QUADRAPAX ELIXIR（一种用于治疗过敏性肠综合症和其他肠道疾病的处方药）。
QUADRAPAX ELIXIR中含有苯巴比妥（一种用作镇静剂的巴比妥酸盐），含有阿托品（常用作腹泻、急性腹痛以及其他肠道疾病）。
QUADRAPAX
By Acella Pharmaceuticals, LLC
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.
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.
ADVERSE REACTIONS:
Adverse reactions associated with anticholinergics and/or anticonvulsants are: dry mouth; tachycardia; urinary hesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss of taste sense;
headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, hives and/or other dermal manifestations; decreased sweating; impotence; suppression of lactation;
constipation; bloated feeling and musculoskeletal pain. Elderly patients may react with symptoms of excitement, agitation and drowsiness 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.
DRUG ABUSE AND DEPENDENCE:
This product is subject to the provisions of the Controlled Substance Act and has been placed in Schedule IV. Phenobarbital may be habit-forming. Tolerance, psychological dependence, and physical dependence may occur following prolonged use.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
OVERDOSAGE:
An overdose of Quadrapax Elixir is a potentially lethal overdose situation. Call your doctor or a Poison Control Center immediately if an overdose is suspected.