Diazepam

Diazepamis used to treat episodes of increased seizures (such as cluster or breakthrough seizures) in people who are already taking medications to control their seizures. This product is only recommended for short-term treatment ofseizureattacks. It is not for ongoing daily use to prevent seizures. Uncontrolled seizures can turn into serious (possibly fatal) seizures that do not stop (status epilepticus).

Diazepam is not recommended for children younger than 6 months of age because of the risk of serious side effects.

Diazepam works by calming the brain and nerves. It belongs to a class of drugs known asbenzodiazepines.

Diazepam is available under the following different brand names:Valium, Diastat, andDiastat AcuDial.

Dosages of Diazepam

Adult and Pediatric Dosage Forms and Strengths

Tablet: Schedule IV

• 2 mg
• 5 mg
• 10 mg

Oral solution: Schedule IV

• 1mg/1mL
• 5mg/mL

Rectalgel: Schedule IV

• 2.5 mg
• 10 mg
• 20 mg

Injectable solution: Schedule IV

• 5mg/mL

Intramusculardevice: Schedule IV

• 5mg/mL

Dosage Considerations – Should be Given as Follows: Anxiety

• 2-10 mg orally every 6-12 hours, OR 2-10 mg intravenously/intramuscularly (IV/IM) every 6-12 hours; no more than 30 mg/8 hours

Alcohol Withdrawal

• 10 mg orally every 6-8 hours during first 24 hours; reduce to 5 mg orally every 6-8 hours as needed
• Initial: 10 mg intravenously/intramuscularly (IV/IM), may give additional doses of 5-10 mg IV every 6-8 hours as needed

Endoscopy

• Intravenously (IV): Titrate dose to 10 mg or less immediately before procedure, not to exceed the cumulative dose of 20 mg; reduce the dose ofnarcoticby one third or omit, OR
• Intramuscularly (IM): 5-10 mg 30 minutes before the procedure

Preoperative Sedation

• 10 mg intramuscularly (IM) before surgery

• 5-10 mg intravenously (IV) 1-2 hours before surgery; 0.03-0.1 mg/kg every 30 minutes to 6 hours

Sedative/Muscle Relaxant, Pediatric

• The potentially toxic dose in patients under 6 years: greater than 0.5 mg/kg

Children under 6 months

• Not recommended

Children over 12 years

• 0.12-0.8 mg/kg/day orally divided every 6-8 hours, OR
• 0.04-0.2 mg/kg IV/IM every 2-4 hours; no more than 0.6 mg/kg within 8 hours

Muscle Spasm

• 2-10 mg orally every 6-8 hours as needed, OR 5-10 mg IV/IM initially; THEN every 3-4 hours if necessary

Seizure Disorder

• 2-10 mg orally every 6-12 hours as an adjunct, OR
• 0.2 mg/kg rectally, repeat after 4-12 hours as needed

Status Epilepticus

• Adult: 5-10 mg IV/IM every 5-10 minutes; not to exceed 30 mg, OR
• 0.5 mg/kg rectally (usingparenteralsolution), THEN 0.25 mg/kg in 10 minutes as needed
• Pediatric: Potentially toxic dose in patients under 6 years: greater than 0.5 mg/kg

Rectally

• 2-6 years: 0.5 mg/kg; may repeat in 4-12 hours as needed
• 6 - 12年:0.3毫克/公斤;可以重复在4 - 12小时吗needed
• Over 12 years: 0.2 mg/kg; may repeat in 4-12 hours as needed

Intravenously (IV)

• Children 6 months-5 years: 0.2-0.5 mg IV initially, repeat every 2-5 minutes; do not exceed 5 mg; may repeat 2-4 hours later as needed
• Children older than 5 years: 1 mg IV given slowly every 2-5 min; not to exceed 10 mg total dose; may repeat in 2-4 hours if necessary

Dosage Modifications

• Renal impairment: No dose adjustment recommended unless administered for a prolonged period; decrease dose in prolonged periods
• Hepatic impairment: 50% of the maintenance dose

Geriatric:

• Due to long-acting metabolite, not considered a drug of choice in the elderly; associated with falls
• 2-2.5 mg orally once/day or every 12 hours initially; increase gradually as needed

Rectal gel:

• Use a lower dose

Side effects of diazepam include:

• Loss of control of bodily movements
• Euphoria(rectal gel)
• Incoordination (rectal gel)
• Drowsiness
• Rash (rectal gel)
• Diarrhea (rectal gel)
• Low blood pressure(hypotension)
• Fatigue
• Muscle weakness
• Respiratory depression
• Urinary retention
• Depression
• Incontinence
• Blurred vision
• Difficulty speaking
• Headache
• Skin rash
• Changes in salivation

Serious side effects of diazepam include:

• Lowwhite blood cell count(neutropenia)
• Yellow skin or eyes (jaundice)
• Local effects: Pain, swelling,blood clot, carpal tunnel syndrome, dead skin
• Phlebitisif too rapid IV push

Postmarketing side effects of diazepam reported include:

Injury,poisoning,程序并发症:跌倒和骨折s; increased risk in those taking concomitant sedatives (including alcoholic beverages) and in the elderly, suicide attempt, suicidal ideation.

