Halcion

Drug monograph for the active ingredient in Halcion

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

BENZODIAZEPINES (Systemic)

Some commonly used brand names are:

In the U.S.—

• Alprazolam Intensol ¹
• Ativan ¹²
• Dalmane ⁹
• Diastat ⁷
• Diazepam Intensol ⁷
• Dizac ⁷
• Doral ¹⁶
• Halcion ¹⁸
• Klonopin ⁵
• Librium ³
• Lorazepam Intensol ¹²
• Niravam ¹
• Paxipam ¹⁰
• ProSom ⁸
• Restoril ¹⁷
• Serax ¹⁴
• Tranxene-SD ⁶
• Tranxene-SD Half Strength ⁶
• Tranxene T-Tab ⁶
• Valium ⁷
• Xanax ¹

In Canada—

• Alti-Alprazolam ¹
• Alti-Bromazepam ²
• Alti-Clonazepam ⁵
• Alti-Triazolam ¹⁸
• Apo-Alpraz ¹
• Apo-Chlordiazepoxide ³
• Apo-Clonazepam ⁵
• Apo-Clorazepate ⁶
• Apo-Diazepam ⁷
• Apo-Flurazepam ⁹
• Apo-Lorazepam ¹²
• Apo-Oxazepam ¹⁴
• Apo-Temazepam ¹⁷
• Apo-Triazo ¹⁸
• Ativan ¹²
• Clonapam ⁵
• Dalmane ⁹
• Diazemuls ⁷
• Frisium ⁴
• Gen-Alprazolam ¹
• Gen-Bromazepam ²
• Gen-Clonazepam ⁵
• Gen-Triazolam ¹⁸
• Halcion ¹⁸
• Lectopam ²
• Mogadon ¹³
• Novo-Alprazol ¹
• Novo-Clopate ⁶
• Novo-Dipam ⁷
• Novo-Flupam ⁹
• Novo-Lorazem ¹²
• Novo-Poxide ³
• Novo-Temazepam ¹⁷
• Novo-Triolam ¹⁸
• Novoxapam ¹⁴
• Nu-Alpraz ¹
• Nu-Loraz ¹²
• PMS-Clonazepam ⁵
• PMS-Diazepam ⁷
• Restoril ¹⁷
• Rivotril ⁵
• Serax ¹⁴
• Somnol ⁹
• Tranxene ⁶
• Valium ⁷
• Vivol ⁷
• Xanax ¹
• Xanax TS ¹

Category

• Amnestic—Diazepam (parenteral only); Lorazepam (parenteral only)
• Antianxiety agent—Alprazolam; Bromazepam; Chlordiazepoxide; Clorazepate; Diazepam; Halazepam; Ketazolam; Lorazepam; Oxazepam; Prazepam
• Anticonvulsant—Clobazam; Clonazepam; Clorazepate; Diazepam; Lorazepam (parenteral only); Nitrazepam
• Antiemetic, in cancer chemotherapy—Lorazepam (parenteral only)
• Antipanic agent—Alprazolam; Chlordiazepoxide (parenteral only); Clonazepam; Diazepam; Lorazepam
• Antitremor agent—Alprazolam; Chlordiazepoxide (oral only); Diazepam (oral only); Lorazepam (oral only)
• Sedative-hypnotic—Alprazolam; Bromazepam; Chlordiazepoxide; Clonazepam; Clorazepate; Diazepam; Estazolam; Flurazepam; Halazepam; Ketazolam; Lorazepam; Nitrazepam; Oxazepam; Prazepam; Quazepam; Temazepam; Triazolam
• Skeletal muscle relaxant adjunct—Diazepam; Lorazepam

Description

Benzodiazepines ((ben-zoe-dye-AZ-e-peens)) belong to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system).

Some benzodiazepines are used to relieve anxiety. However, benzodiazepines should not be used to relieve nervousness or tension caused by the stress of everyday life.

