Product Elements:
Chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochloride lactose monohydrate starch, corn cellulose, microcrystalline sodium starch glycolate type a potato silicon dioxide talc magnesium stearate hypromellose 2910 (6 mpa.s) titanium dioxide polyethylene glycol 6000 d&c yellow no. 10 fd&c blue no. 1 fd&c yellow no. 6 polyethylene glycol 400 amitriptyline hydrochloride amitriptyline chlordiazepoxide chlordiazepoxide ca1 chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochloride lactose monohydrate starch, corn microcrystalline cellulose sodium starch glycolate type a potato silicon dioxide talc magnesium stearate hypromellose 2910 (6 mpa.s) titanium dioxide polyethylene glycol 400 d&c yellow no. 10 fd&c blue no. 1 fd&c yellow no. 6 polyethylene glycol 6000 amitriptyline hydrochloride amitriptyline chlordiazepoxide chlordiazepoxide ca2
Drug Interactions:
Drug-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 gaba a 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.
Boxed Warning:
Warning: risks from concomitant use with opioids; abuse, misuse, and addiction; dependence and withdrawal reactions; and suicidal thoughts and behaviors concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. reserve concomitant prescribing of these drugs for 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 c hlordiazepoxide and amitriptyline hydrochloride tablets , 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 c hlordiazepoxide and amitriptyline hydrochloride tablets and throughout treatment, assess each patientâs risk for abuse, misuse, and addiction (see warnings ). the continued use of benzodiazepines, including c hlordiazepoxide and amitriptyline hydrochloride tablets , 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 c hlordiazepoxide and amitriptyline hydrochloride tablets 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 c hlordiazepoxide and amitriptyline hydrochloride tablets or reduce the dosage (see dosage and administration and warnings ). antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors (see warnings ). c hlordiazepoxide and amitriptyline hydrochloride tablet is not approved for use in pediatric patients (see precautions ).
Indications and Usage:
Indications: chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. the therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.
Warnings:
Warnings: risks from concomitant use with opioids: concomitant use of benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, 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 chlordiazepoxide and amitriptyline hydrochloride tablets 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 chlordiazepoxide and amitriptyline hydrochloride tablets than i
Read more...ndicated in the absence of an opioid and titrate based on clinical response. if an opioid is initiated in a patient already taking chlordiazepoxide and amitriptyline hydrochloride tablets, 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 chlordiazepoxide and amitriptyline hydrochloride tablets are 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 chlordiazepoxide and amitriptyline hydrochloride tablets, 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 chlordiazepoxide and amitriptyline hydrochloride tablets and throughout treatment, assess each patientâs risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). use of chlordiazepoxide and amitriptyline hydrochloride tablets, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of chlordiazepoxide and amitriptyline hydrochloride tablets 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 chlordiazepoxide and amitriptyline hydrochloride tablets or reduce the dosage (a patient-specific plan should be used to taper the dose) (see dosage and administration : discontinuation or dosage reduction of chlordiazepoxide and amitriptyline hydrochloride tablets). 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 chlordiazepoxide and amitriptyline hydrochloride tablets, may lead to clinically significant physical dependence. abrupt discontinuation or rapid dosage reduction of chlordiazepoxide and amitriptyline hydrochloride tablets 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 : dependence ). suicidal thoughts and behaviors in adolescent and young adults: in pooled analyses of placebo-controlled trials of antidepressant drugs (ssris and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. there was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. there were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with mdd. the drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in table 1. table 1: risk differences of the number of patients of suicidal thoughts and behavior in the pooled placebo-controlled trials of antidepressants in pediatric and adult patients age range drug-placebo difference in number of patients of suicidal thoughts or behaviors per 1,000 patients treated increases compared to placebo < 18 years old 14 additional patients 18 to 24 years old 5 additional patients decreases compared to placebo 25 to 64 years old 1 fewer patients ⥠65 years old 6 fewer patients it is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. however, there is substantial evidence from placebo-controlled maintenance trials in adults with mdd