ANXOL is indicated for the management of insomnia, night terrors, sleep walking, anxiety disorders, or for the short-term relief of anxiety. In acute alcohol withdrawal, ANXOL is useful for symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinations. As a preanesthetic medication, ANXOL may be given prior to minor surgery or investigative procedures so as to provide sedative cover.

ANXOL is advocated for relief of skeletal muscle spasm due to reflex spasm to local pathology (such as in inflammation of muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis, and stiffness syndrome.

ANXOL must be given with due precaution in those with renal or hepatic dysfunction. In the elderly and those debilitated, ANXOL dosage must be limited to the smallest effective amount to preclude the development of ataxia or oversedation (2 mg to 2½ mg once or twice daily, initially, to be increased gradually as needed and tolerated).

ANXOL is not of value in psychotic patients and should be employed in lieu of appropriate treatment. Those receiving any central nervous system (CNS) depressants, including ANXOL, should be cautioned against engaging in hazardous occupation requiring complete mental alertness such as operating machinery or driving a motor vehicle.

As with other agents that have anticonvulsant activity, when ANXOL is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of ANXOL in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.

Anxiety or tension associated with stress of everyday life usually does not warrant treatment with an anxiolytic such as ANXOL.

Absorption of diazepam following intramuscular (IM) diazepam (ANXOL Injection) is erratic and provides lower blood concentrations than those obtained by oral therapy.

Patients should be advised that if they become pregnant during therapy with ANXOL, or intend to become pregnant, they should communicate with their physicians about the desirability of discontinuing the drug. For those taking ANXOL on long-term basis, periodic assessment of blood counts and liver function tests are advisable.

ANXOL must be coadministered with caution along with other psychotropic agents such as phenothiazines, narcotics, barbiturates, monoamine oxidase inhibitors (MAOIs), antidepressants, and cimetidine. Other CNS depressants or alcohol are to be avoided simultaneous with ANXOL.

Most common side effects of diazepam (ANXOL) are drowsiness, fatigue and ataxia. Infrequently encountered are confusion, constipation, depression, diplopia, dysarthria, headache, hypotension, incontinence, jaundice, changes in libido, nausea, changes in salivation, skin rash, slurred speech, tremor, urinary retention, vertigo and blurred vision.

Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation are possible with diazepam (ANXOL).
Should any of these latter adverse reactions occur, ANXOL must be discontinued.

ANXOL can interact with cimetidine, and potentiate the actions of other CNS depressant agents such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants.

USUALLY: 10-20 mg ANXOL IM / IV. For intravenous (IV) administration 5 mg (1 ml) ANXOL Injection is recommended over 1 minute slowly in antecubital fossa vein. Patient should be kept in supine position and under medical supervision for at least an hour after administration. The dose can repeated as necessary after 30-60 minutes. For severe muscle spasm, 10 mg diazepam can be repeated every 4 hours, as required.

SEIZURES: After adequate control has been obtained, IV infusion of 3 mg diazepam / kg over 24 hours is recommended to prevent recurrence.