Belladonna Alkaloids, Phenobarbital (Donnatal Extentabs)
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Belladonna Alkaloids, Phenobarbital (Donnatal Extentabs)

Donnatal Extentabs®
(belladonna alkaoids, phenobarbital)

DRUG DESCRIPTION

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains:

Phenobarbital, USP (3/4 gr.) ................................ 48.6 mg
Hyoscyamine Sulfate, USP ................................... 0.3111 mg
Atropine Sulfate, USP ............................................ 0.0582 mg
Scopolamine Hydrobromide, USP ...................... 0.0195 mg

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains the equivalent of three Donnatal® tablets. Extentabs® are designed to release the ingredients gradually to provide effects for up to twelve (12) hours.

In addition, each tablet contains the following inactive ingredients: Anhydrous Lactose, Calcium Sulfate Granular, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, and Stearic Acid. Film Coating and Polishing Solution contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hydroxypropyl Methylcellulose, Polydextrose, Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink contains Titanium Dioxide.

What are the possible side effects of belladonna alkaloids and phenobarbital (Bellatal, Donnatal, D-Tal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • diarrhea;
  • painful or difficult urination;
  • fast or pounding heartbeats;
  • blurred vision with eye pain, or seeing halos around lights;
  • feeling like you might pass out; or
  • mouth sores, red or bleeding gums, or tooth decay (with...

Read All Potential Side Effects and See Pictures of Donnatal Extentabs »

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

The dosage of Donnatal Extentabs® (belladonna alkaloids, phenobarbital) 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

Donnatal Extentabs® (belladonna alkaloids, phenobarbital) 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) [See USP Controlled Room Temperature]. 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

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness: insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.

Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

Read the Donnatal Extentabs (belladonna alkaloids, phenobarbital) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

Donnatal Extentabs® (belladonna alkaloids, phenobarbital) may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.

Phenobarbital may decrease the effect of anticoagulants and necessitate larger doses of the anticoagulant for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs.

Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.

PRECAUTIONS

Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.

Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.

Theoretically, with overdosage, a curare-like action may occur.

Carcinogenesis, mutagenesis: Long-term studies in animals have not been performed to evaluate c arcinogenic potential.

Pregnancy Category C: Animal reproduction studies have not been conducted with Donnatal Extentabs® (belladonna alkaloids, phenobarbital) . It is not known whether Donnatal Extentabs® (belladonna alkaloids, phenobarbital) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal Extentabs® (belladonna alkaloids, phenobarbital) should be given to a pregnant woman only if clearly needed.

Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal Extentabs® (belladonna alkaloids, phenobarbital) is administered to a nursing mother.

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be added.

CONTRAINDICATIONS

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.

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

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

ACTIONS: This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

Donnatal Extentabs®
(belladonna alkaoids, phenobarbital)

DRUG DESCRIPTION

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains:

Phenobarbital, USP (3/4 gr.) ................................ 48.6 mg
Hyoscyamine Sulfate, USP ................................... 0.3111 mg
Atropine Sulfate, USP ............................................ 0.0582 mg
Scopolamine Hydrobromide, USP ...................... 0.0195 mg

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains the equivalent of three Donnatal® tablets. Extentabs® are designed to release the ingredients gradually to provide effects for up to twelve (12) hours.

In addition, each tablet contains the following inactive ingredients: Anhydrous Lactose, Calcium Sulfate Granular, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, and Stearic Acid. Film Coating and Polishing Solution contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hydroxypropyl Methylcellulose, Polydextrose, Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink contains Titanium Dioxide.

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

Donnatal Extentabs®
(belladonna alkaoids, phenobarbital)

DRUG DESCRIPTION

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains:

Phenobarbital, USP (3/4 gr.) ................................ 48.6 mg
Hyoscyamine Sulfate, USP ................................... 0.3111 mg
Atropine Sulfate, USP ............................................ 0.0582 mg
Scopolamine Hydrobromide, USP ...................... 0.0195 mg

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains the equivalent of three Donnatal® tablets. Extentabs® are designed to release the ingredients gradually to provide effects for up to twelve (12) hours.

In addition, each tablet contains the following inactive ingredients: Anhydrous Lactose, Calcium Sulfate Granular, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, and Stearic Acid. Film Coating and Polishing Solution contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hydroxypropyl Methylcellulose, Polydextrose, Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink contains Titanium Dioxide.

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

Donnatal Extentabs®
(belladonna alkaoids, phenobarbital)

DRUG DESCRIPTION

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains:

Phenobarbital, USP (3/4 gr.) ................................ 48.6 mg
Hyoscyamine Sulfate, USP ................................... 0.3111 mg
Atropine Sulfate, USP ............................................ 0.0582 mg
Scopolamine Hydrobromide, USP ...................... 0.0195 mg

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains the equivalent of three Donnatal® tablets. Extentabs® are designed to release the ingredients gradually to provide effects for up to twelve (12) hours.

