Suboxone

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This medication contains 2 medicines buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids.

Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. It has little effect when taken by mouth or dissolved under the tongue. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

Read the Medication Guide provided by your pharmacist before you start taking buprenorphine/naloxone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

There are different brands and forms of this medication available. Because different products may contain different amounts of buprenorphine and naloxone, do not change brands or dosage forms without consulting your doctor or pharmacist.

Use this medication during your treatment maintenance period as directed by your doctor, usually once daily. Place the medication under your tongue for 5 to 10 minutes and let it dissolve completely. If you are prescribed more than one tablet each day, you may place all of the tablets under your tongue at once or place two tablets at a time under your tongue. Do not swallow or chew this medication. It will not work as well.

For most patients, buprenorphine alone is usually used for the first 2 days after you have stopped all other opioids. It is usually given in your doctor’s office. Your doctor will then switch you to this combination buprenorphine/naloxone medication for maintenance treatment. The combination with naloxone works the same way as buprenorphine alone to prevent withdrawal symptoms. For some patients, this combination product may be used to start treatment (called induction). Follow your doctor’s directions carefully.

The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Buprenorphine/naloxone may cause withdrawal symptoms especially if you use it soon after using opioids such as heroin, morphine, or methadone. Follow your doctor’s instructions for your treatment plan.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Do not inject (“shoot up”) buprenorphine/naloxone or inhale it through the nose (“snort”). Doing so is dangerous, and will likely cause severe withdrawal symptoms (see Side Effects section) due to the naloxone in this medication, especially if you have been using opioids such as heroin, morphine or methadone. Consult your doctor or pharmacist for more details.

Tell your doctor right away if you experience any withdrawal reactions.

Before taking this medication, tell your doctor or pharmacist if you are allergic to buprenorphine or naloxone; 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), liver disease, mental/mood disorders (such as confusion, depression), 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. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol also increases your risk for breathing problems.

Buprenorphine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using buprenorphine, tell your doctor or pharmacist of all the drugs you take and 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 buprenorphine safely.

This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

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 side effects of this drug, especially slow/shallow breathing, drowsiness, and QT prolongation (see above).

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. 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.

Buprenorphine passes into breast milk. It is unknown if naloxone passes into breast milk. This product may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. For more details, read the Medication Guide, or consult your pharmacist or local waste disposal company.

Quantity

10mg/30pills, 10mg/50pills, 10mg/100pills

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