Dolophine SolutionGeneric Name: Methadone
Dolophine Solution may cause severe and sometimes fatal heart and breathing problems. These problems may occur some time after you take a dose. Tell your doctor right away if you develop any new or worsening symptoms such as slowed or shallow breathing or irregular heartbeat. Your doctor will perform heart and lung function tests to check for side effects while you take Dolophine Solution. Keep all doctor and laboratory appointments. Talk with your doctor and be sure you understand the risks and benefits of using Dolophine Solution.
Do not take more than the recommended dose or take Dolophine Solution more often than it is prescribed. This can lead to overdose and possible death.
Dolophine Solution is used for:
Treating moderate to severe pain that is not relieved by other pain medicines. It is used in the temporary treatment of narcotic addiction as part of a treatment program in patients who are unable to take medicine by mouth. It may also be used for other conditions as determined by your doctor.
Dolophine Solution is a narcotic analgesic. It works by acting on opiate pain receptors in the brain and on smooth muscle to provide pain relief.
Do NOT use Dolophine Solution if:
- you are allergic to any ingredient in Dolophine Solution
- you have slowed breathing or severe asthma, or if you are having an asthma attack
- you have a stomach or bowel blockage or certain severe bowel problems (eg, paralytic ileus)
- you have diarrhea caused by food poisoning or antibiotic use
- you are taking sodium oxybate (GHB)
- if you have taken a monamine oxidase inhibitor type B (MAOI-B) (eg, rasagiline, selegiline) within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Dolophine Solution:
Some medical conditions may interact with Dolophine Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have lung or breathing problems (eg, asthma), chronic obstructive pulmonary disease (COPD), sleep apnea, stomach or bowel problems (eg, bowel inflammation), stomach pain or constipation, liver or kidney problems, thyroid problems, or Addison disease
- if you have an abnormal curvature of the spine; narrowing of the urethra, trouble urinating, or an enlarged prostate; low blood volume, blood pressure, or blood oxygen levels; low potassium or magnesium blood levels; increased pressure, tumors, or lesions in your head; a recent head injury; or seizures
- if you have a history of heart problems (eg, enlarged heart) or irregular heartbeat
- if you or a family member have a history of mental or mood problems (eg, anxiety, depression), suicidal thoughts or attempts, or alcohol or substance abuse
- if you are elderly, very ill, or very overweight, or if you have recently had stomach or intestine surgery
Some MEDICINES MAY INTERACT with Dolophine Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, midazolam), cimetidine, MAOI-B (eg, rasagiline, selegiline), other narcotic analgesics (eg, morphine), phenothiazines (eg, promethazine), or sodium oxybate (GHB) because side effects such as sedation and slowed breathing may occur
- Antiarrhythmics (eg, amiodarone, dofetilide, flecainide, propafenone), antipsychotics (eg, haloperidol, paliperidone, ziprasidone), calcium channel blockers (eg, nifedipine), certain antiemetics (eg, dolasetron, droperidol), chloroquine, cisapride, diuretics (eg, furosemide), H1 antagonists (eg, astemizole), kinase inhibitors (eg, lapatinib, nilotinib), lithium, macrolide antibiotics (eg, clarithromycin), phenothiazines (eg, chlorpromazine), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin), tacrolimus, or tricyclic antidepressants (eg, desipramine) because the risk of QT prolongation may be increased
- Azole antifungals (eg, fluconazole, ketoconazole, voriconazole) or certain selective serotonin reuptake inhibitors (SSRIs) (eg, fluvoxamine, sertraline) because they may increase the risk of Dolophine Solution's side effects
- Abacavir, carbamazepine, efavirenz, HIV protease inhibitors (eg, amprenavir, lopinavir, nelfinavir, ritonavir), narcotic agonists/antagonists (eg, butorphanol, nalbuphine, pentazocine), narcotic antagonists (eg, naloxone, naltrexone), nevirapine, phenobarbital, phenytoin, rifampin, or St. John's wort because they may decrease Dolophine Solution's effectiveness
- Zidovudine because the risk of its side effects may be increased by Dolophine Solution
- Nucleoside reverse transcriptase inhibitors (NRTIs) (eg, abacavir, didanosine, stavudine) because their effectiveness may be decreased by Dolophine Solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dolophine Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Dolophine Solution:
Use Dolophine Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Dolophine Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Dolophine Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Dolophine Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Dolophine Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Dolophine Solution must be administered under close medical supervision.
- Take Dolophine Solution on a regular schedule to get the most benefit from it. It is more effective in preventing pain than in treating pain after it occurs.
- If Dolophine Solution is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Dolophine Solution properly.
- Always keep Dolophine Solution in a secure place to protect from theft.
- If you miss a dose of Dolophine Solution and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If you miss your doses of Dolophine Solution for more than 2 days, contact your doctor before you start taking Dolophine Solution again.
Ask your health care provider any questions you may have about how to use Dolophine Solution.
Important safety information:
- Dolophine Solution may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Dolophine Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dolophine Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Dolophine Solution may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Breathing problems may occur some time after you take a dose of Dolophine Solution. Tell your doctor or seek medical care immediately if you notice trouble breathing (eg, slowed or shallow breathing) while you take Dolophine Solution.
- Dolophine Solution may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.
- The risk of Dolophine Solution becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use Dolophine Solution for longer than prescribed without talking with your doctor.
- Tell your doctor or dentist that you take Dolophine Solution before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including liver function, lung function, and heart function, may be performed while you use Dolophine Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Dolophine Solution with caution in the ELDERLY; they may be more sensitive to its effects.
- Dolophine Solution should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Dolophine Solution may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dolophine Solution while you are pregnant. Dolophine Solution is found in breast milk. If you are or will be breast-feeding while you use Dolophine Solution, check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time or at high dose, Dolophine Solution may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Dolophine Solution stops working well. Do not take more than prescribed.
Some people who use Dolophine Solution for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.
If you stop taking Dolophine Solution suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, and sweating. Do not stop therapy suddenly or change the dosage without asking your doctor. Discuss overuse with your doctor or pharmacist.
Possible side effects of Dolophine Solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; dizziness; drowsiness; dry mouth; headache; increased sweating; itching; lightheadedness; nausea; pain, redness, or swelling at the injection site; vomiting; weakness.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; decreased sexual desire or ability; excessive drowsiness; fainting; fast, slow, or irregular heartbeat; hallucinations; loss of appetite; menstrual changes; mental or mood changes (eg, agitation, disorientation, exaggerated sense of well-being); seizures; severe or persistent dizziness or lightheadedness; severe or persistent pain, redness, or swelling at the injection site; shortness of breath; slow or shallow breathing; swelling of the arms, feet, or legs; trouble sleeping; trouble urinating; unusual bruising or bleeding.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include cold and clammy skin; coma; fainting; fast, slow, or irregular heartbeat; muscle weakness; pinpoint pupils; severe dizziness, drowsiness, or lightheadedness; slow, shallow, or difficult breathing.Proper storage of Dolophine Solution:
Store Dolophine Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dolophine Solution out of the reach of children and away from pets.
- If you have any questions about Dolophine Solution, please talk with your doctor, pharmacist, or other health care provider.
- Dolophine Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Dolophine Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Dolophine Concise Consumer Information (Cerner Multum)
- Dolophine Prescribing Information (FDA)
- Methadone Prescribing Information (FDA)
- Diskets Prescribing Information (FDA)
- Methadose Prescribing Information (FDA)