Limit dosages and durations to the minimum required. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of Librax after continued use may precipitate acute withdrawal reactions, which can be life-threatening. Abuse, Misuse, and Addiction The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Librax, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
Acute Withdrawal Reactions The continued use of benzodiazepines, including Librax, may lead to clinically significant physical dependence. Effects on the Ability to Drive or Operate Machinery As in the case of other preparations containing CNS-acting drugs, patients receiving Librax should be cautioned about possible combined effects with opioids, alcohol and other CNS depressants.
Usage in Pregnancy An increased risk of congenital malformations associated with the use of minor tranquilizers chlordiazepoxide, diazepam and meprobamate during the first trimester of pregnancy has been suggested in several studies.
Information for Patients Abuse, Misuse, and Addiction Inform patients that the use of Librax, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications e. Withdrawal Reactions Inform patients that the continued use of Librax may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Librax may precipitate acute withdrawal reactions, which can be life-threatening.
Drug Interactions Opioids The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Librax, and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Oral Anticoagulants Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride, a component of Librax.
Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Librax.
Controlled Substance Librax contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Abuse Chlordiazepoxide hydrochloride, a component of Librax, is a CNS depressant with a potential for abuse and addiction. Dependence Physical Dependence Librax may produce physical dependence from continued therapy.
Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions e. Protracted Withdrawal Syndrome Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms e.
Tolerance Tolerance to Librax may develop from continued therapy. Recommended Geriatric Dosage Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. Discontinuation or Dosage Reduction of Librax To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Librax or reduce the dosage.
Keep out of reach of children. Taking Librax with opioid medicines, alcohol, or other central nervous system CNS depressants including street drugs can cause severe drowsiness, breathing problems respiratory depression , coma, and death. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Librax, which can lead to overdose or death. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing.
Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. Librax can cause physical dependence and withdrawal reactions. Stopping Librax suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions.
Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction. What is Librax? Keep Librax in a safe place to prevent misuse and abuse.
Selling or giving away Librax may harm others. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. Librax may harm your unborn baby. Avoid taking Librax during the first trimester of pregnancy.
Tell your healthcare provider right away if you become pregnant during treatment with Librax. Librax may pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Librax. Librax may decrease the amount of breast milk your body makes.
How should I take Librax? Do not change your dose of Librax or suddenly stop taking Librax without talking with your healthcare provider.
What are the possible side effects of Librax? When taken with alcohol or drugs that cause sleepiness or dizziness, Librax may make your sleepiness or dizziness much worse. How should I store Librax? What are the ingredients in Librax? Active ingredients: chlordiazepoxide hydrochloride and clidinium bromide Inactive ingredients: corn starch, lactose monohydrate, and talc. Chlordiazepoxide and clidinium may harm an unborn baby. Avoid taking this medicine during the first trimester of pregnancy.
If you use chlordiazepoxide and clidinium while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. It may not be safe to breastfeed while using this medicine.
Clidinium can slow breast milk production. Ask your doctor about any risk. Chlordiazepoxide and clidinium is not approved for use by anyone younger than 18 years old. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
This medicine can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing. The sedative effects of this medicine may last longer in older adults.
Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury. This is not a complete list of side effects and others may occur. If a person is taking a benzodiazepine near the time of delivery, the newborn might have withdrawal symptoms, which are treatable.
The symptoms of withdrawal might include lax muscle tone, difficulty feeding, irritability, or low body temperature. Not every baby exposed to chlordiazepoxide will have withdrawal symptoms. Does taking chlordiazepoxide in pregnancy cause long-term problems in behavior or learning for the baby? Studies have not been done to see if chlordiazepoxide use in pregnancy could increase the chance for behavior changes or learning difficulties. Chlordiazepoxide has not been well studied for use while breastfeeding.
Since chlordiazepoxide stays in the body for a long time, talk with your healthcare provider to see if another, better studied medication would work for you while you are breastfeeding.
Be sure to talk to your healthcare provider about all of your breastfeeding questions. If my male partner takes chlordiazepoxide can it make it harder for me to pregnant or increase the chance of birth defects? Chlordiazepoxide has not been studied for use in males who are trying to get a partner pregnant. Some interactions can be mitigated by separating the doses by one to four hours.
Others may require a dose reduction or drug substitution. Speak with your healthcare provider to understand which drugs are problematic and how to avoid interactions. Librax should be not be taken with alcohol, as their combined use can increase the sedative effect. This includes alcohol found in over-the-counter cough suppressants or cold remedies like Nyquil. Librax is contraindicated for use in people with certain diseases and medical conditions.
This means that the drug should not be used under any circumstance. The U. Food and Drug Administration FDA advise against using Librax during pregnancy, meaning that studies have shown potential harm to the fetus.
Librax should only be used during pregnancy if the benefits outweigh the risks. Women in their child-bearing years should use contraception if prescribed Librax. The risk of fetal harm is greatest during the first trimester when fetal cells are still specializing. It is unknown if the metabolites of Librax can be passed through breastmilk.
With that said, Librax can suppress the production of breast milk in nursing mothers. One of the most challenging aspects of having IBS is trying to figure out what's safe to eat. Our recipe guide makes it easier. Sign up and get yours now! National Library of Medicine.
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