Product Elements:
Clorazepate dipotassium clorazepate dipotassium clorazepate dipotassium clorazepic acid silicon dioxide magnesium oxide magnesium stearate microcrystalline cellulose potassium carbonate potassium chloride talc fd&c blue no. 2 fd&c red no. 40 pale violet flat beveled edge, slightly mottled t;45 clorazepate dipotassium clorazepate dipotassium clorazepate dipotassium clorazepic acid silicon dioxide magnesium oxide magnesium stearate microcrystalline cellulose potassium carbonate potassium chloride talc d&c red no. 6 barium lake d&c yellow no. 10 flat beveled edge, slightly mottled t;46 clorazepate dipotassium clorazepate dipotassium clorazepate dipotassium clorazepic acid silicon dioxide magnesium oxide magnesium stearate microcrystalline cellulose potassium carbonate potassium chloride talc d&c red no. 6 barium lake fd&c red no. 40 pale pink flat beveled edge, slightly mottled t;47
Drug Interactions:
Drug interactions the concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the cns that control respiration. benzodiazepines interact at gabaa sites and opioids interact primarily at mu receptors. when benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. if clorazepate dipotassium is to be combined with other drugs acting on the central nervous system, careful consideration should be given to the pharmacology of the agents to be employed. animal experience indicates that clorazepate dipotassium prolongs the sleeping time after hexobarbital or after ethyl alcohol, increases the inhibitory effects of chlorpromazine, but does not exhibit monoamine oxidase inhibition
Read more.... clinical studies have shown increased sedation with concurrent hypnotic medications. the actions of the benzodiazepines may be potentiated by barbiturates, narcotics, phenothiazines, monoamine oxidase inhibitors or other antidepressants. if clorazepate dipotassium tablets are used to treat anxiety associated with somatic disease states, careful attention must be paid to possible drug interaction with concomitant medication. in bioavailability studies with normal subjects, the concurrent administration of antacids at therapeutic levels did not significantly influence the bioavailability of clorazepate dipotassium tablets.
Boxed Warning:
Warning: risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. limit dosages and durations to the minimum required. follow patients for signs and symptoms of respiratory depression and sedation (see warnings and precautions ). the use of benzodiazepines, including clorazepate dipotassium, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. before prescribing clorazepate dipotassium and throughout out treatment, assess each patient's risk for abuse, misuse, and addiction (see warnings ). the continued use of benzodiazepines, including clorazepate dipotassium, may lead to clinically significant physical dependence. the risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. abrupt discontinuation or rapid dosage reduction of clorazepate dipotassium after continued use may precipitate acute withdrawal reactions, which can be life-threatening. to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage (see dosage and administration and warnings ).
Indications and Usage:
Indications and usage clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. the effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. long-term studies in epileptic patients, however, have shown continued therapeutic activity. the physician should reassess periodically the usefulness of the drug for the individual patient. clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal.
