Medication Guide

Hydromorphone Hydrochloride Oral Solution is:

• Strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid analgesic, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• Opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Hydromorphone Hydrochloride Oral Solution:

• Get emergency help right away if you take too much Hydromorphone Hydrochloride Oral Solution (overdose). When you first start taking Hydromorphone Hydrochloride Oral Solution, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking Hydromorphone Hydrochloride Oral Solution with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your hydromorphone hydrochloride oral solution. They could die from taking it. Selling or giving away hydromorphone hydrochloride oral solution is against the law.
  
• Store hydromorphone hydrochloride oral solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or have narrowing of the stomach or intestines.

Before taking Hydromorphone Hydrochloride Oral Solution, tell your healthcare provider if you have a history of:

• head injury, seizures               ● liver, kidney, thyroid problems

• problems urinating                  ● pancreas or gallbladder problems

• abuse of street or prescription drugs, alcohol addiction, or mental health problems

Tell your healthcare provider if you are:

• Pregnant or planning to become pregnant. Prolonged use of hydromorphone hydrochloride oral solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

• Breastfeeding. Hydromorphone Hydrochloride Oral Solution passes into breast milk and may harm your baby.

• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydromorphone hydrochloride oral solution with certain other medicines can cause serious side effects that could lead to death.

• Do not change your dose. Take hydromorphone hydrochloride oral solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

• Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

• Call your healthcare provider if the dose you are taking does not control your pain.

• If you have been taking hydromorphone hydrochloride oral solution regularly, do not stop taking hydromorphone hydrochloride oral solution without talking to your healthcare provider.

• Dispose of expired, unwanted, or unused  hydromorphone hydrochloride oral solution by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

• Drive or operate heavy machinery, until you know how hydromorphone hydrochloride oral solution affects you. Hydromorphone hydrochloride oral solution can make you sleepy, dizzy, or lightheaded.

• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with hydromorphone hydrochloride oral solution may cause you to overdose and die.

The possible side effects of Hydromorphone Hydrochloride Oral Solution:

• Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.