BELLADONNAALKALOIDS AND BARBITURATES (Systemic)

Some commonly used brand names are:

In the U.S.?

• Antrocol ²
• Barbidonna ¹
• Barbidonna No. 2 ¹
• Barophen ¹
• Bellalphen ¹
• Butibel ³
• Donnamor ¹
• Donnapine ¹
• Donnatal ¹
• Donnatal Extentabs ¹
• Donnatal No. 2 ¹
• Donphen ¹
• Hyosophen ¹
• Kinesed ¹
• Malatal ¹
• Relaxadon ¹
• Spaslin ¹
• Spasmolin ¹
• Spasmophen ¹
• Spasquid ¹
• Susano ¹

In Canada?

• Donnatal ¹
• Donnatal Extentabs ¹

Category

• Anticholinergic-sedative?Atropine and Phenobarbital; Atropine, Hyoscyamine,Scopolamine, and Phenobarbital; Belladonnaand Butabarbital

Description

Belladonna alkaloids and barbiturates are combination medicinestaken to relieve cramping and spasms of the stomach and intestines. They areused also to decrease the amount of acid formed in the stomach.

These medicines are available only with your doctor's prescription in thefollowing dosage forms:

Oral
• Atropine, Hyoscyamine, Scopolamine, and Phenobarbital
  • Capsules (U.S.)
  • Elixir (U.S. and Canada)
  • Tablets (U.S. and Canada)
  • Chewable tablets (U.S.)
  • Extended-release tablets (U.S. and Canada)
• Atropine and Phenobarbital
  • Capsules (U.S.)
  • Elixir (U.S.)
  • Tablets (U.S.)
• Belladonna and Butabarbital
  • Elixir (U.S.)
  • Tablets (U.S.)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to belladonna alkaloids (atropine, belladonna, hyoscyamine,and scopolamine) or to barbiturates (butabarbital, phenobarbital). Also, tellyour health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Belladonna alkaloids have not been shown to causeproblems in humans. However, barbiturates (contained in this medicine) havebeen shown to increase the chance of birth defects in humans. Also, when takenduring pregnancy, barbiturates may cause bleeding problems in the newbornbaby. Be sure that you have discussed this with your doctor before takingthis medicine.

Breast-feeding?Belladonna alkaloids or barbiturates have not beenshown to cause problems in nursing babies. However, traces of the belladonnaalkaloids and barbiturates pass into the breast milk. Also, because the belladonnaalkaloids tend to decrease the secretions of the body, it is possible thatthe flow of breast milk may be reduced in some patients.

Children?Severe side effects may be more likely to occur ininfants and children, especially those with spastic paralysis or brain damage.Unusual excitement, nervousness, restlessness, or irritability and unusualwarmth, 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 rapidincrease in body temperature may occur. In addition, the barbiturate in thismedicine could cause some children to become hyperactive.

Older adults?Confusion or memory loss; constipation; difficulturination; drowsiness; dryness of mouth, nose, throat, or skin; and unusualexcitement, nervousness, restlessness, or irritability may be more likelyto occur in the elderly, who are usually more sensitive than younger adultsto the effects of belladonna alkaloids and barbiturates. Also, eye pain mayoccur, which may be a sign of glaucoma.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingbelladonna alkaloids and barbiturates, it is especially important that yourhealth care professional know if you are taking any of the following:

• Adrenocorticoids (cortisone-like medicine) or
• Corticotropin (ACTH)?Belladonna alkaloids and barbituratesmay decrease the response to these medicines

• Antacids or
• Diarrhea medicine containing kaolin or attapulgite?These medicationsmay decrease the response to belladonna alkaloids

• Anticholinergics (medicine for abdominal or stomach spasms or cramps)?Belladonnaalkaloids and barbiturates may increase the response to anticholinergics

• Anticoagulants (blood thinners)?Belladonna alkaloids and barbituratesmay decrease the effect of this medicine

• Central nervous system (CNS) depressants (medicines that cause drowsiness)?TheCNS effects of either medicine could be increased

• Ketoconazole (e.g., Nizoral)?Using ketoconazole with this combinationmedicine may lessen the effects of ketoconazole and barbiturates

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g.,Marplan], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil],procarbazine [e.g., Matulane], selegiline [Eldepryl]; tranylcypromine [e.g.,Parnate])?Taking belladonna alkaloids and barbiturates while you aretaking or within 2 weeks of taking monoamine oxidase inhibitors may increasethe effects of the barbiturates

• Potassium chloride (e.g., Slow K or K-Dur)?May cause an increasein lesions (sores) of the stomach or intestine

Other medical problems?The presence of other medicalproblems may affect the use of belladonna alkaloids and barbiturates. Makesure you tell your doctor if you have any other medical problems, especially:

• Asthma, emphysema, or other chronic lung disease or
• Dryness of mouth (severe and continuing) or
• Enlarged prostate or
• Glaucoma or
• Heart disease or
• Hyperactivity (in children) or
• Intestinal blockage or other intestinal problems or
• Urinary tract blockage or difficult urination?Belladonna alkaloidsand barbiturates may make these conditions worse

• Brain damage (in children) or
• Spastic paralysis (in children)?These conditions may increasethe effects of the medicine

• Down's syndrome (mongolism)?This condition may increase theside effects of the medicine

• Kidney disease or
• Liver disease?Higher levels of the belladonna alkaloid andbarbiturate may result, possibly leading to increased side effects

Proper Use of This Medicine

Take thismedicine about 1/2 to 1 hour before meals, unless otherwise directedby your doctor.

