Valium Roche (Diazepam)

VALIUM® ROCHE® ORAL

Roche

Diazepam

Anxiolytic – Sedative

Action And Clinical Pharmacology: Diazepam is an anxiolytic-sedative drug useful in the symptomatic relief of anxiety and tension states. It has also adjunctive value in the relief of certain neurospastic conditions. Peak blood levels after oral administration of diazepam are reached within 1 to 2 hours after single oral dosing. The acute half-life is 6 to 8 hours with a slower decline thereafter, possibly due to tissue storage. However, after repeated doses, blood levels increase significantly over a period of 24 to 48 hours.

In humans, comparable blood levels of diazepam were obtained in maternal and cord blood indicating placental transfer of the drug.

Indications And Clinical Uses: The symptomatic management of mild to moderate degrees of anxiety in conditions dominated by tension, excitation, agitation, fear or aggressiveness, such as may occur in psychoneurosis, anxiety reactions due to stress conditions and anxiety states with somatic expression.

In acute alcoholic withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor and impending acute delirium tremens.

As an adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology, such as inflammation of the muscle and joints or secondary to trauma; spasticity caused by upper motor neuron disorders, such as cerebral palsy and paraplegia; athetosis and the rare “stiff man syndrome”.

Contra-Indications: Myasthenia gravis, known hypersensitivity to the drug and, because of lack of sufficient clinical experience, in children under 6 months of age.

Precautions: Geriatrics: Elderly and debilitated patients or those with organic brain disorders have been found to be prone to CNS depression following even low doses. For these patients it is recommended that the dosage be limited to the smallest effective amount to preclude development of ataxia, oversedation or other possible adverse effects.

Emotional Disorders: Diazepam is not recommended in the treatment of psychotic or severely depressed patients. Precautions are indicated for severely depressed patients or those who show evidence of impending depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary. Since excitement and other paradoxical reactions may result from the use of the drug in psychotic patients, it should not be used in ambulatory patients suspected of having psychotic tendencies.

Epileptic Patients: Careful consideration should be given if diazepam is to be used in patients with epilepsy as the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the doses of standard anticonvulsant medication. An abrupt withdrawal of diazepam is such cases may also be associated with the temporary increase in the frequency and/or severity of seizures.

Pregnancy: Diazepam should not be used during the first trimester of pregnancy except if absolutely necessary.

Potentiation of Drug Effects: Careful consideration should be given if diazepam is to be combined with other psychotropic agents, phenothiazines, barbiturates, MAO inhibitors and other antidepressants because the pharmacological action of these agents might potentiate the action of diazepam. Since diazepam has a CNS depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS depressant drugs during diazepam therapy.

Drug Dependence: Abrupt cessation of large doses of diazepam after prolonged periods may precipitate acute withdrawal symptoms and, in these cases, the drug should be discontinued gradually. Caution should be exercised when it is considered necessary to administer diazepam to addiction prone individuals.

General: Patients receiving diazepam should be advised to proceed cautiously wherever mental alertness and physical coordination are required.

The usual precautions in treating patients with impaired renal and hepatic functions should be observed. If diazepam is administered for protracted periods, periodic blood counts and liver function tests would be highly advisable.

Adverse Reactions: The most common adverse effects reported are drowsiness and ataxia. Other reactions noted less frequently are fatigue, dizziness, nausea, blurred vision, diplopia, vertigo, headache, slurred speech, tremors, hypoactivity, dysarthria, euphoria, impairment of memory, confusion, depression, incontinence or urinary retention, constipation, skin rash, generalized exfoliative dermatitis, hypotension and changes in libido.

The more serious adverse reactions occasionally reported are leukopenia, jaundice, hypersensitivity and paradoxical reactions (such as hyperexcited states, anxiety, excitement, hallucinations, increased muscle spasticity, insomnia, rage, as well as sleep disturbances and stimulation). Should these occur, the drug should be discontinued.

Minor changes in EEG patterns have been observed in patients on diazepam therapy. These changes consist of low to moderate voltage fast activity, 20 to 30 cycles/second and are of no known significance.

Symptoms And Treatment Of Overdose: Symptoms: Drowsiness, oversedation and ataxia. When the effects of drug overdosage begin to wear off, the patient exhibits some jitteriness and overstimulation. The cardinal manifestations of overdosage are drowsiness and confusion, reduced reflexes and coma. There are minimum effects on respiration, pulse and blood pressure unless the overdosage is extreme.

Treatment: Gastric lavage may be beneficial if performed soon after oral ingestion of diazepam. If necessary, a CNS stimulant such as caffeine or methylphenidate may be administered with caution. Supportive measures should be instituted as indicated, such as, maintenance of an adequate airway, levarterenol or metaraminol bitartrate for hypotension. Dialysis appears to be of little value.

Dosage And Administration: Should be individualized for maximal beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In the first few days of administration a cumulative effect of the drug may occur, and therefore, the dosage should be increased only after stabilization is apparent.

Adults: Symptomatic relief of anxiety and tension in psychoneurosis and anxiety reactions: 2 to 10 mg, 2 to 4 times daily depending upon severity of symptoms.

Symptomatic relief in acute alcohol withdrawal: 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed.

Adjunctively for relief of skeletal muscle spasms: 2 to 10 mg, 3 to 4 times daily.

Elderly and debilitated patients, or in the presence of debilitating disease: 2 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated.

Children: Because of varied responses, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months (see Contraindications): 1 to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated.

Availability And Storage: 5 mg: Each pale yellow cylindrical, biplane beveled-edged tablet, engraved ROCHE5 on one side, single scored on both sides, contains: diazepam 5 mg. Nonmedicinal ingredients: iron oxide yellow, lactose and magnesium stearate. Energy: 2.8 kJ (0.7 kcal). Gluten-, paraben-, sodium-, sulfite- and tartrazine-free. Bottles of 100 and 1 000.

10 mg: Each light blue cylindrical, biplane beveled-edged, single scored on one side and engraved ³ on unscored side contains: diazepam 10 mg. Nonmedicinal ingredients: cornstarch, indigotine, lactose and magnesium stearate. Energy: 2.8 kJ (0.7 kcal). Gluten-, paraben-, sodium-, sulfite- and tartrazine-free. Bottles of 100.

Store between 15 and 30°C. Keep in a tightly closed, light-resistant container. (Shown in Product Recognition Section)

VALIUM® ROCHE® ORAL Roche Diazepam Anxiolytic – Sedative

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