Rivotril
--------------------------------------------------------------------------------
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:
--------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------
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 think you may have become mentally or physically dependent on this medicine, check with your doctor . Do not stop taking it suddenly.
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.