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ANAFRANIL
Overview
What is ANAFRANIL?
Anafranil (clomipramine hydrochloride) Capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Anafranil is available as capsules of 25, 50, and 75 mg for oral administration.
Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro--dibenz[] azepine monohydrochloride, and its structural formula is:
Clomipramine hydrochloride USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane.
Inactive Ingredients
What does ANAFRANIL look like?
What are the available doses of ANAFRANIL?
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What should I talk to my health care provider before I take ANAFRANIL?
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How should I use ANAFRANIL?
Anafranil (clomipramine hydrochloride) Capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of Anafranil for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of Anafranil for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Anafranil for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (
).
The treatment regimens described below are based on those used in controlled clinical trials of Anafranil in 520 adults, and 91 children and adolescents with OCD. During initial titration, Anafranil should be given in divided doses with meals to reduce gastrointestinal side effects. The goal of this initial titration phase is to minimize side effects by permitting tolerance to side effects to develop or allowing the patient time to adapt if tolerance does not develop.
Because both CMI and its active metabolite, DMI, have long elimination half-lives, the prescriber should take into consideration the fact that steady-state plasma levels may not be achieved until 2 to 3 weeks after dosage change (
). Therefore, after initial titration, it may be appropriate to wait 2 to 3 weeks between further dosage adjustments.
What interacts with ANAFRANIL?
Anafranil is contraindicated in patients with a history of hypersensitivity to Anafranil or other tricyclic antidepressants.
Monoamine Oxidase Inhibitors (MAOIs)
The use of MAOIs intended to treat psychiatric disorders with Anafranil or within 14 days of stopping treatment with Anafranil is contraindicated because of an increased risk of serotonin syndrome. The use of Anafranil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( ).
Starting Anafranil in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome ( ).
Myocardial Infarction
Anafranil is contraindicated during the acute recovery period after a myocardial infarction.
What are the warnings of ANAFRANIL?
Clinical Worsening and Suicide Risk
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in .
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.
| <18 | 14 additional cases |
| 18-24 | 5 additional cases |
| 25-64 | 1 fewer case |
| ≥65 | 6 fewer cases |
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Screening Patients for Bipolar Disorder –
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Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Anafranil, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of Anafranil with MAOIs intended to treat psychiatric disorders is contraindicated. Anafranil should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Anafranil. Anafranil should be discontinued before initiating treatment with the MAOI ( )
If concomitant use of Anafranil with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Treatment with Anafranil and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Angle-Closure Glaucoma
The pupillary dilation that occurs following use of many antidepressant drugs including Anafranil may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Seizures
During premarket evaluation, seizure was identified as the most significant risk of Anafranil use.
The observed cumulative incidence of seizures among patients exposed to Anafranil at doses up to 300 mg/day was 0.64% at 90 days, 1.12% at 180 days, and 1.45% at 365 days. The cumulative rates correct the crude rate of 0.7% (25 of 3519 patients) for the variable duration of exposure in clinical trials.
Although dose appears to be a predictor of seizure, there is a confounding of dose and duration of exposure, making it difficult to assess independently the effect of either factor alone. The ability to predict the occurrence of seizures in subjects exposed to doses of CMI greater than 250 mg is limited, given that the plasma concentration of CMI may be dose-dependent and may vary among subjects given the same dose. Nevertheless, prescribers are advised to limit the daily dose to a maximum of 250 mg in adults and 3 mg/kg (or 200 mg) in children and adolescents ( ).
Caution should be used in administering Anafranil to patients with a history of seizures or other predisposing factors, e.g., brain damage of varying etiology, alcoholism, and concomitant use with other drugs that lower the seizure threshold.
Rare reports of fatalities in association with seizures have been reported by foreign postmarketing surveillance, but not in U.S. clinical trials. In some of these cases, Anafranil had been administered with other epileptogenic agents; in others, the patients involved had possibly predisposing medical conditions. Thus a causal association between Anafranil treatment and these fatalities has not been established.
Physicians should discuss with patients the risk of taking Anafranil while engaging in activities in which sudden loss of consciousness could result in serious injury to the patient or others, e.g., the operation of complex machinery, driving, swimming, climbing.
DRESS
Rare cases of drug rash with eosinophilia and systemic symptoms (DRESS) have been reported with the use of clomipramine. In the event of severe acute reactions such as DRESS, discontinue clomipramine therapy immediately and institute appropriate treatment.
