Buprenex

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

If you inject too much Buprenex call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Buprenex is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Buprenorphine injection is used to relieve moderate to severe pain.

Buprenorphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped. completely.

This medicine is available only with your doctor's prescription.

A nurse or other trained health professional will give you or your child this medicine. This medicine is given as a shot into a muscle or a vein.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you or your child to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Drowsiness
• relaxed and calm
• sleepiness

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• confusion
• difficult or labored breathing
• feeling, seeing, or hearing things that are not there
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• headache
• severe mood or mental changes
• slurred speech
• tightness of the chest
• unusual behavior

• Anxiety
• cough
• diarrhea
• dry mouth
• hyperventilation
• irregular heartbeats
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of muscle coordination
• nervousness
• noisy breathing
• restlessness
• seizures
• shaking
• trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Nausea

• Constricted, pinpoint, or small pupils (black part of the eye)
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• extremely shallow or slow breathing
• sweating
• vomiting

• Burning, dry, or itching eyes
• chills
• continuing ringing or buzzing or other unexplained noise in the ears
• decrease in the frequency of urination
• decrease in urine volume
• depression
• difficulty in passing urine (dribbling)
• discharge, excessive tearing
• dreaming
• dry mouth
• false or unusual sense of well-being
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• hearing loss
• itching of the skin
• painful urination
• pounding in the ears
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• unusual tiredness or weakness

• Acid or sour stomach
• belching
• bloated
• bluish lips or skin
• change in vision
• excess air or gas in the stomach or intestines
• feeling of unreality
• full feeling
• general feeling of discomfort or illness
• heartburn
• hives or welts, skin rash
• impaired vision
• indigestion
• loss of appetite
• not breathing
• paleness of the skin
• passing gas
• redness of the skin
• sense of detachment from self or body
• stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Buprenex is contraindicated in patients with:

• Significant respiratory depression [See WARNINGS].
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [See WARNINGS].
• Known or suspected gastrointestinal obstruction, including paralytic ileus [See WARNINGS].
• Hypersensitivity to buprenorphine (e.g. anaphylaxis) or any other ingredient in Buprenex [See WARNINGS].

The most frequent side effect in clinical studies involving 1,133 patients was sedation which occurred in approximately two-thirds of the patients. Although sedated, these patients could easily be aroused to an alert state.

Other less frequent adverse reactions occurring in 5-10% of the patients were:

Nausea Dizziness/Vertigo

Occurring in 1-5% of the patients:

Sweating Headache

Hypotension Nausea/Vomiting

Vomiting Hypoventilation

Miosis

The following adverse reactions were reported to have occurred in less than 1% of the patients:

CNS Effect: confusion, blurred vision, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia.

Cardiovascular: hypertension, tachycardia, bradycardia.

Gastrointestinal: constipation.

Respiratory: dyspnea, cyanosis.

Dermatological: pruritus.

Ophthalmological: diplopia, visual abnormalities.

Miscellaneous: injection site reaction, urinary retention, dreaming, flushing/warmth, chills/cold, tinnitus, conjunctivitis, Wenckebach block, and psychosis.

Other effects observed infrequently include malaise, hallucinations, depersonalization, coma, dyspepsia, flatulence, apnea, rash, amblyopia, tremor, and pallor.

The following reactions have been reported to occur rarely: loss of appetite, dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination.

Allergic Reactions: Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the postmarketing experience of Buprenex and other buprenorphine- containing products. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. A history of hypersensitivity to buprenorphine is a contraindication to Buprenex.

In the United Kingdom, buprenorphine hydrochloride was made available under monitored release regulation during the first year of sale, and yielded data from 1,736 physicians on 9,123 patients (17,120 administrations). Data on 240 children under the age of 18 years were included in this monitored release program. No important new adverse effects attributable to buprenorphine hydrochloride were observed.

Postmarketing Experience

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY: Pharmacodynamics].

Buprenex (buprenorphine hydrochloride) is supplied in cartons containing five clear glass snap-ampules of 0.3 mg/mL buprenorphine).

NDC 12496-0757-5

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [USP Controlled Room Temperature]. Protect from prolonged exposure to light.

Manufactured by:

Reckitt Benckiser Healthcare (UK) Ltd.,
Hull, England, HU8 7DS
Distributed by:
Indivior Inc.,
Richmond, VA 23235
Revised December 2016

NDC 12496-0757-1

Buprenex ®

(buprenorphine HCl) Injection

0.3 mg/mL

For Intramuscular or Intravenous Use

Protect from light Mfd. by Reckitt Benckiser,

Hull, England HU8 7DS. RB125447

You should not use this medication if you are allergic to buprenorphine.

To make sure you can safely use buprenorphine, tell your doctor if you have any of these other conditions:

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorders;
• liver or kidney disease;
• a thyroid disorder;
• enlarged prostate, urination problems;
• gallbladder disease;
• curvature of the spine;
• Addison's disease (adrenal gland disorder);
• a history of mental illness, personality disorder, or psychotic episode;
• a history of drug or alcohol addiction; or
• a history of seizures, head injury, or brain tumor.

Buprenorphine may be habit forming and should be used only by the person it was prescribed for. Never share buprenorphine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether buprenorphine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using buprenorphine.

Buprenorphine can pass into breast milk and may harm a nursing baby. Do not breast-feed while you are using buprenorphine.