Some benzodiazepines are used to treat insomnia (trouble in sleeping). However, if used regularly (for example, every day) for insomnia, they usually are not effective for more than a few weeks.

Many of the benzodiazepines are used in the treatment of other conditions, also. Diazepam is used to help relax muscles or relieve muscle spasm. Diazepam injection is used before some medical procedures to relieve anxiety and to reduce memory of the procedure. Chlordiazepoxide, clorazepate, diazepam, and oxazepam are used to treat the symptoms of alcohol withdrawal. Alprazolam and clonazepam are used in the treatment of panic disorder. Clobazam, clonazepam, clorazepate, diazepam, and lorazepam are used in the treatment of certain convulsive (seizure) disorders, such as epilepsy. The benzodiazepines may also be used for other conditions as determined by your doctor.

Benzodiazepines may be habit-forming (causing mental or physical dependence), especially when taken for a long time or in high doses.

These medicines are available only with your doctor's prescription, in the following dosage forms:

Oral
• Alprazolam
  • Oral disintegrating tablets (U.S.)
  • Oral solution (U.S.)
  • Tablets (U.S. and Canada)
• Bromazepam
  • Tablets (Canada)
• Chlordiazepoxide
  • Capsules (U.S. and Canada)
• Clobazam
  • Tablets (Canada)
• Clonazepam
  • Tablets (U.S. and Canada)
• Clorazepate
  • Capsules (Canada)
  • Tablets (U.S.)
  • Extended-release tablets (U.S.)
• Diazepam
  • Oral solution (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Estazolam
  • Tablets (U.S.)
• Flurazepam
  • Capsules (U.S. and Canada)
  • Tablets (Canada)
• Halazepam
  • Tablets (U.S.)
• Lorazepam
  • Oral concentrate (U.S.)
  • Tablets (U.S. and Canada)
  • Sublingual tablets (Canada)
• Nitrazepam
  • Tablets (Canada)
• Oxazepam
  • Capsules (U.S.)
  • Tablets (U.S. and Canada)
• Quazepam
  • Tablets (U.S.)
• Temazepam
  • Capsules (U.S. and Canada)
• Triazolam
  • Tablets (U.S. and Canada)

Parenteral
• Chlordiazepoxide
  • Injection (U.S.)
• Diazepam
  • Injection (U.S. and Canada)
• Lorazepam
  • Injection (U.S. and Canada)

Rectal
• Diazepam
  • For rectal solution (may be prepared in U.S. and Canada from diazepam injection)
  • Rectal gel (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 benzodiazepines, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to benzodiazepines. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Certain benzodiazepine products may contain lactose, parabens, or soybean oil.

Pregnancy—Chlordiazepoxide and diazepam have been reported to increase the chance of birth defects when used during the first 3 months of pregnancy. Although similar problems have not been reported with the other benzodiazepines, the chance always exists since all of the benzodiazepines are related.

Studies in animals have shown that clonazepam, lorazepam, and temazepam cause birth defects or other problems, including death of the animal fetus.

Too much use of a benzodiazepine during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. Also, use of benzodiazepines during pregnancy, especially during the last weeks, may cause body temperature problems, breathing problems, difficulty in feeding, drowsiness, or muscle weakness in the newborn infant.

Benzodiazepines given just before or during labor may cause weakness in the newborn infant. When diazepam is given in high doses (especially by injection) within 15 hours before delivery, it may cause breathing problems, muscle weakness, difficulty in feeding, and body temperature problems in the newborn infant.

Breast-feeding—Benzodiazepines may pass into the breast milk and cause drowsiness, difficulty in feeding, and weight loss in nursing babies of mothers taking these medicines.

Children—Most of the side effects of these medicines are more likely to occur in children, especially the very young. These patients are usually more sensitive than adults to the effects of benzodiazepines.