What are the precautions of ANAFRANIL?
General
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Information for Patients
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with clomipramine hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for clomipramine hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking clomipramine hydrochloride.
- The risk of seizure ( );
- The relatively high incidence of sexual dysfunction among males ( );
- Since Anafranil may impair the mental and/or physical abilities required for the performance of complex tasks, and since Anafranil is associated with a risk of seizures, patients should be cautioned about the performance of complex and hazardous tasks ( );
- Patients should be cautioned about using alcohol, barbiturates, or other CNS depressants concurrently, since Anafranil may exaggerate their response to these drugs;
- Patients should notify their physician if they become pregnant or intend to become pregnant during therapy;
- Patients should notify their physician if they are breast-feeding.
Clinical Worsening and Suicide Risk
–
Physicians are advised to discuss the following issues with patients for whom they prescribe Anafranil:
Patients should be advised that taking Anafranil can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
Drug Interactions
The risks of using Anafranil in combination with other drugs have not been systematically evaluated. Given the primary CNS effects of Anafranil, caution is advised in using it concomitantly with other CNS-active drugs ( ). Anafranil should be used with MAO inhibitors ( ).
Close supervision and careful adjustment of dosage are required when Anafranil is administered with anticholinergic or sympathomimetic drugs.
Several tricyclic antidepressants have been reported to block the pharmacologic effects of guanethidine, clonidine, or similar agents, and such an effect may be anticipated with CMI because of its structural similarity to other tricyclic antidepressants.
The plasma concentration of CMI has been reported to be increased by the concomitant administration of haloperidol; plasma levels of several closely related tricyclic antidepressants have been reported to be increased by the concomitant administration of methylphenidate or hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by the concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin), and such an effect may be anticipated with CMI as well. Administration of CMI has been reported to increase the plasma levels of phenobarbital, if given concomitantly ( ).
Drugs Metabolized by P450 2D6
–
Because Anafranil is highly bound to serum protein, the administration of Anafranil to patients taking other drugs that are highly bound to protein (e.g., warfarin, digoxin) may cause an increase in plasma concentrations of these drugs, potentially resulting in adverse effects. Conversely, adverse effects may result from displacement of protein-bound Anafranil by other highly bound drugs ( ).
Monoamine Oxidase Inhibitors (MAOIs)
( .)
Serotonergic Drugs
( .)
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenicity was found in two 2-year bioassays in rats at doses up to 100 mg/kg, which is 24 and 4 times the maximum recommended human daily dose (MRHD) on a mg/kg and mg/m basis, respectively, or in a 2-year bioassay in mice at doses up to 80 mg/kg, which is 20 and 1.5 times the MRHD on a mg/kg and mg/m basis, respectively.
In reproduction studies, no effects on fertility were found in rats given up to 24 mg/kg, which is 6 times, and approximately equal to, the MRHD on a mg/kg and mg/m basis, respectively.
Pregnancy Category C
No teratogenic effects were observed in studies performed in rats and mice at doses up to 100 mg/kg, which is 24 times the maximum recommended human daily dose (MRHD) on a mg/kg basis and 4 times (rats) and 2 times (mice) the MRHD on a mg/m basis. Slight nonspecific embryo/fetotoxic effects were seen in the offspring of treated rats given 50 and 100 mg/kg and of treated mice given 100 mg/kg.
There are no adequate or well-controlled studies in pregnant women. Withdrawal symptoms, including jitteriness, tremor, and seizures, have been reported in neonates whose mothers had taken Anafranil until delivery. Anafranil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Anafranil has been found in human milk. Because of the potential for adverse reactions, 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 the pediatric population other than pediatric patients with OCD have not been established ( ). Anyone considering the use of Anafranil in a child or adolescent must balance the potential risks with the clinical need.
In a controlled clinical trial in children and adolescents (10 to 17 years of age), 46 outpatients received Anafranil for up to 8 weeks. In addition, 150 adolescent patients have received Anafranil in open-label protocols for periods of several months to several years. Of the 196 adolescents studied, 50 were 13 years of age or less and 146 were 14 to 17 years of age. The adverse reaction profile in this age group ( ) is similar to that observed in adults.
