Wednesday, July 19, 2023

diazepam (dye-az-e-pam) Diastat, Valium

 Indications

Adjunct in the management of: Anxiety Disorder, Athetosis,

Anxiety relief prior to cardioversion (injection),

Stiffman Syndrome, Preoperative sedation, Conscious

sedation (provides light anesthesia and anterograde

amnesia). Treatment of status epilepticus/uncontrolled

seizures (injection). Skeletal muscle relaxant. Management

of the symptoms of alcohol withdrawal. Unlabeled

Use: Anxiety associated with acute myocardial

infarction, insomnia.

Action

Depresses the CNS, probably by potentiating GABA, an

inhibitory neurotransmitter. Produces skeletal muscle

relaxation by inhibiting spinal polysynaptic afferent

pathways. Has anticonvulsant properties due to enhanced

presynaptic inhibition. Therapeutic Effects:

Relief of anxiety. Sedation. Amnesia. Skeletal

muscle relaxation. Decreased seizure activity.

Pharmacokinetics

Absorption: Rapidly absorbed from the GI tract. Absorption

from IM sites may be slow and unpredictable.

Well absorbed (90%) from rectal mucosa.

Distribution: Widely distributed. Crosses the bloodbrain

barrier. Crosses the placenta; enters breast milk.

Metabolism and Excretion: Highly metabolized

by the hepatic P450 enzymes (CYP2C19 and CYP3A4);

the CYP2C19 enzyme system exhibits genetic polymorphism;

15–20% of Asian patients and 3–5% of Caucasian

and Black patients may be poor metabolizers

and may have significantlyqdiazepam concentrations

and anqrisk of adverse effects. Some products of metabolism

are active as CNS depressants.

Half-life: Neonates: 50–95 hr; Infants 1 mo–2 yr:

40–50 hr; Children 2–12 yr: 15–21 hr; Children 12–

16 yr: 18–20 hr; Adults: 20–50 hr (up to 100 hr for

metabolites).

TIME/ACTION PROFILE (sedation)

ROUTE ONSET PEAK DURATION

PO 30–60 min 1–2 hr up to 24 hr

IM within 20 min 0.5–1.5 hr unknown

IV 1–5 min 15–30 min 15–60 min†

Rectal 2–10 min 1–2 hr 4–12 hr

†In status epilepticus, anticonvulsant duration is 15–20

min.

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Cross-sensitivity

with other benzodiazepines may occur; Comatose

patients; Myasthenia gravis; Severe pulmonary impairment;

Sleep apnea; Severe hepatic dysfunction; Pre-existing

CNS depression; Uncontrolled severe pain; Angleclosure

glaucoma; Some products contain alcohol,

propylene glycol, or tartrazine and should be avoided

in patients with known hypersensitivity or intolerance;

OB:qrisk of congenital malformations; Pedi: Children

6 mo (for oral; safety not established); Lactation:

Recommend to discontinue drug or bottle-feed.

Use Cautiously in: Severe renal impairment; History

of suicide attempt or drug dependence; Debilitated

patients (doseprequired); Patients with low albumin;

Pedi: Metabolites can accumulate in neonates. Injection

contains benzyl alcohol which can cause potentially fatal

gasping syndrome in neonates; Geri: Long-acting

benzodiazepines cause prolonged sedation in the elderly.

Appears on Beers list and is associated withq

risk of falls (pdose required or consider short-acting

benzodiazepine).

Adverse Reactions/Side Effects

CNS: dizziness, drowsiness, lethargy, depression,

hangover, ataxia, slurred speech, headache, paradoxical

excitation. EENT: blurred vision. Resp: RESPIRATORY

DEPRESSION. CV: hypotension (IV only). GI: constipation,

diarrhea (may be caused by propylene glycol

content in oral solution), nausea, vomiting, weight gain.

Derm: rashes. Local: pain (IM), phlebitis (IV), venous thrombosis. Misc: physical dependence, psychological

dependence, tolerance.

Interactions

Drug-Drug: Use with opioids or other CNS depressants,

including other benzodiazepines, nonbenzodiazepine

sedative/hypnotics, anxiolytics,

general anesthetics, muscle relaxants, antipsychotics,

and alcohol may cause profound sedation,

respiratory depression, coma, and death; reserve concurrent

use for when alternative treatment options are

inadequate. Cimetidine, hormonal contraceptives,

disulfiram, fluoxetine, isoniazid, ketoconazole,

metoprolol, propranolol, or valproic acid mayp

the metabolism of diazepam, enhancing its actions. May

pthe efficacy of levodopa. Rifampin or barbiturates

mayqthe metabolism andpeffectiveness of diazepam.