that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. consider changing the therapeutic regimen, including possibly discontinuing chlordiazepoxide and amitriptyline hydrochloride tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. activation of mania or hypomania: in patients with bipolar disorder, treating a depressive episode with chlordiazepoxide and amitriptyline hydrochloride tablets or another antidepressant may precipitate a mixed/manic episode. prior to initiating treatment with chlordiazepoxide and amitriptyline hydrochloride tablets, screen patients for any personal or family history of bipolar disorder, mania, or hypomania. angle-closure glaucoma: the pupillary dilation that occurs following use of many antidepressant drugs including chlordiazepoxide and amitriptyline hydrochloride tablets, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. general: because of the atropine-like action of the amitriptyline component, great care should be used in treating patients with a history of urinary retention or angle-closure glaucoma. in patients with glaucoma, even average doses may precipitate an attack. severe constipation may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs. patients with cardiovascular disorders should be watched closely. tricyclic antidepressant drugs, particularly when given in high doses, have been reported to produce arrhythmias, sinus tachycardia and prolongation of conduction time. myocardial infarction and stroke have been reported in patients receiving drugs of this class. because of the sedative effects of chlordiazepoxide and amitriptyline hydrochloride tablets, patients should be cautioned about combined effects with alcohol or other cns depressants. the additive effects may produce a harmful level of sedation and cns depression. patients receiving chlordiazepoxide and amitriptyline hydrochloride tablets should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle. neonatal sedation and withdrawal syndrome: use of chlordiazepoxide and amitriptyline hydrochloride tablets late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate (see precautions : pregnancy ) . monitor neonates exposed to chlordiazepoxide and amitriptyline hydrochloride tablets during pregnancy or labor for signs of sedation and monitor neonates exposed to chlordiazepoxide and amitriptyline hydrochloride tablets during pregnancy for signs of withdrawal; manage these neonates accordingly.
General Precautions:
General: use with caution in patients with a history of seizures. close supervision is required when chlordiazepoxide and amitriptyline hydrochloride tablets are given to hyperthyroid patients or those on thyroid medication. the usual precautions should be observed when treating patients with impaired renal or hepatic function. patients with suicidal ideation should not have easy access to large quantities of the drug. the possibility of suicide in depressed patients remains until significant remission occurs.
Dosage and Administration:
Dosage and administration: optimum dosage varies with the severity of the symptoms and the response of the individual patient. when a satisfactory response is obtained, dosage should be reduced to the smallest amount needed to maintain the remission. the larger portion of the total daily dose may be taken at bedtime. in some patients, a single dose at bedtime may be sufficient. in general, lower dosages are recommended for elderly patients. chlordiazepoxide and amitriptyline hydrochloride 10 mg/25 mg strength tablets are recommended in an initial dosage of 3 or 4 tablets daily in divided doses; this may be increased to 6 tablets daily as required. some patients respond to smaller doses and can be maintained on 2 tablets daily. chlordiazepoxide and amitriptyline hydrochloride 5 mg/12.5 mg in an initial dosage of 3 or 4 tablets daily in divided doses may be satisfactory in patients who do not tolerate higher doses. screen for bipolar disorder prior to starting chlordiazepoxide and amitri
Read more...ptyline hydrochloride tablets prior to initiating treatment with chlordiazepoxide and amitriptyline hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania (see warnings : activation of mania or hypomania). discontinuation or dosage reduction of chlordiazepoxide and amitriptyline hydrochloride tablets to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide and amitriptyline hydrochloride tablets 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 : dependence and withdrawal reactions and drug abuse and dependence : dependence ).
Contraindications:
Contraindications: chlordiazepoxide and amitriptyline hydrochloride tablet is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. it should not be given concomitantly with a monoamine oxidase inhibitor. hyperpyretic crises, severe convulsions and deaths have occurred in patients receiving a tricyclic antidepressant and a monoamine oxidase inhibitor simultaneously. when it is desired to replace a monoamine oxidase inhibitor with chlordiazepoxide and amitriptyline hydrochloride tablets, a minimum of 14 days should be allowed to elapse after the former is discontinued. chlordiazepoxide and amitriptyline hydrochloride tablet should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. this drug is contraindicated during the acute recovery phase following myocardial infarction.
