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Each Libtrax Tablets contains

5 mg chlordiazepoxide hydrochloride
2.5 mg clidinium bromide

Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells may contain methyl and propyl parabens and potassium sorbate.

Libtrax
(chlordiazepoxide - clidinium)
How does this medication work? What will it do for me?

CHLORDIAZEPOXIDE BELONGS TO THE CLASS OF MEDICATIONS CALLED BENZODIAZEPINES. CLIDINIUM BELONGS TO THE CLASS OF MEDICATIONS CALLED ANTICHOLINERGICS. CHLORDIAZEPOXIDE AND CLIDINIUM ARE A COMBINATION OF MEDICATIONS USED TO TREAT STOMACH AND INTESTINAL PROBLEMS SUCH AS IRRITABLE BOWEL SYNDROME (IBS) AND ULCERS.
CHLORDIAZEPOXIDE - CLIDINIUM HELPS BY REDUCING THE AMOUNT OF ACID FORMED IN YOUR STOMACH AS WELL AS BY RELIEVING THE PAIN OF STOMACH SPASMS AND ABDOMINAL CRAMPS. OFTEN, RELIEF FROM SYMPTOMS OCCURS WITH THE FIRST COUPLE OF DOSES.


This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?
The recommended adult dose of this medication is 1 or 2 Tablets taken 1 to 4 times a day. The Tablets should be taken 30 to 60 minutes before a meal, unless otherwise instructed by your doctor. For seniors, the dose should start at 1 capsule 2 times a day, with adjustment to the dose as needed and tolerated. It is important that the dose be individualized to your specific needs to avoid excessive sedation or motor impairment.
This medication may be habit-forming when taken for long periods of time. If you have been taking this medication regularly for a long period of time (i.e., more than 1 month), do not stop taking the medication without first speaking with your doctor. To avoid withdrawal effects, a gradual dose reduction is usually recommended when stopping this medication.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If your next dose is in less than 4 hours, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Chlordiazepoxide - clidinium should not be taken by anyone who:
• is allergic to clidinium, chlordiazepoxide, any other medications belonging to the benzodiazepine class, or to any of the ingredients of the medication
• is breast-feeding
• is pregnant or planning to become pregnant
• has a hiatus hernia with reflux esophagitis
• has a history of drug abuse or dependence
• has an enlarged prostate
• has active heart problems
• has difficulty urinating
• has glaucoma
• has intestinal atony ("lazy bowel")
• has liver disease
• has myasthenia gravis
• has ulcerative colitis
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
• bloated feeling
• decreased sweating
• dizziness
• drowsiness
• dry mouth
• headache
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
• constipation
• eye pain
• insomnia
• mental depression
• nervousness or irritability
• shortness of breath
• skin rash or hives
• slow heartbeat
• sore throat and fever
• unusual excitement
• yellow eyes or skin
Stop taking the medication and seek immediate medical attention if any of the following occur:
• confusion
• difficult urination
• drowsiness (severe)
• dryness of nose, mouth, throat (severe)
• fast heartbeat
• unusual warmth, dryness, and flushing of skin
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Dental problems: Since one of the ingredients may cause a dry mouth, there is an increase risk of dental disease.
Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with benzodiazepines such as chlordiazepoxide - clidinium. Severe withdrawal may occur if the dose is significantly reduced or suddenly discontinued. These symptoms include seizures, irritability, nervousness, sleep problems, agitation, tremors, diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.
Drowsiness/reduced alertness: Because chlordiazepoxide - clidinium may cause drowsiness and sedation, do not engage in activities that require mental alertness, judgment, and physical coordination (such as driving or operating machinery) while taking this medication. This is particularly true when first starting the medication and until you have established that chlordiazepoxide - clidinium does not affect you this way. Alcohol ingestion can increase the drowsiness effects and should be avoided.
Medical conditions: Tell your doctor if you have any of the following conditions, as it may influence whether your doctor recommends this medication:
• chronic obstructive pulmonary disease (COPD)
• depression
• glaucoma (open-angle)
• hiatus hernia
• high blood pressure
• intestinal blockage
• kidney disease
• liver disease
• mental illness
• myasthenia gravis
• overactive thyroid
• ulcerative colitis
• xerostomia (condition with severe loss of saliva)
People with an addiction to alcohol or other medications should not take chlordiazepoxide, except in rare situations under medical supervision.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks.
Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking chlordiazepoxide - clidinium, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors may be at increased risk for the sedative and impaired coordination effects of this medication. They need to use extra caution, for example, when getting up during the night.
What other drugs could interact with this medication?
There may be an interaction between chlordiazepoxide - clidinium and any of the following:
• alcohol
• antacids
