Publisher: CHARLES E. BAKER, Jr.
`General Manager: JACK E. ANGEL
`Production Manager: GEORGE E. QUIST. Jr.
`Compilation Editor: BARBARA B. HUFF
`Medical Consultant: AUSTIN JOYNER, MD.
`Ass't To Production Manager: ELIZABETH H. CARIJSO
`Compilation Editor!-PDR Supplement: JANICE M. CLARK
`Editorial Assistants: EMILY B. BROGELER, GWYNNED L.
`OAKLEY, F. EDYTHE PATERNITI
`Circulation Director: JOSEPH L. KENNA
`Circulation Manager: ETHEI. F. McGlLL|GAN
`Ass‘t To Circulation Manager: ALICE SCHRAMM
`‘Fulfillment Manager: WILLIAM R. BOBBINK
`
`Copyright @ 19?4 by Medical Economics
`compan . Oradell. NJ. 01649. All rights
`reserve . None of the content of this
`‘
`Union publication ma be reproduced, stored in a
`retrieval system. or
`ransnntted in any form
`or by any _means [EIE_CtfOI'IIC, mechanical,‘
`fhotocopymg record:n_g,_or otherwise) \gv:thout
`he prior written pEfl'I"liS5IO|“I of the publisher.
`
`Amerigen Ex. 1049, p. 1
`- Amerl . 1
`
`

`
`Product Information
`
`Acid, 0.1 mg.: Niacinamide, 50 mg.: Biotin. 10
`mcg.; Cal Pantothenate. 25 1113.; E. 10 I.U.; C,
`250 :ng.; lnositol. 25 mg.; LLysine, 20 mg; Glu-
`tamic Acid. 10 mg.; Ferrous Iron 10 mg.; Cal-
`cium Carl:-., 625 mg; desioc. Liver 10 mg. Brew-
`ers yeast 10 mg.; Paba 25 mg.. Wheat germ oil
`10 mg.. Soybean lecithin 50 mg; plus minerals
`in a Natural Base.
`Action and Uses: For prevention of certain
`vitamin deficienoes.
`Administration and Dosage: One b.i.d.
`How Supplied: Bottles of 100 capsules.
`
`
`OLC Laboratories. Inc.
`15383 IVLW.
`'J'T|-1 AVE.
`MIAMI, FLORIDA 33189
`
`TRYPTACIN
`{brand of L.Trypto|:Ihan)
`Description: 'I‘ryptacin—Chsmically, L.‘I‘ryp—
`t-ophan. aminoindol1.L3—propionic acid is white
`to slightly yellowish white crystals or crysta-
`line powder; taste slightly bitter. when dried.
`contains not less than 93.5% and not more
`than 100.5% of L.'I\-yptophan (Cl1;mN2(]2).
`Action and Uses: For oral amino acid ther-
`9P)"-
`.
`Administration and Dosage: As a dietary
`supplement: 125 mg——-1 times a day. 500 mg-—-3
`to 4 tablets after evening meal.
`How Supplied:
`Tablets: 125 mg (NDC—-15558-002) and 500
`?5%(NDC—48558-001} in bottles of 5-0, 100 and
`Capsules: 250 mg in bottles of5(l.1{Xl and 250.
`Literature Available: Yes.
`References:
`
`American Journal Psych. 127:7-«January
`971
`,
`Archives of Gen. Psych. Vol. 31-Sept. 19?»:
`Diseases of the Nervous System. January 1974
`American Journal Psych. 134:4 April 19??
`New England Journal of Med. Jan. 13, 19'1"?’
`
`
`
`Obetrol Pharmaceuticals
`{Division of Rexsr Phnrrnncol Corp.)
`395 ROCKAWAY AVE.
`VALLEY STREAM. NJ’. 11581
`
`osETnoI."'
