Clonazepam

Clonazepam

Clonazepam Recall

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Questions & Answers

  • Question

    JackInhauf

    I’ve been on Clonazepam for Anxiety disorder and PTSD for years. The generics are all over the map depending on brand. My last refill was from a new manufacturer I\\\\\\\’d never had before. The drug is maybe, 50% as effective as the normal generic I am used to. Had PDOC switch me to Klonopin brand name, which is available again. I will try my first dose tonight. I\\\\\\\’m nervous about it, because I\\\\\\\’ve read countless threads on various forums that claim the name brand is super powerful compared to all generics. Any thoughts or comments? BTW, II\\\\\\\’m dosing down by 50% to be safe

    posted on May 14, 2016
  • Side Effects & Adverse Reactions

    Since clonazepam produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle. They should also be warned about the concomitant use of alcohol or other CNS-depressant drugs during clonazepam therapy (see PRECAUTIONS: Drug Interactions and Information for Patients).

     

    Antiepileptic drugs (AEDs), including clonazepam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

    Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43% compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

    The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

    The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.

    Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

    Table 1 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis
    IndicationPlacebo Patients
    with Events
    Per 1000 Patients
    Drug Patients
    with Events
    Per 1000 Patients
    Relative Risk:
    Incidence of Events
    in Drug Patients/Incidence
    in Placebo Patients
    Risk Difference:
    Additional Drug Patients
    with Events
    per 1000 Patients
    Epilepsy1.03.43.52.4
    Psychiatric5.78.51.52.9
    Other1.01.81.90.9
    Total2.44.31.81.9

    The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

    Anyone considering prescribing clonazepam or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

    Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

     

    Data from several sources raise concerns about the use of clonazepam during pregnancy.

     

    In three studies in which clonazepam was administered orally to pregnant rabbits at doses of 0.2, 1, 5 or 10 mg/kg/day (low dose approximately 0.2 times the maximum recommended human dose of 20 mg/day, for seizure disorders and equivalent to the maximum dose of 4 mg/day for panic disorder, on a mg/m2 basis) during the period of organogenesis, a similar pattern of malformations (cleft palate, open eyelid, fused sternebrae and limb defects) was observed in a low, non-dose-related incidence in exposed litters from all dosage groups. Reductions in maternal weight gain occurred at dosages of 5 mg/kg/day or greater and reduction in embryo-fetal growth occurred in one study at a dosage of 10 mg/kg/day. No adverse maternal or embryo-fetal effects were observed in mice and rats following administration during organogenesis of oral doses up to 15 mg/kg/day or 40 mg/kg/day, respectively (4 and 20 times the maximum recommended human dose of 20 mg/day for seizure disorders and 20 and 100 times the maximum dose of 4 mg/day for panic disorder, respectively, on a mg/m2 basis).

     

    Recent reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to diphenylhydantoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.

    In children of women treated with drugs for epilepsy, reports suggesting an elevated incidence of birth defects cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors (eg, genetic factors or the epileptic condition itself) may be more important than drug therapy in leading to birth defects. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy; however, it cannot be said with any confidence that even mild seizures do not pose some hazards to the developing embryo or fetus.

     

    An increased risk of congenital malformations associated with the use of benzodiazepine drugs has been suggested in several studies.

    There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. In addition, children born to mothers receiving benzodiazepines late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period.

     

    In general, the use of clonazepam in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus.

    The specific considerations addressed above regarding the use of anticonvulsants for epilepsy in women of childbearing potential should be weighed in treating or counseling these women.

    Because of experience with other members of the benzodiazepine class, clonazepam is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. Because use of these drugs is rarely a matter of urgency in the treatment of panic disorder, their use during the first trimester should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant, they should communicate with their physician about the desirability of discontinuing the drug.

     

    Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE).

     

    Legal Issues

    There is currently no legal information available for this drug.

    FDA Safety Alerts

    There are currently no FDA safety alerts available for this drug.

    Manufacturer Warnings

    There is currently no manufacturer warning information available for this drug.

    FDA Labeling Changes

    There are currently no FDA labeling changes available for this drug.

    Uses

    Clonazepam is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful.

    In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy.

     

    Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

    The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).

    Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

    The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

     

    History

    There is currently no drug history available for this drug.

    Other Information

    Clonazepam, a benzodiazepine, is available as scored tablets debossed with “1” and “2” containing 0.5 mg of clonazepam and unscored tablets debossed with “C 1” on 1 mg tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of clonazepam. Each tablet contains anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 Lake.

    Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:

    MM1

     