• anticholinergic medications (e.g., atropine, hyoscyamine)
• clarithromycin
• diarrhea medicines that contain kaolin or attapulgite
• fluconazole
• fluvoxamine
• itraconazole
• ketoconazole
• medications that cause sedation (e.g., antidepressants, benzodiazepines, barbiturates, MAO inhibitors, narcotics, phenothiazines, antihistamines)
• nefazodone
• phenytoin
• potassium chloride
• theophylline
• warfarin
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
What is Libtrax?
Libtrax is a capsule containing a combination of chlordiazepoxide and clidinium. Chlordiazepoxide is a benzodiazepine that affects chemicals in the brain that may be unbalanced. Clidinium reduces stomach acid and decreases intestinal spasms.
Libtrax is a medicine that may be effective in treating stomach ulcers, irritable bowel syndrome, or symptoms related to intestinal infection. Libtrax is given together with other medications to treat these conditions.
The U.S. Food and Drug Administration has determined that Libtrax is "possibly" effective in treating these conditions.
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Libtrax varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 Tablets, 3 or 4 times a day administered before meals and at bedtime.
Geriatric Dosing
Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Libtrax Tablets per day, to be increased gradually as needed and tolerated.
Important information
You should not use Libtrax if you have glaucoma, and enlarged prostate, bladder obstruction, or problems with urination.
Do not use Libtrax if you are allergic to chlordiazepoxide or clidinium, or to other benzodiazepines, such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax). Libtrax can cause birth defects in an unborn baby. Do not use this medicine if you are pregnant.
For the Consumer
Applies to chlordiazepoxide / clidinium: oral capsule
In addition to its needed effects, some unwanted effects may be caused by chlordiazepoxide / clidinium. In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking chlordiazepoxide / clidinium:
Incidence not known:
• Abdominal or stomach pain
• chills
• clay-colored stools
• confusion
• cough or hoarseness
• dark urine
• difficulty with speaking
• dizziness
• drooling
• drowsiness
• fever
• fever with or without chills
• general feeling of tiredness or weakness
• headache
• itching
• loss of appetite
• loss of balance control
• lower back or side pain
• muscle trembling, jerking, or stiffness
• nausea
• painful or difficult urination
• pale skin
• rash
• restlessness
• shakiness and unsteady walk
• shuffling walk
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiffness of the limbs
• swelling
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bruising or bleeding
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin
If any of the following symptoms of overdose occur while taking chlordiazepoxide / clidinium, get emergency help immediately:
Symptoms of overdose:
• Blurred vision
• change in consciousness
• difficulty having a bowel movement (stool)
• dry mouth
• lack of coordination
• loss of consciousness
• sleepiness or unusual drowsiness
Minor Side Effects
Some of the side effects that can occur with chlordiazepoxide / clidinium may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Incidence not known:
• Inability to have or keep an erection
• increase or loss in sexual ability, desire, drive, or performance
• increased or decreased interest in sexual intercourse
• menstrual changes
• skin blisters
For Healthcare Professionals
Applies to chlordiazepoxide / clidinium: oral capsule
Nervous system
The elderly and debilitated may be more susceptible to the side effects of chlordiazepoxide-clidinium. Drowsiness, ataxia, and confusion have occasionally been reported at the lower dosage ranges.[Ref]
Nervous system side effects have included drowsiness, ataxia, confusion, and extrapyramidal symptoms. Chlordiazepoxide-clidinium may impair the psychomotor skills necessary for driving. Changes in electroencephalogram (EEG) patterns (low-voltage fast activity) have been reported during and after chlordiazepoxide treatment.[Ref]
Gastrointestinal
Gastrointestinal side effects have included nausea, constipation, and dryness of the mouth.[Ref]
Hematologic
Hematologic side effects have included blood dyscrasias (including agranulocytosis).[Ref]
Hepatic
Hepatic side effects have included jaundice and hepatic dysfunction.[Ref]
Other
Other side effects have included increased and decreased libido, edema, and withdrawal symptoms. Rarely, syncope has been reported.[Ref]
Withdrawal symptoms after abrupt cessation of chlordiazepoxide-clidinium may include dysphoria, insomnia, convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, agitation, restlessness, and anxiety.
How should I take Libtrax?
Take Libtrax exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Libtrax is usually taken before meals and at bedtime. Follow your doctor's instructions.
Chlordiazepoxide may be habit-forming. Never share Libtrax with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Libtrax.
Call your doctor if your symptoms do not improve, or if they get worse.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Libtrax is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Libtrax dosing information


Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds.

USES

This medication is used along with medications that treat stomach ulcers. This combination product contains 2 medicines, chlordiazepoxide and clidinium. Chlordiazepoxide belongs to a class of drugs known as benzodiazepine anxiolytics. It works by relieving anxiety. Clidinium belongs to a class of drugs known as anticholinergics. It may help symptoms of cramping and abdominal/stomach pain by decreasing stomach acid, and slowing the intestines.

DOSAGE AND ADMINISTRATION
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Libtrax varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 Tablets, 3 or 4 times a day administered before meals and at bedtime.
Geriatric Dosing

Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Libtrax Tablets per day, to be increased gradually as needed and tolerated.

WARNINGS

As in the case of other preparations containing CNS-acting drugs, patients receiving Libtrax should be cautioned about possible combined effects with alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle.

CONTRAINDICATIONS

Libtrax is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide.

PATIENT INFORMATION

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

SIDE EFFECTS

Drowsiness, blurred vision, dry mouth, dry eyes, constipation, or increased heartbeat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on hard candy or ice chips, chew gum, drink water, or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, and drink plenty of water. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Presentation

Usual Adult Dose for Peptic Ulcer:
Chlordiazepoxide 5 mg-clidinium 2.5 mg oral Tablets: 1 or 2 Tabletss orally 3 or 4 times daily before meals and at bedtime
Usual Adult Dose for Irritable Bowel Syndrome:
Chlordiazepoxide 5 mg-clidinium 2.5 mg oral Tablets: 1 or 2 Tabletss orally 3 or 4 times daily before meals and at bedtime
Usual Adult Dose for Enterocolitis:
Chlordiazepoxide 5 mg-clidinium 2.5 mg oral Tablets: 1 or 2 Tabletss orally 3 or 4 times daily before meals and at bedtime
Usual Geriatric Dose for Peptic Ulcer:
Chlordiazepoxide 5 mg-clidinium 2.5 mg oral Tablets: 1 Tablets orally twice daily
Dose may be increased gradually as needed and tolerated.
Usual Geriatric Dose for Irritable Bowel Syndrome:
Chlordiazepoxide 5 mg-clidinium 2.5 mg oral Tablets: 1 Tablets orally twice daily
Dose may be increased gradually as needed and tolerated.
Usual Geriatric Dose for Enterocolitis:
Chlordiazepoxide 5 mg-clidinium 2.5 mg oral Tablets: 1 Tablets orally twice daily
Dose may be increased gradually as needed and tolerated.


Libtrax

Note :
This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).


 

 

 

 



 

 

 


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