Description and Brand Names

Información sobre medicamentos proporcionada por: IBM Micromedex

US Brand Name

  1. Diazepam Intensol
  2. Valium

Descriptions


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.

This product is available in the following dosage forms:

  • Tablet
  • Solution

Before Using

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.

Pediatric

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 tablets is not recommended in children up to 6 months of age.

Geriatric

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.

Pregnancy

Information about this diazepam-oral-route
Pregnancy Category Explanation
All Trimesters D Studies 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.

Breastfeeding

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.

Drug Interactions

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.

  • Alfentanil
  • Amobarbital
  • Benzhydrocodone
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Calcifediol
  • Cannabidiol
  • Carbinoxamine
  • Carisoprodol
  • Cetirizine
  • Chloral Hydrate
  • Chlorzoxazone
  • Clobazam
  • Cobicistat
  • Codeine
  • Conivaptan
  • Dantrolene
  • Dihydrocodeine
  • Doxylamine
  • Esketamine
  • Eslicarbazepine Acetate
  • Ethchlorvynol
  • Etravirine
  • Fentanyl
  • Flibanserin
  • Fosnetupitant
  • Fosphenytoin
  • Fospropofol
  • Gabapentin
  • Gabapentin Enacarbil
  • Hydrocodone
  • Hydromorphone
  • Lemborexant
  • Levorphanol
  • Lofexidine
  • Loxapine
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Metoclopramide
  • Midazolam
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Netupitant
  • Orlistat
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Pentobarbital
  • Periciazine
  • Phenobarbital
  • Phenytoin
  • Pregabalin
  • Primidone
  • Propofol
  • Scopolamine
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Thiopental
  • Tramadol
  • Trazodone
  • 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
  • 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
  • Depression, or history of or
  • Drug abuse or dependence, 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

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.

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 the 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 the 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 the 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

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

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

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

  1. Shakiness and unsteady walk
  2. unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

  1. Abdominal or stomach pain
  2. agitation
  3. black, tarry stools
  4. blistering, flaking, or peeling of the skin
  5. blurred vision
  6. changes in patterns and rhythms of speech
  7. chills
  8. confusion
  9. cough
  10. dark urine
  11. decrease in the frequency of urination
  12. decrease in urine volume
  13. difficulty in passing urine (dribbling)
  14. discouragement
  15. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  16. false beliefs that cannot be changed by facts
  17. fast heartbeat
  18. fast or irregular breathing
  19. feeling sad or empty
  20. feeling that others are watching you or controlling your behavior
  21. feeling that others can hear your thoughts
  22. feeling, seeing, or hearing things that are not there
  23. fever
  24. headache
  25. hyperexcitability
  26. increased muscle spasms or tone
  27. irritability
  28. itching or rash
  29. lack of memory of what takes place after a certain event
  30. loss of appetite
  31. loss of bladder control
  32. loss of interest or pleasure
  33. lower back or side pain
  34. nausea
  35. nightmares
  36. outbursts of anger
  37. painful or difficult urination
  38. pale skin
  39. restlessness
  40. seizures
  41. slurred speech
  42. sore throat
  43. sweating
  44. trouble concentrating
  45. trouble sleeping
  46. trouble speaking
  47. ulcers, sores, or white spots in the mouth
  48. unpleasant breath odor
  49. unusual behavior
  50. unusual bleeding or bruising
  51. unusual feeling of excitement
  52. unusual tiredness or weakness
  53. vomiting of blood
  54. yellow eyes or skin

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

Symptoms of overdose

  1. Change in consciousness
  2. difficult or troubled breathing
  3. irregular, fast or slow, or shallow breathing
  4. lack of coordination
  5. loss of consciousness
  6. loss of strength or energy
  7. muscle pain or weakness
  8. pale or blue lips, fingernails, or skin
  9. sleepiness
  10. 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

  1. Constipation
  2. decreased interest in sexual intercourse
  3. diarrhea
  4. difficulty with swallowing
  5. double vision
  6. dry mouth
  7. feeling of constant movement of self or surroundings
  8. inability to have or keep an erection
  9. increase in sexual ability, desire, drive, or performance
  10. increased interest in sexual intercourse
  11. increased watering of the mouth
  12. indigestion
  13. loss of sexual ability, desire, drive, or performance
  14. passing of gas
  15. seeing double
  16. 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.