    Clonazepam Manufacturers


    • Remedyrepack Inc.
      Clonazepam Tablet [Remedyrepack Inc. ]
    • A-s Medication Solutions Llc
      Clonazepam Tablet [A-s Medication Solutions Llc]
    • Kaiser Foundation Hospitals
      Clonazepam Tablet [Kaiser Foundation Hospitals]
    • Proficient Rx Lp
      Clonazepam Tablet [Proficient Rx Lp]
    • Direct Rx
      Clonazepam Tablet [Direct Rx]
    • Watson Laboratories, Inc.
      Clonazepam (Clonazepam) Tablet [Watson Laboratories, Inc.]
    • Rebel Distributors
      Clonazepam Tablet [Rebel Distributors]
    • Contract Pharmacy Services-pa
      Clonazepam Tablet [Contract Pharmacy Services-pa]
    • Mckesson Packaging Services Business Unit Of Mckesson Corporation
      Clonazepam Tablet [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
    • Accord Healthcare Inc.
      Clonazepam Tablet [Accord Healthcare Inc.]
    • Physicians Total Care, Inc.
      Clonazepam Tablet, Orally Disintegrating [Physicians Total Care, Inc.]
    • Cardinal Health
      Clonazepam Tablet [Cardinal Health]
    • Remedyrepack Inc.
      Clonazepam (Clonazepan) Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Clonazepam Tablet [Remedyrepack Inc. ]
    • Bryant Ranch Prepack
      Clonazepam Tablet [Bryant Ranch Prepack]
    • Actavis Elizabeth Llc
      Clonazepam Tablet [Actavis Elizabeth Llc]
    • Par Pharmaceutical, Inc.
      Clonazepam (Clonazepam) Tablet, Orally Disintegrating [Par Pharmaceutical, Inc.]
    • Dispensing Solutions, Inc.
      Clonazepam Tablet [Dispensing Solutions, Inc.]
    • Stat Rx Usa Llc
      Clonazepam Tablet [Stat Rx Usa Llc]
    • H.j. Harkins Company, Inc.
      Clonazepam Tablet [H.j. Harkins Company, Inc.]
    • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
      Clonazepam Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
    • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
      Clonazepam Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
    • Pd-rx Pharmaceuticals, Inc.
      Clonazepam Tablet [Pd-rx Pharmaceuticals, Inc.]
    • Unit Dose Services
      Clonazepam Tablet [Unit Dose Services]
    • Stat Rx Usa Llc
      Clonazepam Tablet [Stat Rx Usa Llc]
    • Stat Rx Usa Llc
      Clonazepam Tablet [Stat Rx Usa Llc]
    • Unit Dose Services
      Clonazepam Tablet [Unit Dose Services]
    • Physicians Total Care, Inc.
      Clonazepam Tablet [Physicians Total Care, Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Clonazepam Tablet [Pd-rx Pharmaceuticals, Inc.]
    • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
      Clonazepam Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
    • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
      Clonazepam Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
    • Mckesson Contract Packaging
      Clonazepam Tablet [Mckesson Contract Packaging]
    • Bryant Ranch Prepack
      Clonazepam Tablet [Bryant Ranch Prepack]
    • Bryant Ranch Prepack
      Clonazepam Tablet [Bryant Ranch Prepack]
    • Major Pharmaceuticals
      Clonazepam Tablet [Major Pharmaceuticals]
    • Unit Dose Services
      Clonazepam Tablet [Unit Dose Services]
    • Remedyrepack Inc.
      Clonazepam Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Clonazepam Tablet [Remedyrepack Inc. ]
    • A-s Medication Solutions Llc
      Clonazepam Tablet [A-s Medication Solutions Llc]
    • Barr Laboratories Inc.
      Clonazepam Tablet, Orally Disintegrating [Barr Laboratories Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Clonazepam Tablet [Pd-rx Pharmaceuticals, Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Clonazepam Tablet [Pd-rx Pharmaceuticals, Inc.]
    • Teva Pharmaceuticals Usa Inc
      Clonazepam Tablet [Teva Pharmaceuticals Usa Inc]
    • Golden State Medical Supply, Inc
      Clonazepam Tablet [Golden State Medical Supply, Inc]
    • Caraco Pharmaceutical Laboratories, Ltd.
      Clonazepam Tablet [Caraco Pharmaceutical Laboratories, Ltd.]
    • Remedyrepack Inc.
      Clonazepam Tablet [Remedyrepack Inc. ]
    • Aidarex Pharmaceuticals Llc
      Clonazepam Tablet [Aidarex Pharmaceuticals Llc]
    • Qualitest Pharmaceuticals
      Clonazepam Tablet [Qualitest Pharmaceuticals]
    • Eon Labs, Inc.
      Clonazepam Tablet [Eon Labs, Inc.]
    • Direct Rx
      Clonazepam Tablet [Direct Rx]
    • Direct Rx
      Clonazepam Tablet [Direct Rx]
    • Aphena Pharma Solutions – Tennessee, Llc
      Clonazepam Tablet [Aphena Pharma Solutions – Tennessee, Llc]
    • Aphena Pharma Solutions – Tennessee, Llc
      Clonazepam Tablet [Aphena Pharma Solutions – Tennessee, Llc]
    • Aphena Pharma Solutions – Tennessee, Llc
      Clonazepam Tablet [Aphena Pharma Solutions – Tennessee, Llc]
    • Mylan Institutional Inc.
      Clonazepam Tablet [Mylan Institutional Inc.]
    • Cardinal Health
      Clonazepam Tablet [Cardinal Health]
    • Cardinal Health
      Clonazepam Tablet [Cardinal Health]
    • Northwind Pharmaceuticals
      Clonazepam Tablet [Northwind Pharmaceuticals]
    • Cardinal Health
      Clonazepam Tablet [Cardinal Health]
    • Remedyrepack Inc.
      Clonazepam Tablet [Remedyrepack Inc. ]
    • Preferred Pharmaceuticals, Inc.
      Clonazepam Tablet [Preferred Pharmaceuticals, Inc.]
    • Tya Pharmaceuticals
      Clonazepam Tablet [Tya Pharmaceuticals]
    • Tya Pharmaceuticals
      Clonazepam Tablet [Tya Pharmaceuticals]
    • Mylan Pharmaceuticals Inc.
      Clonazepam Tablet [Mylan Pharmaceuticals Inc.]
    • Upsher-smith Laboratories, Inc.
      Clonazepam Tablet [Upsher-smith Laboratories, Inc.]
    • Preferred Pharmaceuticals, Inc.
      Clonazepam Tablet [Preferred Pharmaceuticals, Inc.]
    • Preferred Pharmaceuticals, Inc.
      Clonazepam Tablet [Preferred Pharmaceuticals, Inc.]
    • Medsource Pharmaceuticals
      Clonazepam Tablet [Medsource Pharmaceuticals]

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