Drug Details
Drug Name(s) BANTHINE
FDA Application No. (NDA) 007390
Active Ingredient(s) METHANTHELINE BROMIDE
Company SHIRE
Original Approval or Tentative Approval Date July 3, 1951
Chemical Type 1 New molecular entity (NME)
Review Classification S Standard review drug
Uses
Propantheline is used with other medications to treat peptic ulcers. It works by decreasing the release of acid in the stomach.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by yourhealth care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used with other medications to treat extra stomach acid (e.g., Zollinger-Ellison syndrome) or certain bowel disorders (e.g., irritable bowel syndrome). For bowel disorders, the medication works by decreasing the movement of the stomach/intestines.
How to use Pro-BanthineTake this medication by mouth, usually 30 minutes before each meal and at bedtimeor as directed by your doctor.
Dosage is based on your medical condition and response to therapy.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Inform your doctor if your condition persists or worsens.
Propantheline is used with other medications to treat peptic ulcers. It works by decreasing the release of acid in the stomach.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by yourhealth care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used with other medications to treat extra stomach acid (e.g., Zollinger-Ellison syndrome) or certain bowel disorders (e.g., irritable bowel syndrome). For bowel disorders, the medication works by decreasing the movement of the stomach/intestines.
How to use Pro-BanthineTake this medication by mouth, usually 30 minutes before each meal and at bedtimeor as directed by your doctor.
Dosage is based on your medical condition and response to therapy.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Inform your doctor if your condition persists or worsens.
Side Effects
Dry mouth, decreased sweating, dizziness, drowsiness, blurred vision, widened pupils, nausea/vomiting, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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: mental/mood changes, eye pain/pressure, fast/pounding heartbeat, difficulty urinating.
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.
Dry mouth, decreased sweating, dizziness, drowsiness, blurred vision, widened pupils, nausea/vomiting, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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: mental/mood changes, eye pain/pressure, fast/pounding heartbeat, difficulty urinating.
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.
Precautions
Before taking propantheline, tell your doctor or pharmacist if you are allergic to it; 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: glaucoma, myasthenia gravis, movement/blockage disorders of the stomach/bowels (e.g., paralytic ileus, pyloroduodenal stenosis, achalasia, intestinal atony), difficulty urinating (e.g., prostatic hypertrophy), overactive thyroid (hyperthyroidism), liver disease, kidney disease, high blood pressure, heart/blood vessel disease (e.g., congestive heart failure, coronary artery disease, tachycardia), esophagus problems (e.g., GERD), nerve disorders (e.g., autonomic neuropathy), diarrhea, breathing problems (e.g., asthma), ulcerative colitis.
Before having surgery, tell your doctor or dentist that you are using this medication.
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. Limit alcoholic beverages.
This medication can decrease sweating. To prevent heatstroke, avoid becoming overheated in hot weather, in saunas, and during exercise/other strenuous activities.
Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Before taking propantheline, tell your doctor or pharmacist if you are allergic to it; 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: glaucoma, myasthenia gravis, movement/blockage disorders of the stomach/bowels (e.g., paralytic ileus, pyloroduodenal stenosis, achalasia, intestinal atony), difficulty urinating (e.g., prostatic hypertrophy), overactive thyroid (hyperthyroidism), liver disease, kidney disease, high blood pressure, heart/blood vessel disease (e.g., congestive heart failure, coronary artery disease, tachycardia), esophagus problems (e.g., GERD), nerve disorders (e.g., autonomic neuropathy), diarrhea, breathing problems (e.g., asthma), ulcerative colitis.
Before having surgery, tell your doctor or dentist that you are using this medication.
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. Limit alcoholic beverages.
This medication can decrease sweating. To prevent heatstroke, avoid becoming overheated in hot weather, in saunas, and during exercise/other strenuous activities.
Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.