Diazepam GPO

Diazepam GPO

diazepam

Manufacturer:

GPO

Distributor:

GPO
Full Prescribing Info
Contents
Diazepam.
Description
Tablet: Each tablet contains Diazepam 2 mg, 5 mg and 10 mg.
Injection: Each 2 ml contains Diazepam 10 mg.
Indications/Uses
Tablet: To relieve anxiety & relax muscle.
Injection: For the management of anxiety, mental tension, restlessness, and agitation.
As preoperative medication.
As an adjunctive therapy in status epilepticus and severe recurrent convulsive seizures.
As an adjunct for the relief of skeletal muscle spasm.
For the management of acute alcohol withdrawal symptoms such as agitation, tremor, and hallucinations.
Dosage/Direction for Use
Tablet: Anxiety: Adult: 2-10 mg orally 2-4 times daily or as directed by doctor.
To relax muscle: Adult: 2-10 mg orally 3-4 times daily, elderly or physical illness: dose reduction should be considered, children: as directed by doctor.
Injection: Adults: Antianxiety: IM or IV, 2-10 mg, the dosage may be repeated in three or four hours if necessary.
Skeletal muscle relaxant adjunct: IM or IV, 5-10 mg initially, the dosage may be repeated in three or four hours if necessary.
Note: IV administration is usually preferred, since absorption may be slow and erratic following IM administration.
For IV injections, the solutions should be injected slowly, into a large vein, at least one minute being taken for reach 5 mg (1 ml) of the drug.
Contraindications
Tablet: This product should not be used in the following conditions unless directed by doctor; allergic to this product, acute close-angle glaucoma, psychoses, not to be used with CNS depressants or alcohol consumption or product containing alcohol.
Injection: Tolerance and psychologic and physical dependence may occur following prolonged use of diazepam.
May cause drowsiness, avoid driving, using machines, or doing other jobs requiring alertness.
Avoid taking alcohol during medication.
Diazepam should be used with caution in patients with hepatic disease, renal disease, glaucoma, myasthenia gravis, porphyria, chronic pulmonary insufficiency, during pregnancy and in nursing women.
Caution is recommended when concomitantly used with other drugs such as CNS depressants, tricyclic antidepressants, cimetidine and disulfiram.
Special Precautions
Tablet: Not to be used in patients with history of benzodiazepines allergy; may cause drowsiness, driving or operating machine or dealing with risky work is not recommended while taking this product; should not be used continuously for a long time as it can cause drug addiction unless directed by doctor. If routine use is necessary, drug use monitoring should be conducted regularly. Should consult doctor before stop using this product as drug withdrawal can occur if the dose is not gradually decreased; Use with caution in pregnancy as drug can be transferred across placenta and cause teratogenic effects. In mother is addicted to this product, the newborn may present with the drug withdrawal; Use with caution in breastfeeding, liver or renal impairment, closed-angle glaucoma, myasthenia gravis, porphyria, respiratory disorders, sleep apnea, chronic alcoholism, psychiatric disorders including psychosis, depression, drug abusers; Use with caution if the concomitant drugs are inducers/inhibitors of liver enzyme metabolizing benzodiazepines. Doctor should be consulted if the concomitant use is required; Paradoxical effects can be observed in children and elderly when using this product; Can cause abnormal blood profile, liver or renal function; In presence of insomnia, hallucination, abnormal behaviour, ataxia or fever, should stop using this product and the consult doctor; Use with caution in hypoalbuminemic patients.
Injection: In patients with acute alcohol intoxication with depressed vital signs, severe chronic obstructive pulmonary disease, acute angle-closure glaucoma, hypersensitivity to benzodiazepines and during the first trimester of pregnancy.
Use in Pregnancy & Lactation: Tablet: Use with caution in pregnancy as drug can be transferred across placenta and cause teratogenic effects. In mothers addicted to this product, the newborn may present with the drug withdrawal; use with caution in breastfeeding.
Injection: Use with caution during pregnancy and in nursing women.
Use In Pregnancy & Lactation
Tablet: Use with caution in pregnancy as drug can be transferred across placenta and cause teratogenic effects. In mothers addicted to this product, the newborn may present with the drug withdrawal; use with caution in breastfeeding.
Injection: Use with caution in pregnancy and in nursing women.
Adverse Reactions
Tablet: CNS depression including drowsiness, uncooperative muscle movement, loss of movement control, confusion, dizziness, vertigo, palpitation, tachycardia, temporary loss of memory, GI irritation, skin reactions.
From Intravenous diazepam only: Phlebitis, blood vessel clot.
Side Effects
Injection: Adverse CNS effects include drowsiness, ataxia, fatigue, dizziness, vertigo and syncope may occur.
Parenteral diazepam may cause apnea, hypotension, bradycardia or cardiac arrest, especially in geriatric or severely ill patients or if IV administration of the drug is too rapid.
Drug Interactions
Tablet: Alcohol consumption, CNS depressants: Increase CNS effects of diazepam and increase risk of apnea; CYP2C19 inhibitors including cimetidine, quinidine, tranylcypromine: Decrease diazepam clearance causing the longer duration of diazepam effect; CYP2C19 indcuers including rifampicin: Increase diazepam clearance; ranitidine: Decrease diazepam absorption.
Storage
Injection: Store below 25°C, protect from light and freezing.
MIMS Class
ATC Classification
N05BA01 - diazepam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
Presentation/Packing
Tab 2 mg x 500's. 5 mg x 1000's. 10 mg x 1,000's. Inj (amp) 10 mg/2 mL x 50 x 1's.
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