Se-Donna PB Hyos

Name: Se-Donna PB Hyos

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 Se-Donna PB Hyos. 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.

Description

Each 5 mL (one teaspoonful) for oral administration contains:
Phenobarbital, USP...........................................16.2 mg
(WARNING: may be habit forming)
Hyoscyamine sulfate, USP.............................0.1037 mg
Atropine sulfate, USP.....................................0.0194 mg
Scopolamine hydrobromide, USP.....................0.0065 mg
Alcohol....................................................................23%

Inactive ingredients

Artificial grape flavor, ethyl alcohol, FD&C blue #1, FD&C red #40, glycerin, purified water USP, sodium saccharin, sorbitol solution 70%, and sucrose.

Phenobarbital is a barbiturate with the chemical name:  5-Ethyl-5-phenylbarbituric acid.  It has the following structural formula:




Hyoscyamine sulfate is a belladonna alkaloid with the chemical name:  Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate.  It has the following structural formula:



Atropine sulfate is a belladonna alkaloid with the chemical name:  Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate.  It has the following structural formula:




Scopolamine hydrobromide is a belladonna alkaloid with the chemical name:  Benzeneacetic acid, α-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo [3.31.0.2,4]non-[7-yl ester, hydrobromide, trihydrte, [7(S)-(1α,2β,4β,5α,7β)]-.  It has the following structural formula:


Contraindications

Se-Donna Pb Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients.  Phenobarbital is contraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital produces restlessness and/or excitement.

It is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis; intestinal atony; unstable cardiovascular status in acute hemorrhage; hiatal hernia associated with reflux esophagitis; obstructive disease of the gastrointestinal tract; or severe ulcerative colitis.

Dosage and administration

The dosage of Se-Donna Pb Hyos Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

Adults:  One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.

Pediatric patients:  may be dosed every 4 to 6 hours.



                                           Starting dosage
Body weight
q4h q6h
10 lb. (4.5 kg)
0.5 mL
0.75 mL
20 lb. (9.1 kg)
1.0 mL
1.5 mL
30 lb. (13.6 kg)
1.5 mL
2.0 mL
50 lb. (22.7 kg)
1/2 tsp
3/4 tsp
75 lb. (34 kg)
3/4 tsp
1 tsp
100 lb. (45.4 kg)
1 tsp
1 1/2 tsp
Children under 2 years of age:  as directed by a physician.


Product packaging

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 13925-158-16

SE-DONNA
PB HYOS ELIXIR

Grape Flavored Oral Liquid

Each 5 mL (one teaspoonful) for oral administration contains:

Phenobarbital, USP.........................................16.2 mg
       (WARNING:  may be habit forming)
Hyoscyamine sulfate, USP...........................0.1037 mg
Atropine sulfate, USP...................................0.0194 mg
Scopolamine hydrobromide, USP..................0.0065 mg
Alcohol...............................................................23 %

CIV

Bulk Container

Not For Household Use

Rx ONLY

1 Pint

(16 fl oz / 473 mL)

SETON
PHARMACEUTICALS

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

WARNINGS:  KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.  IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

May be habit forming.

Store at 20° -25°C(68°-77°F)[see USP Controlled Room Temperature].
Excursions permitted to 15°-30°C(59°-86°F).

Avoid freezing.

Protect from light.

Dispense in a tight, light-resistant container, as defined in the USP/NF, with a child-resistant cap.

You may report side effects to the FDA at 1-800-FDA-1088

All prescriptions using this product shall be pursuant to state statutes as applicable.  This is not an Orange Book product.  This product may be administered only under a physician's supervision.  There are no implied or explicit claims on the therapeutic equivalence.

Manufactured for:

Seton Pharmaceuticals
Manasquan, NJ  08736
1-800-510-3401

Iss. 01/12









Se-Donna Pb Hyos  
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-158
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenobarbital (Phenobarbital) Phenobarbital 16.2 mg  in 5 mL
Hyoscyamine Sulfate (Hyoscyamine) Hyoscyamine Sulfate 0.1037 mg  in 5 mL
Atropine Sulfate (Atropine) Atropine Sulfate 0.0194 mg  in 5 mL
Scopolamine Hydrobromide (Scopolamine) Scopolamine Hydrobromide 0.0065 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Alcohol  
Glycerin  
Water  
Saccharin Sodium Dihydrate  
Sorbitol  
Sucrose  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:13925-158-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/09/2011
Labeler - Seton Pharmaceuticals (828898002)
Revised: 04/2012   Seton Pharmaceuticals

For the Consumer

Applies to atropine / hyoscyamine / phenobarbital / scopolamine: oral capsule, oral elixir, oral liquid, oral tablet, oral tablet extended release

Along with its needed effects, atropine / hyoscyamine / phenobarbital / scopolamine 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 while taking atropine / hyoscyamine / phenobarbital / scopolamine:

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

Some side effects of atropine / hyoscyamine / phenobarbital / scopolamine 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

For Healthcare Professionals

Applies to atropine / hyoscyamine / phenobarbital / scopolamine: oral capsule, oral elixir, oral liquid, oral tablet, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects have included xerostomia, nausea, vomiting, constipation, and bloating.[Ref]

Genitourinary

Genitourinary side effects have included urinary hesitancy, urinary retention, and impotence.[Ref]

Cardiovascular

Cardiovascular side effects have included tachycardia and palpitation.[Ref]

Ocular

Ocular side effects have included blurred vision, mydriasis, cycloplegia, and increased ocular tension.[Ref]

Hypersensitivity

Hypersensitivity reactions have included severe allergic reactions, anaphylaxis, urticaria, and other dermal manifestations.[Ref]

Endocrine

Endocrine side effects have included suppression of lactation.[Ref]

Musculoskeletal

Musculoskeletal side effects have included musculoskeletal pain.[Ref]

Nervous system

Nervous system side effects have included headache, excitement, and agitation.[Ref]

Psychiatric

Psychiatric side effects have included excitement in some patients and sedation in other patients with use of phenobarbital. Abrupt withdrawal from phenobarbital may produce delirium or convulsions.[Ref]

General

General side effects have included drowsiness, weakness, loss of taste sense, decreased sweating, and insomnia. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.[Ref]

Some side effects of Se-Donna PB HYOS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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