`OIIETROL TABLETS
`
`u
`
`AMPHETAMINES HAVE A HIGH PO-
`TENTIAL FOR ABUSE. THEY SHOULD
`THUS BE TRIED ONLY IN WEIGHT RE-
`DUCTION PROGRAMS FOR PATIENTS
`IN WHOM ALTERNATIVE THERAPY
`HAS BEEN INE . ADMINIS
`TRATION OF AMPHEPAMINES FOR
`PROLONGED PERIODS OF TIME IN
`OBESITY MAY LEAD TO DRUG DE»
`PENDENCE AND MUST BE AVOIIDED.
`PARTICULAR A'I'I'EN"l'ION SHOULD
`BE PAID TO THE POSSIBILITY OF SUB-
`JECTS OBTAINING AMPHETAMINES
`FOR NON-THERAPEUTIC USE OR DIS-
`"l‘RlBU'I'ION TO CHEERS. AND THE
`DRUGS SHOULD BE PRESCRLBED OR
`
`DISPENSED SPARINGLY.
`
`Description: A single. entity amphetamine
`product combining the neutral sulfate salts of
`dextroamphetamine and amphetamine, with
`the dextro isomer of amphetamine sscchsrate
`and d, l amphetamine aspartate.
`Actions: Amphetamines are sympathomi-
`metio amines with CNS stimulant activity.
`Peripheral actions include elevation ofsystolic
`and diastolic blood pressures and weal: bron-
`chodilstor and respiratory stimulant action.
`
`1201
`
`Drugs of this class used in obesity are com-
`monly known as "anorectica" or “anorexigon-
`ice". It has not been established. however. that
`the action of such drugs in treating obesity is
`primarily one of appetite suppression. Other
`central nervous system actions, or metabolic
`effects. may be involved. for example.
`Adult obese subjects instructed in dietary
`management and treated with "anorectic"
`drugs. lose more weight on the average than
`those treated with placebo and diet. as deter-
`mined in relatively shorbterrn clinical trials.
`The magnitude of increased weight
`loss of
`drug-treated patients over placebo-treated pa-
`tients is only a fraction ofa pound a week. The
`rate ofweight loss is greatest in the first weeks
`of therapy for both drug and placebo subjects
`and tends to decrease in succeeding weeks. The
`origins of the increased weight loss due to the
`various possible drug efiects are not estob
`iished. The amount of weight loss associated
`with the use of an "anorectic" drug varies from
`trial to trial. and the increased weight loss ap-
`pears to be related in part to variables other
`than the drug prescribed. such as the physi-
`cian-investigator, the population treated, and
`the diet prescribed. Studies do not permit con-
`clusions as to the relative importance of the
`drug and non-drug factors on weight loss.
`The natural history of obesity is measured in
`years, whereas the studies cited are restricted
`to a few weeks duration; thus. the total impact
`of drug-induced weight loss over that of diet
`alone must be considered clinically limited.
`Indications:
`Narcolepsy
`Minimal Brain Dyshrnotion in Children
`—as adjunctive therapy to other remedial
`measures (psychological, educational. social).
`Special Diagnostic Considerations:
`Special etiology of Minimal Brain Dysfunction
`(MED) is unknown, and there is no single diam
`nostic test. Adequate diagnosis requires the
`use not only of medical but of special psycho-
`logical. educational, and social resources.
`The characteristic signs most often observed
`are chronic history of short attention span.
`distractibility. emotional lability. impulsivity.
`moderate to severe hyperactivity, minor neu-
`rological signs and abnormal EEG. Learning
`disabilities may or may not be present. The
`diagnosis of MBD must be based upon a com-
`plete history and evaluation of the child and
`not solely on the presence of one or more of
`these signs.
`Drug treatment is not indicated for all children
`with MED. Appropriate educational place-
`ment is essential and psychological or social
`intervention may be necessary. when reme-
`dial measures alone are insuflicient. the’deci-
`sion to prescribe stimulant medication will
`depend upon the physician's assessment of tho"
`chronicity and severity of the child's symp-
`toms.
