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When taking this medication, it is essential to choose the correct strength, especially if you have been using opioid pain medications for a prolonged period. Using a higher strength intended for long-term opioid users can cause severe and potentially fatal breathing issues in those not accustomed to opioids.

Key Safety Information and Warnings:

• Naloxone Availability: Consult your doctor or pharmacist about having naloxone on hand to manage potential opioid overdoses. Educate family members or housemates on recognizing and responding to signs of an opioid overdose.

• Risk of Abuse and Addiction: Hydromorphone carries a risk of addiction, which can result in overdose and death. It can also lead to severe and potentially fatal breathing problems. To minimize this risk, use the lowest effective dose for the shortest necessary duration, as guided by your doctor.

• Breathing Complications: The risk of severe breathing issues is heightened at the start of treatment, after dosage increases, or when using an incorrect dose or strength. Combining this medication with alcohol or other drugs that induce drowsiness or respiratory issues can lead to severe side effects, including death.

• Emergency Situations: Seek immediate medical attention if you experience slow or shallow breathing, unusual lightheadedness, severe drowsiness or dizziness, or difficulty waking up.

• Medication Security: Store this medication securely to prevent theft, misuse, or abuse. If someone accidentally ingests this drug, seek emergency assistance immediately.

• Use in Women of Childbearing Age: Women should discuss the risks and benefits of this medication with their doctor, especially if pregnant or planning to become pregnant. Use during pregnancy should only occur when absolutely necessary, as it may increase the risk of birth defects in the first two months. Prolonged use or high doses near delivery might harm the unborn child, leading to withdrawal symptoms in the newborn.

• Newborn Monitoring: Newborns exposed to this drug for extended periods may exhibit severe withdrawal symptoms. Contact a doctor immediately if your newborn shows persistent crying, slow or shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

Always follow your healthcare provider's instructions and report any side effects or concerns promptly to ensure safe use of this medication.

Common side effects:

• Nausea
• Vomiting
• Constipation
• Flushing
• Dry mouth
• Lightheadedness
• Dizziness
• Drowsiness
• Sweating
• Pain at the injection site
• Redness at the injection site
• Swelling at the injection site

Less common but important to monitor:

• Interrupted breathing during sleep
• Severe stomach or abdominal pain
• Fainting
• Mood or mental changes (agitation or hallucinations)
• Seizures
• Difficulty urinating
• Loss of appetite
• Unusual tiredness
• Weight loss

Serious side effects:

• Extreme drowsiness
• Difficulty waking
• Slow or irregular breathing
• Rapid or irregular heartbeat
• Allergic reactions (rash, itching, swelling of face, tongue, or throat, severe dizziness, trouble breathing)

Interactions with high risk of serious adverse effects and should be avoided:

• Other opioid pain or cough medications (such as codeine, hydrocodone)
• Alcohol
• Marijuana (cannabis)
• Sleep or anxiety medications (such as alprazolam, lorazepam, zolpidem)
• Muscle relaxants (such as carisoprodol, cyclobenzaprine)
• Antihistamines (such as cetirizine, diphenhydramine)

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Mixed opioid agonists/antagonists (such as butorphanol, nalbuphine, pentazocine)
• Cimetidine
• Drugs that slow down the movement of the gut (such as belladonna alkaloids, oxybutynin)
• Naltrexone
• Samidorphan