In addition, each tablet contains the following inactive ingredients: Anhydrous Lactose, Calcium Sulfate Granular, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, and Stearic Acid. Film Coating and Polishing Solution contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hydroxypropyl Methylcellulose, Polydextrose, Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink contains Titanium Dioxide.

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

Donnatal Extentabs Patient Information Including Side Effects

Brand Names: Bellatal, Donnatal, D-Tal

Generic Name: belladonna alkaloids and phenobarbital (Pronunciation: BEL a DON a AL ka loids and FEEN oh BAR bi tal)

What is belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

Phenobarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Phenobarbital slows the activity of your brain and nervous system.

Belladonna alkaloids produce many effects in the body, including reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs.

The belladonna alkaloids included in this medication include atropine, hyoscyamine, and scopolamine.

The combination of belladonna alkaloids and phenobarbital is used to treat irritable bowel syndrome and ulcers in the intestine.

Belladonna alkaloids and phenobarbital may also be used for other purposes not listed in this medication guide.

Donnatal

round, white, imprinted with R, 42 50

What are the possible side effects of belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • diarrhea;
  • painful or difficult urination;
  • fast or pounding heartbeats;
  • blurred vision with eye pain, or seeing halos around lights;
  • feeling like you might pass out; or
  • mouth sores, red or bleeding gums, or tooth decay (with long-term use).

Less serious side effects may include:

  • drowsiness;
  • blurred vision, increased sensitivity to light;
  • dry mouth;
  • decreased taste sensation;
  • decreased sweating or urination;
  • headache, dizziness, weakness;
  • sleep problems (insomnia);
  • nausea, vomiting, constipation, bloating;
  • feeling restless or excited; or
  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Donnatal Extentabs (belladonna alkaloids, phenobarbital) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

Phenobarbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not take this medication together with a potassium supplement unless your doctor has told you to.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by belladonna alkaloids and phenobarbital.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while taking this medication or you could have increased dizziness and drowsiness.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Belladonna alkaloids and phenobarbital can decrease perspiration and you may be more prone to heat stroke.

Call your doctor if your symptoms do not improve, or if they get worse.

Side Effects Centers

Donnatal Extentabs Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

You should not use this medication if you are allergic to atropine, hyoscyamine, scopolamine, or phenobarbital. You may not be able use this medication if you have:

  • enlarged prostate, urination problems;
  • a blockage in your intestines or digestive tract;
  • a stomach condition called paralytic ileus;
  • active bleeding;
  • severe ulcerative colitis or toxic megacolon;
  • a muscle disorder called myasthenia gravis;
  • a hiatal hernia or reflux disease; or
  • porphyria.

Before taking this medication, tell your doctor if you are allergic to any drugs or if you have:

  • a colostomy or ileostomy;
  • liver disease;
  • kidney disease;
  • glaucoma;
  • a thyroid disorder;
  • heart disease, high blood pressure, congestive heart failure;
  • a heart rhythm disorder; or
  • ulcerative colitis or stomach ulcer.

If you have any of these conditions, you may not be able to take belladonna alkaloids and phenobarbital, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. However, belladonna alkaloids and phenobarbital can slow breast milk production. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child without the advice of a doctor.

Older adults may be more likely to have side effects such as constipation, dry mouth, problems with urination, agitation, confusion, or severe memory problems.

How should I take belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the medicine with a full glass of water.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, or if they get worse.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using belladonna alkaloids and phenobarbital.

Store belladonna alkaloids and phenobarbital at room temperature away from moisture and heat.

Keep track of how much of this medicine has been used from each new bottle. Phenobarbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Side Effects Centers

Donnatal Extentabs Patient Information including If I Miss a Dose

What happens if I miss a dose (Donnatal Extentabs)?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Donnatal Extentabs)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, dizziness, nausea, vomiting, dry mouth, blurred vision, hot or dry skin, trouble swallowing, feeling excited or agitated,

What should I avoid while taking belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

Do not take this medication together with a potassium supplement unless your doctor has told you to.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by belladonna alkaloids and phenobarbital.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while taking this medication or you could have increased dizziness and drowsiness.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Belladonna alkaloids and phenobarbital can decrease perspiration and you may be more prone to heat stroke.

What other drugs will affect belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

The following drugs can interact with belladonna alkaloids and phenobarbital. Tell your doctor if you are using any of these:

  • a blood thinner such as warfarin (Coumadin);
  • ketoconazole (Nizoral);
  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
  • glycopyrrolate (Robinul);
  • mepenzolate (Cantil);
  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with belladonna alkaloids and phenobarbital. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about belladonna alkaloids and phenobarbital.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.04. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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