Amitriptyline and chlordiazepoxide

Name: Amitriptyline and chlordiazepoxide

What is amitriptyline and chlordiazepoxide?

Amitriptyline is a tricyclic antidepressant. Chlordiazepoxide is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). These medicines affect chemicals in the brain that may be unbalanced in people with depression.

Amitriptyline and chlordiazepoxide is a combination medicine used to treat moderate to severe depression and anxiety.

Amitriptyline and chlordiazepoxide may also be used for purposes not listed in this medication guide.

Amitriptyline and chlordiazepoxide dosing information

Usual Adult Dose for Anxiety:

Amitriptyline 25 mg-chlordiazepoxide 10 mg tablets:
-Initial dose: 3 to 4 tablets orally per day, given in divided doses
-Maintenance dose: 2 to 6 tablets orally per day, given in divided doses
Maximum dose: 6 tablets/day

Comments:
-Doses should be reduced to the lowest effective amount once a satisfactory response is obtained.
-The larger portion of the total dose may be given at bedtime.
-A single daily dose (given at bedtime) may be sufficient for some patients.

Use: Treatment of patients with moderate to severe depression associated with moderate to severe anxiety

Usual Adult Dose for Depression:

Amitriptyline 25 mg-chlordiazepoxide 10 mg tablets:
-Initial dose: 3 to 4 tablets orally per day, given in divided doses
-Maintenance dose: 2 to 6 tablets orally per day, given in divided doses
Maximum dose: 6 tablets/day

Comments:
-Doses should be reduced to the lowest effective amount once a satisfactory response is obtained.
-The larger portion of the total dose may be given at bedtime.
-A single daily dose (given at bedtime) may be sufficient for some patients.

Use: Treatment of patients with moderate to severe depression associated with moderate to severe anxiety

How is this medicine (Amitriptyline and Chlordiazepoxide) best taken?

Use amitriptyline and chlordiazepoxide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. See individual agents.

In Summary

More frequently reported side effects include: suicidal tendencies. See below for a comprehensive list of adverse effects.

Amitriptyline / chlordiazepoxide Pregnancy Warnings

Safety has not been established during pregnancy; use should be avoided. US FDA pregnancy category: Not Assigned. Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk. Comments: -A pregnancy exposure registry is available. -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 harm to the fetus. -Neonatal withdrawal and depression of the newborn may occur in neonates exposed to this drug.

Animal studies with the combination amitriptyline-chlordiazepoxide have not been reported. Animal studies with chlordiazepoxide have revealed evidence of decreased viability and body weight at maternally toxic doses. There are no controlled data in human pregnancy. Amitriptyline use during the first trimester has resulted in case reports of limb reduction anomalies and other malformations. Use of chlordiazepoxide during gestation resulted in reports of major skeletal anomalies, neonatal withdrawal; when used close to birth, depression of the newborn was reported. To monitor the outcomes of pregnant women exposed to antidepressants, a National Pregnancy Registry for Antidepressants has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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