The risks, if any, that may be associated with Anafranil's extended use in children and adolescents with OCD have not been systematically assessed. The evidence supporting the conclusion that Anafranil is safe for use in children and adolescents is derived from relatively short term clinical studies and from extrapolation of experience gained with adult patients. In particular, there are no studies that directly evaluate the effects of long term Anafranil use on the growth, development, and maturation of children and adolescents. Although there is no evidence to suggest that Anafranil adversely affects growth, development or maturation, the absence of such findings is not adequate to rule out a potential for such effects in chronic use.
The safety and effectiveness in pediatric patients below the age of 10 have not been established. Therefore, specific recommendations cannot be made for the use of Anafranil in pediatric patients under the age of 10.
Geriatric Use
Clinical studies of Anafranil did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects; 152 patients at least 60 years of age participating in various U.S. clinical trials received Anafranil for periods of several months to several years. No unusual age-related adverse events were identified in this population. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.
What are the side effects of ANAFRANIL?
Commonly Observed
The most commonly observed adverse events associated with the use of Anafranil and not seen at an equivalent incidence among placebo-treated patients were gastrointestinal complaints, including dry mouth, constipation, nausea, dyspepsia, and anorexia; nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes.
Leading to Discontinuation of Treatment
Approximately 20% of 3616 patients who received Anafranil in U.S. premarketing clinical trials discontinued treatment because of an adverse event. Approximately one-half of the patients who discontinued (9% of the total) had multiple complaints, none of which could be classified as primary. Where a primary reason for discontinuation could be identified, most patients discontinued because of nervous system complaints (5.4%), primarily somnolence. The second-most-frequent reason for discontinuation was digestive system complaints (1.3%), primarily vomiting and nausea.
There was no apparent relationship between the adverse events and elevated plasma drug concentrations.
Incidence in Controlled Clinical Trials
The following table enumerates adverse events that occurred at an incidence of 1% or greater among patients with OCD who received Anafranil in adult or pediatric placebo-controlled clinical trials. The frequencies were obtained from pooled data of clinical trials involving either adults receiving Anafranil (N=322) or placebo (N=319) or children treated with Anafranil (N=46) or placebo (N=44). The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that 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, provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the populations studied.
| Somnolence | 54 | 16 | 46 | 11 | |
| Tremor | 54 | 2 | 33 | 2 | |
| Dizziness | 54 | 14 | 41 | 14 | |
| Headache | 52 | 41 | 28 | 34 | |
| Insomnia | 25 | 15 | 11 | 7 | |
| Libido change | 21 | 3 | - | - | |
| Nervousness | 18 | 2 | 4 | 2 | |
| Myoclonus | 13 | - | 2 | - | |
| Increased appetite | 11 | 2 | - | 2 | |
| Paresthesia | 9 | 3 | 2 | 2 | |
| Memory impairment | 9 | 1 | 7 | 2 | |
| Anxiety | 9 | 4 | 2 | - | |
| Twitching | 7 | 1 | 4 | 5 | |
| Impaired concentration | 5 | 2 | - | - | |
| Depression | 5 | 1 | - | - | |
| Hypertonia | 4 | 1 | 2 | - | |
| Sleep disorder | 4 | - | 9 | 5 | |