Warnings:
Warnings risks from concomitant use with opioids concomitant use of benzodiazepines, including clorazepate dipotassium, and opioids may result in profound sedation, respiratory depression, coma, and death. because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. if a decision is made to prescribe clorazepate dipotassium concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. in patients already receiving an opioid analgesic, prescribe a lower initial dose of clorazepate dipotassium than indicated in the absence of an opioid and titrate based on clinical response. if an opioid is initiate
Read more...d in a patient already taking clorazepate dipotassium, prescribe a lower initial dose of the opioid and titrate based upon clinical response. advise both patients and caregivers about the risks of respiratory depression and sedation when clorazepate dipotassium is used with opioids. advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see precautions: drug interactions ). abuse, misuse, and addiction the use of benzodiazepines, including clorazepate dipotassium, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see drug abuse and dependence: abuse ). before prescribing clorazepate dipotassium and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). use of clorazepate dipotassium, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of clorazepate dipotassium along with monitoring for signs and symptoms of abuse, misuse, and addiction. prescribe the lowest effective dosage; avoid or minimize concomitant use of cns depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. if a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. dependence and withdrawal reactions to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage (a patient-specific plan should be used to taper the dose) (see dosage and administration: discontinuation of dosage reduction of clorazepate dipotassium ). patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. acute withdrawal reactions the continued use of benzodiazepines, including clorazepate dipotassium, may lead to clinically significant physical dependence. abrupt discontinuation or rapid dosage reduction of clorazepate dipotassium after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see drug abuse and dependence: dependence ). protracted withdrawal syndrome in some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see drug abuse and dependence ). use in depressive neuroses or psychotic reactions clorazepate dipotassium tablets are not recommended for use in depressive neuroses or in psychotic reactions. use in children because of the lack of sufficient clinical experience, clorazepate dipotassium tablets are not recommended for use in patients less than 9 years of age. interference with psychomotor performance patients taking clorazepate dipotassium tablets should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating dangerous machinery including motor vehicles. concomitant use with cns depressants since clorazepate dipotassium has a central nervous system depressant effect, patients should be advised against the simultaneous use of other cns depressant drugs, and cautioned that the effects of alcohol may be increased. suicidal behavior and ideation antiepileptic drugs (aeds), including clorazepate dipotassium, 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 indication placebo 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 epilepsy 1.0 3.4 3.5 2.4 psychiatric 5.7 8.5 1.5 2.9 other 1.0 1.8 1.9 0.9 total 2.4 4.3 1.8 1.9 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 clorazepate dipotassium tablets 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. usage in pregnancy an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. clorazepate dipotassium, a benzodiazepine derivative, has not been studied adequately to determine whether it, too, may be associated with an increased risk of fetal abnormality. because use of these drugs is rarely a matter of urgency, their use during this period 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. patients should 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. to provide information regarding the effects of in utero exposure to clorazepate dipotassium, physicians are advised to recommend that pregnant patients taking clorazepate dipotassium enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. usage during lactation clorazepate dipotassium tablets should not be given to nursing mothers since it has been reported that nordiazepam is excreted in human breast milk.
Dosage and Administration:
Dosage and administration for the symptomatic relief of anxiety clorazepate dipotassium tablets are administered orally in divided doses. the usual daily dose is 30 mg. the dose should be adjusted gradually within the range of 15 to 60 mg daily in accordance with the response of the patient. in elderly or debilitated patients it is advisable to initiate treatment at a daily dose of 7.5 to 15 mg. clorazepate dipotassium tablets may also be administered in a single dose daily at bedtime; the recommended initial dose is 15 mg. after the initial dose, the response of the patient may require adjustment of subsequent dosage. lower doses may be indicated in the elderly patient. drowsiness may occur at the initiation of treatment and with dosage increment. for the symptomatic relief of acute alcohol withdrawal the following dosage schedule is recommended: 1st 24 hours (day 1) 30 mg initially; followed by 30 to 60 mg in divided doses 2nd 24 hours (day 2) 45 to 90 mg in divided doses 3rd 24 hour
Read more...s (day 3) 22.5 to 45 mg in divided doses day 4 15 to 30 mg in divided doses thereafter, gradually reduce the daily dose to 7.5 to 15 mg. discontinue drug therapy as soon as patient's condition is stable. the maximum recommended total daily dose is 90 mg. avoid excessive reductions in the total amount of drug administered on successive days. as an adjunct to antiepileptic drugs in order to minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded. adults the maximum recommended initial dose in patients over 12 years old is 7.5 mg three times a day. dosage should be increased by no more than 7.5 mg every week and should not exceed 90 mg/day. children (9 to 12 years) the maximum recommended initial dose is 7.5 mg two times a day. dosage should be increased by no more than 7.5 mg every week and should not exceed 60 mg/day. discontinuation or dosage reduction of clorazepate dipotassium to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage. if a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. subsequently decrease the dosage more slowly (see warnings and drug abuse and dependence ).
