Domina

COMPOSITION:

Each 1ml solution contains 5mg Diazepam.

MECHANISM OF ACTION:

Diazepam is a psychotropic substance from the class of 1, 4-benzodiazepines. It binds to specific receptors in the central nervous system and particular peripheral organs. The benzodiazepine receptors in the CNS have a close functional connection with receptors of the GABA-ergic transmitter system. After binding to the benzodiazepine receptor, Diazepam augments the inhibitory effect of GABA-ergic transmission.

INDICATIONS:

Diazepam Domina injection may be used in severe or disabling anxiety and agitation, for the control of status epilepticus, epileptic and febrile convulsions.

It is also used to relieve muscle spasm, as a sedative in minor surgical and dental procedures, or other circumstances in which a rapid effect is required.

DOSAGE AND ADMINISTRATION:

Dosage depends on individual response, age and weight.

In adults: Administer by direct IV injection slowly at a rate not exceeding 1ml/min .

In children: administration should be over not less than 3 minutes.

Avoid extravasation.

Adults:

In severe anxiety or acute muscle spasm: Diazepam Domina 10mg may be given intravenously or intramuscularly and repeated after 4 hours.
In tetanus: 0.1 to 0.3mg per kg body weight may be given intravenously and repeated every 1-4 hours, alternatively, a continuous infusion of 3 to 10mg per kg every 24 hours may be used or similar doses may be given by nasoduodenal tube.
In status epilepticus or epileptic convulsions: 0.15 to 0.25mg per kg (usually 10-20mg) is given by intravenous injection. The dose can be repeated if necessary after 30 to 60 minutes. Once the patient is controlled, recurrence of seizures may be prevented by a slow infusion (maximum total dose 3mg per kg over 24 hours).
In minor surgical procedures and dentistry: 0.1 to 0.2mg per kg by injection (usually 10-20mg) adjusted to the patient's requirements.

Elderly:

Elderly or debilitated patients should be given not more than half of the usual dose.

Hepatic/renal impairment: Dosage reduction may also be required in patients with liver or kidney dysfunction.

Children:

In status epilepticus or epileptic convulsions: 0.2 to 0.3mg per kg (or 1mg per year of life) is given by intravenous injection. The dose can be repeated if necessary after 30 to 60 minutes.
Sedation or muscle relaxation: up to 0.2mg per kg may be given parenterally.

Neonates:

Not recommended, dosage has not been established and Diazepam Domina injection contains benzyl alcohol which should be avoided in injections to neonates.

SIDE EFFECTS:

Hypotension, bradycardia, chest pain, ataxia, dizziness, oversedation which may lead to falls and other accidents, visual disturbance, fatigue, raised liver enzymes, jaundice, headache, confusion, slurred speech, paradoxical reactions, changes in libido, skin reaction, urinary retention, incontinence, and rarely respiratory depression and apnoea.

CONTRAINDICATIONS:

Known sensitivity to benzadiazepines or any of the ingredients, respiratory depression, acute pulmonary insufficiency, sleep apnoea syndrome, severe hepatic impairment, not for chronic psychosis, should not be used alone in depression or in anxiety with depression, avoid the product on neonates.

DRUG INTERACTIONS:

Concurrent administration of these drug agents may increase the sedation or respiratory and cardiovascular depression: Alcohol, anaesthetics and narcotic analgesics, antidepressants, antiepileptics, antihistamines, antipsychotics, antivirals, anxiolytics, hypnotics, muscle relaxants, sedatives, ulcer-healing drugs, oral contraceptives, disulfiram.
Clearance of benzodiazepines increases with rifampicin, carbamazepine, phenytoin.
Metabolism of Diazepam is accelerated with nicotine, and theophylline.
Clearance of benzodiazepines decreases with erythromycin, isoniazid, amprenavir, ritonavir, disulfiram, oral contraceptives, cemitidine and omeprazole.
Diazepam decreases digoxin clearance.
Diazepam may cause inhibition of levodopa.
Enhanced hypotensive effect of antihypertensive drugs, enhanced sedation effect with alpha blockers, and antipsychotics. Severe hypotension, respiratory depression, potentially fatal respiratory arrest have been reported in a few patients on benzodiazepines and clozapine, so caution is advised when initiating clozapine therapy in patients taking benzodiazepines.
When intravenous Diazepam Domina is to be administered concurrently with a narcotic analgesic agent (e.g. fentanyl), it is recommended that the injection be given after the analgesic and that the dose be carefully titrated.

PRECAUTIONS:

In order to reduce the likelihood of adverse effects during intravenous administration the injection should be given slowly (1.0ml solution per minute). It is advisable to keep the patient supine for at least an hour after administration. Except in emergencies, a second person should always be present during intravenous use and facilitates for resuscitation should always be available.
The injection should be used with caution in patients with respiratory disease, renal or hepatic dysfunction, muscle weakness, history of drug or alcohol abuse, or organic brain changes, particularly arteriosclerosis, marked personality disorder, special precautions for intravenous injection, porphyria.
Dependence: The dependence potential of Diazepam Domina increases with dose and duration of treatment and is greater in patients with a history of alcohol or drug abuse. It is also low when limited to short term use. Withdrawal symptoms may occur following normal use of therapeutic doses for only short period. This should be considered when treating patients for more than a few days, abrupt discontinuation should be avoided and the dose reduced gradually.
Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours after administration. To reduce the risk, patients should be able to have an uninterrupted sleep of 7-8 hours after administration.
There is a risk of benzyl alcohol poisoning with prolonged use of high-dose intravenous infusions of Diazepam Domina injection containing benzyl alcohol. It may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Driving or using machinery: Patients treated with the product should not drive or use machinery.

USE IN PREGNANCY OR LACTATION:

There is no evidence regarding the safety of the product in pregnancy. It should not be used, especially in the first and third trimesters, unless the benefits are considered to outweigh the risks. If the product prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding the discontinuance of the product if she intends to become or suspects that she is pregnant. Since benzodiazepines are found in the breast milk, benzodiazepines should not be given to breast feeding mothers.