Vivitrol Powder For Suspension For Injection, Extended Release 380Mg Drug Medication Dosage Information
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Vivitrol: Powder for suspension for injection, Extended Release (380mg)

Detailed Information
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What is this Medicine?

NALTREXONE (nal TREX one) is used to treat certain types of drug dependence.

In-Depth Information

Vivitrol 380mg Powder for Injection

NDC: 657570300
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Ethanol Dependence, Opiate Agonist Dependence

Storage Information
Do not expose product to temperatures above 77 degrees F
Do not freeze
Unrefrigerated product can be stored at temperatures not exceeding 77 degrees F for no more than 7 days prior to administration
Store between 36 to 46 degrees F
Vivitrol 380mg Powder for Injection
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Reported Side Effects for Vivitrol 380mg Powder for Injection

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Irritability Incidence:
<10.0%*
Severity: MILD
Onset: DELAYED
Injection Site Reaction Incidence:
<69.0%*
Severity: MILD
Onset: RAPID
Hoarseness Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Hallucinations Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Confusion Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Chills Incidence:
<10.0%*
Severity: MILD
Onset: RAPID
Blurred Vision Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Causing To Be Hungry Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Fainting Incidence:
<13.0%*
Severity: MILD
Onset: EARLY
Yawning Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Weight Loss Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Weight Gain Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Rapid Heart Rate Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Restlessness Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
<10.0%*
Severity: MILD
Onset: EARLY
Excessive Thirst Incidence:
<10.0%*
Severity: MILD
Onset: EARLY
Irritated Blood Vessels Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Stomach Ulcer Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Paranoia Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Rapid Heart Rate Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Ear Pain Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Eye Irritation Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Nightmares Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Decreased Sexual Desire Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Hot Flashes Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Hemorrhoids Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Gas Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Nose Bleed Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Swelling Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Painful Urination Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Shortness Of Breath Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Drowsiness Incidence:
<4.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
<13.0%*
Severity: MILD
Onset: EARLY
Cough Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Constipation Incidence:
<10.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
<14.0%*
Severity: MILD
Onset: EARLY
Dry Mouth Incidence:
<5.0%*
Severity: MILD
Onset: EARLY
Shaking Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Ringing In Ears Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Sneezing Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Runny Nose Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Itching Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
High Blood Pressure Incidence:
<5.0%*
Severity: MODERATE
Onset: EARLY
Stuffy Nose Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Eye Inflammation Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Light Sensitivity Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Nervousness Incidence:
2.0-12.0%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
3.0-14.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
3.0-25.0%*
Severity: MILD
Onset: EARLY
Inability To Sleep Incidence:
3.0-14.0%*
Severity: MILD
Onset: EARLY
Tooth Pain Incidence:
4.0%*
Severity: MILD
Onset: DELAYED
Tired Incidence:
>4.0%*
Severity: MILD
Onset: EARLY
Lightheadedness Incidence:
4.0-13.0%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
6.0%*
Severity: MILD
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
7.0-20.0%*
Severity: MODERATE
Onset: DELAYED
Muscle Cramps Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Decreased Appetite Incidence:
9.0-14.0%*
Severity: MILD
Onset: DELAYED
Muscle Pain Incidence:
>10.0%*
Severity: MILD
Onset: EARLY
Joint Pain Incidence:
>10.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
10.0-33.0%*
Severity: MILD
Onset: EARLY
Weakness Incidence:
23.0%*
Severity: MILD
Onset: DELAYED
*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.
Pregnancy & Lactation Information
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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.


Learning More About
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Patient Experiences with Vivitrol

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