methadone - injection, Dolophine (cont.)
SIDE EFFECTS: See also Warning section.Nausea, vomiting, constipation, lightheadedness, dizziness, dry mouth, drowsiness, and increased sweating may occur. Pain, redness, or swelling at the injection site may occur if this medication is given into a muscle or under the skin. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), difficulty urinating, vision changes.Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using methadone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (such as propoxyphene); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain bowel diseases (paralytic ileus, infectious diarrhea).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), a certain spinal problem (kyphoscoliosis), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), adrenal gland problem (such as Addison's disease), mental/mood disorders (such as toxic psychosis), intestinal diseases (such as colitis), disease of the pancreas (such as pancreatitis), gallbladder disease.Methadone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using methadone, tell your doctor or pharmacist if you have any of the following conditions: family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death), certain heart problems (slow/fast/irregular heartbeat, QT prolongation in the EKG, heart failure).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using methadone safely.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Before having surgery, tell your doctor or dentist that you are using this medication.Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing and drowsiness.Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Pregnancy may affect the amount of this drug in your body, so tell your doctor if you are pregnant or if you plan to become pregnant. You may require different dosing. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding or if you plan to stop breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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