It is possible that using clonazepam for long periods of time may cause unwanted effects on physical and mental growth in children. If such effects do occur, they may not be noticed until many years later. Before this medicine is given to children for long periods of time, you should discuss its use with your child's doctor.

Older adults—Most of the side effects of these medicines are more likely to occur in the elderly, who are usually more sensitive to the effects of benzodiazepines.

Taking benzodiazepines for trouble in sleeping may cause more daytime drowsiness in elderly patients than in younger adults. In addition, falls and related injuries are more likely to occur in elderly patients taking benzodiazepines.

Other medicines—Although certain medicines should not be used together at all, in other cases two 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 or receiving benzodiazepines it is especially important that your health care professional know if you are taking any of the following:

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—The CNS depressant effects of either these medicines or benzodiazepines may be increased; your doctor may want to change the dose of either or both medicines

• Fluvoxamine (e.g., Luvox) or
• Nefazodone (e.g., Serzone)—Higher blood levels of benzodiazepines may occur, increasing the chance that side effects will occur; your doctor may want to change the dose of either or both medicines, or give you a different medicine

• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral)—These medicines should NOT be used if you are taking a benzodiazepine.

Other medical problems—The presence of other medical problems may affect the use of benzodiazepines. 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 benzodiazepines may be more likely to develop

• Brain disease—CNS depression and other side effects of benzodiazepines may be more likely to occur

• Difficulty in swallowing (in children) or
• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Hyperactivity or
• Mental depression or
• Mental illness (severe) or
• Myasthenia gravis or
• Porphyria or
• Sleep apnea (temporary stopping of breathing during sleep)—Benzodiazepines may make these conditions worse

• Epilepsy or history of seizures—Although some benzodiazepines are used in treating epilepsy, starting or suddenly stopping treatment with these medicines may increase seizures

• Glaucoma, acute narrow angle—Benzodiazepines should NOT be used if you have this condition.

• Glaucoma, open angle—Benzodiazepines can be used but your doctor should be monitoring your condition carefully.

• Kidney or liver disease—Higher blood levels of benzodiazepines may result, increasing the chance that side effects will occur

Proper Use of This Medicine

For caregivers administering diazepam rectal gel :

• Discuss with the patient's medical doctor exactly when and how to use diazepam rectal gel.
• Discuss with the patient's medical doctor when you should call for emergency help.
• Read the instructions that you received with the medicine before you need to use it.
• Stay with the patient after administering diazepam rectal gel to check his or her condition as instructed by the doctor.

For patients taking clorazepate extended-release tablets :

• Swallow tablets whole.
• Do not crush, break, or chew before swallowing.

For patients taking alprazolam, diazepam, or lorazepam concentrated oral solution :

• Measure each dose carefully using the dropper provided with the medicine.
• It is recommended that each dose be mixed with water, soda or soda-like beverages, or semisolid food such as applesauce or pudding, just before it is taken.
• Take the entire mixture right away. It should not be saved to be used later.

For patients taking lorazepam sublingual tablets :

• Do not chew or swallow the tablet. This medicine is meant to be absorbed through the lining of the mouth. Place the tablet under your tongue (sublingual) and let it slowly dissolve there. Do not swallow for at least 2 minutes.

For patients taking alprazolam oral disintegrating tablets :

• Make sure your hands are dry. Just prior to taking the tablet, remove the tablet from the bottle. Immediately place the tablet on top of the tongue. The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet. If you have split apart a tablet and only taken one half of the tablet, you should throw away the unused part of the tablet right away because it may not remain stable.

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 (causing mental or physical dependence).

If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose . Instead, check with your doctor.

For patients taking this medicine on a regular schedule for epilepsy or other seizure disorder :

• In order for this medicine to control your seizures, it must be taken every day in regularly spaced doses as ordered by your doctor . This is necessary to keep a constant amount of the medicine in the blood. To help keep the amount constant, do not miss any doses.