Contraindications:
Contraindications clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.
Adverse Reactions:
Adverse reactions the side effect most frequently reported was drowsiness. less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor and slurred speech. there have been reports of abnormal liver and kidney function tests and of decrease in hematocrit. decrease in systolic blood pressure has been observed. to report suspected adverse reactions, contact taro pharmaceuticals u.s.a., inc. at 1-866-923-4914 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Drug Interactions:
Drug interactions the concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the cns that control respiration. benzodiazepines interact at gabaa sites and opioids interact primarily at mu receptors. when benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. if clorazepate dipotassium is to be combined with other drugs acting on the central nervous system, careful consideration should be given to the pharmacology of the agents to be employed. animal experience indicates that clorazepate dipotassium prolongs the sleeping time after hexobarbital or after ethyl alcohol, increases the inhibitory effects of chlorpromazine, but does not exhibit monoamine oxidase inhibition
Read more.... clinical studies have shown increased sedation with concurrent hypnotic medications. the actions of the benzodiazepines may be potentiated by barbiturates, narcotics, phenothiazines, monoamine oxidase inhibitors or other antidepressants. if clorazepate dipotassium tablets are used to treat anxiety associated with somatic disease states, careful attention must be paid to possible drug interaction with concomitant medication. in bioavailability studies with normal subjects, the concurrent administration of antacids at therapeutic levels did not significantly influence the bioavailability of clorazepate dipotassium tablets.
Pediatric Use:
Pediatric use see warnings .
Geriatric Use:
Geriatric use clinical studies of clorazepate dipotassium were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects. elderly or debilitated patients may be especially sensitive to the effects of all benzodiazepines, including clorazepate dipotassium. in general, elderly or debilitated patients should be started on lower doses of clorazepate dipotassium tablets and observed closely, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. dose adjustments should also be made slowly, and with more caution in this patient population (see precautions and dosage and administration ).
Overdosage:
Overdosage overdosage is usually manifested by varying degrees of cns depression ranging from slight sedation to coma. as in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. the treatment of overdosage should consist of the general measures employed in the management of overdosage of any cns depressant. gastric evacuation either by the induction of emesis, lavage, or both, should be performed immediately. general supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. hypotension, though rarely reported, may occur with large overdoses. in such cases the use of agents such as norepinephrine bitartrate injection, usp or metaraminol bitartrate injection, usp should be considered. while reports indicate that individuals have survived overdoses of clorazepate dipotassium as high as 450 to 675 mg, these doses are not necessarily an accurate indication of the amount of drug absorbed since the time interval between ingestion and the institution of treatment was not always known. sedation in varying degrees was the most common physiological manifestation of clorazepate dipotassium overdosage. deep coma when it occurred was usually associated with the ingestion of other drugs in addition to clorazepate dipotassium. flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. the prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. the complete flumazenil package insert including contraindications, warnings, and precautions should be consulted prior to use.
dependence:
Dependence physical dependence clorazepate dipotassium may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions ). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of clorazepate dipotassium and warnings: dependence and withdrawal reactions ). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.
