Belladonna alkaloids and phenobarbital (oral route)

Brand Name

US Brand Name

Antispasmodic

Belladonna/Phenobarbital

Donnatal

RE-PB Hyos

Se-Donna PB Hyos

Description

Belladonna alkaloids and phenobarbital combination is used to treat cramping and spasms in the stomach and intestines. It may also be used for stomach ulcers.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet
Elixir

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Severe side effects may be more likely to occur in infants and children, especially those with spastic paralysis or brain damage. Unusual excitement, nervousness, restlessness, or irritability and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of belladonna alkaloids. Also, when belladonna alkaloids are given to children during hot weather, a rapid increase in body temperature may occur. In addition, the barbiturate in this medicine could cause some children to become hyperactive.

Geriatric

Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of mouth, nose, throat, or skin; and unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of belladonna alkaloids and barbiturates. Also, eye pain may occur, which may be a sign of glaucoma.

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.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ambenonium
Atazanavir
Boceprevir
Cabotegravir
Cobicistat
Darunavir
Dasabuvir
Delamanid
Doravirine
Elvitegravir
Isavuconazonium Sulfate
Isocarboxazid
Lonafarnib
Maraviroc
Mavacamten
Nirmatrelvir
Ombitasvir
Paritaprevir
Potassium Chloride
Potassium Citrate
Ranolazine
Rilpivirine
Ritonavir
Rivaroxaban
Telaprevir
Tenofovir Alafenamide
Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abemaciclib
Abiraterone Acetate
Abiraterone Acetate, Micronized
Abrocitinib
Acalabrutinib
Acenocoumarol
Acepromazine
Aclidinium
Alfentanil
Alfuzosin
Alprazolam
Amantadine
Amifampridine
Amiodarone
Amisulpride
Amitriptyline
Amlodipine
Amobarbital
Amoxapine
Amprenavir
Anagrelide
Anileridine
Anisindione
Apalutamide
Apixaban
Apomorphine
Aprepitant
Aprobarbital
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Arsenic Trioxide
Asenapine
Astemizole
Atogepant
Atorvastatin
Atrasentan
Atropine
Avacopan
Avanafil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Arbutamine
Betamethasone
Bexarotene
Cortisone
Digitoxin
Ethosuximide
Ginkgo
Griseofulvin
Leucovorin
Levomethadyl
Methylprednisolone
Metoprolol
Ospemifene
Prednisone
Rufinamide
Theophylline
Tiagabine
Topiramate

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use

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

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.

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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