For patients taking this medicine for insomnia :

• Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours) . If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

For patients taking flurazepam :

• When you begin to take this medicine, your sleeping problem will improve somewhat the first night. However, 2 or 3 nights may pass before you receive the full effects of this medicine .

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

The number of capsules or tablets, or the amount of solution that you take, or the number of injections you receive, 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 taking benzodiazepines .

For alprazolam
• For oral dosage form (solution or tablets):
  • For anxiety:
    • Adults—At first, 0.25 to 0.5 milligram (mg) three times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 4 mg a day.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, 0.25 mg two or three times a day. Your doctor may increase your dose if needed.
  • For panic disorder:
    • Adults—At first, 0.5 mg three times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 10 mg a day.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.

For bromazepam
• For oral dosage form (tablets):
  • For anxiety:
    • Adults—6 to 30 milligrams (mg) a day, taken in smaller doses during the day.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, up to 3 mg a day. Your doctor may change your dose if needed.

For chlordiazepoxide
• For oral dosage form (capsules):
  • For anxiety:
    • Adults—5 to 25 milligrams (mg) three or four times a day.
    • Children 6 years of age and older—5 mg two to four times a day. Your doctor may increase your dose if needed.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, 5 mg two to four times a day. Your doctor may increase your dose if needed.
  • For sedation during withdrawal from alcohol:
    • Adults—At first, 50 to 100 mg, repeated if needed. However, the dose usually is not more than 400 mg a day.
    • Children—Use and dose must be determined by your doctor.
• For injection dosage form:
  • For anxiety:
    • Adults—At first, 50 to 100 mg, injected into a muscle or vein. Then, if needed, 25 to 50 mg three or four times a day.
    • Teenagers—25 to 50 mg, injected into a muscle or vein.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • Older adults—25 to 50 mg, injected into a muscle or vein.
  • For sedation during withdrawal from alcohol:
    • Adults—At first, 50 to 100 mg, injected into a muscle or vein. If needed, the dose may be repeated in two to four hours.
    • Children—Use and dose must be determined by your doctor.

For clobazam
• For oral dosage form (tablets):
  • For control of seizures:
    • Adults—At first, 5 to 15 milligrams (mg) a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 80 mg a day.
    • Children 2 to 16 years of age—At first, 5 mg a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
    • Children younger than 2 years of age—Dose is based on body weight and must be determined by your doctor.

For clonazepam
• For oral dosage form (tablets):
  • For control of seizures:
    • Adults—At first, 0.5 milligram (mg) three times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 20 mg a day.
    • Infants and children younger than 10 years of age—Dose is based on body weight and must be determined by your doctor.
  • For panic disorder:
    • Adults—At first, 0.25 mg two times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 4 mg a day.
    • Children—Use and dose must be determined by your doctor.

For clorazepate
• For oral dosage form (capsules or tablets):
  • For anxiety:
    • Adults and teenagers—7.5 to 15 mg two to four times a day. Or your doctor may want you to start by taking 15 mg at bedtime.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, 3.75 to 15 mg a day. Your doctor may increase your dose if needed.
  • For sedation during withdrawal from alcohol:
    • Adults and teenagers—At first, 30 mg. Your doctor will set up a schedule that will gradually reduce your dose.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For control of seizures:
    • Adults and teenagers—At first, up to 7.5 mg taken three times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 90 mg a day.
    • Children 9 to 12 years of age—At first, up to 7.5 mg two times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children younger than 9 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets):
  • For anxiety:
    • Adults and teenagers—Your doctor may change your dosage form to the extended-release tablet if you are already taking 3.75 or 7.5 milligrams (mg) of clorazepate three times a day. The extended-release tablet is taken one time each day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For control of seizures:
    • Adults, teenagers, and children 9 to 12 years of age—Your doctor may change your dosage form to the extended-release tablet if you are already taking 3.75 or 7.5 milligrams (mg) of clorazepate three times a day. The extended-release tablet is taken one time each day.
    • Children younger than 9 years of age—Use and dose must be determined by your doctor.

