Belladonna / Phenobarbital

Name: Belladonna / Phenobarbital

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For stomach or intestine problems:
    • For oral dosage forms (capsules or tablets):
      • Older adults, adults, and teenagers—1 or 2 capsules 2 to 4 times a day. Your doctor may adjust the dose if needed.
      • Children—Dose must be determined by your doctor.
    • For oral dosage form (solution):
      • Adults and teenagers—The usual dose is 1 to 2 teaspoons (5 to 10 milliliters (mL)) 3 or 4 times a day. Your doctor may adjust the dose if needed.
      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 to 7.5 mL every 4 to 6 hours. Your doctor may adjust the dose if needed.
    • For oral dosage form (chewable tablets):
      • Older adults, adults, and teenagers—Chew 1 or 2 tablets 3 or 4 times a day. Your doctor may adjust the dose if needed.
      • Children 2 to 12 years of age—Chew one-half to 1 tablet 3 or 4 times a day. Your doctor may adjust the dose if needed.
      • Children up to 2 years of age—Use is not recommended.
    • For long-acting oral dosage form (extended-release tablets):
      • Older adults, adults, and teenagers—1 tablet every 8 to 12 hours. Your doctor may adjust the dose if needed.
      • Children—Use is not recommended.

Commonly used brand name(s)

In the U.S.

  • Antispasmodic
  • Belladonna/Phenobarbital
  • Donnatal
  • RE-PB Hyos
  • Se-Donna PB Hyos

Available Dosage Forms:

  • Elixir
  • Tablet, Extended Release
  • Liquid
  • Capsule
  • Tablet

Therapeutic Class: Antimuscarinic Combination

Pharmacologic Class: Atropine

Proper Use of belladonna alkaloids and phenobarbital

This section provides information on the proper use of a number of products that contain belladonna alkaloids and phenobarbital. It may not be specific to Belladonna/Phenobarbital. Please read with care.

Take this medicine about 30 minutes to 1 hour before meals, unless otherwise directed by your doctor.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For stomach or intestine problems:
    • For oral dosage forms (capsules or tablets):
      • Older adults, adults, and teenagers—1 or 2 capsules 2 to 4 times a day. Your doctor may adjust the dose if needed.
      • Children—Dose must be determined by your doctor.
    • For oral dosage form (solution):
      • Adults and teenagers—The usual dose is 1 to 2 teaspoons (5 to 10 milliliters (mL)) 3 or 4 times a day. Your doctor may adjust the dose if needed.
      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 to 7.5 mL every 4 to 6 hours. Your doctor may adjust the dose if needed.
    • For oral dosage form (chewable tablets):
      • Older adults, adults, and teenagers—Chew 1 or 2 tablets 3 or 4 times a day. Your doctor may adjust the dose if needed.
      • Children 2 to 12 years of age—Chew one-half to 1 tablet 3 or 4 times a day. Your doctor may adjust the dose if needed.
      • Children up to 2 years of age—Use is not recommended.
    • For long-acting oral dosage form (extended-release tablets):
      • Older adults, adults, and teenagers—1 tablet every 8 to 12 hours. Your doctor may adjust the dose if needed.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Belladonna/Phenobarbital

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

Do not take this medicine within 1 hour of taking antacids or medicine for diarrhea. Taking them too close together will make the belladonna alkaloids less effective.

Belladonna alkaloids will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, as overheating could possibly result in heat stroke. This is especially important in children taking belladonna alkaloids.

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

This medicine may cause some people to have blurred vision or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

This medicine may cause a dry mouth, nose, or throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Belladonna/Phenobarbital Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Eye pain
  • skin rash or hives
  • sore throat and fever
  • unusual bleeding or bruising
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • decreased sweating
  • dizziness
  • dry mouth, nose, throat, or skin
Less common or rare
  • Bloated feeling
  • blurred vision
  • decreased flow of breast milk
  • difficult urination
  • difficulty in swallowing
  • headache
  • increased sensitivity of eyes to sunlight
  • loss of memory
  • nausea or vomiting
  • unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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