Sedative effects may bepby theophylline. Concurrent

use of ritonavir is not recommended.

Drug-Natural Products: Concomitant use of

kava-kava, valerian, or chamomile canqCNS depression.

Route/Dosage

Antianxiety

PO (Adults): 2–10 mg 2–4 times daily.

IM, IV (Adults): 2–10 mg, may repeat in 3–4 hr as

needed.

PO (Children 6 mo): 1–2.5 mg 3–4 times daily.

IM, IV (Children 1mo): 0.04–0.3 mg/kg/dose q

2–4 hr to a maximum of 0.6 mg/kg within an 8 hr period

if necessary.

Precardioversion

IV (Adults): 5–15 mg 5–10 min precardioversion.

Pre-endoscopy

IV (Adults): 2.5–20 mg.

IM (Adults): 5–10 mg 30 min pre-endoscopy.

Pediatric Conscious Sedation for Procedures

PO (Children 6 mo): 0.2–0.3 mg/kg (not to exceed

10 mg/dose) 45–60 min prior to procedure.

Status Epilepticus/Acute Seizure Activity

IV (Adults): 5–10 mg, may repeat q 10–15 min to a

total of 30 mg, may repeat regimen again in 2–4 hr

(IM route may be used if IV route unavailable); larger

doses may be required.

IM, IV (Children 5 yr): 0.05–0.3 mg/kg/dose given

over 3–5 min q 15–30 min to a total dose of 10 mg,

repeat q 2–4 hr.

IM, IV (Children 1 mo–5 yr ): 0.05–0.3 mg/kg/

dose given over 3–5 min q 15–30 min to maximum

dose of 5 mg, repeat in 2–4 hr if needed.

IV (Neonates): 0.1–0.3 mg/kg/dose given over 3–5

min q 15–30 min to maximum dose of 2 mg.

Rect (Adults and Children 12 yr): 0.2 mg/kg; may

repeat 4–12 hr later.

Rect (Children 6–11 yr): 0.3 mg/kg; may repeat 4–

12 hr later.

Rect (Children 2–5 yr): 0.5 mg/kg; may repeat 4–

12 hr later.

Febrile Seizure Prophylaxis

PO (Children 1 mo): 1 mg/kg/day divided q 8 hr at

first sign of fever and continue for 24 hr after fever is

gone.

Skeletal Muscle Relaxation

PO (Adults): 2–10 mg 3–4 times daily.

PO (Geriatric Patients or Debilitated Patients):

2–2.5 mg 1–2 times daily initially.

PO (Children 6 mo): 1–2.5 mg 3–4 times daily.

IM, IV (Adults): 5–10 mg; may repeat in 2–4 hr

(larger doses may be required for tetanus).

IM, IV (Geriatric Patients or Debilitated Patients):

2–5 mg; may repeat in 2–4 hr (larger doses

may be required for tetanus).

IM, IV (Children 5 yr): Tetanus—5–10 mg q 3–

4 hr.

IM, IV (Children 1mo): Tetanus—1–2 mg q 3–

4 hr.

Alcohol Withdrawal

PO (Adults): 10 mg 3–4 times in first 24 hr,pto 5

mg 3–4 times daily.

IM, IV (Adults): 10 mg initially, then 5–10 mg in 3–

4 hr as needed; larger or more frequent doses have

been used.

Psychoneurotic Reactions

IM, IV (Adults): 2–10 mg, may be repeated in 3–4

hr.

Availability (generic available)

Tablets: 2 mg, 5 mg, 10 mg. Cost: Generic—2 mg

$7.51/100, 5 mg $10.74/100, 10 mg $10.84/100. Oral

solution: 1 mg/mL, 5 mg/mL (Intensol). Cost: Generic—

1 mg/mL $2.44/5 mL, 5 mg/mL $33.98/30 mL.

Injection: 5 mg/mL (contains 10% alcohol and 40%

propylene glycol). Rectal gel delivery system: 2.5

mg, 10 mg, 20 mg.

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