Naltrexone Information
What is this drug used for?
• It is used to help keep you alcohol-free.
• It is used to keep a drug-free state.
• It may be given to you for other reasons. Talk with the doctor.
Possible side effects
Naltrexone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
All products:
• Feeling nervous and excitable.
• Anxiety.
• Headache.
• Muscle cramps.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• More thirst.
• Trouble sleeping.
• Feeling dizzy, sleepy, tired, or weak.
• Back, muscle, or joint pain.
• Signs of a common cold.
• Tooth pain.
Injection:
• Irritation where the shot is given.
• Nose or throat irritation.
• Dry mouth.
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
All products:
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• New or worse behavior or mood changes like depression or thoughts of suicide.
• Feeling confused.
• Trouble breathing, slow breathing, or shallow breathing.
• Sex problems in men.
Injection:
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Area that feels hard, blisters, dark scab, lumps, open wound, pain, swelling, or other very bad skin irritation where the shot was given.
Medication Safety Issues
Sound-alike/look-alike issues:
Naltrexone may be confused with methylnaltrexone, naloxone
ReVia may be confused with Revatio
Administration issues:
Vivitrol: For intramuscular (IM) gluteal injection only
Storage/Stability
Injection: Store unopened kit at 2°C to 8°C (36°F to 46°F). Kit may be kept at room temperature of ≤25°C (77°F) for ≤7 days prior to use; do not freeze. Following reconstitution of the suspension, administer immediately.
Tablet: Store at 20°C to 25°C (68°F to 77°F).
Adverse Reactions
>10%:
Cardiovascular: Syncope (≤13%)
Central nervous system: Headache (25%), insomnia (≤14%), sleep disorder (≤14%), dizziness (≤13%), anxiety (12%)
Gastrointestinal: Nausea (33%), vomiting (14%), anorexia (≤14%), change in appetite (≤14%), decreased appetite (≤14%), diarrhea (13%), abdominal pain (11%)
Hepatic: Increased serum transaminases (20%), increased serum aspartate aminotransferase (2% to 14%)
Local: Injection site reaction (69%), tenderness at injection site (45%), induration at injection site (35%), pain at injection site (17%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (11% to 39%), asthenia (23%), arthralgia (≤12%), arthritis (≤12%), joint stiffness (≤12%)
Respiratory: Pharyngitis (11%)
1% to 10%:
Central nervous system: Depression (8% to 10%), drowsiness (≤4%), sedated state (≤4%), suicidal ideation (≤1%), suicidal tendencies (≤1%)
Dermatologic: Skin rash (6%)
Gastrointestinal: Xerostomia (5%)
Local: Itching at injection site (10%), bruising at injection site (7%)
Neuromuscular & skeletal: Muscle cramps (8%), back pain (≤6%), back stiffness (≤6%)
Frequency not defined:
Cardiovascular: Acute ischemic stroke, acute myocardial infarction, angina pectoris, atrial fibrillation, cardiac failure, cerebral aneurysm, chest pain, chest tightness, coronary arteriosclerosis, deep vein thrombosis, facial edema, palpitations, pulmonary embolism, unstable angina pectoris
Central nervous system: Abnormal dreams, agitation, alcohol withdrawal syndrome, chills, decreased mental acuity, delirium, disturbance in attention, euphoria, heat exhaustion, irritability, lethargy, migraine, paresthesia, peripheral pain, rigors, seizure
Dermatologic: Diaphoresis, night sweats, pruritus
Endocrine & metabolic: Decreased libido, dehydration, hot flash, hypercholesterolemia, weight gain, weight loss
Gastrointestinal: Abdominal discomfort, acute pancreatitis, cholecystitis, cholelithiasis, colitis, constipation, dysgeusia, flatulence, gastroenteritis, gastroesophageal reflux disease, gastrointestinal hemorrhage, hemorrhoids, increased appetite, paralytic ileus
Genitourinary: Abscess of rectum and/or peri-rectal area, urinary tract infection
Hematologic & oncologic: Decreased platelet count, eosinophilia, leukocytosis, lymphadenopathy
Hepatic: Increased serum alanine aminotransferase
Hypersensitivity: Seasonal allergy
Infection: Tooth abscess
Neuromuscular & skeletal: Muscle spasm, myalgia
Ophthalmic: Blurred vision, conjunctivitis
Respiratory: Bronchitis, chronic obstructive pulmonary disease, dyspnea, laryngitis, nasal congestion, pharyngolaryngeal pain, pneumonia, sinusitis, upper respiratory tract infection
Miscellaneous: Fever
Postmarketing: Anaphylaxis, angioedema, eosinophilic pneumonitis, hepatic insufficiency, hepatitis, hypersensitivity reaction, opioid withdrawal syndrome, retinal artery occlusion, urticaria
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