If your doctor has directed you to use this medication fordiabetes, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe interactions of diazepam include:

• sodium oxybate

Serious Interactions of diazepam include:

• carbamazepine
• cimetidine
• clarithromycin
• darunavir
• erythromycinbase
• erythromycin ethylsuccinate
• erythromycin lactobionate
• erythromycin stearate
• hydrocodone
• idelalisib
• itraconazole
• ketoconazole
• nefazodone
• rifabutin
• rifampin
• st john's wort
• valerian

Diazepam has moderate interactions with at least 238 different drugs.

Diazepam has moderate interactions with at least 46 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

Risks from concomitant use with opioids

• Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death
• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate
• Limit dosages and durations to the minimum required
• Follow patients for signs and symptoms of respiratory depression and sedation
• Inform patients and caregivers that potentially fatal additive effects may occur if diazepam is used with opioids and that such drugs should not be used concomitantly unless supervised by a health care provider
• Prescribers are strongly advised to take all reasonable steps to ensure that caregivers fully understand their role and obligations vis a vis the administration ofdiazepam rectal gelto individuals in their care
• Prescribers should advise caregivers that they expect to be informed immediately if a patient develops any new findings which are not typical of the patient's characteristic seizure episode.

This medication contains diazepam. Do not take Valium, Diastat, or Diastat AcuDial if you are allergic to diazepam or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Documented hypersensitivity
• Acute alcohol intoxication
• Myasthenia gravis(allowable in limited circumstances)
• Acute narrow-angleglaucomaandopen-angle glaucomaunless patients receiving appropriate therapy
• Severe respiratory depression
• Intravenous (IV) use inshock, coma, depressedrespiration, patients who recently received other respiratory depressants
• Sleep apnea
• Children under 6 months

Effects of Drug Abuse

• Use with caution in patients with a history of drug abuse or acutealcoholism; tolerance, psychological, and physical dependence may occur with prolonged use (greater than 10 days).

Short-Term Effects

• Advise both patients and caregivers about risks of respiratory depression and sedation when diazepam is used with opioids; advise patients not to drive or operate heavy machinery until the effects of concomitant use with theopioidhave been determined.
• See "What Are Side Effects Associated with Using Diazepam?"

Long-Term Effects

• Administration for prolonged periods of time may lead to drug dependence and must be avoided.
• Heart muscledisease (cardiomyopathy) (isolated reports associated with chronic use)
• See "What Are Side Effects Associated with Using Diazepam?"

Cautions

• Concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory depression, coma, and death; reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate; reduceopiatedose one-third when diazepam is added.
• Advise both patients and caregivers about risks of respiratory depression and sedation when diazepam is used with opioids; advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined.
• Use caution inCOPD, sleepapnea, renal/hepatic disease, open-angle glaucoma (questionable), depression, suicide ideation, impaired gag reflex, history of drug abuse, orobesepatients (prolonged action when discontinued).
• The use of benzodiazepines, including diazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression.
• May impair the ability to perform hazardous tasks.
• Use with caution in patients with a history of drug abuse or acute alcoholism; tolerance, psychological, and physical dependence may occur with prolonged use (greater than 10 days).
• Anterogradeamnesiareported with benzodiazepine use.
• Avoid extravasation with intravenous (IV) dosing.
• Paradoxical reactions may occur including hallucinations, aggressive behavior, and psychoses; discontinue use if reactions occur.
• Abrupt withdrawal may result in a temporary increase in seizures.

Drug interaction overview:

• When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists; limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation
• If the rectal gel is to be combined with other psychotropic agents or other CNS depressants, careful consideration should be given to thepharmacologyempl的代理oyed particularly with known compounds that may potentiate the action of diazepams, such as phenothiazines, narcotics,barbiturates, MAO inhibitors, and otherantidepressants
• Valproate may potentiate the CNS-depressant effects of diazepam

Pregnancy and Lactation

• Use diazepam during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk. Minor tranquilizers should be avoided in the first trimester of pregnancy due to the increased risk ofcongenitalmalformations.
• Maternal use shortly before delivery is associated with floppy infant syndrome (good and consistent evidence).Prenatalbenzodiazepine exposure slightly increased oral cleft risk (limited or inconsistent evidence).
• Diazepam enters breast milk; it is not recommended for use while breastfeeding.