Description
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 buccal film is used as short-term treatment for seizure clusters (also known as acute repetitive seizures) in patients 2 to 5 years of age. 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 tablets and oral liquid 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.
Appropriate studies have not been performed on the relationship of age to the effects of diazepam buccal film in children younger than 2 years of age and older than 5 years of age. Safety and efficacy have not been established. Diazepam buccal film should not be used in newborns or infants.
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.
Use of diazepam buccal film is not recommended in the elderly.
Breastfeeding
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.
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
- Isocarboxazid
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
- Acepromazine
- Alfentanil
- Alprazolam
- Amobarbital
- Anileridine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Asenapine
- Avacopan
- Baclofen
- Benperidol
- Benzhydrocodone
- Bromazepam
- Bromopride
- Buprenorphine
- Buspirone
- Butabarbital
- Butalbital
- Butorphanol
- Calcifediol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbidopa
- Carbinoxamine
- Carisoprodol
- Carphenazine
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
- Chlorpromazine
- Chlorzoxazone
- Clarithromycin
- Clobazam
- Clonazepam
- Clorazepate
- Clozapine
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
- Levonorgestrel
- Mavacamten
- 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 is usually not recommended, 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.
- Ethanol
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 use disorder 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
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 and patient instructions. 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.
To use the buccal film:
- Family members, caregivers, and others should be taught on how to give this medicine in case a seizure cluster happens.
- Make sure your hands are clean and dry before handling this medicine so the film does not stick to your fingers.
- Open the pouch and remove the film. Fold the foil pouch along the solid line. Check where the vertical slit is and carefully tear down the side of the pouch at the slit along the arrow to open the pouch.
- Remove the medicine from the foil pouch. Stretch either cheek open with one hand and place one film flat against the cheek with your other hand. Do not rub the film into the cheek with your finger. Place the film directly onto the inside of the cheek. Do not place it on the teeth.
- Remove fingers from the cheek. If the film is spit out or blown out immediately, give another dose using a new film. Do not give this medicine with liquids.
- Allow the film to dissolve. Do not give another dose if the film is swallowed or chewed.
- The film will stick to the inside of the cheek and begin to dissolve. Saliva may be swallowed normally while the film dissolves.
- Take note of the time you first gave the dose and changes in the resting breath rate.
- Do not give a second dose if you are concerned about the child's breathing, an emergency rescue treatment with breathing help is needed, or there is more sleepiness than normal.
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.
- For anxiety:
- For buccal dosage form (film):
- For seizure clusters:
- Children 2 to 5 years of age—Dose is based on body weight and must be determined by your doctor. If a second dose is needed, it may be given at least 4 hours after the first dose. Do not use more than 2 doses to treat a single episode. Do not use this medicine for more than 1 episode every 5 days or more than 5 episodes per month.
- Weighing 26 kilograms (kg) to 30 kg—15 milligrams (mg) per episode.
- Weighing 21 kg to 25 kg—12.5 mg per episode.
- Weighing 16 kg to 20 kg—10 mg per episode.
- Weighing 11 kg to 15 kg—7.5 mg per episode.
- Weighing 6 kg to 10 kg—5 mg per episode.
- Children younger than 2 years of age or older than 5 years of age—Use and dose must be determined by your doctor.
- Children 2 to 5 years of age—Dose is based on body weight and must be determined by your doctor. If a second dose is needed, it may be given at least 4 hours after the first dose. Do not use more than 2 doses to treat a single episode. Do not use this medicine for more than 1 episode every 5 days or more than 5 episodes per month.
- For seizure clusters:
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.
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 respiratory depression, a serious breathing problem that can be life-threatening, when used together with opioid pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficult or trouble breathing, or irregular, fast or slow, or shallow breathing.
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. 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. 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 might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).
Do not change or 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, 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 contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Discuss this with your doctor if you are concerned.
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
- 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
- changes in vision
- 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
- loss of vision
- 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.
DRG-20072333
