Advertisement

Topics

PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR | PHENOBARBITAL WITH BELLADONNA ALKALOIDS [ATLANTIC BIOLOGICALS CORP.] | BioPortfolio

12:25 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

PHENOBARBITAL with BELLADONNA ALKALOIDS ELIXIR

​Rx Only

Rev. 1/18​

Each 5 mL (teaspoonful) of elixir contains:

Phenobarbital, USP ................................................... 16.2 mg

Hyoscyamine Sulfate, USP ................................... 0.1037 mg

Atropine Sulfate, USP ........................................... 0.0194 mg

Scopolamine Hydrobromide, USP ......................... 0.0065 mg

Ethyl Alcohol, Purified Water, Glycerin, Methylparaben Sodium, Propylparaben Sodium, Saccharin Sodium, Xylitol, Citric Acid, Stevia Reb-A, Natural and Artificial Grape Flavor

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

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.

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.

Phenobarbital with Belladonna Alkaloids Elixir 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.

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.

Phenobarbital with Belladonna Alkaloids Elixir 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 the 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.

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.

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Animal reproduction studies have not been conducted with Phenobarbital with Belladonna Alkaloids Elixir. It is not known whether Phenobarbital with Belladonna Alkaloids Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenobarbital with Belladonna Alkaloids Elixir should be given to a pregnant woman only if clearly needed.

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.

The dosage of Phenobarbital with Belladonna Alkaloids Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

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

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. (45.4kg) 1 tsp 1 1/2 tsp

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, 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.

Phenobarbital with Belladonna Alkaloids Elixir is supplied as a purple colored, grape flavored liquid.

4 oz. bottles

NDC: 17856-0162-1

NDC: 17856-0162-2

NDC: 17856-0162-3

AVOID FREEZING

Store at 20° – 25° C (68°- 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure.

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.

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.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 116th PLACE 

MIAMI, FL 33179

NDC 17856-0162-1

PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR

10mL/72 Cup

Rx Only

NDC 17856-0162-2

PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR

5mL/72 Cup

Rx Only

NDC 17856-0162-3

PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR

5mL/10 Cup

Rx Only

NDC 17856-0162-4

PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR

10mL/10 Cup

Rx Only

Manufacturer

ATLANTIC BIOLOGICALS CORP.

Active Ingredients

Source

Drugs and Medications [238 Associated Drugs and Medications listed on BioPortfolio]

Phenobarbital with belladonna alkaloids [lazarus pharmaceuticals, inc.]

PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR

Belladonna alkaloids with phenobarbital [west-ward pharmaceuticals corp]

BELLADONNA ALKALOIDS WITH PHENOBARBITAL TABLETSRx OnlyRev. 07/16

Belladonna alkaloids with phenobartbital [liberty pharmaceuticals, inc.]

BELLADONNAALKALOIDS WITHPHENOBARBITALTABLETSRx OnlyRev. 04/05

Belladonna alkaloids with phenobartbital [rebel distributors corp]

BELLADONNAALKALOIDS WITHPHENOBARBITALTABLETSRx OnlyRev. 04/05

Belladonna alkaloids with phenobartbital [legacy pharmaceutical packaging]

BELLADONNAALKALOIDS WITHPHENOBARBITALTABLETSRx OnlyRev. 04/05

Clinical Trials [31 Associated Clinical Trials listed on BioPortfolio]

Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for ...

Study of Phenobarbital Inhibition of Catamenial Epilepsy

The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy. We propose that since the catamenial seizures are associated with...

Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 w...

Prophylactic Phenobarbital After Neonatal Seizures

The treatment of infants with medications after their seizures have stopped is very variable. No one knows if continuing treatment with phenobarbital for up to several months is helpful o...

Effects of Perioperative Belladonna and Opium Suppositories on Postoperative Pain and Morphine Consumption on Patients After Robotic Assisted Laparoscopic Radical Prostatectomy

This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer....

PubMed Articles [220 Associated PubMed Articles listed on BioPortfolio]

Evaluation of Transdermal Administration of Phenobarbital in Healthy Cats.

The purpose was to determine the safety and achievable serum concentrations of transdermally administered phenobarbital in healthy cats. The hypothesis was that transdermal phenobarbital would achieve...

Bisbenzylisoquinoline Alkaloids.

The present review covers the literature on bisbenzylisoquinoline alkaloids from 1999 through early 2018. About 500 natural products belong to this large alkaloid class, of which 65 were characterized...

Norditerpenoid alkaloids from Delphinium pseudoaemulans C. Y. Yang et B. Wang.

Eight previously undescribed norditerpenoid alkaloids, pseudophnines A-D, pseudorenines A-B, and pseudonidines A-B, together with ten known norditerpenoid alkaloids, tianshanisine E, sharwuphinine B, ...

The Alstoscholarisine Alkaloids: Isolation, Structure Determination, Biogenesis, Biological Evaluation, and Synthesis.

The alstoscholarisines are a small family of biologically and structurally interesting polycyclic monoterpenoid indole alkaloids isolated from the leaf extracts of Alstonia scholaris. The alkaloids ca...

Cytotoxic and anti-inflammatory active plicamine alkaloids from Zephyranthes grandiflora.

Phytochemical investigation on the 95% EtOH extract of the whole plants of Zephyranthes grandiflora resulted in the isolation of six new 4a-epi-plicamine-type alkaloids, zephygranditines A-F (1-6), in...

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Irritable Bowel Syndrome IBS
Irritable bowel syndrome (IBS) is a common but poorly understood chronic (long-term) condition where the normal functions of the bowel are disrupted. Symptoms of IBS include abdominal pain or discomfort, changes in bowel habits and bloated feelings. ...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record