`'
`Drug treatment is not intended for use in the
`child whose hyperactivity is due to environ-
`mental factors and./or primary psychiatric
`disorders.
`.
`Exogenous obesity as a short-term (a few
`weeks) adjunct in a regimen of weight reduc-
`tion based on caloric restriction, for patients
`refractory to alternative therapy, e.g.,
`re-
`peated diets, group programs. and other drugs.
`The limited usefulness of amphetamines (see
`ACTIONS) should be weighed against possible
`risks inherent in use of the drug. such as those
`described below.
`Contraindications: Advanced arteriosclero
`sis. symptomatic cardiovascular disease. mod-
`erate to severe hypertension. hyperthyroidism.
`known hypersensitivity or idiosyncrasy to the
`sympathomimetic amines. glaucoma.
`
`Continued on next page
`
`Amerigen Ex. 1049, p. 2
`Amelrigen Ex. 104, p. 2
`
`
`
`and Uses: Whenever thyroid is indi-
`.yxede1'na, simple (non-toxic) goiter.
`_.
`idisrn.
`gs
`tration and Dosage: Depending on
`_
`_-. severity of the condition and the re-
`_of the patient. initial dosage is usually
`_cg. Lthyroxine Sod.
`100 mcg. L-
`' H sSod. is metabolically equivalent to 1
`7- id extract.
`_. -tlons: Side effects include tachycardia.
`'
`- ess and sweating which disappear on
`'«- . of dosage.
`heart
`~ ‘cations: Thyrotoxicosis.
`and
`rtension.
`‘Supplied: Oval bisected tablets——100
`;i te) and 200 mcg. (pink). in bottles of
`-‘. soc. Also 10 cc. vials, 100 mcg. per cc.
`:- . 0!‘ LV. use.
`
`
`
`,- ICOI. I-Complex In Ssfliowor on base
`"
`«
`tton: One capsule t.i.d. will supply:
`fl. r Oil 1530 mg.. Inositol 100 mg.; Natu-
`'é ed Tocopherols 2!} mg.; Ba. 10 mg.; B13. 5
`_'Panthenol 5 1:13.; Soybean Lecithin coo
`' and Uses: Dietary supplement.
`‘ pplled: Bottles of 90 Capsules.
`
`I I.TRlC® I.-Giutarnsts isocliurn Free}
`'.
`lion: 2 tablets t.i.d. provides: ca1c‘.'L.
`_, -- to. 3 Grams; I.rLysine 26 mg.; Ferrous
`)3 mg., Calcium 300 mg. (from the Cole.
`'
`- ate): Vitamins — A. 4000 Units; B1, 1
`'Ii
`1.2 mg.; B5. 1 mg.; 8.2. 5 mcg.; C, 30
`olic Acid 25 mcg.; Cal. Pant. 1 mg.; NIA-
`" ’ DIR
`A - and Uses: Dietary supplement.
`' e: 2 tablets t.i.d.
`jfiuppliod: Bottle of 90 tablets.
`
`_
`
`p_ llE8'l'® Therapeutic Vitamin
`II is with Ferrous Iron and
`' ems-tree Calcium in a Natural Base
`.
`. tion: One Capsule b.i.d. provides:
`-A. 25,000 Units; D, 400 Units; 3.. 25
`, 12 mg; Be, 10 mg.; B13. 10 _mcg.; Folic
`
`,
`-'-
`
`e revisions
`
`ition Control Products
`of Phsrrnex Inc.
`LINCOLN STREET
`OK 161
`If YWOOD, FLORIDA 33022
`
`E81’ Therapeutic B-complex 0
`lion: One Kapule b.i.d. provides: Vi-
`._- .30 ms: 32. 20 ms; Ba. 10 ms; 3:2. 3
`‘_ :Pant. -10 mg.; Niacinamide, 200 mg.:
`'3'" mg. Desicc. Liver 250 mg‘.
