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    H-Tran Plus Capsule

    GENERIC NAME(S): Chlordiazepoxide-Clidinium

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    WARNINGS:

    Taking chlordiazepoxide with opioid medications (such as codeine, hydrocodone) may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of chlordiazepoxide that works, and take it for the shortest possible time. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

    Who should not take H-Tran Plus Capsule?
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    Uses

    This medication is a combination of 2 drugs, clidinium and chlordiazepoxide. It is used along with other medications to help treat stomach/intestinal disorders (such as ulcers, irritable bowel syndrome, bowel infections). Clidinium helps to reduce the symptoms of stomach and intestinal cramping. It works by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Clidinium belongs to a class of drugs known as anticholinergics/antispasmodics. Chlordiazepoxide helps to reduce anxiety. It acts on the brain and nerves to produce a calming effect. It belongs to a class of drugs known as benzodiazepines.

    How to use H-Tran Plus Capsule

    Read the Medication Guide provided by your pharmacist before you start taking clidinium/chlordiazepoxide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

    Take this medication by mouth, usually 3 to 4 times a day (30 to 60 minutes before meals and at bedtime) or as directed by your doctor.

    If you are taking an antacid, take it after meals and take this medication before meals.

    The dosage is based on your age, medical condition, and response to treatment. Older adults usually start with a lower dose to decrease the risk of side effects.

    Do not increase your dose or take this drug more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may increase.

    This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as shakiness, sweating, nausea, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

    When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

    Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

    Tell your doctor if your condition persists or worsens.

    Side Effects

    See also Warning section.

    Dizziness, drowsiness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

    To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To relieve dry eyes, consult your pharmacist for artificial tears or other eye lubricants.

    To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your doctor right away if any of these unlikely but serious side effects occur: decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, loss of coordination, slurred speech, fainting, uncontrollable/unusual muscle movements, mental/mood changes (such as confusion, agitation, unusual excitement, depression, strange thoughts), difficulty urinating, decreased sexual ability.

    Tell your doctor right away if any of these rare but serioussigns of infection (such as fever, persistent sore throat), signs of liver problems (dark urine, persistent nausea, vomiting, stomach/abdominal pain, yellowing eyes/skin, unusual tiredness).

    Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).

    A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before taking this medication, tell your doctor or pharmacist if you are allergic to clidinium or chlordiazepoxide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of glaucoma (angle-closure type), enlarged prostate, problems with urination due to a blocked urinary tract, other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, little/no stomach acid, ileostomy/colostomy patients with diarrhea), overactive thyroid, heart problems (such as coronary artery disease, angina, congestive heart failure, fast/irregular heartbeat, heart problems due to severe bleeding), high blood pressure, heartburn problems (such as acid reflux, hiatal hernia, esophagus problems), a certain nervous system problem (autonomic neuropathy), myasthenia gravis, liver problems, kidney problems, breathing/lung problems, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood conditions (such as depression, thoughts of suicide, psychosis, schizophrenia), a certain blood disorder (porphyria).

    This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

    This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

    Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, unusual excitement, memory problems, constipation, urination problems, and unsteadiness. Drowsiness, confusion, and unsteadiness can increase the risk of falling.

    This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. If you become pregnant or think you may be pregnant while taking this medication, tell your doctor right away.

    This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

    Interactions

    See also Warning and How to Use sections.

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    Some products that may interact with this drug include: potassium tablets/capsules, sodium oxybate, drugs that are affected by slowed gut movement (such as pramlintide).

    This medication may affect the absorption of other products such as certain azole anti-fungal drugs (ketoconazole, itraconazole), slowly-dissolving forms of digoxin, among others. If you are taking either ketoconazole or itraconazole, take it at least 2 hours before this medication.

    Other medications can affect the removal of chlordiazepoxide from your body, which may affect how this drug works. Examples include cimetidine, disulfiram, among others.

    Cigarette smoking decreases blood levels of chlordiazepoxide. Tell your doctor if you smoke or if you have recently stopped smoking.

    Many other drugs that also cause dry mouth and constipation may interact with anticholinergics/antispasmodics such as clidinium. Tell your doctor or pharmacist about all the products you take, including: amantadine, other anticholinergic drugs (such as atropine, glycopyrrolate, scopolamine), other antispasmodic drugs (such as dicyclomine, propantheline), belladonna alkaloids, certain drugs used to treat Parkinson's disease (such as benztropine, trihexyphenidyl), certain drugs used to treat irregular heart rhythms (such as disopyramide, quinidine), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), phenothiazines (such as chlorpromazine), tricyclic antidepressants (such as amitriptyline).

    The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

    Check the labels on all your medicines (such as allergy or cough-and-cold products, diet aids) because they may contain ingredients that cause drowsiness or a fast heartbeat. Ask your pharmacist about using those products safely.

    This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, hot/dry skin, fever, severe dizziness, severe thirst, mental/mood changes (such as confusion, unusual excitement), fast/irregular heartbeat, muscle weakness, inability to move (paralysis), slowed breathing, fainting, seizures.

    Notes

    Do not share this medication with others.

    Management of digestive disorders may include lifestyle changes such as stress reduction programs, exercise, stopping smoking, and dietary changes, in addition to medication. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

    If this medication is used for an extended period of time, laboratory and/or medical tests (such as blood counts, liver function tests) may be performed periodically to check for side effects. Consult your doctor for more details.

    Missed Dose

    If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.

    Storage

    Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

    Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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