For diazepam
• For oral dosage form (solution or tablets):
  • For anxiety:
    • Adults—2 to 10 mg two to four times a day.
    • Children 6 months of age and older—Dose is based on body weight or size and must be determined by your doctor.
    • Children younger than 6 months of age—Use is not recommended.
    • Older adults—2 to 2.5 mg one or two times a day. Your doctor may increase your dose if needed.
  • For sedation during withdrawal from alcohol:
    • Adults—At first, 10 mg three or four times a day. Your doctor will set up a schedule that will gradually decrease your dose.
    • Children—Use and dose must be determined by your doctor.
  • For control of seizures:
    • Adults—2 to 10 mg two to four times a day.
    • Children 6 months of age and older—Dose is based on body weight or size and must be determined by your doctor.
    • Children younger than 6 months of age—Use is not recommended.
    • Older adults—2 to 2.5 mg one or two times a day. Your doctor may increase your dose if needed.
  • For relaxing muscles:
    • Adults—2 to 10 mg three or four times a day.
    • Children 6 months of age and older—Dose is based on body weight or size and must be determined by your doctor.
    • Children younger than 6 months of age—Use is not recommended.
    • Older adults—2 to 2.5 mg one or two times a day. Your doctor may increase your dose if needed.
• For injection dosage form:
  • For anxiety:
    • Adults—2 to 10 mg, injected into a muscle or vein.
    • Children—Use and dose must be determined by your doctor.
    • For older adults—2 to 5 mg, injected into a muscle or vein.
  • For sedation during withdrawal from alcohol:
    • Adults—At first, 10 mg injected into a muscle or vein. If needed, 5 to 10 mg may be given three or four hours later.
    • Children—Use and dose must be determined by your doctor.
  • For sedation before surgery or other procedures:
    • Adults—5 to 20 mg, injected into a muscle or vein.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—2 to 5 mg, injected into a muscle or vein.
  • For control of seizures:
    • Adults—At first, 5 to 10 mg, usually injected into a vein every ten to fifteen minutes, stopping if the total dose reaches 30 mg. If needed, this treatment may be repeated in two to four hours.
    • Children 5 years of age and older—At first, 1 mg, usually injected into a vein every two to five minutes, stopping if the total dose reaches 10 mg. This treatment may be repeated in two to four hours.
    • Infants older than 30 days of age and children younger than 5 years of age—At first, 0.2 to 0.5 mg, usually injected into a vein every two to five minutes, stopping if the total dose reaches 5 mg. This treatment may be repeated in two to four hours.
    • Newborns and infants 30 days of age and younger—Use and dose must be determined by your doctor.
    • Older adults—2 to 5 mg, injected into a muscle or vein.
  • For relaxing muscle spasms:
    • Adults—At first, 5 to 10 mg injected into a muscle or vein. The dose may be repeated in three or four hours.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—2 to 5 mg, injected into a muscle or vein.
  • For relaxing muscles in tetanus:
    • Adults—At first, 5 to 10 mg injected into a muscle or vein. Your doctor may increase your dose if needed.
    • Children 5 years of age and older—5 to 10 mg, injected into a muscle or vein. The dose may be repeated every three to four hours if needed.
    • Infants older than 30 days of age and children younger than 5 years of age—1 to 2 mg, injected into a muscle or vein. The dose may be repeated every three to four hours if needed.
    • Newborns and infants 30 days of age and younger—Use and dose must be determined by your doctor.
• For rectal dosage form (gel or solution):
  • For control of seizures:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor.
    • Children—Dose is based on body weight and must be determined by your doctor.

For estazolam
• For oral dosage form (tablets):
  • For trouble in sleeping:
    • Adults—1 milligram (mg) at bedtime. Your doctor may increase your dose if needed. However, the dose usually is not more than 2 mg.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.

