Dvorah

Dvorah is a combination medicine used to relieve moderate to severe pain.

Dvorah may also be used for reasons not mentioned in this medication guide.

Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel a stronger urge to take more of this medicine.

Never share opioid medicine with anyone else, especially someone who has a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot reach it. Selling or giving away opioid medicine is against the law.

If you need surgery or medical tests, tell the doctor in advance that you are using this medicine.

Do not stop using this medicine suddenly after long-term use, or you could experience unpleasant withdrawal symptoms. Ask your doctor how to safely stop using the medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to find a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Do not give this medicine to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

You should not use Dvorah if you are allergic to acetaminophen, caffeine, or dihydrocodeine, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

This medicine is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• liver or kidney disease;
• alcoholism or drug addiction;
• mental illness or psychosis;
• a seizure or head injury;
• urination problems; or
• problems with your pancreas, thyroid, or adrenal gland.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Do not breastfeed. Dihydrocodeine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could happen even if you have taken acetaminophen before without any reaction. Stop taking Dvorah and call your doctor immediately if you notice skin redness or a rash that spreads and causes blistering and peeling.

Opioid medicine can slow or stop your breathing, which may lead to death. A person caring for you should seek emergency medical help if you have slow breathing with long pauses, blue-colored lips, or if you are difficult to wake up.

Dvorah may cause serious side effects. Call your doctor right away if you experience:

• noisy breathing, sighing, shallow breathing, or breathing that stops during sleep;
• chest pain, fast or pounding heartbeats, feeling light-headed, or fainting;
• confusion, extreme drowsiness, or unusual thoughts or behavior;
• painful or difficult urination;
• severe constipation;
• liver problems—nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low cortisol levels—nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention immediately if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or weakened.

Long-term use of opioid medication may affect fertility (the ability to have children) in both men and women. It is not known if the effects on fertility are permanent.

Common side effects include:

• dizziness, drowsiness, tiredness, headache;
• nausea, vomiting, stomach pain, constipation;
• sweating, itching; or
• skin rash.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Since Dvorah is used for pain, you are unlikely to miss a dose. If you do miss a dose and it’s almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or another person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

Avoid driving or operating machinery until you know how Dvorah will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking too much acetaminophen can lead to a fatal overdose.

You may experience breathing issues or withdrawal symptoms if you start or stop taking certain other medicines. Inform your doctor if you are also using an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine for HIV or hepatitis C.

Opioid medication can interact with many other drugs, leading to serious side effects or death. Make sure your doctor is aware if you are also using:

• other narcotic medications--opioid pain medicine or prescription cough medicine;
• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that cause drowsiness or slow your breathing--a sleeping pill, muscle relaxant, or medicine for mood disorders or mental illness; or
• drugs that influence serotonin levels in your body--a stimulant or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not comprehensive. Other drugs may interact with Dvorah, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all potential interactions are mentioned here.