| Psychosomatic disorder | 3 | - | - | - | |
| Yawning | 3 | - | - | - | |
| Confusion | 3 | - | 2 | - | |
| Speech disorder | 3 | - | - | - | |
| Abnormal dreaming | 3 | - | - | 2 | |
| Agitation | 3 | - | - | - | |
| Migraine | 3 | - | - | - | |
| Depersonalization | 2 | - | 2 | - | |
| Irritability | 2 | 2 | 2 | - | |
| Emotional lability | 2 | - | - | 2 | |
| Panic reaction | 1 | - | 2 | - | |
| Aggressive reaction | - | - | 2 | - | |
| Paresis | - | - | 2 | - | |
| Increased sweating | 29 | 3 | 9 | - | |
| Rash | 8 | 1 | 4 | 2 | |
| Pruritus | 6 | - | 2 | 2 | |
| Dermatitis | 2 | - | - | 2 | |
| Acne | 2 | 2 | - | 5 | |
| Dry skin | 2 | - | - | 5 | |
| Urticaria | 1 | - | - | - | |
| Abnormal skin odor | - | - | 2 | - | |
| Dry mouth | 84 | 17 | 63 | 16 | |
| Constipation | 47 | 11 | 22 | 9 | |
| Nausea | 33 | 14 | 9 | 11 | |
| Dyspepsia | 22 | 10 | 13 | 2 | |
| Diarrhea | 13 | 9 | 7 | 5 | |
| Anorexia | 12 | - | 22 | 2 | |
| Abdominal pain | 11 | 9 | 13 | 16 | |
| Vomiting | 7 | 2 | 7 | - | |
| Flatulence | 6 | 3 | - | 2 | |
| Tooth disorder | 5 | - | - | - | |
| Gastrointestinal disorder | 2 | - | - | 2 | |
| Dysphagia | 2 | - | - | - | |
| Esophagitis | 1 | - | - | - | |
| Eructation | - | - | 2 | 2 | |
| Ulcerative stomatitis | - | - | 2 | - | |
| Fatigue | 39 | 18 | 35 | 9 | |
| Weight increase | 18 | 1 | 2 | - | |
| Flushing | 8 | - | 7 | - | |
| Hot flushes | 5 | - | 2 | - | |
| Chest pain | 4 | 4 | 7 | - | |
| Fever | 4 | - | 2 | 7 | |
| Allergy | 3 | 3 | 7 | 5 | |
| Pain | 3 | 2 | 4 | 2 | |
| Local edema | 2 | 4 | - | - | |
| Chills | 2 | 1 | - | - | |
| Weight decrease | - | - | 7 | - | |
| Otitis media | - | - | 4 | 5 | |
| Asthenia | - | - | 2 | - | |
| Halitosis | - | - | 2 | - | |
| Postural hypotension | 6 | - | 4 | - | |
| Palpitation | 4 | 2 | 4 | - | |
| Tachycardia | 4 | - | 2 | - | |
| Syncope | - | - | 2 | - | |
| Pharyngitis | 14 | 9 | - | 5 | |
| Rhinitis | 12 | 10 | 7 | 9 | |
| Sinusitis | 6 | 4 | 2 | 5 | |
| Coughing | 6 | 6 | 4 | 5 | |
| Bronchospasm | 2 | - | 7 | 2 | |
| Epistaxis | 2 | - | - | 2 | |
| Dyspnea | - | - | 2 | - | |
| Laryngitis | - | 1 | 2 | - | |
| Micturition disorder | 14 | 2 | 4 | 2 | |
| Urinary tract infection | 6 | 1 | - | - | |
| Micturition frequency | 5 | 3 | - | - | |
| Urinary retention | 2 | - | 7 | - | |
| Dysuria | 2 | 2 | - | - | |
| Cystitis | 2 | - | - | - | |
| Dysmenorrhea | 12 | 14 | 10 | 10 | |
| Lactation (nonpuerperal) | 4 | - | - | - | |
| Menstrual disorder | 4 | 2 | - | - | |
| Vaginitis | 2 | - | - | - | |
| Leukorrhea | 2 | - | - | - | |
| Breast enlargement | 2 | - | - | - | |
| Breast pain | 1 | - | - | - | |
| Amenorrhea | 1 | - | - | - | |
| Ejaculation failure | 42 | 2 | 6 | - | |
| Impotence | 20 | 3 | - | - | |
| Abnormal vision | 18 | 4 | 7 | 2 | |
| Taste perversion | 8 | - | 4 | - | |
| Tinnitus | 6 | - | 4 | - | |
| Abnormal lacrimation | 3 | 2 | - | - | |
| Mydriasis | 2 | - | - | - | |
| Conjunctivitis | 1 | - | - | - | |
| Anisocoria | - | - | 2 | - | |
| Blepharospasm | - | - | 2 | - | |
| Ocular allergy | - | - | 2 | - | |
| Vestibular disorder | - | - | 2 | 2 | |
| Myalgia | 13 | 9 | - | - | |
| Back pain | 6 | 6 | - | - | |
| Arthralgia | 3 | 5 | - | - | |
| Muscle weakness | 1 | - | 2 | - | |
| Purpura | 3 | - | - | - | |
| Anemia | - | - | 2 | 2 | |
| Thirst | 2 | 2 | - | 2 | |
Other Events Observed During the Premarketing Evaluation of Anafranil
During clinical testing in the U.S., multiple doses of Anafranil were administered to approximately 3600 subjects. Untoward events associated with this exposure were 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 untoward events into a smaller number of standardized event categories.