Take this medicine only as directed. Do nottake more or less of it, do not take it more often, and do not take it fora longer time than your doctor ordered. To do so may increase the chance ofside effects.

Dosing?The dose of belladonna alkaloids and barbituratescombination will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of these combination medicines. If your dose is different, do not change it unlessyour doctor tells you to do so.

The number of capsules or tablets or the amount of solution you take dependson the strength of the medicine. Also, the number ofdoses you take each day, the time allowed between doses, and the length oftime you take the medicine depend on the medical problem for which you aretaking these combination products.

For atropine, hyoscyamine, scopolamine, and phenobarbital combination
• For stomach or intestine problems:
  • For oral dosage form (capsules or tablets):
    • Older adults, adults, and teenagers?1 or 2 capsules two tofour times a day. Your doctor may change 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 teaspoonfuls(5 to 10 milliliters [mL]) three or four times a day. Your doctor may changethe dose if needed.
    • Children?Dose is based on body weight and must be determinedby your doctor. The usual dose is 0.5 to 7.5 mL every four to six hours. Yourdoctor may change the dose if needed.
  • For oral dosage form (chewable tablets):
    • Older adults, adults, and teenagers?Chew 1 or 2 tablets threeor four times a day. Your doctor may change the dose if needed.
    • Children up to 2 years of age?Use is not recommended.
    • Children 2 to 12 years of age?1/2 to 1 tablet three orfour times a day. Your doctor may change the dose if needed.
  • For oral dosage form (extended-releasetablets):
    • Older adults, adults, and teenagers?1 tablet every eight totwelve hours. Your doctor may change the dose if needed.
    • Children?Use is not recommended.

For atropine and phenobarbital
• For stomach or intestine problems:
  • For oral dosage form (capsules or tablets):
    • Older adults, adults, and teenagers?1 or 2 capsules or tabletstwo to four times a day. Your doctor may change the dose if needed.
    • Children?Dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Older adults, adults, and teenagers?1 to 2 teaspoonfuls (5to 10 milliliters [mL]) three or four times a day. Your doctor may changethe dose if needed.
    • Children?Dose is based on body weight and must be determinedby your doctor. The usual dose is 0.5 to 3 mL every four to six hours. Yourdoctor may change the dose if needed.

For belladonna and butabarbital
• For stomach or intestine problems:
  • For oral dosage form (solution):
    • Older adults, adults and teenagers?1 to 2 teaspoonfuls (5 to10 milliliters [mL]) three or four times a day. Your doctor may change thedose if needed.
    • Children up to 6 years of age?1.25 to 2.5 mL three or fourtimes a day. Your doctor may change the dose if needed.
    • Children 6 to 12 years of age?2.5 to 5 mL three or four timesa day. Your doctor may change the dose if needed.
  • For oral dosage form (tablets):
    • Older adults, adults, and teenagers?1 or 2 tablets three orfour times a day. Your doctor may change the dose if needed.
    • Children?Dose must be determined by your doctor.

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

Storage?To store this medicine:

• Keep this medicine out of the reach of children. Overdose of belladonnaalkaloids and barbiturates is especially dangerous in young children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom,near the kitchen sink, or in other damp places. Heat or moisture may causethe medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Thismedicine will add to the effects of alcohol and other CNS depressants (medicinesthat slow down the nervous system, possibly causing drowsiness). Some examplesof CNS depressants are antihistamines or medicine for hay fever, other allergies,or colds; sedatives, tranquilizers, or sleeping medicine; prescription painmedicine or narcotics; barbiturates; medicine for seizures; muscle relaxants;or anesthetics, including some dental anesthetics. Checkwith your doctor before taking any of the above while you are taking thismedicine.

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

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

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

This medicine may cause some people to have blurred vision or to becomedrowsy, 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 tosee well.

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

Side Effects of This Medicine

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 mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Rare

Eye pain; skin rash or hives; sore throat and fever; unusual bleedingor bruising; yellow eyes or skin

Symptoms of overdose

Blurred vision (continuing) or changes in near vision; clumsiness or unsteadiness; confusion; convulsions (seizures); dizziness (continuing); drowsiness (severe); dryness of mouth, nose, or throat (severe); fast heartbeat; fever; hallucinations (seeing, hearing, or feeling things that are not there); shortness of breath or troubled breathing; slurred speech; unusual excitement, nervousness,restlessness, or irritability; unusual warmth, dryness,and flushing of skin

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

More common

Constipation; decreased sweating; dizziness; drowsiness; dryness of mouth, nose, throat, or skin

Less common or rare

Bloated feeling; blurred vision; decreased flow of breast milk; difficulturination; difficulty in swallowing; headache; increased sensitivity of eyesto sunlight; loss of memory; nausea or vomiting; unusual tiredness or weakness

Other side effects notlisted above may also occur in some patients. If you notice any other effects,check with your doctor.