Get emergency medical help if you have signs of an allergic reaction to Clonafit: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
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.
Call your doctor at once if you have:
new or worsening seizures;
unusual changes in mood or behavior;
confusion, aggression, hallucinations;
thoughts of suicide or hurting yourself;
weak or shallow breathing;
pounding heartbeats or fluttering in your chest; or
unusual or involuntary eye movements.
Common Clonafit side effects may include:
feeling tired or depressed;
memory problems; or
problems with balance or coordination.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Clonafit in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
The adverse experiences for Clonafit are provided separately for patients with seizure disorders and with panic disorder.
The most frequently occurring side effects of Clonafit are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Others, listed by system, including those identified during postapproval use of Clonafit are:
Dermatologic: Hair loss, hirsutism, skin rash, ankle and facial edema
Psychiatric: Confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis (the behavior effects are more likely to occur in patients with a history of psychiatric disturbances). The following paradoxical reactions have been observed: excitability, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and vivid dreams
Respiratory: Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper respiratory passages
Adverse events during exposure to Clonafit were obtained by spontaneous report 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, CIGY dictionary terminology has been used to classify reported adverse events, except in certain cases in which redundant terms were collapsed into more meaningful terms, as noted below.
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
Overall, the incidence of discontinuation due to adverse events was 17% in Clonafit compared to 9% for placebo in the combined data of two 6-to 9-week trials. The most common events ( ≥ 1%) associated with discontinuation and a dropout rate twice or greater for Clonafit than that of placebo included the following:
Table 2 : Most Common Adverse Events ( ≥ 1%) Associated with Discontinuation of Treatment
Intellectual Ability Reduced
Adverse Events Occurring At An Incidence Of 1% Or More Among Clonafit-Treated Patients:
Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6to 9-week trials. Events reported in 1% or more of patients treated with Clonafit (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included.
The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where 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, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.
* Events reported by at least 1% of patients treated with Clonafit and for which the incidence was greater than that for placebo.
† Indicates that the p-value for the dose-trend test (Cochran-Mantel-Haenszel) for adverse event incidence was ≤ 0.10.
‡ Denominators for events in gender-specific systems are: n=240 (Clonafit), 102 (placebo) for male, and 334 (Clonafit), 192 (placebo) for female.
Commonly Observed Adverse Events
Table 4 : Incidence of Most Commonly Observed Adverse Events* in Acute Therapy in Pool of 6-to 9-Week Trials
Adverse Event (Genentech Preferred Term)
* Treatment-emergent events for which the incidence in the Clonafit patients was ≥ 5% and at least twice that in the placebo patients.
Treatment-Emergent Depressive Symptoms
In the pool of two short-term placebo-controlled trials, adverse events classified under the preferred term “depression” were reported in 7% of Clonafit-treated patients compared to 1% of placebo-treated patients, without any clear pattern of dose relatedness. In these same trials, adverse events classified under the preferred term “depression” were reported as leading to discontinuation in 4% of Clonafit-treated patients compared to 1% of placebo-treated patients. While these findings are noteworthy, Hamilton Depression Rating Scale (HAM-D) data collected in these trials revealed a larger decline in HAM-D scores in the Clonafit group than the placebo group suggesting that clonazepamtreated patients were not experiencing a worsening or emergence of clinical depression.
Other Adverse Events Observed During The Premarketing Evaluation Of Clonafit In Panic Disorder
Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with Clonafit at multiple doses during clinical trials. 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 events reported only once and which did not have a substantial probability of being acutely life-threatening. It is important to emphasize that, although the events occurred during treatment with Clonafit, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency. These adverse events were reported infrequently, which is defined as occurring in 1/100 to 1/1000 patients.
Body as a Whole: weight increase, accident, weight decrease, wound, edema, fever, shivering, abrasions, ankle edema, edema foot, edema periorbital, injury, malaise, pain, cellulitis, inflammation localized
Central and Peripheral Nervous System Disorders: migraine, paresthesia, drunkenness, feeling of enuresis, paresis, tremor, burning skin, falling, head fullness, hoarseness, hyperactivity, hypoesthesia, tongue thick, twitching
Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (eg, convulsions, psychosis, hallucinations, behavioral disorder, tremor, abdominal and muscle cramps) have occurred following abrupt discontinuance of Clonafit. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Clonafit or other psychotropic agents because of the predisposition of such patients to habituation and dependence.
Following the short-term treatment of patients with panic disorder in Studies 1 and 2, patients were gradually withdrawn during a 7-week downward-titration (discontinuance) period. Overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. However, there are not sufficient data from adequate and well-controlled long-term Clonafit studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use.
What is the most important information I should know about Clonafit?
Clonafit orally disintegrating tablets may cause drowsiness, dizziness, lightheadedness, blurred vision, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use Clonafit orally disintegrating tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Clonafit orally disintegrating tablets may cause you to lose consciousness if you have a history of seizures. Use Clonafit orally disintegrating tablets with caution. Do not perform tasks that could be unsafe for you or others if you should lose consciousness (eg, driving, swimming, running heavy machinery).
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Clonafit orally disintegrating tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Patients who take Clonafit orally disintegrating tablets may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Clonafit orally disintegrating tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as anxious, restless, or irritable behavior; depressed mood; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Notify your doctor if seizure control worsens.
Carry an ID card at all times that says you take Clonafit orally disintegrating tablets if it is used for seizures.
Lab tests, including liver function, complete blood cell counts, and electrocardiograms, may be performed while you use Clonafit orally disintegrating tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Clonafit orally disintegrating tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion and drowsiness.
Clonafit orally disintegrating tablets should not be used in CHILDREN younger than 18 years old with panic disorder; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Clonafit orally disintegrating tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clonafit orally disintegrating tablets while you are pregnant. Clonafit orally disintegrating tablets is found in breast milk. Do not breast-feed while taking Clonafit orally disintegrating tablets.
When used for long periods of time or at high doses, Clonafit orally disintegrating tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Clonafit orally disintegrating tablets stops working well. Do not take more than prescribed.
When used for longer than a few weeks or at high doses, some people develop a need to continue taking Clonafit orally disintegrating tablets. This is known as DEPENDENCE or addiction. If you stop taking Clonafit orally disintegrating tablets suddenly, you may have WITHDRAWAL symptoms. These may include abnormal thoughts or behavioral disorder, anxiety, depression, hallucinations, personality changes, or loss of contact with reality; convulsions (seizures); insomnia; stomach and muscle cramps; tremor. Do not suddenly stop taking Clonafit orally disintegrating tablets. If you need to stop Clonafit orally disintegrating tablets, your doctor will lower your dose over time.
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
You should not use this medication if you have severe liver disease, of if you are allergic to Clonafit or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).
Clonafit may cause harm to an unborn baby, and may cause breathing or feeding problems in a newborn. But having seizures during pregnancy could harm both mother and baby. Do not start or stop taking Clonafit during pregnancy without medical advice.
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, irritable, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Before you take Clonafit, tell your doctor if you have kidney or liver disease, glaucoma, any breathing problems, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.
Do not drink alcohol while taking Clonafit. This medication can increase the effects of alcohol.
Clonafit may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
DailyMed. "CLONAZEPAM: 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/dailyme... (accessed September 17, 2018).
DTP/NCI. "clonazepam: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "Clonazepam: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Clonafit 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 Clonafit. 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.
1 consumer reported side effects
Did you experience side effects while taking Clonafit drug? According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Clonafit drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
No side effects
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