Diazepam Oral Solution

Diazepam is indicated for the management of anxiety disorders or for the short-term 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, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

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

The effectiveness of diazepam 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.

Diazepam Oral Solution

The 5 mg per 5 mL oral solution is supplied as a (wintergreen-spice flavored) clear, orangecolored solution.

NDC 0054-3188-63: Bottle of 500 mL

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP/NF.

Diazepam Intensol™ Oral Solution (Concentrate)

The 25 mg per 5 mL (5 mg/mL) oral solution (concentrate) is supplied as a clear, yellow solution.

NDC 0054-3185-44: Bottle of 30 mL with calibrated dropper [graduations of 0.2 mL (1 mg), 0.4 mL (2 mg), 0.6 mL (3 mg), 0.8 mL (4 mg), 1.0 mL (5 mg) on the dropper.]

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Discard opened bottle after 90 days .

PROTECT FROM LIGHT.

Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. Revised: May 2016

Side effects most commonly reported were drowsiness, fatigue, muscle weakness and ataxia. The following have also been reported:

Central Nervous System: confusion, depression, dysarthria, headache, slurred speech, tremor, vertigo

Gastrointestinal System: constipation, nausea, gastrointestinal disturbances

Special Senses: blurred vision, diplopia, dizziness

Cardiovascular System: hypotension

Psychiatric and Paradoxical Reactions: stimulation, restlessness, acute hyperexcited states, anxiety, agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, increased muscle spasticity, 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. They are more likely to occur in children and in the elderly.

Urogenital System: incontinence, changes in libido, urinary retention

Skin and Appendages: skin reactions

Laboratories: elevated transaminases and alkaline phosphatase

Other: changes in salivation, including dry mouth, hypersalivation

Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behavior.

Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known significance.

Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy.

Postmarketing Experience

Injury, Poisoning And Procedural Complications

There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcohol), and in the elderly.

Drug Abuse And Dependence

Diazepam is subject to Schedule IV control under the Controlled Substance Act of 1970. Abuse and dependence of benzodiazepines have been reported. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving diazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence. Once physical dependence to benzodiazepines has developed, termination of treatment will be accompanied by withdrawal symptoms. The risk is more pronounced in patients on long-term therapy.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance of diazepam. These withdrawal symptoms may consist of tremor, abdominal and muscle cramps, vomiting, sweating, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuance should generally be avoided and a gradual dosage tapering schedule followed.

Chronic use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena.

Rebound Anxiety

A transient syndrome whereby the symptoms that led to treatment with diazepam recur in an enhanced form. This may occur upon discontinuation of treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness.

Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how diazepam oral solution affects you.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you are 65 or older, use diazepam oral solution with care. You could have more side effects.
• This medicine may be habit-forming with long-term use.
• Do not change the dose or stop this medicine. This could cause seizures. Talk with your doctor.
• If you have been taking diazepam oral solution on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this medicine all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• Have your blood work checked if you are on diazepam oral solution for a long time. Talk with your doctor.
• Use with care in children. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling tired or weak.
• Muscle weakness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time diazepam oral solution is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take diazepam oral solution or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to diazepam oral solution. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Diazepam is used to treat anxiety, alcohol withdrawal, muscle spasms, and certain types of seizures.

This drug can interfere with your judgment, thinking, and motor skills. You shouldn’t drink alcohol or use other drugs that can also slow down your brain’s activity while you’re on diazepam. You also shouldn’t drive, operate machinery, or do other tasks that require alertness until you know how this drug affects you.

Diazepam is available in several different forms, including oral tablet, oral solution, and rectal gel.

Diazepam can be habit-forming. It can lead to dependence and tolerance, meaning that you’ll need more of the drug for it to work. Keep it in a safe place, and never give it to anyone else because it may harm them. Selling or giving away this medication is against the law.

You shouldn’t stop taking diazepam without talking to your doctor first. Stopping this drug can cause severe withdrawal symptoms. Your risk may be higher if you’ve been on diazepam for a long time.

• Sedation See Details

• Medication dosage See Details

• Increased seizures See Details

What is diazepam?

Diazepam is a controlled substance drug. It is available in these forms: oral tablet, oral solution, oral solution concentrate, and rectal gel.

Diazepam is available in its generic form. Generic drugs usually cost less. In some cases they may not be available in every strength or form as the brand. Talk to your healthcare provider to see if the generic will work for you.

This drug may be used as part of a combination therapy. That means you need to take it with other drugs.

Why it's used

Diazepam oral solution is used to treat the following conditions:

• anxiety
• symptoms caused by alcohol withdrawal, such as agitation or tremors
• add-on treatment for skeletal muscle spasms
• add-on treatment for certain types of seizures

How it works

Diazepam belongs to a class of drugs called benzodiazepines. A class of drugs refers to medications that work similarly. They have a similar chemical structure and are often used to treat similar conditions.

More Details