Description
Diazepam rectal gel is used to control seizures (eg, seizure clusters, acute repetitive seizures) in patients who have epilepsy. 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:
- Gel/Jelly
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
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of diazepam rectal gel in children below 2 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazepam rectal gel in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness), which may require caution and an adjustment in the dose for patients receiving diazepam rectal gel.
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 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
- 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 and drug abuse or dependence, or history of—Dependence on diazepam may develop.
- Glaucoma, acute narrow angle—Should not be used in patients with this condition.
- Glaucoma, open angle or
- Lung or breathing problems (eg, asthma, pneumonia)—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
Apply this medicine only as directed by your doctor. Do not apply more of it, do not apply it more often, and do not apply it for a longer time than your doctor ordered. Never take rectal medicine by mouth. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.
This medicine is not to be used every day. Do not use this medicine for more than 1 episode every 5 days or more than 5 episodes per month.
If a second dose is needed, use it at least 4 to 12 hours after the first dose..
This medicine will need to be given to you while you are having a seizure. A family member or other caregiver will give the medicine to you since you will most likely be unable to give it to yourself.
For caregivers administering this medicine:
- Discuss with the patient's medical doctor exactly when and how to use diazepam rectal gel.
- Discuss with the patient's medical doctor when you should call for emergency help.
- Read the instructions that you received with the medicine before you need to use it.
- Stay with the patient after administering diazepam rectal gel to check his or her condition as instructed by the doctor.
This medicine comes in a prefilled plastic applicator. Remove the cap from the prefilled applicator before inserting it. To make the applicator easier to insert, use the lubricating gel that came with the medicine.
Before using the Diastat® Acudial™ syringe, make sure you can see the prescribed dose in the dose display window and that it is correct. Also, look for the green "ready" band on the syringe before inserting it. If the dose is not correct, or if the green band is not on the syringe, call your doctor or pharmacist right away.
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 rectal dosage form (gel):
- For control of seizures:
- Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
- Adults and children 12 years of age and older—The dose is usually 0.2 milligram (mg) per kilogram (kg) body weight.
- Weighing 88 to 111 kilograms (kg)—20 milligrams (mg) once a day.
- Weighing 76 to 87 kg—17.5 mg once a day.
- Weighing 63 to 75 kg—15 mg once a day.
- Weighing 51 to 62 kg—12.5 mg once a day.
- Weighing 38 to 50 kg—10 mg once a day.
- Weighing 26 to 37 kg—7.5 mg once a day.
- Weighing 14 to 25 kg—5 mg once a day.
- Children 6 to 11 years of age—The dose is usually 0.3 milligram (mg) per kilogram (kg) body weight.
- Weighing 59 to 74 kilograms (kg)—20 milligrams (mg) once a day.
- Weighing 51 to 58 kg—17.5 mg once a day.
- Weighing 42 to 50 kg—15 mg once a day.
- Weighing 34 to 41 kg—12.5 mg once a day.
- Weighing 26 to 33 kg—10 mg once a day.
- Weighing 17 to 25 kg—7.5 mg once a day.
- Weighing 10 to 16 kg—5 mg once a day.
- Children 2 to 5 years of age—The dose is usually 0.5 milligram (mg) per kilogram (kg) body weight.
- Weighing 36 to 44 kilograms (kg)—20 milligrams (mg) once a day.
- Weighing 31 to 35 kg—17.5 mg once a day.
- Weighing 26 to 30 kg—15 mg once a day.
- Weighing 21 to 25 kg—12.5 mg once a day.
- Weighing 16 to 20 kg—10 mg once a day.
- Weighing 11 to 15 kg—7.5 mg once a day.
- Weighing 6 to 10 kg—5 mg once a day.
- Adults and children 12 years of age and older—The dose is usually 0.2 milligram (mg) per kilogram (kg) body weight.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
- For control of seizures:
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 your progress at regular visits to make sure this medicine is working properly and to check for 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 will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other 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 stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.
Do not change your dose or 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 seizures and reduce the possibility of withdrawal symptoms, including hallucinations, stomach or muscle cramps, sweating, tremors, or unusual behavior.
Symptoms of an overdose include: change or loss of consciousness, confusion, lack of coordination, or sleepiness or unusual drowsiness. Call your doctor right away if you notice these symptoms.
This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to diazepam 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.
Call your doctor right away:
- If your seizures still continue after using this medicine.
- If your seizures are different from your previous episodes.
- If you are alarmed by the number or severity of your seizure episodes.
- If you are alarmed by the color or breathing of the patient.
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:
Less common
- Anxiety
- blurred vision
- changes in patterns and rhythms of speech
- chest tightness
- confusion
- cough
- crying
- delusions
- dementia
- depersonalization
- difficulty breathing
- difficulty in speaking
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- dysphoria
- false or unusual sense of well-being
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- headache
- irregular heartbeat
- irritability
- lack of coordination
- mental depression
- mood or mental changes
- nervousness
- noisy breathing
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods
- restlessness
- seizures
- shakiness and unsteady walk
- slurred speech
- sweating
- trouble breathing
- trouble in speaking
- trouble sleeping
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual tiredness or weakness
Rare
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- fever or chills
- frequent urge to urinate
- increase in body movements
- lower back or side pain
- painful or difficult urination
- pale skin
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- unusual bleeding or bruising
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation
- change or loss of consciousness
- changes in patterns and rhythms of speech
- confusion
- excitement
- irritability
- loss of strength or energy
- muscle pain or weakness
- restlessness
- shakiness and unsteady walk
- sleepiness or unusual drowsiness
- 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
- Diarrhea
- feeling of constant movement of self or surroundings
- hiccups
- lack or loss of strength
- rash
- runny or stuffy nose
- sensation of spinning
- sneezing
Rare
- Bigger, dilated, or enlarged pupils (black part of eye)
- increased sensitivity of the eyes to light
- itching skin
- loss of appetite
- vomiting
- weight loss
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.
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