`l Kapule h.i.d.
`,| plied: Bottle of 60 Kapules.
`
`'
`
`: 81' Double Strength Binflnvonoid
`. with Ilutirrsnd Vitamin C.
`‘ don: Each Tabseal provides 200 mg.‘
`_f
`.
`: Bioflavonoid Complex, 250 mg.
`_
`- Acid. 50 mg. Rutin.
`-land Uses: Dietary supplement.
`___ppIied: Bottle of I00 Tsbseals.
`
`rI~Ieno:.® {Soluhllind vim-am at
`Eton: 100 I.U. Vitamin E solubilimed
`r -- Soybean Lecithin for better absorp-
`'_» utilisation.
`-
`I ppliod: Bottle of 100 Knpules.
`
`R
`' -® {L-Thyroxlne sun r— 4
`' lion: L-Thyroxine Sod. (L—'I‘etraiodt>
`e) the active principle of the thyroid
`» pure crystalline form. Each cc. injec-
`_. tains L-thyroxine Sod. mo mcgz; Sod.
`_
`- hyde Sulfoxylate 0.1%. Phenol 0.5%.
`'
`xidea'Glyci.ne buffer in Water for
`
`_
`
`

`
`
`
`--
`
`.-
`_
`
`
`
`
`
`
`
`-'7.---._.m‘S‘
`
`1 202
`
`0betroI—Cont.
`
`Agitated states.
`Patients with a history of drug abuse.
`During or within 14 days following administra-
`tion of monoamine oxidase inhibitors (hyper-
`tensive crises may result).
`Warnings: When tolerance to the "anorec-
`tic" effect develops, the recommended dose
`should not be exceeded in an attempt to in-
`crease the effect; rather, the drug should be
`discontinued. Amphetamines may impair the
`ability of the patient to engage i.n potentially
`hazardous activities such as operating machin-
`ery or driving a motor vehicle; the patient
`should therefore be cautioned accordingly.
`Drug Dependence: Amphetamines have
`been extensively abused. Tolerance, extreme
`psychological dependence, and severe social
`disability have occurred. There are reports of
`patients who have increased the dosage to
`many times that recommended. Abrupt cessa-
`tion following prolonged high dosage adminis-
`tration results in extreme fatigue and mental
`depression; changes are also noted on the sleep
`EEG. Manifestations of chronic intoxication
`with amphetamines include severe dsrmato
`ses. marked insomnia. irritability. hyperactiv-
`ity. and personality changes. The most severe
`manifestation of chronic intoxication is pay-
`chosis. often clinically indistinguishable from
`schizophrenia.
`.
`Usage in Pregnancy: Safe use in pregnancy
`has not been established. Reproduction studies
`in mammals at high multiples of the human
`dose have suggested both an embryotoxic and a
`teratoganic potential. Use ofamphetamines by
`women who are or who may become pregnant.
`and especially those in the first trimester of
`per-sgnsncy, requires that the potential benefit
`"weighed against
`the possible hazard to
`mother and infant.
`Usage in Children: Amphetamines are not
`recommended for use as anorectic agents in
`children under 12 years of age.
`Precautions: Caution is to be exercised in
`prescribing amphetamines for patients with
`even mild hypertension.
`Insulin requirements in diabetes mellitus may
`be altered in association with the use of am-
`phetamines and the concomitant dietary regi-
`men.
`Amphetamines may decrease the hypntensive
`effect of guanethidine.
`The least amount feasible should be prescribed
`or dispensed at one time in order to minimize
`the possibility of overdosage.
`Adverse Reactions:
`Cardiovascular: Palpitation,
`elevation of blood pressure.
`Central nervous system: Ovorstimulation,
`restlessness, dizziness,
`insomnia, euphoria,
`dysphoria. tremor. headache; rarely. psychotic
`episodes at recommended doses.
