Medication info

Samjin Diazepam Injection

Prescription medicationInjectionsIntramuscular injection · Intravenous injection
Ingredient · strength
Diazepam›5mg / 1mL
Manufacturer / importer
Samjin Pharmaceutical Co., Ltd.
Appearance
Brown ampoules containing a colorless or pale yellow liquid
Packaging
20 ampoules/box [2 mL/ampoule x 20]
Approval status
Active

MFDS item code 197900546 · Approved 1979.02.14 · Insurance code 647800761

Summary

Main use
Treatment of convulsions and epilepsy; relief of anxiety and alcohol withdrawal; relief of anxiety before anesthesia or examinations
Who receives it
Adults · Children
Adult administration
1. Anxiety and tension: For severe cases, inject 5-10㎎ of diazepam; for mild or moderate cases, inject 2-5㎎ intravenously or intramuscularly. The dose may be repeated after 3-4 hours if needed. However, do not administer more than 30㎎ within 8 hours. 2. Adjunct for relief of skeletal muscle spasms: Inject 5-10㎎ of this drug intravenously or intramuscularly. The dose may be repeated after 3-4 hours if needed. Higher doses may be required for tetanus. 3. Adjunctive treatment of convulsive seizures or status epilepticus: Administer an initial dose of 5-10㎎ of this drug intravenously, followed, if needed, by slow intravenous injections at 10-15-minute intervals, up to a maximum of 30㎎. Consider the active metabolites that may remain; use with extreme caution in patients with chronic pulmonary disease or unstable cardiovascular status. 4. Premedication for anesthesia: Inject 10㎎ of this drug intramuscularly before surgery. 5. Alcohol withdrawal symptoms: Administer an initial dose of 10㎎ of this drug intravenously or intramuscularly. If needed, repeat 5-10㎎ doses after 3-4 hours. 6. Endoscopy: Administer 10㎎ or less of this drug intravenously. The dose may be increased to 20㎎ if needed. If intravenous injection is not possible, inject 5-10㎎ slowly intramuscularly 30 minutes before the examination. 7. Cardioversion: Inject 5-15㎎ slowly intravenously 5-10 minutes beforehand.
Child administration
Anxiety and tension — Administer 0.04-0.2㎎/kg intravenously. The dose may be repeated every 2-4 hours if needed. However, do not administer more than 0.6㎎/kg within 8 hours. Infants aged 1 month or older and children under 5 years — Slowly administer 0.2-0.5㎎ intravenously at 2-5-minute intervals, up to a maximum of 5㎎. The dose may be repeated every 2-4 hours if needed. Children aged 5 years and older — Slowly administer 1㎎ intravenously at 2-5-minute intervals until a maximum dose of 10㎎ is reached. The dose may be repeated every 2-4 hours if needed. Relief of convulsions in tetanus, infants aged 1 month or older and children under 5 years — Slowly administer 1-2㎎ intravenously. The dose may be repeated every 3-4 hours if needed. Relief of convulsions in tetanus, children aged 5 years and older — Slowly administer 5-10㎎ intravenously. The dose may be repeated every 3-4 hours if needed.

Ingredients

Manufacturer
Samjin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of convulsions and epilepsy; relief of anxiety and alcohol withdrawal; relief of anxiety before anesthesia or examinations

  • Anxiety
  • tension
  • depression
  • alcohol withdrawal symptoms
  • skeletal muscle spasms
  • absence seizures
  • convulsive seizures
  • status epilepticus
View approved original text

This medication is used to relieve anxiety and tension caused by neurosis. It also helps with anxiety, tension, and depressive symptoms arising from psychosomatic disorders, such as gastrointestinal diseases, circulatory diseases, autonomic nervous system dysregulation, and menopausal disorders. Additionally, it is used for pre-anesthetic administration or to alleviate alcohol withdrawal symptoms. It acts as an adjunct in the treatment of specific seizures in epilepsy, namely skeletal muscle spasms or absence seizures, and is effective for the treatment of convulsive seizures or status epilepticus. It is also used to reduce anxiety and tension prior to procedures such as endoscopies or cardioversion. Overall, it helps to improve anxiety and tension associated with various neurological and psychiatric symptoms.

How it is given

Adult administration

1. Anxiety and tension: For severe cases, inject 5-10㎎ of diazepam; for mild or moderate cases, inject 2-5㎎ intravenously or intramuscularly. The dose may be repeated after 3-4 hours if needed. However, do not administer more than 30㎎ within 8 hours. 2. Adjunct for relief of skeletal muscle spasms: Inject 5-10㎎ of this drug intravenously or intramuscularly. The dose may be repeated after 3-4 hours if needed. Higher doses may be required for tetanus. 3. Adjunctive treatment of convulsive seizures or status epilepticus: Administer an initial dose of 5-10㎎ of this drug intravenously, followed, if needed, by slow intravenous injections at 10-15-minute intervals, up to a maximum of 30㎎. Consider the active metabolites that may remain; use with extreme caution in patients with chronic pulmonary disease or unstable cardiovascular status. 4. Premedication for anesthesia: Inject 10㎎ of this drug intramuscularly before surgery. 5. Alcohol withdrawal symptoms: Administer an initial dose of 10㎎ of this drug intravenously or intramuscularly. If needed, repeat 5-10㎎ doses after 3-4 hours. 6. Endoscopy: Administer 10㎎ or less of this drug intravenously. The dose may be increased to 20㎎ if needed. If intravenous injection is not possible, inject 5-10㎎ slowly intramuscularly 30 minutes before the examination. 7. Cardioversion: Inject 5-15㎎ slowly intravenously 5-10 minutes beforehand.

