Pronunciation:

dye-AZ-e-pam

Brand Names:

• Valium

Dosage Forms:

• 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 injection, 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 injection and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although diazepam injection is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of diazepam injection may precipitate acute withdrawal reactions, which can be life-threatening. For patients using diazepam injection more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam injection .

Classifications:

Therapeutic—

Antianxiety

Pharmacologic—

Benzodiazepine, Long Acting

Uses of This Medicine:

Diazepam injection is used to relieve symptoms of anxiety and alcohol withdrawal. It is also used to relieve anxiety before surgery or certain procedures. When diazepam is used before surgery, the patient will not remember some of the details about the procedure.

Diazepam injection is also used to treat seizures, including status epilepticus. It may also be used to help relax muscle or relieve muscle spasms.

Diazepam injection 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 given only by or under the direct supervision of your doctor.

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 injection in newborn babies (30 days of age and younger). Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazepam injection in the elderly. However, elderly patients are more likely to have trouble breathing, heart attack, or age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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 receiving 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
• Carbinoxamine
• Carisoprodol
• Cetirizine
• Chloral Hydrate
• Chlorzoxazone
• 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
• 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
• Tocilizumab
• 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
• Clarithromycin
• 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 intoxication or
• Glaucoma, acute narrow-angle or
• Loss of consciousness (coma) or
• Shock—Should not be used in patients with these conditions.

• Alcohol or drug abuse or dependence, or history of—Dependence on diazepam injection may develop.

• Breathing problems or lung disease or
• Heart or blood vessel disease or
• Hypotension (low blood pressure) or
• Muscle weakness—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins or as a shot into one of your muscles.

After you receive a shot of this medicine, your doctor will watch you closely to make sure it is working properly and to check for unwanted effects.

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 dizziness or drowsiness, or trouble with thinking.Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. 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 (used for seizures), muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you or your child stop taking this medicine. Check with your doctor before taking any of the above while you or your child are using this medicine.

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 cause respiratory depression (serious breathing problem that can be life-threatening), especially when used with narcotic pain medicines. Tell your doctor if you are using any narcotic medicine.

Do not stop taking it without checking with your doctor first. 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, tremors, or unusual behavior.

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

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

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

Less common

Black, tarry stools

blurred vision

changes in patterns and rhythms of speech

chest pain or discomfort

chills

cold, clammy, or pale skin

confusion

cough

dark urine

decrease in frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

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

fear or nervousness

fever

hallucinations

headache

irregular heartbeats

itching

loss of appetite

loss of bladder control

lower back or side pain

muscle spasm

nausea

nightmares

outbursts of anger

painful or difficult urination

pale skin

rash

shakiness in the legs, arms, hands, or feet

slow or irregular heartbeat

slurred speech

sore throat

stomach pain

sweating

trembling or shaking of hands or feet

trouble in speaking

trouble sleeping

ulcers, sores, or white spots in the mouth

unpleasant breath odor

unusual bleeding or bruising

unusual excitement, nervousness, restlessness, or irritability

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Incidence not known

Chest tightness

deep or fast breathing with dizziness

difficult or trouble breathing

irregular, fast or slow, or shallow breathing

numbness of the feet, hands, and around the mouth

pale or blue lips, fingernails, 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

excitement

irritability

lack of coordination

loss of consciousness

loss of strength or energy

muscle pain or weakness

restlessness

shakiness and unsteady walk

sleepiness

slurred speech

talkativeness

trouble in speaking

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

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

unusual weak feeling

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:

Less common

Constipation

decreased interest in sexual intercourse

difficulty in swallowing

discouragement

double vision

dry mouth

feeling of constant movement of self or surroundings

feeling sad or empty

hiccups

hives or welts, itching

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

lack of appetite

loss in sexual ability, desire, drive, or performance

loss of interest or pleasure

redness of skin

seeing double

sensation of spinning

trouble concentrating

uncontrolled eye movements

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.