`the mouth,
`Gastrointestinal: Dryness of
`unpleasant taste, diarrhea, constipation. other
`gastrointestinal disturbances. Anorexia and
`weight loss may occur as undesirable effects
`when amphetamines are used for other than
`the anorectic effect.
`Allergic: Urticaria.
`Endocrine:
`Impotence. changes in libido.
`Dosage and Administration: Regardless of
`indication, amphetamines should be adminis-
`tered at the lowest effective dosage and dosage
`should be individually adjusted. Late evening
`medication should be avoided because of the
`resulting insornnis.
`1. Narcolepsy: Usual dose 5 to E0 milli-
`grams per day in divided doses.
`2. Minimal brain dysfunction:
`a. Not recommended for children under 3
`years of age.
`b. Children from 3 to 6 years of age: 2.5
`milligrams daily. raised in increments
`
`tachycardia.
`
`Product Information
`
`of 2.5 milligrams at weekly intervals
`until optimal response is obtained.
`c. Children 6 years of age and older: 5 mil-
`ligrams once or twice daily, increased
`in increments of 5 milligrams at
`weekly intervals. Only in rare cases
`ivillitbenecesaarytoexceedatotal of
`40 milligrams per day.
`3. Obesity: Usual adult dose 5 to 30 milli-
`grams per day in divided doses.
`Overdosage: Manifestations of acute over-
`dos.age with amphetamines include restless-
`neas. tremor. hyperreflexia, rapid respiration.
`confusion.
`assaultiveness,
`hallucinations.
`panic states.
`Fatigue and depression usually follow the cen-
`tral stimulation.
`Cardiovascular effects include arrhythmias.
`hypertension or hypotension and circulatory
`collapse. Gastrointestinal symptoms include
`nausea, vomiting, diarrhea. and abdominal
`cramps. Fatal poisoning usually terminates in
`convulsions and coma.
`Management of acute amphetamine intoxica-
`tion is largely symptomatic and includes la-
`vage and sedation with a barbiturate. Experi-
`ence with hemodialysis or peritoneal dialysis is
`inadequate to permit recommendation in this
`regard. Acidification of the urine increases
`amphetamine excretion. Intravenous phantol-
`amine Cflegitine) has been suggested for possi-
`ble acute. severe hypertension. if this compli-
`cates amphetamine overdosage.
`Caution: FEDERAL LAW PRO!-IIBl"i‘S DIS-
`PENSING WITHOUT PRESCRIPTION.
`How Supplied:
`OBETROL TABIEPS
`Each tablet contains:
`Dextrosmphetsmine
`
`Q mg.
`
`20 _n_1g=
`
`5 mg.
`mg.
`5 mg.
`mg.
`Amphetamine Aspartate
`5 mg.
`Dextrosmphetsrnins Su_lfate..2.5 mg.
`5 mg.
`Amphetamine Sulfate
`mg
`Available in bottles of 100's. 500's and 1000’s.
`LG-NDC-O-l’1"’?
`US PATENT 2,113,052
`Other Patents Pending
`[Shown in Product Identification Section}
`
`O‘Neal. Jones 8: Feldman
`2510 METRO BLVD.
`MARYLAND HEIGHTS. MO. 03043
`
`AHTILIIIIUM AMPULES
`{physonigmina ullcvlstsl
`Each ml. contains:
`Physostigmine Salicylste...........................1 mg.
`Description: ANTIIJRIUM (physostigmine
`salicylate) is OJF’s brand of physoatigmine
`salicylate.
`Action: ANTILIRIUM (physostigmine salicyl-
`ate) is a salicylic acid derivative ofan alkaloid
`extracted from seeds of Physostigma Veneno
`sum (calabar bean). The action of the parasym-
`pathetic nerves is intermediated by the forma-
`tion of acstylcholine at the peripheral end of
`these nerves. The action of acetylcholine is
`normally very fleeting because of its hydrolysis
`by a specific enzyme. Physostigmine inhibits
`the destructive action of cholinesterase and
`thereby prolongs and exaggeratas the effect of
`the scetylcholine. The changes in body func-
`tion which are produced by the injection of
`physostigmine are. therefore. very similar to
`those which would occur from simultaneous
`stimulation of the parasympathetic nerves and
`include contraction of the pupil, increased to-
`nus of the intestinal musculature. constriction
`of the bronchi and stimulation of secretion of
`the salivary and sweat glands.
