Generic name: Acetaminophen, caffeine, and dihydrocodeine
Pregnancy & Lactation: Risk data not available
What is Dvorah?
Acetaminophen, caffeine, and dihydrocodeine is a combination medicine used to relieve moderate to severe pain.
Acetaminophen, caffeine, and dihydrocodeine may also be used for purposes not listed in this medication guide.
Warnings
You should not use this medicine 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.
How should I use Dvorah
Use Dvorah (Acetaminophen, Caffeine, And Dihydrocodeine) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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 an increased urge to take more of this medicine.
Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.
If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.
Do not stop using this medicine suddenly after long-term use, or you could have 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 locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.
Dvorah side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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 occur even if you have taken acetaminophen in the past and had no reaction. 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.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
- chest pain, fast or pounding heartbeats, feeling light-headed, fainting;
- confusion, extreme drowsiness, 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 right away 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 debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid 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 FDA at 1-800-FDA-1088.
What other drugs will affect Dvorah?
Avoid driving or operating machinery until you know how this medicine 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.