebo) are shown in TABLE 2. It should be noted that one patient can report more than one reason for discontinuation and be counted more than once in this table.
TABLE 2: Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled, Depression Trials
|Percentage of Patients Discontinuing Due to Adverse Event|
|Body System/Adverse Event|
|Dry Mouth||1%||< 1%|
|Central and Peripheral|
|Nervous System Disorders|
Adverse Events Occurring at an Incidence of 2% or More Among Lopracil-Treated Patients
Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred among 1063 depressed patients who received Lopracil at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration. Events included are those occurring in 2% or more of patients treated with Lopracil and for which the incidence in patients treated with Lopracil was greater than the incidence in placebo-treated patients.
The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.
The only commonly observed adverse event that occurred in Lopracil patients with an incidence of 5% or greater and at least twice the incidence in placebo patients was ejaculation disorder (primarily ejaculatory delay) in male patients.
TABLE 3: Treatment-Emergent Adverse Events: Incidence in Placebo-Controlled Clinical Trials*
|Body System/Adverse Event||(Percentage of Patients Reporting Event)|
|Autonomic Nervous System Disorders|
|Central & Peripheral Nervous System Disorders|
|Musculoskeletal System Disorders|
|DysmenorrheaDenominator used was for males only (N=425 Lopracil; N=194 placebo).|
Dose Dependency of Adverse Events
The potential relationship between the dose of Lopracil administered and the incidence of adverse events was examined in a fixed-dose study in depressed patients receiving placebo or Lopracil 10, 20, 40, and 60 mg. Jonckheere's trend test revealed a positive dose response (p < 0.05) for the following adverse events: fatigue, impotence, insomnia, sweating increased, somnolence, and yawning.
Male and Female Sexual Dysfunction with SSRIs
Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences.
Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.
The table below displays the incidence of sexual side effects reported by at least 2% of patients taking Lopracil in a pool of placebo-controlled clinical trials in patients with depression.
|Treatment||Lopracil (425 males)||Placebo (194 males)|
|Abnormal Ejaculation (mostly ejaculatory delay)||6.1% (males only)||1% (males only)|
|Libido Decreased||3.8% (males only)||< 1% (males only)|
|Impotence||2.8% (males only)||< 1% (males only)|
In female depressed patients receiving Lopracil, the reported incidence of decreased libido and anorgasmia was 1.3% (n=638 females) and 1.1% (n=252 females), respectively.
There are no adequately designed studies examining sexual dysfunction with Lopracil treatment.
Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.
Vital Sign Changes
Lopracil and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses did not reveal any clinically important changes in vital signs associated with Lopracil treatment. In addition, a comparison of supine and standing vital sign measures for Lopracil and placebo treatments indicated that Lopracil treatment is not associated with orthostatic changes.
Patients treated with Lopracil in controlled trials experienced a weight loss of about 0.5 kg compared to no change for placebo patients.
Lopracil and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with Lopracil treatment.
In a thorough QT study, Lopracil was found to be associated with a dose-dependent increase in the QTc interval.
Electrocardiograms from Lopracil (N=802) and placebo (N=241) groups were compared with respect to outliers defined as subjects with QTc changes over 60 msec from baseline or absolute values over 500 msec post-dose, and subjects with heart rate increases to over 100 bpm or decreases to less than 50 bpm with a 25% change from baseline (tachycardic or bradycardic outliers, respectively). In the Lopracil group 1.9% of the patients had a change from baseline in QTcF > 60 msec compared to 1.2% of the patients in the placebo group. None of the patients in the placebo group had a post-dose QTcF > 500 msec compared to 0.5% of the patients in the Lopracil group. The incidence of tachycardic outliers was 0.5% in the Lopracil group and 0.4% in the placebo group. The incidence of bradycardic outliers was 0.9% in the Lopracil group and 0.4% in the placebo group.
Other Events Observed During The Premarketing Evaluation Of Lopracil (Lopracil HBr)
Following is a list of WHO terms that reflect treatment-emergent adverse events, as defined in the introduction to the ADVERSE REACTIONS section, reported by patients treated with Lopracil at multiple doses in a range of 10 to 80 mg/day during any phase of a trial within the premarketing database of 4422 patients. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those occurring in only one patient. It is important to emphasize that, although the events reported occurred during treatment with Lopracil, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Cardiovascular - Frequent: tachycardia, postural hypotension, hypotension. Infrequent: hypertension, bradycardia, edema (extremities), angina pec toris, extrasystoles, cardiac failure, flushing, myocardial infarction, cerebrovascular accident, myocardial ischemia. Rare: transient ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block.
