Diazepam, Oral/Injection

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KEY POINTS

• This medicine is taken by mouth to treat anxiety, seizures, alcohol withdrawal, and muscles spasms. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antianxiety; benzodiazepine; tranquilizer; antiseizure; muscle relaxant

Generic and brand names: diazepam, injection; diazepam, oral; Diazepam Intensol; Diazepam Oral Solution; Valium

What is this medicine used for?

This medicine is taken by mouth to treat anxiety disorders.

It is also used to:

• Treat the symptoms of acute alcohol withdrawal
• Relieve muscle spasms
• Treat seizure disorders
• Treat anxiety before surgery or medical or dental procedures
• Make anesthesia more effective

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Depression, thoughts of suicide, or other mental health problem
• Glaucoma
• Liver or kidney disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Myasthenia gravis or muscular dystrophy
• Parkinson’s disease
• Problems with drug or alcohol abuse
• Seizures

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it longer than prescribed because it may be habit-forming.

Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually. Stopping too quickly may cause withdrawal symptoms, which may include seizures.

Check with your healthcare provider before using this medicine in children under age 6 months.

This medicine comes in the form of tablets, liquid, and injections. Injections of this medicine will usually be given by a healthcare provider.

The tablets may be taken with or without food. Take tablets with a full glass of water.

If you are using the liquid, there are 2 different strengths. The Intensol liquid is more concentrated than the regular liquid. Make sure you have the correct strength. Ask your healthcare provider or pharmacist if you have any questions. Use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct. If you have the Intensol liquid, mix the solution with water or juice, or in applesauce or pudding. Take the medicine right away. Do not save it to be used later.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: confusion, extreme drowsiness, lightheadedness, fainting, loss of balance, muscle weakness, shallow breathing, trouble walking, coma, slurred speech, tremors, slow heartbeat.

What should I watch out for?

You may need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol while taking this medicine. Do not take other medicines unless your healthcare provider approves.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery until you are fully alert and can see clearly.

Antiseizure medicines may increase suicidal thoughts or actions in some people.

Contact your provider right away if you or your family notice:

• More outgoing or aggressive behavior than normal
• Mood changes
• New or worsening depression
• New or increased thoughts of suicide

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If taken for a long time, this medicine may become less effective. Talk with your healthcare provider about this.

This medicine is a controlled substance and may be habit forming. It is illegal to give it to anyone else.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Irregular, slow, or fast heartbeat; severe rash; severe dizziness or fainting; trouble breathing; severe drowsiness or weakness; unexplained fever, cough, or sore throat; hallucinations (seeing; hearing; or feeling things that aren't there) or severe confusion; unusual mood or behavior changes; depression; thoughts of suicide; yellowing of the skin or eyes; dark urine; trouble urinating; trouble walking; slurred speech; blurred vision or other vision problems; memory problems; muscle movement or twitching that you can't control; new or worsening seizures; injection site redness, pain, or irritation.

Other: Mild drowsiness or tiredness, unusual dreams, trouble sleeping, mild dizziness, mild weakness, restlessness, mild itching, constipation, diarrhea, dry mouth, headache, nausea, heartburn, appetite changes, weight changes, loss of interest in sex, flushing, sweating.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as chloramphenicol, clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), levomilnacipran (Fetzima), nefazodone, nortriptyline (Pamelor), protriptyline (Vivactil), sertraline (Zoloft), trazodone, trimipramine (Surmontil), venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), loxapine (Loxitane), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ezogabine (Potiga), felbamate (Felbatol), lacosamide (Vimpat), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), perampanel (Fycompa), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga), bortezomib (Velcade), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), and mitotane (Lysodren)
• Conivaptan (Vaprisol)
• Disulfiram (Antabuse)
• Doxepin (Silenor)
• Flibanserin (Addyi)
• Gemfibrozil (Lopid)
• Heart medicines such as diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings
• Levodopa/carbidopa (Duopa, Rytary, Sinemet)
• Lumacaftor/ivacaftor (Orkambi)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), and omeprazole (Prilosec)
• Mifepristone (Korlym, Mifeprex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, melatonin, St. John's wort, and valerian
• Nausea medicines such as aprepitant (Emend), prochlorperazine (Compro), and promethazine
• Other antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clorazepate (Gen-Xene, Tranxene), lorazepam (Ativan), and oxazepam
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxymorphone (Opana), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Scopolamine (Transderm Scop)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, ramelteon (Rozerem), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Theophylline

Do not drink alcohol while you are taking this medicine.

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

If you are using the Intensol liquid, discard the opened bottle after 90 days.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.