For flurazepam
• For oral dosage form (capsules or tablets):
  • For trouble in sleeping:
    • Adults—15 or 30 milligrams (mg) at bedtime.
    • Children younger than 15 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, 15 mg at bedtime. Your doctor may increase your dose if needed.

For halazepam
• For oral dosage form (tablets):
  • For anxiety:
    • Adults—20 to 40 milligrams (mg) three or four times a day.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.
    • Older adults—20 mg one or two times a day.

For lorazepam
• For oral dosage form (concentrate or tablets):
  • For anxiety:
    • Adults and teenagers—1 to 3 milligrams (mg) two or three times a day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • Older adults—0.5 to 2 mg a day, taken in smaller doses during the day.
  • For trouble in sleeping:
    • Adults and teenagers—2 to 4 mg taken at bedtime.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For sublingual tablet dosage form:
  • For anxiety:
    • Adults—2 to 3 mg a day, in smaller doses placed under the tongue during the day. Your doctor may increase your dose if needed. However, the dose usually is not more than 6 mg a day.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, 0.5 mg a day. Your doctor may increase your dose if needed.
  • For sedation before surgery:
    • Adults—Dose is based on body weight and will be determined by your doctor. However, the dose usually is not more than 4 mg, placed under the tongue, one to two hours before surgery.
    • Children—Use and dose must be determined by your doctor.
• For injection dosage form:
  • For sedation before surgery or other procedures:
    • Adults—Dose is based on body weight and will be determined by your doctor. However, the dose usually is not more than 4 mg, injected into a muscle or vein.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.
  • For control of seizures:
    • Adults—At first, 4 mg slowly injected into a vein. The dose may be repeated after ten to fifteen minutes if needed.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.

For nitrazepam
• For oral dosage form (tablets):
  • For trouble in sleeping:
    • Adults—5 to 10 milligrams (mg) at bedtime.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 2.5 mg taken at bedtime. Your doctor may increase your dose if needed.
  • For control of seizures:
    • Children less than 30 kilograms (66 pounds) of body weight—Dose is based on body weight and will be determined by your doctor.

For oxazepam
• For oral dosage form (capsules or tablets):
  • For anxiety:
    • Adults—10 to 30 milligrams (mg) three or four times a day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, 5 mg one or two times a day or 10 mg three times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 15 mg four times a day.
  • For sedation during withdrawal from alcohol:
    • Adults—15 to 30 mg three or four times a day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

For quazepam
• For oral dosage form (tablets):
  • For trouble in sleeping:
    • Adults—7.5 to 15 milligrams (mg) at bedtime.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.

For temazepam
• For oral dosage form (capsules):
  • For trouble in sleeping:
    • Adults—15 milligrams (mg) at bedtime. Your doctor may change your dose if needed.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, 7.5 mg at bedtime. Your doctor may increase your dose if needed.

For triazolam
• For oral dosage form (tablets):
  • For trouble in sleeping:
    • Adults—0.125 to 0.25 milligram (mg) at bedtime.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.
    • Older adults—At first, 0.125 mg at bedtime. Your doctor may increase your dose if needed.

Missed dose—If you are taking this medicine regularly (for example, every day as for epilepsy) and you miss a dose, take it right away if you remember within an hour or so of the missed dose. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children. Overdose of benzodiazepines may be especially dangerous in children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Keep the oral disintegrating tablet form of this medicine in a tightly sealed bottle and discard any cotton that was included in the bottle
• 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 a benzodiazepine regularly for a long time :

• Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects. If you are taking a benzodiazepine for convulsions (seizures), this is also important during the first few months of treatment.
• Check with your doctor at regular visits to see if you need to continue taking this medicine.

If you are taking a benzodiazepine for epilepsy or another seizure disorder :

• Your doctor may want you to carry a medical identification card or bracelet stating that you are taking this medicine.

If you are taking a benzodiazepine for insomnia (trouble in sleeping):

• If you think you need this medicine for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.
• You may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking this medicine.