In the tabulations that follow, a modified World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the 3525 individuals exposed to Anafranil who experienced an event of the type cited on at least one occasion while receiving Anafranil. All events are included except those already listed in the previous table, those reported in terms so general as to be uninformative, and those in which an association with the drug was remote. It is important to emphasize that although the events reported occurred during treatment with Anafranil, 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 1/100 to 1/1000 patients; rare events are those occurring in less than 1/1000 patients.
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Postmarketing Experience
The following adverse drug reaction has been reported during post-approval use of Anafranil. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency.
Eye Disorders –
Immune System Disorders –
What should I look out for while using ANAFRANIL?
Anafranil is contraindicated in patients with a history of hypersensitivity to Anafranil or other tricyclic antidepressants.
Monoamine Oxidase Inhibitors (MAOIs)
The use of MAOIs intended to treat psychiatric disorders with Anafranil or within 14 days of stopping treatment with Anafranil is contraindicated because of an increased risk of serotonin syndrome. The use of Anafranil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (
).
Starting Anafranil in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (
).
Myocardial Infarction
Anafranil is contraindicated during the acute recovery period after a myocardial infarction.
What might happen if I take too much ANAFRANIL?
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic overdose. Therefore, hospital monitoring is required as soon as possible.
How should I store and handle ANAFRANIL?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Anafranil™ (clomipramine hydrochloride) Capsules USPCapsules 25 mg Capsules 50 mg Capsules 75 mg Storage – Dispense in well-closed containers with a child-resistant closure. Protect from moisture.Anafranil™ (clomipramine hydrochloride) Capsules USPCapsules 25 mg Capsules 50 mg Capsules 75 mg Storage – Dispense in well-closed containers with a child-resistant closure. Protect from moisture.Anafranil™ (clomipramine hydrochloride) Capsules USPCapsules 25 mg Capsules 50 mg Capsules 75 mg Storage – Dispense in well-closed containers with a child-resistant closure. Protect from moisture.Anafranil™ (clomipramine hydrochloride) Capsules USPCapsules 25 mg Capsules 50 mg Capsules 75 mg Storage – Dispense in well-closed containers with a child-resistant closure. Protect from moisture.Anafranil™ (clomipramine hydrochloride) Capsules USPCapsules 25 mg Capsules 50 mg Capsules 75 mg Storage – Dispense in well-closed containers with a child-resistant closure. Protect from moisture.Anafranil™ (clomipramine hydrochloride) Capsules USPCapsules 25 mg Capsules 50 mg Capsules 75 mg Storage – Dispense in well-closed containers with a child-resistant closure. Protect from moisture.Anafranil™ (clomipramine hydrochloride) Capsules USPCapsules 25 mg Capsules 50 mg Capsules 75 mg Storage – Dispense in well-closed containers with a child-resistant closure. Protect from moisture.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clomipramine (CMI) is presumed to influence obsessive and compulsive behaviors through its effects on serotonergic neuronal transmission. The actual neurochemical mechanism is unknown, but CMI's capacity to inhibit the reuptake of serotonin (5-HT) is thought to be important.
Non-Clinical Toxicology
Anafranil is contraindicated in patients with a history of hypersensitivity to Anafranil or other tricyclic antidepressants.Monoamine Oxidase Inhibitors (MAOIs)
The use of MAOIs intended to treat psychiatric disorders with Anafranil or within 14 days of stopping treatment with Anafranil is contraindicated because of an increased risk of serotonin syndrome. The use of Anafranil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( ).
Starting Anafranil in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome ( ).
Myocardial Infarction
Anafranil is contraindicated during the acute recovery period after a myocardial infarction.
The risks of using Anafranil in combination with other drugs have not been systematically evaluated. Given the primary CNS effects of Anafranil, caution is advised in using it concomitantly with other CNS-active drugs ( ). Anafranil should be used with MAO inhibitors ( ).
Close supervision and careful adjustment of dosage are required when Anafranil is administered with anticholinergic or sympathomimetic drugs.
Several tricyclic antidepressants have been reported to block the pharmacologic effects of guanethidine, clonidine, or similar agents, and such an effect may be anticipated with CMI because of its structural similarity to other tricyclic antidepressants.
The plasma concentration of CMI has been reported to be increased by the concomitant administration of haloperidol; plasma levels of several closely related tricyclic antidepressants have been reported to be increased by the concomitant administration of methylphenidate or hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by the concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin), and such an effect may be anticipated with CMI as well. Administration of CMI has been reported to increase the plasma levels of phenobarbital, if given concomitantly ( ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).