Tropax

Based on a review of this drug by the National Academy of Sciences–National Research Council and/or other information, FDA has classified the following indications as: “possibly” effective:

For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

May also be useful as adjunctive therapy in the treatment of duodenal ulcer.

IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

Treating irritable bowel syndrome and intestinal inflammation in combination with other medicines. It may also be used along with other medicines to treat intestinal ulcers. It may also be used for other conditions as determined by your doctor.

Tropax is an anticholinergic and barbiturate combination. It works by decreasing the motion of the muscles in the stomach and intestine and providing mild sedation.

The dosage of Tropax® (belladonna alkaloids, Phenobarbital (Tropax)) should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The usual dose is one tablet every twelve (12) hours. If indicated, one tablet every eight (8) hours may be given.

How supplied

Tropax® (belladonna alkaloids, Phenobarbital (Tropax)) Tablets are supplied as: film coated green, round, compressed tablets printed "P421" in black ink.

• Bottles of 100 tablets
• Bottles of 500 tablets

Store at 20-25°C (68-77°F). Protect from light and moisture.

Dispense in a well-closed, light-resistant container as defined in the USP using a child-resistant closure.

Also available: Donnatal® Tablets in bottles of 100 and 1000 tablets and Donnatal® Elixir in 4 fl oz bottles and 1 pint bottles.

PBM Pharmaceuticals, Inc. Gordonsville, VA 22942. FDA Rev date: n/a

See also:
What is the most important information I should know about Tropax?

Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis.

Tropax® (belladonna alkaloids, Phenobarbital (Tropax)) is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital (Tropax) is contraindicated,in acute intermittent porphyria and in those patients in whom Phenobarbital (Tropax) produces restlessness and/or excitement.

Use Tropax as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tropax by mouth with or without food.
• If you miss a dose of Tropax, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tropax.

This product contains several medications: belladonna alkaloids (made up of the drugs Hyoscyamine (Tropax), Atropine (Tropax), and Scopolamine (Tropax)) and Phenobarbital (Tropax). Belladonna alkaloids help to reduce the symptoms of stomach and intestinal cramping. They work by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Belladonna alkaloids belong to a class of drugs known as anticholinergics/antispasmodics. Phenobarbital (Tropax) helps to reduce anxiety. It acts on the brain to produce a calming effect. Phenobarbital (Tropax) belongs to a class of drugs known as barbiturate sedatives.

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 your health 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 to relieve the symptoms of irritable bowel syndrome.

How to use Tropax

Take this medication by mouth as directed by your doctor. If you are taking the immediate-release tablets or liquid form of this medication, take it usually 3 to 4 times a day or as directed by your doctor.

If you are using the liquid, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If you are taking the extended-release tablets, take them usually every 12 hours or as directed by your doctor. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Antacids lower the absorption of this medication. If you are taking an antacid, take it at least 2 hours apart from this medication.

The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight.

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 anxiety, muscle twitching, shakiness, dizziness, worsening weakness, nausea, vomiting) may occur if you suddenly stop using this medication. Withdrawal from the Phenobarbital (Tropax) can be severe and include seizures and (rarely) death. 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.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition persists or worsens.

See also:
What other drugs will affect Tropax?

Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, thioridazine), quinine, stiripentol, tricyclic antidepressants (eg, amitriptyline), valproic acid, or other anticholinergics (eg, Scopolamine (Tropax)) because they may increase the risk of Tropax ’s side effects

Methoxyflurane orsodium oxybate (GHB) because the risk of their side effects may be increased by Tropax

Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin, doxycycline, erlotinib, estrogens (eg, estradiol), imatinib, metronidazole, quinidine, steroidal contraceptives (eg, birth control pills), theophylline, or voriconazole because their effectiveness may be decreased by Tropax

Halothane because

See also:
What are the possible side effects of Tropax?

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 you have any serious side effects, including: decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, loss of coordination, slurred speech, fainting, mental/mood changes (such as confusion, agitation, unusual excitement, depression, rare thoughts of suicide), difficulty urinating, decreased sexual ability, slow/shallow breathing, signs of anemia (such as unusual tiredness, pale skin), signs of infection (such as fever, persistent sore throat), easy bruising/bleeding.

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, get medical help right away 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.