Buprenorphine Solution For Injection 0.3Mg Drug Medication Dosage Information
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Buprenorphine: Solution for injection (0.3mg)

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What is this Medicine?

BUPRENORPHINE (byoo pre NOR feen) is a pain reliever. It is used to treat moderate to severe pain.

In-Depth Information
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Buprenorphine Hydrochloride 0.3mg/ml Solution for Injection

NDC: 553900100
  • Prescription Required
  • Federally Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Severe Pain, Moderate Pain

Storage Information
Protect from light
Store at controlled room temperature (between 68 and 77 degrees F)
Avoid excessive heat (above 104 degrees F)
Buprenorphine Hydrochloride 0.3mg/ml Solution for Injection

Reported Side Effects for Buprenorphine Hydrochloride 0.3mg/ml Solution for Injection

Hallucinations Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Flushing Incidence:
<4.9%*
Severity: MILD
Onset: RAPID
Elated Mood Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Emotional Lability Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Dysphoria Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Metallic Taste Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Dysarthria Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Double Vision Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Cyanosis Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Conjunctivitis Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Confusion Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Chills Incidence:
<7.8%*
Severity: MILD
Onset: RAPID
Chest Pain Incidence:
<0.2%*
Severity: MODERATE
Onset: EARLY
Breathing Difficulties Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Blurred Vision Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Weakness Incidence:
<14.0%*
Severity: MILD
Onset: DELAYED
Decreased Breathing Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Anaphylactoid Reactions Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Fainting Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Brain Attack Incidence:
<0.2%*
Severity: SEVERE
Onset: EARLY
Decreased Breathing Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Long Qt Syndrome Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Psychosis Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Decreased Memory Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Withdrawal Incidence:
<24.0%*
Severity: MODERATE
Onset: EARLY
Wheezing Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Weakness Incidence:
<14.0%*
Severity: MILD
Onset: EARLY
Visual Impairment Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Rapid Heart Rate Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Rhinitis Incidence:
<11.0%*
Severity: MILD
Onset: EARLY
Restlessness Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
<5.0%*
Severity: MILD
Onset: EARLY
Peripheral Vasodilation Incidence:
<3.9%*
Severity: MODERATE
Onset: RAPID
Paresthesias Incidence:
<5.0%*
Severity: MILD
Onset: DELAYED
Rapid Heart Rate Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Pale Skin Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Nightmares Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Muscle And/Or Bone Pain Incidence:
<5.0%*
Severity: MILD
Onset: EARLY
Miosis Incidence:
<5.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Injection Site Reaction Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Shallow, Slow Breathing Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Hypoesthesia Incidence:
<5.0%*
Severity: MILD
Onset: DELAYED
Overbreathing Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Hiccups Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Bowel Obstruction Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Low Blood Pressure Incidence:
<5.0%*
Severity: MODERATE
Onset: RAPID
High Blood Pressure Incidence:
<5.0%*
Severity: MODERATE
Onset: EARLY
Gas Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Shortness Of Breath Incidence:
<5.0%*
Severity: MODERATE
Onset: EARLY
Upset Stomach Incidence:
<5.0%*
Severity: MILD
Onset: EARLY
Drowsiness Incidence:
<13.0%*
Severity: MILD
Onset: EARLY
Depression Incidence:
<11.0%*
Severity: MODERATE
Onset: DELAYED
Dehydration Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Cough Incidence:
<5.0%*
Severity: MILD
Onset: DELAYED
Constipation Incidence:
<13.0%*
Severity: MODERATE
Onset: DELAYED
Coma Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Cholecystitis Incidence:
<0.2%*
Severity: SEVERE
Onset: DELAYED
Slow Heart Beat Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Heart Block Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Irregular Heart Beat Incidence:
<0.2%*
Severity: SEVERE
Onset: EARLY
Decreased Appetite Incidence:
<5.0%*
Severity: MILD
Onset: DELAYED
Angioedema Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Chest Pain Incidence:
<5.0%*
Severity: MODERATE
Onset: EARLY
Severe Allergy Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Lazy Eye Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Distressed Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Difficulty Swallowing Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Dry Eyes Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Balance Problems Incidence:
<10.0%*
Severity: MILD
Onset: EARLY
Hives Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Retaining Urine Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Uncontrolled Urination Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Shaking Incidence:
<5.0%*
Severity: MILD
Onset: EARLY
Ringing In Ears Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Sinus Infection Incidence:
<4.9%*
Severity: MILD
Onset: DELAYED
Runny Nose Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Itching Incidence:
<5.0%*
Severity: MILD
Onset: RAPID
Inability To Sleep Incidence:
<21.4%*
Severity: MILD
Onset: EARLY
Postural Low Blood Pressure Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Migraine Incidence:
<5.0%*
Severity: MODERATE
Onset: EARLY
Infection Incidence:
1.0-11.7%*
Severity: MILD
Onset: DELAYED
Fluid Retention Incidence:
1.0-4.9%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
1.0-11.7%*
Severity: MILD
Onset: EARLY
Anemia Incidence:
1.0-4.9%*
Severity: MODERATE
Onset: DELAYED
Nervousness Incidence:
1.0-12.0%*
Severity: MILD
Onset: DELAYED
Joint Pain Incidence:
1.0-4.9%*
Severity: MILD
Onset: DELAYED
Muscle Pain Incidence:
1.0-4.9%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
1.0-9.0%*
Severity: MILD
Onset: EARLY
Excessive Sweating Incidence:
1.0-4.9%*
Severity: MILD
Onset: DELAYED
Diaphoresis Incidence:
1.0-12.6%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
1.0-14.0%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
1.0-29.1%*
Severity: MILD
Onset: EARLY
Tiredness Incidence:
1.0-4.9%*
Severity: MILD
Onset: EARLY
Fever Incidence:
1.0-4.9%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
1.0-4.9%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
2.0-15.0%*
Severity: MILD
Onset: EARLY
Epiphora Incidence:
5.0%*
Severity: MODERATE
Onset: EARLY
Dry Mouth Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
5.0-33.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Buprenorphine Hydrochloride 0.3mg/ml Solution for Injection

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Alcohol and Buprenorphine Hydrochloride 0.3mg/ml Solution for Injection(Buprenorphine Hydrochloride)
Alcohol and CNS Depressants(Buprenorphine Hydrochloride)
Avoid alcohol-containing drinks while taking this medicine. Using this drug along with alcohol can lead to serious side effects. You may feel drowsy or more tired when taking these drugs together. Do not drive or operate machinery until you know how this drug affects you, and especially if you are drinking alcohol-containing beverages. If you notice slurred speech, confusion, severe weakness, or difficulty breathing, contact your health care provider immediately.
Minor Lifestyle Interaction
Grapefruit juice and Buprenorphine Hydrochloride 0.3mg/ml Solution for Injection(Buprenorphine Hydrochloride)
Grapefruit juice and Buprenorphine(Buprenorphine Hydrochloride)
Grapefruit juice and grapefruit-containing foods may increase the side effects of Buprenorphine. Do not significantly alter grapefruit juice intake while taking this drug, or avoid grapefruit juice if possible. If you notice slurred speech, confusion, severe weakness, difficulty breathing, palpitations, shortness of breath, or a change in your usual heart beat (fast, slow, or irregular heart beat), contact your health care prescriber.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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