Child administration

Anxiety and tension — Administer 0.04-0.2㎎/kg intravenously. The dose may be repeated every 2-4 hours if needed. However, do not administer more than 0.6㎎/kg within 8 hours. Infants aged 1 month or older and children under 5 years — Slowly administer 0.2-0.5㎎ intravenously at 2-5-minute intervals, up to a maximum of 5㎎. The dose may be repeated every 2-4 hours if needed. Children aged 5 years and older — Slowly administer 1㎎ intravenously at 2-5-minute intervals until a maximum dose of 10㎎ is reached. The dose may be repeated every 2-4 hours if needed. Relief of convulsions in tetanus, infants aged 1 month or older and children under 5 years — Slowly administer 1-2㎎ intravenously. The dose may be repeated every 3-4 hours if needed. Relief of convulsions in tetanus, children aged 5 years and older — Slowly administer 5-10㎎ intravenously. The dose may be repeated every 3-4 hours if needed.

Precautions

This drug contains benzyl alcohol, which may cause fatal respiratory symptoms in premature infants, thus caution is advised. When used with narcotics, the sedative effect may become excessively strong, leading to respiratory depression, coma, and potentially death, so co-administration should be done with great care. This medication should not be used in certain patients, such as those with acute glaucoma, severe myasthenia gravis, severe respiratory failure, or in patients with alcohol or drug dependence. In patients with compromised cardiac, liver, or kidney function, as well as older adults or those with depression, the effect of this drug may be enhanced, thus it should be administered with caution. Long-term use may lead to dependence or withdrawal symptoms, so it should be administered for the shortest duration possible, and upon discontinuation, the dose should be gradually reduced. This medication can cause drowsiness and decreased concentration, so driving or operating hazardous machinery should be avoided. It is advisable for women in early pregnancy or during lactation not to use this drug, and if unavoidable, consultation with a healthcare professional is recommended. In cases of overdose, severe symptoms such as coma and respiratory depression may occur, requiring immediate medical attention. This drug interacts with various medications, necessitating caution when taken with other central nervous system depressants, antidepressants, or narcotic analgesics. If unusual reactions such as anxiety, agitation, hallucinations, or amnesia occur during use, immediate consultation with a doctor is advised.

Side effects

  • Dependence
  • withdrawal symptoms
  • rebound anxiety
  • anxiety
  • agitation
  • depression
  • irritability
  • confusion
  • hallucination
  • psychosis
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  • behavioral disorders
  • drowsiness
  • staggering
  • dizziness
  • gait ataxia
  • headache
  • urinary incontinence
  • speech disorders
  • tremors
  • euphoria
  • syncope
  • nystagmus
  • blurred vision
  • leukopenia
  • granulocytopenia
  • blood dyscrasia
  • jaundice
  • ALT elevation
  • AST elevation
  • ALP elevation
  • tachycardia
  • bradycardia
  • hypotension
  • circulatory shock
  • nausea
  • vomiting
  • anorexia
  • gastrointestinal disturbances
  • constipation
  • thirst
  • changes in saliva secretion
  • rash
  • upper airway obstruction
  • fatigue
  • weakness
  • edema
  • changes in libido
  • urinary retention
  • changes in EEG
  • fatigue
  • somnolence
  • muscle weakness
  • impaired coordination
  • stuttering
  • unclear speech
  • tremors
  • vertigo
  • restlessness
  • anxiety
  • irritability
  • aggressiveness
  • delusions
  • anger
  • nightmares
  • confusional state
  • emotional deficiency
  • decreased arousal
  • increased or decreased libido
  • amnesia
  • nausea
  • dry mouth
  • excessive salivation
  • diplopia
  • blurred vision
  • hypotension
  • circulatory suppression
  • irregular heart rate
  • increased aminotransferase
  • increased blood alkaline phosphatase
  • skin reactions
  • dizziness
  • cardiac arrest
  • heart failure
  • respiratory failure
  • respiratory depression
  • jaundice
  • ataxia
  • over-sedation
  • absent reflexes
  • apnea
  • hypotension
  • cardiovascular system suppression
  • coma
  • confusion
  • deep sleep
  • weakness
  • reflex disorder
  • forgetfulness

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to light, so it should be stored in an opaque, sealed container that prevents light exposure. Additionally, it is best to store the medication at a cool room temperature, between 1 to 30 degrees Celsius. Storing it this way maintains the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

Brown ampoules containing a colorless or pale yellow liquid

Package unit

20 ampoules/box [2 mL/ampoule x 20]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.