PHENOBARBITAL WITH BELLADONNA ALKALOIDS

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Overview

What is PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

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

What does PHENOBARBITAL WITH BELLADONNA ALKALOIDS look like?

What are the available doses of PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

Sorry No records found.

What should I talk to my health care provider before I take PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

Sorry No records found

How should I use PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

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.

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

What interacts with PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

Sorry No Records found

What are the warnings of PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

Sorry No Records found

What are the precautions of PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

Sorry No Records found

What are the side effects of PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

Sorry No records found

What should I look out for while using PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

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

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

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.

What might happen if I take too much PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

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.

How should I store and handle PHENOBARBITAL WITH BELLADONNA ALKALOIDS?

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.Phenobarbital with Belladonna Alkaloids Elixir4 oz. bottlesNDC: 71914-162-0416 oz. (Pint) bottlesNDC: 71914-162-16AVOID FREEZINGStore 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.Manufactured for:Lazarus Pharmaceuticals, Inc.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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

Non-Clinical Toxicology

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

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

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.

Cytochrome inducers/inhibitors:

HMG-CoA reductase inhibitors:

Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.

Ivabradine:

Aspirin:

Grapefruit juice:

Alcohol:

Beta-blockers:

In one study involving 15 patients treated with high doses of propranolol (median dose: 480 mg/day; range: 160 to 1,280 mg/day) for severe angina, with preserved left ventricular function (ejection fraction greater than 35%), the hemodynamic effects of additional therapy with verapamil HCl were assessed using invasive methods. The addition of verapamil to high-dose beta-blockers induced modest negative inotropic and chronotropic effects that were not severe enough to limit short-term (48 hours) combination therapy in this study. These modest cardiodepressant effects persisted for greater than 6 but less than 30 hours after abrupt withdrawal of beta-blockers and were closely related to plasma levels of propranolol. The primary verapamil/beta-blocker interaction in this study appeared to be hemodynamic rather than electrophysiologic.

In other studies, verapamil did not generally induce significant negative inotropic, chronotropic, or dromotropic effects in patients with preserved left ventricular function receiving low or moderate doses of propranolol (less than or equal to 320 mg/day); in some patients, however, combined therapy did produce such effects. Therefore, if combined therapy is used, close surveillance of clinical status should be carried out. Combined therapy should usually be avoided in patients with atrioventricular conduction abnormalities and those with depressed left ventricular function.

Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.

A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together.

Digitalis:

Antihypertensive agents:

Antiarrhythmic agents:

The electrophysiologic effects of quinidine and verapamil on AV conduction were studied in 8 patients. Verapamil significantly counteracted the effects of quinidine on AV conduction. There has been a report of increased quinidine levels during verapamil therapy.

Other agents:

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.

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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