Lapas attēli

Brief Summary of Prescribing Information

Indications: Sleep. Daytime sedation.

Usual Adult Dose: For sleep, 150-300 mg. at bedtime. For pa tients previously on other hypnotics, 300 mg. for five to seven nights. For sedation, 75 mg, t.i.d. or q.i.d. Not recommended in children. Dosage should be individualized for aged, debilitated or highly agitated patients.

Overdosage: Acute overdosage may result in delirium and coma, with restlessness and hypertonia, progressing to convulsions. Evacuate gastric contents, maintain adequate ventilation and support blood pressure, if necessary. Dialysis may be helpful. Analeptics are contraindicated. Succinylcholine accompanied by assisted respiration has been proposed for prolonged convulsions. Overdoses of methaqualone appear to be less often associated with cardiac or respiratory depression than are overdoses of oral barbiturates, but shock and respiratory arrest may occasionally occur.

Contraindications: Contraindicated in women who are or may become pregnant; or patients with known hypersensitivity. Warnings: Take hypnotic dose only at bedtime. Not recom. mended in children. Warn patient on Quaalude (methaqualone) against driving a car or operating dangerous machinery. Care needed when administered with other sedatives, analgesic or psychotropic drugs or alcohol because of possible additive effects. Pending longer clinical experience, Quaalude should not be used continuously for periods exceeding three months. Psychological dependence occasionally occurs. Physical dependence rarely reported. However, caution needed with addictionprone patients.

Precautions: Use with caution and prescribe small quantities in patients with anxiety states where impending depression or suicidal tendencies exist. Give in reduced doses, if at all, in patients with impaired hepatic function.

Adverse Reactions: Neuropsychiatric: headache, hangover, fatigue, dizziness, torpor, transient paresthesia of the extremities. An occasional patient has experienced restlessness or anxiety. Hematologic: aplastic anemia possibly related to methaqualone has been very rarely reported. Gastrointestinal: dry mouth, anorexia, nausea, emesis, epigastric discomfort, diarrhea. Dermatologic: diaphoresis, bromhidrosis, exanthema. Urticaria has been particularly well documented.

Supplied: Quaalude-150 (150 mg. white, scored tablets).
Quaalude-300 (300 mg. white, scored tablets).
Consult complete literature before prescribing.

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Chief, Division of Drug Control, Department of Health and Mental Hygiene, State of Maryland, Baltimore, Md.

DEAR SIR: This is in response to your notice of a formal hearing to be held on Friday, October 27, 1972, regarding a proposal by the State Department of

Health and Mental Hygiene, Division of Drug Control, that methaqualone be scheduled as a controlled dangerous substance. We regret that we will be unable to attend the hearing. We would, however, like to submit this letters as part of the official record.

Arnar-Stone currently markets a prescription drug under the tradename Sopor which contains methaqualone. Anar-Stone exercises surveillance over all purchases of this product and has cooperated with all federal, state and local authorities whenever possible diversion has existed. If diversion of methaqualonecontaining products from legitimate distribution is of concern to the Division, it is the opinion of Arnar-Stone that existing state and federal laws governing the dispensing of prescription drugs, if enforced, are sufficient to control such diversion.

Arnar-Stone is aware that counterfeit methaqualone tablets have been distributed through illicit channels of distribution. We have been sent samples of tablets containing methaqualone which on the surface appeared to be Sopor tablets, but upon careful examination they were found to be counterfeit and not of our manufacture. If the Division concludes that listing methaqualone as a controlled substance is necessary to eliminate counterfeit tablets from illicit distribution, Arnar-Stone suggests that methaqualone be placed under Schedule IV of the Maryland Controlled Drug Substances Act. Arnar-Stone is unaware of any well documented cases in which true physical dependence to methaqualone has been demonstrated. True physical dependence is characterized by the development of tolerance to the pharmacological effects of the drug and the presence of withdrawal symptoms upon cessation of drug administration. To the best of Arnar-Stone's knowledge, no clear cut demonstration of such effects following the use of methaqualone has been documented.

Arnar-Stone appreciates the opportunity to comment regarding this matter and trusts that the Division will not find it necessary to unduly restrict the legitimate distribution of methaqualone-containing prescription drugs.

JOHN F. ZAROSLINSKI, Ph. D., Vice President, Research and Development.


Mr. FRENCH. Mr. Chairman,

Senator BAYH. Mr. French is, I understand, representing Mr. Parcell, the President, Arnar-Stone Laboratories.

Would you identify the other gentleman with you, please?

Mr. FRENCH. Yes, sir. With me this morning, is Mr. Richard D. Manthei, who is secretary and counsel for our firm and he is to my left.

Senator BAYI. Is Mr. Stanley Temko present here?

Mr. FRENCH. No, sir.

Senator BAYH. Please proceed.

Mr. FRENCH. I would appreciate it if we could read our statement to the committee.

Senator BAYH. That will be fine.

Mr. FRENCH. Mr. Chairman and members of the subcommittee, my name is Glendon E. French. I am executive vice president and chief administrative officer of Arner-Stone Laboratories, Inc.

Since this is our first appearance before a congressional committee, let me briefly review the background of our company. Arnar-Stone Laboratories, Inc. is a manufacturer and distributor of ethical pharmaceutical products with manufacturing, research and development, and general oflice facilities in Mount Prospect, Ill. In 1972, which was our 26th year of operation, Arnal-Stone's total sales were in the neighborhood of $5 million.

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