Norzim Tablet

Norzim Tablet is used for: Depression with Anxiety, agitation or tension.

Depression with Anxiety 1 tablet (5-10 mg chlordiazepoxide/12.5-25 mg amitriptyline) PO three/four times daily; may increase to 6 tablets if necessary; 2 tablets reported to be effective in some patients. Elderly: Avoid; strong anticholinergic and sedative effects; may cause orthostatic hypotension (Beers criteria) Consider alternatives; if must use, initiate with lower initial dose; long-acting active metabolites 1 tablet (5 mg/12.5 mg) PO three times daily

Hypersensitivity Severe cardiovascular disorders Angle clossure glaucoma Within 14 days of MAOIs Any drugs or conditions that prolong QT interval Acute recovery post-MI

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. The use of benzodiazepines, including Amitriptyline + Chlordiazepoxide, 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 LIMBITROL and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction The continued use of benzodiazepines, including Amitriptyline + Chlordiazepoxide, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily doses. Abrupt discontinuation or rapid dosage reduction of Amitriptyline + Chlordiazepoxide 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 Amitriptyline + Chlordiazepoxide or reduce the dosage. 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 the emergence of suicidal thoughts and behaviors. Amitriptyline + Chlordiazepoxide is not approved for use in pediatric patients. Caution in BPH, urinary/GI retention, increased IOP, thyroid dysfunction, open-angle glaucoma, seizure disorders, brain tumor, respiratory impairment, respiratory disease. Risk of anticholinergic side-effects. May cause orthostatic hypotension. Paradoxical reactions including hyperactive or aggressive behavior reported. Both agents may cause sedation and impair the ability to perform tasks requiring mental alertness Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; monitor during the initial 1-2 months of therapy and dosage adjustments. Not approved for treatment of dementia-related psychosis.

Pregnancy Use of this medication 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 Advise pregnant females that receiving therapy 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 newborns Instruct patients to inform their healthcare provider if they are pregnant Monitor neonates exposed during pregnancy or labor for signs of sedation and monitor neonates exposed during pregnancy for signs of withdrawal; manage these neonates accordingly Lactation Advise patients that breastfeeding is not recommended during treatment

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. Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels. Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6. The effects of concomitant administration of LIMBITROL and other psychotropic drugs have not been evaluated. Sedative effects may be additive. Cimetidine is reported to reduce the hepatic metabolism of certain tricyclic antidepressants and benzodiazepines, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine Contraindicated (17) disopyramide dronedarone ibutilide indapamide iobenguane I 123 isocarboxazid mavorixafor pentamidine phenelzine pimozide procainamide procarbazine quinidine safinamide selegiline sotalol tranylcypromine

Side effects of Amitriptyline + Chlordiazepoxide : Frequency Not Defined Drowsiness Dry mouth Constipation Blurred vision Dizziness Bloating Vivid dreams Impotence Tremor Confusion Nasal congestion Edema Syncope Ataxia EEG abnormalities Menstrual irregularities Blood dyscrasias (agranulocytosis) Hepatic dysfunction (jaundice)

Chlordiazepoxide: Antianxiety agent; depresses all levels of CNS, including limbic and reticular formation, possibly by increasing gamma-aminobutyric acid (GABA) activity, a major inhibitory neurotransmitter. Amitriptyline: Antidepressant; neurotransmitter (especially norepinephrine and serotonin) reuptake inhibitor; elicits anticholinergic effects.

Norzim 12.5 mg + 5 mg Tablet manufactured by Aristopharma Limited. Its generic name is Amitriptyline + Chlordiazepoxide. Norzim is availble in Bangladesh. Farmaco BD drug index information on Norzim Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.