Central and Peripheral Nervous System Disorders - Frequent: paresthesia, migraine. Infrequent: hyperkinesia, vertigo, hypertonia, extrapyramidal disorder, leg cramps, involuntary muscle contractions, hypokinesia, neuralgia, dystonia, abnormal gait, hypesthesia, ataxia. Rare: abnormal coordination, hyperesthesia, ptosis, stupor.
Endocrine Disorders - Rare: hypothyroidism, goiter, gynecomastia.
Gastrointestinal Disorders - Frequent: saliva increased, flatulence. Infrequent: gastritis, gastroenteritis, stomatitis, eructation, hemorrhoids, dysphagia, teeth grinding, gingivitis, esophagitis. Rare: colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulitis, rectal hemorrhage, hiccups.
General - Infrequent: hot flushes, rigors, alcohol intolerance, syncope, influenza-like symptoms. Rare: hayfever.
Hemic and Lymphatic Disorders - Infrequent: purpura, anemia, epistaxis, leukocytosis, leucopenia, lymphadenopathy. Rare: pulmonary embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, gingival bleeding.
Metabolic and Nutritional Disorders - Frequent: decreased weight, increased weight. Infrequent: increased hepatic enzymes, thirst, dry eyes, increased alkaline phosphatase, abnormal glucose tolerance. Rare: bilirubinemia, hypokalemia, obesity, hypoglycemia, hepatitis, dehydration.
Musculoskeletal System Disorders - Infrequent: arthritis, muscle weakness, skeletal pain. Rare: bursitis, osteoporosis.
Psychiatric Disorders - Frequent: impaired concentration, amnesia, apathy, depression, increased appetite, aggravated depression, suicide attempt, confusion. Infrequent: increased libido, aggressive reaction, paroniria, drug dependence, depersonalization, hallucination, euphoria, psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, psychosis. Rare: catatonic reaction, melancholia.
Reproductive Disorders/Female* - Frequent: amenorrhea. Infrequent: galactorrhea, breast pain, breast enlargement, vaginal hemorrhage.
*% based on female subjects only: 2955
Respiratory System Disorders - Frequent: coughing. Infrequent: bronchitis, dyspnea, pneumonia. Rare: asthma, laryngitis, bronchospasm, pneumonitis, sputum increased.
Skin and Appendages Disorders - Frequent: rash, pruritus. Infrequent: photosensitivity reaction, urticaria, acne, skin discoloration, eczema, alopecia, dermatitis, skin dry, psoriasis. Rare: hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, pruritus ani.
Special Senses - Frequent: accommodation abnormal, taste perversion. Infrequent: tinnitus, conjunctivitis, eye pain. Rare: mydriasis, photophobia, diplopia, abnormal lacrimation, cataract, taste loss.
Urinary System Disorders - Frequent: polyuria. Infrequent: micturition frequency, urinary incontinence, urinary retention, dysuria. Rare: facial edema, hematuria, oliguria, pyelonephritis, renal calculus, renal pain.
Other Events Observed During The Postmarketing Evaluation Of Lopracil (Lopracil HBr)
It is estimated that over 30 million patients have been treated with Lopracil since market introduction. Although no causal relationship to Lopracil treatment has been found, the following adverse events have been reported to be temporally associated with Lopracil treatment, and have not been described elsewhere in labeling: acute renal failure, akathisia, allergic reaction, anaphylaxis, angioedema, choreoathetosis, chest pain, delirium, dyskinesia, ecchymosis, epidermal necrolysis, erythema multiforme, gastrointestinal hemorrhage, angle closure glaucoma, grand mal convulsions, hemolytic anemia, hepatic necrosis, myoclonus, nystagmus, pancreatitis, priapism, prolactinemia, prothrombin decreased, QT prolonged, rhabdomyolysis, spontaneous abortion, thrombocytopenia, thrombosis, ventricular arrhythmia, torsade de pointes, and withdrawal syndrome.
