QUADRAPAX

QUADRAPAX- phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide elixir
Acella Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 and C blue #1, FD and 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:
Phenobarbital structural formula
Hyoscyamine sulfate is a belladonna alkaloid with the chemical name Benzeneacetic acid, α-(hydroxmethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate. It has the following structural formula:
Hyoscyamine sulfate structural formula
Atropine sulfate is 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:
Atropine sulfate structural formula
Scopolamine is a belladonna alkaloid with the chemical name Benezeneacetic acid, α-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3.31.0. 2,4]non-[7-yl ester, hydrobromide, trihydrate, [7(S)-(1 α,2 β,4 β,5 α,7 β)]-. It has the following structural formula:
Scopolamine structural formula

CLINICAL PHARMACOLOGY:

Phenobarbital is a barbiturate, nonselective central nervous system depressant which is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses. Atropine Sulfate, Hyoscyamine Sulfate and Scopolamine Hydrobromide are belladonna alkaloids classified as anticholinergic, antimuscarinic drugs and act to inhibit muscarinic actions of acetycholine at postganglionic parasympathetic neuron effector sites. These drugs are also used as antispasmodics due to their anticholinergic action and produce the effect in the body of reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs. This drug combination provides peripheral anticholinergic/antispasmodic action and mild sedation.

INDICATIONS AND USAGE:

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.

CONTRAINDICATIONS:

Quadrapax 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.

WARNINGS:

Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug could be harmful.

Quadrapax Elixir

may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be needed 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 patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence.
Barbiturates should be used with caution in patients with hepatic dysfunction.

PRECAUTIONS:

GENERAL:


Use with caution in patients with prostatic hypertrophy, 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. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, a curare-like action may occur.

INFORMATION FOR PATIENTS:


Practitioners should give the following information and instructions to patients:

  • Do not increase the dose of this drug without consulting a physician.
  • Do not share this medication with others.

The use of this product caries with it an associated risk of psychological and/or physical dependence.
The use of this product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving or operating machinery.
Use of this product with alcohol may result in additional central nervous system depressant effects.
Tell your doctor or pharmacist if you also take antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotic pain relievers, or psychiatric medicines.
This drug may increase the risk for heatstroke because it decreases sweating. Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity.

DRUG INTERACTIONS:


Do not take this medicine with the following medications:

  • voriconazole
  • pramlintide.

This medicine may also interact with the following medication:
CNS depressants
cyclosporine
female hormones, like estrogens or progestins and birth control pills
medicines for HIV infection like indinavir, nelfinavir, ritonavir, and saquinavir
warfarin
amantadine
anti-Parkinson’s drugs levodopa, benztropine, trihexphenidyl
antispasmodic drugs clidinium, dicyclomine, propantheline
MAO inhibitors furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcpromine
anti-arrhythmic drugs disopyramide, procainamide, quinidine
azole anti-fungal drugs ketoconazole, itraconzole
bisphosphonate drugs alendronate, risedronate
corticosteroid prednisone
digoxin (slow-dissolving tablets)
phenothiazines (Promethazine)
potassium tablets/capsules
anti-seizure drug carbamazepine
anti-anxiety drugs alprazolam, diazepam, zolpidem
narcotic pain relievers
psychiatric drugs chlorpromazine, haloperidol, amitriptyline,risperidone
certain antihistamines diphenhydramine, meclizine
muscle relaxants

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:


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

PREGNANCY TERATOGENIC EFFECTS:


Pregnancy Category D.

Quadrapax Elixir

can cause fetal harm when administered to a pregnant woman. Retrospective case-controlled studies have suggested a connection between the maternal consumption of phenobarbital and higher than expected incidence of fetal abnormalities. Following oral administration, phenobarbital readily crosses the placental barrier and is distributed throughout fetal tissues with highest concentrations found in the placenta, fetal liver, and brain. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

NONTERATOGENIC EFFECTS:


Reports of infants suffering from long-term phenobarbital exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days.

LABOR AND DELIVERY:


Administration of

Quadrapax Elixir

to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects.

NURSING MOTHERS:


Caution should be exercised when

Quadrapax Elixir

is administered to a nursing woman. The active ingredients contained in this drug product are known to be excreted in human milk.

SPECIAL PATIENT POPULATION:


Dosage should be reduces in the debilitated because these patients may be more sensitive to phenobarbital. Dosage should be reduced for patients with impaired renal function or hepatic disease.

PEDIATRIC USE:


Use

Quadrapax Elixir

with caution in children as they may be more susceptible to the effects of this product especially infants, children with Down’s syndrome, spastic paralysis or brain damage.


GERIATRIC USE:

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of

Quadrapax Elixir

and observed closely. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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