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Diazepam (Oral route)

Pronunciation:

dye-AZ-e-pam

Brand Names:

  • Diazepam Intensol
  • Valium

Dosage Forms:

  • Tablet
  • Solution
  • Capsule, Extended Release

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 infants below 6 months of age. 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 in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving diazepam.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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 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.

  • Alfentanil
  • Amobarbital
  • Anileridine
  • Aprobarbital
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlorzoxazone
  • Cobicistat
  • Codeine
  • Dantrolene
  • Eslicarbazepine Acetate
  • Ethchlorvynol
  • Etravirine
  • Fentanyl
  • Fosphenytoin
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Itraconazole
  • Ketorolac
  • Levorphanol
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Orlistat
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Propoxyphene
  • Remifentanil
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Suvorexant
  • Tapentadol
  • Thiopental
  • Zolpidem

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
  • Disulfiram
  • Erythromycin
  • Fluvoxamine
  • Ginkgo
  • Isoniazid
  • Perampanel
  • 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 abuse, or history of, or
  • Drug abuse or dependence, or history of—Dependence on diazepam may develop.
  • Breathing problems or lung disease, 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.
  • Depression, or history of—Use with caution. May make this condition worse.
  • 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.

To use the oral solution:

  • Measure the oral liquid with the medicine dropper 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 form (tablets or solution):
    • For anxiety:
      • Adults—2 to 10 milligrams (mg) two to four times per day.
      • Older adults—At first, 2 to 2.5 milligrams (mg) once or twice per day. Your doctor may gradually increase the dose if needed.
      • Children 6 months of age and older—At first, 1 to 2.5 milligrams (mg) three or four times per day. Your child's doctor may increase the dose if needed.
      • Infants below 6 months of age—Use and dose must be determined by your doctor.
    • For alcohol withdrawal:
      • Adults—10 milligrams (mg) three or four times for the first 24 hours, then 5 mg three to four times per day as needed.
      • Older adults—At first, 2 to 2.5 milligrams (mg) once or twice per day. Your doctor may gradually increase the dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For muscle spasm:
      • Adults—2 to 10 milligrams (mg) three or four times per day.
      • Older adults—At first, 2 to 2.5 milligrams (mg) once or twice per day. Your doctor may gradually increase the dose if needed.
      • Children 6 months of age and older—At first, 1 to 2.5 milligrams (mg) three or four times per day. Your child's doctor may increase the dose if needed.
      • Infants below 6 months of age—Use and dose must be determined by your doctor.
    • For seizures:
      • Adults—2 to 10 milligrams (mg) two to four times per day.
      • Older adults—At first, 2 to 2.5 milligrams (mg) once or twice per day. Your doctor may gradually increase the dose if needed.
      • Children 6 months of age and older—At first, 1 to 2.5 milligrams (mg) three or four times per day. Your child's doctor may increase the dose if needed.
      • Infants below 6 months of age—Use and dose must be determined by your doctor.

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.

Destroy any medicine that you do not need by flushing it down the toilet.

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.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. 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. 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.

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 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, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

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
Abdominal or stomach pain
agitation
anxiety
black, tarry stools
blistering, flaking, or peeling of skin
blurred vision
changes in patterns and rhythms of speech
chills
confusion
cough
dark urine
decrease in frequency of urination
decrease in urine volume
difficulty in passing urine (dribbling)
discouragement
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
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
lack of appetite
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
mood or other mental changes
nausea
nervousness
nightmares
outbursts of anger
painful or difficult urination
pale skin
rash
restlessness
seizures
shakiness in the legs, arms, hands, or feet
shortness of breath
sleeplessness
slurred speech
sore throat
sweating
trembling or shaking of the hands or feet
tremor
trouble concentrating
trouble in speaking
trouble sleeping
ulcers, sores, or white spots in the mouth
unable to sleep
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
Change in consciousness
difficult or troubled breathing
irregular, fast or slow, or shallow breathing
lack of coordination
loss of consciousness
loss of strength or energy
muscle pain or weakness
pale or blue lips, fingernails, or skin
sleepiness
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 in 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 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.


Last Updated: 11/4/2014

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