Vivol

Action

Produces anxiolytic effect and CNS depression by stimulating gamma-aminobutyric acid receptors. Relaxes skeletal muscles of spine by inhibiting polysynaptic afferent pathways. Controls seizures by enhancing presynaptic inhibition.

Availability

Injection: 5 mg/ml

Oral solution: 1 mg/ml, 5 mg/5 ml

Tablets: 2 mg, 5 mg, 10 mg

Indications and dosages

➣ Anxiety disorders

Adults: 2 to 10 mg P.O. two to four times daily, depending on symptom severity. Alternatively, for moderate anxiety, 2 to 5 mg I.V., repeated in 3 to 4 hours if needed. For severe anxiety, 5 to 10 mg I.V., repeated in 3 to 4 hours if needed.

Children age 6 months and older: 1 to 2.5 mg P.O. three to four times daily; may increase gradually as needed

➣ Before cardioversion

Adults: 5 to 15 mg I.V. 5 to 10 minutes before cardioversion

➣ Before endoscopy

Adults: Usually, 10 mg I.V. is sufficient; may be increased to 20 mg I.V. Alternatively, 5 to 10 mg I.M. 30 minutes before endoscopy.

➣ Status epilepticus and severe recurrent convulsive seizures

Adults: 5 to 10 mg I.V. slowly, repeated as needed q 10 to 15 minutes, to a maximum of 30 mg; may repeat regimen if needed in 2 to 4 hours. May give I.M. if I.V. delivery is impossible.

Children ages 5 and older: 1 mg I.V. slowly q 2 to 5 minutes, to a maximum of 10 mg; repeat in 2 to 4 hours if needed. May give I.M. if I.V. delivery is impossible.

Children over 1 month to 5 years: 0.2 to 0.5 mg I.V. slowly q 2 to 5 minutes, to a maximum of 5 mg I.V. May give I.M. if I.V. delivery is impossible.

➣ Muscle spasm associated with local pathology, cerebral palsy, athetosis, "stiff-man" syndrome, or tetanus

Adults: 2 to 10 mg P.O. three to four times daily. Or initially, 5 to 10 mg I.V. or I.M., repeated in 3 to 4 hours if needed. Tetanus may necessitate higher dosages.

Elderly or debilitated patients: Initially, 2 to 2.5 mg P.O. once or twice daily, increased gradually as needed and tolerated

Children ages 5 and older: 5 to 10 mg I.M. or I.V., repeated q 3 to 4 hours as needed to control tetanus spasm

Children over 1 month to 5 years: 1 to 2 mg I.M. or I.V. slowly, repeated q 3 to 4 hours as needed to control tetanus spasm

➣ Acute alcohol withdrawal

Adults: Initially, 10 mg P.O. three to four times during first 24 hours, decreased to 5 mg P.O. three to four times daily p.r.n. Or initially, 10 mg I.M. or I.V.; then 5 to 10 mg I.M. or I.V. in 3 to 4 hours p.r.n.

Off-label uses

• Panic attacks

• Adjunct to general anesthesia

Contraindications

• Hypersensitivity to drug, other benzodiazepines, alcohol, or tartrazine

• Coma or CNS depression

• Narrow-angle glaucoma

Precautions

Use cautiously in:

• hepatic dysfunction, severe renal impairment

• elderly patients

• pregnant or breastfeeding patients (use not recommended)

• children.

Administration

• Give P.O. dose with or without food.

See Administer I.V. infusion slowly into large vein, taking at least 1 minute for each 5 mg in adults or at least 3 minutes for each 0.25 mg/kg in children.

• Know that I.V. route is preferred over I.M. route because of slow or erratic I.M. absorption.

• Don't mix with other drugs or solutions in syringe or container.

• Enforce bed rest for at least 3 hours after I.V. injection.

• Give I.M. injection deeply and slowly into large muscle mass.

• If desired, mix oral solution with liquid or soft food.

Adverse reactions

CNS: dizziness, drowsiness, lethargy, depression, light-headedness, disorientation, anger, manic or hypomanic episodes, restlessness, paresthesia, headache, slurred speech, dysarthria, stupor, tremor, dystonia, vivid dreams, extrapyramidal reactions, mild paradoxical excitation

CV: bradycardia, tachycardia, hypertension, hypotension, palpitations, cardiovascular collapse

EENT: blurred vision, diplopia, nystagmus, nasal congestion

GI: nausea, vomiting, diarrhea, constipation, gastric disorders, difficulty swallowing, increased salivation

GU: urinary retention or incontinence, menstrual irregularities, gynecomastia, libido changes

Hematologic: blood dyscrasias including eosinophilia, leukopenia, agranulocytosis, and thrombocytopenia

Hepatic: hepatic dysfunction

Musculoskeletal: muscle rigidity, muscular disturbances

Respiratory: respiratory depression

Skin: dermatitis, rash, pruritus, urticaria, diaphoresis

Other: weight gain or loss, decreased appetite, edema, hiccups, fever, physical or psychological drug dependence or tolerance

Interactions

Drug-drug. Antidepressants, antihistamines, barbiturates, opioids: additive CNS depression

Cimetidine, disulfiram, fluoxetine, hormonal contraceptives, isoniazid, ketoconazole, metoprolol, propoxyphene, propranolol, valproic acid: decreased metabolism and enhanced action of diazepam

Digoxin: increased digoxin blood level, possible toxicity

Levodopa: decreased levodopa efficacy

Rifampin: increased metabolism and decreased efficacy of diazepam

Theophylline: decreased sedative effect of diazepam

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase: increased levels

Neutrophils, platelets: decreased counts

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

• Monitor vital signs and respiratory and neurologic status.

• Supervise ambulation, especially in elderly patients.

• Monitor CBC and kidney and liver function test results.

See Avoid sudden drug withdrawal. Taper dosage gradually to termination of therapy.

Patient teaching

• Inform patient he may take drug with or without food; recommend taking it with food if it causes stomach upset.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

See Tell patient to notify prescriber immediately if easy bruising or bleeding occurs.

• Instruct patient to move slowly when sitting up or standing, to avoid dizziness from blood pressure decrease. Advise him to dangle legs briefly before getting out of bed.

See Advise patient not to stop taking drug abruptly.

• Advise patient to avoid alcohol and other depressants such as sedatives while taking drug.

• Tell female patient not to take drug if she is pregnant or plans to breastfeed.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.