Belladonna alkaloids/ phenobarbital elixir

Generic Name: belladonna alkaloids/phenobarbital (bell-a-DON-a/fee-noe-BAR-bih-tal)
Brand Name: Donnatal

Belladonna alkaloids/ phenobarbital elixir is used for:

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.

Belladonna alkaloids/phenobarbital elixir is an anticholinergic and barbiturate combination. It works by decreasing the motion of the muscles in the stomach and intestine and providing mild sedation.

Do NOT use belladonna alkaloids/ phenobarbital elixir if:

  • you are allergic to any ingredient in belladonna alkaloids/phenobarbital elixir
  • you have previously experienced restlessness or excitement after taking phenobarbital
  • you have glaucoma; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); a blockage of the stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or heart problems with severe bleeding
  • you have a history of the blood disorder porphyria
  • you have a history of alcohol or substance abuse or dependence or may be at risk for an addiction
  • you are taking methoxyflurane, sodium oxybate (GHB), or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using belladonna alkaloids/ phenobarbital elixir:

Some medical conditions may interact with belladonna alkaloids/phenobarbital elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have nerve problems, prostate problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, diarrhea, fever, risk factors for glaucoma, kidney or liver problems, gallbladder problems, lung or breathing problems, an overactive thyroid, high blood pressure, difficulty urinating, or ulcer
  • if you have depression, pain, a history of suicidal thoughts or attempts, or are in shock
  • if you have been very ill or severely weakened
  • if you regularly consume alcohol

Some MEDICINES MAY INTERACT with belladonna alkaloids/phenobarbital elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • 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) because they may increase the risk of belladonna alkaloids/phenobarbital elixir's side effects
  • Methoxyflurane orsodium oxybate (GHB) because the risk of their side effects may be increased by belladonna alkaloids/phenobarbital elixir
  • 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 belladonna alkaloids/phenobarbital elixir
  • Halothane because belladonna alkaloids/phenobarbital elixir may mask the symptoms of halothane toxicity

This may not be a complete list of all interactions that may occur. Ask your health care provider if belladonna alkaloids/phenobarbital elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use belladonna alkaloids/ phenobarbital elixir:

Use belladonna alkaloids/phenobarbital elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take belladonna alkaloids/phenobarbital elixir by mouth with or without food.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you miss a dose of belladonna alkaloids/phenobarbital elixir, 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 belladonna alkaloids/phenobarbital elixir.

Important safety information:

  • Belladonna alkaloids/phenobarbital elixir may cause dizziness, drowsiness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use belladonna alkaloids/phenobarbital elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using belladonna alkaloids/phenobarbital elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
  • Belladonna alkaloids/phenobarbital elixir may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
  • Use belladonna alkaloids/phenobarbital elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.
  • Belladonna alkaloids/phenobarbital elixir should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using belladonna alkaloids/phenobarbital elixir. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • PREGNANCY and BREAST-FEEDING: Belladonna alkaloids/phenobarbital elixir has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using belladonna alkaloids/phenobarbital elixir while you are pregnant. Belladonna alkaloids/phenobarbital elixir is found in breast milk. If you are or will be breast-feeding while you use belladonna alkaloids/phenobarbital elixir, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, belladonna alkaloids/phenobarbital elixir may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if belladonna alkaloids/phenobarbital elixir stops working well. Do not take more than prescribed.

Some people who use belladonna alkaloids/phenobarbital elixir for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking belladonna alkaloids/phenobarbital elixir suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.

Possible side effects of belladonna alkaloids/ phenobarbital elixir:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; excessive daytime drowsiness ("hangover effect"); feeling of a whirling motion; headache; lightheadedness; nausea; nervousness; tired feeling; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; loss of coordination; loss of taste; memory loss; muscle pain; pounding in the chest; severe or persistent trouble sleeping; trouble urinating; unusual weakness; very slow breathing; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include change in size of pupil; deep sleep; hot, dry skin; loss of consciousness; severe dry mouth; severe or persistent headache or nausea; slowed or fast breathing; trouble swallowing; vomiting.

Proper storage of belladonna alkaloids/phenobarbital elixir:

Store belladonna alkaloids/phenobarbital elixir at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep belladonna alkaloids/phenobarbital elixir out of the reach of children and away from pets.

General information:

  • If you have any questions about belladonna alkaloids/phenobarbital elixir, please talk with your doctor, pharmacist, or other health care provider.
  • Belladonna alkaloids/phenobarbital elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take belladonna alkaloids/phenobarbital elixir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about belladonna alkaloids/phenobarbital elixir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to belladonna alkaloids/phenobarbital elixir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using belladonna alkaloids/phenobarbital elixir.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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