Diazepam Intensol

Overdose of benzodiazepines is usually manifested by central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, confusion and lethargy. In more serious cases, symptoms may include ataxia, diminished reflexes, hypotonia, hypotension, respiratory depression, coma (rarely), and death (very rarely). Overdose of benzodiazepines in combination with other CNS depressants (including alcohol) may be fatal and should be closely monitored.

Management Of Overdosage

Following overdose with oral benzodiazepines, general supportive measures should be employed including the monitoring of respiration, pulse and blood pressure. Vomiting should be induced (within 1 hour) if the patient is conscious. Gastric lavage should be undertaken with the airway protected if the patient is unconscious. Intravenous fluids should be administered. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiac function in intensive care. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Should hypotension develop, treatment may include intravenous fluid therapy, repositioning, judicious use of vasopressors appropriate to the clinical situation, if indicated, and other appropriate countermeasures. Dialysis is of limited value.

As with the management of intentional overdosage with any drug, it should be considered that multiple agents may have been ingested.

Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. Caution should be observed in the use of flumazenil in epileptic patients treated with benzodiazepines. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see Drug Abuse And Dependence section).

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.

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.

This section provides information on the proper use of a number of products that contain diazepam. It may not be specific to Diazepam Intensol. Please read with care.

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.

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

For all patients taking this medicine:

• If you have an allergy to diazepam or any other part of Diazepam Intensol.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Breathing problems, glaucoma, liver disease, myasthenia gravis, or sleep apnea.
• If you have psychosis.
• If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.
• If you are breast-feeding. Do not breast-feed while you take this medicine. You may also need to avoid breast-feeding for some time after your last dose. Talk with your doctor to see if you need to avoid breast-feeding after your last dose.

Children:

• If your child is younger than 6 months of age. Do not give Diazepam Intensol to an infant younger than 6 months of age.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Diazepam Intensol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Diazepam Intensol affects you.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you are 65 or older, use Diazepam Intensol with care. You could have more side effects.
• This medicine may be habit-forming with long-term use.
• Do not change the dose or stop this medicine. This could cause seizures. Talk with your doctor.
• If you have been taking Diazepam Intensol on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this medicine all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• Have your blood work checked if you are on Diazepam Intensol (diazepam oral concentrate) for a long time. Talk with your doctor.
• Use with care in children. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Throw away any part not used after 3 months.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Common side effects of Diazepam Intensol include: hypotonia. See below for a comprehensive list of adverse effects.

Applies to diazepam: oral capsule extended release, oral solution, oral tablet

Other dosage forms:

• injection emulsion, injection solution
• rectal gel/jelly, rectal kit

Along with its needed effects, diazepam (the active ingredient contained in Diazepam Intensol) 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 while taking diazepam:

• Shakiness and unsteady walk
• unsteadiness, trembling, or other problems with muscle control or coordination

• Abdominal or stomach pain
• 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
• 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 while taking diazepam:

• 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 of diazepam 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:

• 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

Applies to diazepam: injectable solution, intravenous suspension, oral capsule extended release, oral concentrate, oral solution, oral tablet, rectal kit

General

The most commonly reported side effects include sedation/drowsiness, ataxia, and muscle weakness.[Ref]

Nervous system

Very common (10% or more): Drowsiness/somnolence (up to 23%)
Common (1% to 10%): Anterograde amnesia/amnesia, ataxia, nervousness, unsteadiness, incoordination, impaired motor ability, hyperkinesia, tremor, epileptic attacks, sedation, headache, dizziness, slurred speech, hangover effect, decreased/reduced alertness, disrupted sensory perception
Uncommon (0.1% to 1%): Concentration difficulties, balance disorder
Rare (0.01% to 0.1%): Memory loss, dysarthria, syncope, unconsciousness, nystagmus, convulsions/grand mal convulsions, vertigo, lightheadedness, dystonia/dystonic effects, extrapyramidal effects, abnormal taste, hypersensitivity to physical, visual, and auditory stimuli
Frequency not reported: Oversedation, dementia, lethargy, minor EEG pattern changes
Postmarketing reports: Speech disorder[Ref]

Drowsiness, headache, dizziness, ataxia, and reduced alertness occurred at the start of treatment, but usually disappeared with continued use.

Anterograde amnesia is a dose-related side effect that may occur at therapeutic doses.

Tremor, disrupted sensory perception, and epileptic attacks occurred in patients with withdrawal symptoms.

Drowsiness, sedation, unsteadiness, and ataxia are dose-related and may persist into the following day, even with single doses.

Prolonged use of treatment in elderly patients may result in dementia.[Ref]

Psychiatric

Common (1% to 10%): Confusion, withdrawal symptoms, euphoria, increased anxiety/anxiety, panic, irritability, delirium, aggressiveness/aggression, numbed emotions, instability, restlessness, agitation, inappropriate behavior, delusions, rage, hallucinations, nightmares, confusional or paranoid psychosis/psychoses
Rare (0.01% to 0.1%): Excitation, insomnia, hostility, disinhibition, emotional poverty, other adverse behavioral effects, delirium tremens-like state, broken sleep with vivid dreams, increased REM sleep, increased or decreased libido
Frequency not reported: Drug abuse, unmasking of depression, inhibited female orgasm, acute hyperexcited states, stimulation, hypoactivity, physical and psychic dependence
Postmarketing reports: Emotional lability, abnormal thinking[Ref]

Confusion and numbed emotions occurred at the start of treatment, but usually disappeared with continued use. Confusion has occurred in elderly patients who received high doses.