Adverse Reactions:
Adverse reactions: adverse reactions to chlordiazepoxide and amitriptyline hydrochloride tablets are those associated with the use of either component alone. most frequently reported were drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating. other side effects occurring less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion. many symptoms common to the depressive state, such as anorexia, fatigue, weakness, restlessness and lethargy, have been reported as side effects of treatment with both chlordiazepoxide and amitriptyline hydrochloride tablets and amitriptyline. granulocytopenia, jaundice and hepatic dysfunction of uncertain etiology have also been observed rarely with chlordiazepoxide and amitriptyline hydrochloride tablets. when treatment with chlordiazepoxide and amitriptyline hydrochloride tablet is prolonged, periodic blood counts and liver function tests are advisable. note: included in the listing which follows are adverse
Read more... reactions which have not been reported with chlordiazepoxide and amitriptyline hydrochloride tablets. however, they are included because they have been reported during therapy with one or both of the components or closely related drugs. cardiovascular: hypotension, hypertension, tachycardia, palpitations, myocardial infarction, arrhythmias, heart block, stroke. psychiatric: euphoria, apprehension, poor concentration, delusions, hallucinations, hypomania and increased or decreased libido. neurologic: incoordination, ataxia, numbness, tingling and paresthesias of the extremities, extrapyramidal symptoms, syncope, changes in eeg patterns. anticholinergic: disturbance of accommodation, paralytic ileus, urinary retention, dilatation of urinary tract. allergic: skin rash, urticaria, photosensitization, edema of face and tongue, pruritus. hematologic: bone marrow depression including agranulocytosis, eosinophilia, purpura, thrombocytopenia. gastrointestinal: nausea, epigastric distress, vomiting, anorexia, stomatitis, peculiar taste, diarrhea, black tongue. endocrine: testicular swelling and gynecomastia in the male, breast enlargement, galactorrhea and minor menstrual irregularities in the female, elevation and lowering of blood sugar levels, and syndrome of inappropriate adh (antidiuretic hormone) secretion. other: headache, weight gain or loss, increased perspiration, urinary frequency, mydriasis, jaundice, alopecia, parotid swelling.
Drug Interactions:
Drug-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 gaba a 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.
Use in Pregnancy:
Pregnancy: pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including chlordiazepoxide and amitriptyline hydrochloride tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/ . risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see warnings : neonatal sedation and withdrawal syndrome, and precautions : clinical considerations) . available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see data). the background risk of major birth defects and miscarriage for the indicated population is unkno
Read more...wn. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions benzodiazepines cross the placenta and may produce respiratory depression, hypotonia and sedation in neonates. monitor neonates exposed to chlordiazepoxide and amitriptyline hydrochloride tablets during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. monitor neonates exposed to chlordiazepoxide and amitriptyline hydrochloride tablets during pregnancy for signs of withdrawal. manage these neonates accordingly (see warnings : neonatal sedation and withdrawal syndrome) . data human data published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. in addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings.
Pediatric Use:
Pediatric use: safety and effectiveness in the pediatric population have not been established (see box warning and warnings - suicidal thoughts and behaviors in adolescents and young adults). anyone considering the use of chlordiazepoxide and amitriptyline hydrochloride tablets in a child or adolescent must balance the potential risks with the clinical need.
Geriatric Use:
Geriatric use: in elderly and debilitated patients it is recommended that dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation, confusion or anticholinergic effects. of the total number of subjects in clinical studies of chlordiazepoxide and amitriptyline hydrochloride tablets, 74 individuals were 65 years and older. an additional 34 subjects were between 60 and 69 years of age. no overall differences in safety and effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the active ingredients in chlordiazepoxide and amitriptyline hydrochloride tablets are known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of chlordiazepoxide and amitriptyline hydrochloride tablets and observed closely. clinical studies of chlordiazepoxide and amitriptyline hydrochloride tablets did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. 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.