`.l.ndleations: To reverse the toxic effects
`upon the central nervous system caused by
`drugs in clinical or toxic dosages capable of
`producing anticholinergic poisoning. Central
`toxic effects include:
`
`Always consult Su- I":
`Hallucinations
`Delirium
`Disorientation
`.-
`Anxiety
`a‘
`'
`Hyperactivity
`Severe anticholinergic poisoning may --
`Coma
`.
`Medullary Paralysis
`Death
`Contraindications: Physostigmine .
`injections should not be used in the p '
`asthma, gangrene. diabetes. cardt
`disease. mechanical-obstruction of
`tines or urogenital tract or a‘nyvago
`I
`and in patients receiving choline
`depolarizing‘ neuromuscular blocking
`(decamethonium.succinylcholinel.
`"
`Warning:
`if excessive symptoms ed."
`tion. emesis, urination and defecst' "
`the useofANTl'LIRl”UM shouldbsts
`If excessive sweating or nausea occur, 1
`age should be reduced.
`'
`Intravenous administration should -‘,
`slow, controlled rate. no more than
`'
`minute (see dosage). Rapid adminis .
`cause ‘bradycardia, hypersalivation I
`respiratory difficulties and posiibly
`sions.
`-
`An overdosage of AN'I‘ILIRIUM can _
`cholinergic crisis.
`Precautions: Because of the possilf ‘
`persensitivity in an occasional
`pine sulfate injection should alwsysbé _
`since it is an antagonist and a.ntidotef'_
`stigmine.
`'
`-
`Administration and Dosage:
`..
`adult dose of ANTILIRIUM is 0.5 to
`intramuacularly or
`intravenously. '_
`nous administration should be at s I
`'
`trolled rate of no more than 1 mg. per '
`It may be necessary to repeat dosages
`to 4 mg. at intervals as life throats _'
`such as arrhythmias. convulsions -
`
`coma recur. Physostigmine salicyla -
`'-
`idly metabolized in the bod .
`IS-ONIN
`IN ALL CASES OF
`USUAL
`SUPPOR'I'l'V'E
`SHOULD BE UNDERTAKEN.
`How Supplied: 2 ml. ampules. psc
`pules per box.
`
`IANALGG) HNIMEHT
`
`_
`
`Composition: Menthol. Camphongl,
`Salicylate. and Eucalyptus Oil in a --
`base.
`.
`Action and Uses: For minor in '
`and pains, athletic soreness. and ._
`relief of minor pains of arthritis and _
`tism. Mild. effective. nongressy.
`-
`.
`use. quick action; no bandage
`Administration: Apply with gentle
`several times daily. or as needed.
`'
`Caution:
`If pain persists for man.
`days, or redness is present. or in -
`'
`affecting children under 12 years of __
`sult a physician immediately. Do -
`covering or heat.
`;
`Warning: Keep out of the reach --
`to avoid accidental poisoning.
`" .
`Precautions: Avoid getting into .
`'
`mucous membranes. Discontinue use
`
`sive irritation of the skin develops. J
`
`'_.
`BAHCAP CAPSULES
`BAHCAP E CODEINE CAP8Ul.EI_;
`BANCAP CAPSULIEB
`Each capsule contains:
`Salicylsmide
`Acetaminophen
`BANCAP E CODEINE CAPS
`Each capsule contains:
`-
`Salicylamide
`Acetaminophen
`
`Amerigen Ex. 1049, p. 3
`Amerigen Ex. 1049, p. 3