Hydrocodone Bitartrate and Acetaminophen

💊 What is Hydrocodone Bitartrate and Acetaminophen used for?

• •The label says it is used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The label also says it should be reserved for people whose other pain treatment options have not worked, are not expected to work, or have not been tolerated. It should not be used for a long time unless the pain stays severe enough to need an opioid and other options still do not work.

How it works

How it is usually taken

• •The label says the medicine is taken by mouth as tablets. It is prescribed as needed for pain, and the label says to use the lowest effective dose for the shortest time that fits the person's treatment goals. The label sets a maximum total daily amount for the tablets, and it sets a daily maximum for acetaminophen. Follow the instructions from your prescriber or pharmacist about how many tablets to take and how often. The label does not say whether the medicine should be taken with food.

Comes as

• •Tablets, 5 mg/325 mg (hydrocodone/acetaminophen)
• •Tablets, 7.5 mg/325 mg (white, capsule-shaped, one side scored, other side marked "WES 302")
• •Tablets, 10 mg/325 mg

⚠️ Hydrocodone Bitartrate and Acetaminophen side effects

🛑 Who should not take Hydrocodone Bitartrate and Acetaminophen, and who should be careful

The label says not to take it if

• 🚨You have significant respiratory depression (slowed breathing).
• 🚨You have acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment available.
• 🚨You have known or suspected gastrointestinal obstruction, including paralytic ileus.
• 🚨You have had a hypersensitivity (allergic reaction) to hydrocodone or acetaminophen, such as anaphylaxis.

Tell your doctor before taking it if

• •Tell your prescriber about all your medicines, including any that affect the brain or breathing, and any alcohol use.
• •Tell your prescriber if you take or plan to take serotonergic medicines, since the label says this may cause serotonin syndrome.
• •Do not take this medicine while using any monoamine oxidase inhibitor (MAOI), and do not start an MAOI while taking it, according to the label.
• •Tell your prescriber about any personal or family history of substance abuse or mental illness, since the label says these raise the risk of addiction, abuse, and misuse.
• •Do not share this medicine with others, and protect it from theft or misuse.
• •The label says you should not stop this medicine suddenly. Talk with your prescriber about a tapering plan to avoid withdrawal symptoms.
• •The label says this medicine may impair your ability to drive or operate heavy machinery.

🔀 Hydrocodone Bitartrate and Acetaminophen with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

• •CYP3A4 inhibitors, such as macrolide antibiotics (for example erythromycin), azole antifungals (for example ketoconazole), and protease inhibitors (for example ritonavir). These can increase the amount of hydrocodone in the body and prolong opioid effects.
• •CYP2D6 inhibitors. The label says effects may be more pronounced when used with both CYP3A4 and CYP2D6 inhibitors.
• •CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin. These can lower the amount of hydrocodone in the body, which may reduce pain relief or cause withdrawal symptoms.
• •Benzodiazepines and other CNS depressants, including alcohol. The label warns of profound sedation, respiratory depression, coma, and death.
• •Serotonergic drugs, which may cause serotonin syndrome.
• •Monoamine oxidase inhibitors (MAOIs). The label says to avoid using them with this medicine.

Alcohol and food

The label says alcohol can cause profound sedation, slowed breathing, coma, and death when combined with this medicine, and that these effects may be potentially fatal. It says not to use alcohol with benzodiazepines or other CNS depressants unless a healthcare provider supervises. The label does not give specific food instructions.

🤰 Hydrocodone Bitartrate and Acetaminophen in pregnancy and breastfeeding

Pregnancy

The label says there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The label says extended opioid use during pregnancy can cause physical dependence in the newborn and neonatal opioid withdrawal syndrome (NOWS). Signs in newborns can include irritability, hyperactivity, abnormal sleep, high-pitched crying, tremor, vomiting, diarrhea, and failure to gain weight. Newborns should be watched for these symptoms.

Breastfeeding

The label says hydrocodone is present in human milk. The benefits of breastfeeding and the mother's need for the medicine should both be considered, along with possible effects on the baby. Breastfed infants should be monitored for excess sleepiness and slowed breathing. Withdrawal symptoms can occur in breastfed infants when the mother stops taking an opioid or when breastfeeding stops.

🗓️ Storage, missed doses and taking too much

Storage

The label says to store at 20 to 25 degrees C (68 to 77 degrees F). Keep it in a tight, light-resistant container with a child-resistant closure. Store it securely, out of sight and reach of children, and in a place others cannot access, including visitors. The label says the medicine is affected by light. If a drug take-back option is not available, the label says to flush unused or expired tablets, and the FDA list is at www.fda.gov/drugdisposal.

If a dose is missed

The label does not say.

If too much is taken

The label says an overdose can cause slowed breathing, extreme sleepiness progressing to stupor or coma, muscle limpness, cold and clammy skin, small pupils, and, in some cases, death. Acetaminophen overdose can cause dose-dependent, potentially fatal liver damage (hepatic necrosis), which the label calls the most serious effect of acetaminophen overdose. The label says to call 911 or get emergency medical help right away for any known or suspected overdose, even if naloxone is given. Naloxone's effects are temporary. The label says to discuss naloxone availability with your prescriber.

🗒️ Questions to ask about Hydrocodone Bitartrate and Acetaminophen

• Is this medicine right for my pain, and have other pain treatments been tried first?
• How will you check my breathing and watch for side effects when I start or when my dose changes?
• Should I have naloxone at home, and how will my family learn to use it?
• What is the safest way to store this medicine, given my household and any children who visit?
• Which of my other medicines or supplements could interact with this one, including alcohol?
• What is my tapering plan if I need to stop this medicine?
• How much acetaminophen is safe in a day when I add other products that contain it?

❓ Hydrocodone Bitartrate and Acetaminophen: frequently asked questions