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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: hydrocodone and homatropine (hye dro KOE done and hom a TROE peen)
Brand name(s):
GENERIC: not available FAMILY: Combination antihistamine, decongestants and/or cough preparations
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

See individual drug families.

Safety Warnings For This Drug [top]

FDA BLACK-BOX WARNING

All hydrocodone-containing products have a lengthy FDA-approved black-box warning. The following are highlights from that warning:

Addiction, Abuse and Misuse

Hydrocodone exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death.

Life-Threatening Respiratory Depression

Serious, life-threatening or fatal respiratory depression may occur with use of hydrocodone.

Accidental Ingestion

Accidental ingestion of even one dose of hydrocodone, especially by children, can result in a fatal overdose of hydrocodone.

Risk of Medication Errors

Ensure accuracy when prescribing, dispensing and administering hydrocodone. Dosing errors can result in accidental overdose and death.

Risks of Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids, like hydrocodone, with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death.

Interaction with Alcohol

Do not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone. The co-ingestion of alcohol with hydrocodone may result in increased blood levels and a potentially fatal overdose of hydrocodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of hydrodone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated appropriately.

Facts About This Drug [top]

The prescription drug combination of hydrocodone and homatropine (generic only) should not be used because it is an irrational combination of two single ingredients, each of which is safe, effective and sensible to use alone if treating the symptom for which it is intended. In general, combination drugs usually will not add any benefit and instead can increase the risk of adverse effects. Further, combination drugs will invariably cost much more than the single ingredient alone. It represents...

The prescription drug combination of hydrocodone and homatropine (generic only) should not be used because it is an irrational combination of two single ingredients, each of which is safe, effective and sensible to use alone if treating the symptom for which it is intended. In general, combination drugs usually will not add any benefit and instead can increase the risk of adverse effects. Further, combination drugs will invariably cost much more than the single ingredient alone. It represents a "shotgun" approach to multiple symptoms of colds, coughs and allergies that rarely occur in force in the combination that is suggested by the ingredients in these products. The inclusion of an anticholinergic drug (such as homatropine) in a cough medicine adds considerable risk without any significant benefit.

Alternative treatments include nasal spray or drops for a stuffed nose from a cold (see oxymetazoline [AFRIN]) or a single-ingredient oral antihistamine for allergies (see chlorpheniramine). The use of antihistamines can impair the healing from a cold. It is best not to use drugs to treat coughs associated with upper respiratory infections.

Regulatory actions surrounding this combination drug

2018: The Food and Drug Administration (FDA) updated the drug product label of prescription cough and cold medicines containing codeine or hydrocodone to warn that these medicines are not recommended in children younger than 18 years because their risks outweigh their benefits in this age group. Additional safety information on the risks of misuse, abuse, addiction, overdose, death and slowed or difficult breathing has been added to the black-box warning of these medicines.[1]

last reviewed February 28, 2021