Benzodiazepines may be habit-forming (causing mental or physical dependence) , especially when taken for a long time or in high doses. Some signs of dependence on benzodiazepines are:

• A strong desire or need to continue taking the medicine.
• A need to increase the dose to receive the effects of the medicine.
• Withdrawal effects (for example, irritability, nervousness, trouble in sleeping, abdominal or stomach cramps, trembling or shaking) occurring after the medicine is stopped.

If you have been taking this medicine in large doses or for a long time, 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. Stopping this medicine suddenly may cause withdrawal side effects, including seizures. Stopping this medicine suddenly is most likely to cause seizures if you have been taking it for epilepsy or another seizure disorder.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing 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. This effect may last for a few days after you stop taking this medicine. 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 a benzodiazepine or taking alcohol or other CNS depressants with the benzodiazepine may lead to unconsciousness and possibly death. Some signs of an overdose are continuing slurred speech or confusion, severe drowsiness, severe weakness, and staggering.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of the metyrapone test may be affected by chlordiazepoxide.

If you develop any unusual and strange thoughts or behavior while you are taking this medicine, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, agitation, and hallucinations (seeing, hearing, or feeling things that are not there).

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, 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:

Less common

Anxiety; confusion (may be more common in the elderly); fast, pounding, or irregular heartbeat; lack of memory of events taking place after benzodiazepine is taken (may be more common with triazolam); mental depression

Rare

Abnormal thinking, including disorientation, delusions (holding false beliefs that cannot be changed by facts), or loss of sense of reality; agitation; behavior changes, including aggressive behavior, bizarre behavior, decreased inhibition, or outbursts of anger; convulsions (seizures); hallucinations (seeing, hearing, or feeling things that are not there); hypotension (low blood pressure); muscle weakness; skin rash or itching; sore throat, fever, and chills; trouble in sleeping; ulcers or sores in mouth or throat (continuing); uncontrolled movements of body, including the eyes; unusual bleeding or bruising; unusual excitement, nervousness, or irritability; unusual tiredness or weakness (severe); yellow eyes or skin

Symptoms of overdose

Confusion (continuing); convulsions (seizures); drowsiness (severe) or coma; shakiness; slow heartbeat; slow reflexes; slurred speech (continuing); staggering; troubled breathing; weakness (severe)

For patients having chlordiazepoxide, diazepam, or lorazepam injected :

• Check with your doctor if there is redness, swelling, or pain at the place of injection.

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:

More common

Clumsiness or unsteadiness; dizziness or lightheadedness; drowsiness; slurred speech

Less common or rare

Abdominal or stomach cramps or pain; blurred vision or other changes in vision; changes in sexual desire or ability; constipation; diarrhea; dryness of mouth or increased thirst; false sense of well-being; headache; increased bronchial secretions or watering of mouth; muscle spasm; nausea or vomiting; problems with urination; trembling or shaking; unusual tiredness or weakness

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the benzodiazepines are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. During this time, check with your doctor if you notice any of the following side effects:

More common

Irritability; nervousness; trouble in sleeping

Less common

Abdominal or stomach cramps; confusion; fast or pounding heartbeat; increased sense of hearing; increased sensitivity to touch and pain; increased sweating; loss of sense of reality; mental depression; muscle cramps; nausea or vomiting; sensitivity of eyes to light; tingling, burning, or prickly sensations; trembling or shaking

Rare

Confusion as to time, place, or person; convulsions (seizures); feelings of suspicion or distrust; hallucinations (seeing, hearing, or feeling things that are not there)

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, some of the benzodiazepines are used in certain patients with the following medical conditions:

• Nausea and vomiting caused by cancer chemotherapy
• Tension headache
• Tremors

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 02/24/2005

The information contained in the Thomson Healthcare products is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare makes no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Copyright © 2004 Thomson Healthcare Inc. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.

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