Dolophine

DRUG DESCRIPTION

DOLOPHINE® HYDROCHLORIDE (Methadone Hydrochloride Tablets, USP), for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.

Methadone hydrochloride is a white, crystalline material that is water-soluble.
Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO • HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5.

It has the following structural formula:

Methadone Hydrochloride structural formula illustration

Other ingredients of DOLOPHINE (methadone) include: magnesium stearate, microcrystalline cellulose, and starch.

What are the possible side effects of methadone (Diskets, Dolophine, Methadose)?

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

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing;
  • hallucinations or confusion;
  • chest pain, dizziness, fainting, fast or pounding heartbeat; or
  • trouble breathing, feeling light-headed, or fainting.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Dolophine »

What are the precautions when taking methadone (Dolophine)?

Before taking methadone, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...

Read All Potential Precautions of Dolophine »


Dolophine Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, constipation, lightheadedness, dizziness, dry mouth, drowsiness, or sweating may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat 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).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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 right away if you have any unlikely but serious side effects, including: mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, difficulty urinating.

Get medical help right away if you have any rare but serious side effects, including: seizure, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 taking methadone, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

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.

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. Before using methadone, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

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.

Liquid products may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid these substances in your diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems.

During pregnancy, this medication should be used only when clearly needed. Pregnancy may affect the amount of this drug in your body, so tell your doctor right away if you become pregnant. Use for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Babies born to mothers who have used this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

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.


Dolophine Patient Information Including Side Effects

Brand Names: Diskets, Dolophine, Methadose

Generic Name: methadone (Pronunciation: METH a done)

  • What is methadone (Dolophine)?
  • What are the possible side effects of methadone (Dolophine)?
  • What is the most important information I should know about methadone (Dolophine)?
  • What should I discuss with my healthcare provider before using methadone (Dolophine)?
  • How should I use methadone (Dolophine)?
  • What happens if I miss a dose (Dolophine)?
  • What happens if I overdose (Dolophine)?
  • What should I avoid while using methadone (Dolophine)?
  • What other drugs will affect methadone (Dolophine)?
  • Where can I get more information?

What is methadone (Dolophine)?

Methadone is a narcotic pain reliever, similar to morphine. Methadone also reduces withdrawal symptoms in people addicted to heroin or other narcotic drugs without causing the "high" associated with the drug addiction.

Methadone is used as a pain reliever and as part of drug addiction detoxification and maintenance programs.

Methadone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of methadone (Dolophine)?

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

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing;
  • hallucinations or confusion;
  • chest pain, dizziness, fainting, fast or pounding heartbeat; or
  • trouble breathing, feeling light-headed, or fainting.

Less serious side effects may include:

  • feeling anxious, nervous, or restless;
  • sleep problems (insomnia);
  • feeling weak or drowsy;
  • dry mouth, nausea, vomiting, diarrhea, constipation, loss of appetite; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about methadone (Dolophine)?

Taking methadone improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from methadone. Follow all dosing instructions carefully.

Like other narcotic medicines, methadone can slow your breathing, even long after the pain-relieving effects of the medication wear off. Death may occur if breathing becomes too weak. Never use more methadone than your doctor has prescribed. Call your doctor if you think the medicine is not working.

Do not stop using methadone suddenly, or you could have unpleasant withdrawal symptoms. Call your doctor if you miss doses or forget to take this medication for longer than 3 days in a row.

Do not drink alcohol while you are taking methadone. Dangerous side effects or death can occur when alcohol is combined with methadone. Check your food and medicine labels to be sure these products do not contain alcohol.

Methadone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Related Drug Centers
  • Dolophine
  • Methadose
  • Methadone Hydrochloride


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