Diastat AcuDial Side Effects

Generic name: diazepam

Note: This document contains side effect information about diazepam. Some of the dosage forms listed on this page may not apply to the brand name Diastat AcuDial.

Some side effects of Diastat AcuDial may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to diazepam: oral concentrate, oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking diazepam (the active ingredient contained in Diastat AcuDial) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• confusion, hallucinations, unusual thoughts or behavior;

• unusual risk-taking behavior, decreased inhibitions, no fear of danger;

• depressed mood, thoughts of suicide or hurting yourself;

• hyperactivity, agitation, aggression, hostility;

• new or worsening seizures;

• weak or shallow breathing, a feeling like you might pass out;

• muscle twitching, tremor;

• loss of bladder control; or

• little or no urinating.

Common side effects may include:

• drowsiness, tired feeling, memory problems;

• dizziness, spinning sensation;

• feeling restless or irritable;

• muscle weakness;

• nausea, constipation;

• drooling or dry mouth, slurred speech;

• blurred vision, double vision;

• mild skin rash, itching; or

• loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to diazepam: injectable solution, intravenous suspension, oral capsule extended release, oral concentrate, oral solution, oral tablet, rectal kit

Nervous system

Nervous system side effects are common and include drowsiness, fatigue, confusion, depression, psychomotor impairment, cognitive impairment, headache, syncope, slurred speech, tremor, vertigo, dysarthria, dizziness, and ataxia. Acute dystonic reactions and coma have been rarely reported.

One study has suggested that the acute pharmacodynamic profile of diazepam with respect to euphoria and subject liking is similar to barbiturates.

Another study has suggested that long-term benzodiazepine therapy may be associated with significant cognitive impairments which may persist following benzodiazepine withdrawal.

Cases of paradoxical reactions to diazepam (increased agitation and hyperactivity) have been reported rarely.

Local

One recent study has reported that a palpable venous cord was present in as many as 23% of patients treated with intravenous diazepam (the active ingredient contained in Diastat AcuDial)

Local reactions at the site of injection (such as venous thrombosis, phlebitis, local irritation and swelling) occur in about 8% of patients. Rarely, vascular impairment has occurred, sometimes with severe consequences. Diazepam emulsified injection (Dizac) has been associated with a lower frequency of thrombophlebitis and pain on injection. (Diazepam emulsified injection has been approved for intravenous use only.)

Psychiatric

Psychiatric side effects have included stimulation, restlessness, acute hyperexcited states, anxiety, agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, insomnia, sleep disturbances, and nightmares. Inappropriate behavior and other adverse behavioral effects have been reported when using benzodiazepines.

Should these occur, use of the drug should be discontinued. These side effects are more likely to occur in children and in the elderly.

Respiratory

Respiratory arrest may occur, especially with parenteral administration of diazepam (the active ingredient contained in Diastat AcuDial) Equipment for resuscitation should be immediately available when parenteral diazepam is used.

Diazepam, particularly when given by parenteral routes of administration may decrease the sensitivity of upper airway reflexes and thereby increase the risk of aspiration.

Other

Some investigators have also suggested that the presence of psychosensory symptoms such as depersonalization, derealization, and perceptual distortion are a unique feature of the withdrawal syndrome. A recent study which confirmed that an increase in symptoms often accompanies withdrawal, concluded that withdrawal symptoms were neither intense nor excessively difficult for patients following discontinuation of low-dose diazepam (the active ingredient contained in Diastat AcuDial)

Withdrawal symptoms after abrupt cessation of diazepam may include convulsions, tremor, abdominal cramps, panic attacks, depression, vomiting, anxiety, agitation, insomnia and sweating. Catatonia following benzodiazepine withdrawal has been reported in five patients, two of whom withdrew from diazepam.

Gastrointestinal

Gastrointestinal effects include constipation, gastrointestinal disturbances, and nausea. Changes in salivation have also been reported including dry mouth and hypersalivation.

Genitourinary

Genitourinary effects such as sexual dysfunction, incontinence, changes in libido, and urinary retention have been reported.

Hypersensitivity

Hypersensitivity side effects including rash, pruritus, and severe bronchospasm have been rarely reported.

Hepatic

Hepatic effects including granulomatous hepatitis have been reported. Elevated liver function tests have been rarely reported. Periodic monitoring of liver function tests is recommended for patients on long-term diazepam (the active ingredient contained in Diastat AcuDial) therapy, particularly for patients with preexisting liver disease.

Hematologic

Neutropenia has been rarely reported. Periodic monitoring of blood counts may be useful in patients on long term diazepam (the active ingredient contained in Diastat AcuDial) therapy.

Endocrine

Endocrine side effects including a single case of gynecomastia has been reported in association with diazepam (the active ingredient contained in Diastat AcuDial) therapy.

Musculoskeletal

Musculoskeletal side effects have included increased muscle spasticity. One case report has suggested that diazepam (the active ingredient contained in Diastat AcuDial) may contribute to rhabdomyolysis in patients with hyponatremia.

Cardiovascular

Cardiovascular effects of diazepam (the active ingredient contained in Diastat AcuDial) including hypotension and possible anti-ischemic effects by reducing myocardial oxygen consumption have been reported.

Ocular

Ocular side effects including blurred vision and diplopia have been reported. A case of maculopathy has also been reported.

Other

A case of acute febrile neutrophilic dermatosis (Sweet's syndrome) has been reported consisting of an acute painful rash, high fever, and severe arthralgias.

Dermatologic

Dermatologic side effects including skin reactions have been reported.

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