Pronunciation:

dye-AZ-e-pam

Brand Names:

• Diazepam Intensol
• Valium

Dosage Forms:

• Tablet
• Solution

Warnings:

Risks From Concomitant use with Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression.The use of benzodiazepines, including diazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with increased frequency of serious adverse outcomes. Before prescribing diazepam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines, including diazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of diazepam may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam or reduce the dosage .

Classifications:

Therapeutic—

Antianxiety

Pharmacologic—

Benzodiazepine, Long Acting

Uses of This Medicine:

Diazepam is used to relieve symptoms of anxiety and alcohol withdrawal. This medicine may also be used to treat certain seizure disorders and help relax muscles or relieve muscle spasm. Diazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of diazepam in children younger than 6 months of age. Safety and efficacy have not been established. Use of diazepam is not recommended in children younger than 6 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazepam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving diazepam.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Flumazenil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprepitant
• Aripiprazole
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Cetirizine
• Chloral Hydrate
• Chlorzoxazone
• Clarithromycin
• Clobazam
• Clonazepam
• Cobicistat
• Codeine
• Conivaptan
• Dabrafenib
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Doxylamine
• Esketamine
• Eslicarbazepine Acetate
• Ethchlorvynol
• Ethylmorphine
• Etravirine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluvoxamine
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Itraconazole
• Ivacaftor
• Ketamine
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Metoclopramide
• Midazolam
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Netupitant
• Nicomorphine
• Olanzapine
• Oliceridine
• Omaveloxolone
• Omeprazole
• Opium
• Opium Alkaloids
• Orlistat
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Phenytoin
• Piritramide
• Potassium Oxybate
• Pregabalin
• Primidone
• Propofol
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sparsentan
• Sufentanil
• Tapentadol
• Thiopental
• Tilidine
• Topiramate
• Tramadol
• Trazodone
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Amprenavir
• Dalfopristin
• Desogestrel
• Dienogest
• Disulfiram
• Drospirenone
• Erythromycin
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Fluoxetine
• Gestodene
• Ginkgo
• Isoniazid
• Levonorgestrel
• Mestranol
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Quinupristin
• Rifapentine
• Roxithromycin
• St John's Wort
• Theophylline
• Troleandomycin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol or drug abuse or dependence, or history of, or
• Depression, or history of or
• Lung or breathing problems (eg, respiratory depression) or
• Mental health problems, or history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• Breathing problems, severe or
• Glaucoma, narrow-angle or
• Liver disease, severe or
• Myasthenia gravis or
• Sleep apnea (temporary stopping of breathing during sleep)—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it.

To use the oral solution:

• Measure the oral liquid with the medicine dropper that comes from the package.
• Mix each dose with water, juice, soda or a soda-like beverage before you take it. You may also mix the liquid with a semisolid food such as applesauce or pudding.
• Take the entire mixture right away. It should not be saved to use later.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution or tablets):
  • For anxiety:
    • Adults—2 to 10 milligrams (mg) 2 to 4 times a day.
    • Older adults—At first, 2 to 2.5 mg 1 or 2 times a day. Your doctor may increase your dose if needed.
    • Children 6 months of age and older—At first, 1 to 2.5 mg 3 or 4 times per day. Your child's doctor may increase the dose if needed.
    • Children up to 6 months of age—Use is not recommended.
  • For alcohol withdrawal:
    • Adults—10 milligrams (mg) 3 or 4 times for the first 24 hours, then 5 mg 3 to 4 times per day as needed.
    • Older adults—At first, 2 to 2.5 mg 1 or 2 times a day. Your doctor will gradually increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For muscle spasm:
    • Adults—2 to 10 milligrams (mg) 3 or 4 times a day.
    • Older adults—At first, 2 to 2.5 mg 1 or 2 times a day. Your doctor may increase your dose if needed.
    • Children 6 months of age and older—At first, 1 to 2.5 mg 3 or 4 times per day. Your child's doctor may increase the dose if needed.
    • Children up to 6 months of age—Use is not recommended.
  • For seizures:
    • Adults—2 to 10 milligrams (mg) 2 to 4 times a day.
    • Older adults—At first, 2 to 2.5 mg 1 or 2 times a day. Your doctor may increase your dose if needed.
    • Children 6 months of age and older—At first, 1 to 2.5 mg 3 or 4 times per day. Your child's doctor may increase the dose if needed.
    • Children up to 6 months of age—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits to see if the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you or your child stop using this medicine. Check with your doctor before taking any of the above while you or your child are using this medicine.

If you or your child develop any unusual or strange thoughts and behavior while taking diazepam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, including hallucinations, seizures, stomach or muscle cramps, sweating, tremors, or unusual behavior.

Symptoms of an overdose include: change or loss of consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, irregular, fast or slow, or shallow breathing, lack of coordination, loss of strength or energy, muscle pain or weakness, pale or blue lips, fingernails, or skin, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, sweating, trouble breathing, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

More common

Shakiness and unsteady walk

unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

Agitation

black, tarry stools

blistering, flaking, or peeling of the skin

blurred vision

changes in patterns and rhythms of speech

chills

confusion

cough

dark urine

decrease in the frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

discouragement

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

false beliefs that cannot be changed by facts

fast heartbeat

fast or irregular breathing

feeling sad or empty

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

fever

headache

hyperexcitability

increased muscle spasms or tone

irritability

itching or rash

lack of memory of what takes place after a certain event

loss of appetite

loss of bladder control

loss of interest or pleasure

lower back or side pain

nausea

nightmares

outbursts of anger

painful or difficult urination

pale skin

restlessness

seizures

slurred speech

sore throat

stomach pain

sweating

trouble concentrating

trouble sleeping

trouble speaking

ulcers, sores, or white spots in the mouth

unpleasant breath odor

unusual behavior

unusual bleeding or bruising

unusual feeling of excitement

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

change in consciousness

changes in patterns and rhythms of speech

confusion

difficult or trouble breathing

excitement

irregular, fast or slow, or shallow breathing

irritability

lack of coordination

loss of consciousness

loss of strength or energy

muscle pain or weakness

pale or blue lips, fingernails, or skin

restlessness

shakiness and unsteady walk

sleepiness

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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:

Incidence not known

Constipation

decreased interest in sexual intercourse

diarrhea

difficulty with swallowing

double vision

dry mouth

feeling of constant movement of self or surroundings

inability to have or keep an erection

increase in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

increased watering of the mouth

indigestion

loss of sexual ability, desire, drive, or performance

passing of gas

seeing double

sensation of spinning

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.