Overdosage:
Overdosage: overdosage of chlordiazepoxide and amitriptyline hydrochloride tablets, which contains a benzodiazepine (chlordiazepoxide) and a tricyclic antidepressant (amitriptyline hydrochloride), may manifest signs and symptoms related to either of its components. deaths may occur from overdosage with this class of drugs. multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose. critical manifestations of tricyclic antidepressant overdosage include cardiac dysrhythmias, severe hypotension, convulsions and cns depression, including coma. changes in the electrocardiogram, particularly in qrs axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. obtain an ecg and immediately initiate cardiac monitoring; hospital monitoring is required as soon as possible. other signs of overdosage may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia or any of the symptoms listed under adverse reactions. overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. in mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. in severe overdosage cases, patients may develop respiratory depression and coma. overdosage of benzodiazepines in combination with other cns depressants (including alcohol and opioids) may be fatal (see warnings : abuse, misuse, and addiction). markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. in managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures with chlordiazepoxide and amitriptyline hydrochloride tablets because overdosage with amitriptyline and other tricyclic and tetracyclic antidepressants increases the risk of seizures. seizure risk is also increased in patients with long-term benzodiazepine use and physical dependency. the risk of withdrawal seizures with flumazenil use also may be increased in patients with epilepsy. flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). contact the poison help line (1-800-222-1222) or medical toxicologist for additional overdosage management recommendations.
dependence:
Dependence physical dependence chlordiazepoxide and amitriptyline hydrochloride tablets 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 chlordiazepoxide and amitriptyline hydrochloride tablets or reduce the dosage (see dosage and administration : discontinuation or dosage reduction of chlordiazepoxide and amitriptyline hydrochloride tablets 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. tolerance tolerance to chlordiazepoxide and amitriptyline hydrochloride tablets may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of chlordiazepoxide and amitriptyline hydrochloride tablets may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.
Description:
Description: chlordiazepoxide and amitriptyline hydrochloride tablets, usp combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. it is available in as white, round, biconvex film-coated tablets debossed 'ca2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film- coated tablets debossed 'ca1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch , silicon dioxide, sodium starch glycolate, talc and titanium dioxide. in addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains d&c yellow no.10, fd&c blue no.1, fd & c yellow no. 6 and polyethylene glycol 6000. chlordiazepoxide usp is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5 phenyl- 3h -1,4-benzodiazepine 4-oxide. it is a slightly yellow crystalline material and is insoluble in water. the molecular weight is 299.76. amitriptyline hydrochloride usp is a dibenzocycloheptadiene derivative. the formula is 10,11-dihydro- n,n- dimethyl-5h-dibenzo [a,d] cycloheptene-Π5, γ -propylamine hydrochloride. it is a white or practically white crystalline compound that is freely soluble in water. the molecular weight is 313.87.
How Supplied:
How supplied: the 5 mg/12.5 mg tablets are green, round, biconvex, film-coated tablets, debossed "ca 1" on one side and plain on the other side. they are available as follows: bottles of 100 ndc 42571-302-01 bottles of 500 ndc 42571-302-05 the 10 mg/25 mg tablets are white, round, biconvex, film-coated tablets, debossed "ca2"on one side, plain on the other side. they are available as follows:� bottles of 100 ndc 42571-303-01 bottles of 500 ndc 42571-303-05 store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] store in a dry place. keep in a tightly closed, child-resistant container and out of the light. manufactured for: micro labs usa, inc. somerset, nj 08873 revised: 01/2023
Package Label Principal Display Panel:
Package label.principal display panel ndc 42571-302-01 chlordiazepoxide and amitriptyline hydrochloride tablets, usp civ 5 mg/12.5 mg* 100 tablets rx only pharmacist: dispense the accompanying medication guide to each patient. micro labs limited ndc 42571-303-01 chlordiazepoxide and amitriptyline hydrochloride tablets, usp civ 10 mg/25 mg* 100 tablets rx only pharmacist: dispense the accompanying medication guide to each patient. micro labs limited chlordiazepoxide-lbla.jpg chlordiazepoxide-lblb.jpg