Paraldehyde (Oral, Injection, Rectal)

Paraldehyde is used to treat certain convulsive disorders. It has also been used to help with alcoholism and to calm or relax patients who are nervous or tense, as well as to help them sleep. However, this medicine is usually not used anymore because there are safer and more effective options available for treating alcoholism and nervous and mental conditions.

This medicine is available only with your doctor's prescription.

If you will be using this medicine regularly for a long time:

• Your doctor should check your progress at regular visits.
• Do not stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, which may cause drowsiness). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; barbiturates; medicines for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Before you have any medical tests, inform the medical doctor in charge that you are taking this medicine. The results of some tests, such as the metyrapone test and the phentolamine test, may be affected by this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help immediately. Taking an overdose of paraldehyde or taking alcohol or other CNS depressants with paraldehyde may lead to unconsciousness and possibly death. Some signs of an overdose are confusion, muscle tremors, nausea or vomiting (continuing or severe), severe stomach cramps, severe weakness, shortness of breath or slow or troubled breathing, and slow heartbeat.

This medicine may cause some people to feel drowsy or less alert than usual. Even if taken at bedtime, it may cause some people to feel drowsy or less alert upon waking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

In deciding to use a medicine, it's important to consider the risks of taking the medicine against the benefits it may provide. This decision is made together with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other types of allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There is no specific information comparing the use of paraldehyde in children with its use in other age groups. This medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older adults. Therefore, it may not be known whether they work the same way in older people as they do in younger adults or if they cause different side effects or problems. There is no specific information comparing the use of paraldehyde in the elderly with its use in other age groups.

Breast Feeding

There have not been enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could occur. In such cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you are taking.

• Disulfiram

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Fospropofol
• Propofol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Ginkgo

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are based on their potential significance and are not necessarily a complete list.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on paraldehyde may develop

• Colitis—Using paraldehyde rectally may worsen this condition

• Emphysema, asthma, bronchitis, or other chronic lung diseases, or
• Liver disease—Higher levels of paraldehyde in the blood may occur, increasing the chance of side effects

• Gastroenteritis (stomach flu) or
• Stomach ulcer—Taking paraldehyde by mouth may worsen this condition

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Coughing (with injection only)
• Skin rash

Less common

• Redness, swelling, or pain at injection site

With long-term use

• Yellow eyes or skin

Symptoms of overdose

• Cloudy urine
• Confusion
• Decreased urination
• Fast and deep breathing
• Muscle tremors
• Nausea or vomiting (continuing or severe)
• Nervousness, restlessness, or irritability
• Shortness of breath or slow or troubled breathing
• Slow heartbeat
• Stomach cramps (severe)
• Weakness (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Drowsiness
• Nausea or vomiting (when taken by mouth)
• Stomach pain (when taken by mouth)
• Unpleasant breath odor

Less common

• Clumsiness or unsteadiness
• Dizziness
• "Hangover" effect

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Convulsions (seizures)
• Hallucinations (seeing, hearing, or feeling things that are not there)
• Increased sweating
• Muscle cramps
• Nausea and vomiting
• Stomach cramps
• Trembling

Paraldehyde will cause your breath to have a strong unpleasant odor. This effect will last until about one day after you have stopped using this medicine.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much is used, the medicine may become habit-forming.

Do not use if liquid turns brownish in color or if it has a strong vinegar-like odor, since this means the paraldehyde is breaking down. If you have any questions about this, check with your health care professional.

For patients taking this medicine by mouth:

• Do not use a plastic spoon, plastic glass, or any other plastic container to take this medicine, since paraldehyde may react with the plastic. Use a metal spoon or glass container.
• Take this medicine mixed in a glass of milk or iced fruit juice to improve the taste and odor and to lessen stomach upset.

For patients using this medicine rectally:

• Do not use paraldehyde in any plastic container since it may react with the plastic.
• Before using paraldehyde rectally, make sure you understand exactly how to use it. Paraldehyde may need to be diluted. If you have any questions about this, check with your health care professional.

Keep this medicine away from the eyes and avoid getting it on the skin and clothing.

Keep this medicine away from heat, open flame, and sparks.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral and rectal dosage forms (liquid): Adults: Dose must be determined by your doctor. Children: Dose is based on body weight, and must be determined by the doctor.
• For injection dosage form: Adults: Dose must be determined by your doctor. It will be injected into a muscle or a vein. Children: Dose is based on body weight, and must be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.