Hydrocodone and Homatropine Tablets
Generic name: hydrocodone bitartrate and homatropine methylbromide
Dosage form: tablet
Drug class:Upper respiratory combinations
Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Drug Abuse and Dependence
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME
Addiction, Abuse, and Misuse
Hydrocodone Bitartrate and Homatropine Methylbromide Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment [see Warnings and Precautions (5.1)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets therapy or when used in patients at higher risk [