Description:
Description chemically, clorazepate dipotassium usp is a benzodiazepine. the empirical formula is c 16 h 11 clk 2 n 2 o 4 ; the molecular weight is 408.92; 1 h -1, 4-benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows: the compound occurs as a fine, light yellow, practically odorless powder. it is insoluble in the common organic solvents, but very soluble in water. aqueous solutions are unstable, clear, light yellow, and alkaline. clorazepate dipotassium tablets usp contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium usp. in addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium oxide heavy, magnesium stearate, microcrystalline cellulose, potassium carbonate anhydrous, potassium chloride, talc and the following coloring agents: 3.75 mg - fd&c blue no. 2 lake and fd&c red no. 40 lake 7.5 mg - d&c red no. 6 barium lake and d&c yellow no. 10 lake 15 mg - d&c red no. 6 barium lake and fd&c red no. 40 lake chemical structure
Clinical Pharmacology:
Clinical pharmacology pharmacologically, clorazepate dipotassium has the characteristics of the benzodiazepines. it has depressant effects on the central nervous system. the primary metabolite, nordiazepam, quickly appears in the blood stream. the serum half-life is about 2 days. the drug is metabolized in the liver and excreted primarily in the urine. studies in healthy men have shown that clorazepate dipotassium has depressant effects on the central nervous system. prolonged administration of single daily doses as high as 120 mg was without toxic effects. abrupt cessation of high doses was followed in some patients by nervousness, insomnia, irritability, diarrhea, muscle aches, or memory impairment. since orally administered clorazepate dipotassium is rapidly decarboxylated to form nordiazepam, there is essentially no circulating parent drug. nordiazepam, the primary metabolite, quickly appears in the blood and is eliminated from the plasma with an apparent half-life of about 40 to 5
Read more...0 hours. plasma levels of nordiazepam increase proportionally with clorazepate dipotassium dose and show moderate accumulation with repeated administration. the protein binding of nordiazepam in plasma is high (97 to 98%). within 10 days after oral administration of a 15 mg (50 μci) dose of 14 c-clorazepate dipotassium to two volunteers, 62 to 67% of the radioactivity was excreted in the urine and 15 to 19% was eliminated in the feces. both subjects were still excreting measurable amounts of radioactivity in the urine (about 1% of the 14 c-dose) on day ten. nordiazepam is further metabolized by hydroxylation. the major urinary metabolite is conjugated oxazepam (3-hydroxynordiazepam), and smaller amounts of conjugated p-hydroxynordiazepam and nordiazepam are also found in the urine.
How Supplied:
How supplied clorazepate dipotassium tablets usp are available as tablets containing 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, usp. the 3.75 mg tablets are round flat beveled edge, pale violet colored slightly mottled tablet. one side is scored and engraved with "t" above the score and "45" below the score. other side is plain. bottles of 100 (ndc 51672-4042-1) bottles of 500 (ndc 51672-4042-2) bottles of 1,000 (ndc 51672-4042-3) the 7.5 mg tablets are round flat beveled edge, orange colored, slightly mottled tablet. one side is scored and engraved with "t" above the score and "46" below the score. other side is plain. bottles of 100 (ndc 51672-4043-1) bottles of 500 (ndc 51672-4043-2) bottles of 1,000 (ndc 51672-4043-3) the 15 mg tablets are round flat beveled edge, pale pink colored, slightly mottled tablet. one side is scored and engraved with "t" above the score and"47" below the score. other side is plain. bottles of 100 (ndc 51672-4044-1) bottles of 500 (ndc 51672-4044
Read more...-2) bottles of 1,000 (ndc 51672-4044-3) recommended storage protect from moisture. keep bottle tightly closed. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. dispense in a usp tight, light-resistant container. this product label may have been updated. for the most recent prescribing information, please visit www.taro.com.
Information for Patients:
Information for patients advise the patient to read the fda-approved patient labeling (medication guide).
Package Label Principal Display Panel:
Principal display panel - 3.75 mg tablet bottle label ndc 51672-4042-1 100 tablets dispense the accompanying medication guide to each patient. clorazepate dipotassium tablets usp, 3.75 mg civ rx only principal display panel - 3.75 mg tablet bottle label
Principal display panel - 7.5 mg tablet bottle label ndc 51672-4043-1 100 tablets dispense the accompanying medication guide to each patient. clorazepate dipotassium tablets usp, 7.5 mg civ rx only principal display panel - 7.5 mg tablet bottle label
Principal display panel - 15 mg tablet bottle label ndc 51672-4044-1 100 tablets dispense the accompanying medication guide to each patient. clorazepate dipotassium tablets usp, 15 mg civ rx only principal display panel - 15 mg tablet bottle label