Inappropriate behavior may occur with anterograde amnesia.

Psychic and physical dependence occurred with chronic use at therapeutic doses; withdrawal symptoms may occur in patients with dependence when treatment is discontinued.

Anxiety, panic, irritability, aggressiveness/aggression, paranoid psychosis, and delirium occurred in patients with withdrawal symptoms.

Restlessness, agitation, irritability, aggressiveness/aggression, rage, delusions, nightmares, psychoses, hallucinations, and inappropriate behavior occurred in patients with paradoxical reactions, especially in elderly and pediatric patients.

Increased REM sleep and broken sleep with vivid dreams may persist for weeks after treatment is discontinued.[Ref]

Other

Common (1% to 10%): Fatigue, general malaise, paradoxical reactions, asthenia
Frequency not reported: Falls, rebound effect, tinnitus, pain, infection[Ref]

Fatigue occurred at the start of treatment, but usually disappeared with continued use.

Elderly patients have an increased risk of falling.

Patients with physical/psychic dependence may experience rebound effects during discontinuation.

General malaise occurred in patients with withdrawal symptoms.

Pain occurred with injection formulations.[Ref]

Gastrointestinal

Increased salivation has been reported, especially in pediatric patients.

Gastrointestinal disorders occurred in patients with withdrawal symptoms.[Ref]

Common (1% to 10%): Gastrointestinal disorders/disturbances, abdominal pain, diarrhea
Uncommon (0.1% to 1%): Nausea, vomiting, constipation, dry mouth, increased salivary secretion/hypersalivation
Rare (0.01% to 0.1%): Obstipation, epigastric pain, abdominal cramps[Ref]

Dermatologic

Sweating occurred in patients with withdrawal symptoms.[Ref]

Common (1% to 10%): Sweating, rash
Uncommon (0.1% to 1%): Itching/pruritus, erythema
Very rare (less than 0.01%): Urticaria
Frequency not reported: Steven-Johnson syndrome, skin reactions[Ref]

Cardiovascular

Palpitations occurred in patients with withdrawal symptoms.

Thrombophlebitis and venous thrombosis have occurred with injection formulations.

Ischemia occurred with inadvertent intra-arterial administration.[Ref]

Common (1% to 10%): Palpitations, vasodilation
Uncommon (0.1% to 1%): Hypotension
Rare (0.01% to 0.1%): Bradycardia, mild systolic hypertension, tachycardia, orthostatic hypotension, chest pain, heart failure and cardiac arrest
Frequency not reported: Thrombophlebitis, venous thrombosis, ischemia, cardiovascular collapse[Ref]

Respiratory

Increased bronchial secretions were reported, especially in pediatric patients.

Respiratory depression and apnea occurred, especially with high doses.

Coughing, respiratory depression, dyspnea, hyperventilation, laryngospasm, and throat/chest pain have been reported in patients undergoing peroral endoscopic procedures.[Ref]

Common (1% to 10%): Asthma, rhinitis
Uncommon (0.1% to 1%): Respiratory depression
Rare (0.01% to 0.1%): Respiratory arrest, increased bronchial secretion, laryngeal spasm/laryngospasm, apnea
Frequency not reported: Hypoventilation, increased cough, hiccups, dyspnea, hyperventilation, throat and chest pain[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms/increased muscle spasticity, muscle weakness
Uncommon (0.1% to 1%): Myasthenia
Rare (0.01% to 0.1%): Muscle twitching
Frequency not reported: Fractures, tissue necrosis, muscle aches and cramps[Ref]

Muscle weakness occurred at the start of treatment, but usually disappeared with continued use.

Elderly patients and/or those taking sedatives/alcohol concomitantly have an increased risk of fractures associated with falls.

Muscle spasms occurred in patients with withdrawal symptoms.

Tissue necrosis occurred with inadvertent intra-arterial administration.[Ref]

Ocular

Common (1% to 10%): Double vision/diplopia
Rare (0.01% to 0.1%): Blurred vision, other visual disturbances/reversible disorders of vision
Frequency not reported: Mydriasis[Ref]

Double vision occurred at the start of treatment, but usually disappeared with continued use.[Ref]

Metabolic

Common (1% to 10%): Appetite loss
Rare (0.01% to 0.1%): Increased appetite
Frequency not reported: Anorexia[Ref]

Appetite loss occurred in patients with withdrawal symptoms.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention, incontinence
Rare (0.01% to 0.1%): Impotence, menstrual changes
Frequency not reported: Galactorrhea, urinary tract infection[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic skin reactions
Very rare (less than 0.01%): Anaphylaxis
Frequency not reported: Angioedema[Ref]

Hepatic

Rare (0.01% to 0.1%): Jaundice, cholestatic/hepatocellular jaundice, cholestasis, changes of hepatic parameters/increased ALT, AST, and alkaline phosphatase[Ref]

Hematologic

Rare (0.01% to 0.1%): Blood dyscrasias, thrombocytopenia
Very rare (less than 0.01%): Leukopenia, neutropenia
Frequency not reported: Agranulocytosis, lymphadenopathy, anemia[Ref]

Endocrine

Rare (0.01% to 0.1%): Gynecomastia
Frequency not reported: Increased prolactin and testosterone levels[Ref]

Some side effects of Diazepam Intensol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.