What is Valium (Diazepam) and how is it used?

Valium (Diazepam)  is a prescription medicine used to treat symptoms of anxiety, muscle spasm, alcohol withdrawal and as a sedative before surgery or to treat seizures. Valium may be used alone or with other medications.

Valium belongs to a class of drugs called Antianxiety Agents; Anxiolytics, Benzodiazepines; Skeletal Muscle Relaxants; Anticonvulsants, Benzodiazepine.

It is not known if Valium (Diazepam) is safe and effective in children younger than 6 months of age.

What are the possible side effects of Valium?

Valium may cause serious side effects including:

  • weak or shallow breathing,
  • severe drowsiness,
  • lightheadedness,
  • depressed mood,
  • thoughts of suicide or hurting yourself,
  • confusion,
  • hallucinations,
  • anxiety,
  • panic attacks,
  • trouble sleeping,
  • hyperactivity,
  • agitation,
  • aggression,
  • hostility,
  • unusual risk-taking behavior, and
  • new or worsening seizures

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Valium include:

  • drowsiness,
  • tiredness,
  • muscle weakness, and
  • loss of coordination

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Valium. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Valium (diazepam) is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin- 2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows:

 

 

VALIUM® (diazepam) Structural Formula Illustration

 

Valium is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate with the following dyes: 5-mg tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; 10-mg tablets contain FD&C Blue No. 1. Valium 2-mg tablets contain no dye.

INDICATIONS

Valium (Diazepam) is indicated for the management of anxiety disorders or for the shortterm relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

Valium is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.

Oral Valium may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.

The effectiveness of Valium in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Dosage should be individualized for maximum 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 such cases dosage should be increased cautiously to avoid adverse effects.

ADULTS: USUAL DAILY DOSE:
Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms—2 mg to 10 mg, 2 to 4 times daily
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 Spasm. 2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated

 

HOW SUPPLIED

For oral administration, Valium (Diazepam) is supplied as round, flat-faced scored tablets with V-shaped perforation and beveled edges. Valium (Diazepam) is available as follows: 2 mg, white – bottles of 100 (NDC 0140-0004-01); 5 mg, yellow – bottles of 100 (NDC 0140-0005-01) and 500 (NDC 0140-0005-14); 10 mg, blue – bottles of 100 (NDC 0140-0006-01) and 500 (NDC 0140-0006-14).

Engraved on tablets:

2 mg – 2 Valium (Diazepam) (front) ROCHE (twice on scored side)

5 mg – 5 Valium (Diazepam) (front) ROCHE (twice on scored side)

10 mg – 10 Valium (Diazepam)(front) ROCHE (twice on scored side)

Storage:Store at room temperature 59° to 86°F (15° to 30°C). Dispense in tight, lightresistant containers as defined in USP/NF.

Also check:Xanax (Alprazolam) 1 mg – 60 Pills

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