Drug Abuse And Dependence
Controlled Substance Class
Lopracil (Lopracil HBr) is not a controlled substance.
Physical And Psychological Dependence
Animal studies suggest that the abuse liability of Lopracil is low. Lopracil has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with Lopracil did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate Lopracil patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).
You should not use Lopracil if you are allergic to it, or if you also take pimozide.
Do not use Lopracil if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
Before taking Lopracil, tell your doctor if you have a heart rhythm disorder, a personal or family history of Long QT syndrome, or an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).
Tell your doctor about all other medicines you use. There are many other medicines that can increase your risk of heart rhythm problems if you use them together with Lopracil.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Lopracil. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Tell your doctor right away if you become pregnant while taking this medication. Do not start or stop taking Lopracil during pregnancy without your doctor's advice.
Active ingredient matches for Lopracil:
Citalopram in Greece.
List of Lopracil substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|LOPRAM Capsule/ Tablet / 10mg / 10 units (Ind-Swift)||$ 0.33|
|LOPRAM Capsule/ Tablet / 20mg / 10 units (Ind-Swift)||$ 0.60|
|Lopram 10mg TAB / 10 (Ind-Swift)||$ 0.33|
|Lopram 20mg TAB / 10 (Ind-Swift)||$ 0.60|
|10 mg x 10's (Ind-Swift)||$ 0.33|
|20 mg x 10's (Ind-Swift)||$ 0.60|
|LOPRAM 10MG TABLET 1 strip / 10 tablets each (Ind-Swift)||$ 0.33|
|LOPRAM 20MG TABLET 1 strip / 10 tablets each (Ind-Swift)||$ 0.60|
|LOPRAM tab 10 mg x 10's (Ind-Swift)||$ 0.33|
|LOPRAM tab 20 mg x 10's (Ind-Swift)||$ 0.60|
|Lopram 10mg Tablet (Ind-Swift)||$ 0.03|
|Lopram 20mg Tablet (Ind-Swift)||$ 0.06|
|Lopram 20mg (Oman)|
|Lowdep 20 mg x 10 Blister x 10 Tablet|
|Lupram 20 mg x 14's (Lundbeck)||$ 37.11|
|MADAM Capsule/ Tablet / 20mg / 10 units (Panacea)||$ 0.67|
|MADAM Capsule/ Tablet / 40mg / 10 units (Panacea)||$ 1.12|
|MADAM Capsule/ Tablet / 10mg / 10 units (Panacea)||$ 0.34|
|Madam 10mg FC-TAB / 10 (Panacea)||$ 0.34|
|Madam 20mg FC-TAB / 10 (Panacea)||$ 0.67|
|Madam 40mg FC-TAB / 10 (Panacea)||$ 1.12|
|10 mg x 10's (Panacea)||$ 0.34|
|20 mg x 10's (Panacea)||$ 0.67|
|40 mg x 10's (Panacea)||$ 1.12|
|MADAM 10MG TABLET 1 strip / 10 tablets each (Panacea)||$ 0.34|
|MADAM 20MG TABLET 1 strip / 10 tablets each (Panacea)||$ 0.67|
|MADAM film-coated tab 10 mg x 10's (Panacea)||$ 0.34|
|MADAM film-coated tab 20 mg x 10's (Panacea)||$ 0.67|
|MADAM film-coated tab 40 mg x 10's (Panacea)||$ 1.12|
|Madam 10mg FC-TAB / 10 (Panacea)||$ 0.34|
|Madam 20mg FC-TAB / 10 (Panacea)||$ 0.67|
|Madam 40mg FC-TAB / 10 (Panacea)||$ 1.12|
|Madam 10mg Tablet (Panacea)||$ 0.03|
|Madam 20mg Tablet (Panacea)||$ 0.07|
|Mahapram NA Tablet (Sanmai Pharma)||$ 0.16|
|Mai Ke Wei (China)|
- PubChem. "citalopram". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "citalopram". http://www.drugbank.ca/drugs/DB00215 (accessed September 17, 2018).
- MeSH. "Antidepressive Agents, Second-Generation". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Lopracil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Lopracil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
Consumer reported time for resultsNo survey data has been collected yet
Consumer reported ageNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology