Diazepam Intensol (Oral)

Diazepam is used to ease symptoms of anxiety and alcohol withdrawal. This medicine may also be used to treat some seizure disorders and to help relax muscles or relieve muscle spasms. Diazepam is a benzodiazepine. Benzodiazepines are part of a group of medicines known as central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check how you or your child are doing at regular visits to see if the medicine is working well. Blood tests may be needed to look for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during late pregnancy may cause problems for your newborn baby (for example, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an unusual 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 some people, especially older individuals, to feel drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than usual. It may also cause double vision or other vision issues. 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 increase the effects of alcohol and other central nervous system (CNS) depressants. Some examples of CNS depressants include antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicines, prescription pain medicines 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 experience any unusual or strange thoughts and behaviors while taking diazepam, be sure to talk to your doctor. Some changes that have happened in people taking this medicine can be similar to those seen in people who drink too much alcohol. Other changes might include 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 first checking with your doctor. Your doctor may want you or your child to slowly reduce the amount you are using before stopping it completely. This may help prevent your condition from getting worse and reduce the chance 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 walking, unsteadiness, trembling, or other problems with muscle control or coordination, sweating, trouble breathing, unusual drowsiness, dullness, tiredness, weakness or feeling sluggish, or an unusual weak feeling. Call your doctor right away if you notice these symptoms.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for instructions.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, it's important to weigh the risks against the benefits. This is a choice you and your doctor will make together. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or other medicines. Also, inform your healthcare professional about any other allergies you may have, like those to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how diazepam affects children younger than 6 months old. Its safety and effectiveness are not known. Using diazepam is not recommended for children younger than 6 months.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of diazepam. However, older patients may be more likely to experience side effects (like severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and age-related kidney issues, which might require caution and a dose adjustment for those taking diazepam.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you're taking this medicine, it's especially important for your healthcare professional to know if you're taking any of the medicines listed below. The following interactions are significant 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 necessary in some cases. If both medicines are prescribed, your doctor may change the dose or frequency of 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 increase the 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken while eating or around the time of certain foods, as interactions may happen. Combining alcohol or tobacco with some medicines may also lead to interactions. The following interactions are significant and are not necessarily all-inclusive.

Using this medicine with any of the following may increase the 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 provide special instructions about food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Other medical conditions may affect how this medicine works. Be sure to tell your doctor if you have any other medical problems, especially:

• Alcohol or drug abuse 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 worsen these conditions.

• Severe breathing problems
• Narrow-angle glaucoma
• Severe liver disease
• Myasthenia gravis
• Sleep apnea (temporary stopping of breathing during sleep)—Should not be used in these conditions.

• Kidney disease or
• Mild or moderate liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

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
• 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
• 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 right away if any of the following symptoms of overdose happen:

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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also 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, 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.

In the U.S.

• Diazepam Intensol
• Valium

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Long Acting

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. 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 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.

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