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|Ethchlorvynol

ETHCHLORVYNOL (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Placidyl

Generic name product may be available in the U.S.

† Not commercially available in Canada.

Category

• Sedative-hypnotic

Description

Ethchlorvynol (eth-klor-VI-nole) is used to treat insomnia (trouble in sleeping). However, it has generally been replaced by other medicines for the treatment of insomnia. If ethchlorvynol is used regularly (for example, every day) to help produce sleep, it is usually not effective for more than 1 week.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Capsules (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ethchlorvynol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ethchlorvynol or tartrazine (FD&C Yellow No. 5). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Ethchlorvynol has not been studied in pregnant women. However, use of ethchlorvynol during the first 6 months of pregnancy is not recommended because studies in animals have shown that high doses of ethchlorvynol increase the chance of stillbirths and decrease the chance of the newborn surviving. Taking ethchlorvynol during the last 3 months of pregnancy may cause slow heartbeat, shortness of breath, troubled breathing, or withdrawal side effects in the newborn baby.

Breast-feeding—It is not known whether ethchlorvynol passes into the breast milk. However, this medicine may cause unwanted effects in nursing babies. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients and there is no specific information comparing use of ethchlorvynol in children with use in other age groups.

Older adults—Elderly people may be especially sensitive to the effects of ethchlorvynol. This may increase the chance of side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ethchlorvynol, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners)—Ethchlorvynol may change the amount of anticoagulant you need to take

• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Using these medicines together with ethchlorvynol may increase the CNS and other depressant effects

Other medical problems—The presence of other medical problems may affect the use of ethchlorvynol. Make sure you tell 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 ethchlorvynol may develop

• Kidney disease or
• Liver disease—Higher blood levels of ethchlorvynol may result and increase the chance of side effects

• Mental depression or
• Porphyria—Ethchlorvynol may make the condition worse

Proper Use of This Medicine

Ethchlorvynol is best taken with food or a glass of milk to lessen the possibility of dizziness, clumsiness, or unsteadiness, which may occur shortly after you take this medicine.

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

Dosing—The dose of ethchlorvynol 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 ethchlorvynol. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage forms (capsules):
  • Adults: 500 to 1000 milligrams at bedtime.
  • Children: Dose must be determined by the doctor.

Storage—To store this medicine:

• Keep out of the reach of children. Overdose of ethchlorvynol is especially dangerous in children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

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

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

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once . Taking an overdose of ethchlorvynol or taking alcohol or other CNS depressants with ethchlorvynol may lead to unconsciousness and possibly death. Some signs of an overdose are continuing confusion, severe weakness, shortness of breath or slow or troubled breathing, slurred speech, staggering, and slow heartbeat.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. 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 dizzy or are not alert .

Side Effects of This Medicine

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:

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

After you stop using this medicine, your body may need time to adjust. If you took this medicine in high doses or for a long time, this may take up to 2 weeks. During this period of time check with your doctor if you notice any of the following side effects:

Confusion as to time, place, or person; convulsions (seizures); dizziness; hallucinations (seeing, hearing, or feeling things that are not there); loss of appetite; memory loss; muscle twitching; nausea or vomiting; restlessness, nervousness, or irritability; slurred speech; sweating; trembling; trouble in sleeping; weakness; weight loss, unexplained

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

Revised: 03/14/2000

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