EIGHTEENTH EDITION
`
`to
`PHARMACEUTICAL SPECIALTIES
`and BIOLOGICALS
`
`J. PAUL FoLsoM
`General Manager
`
`ALBERT B. MILLER
`Assistant General Manager
`
`HENRIETTA BuLL
`Managing Editor
`
`BARBARA HUFF
`Compilation Editor
`w. ALAN WRIGHT, M.D.
`Medical Consultant
`
`ETHEL F. McGILLIGAN
`Circulation Manager
`
`IN SIX SECTIONS
`An arbitrary page numbering plan is
`used to facilitate the compilation of this
`reference book.
`SECTION ONE (Pink)
`ALPHABETICAL INDEX
`SECTION TWO (Yellow)
`DRUG, CHEMICAL AND PHARMACOLOG-
`ICAL
`INDEX
`SECTION THREE (Blue)
`THERAPEUTIC INDICATIONS INDEX
`SECTION FOUR
`PRODUCT IDENTIFICATION SECTION
`SECTION FIVE (White)
`PROFESSIONAL PRODUCTS INFORMATION
`SECTION SIX (White)
`MANUFACTURERS' SERVICE MATERIAL
`
`101
`
`201
`
`301
`
`I-XXIV
`
`501
`
`1029
`
`PUBLISHED BY MEDICAL ECONOMICS, INC.," ORADELL, N. J.
`ALL RIGHTS RESERVED • © CoPYRIGHT 1963 BY MEDICAL EcoNOMics, INc. • PRINTED IN u.s.A.
`
`IPR2016-01033 SHIRE EX2038, p. 1
`
`IPR2017-00011 SHIRE EX2038, p. 1
`
`

`
`FOREWORD TO THE EIGHTEENTH EDITION
`
`PHYSICIANS' DEsK REFERENCE is published annually by Medical Economics, Inc. with
`the cooperation of the 234 manufacturers whose major products are described in
`Professional Products Information (White Section). During the year, Medical Eco(cid:173)
`nomics, Inc. also publishes the PDR Quarterly Supplement which contains product
`information on new and reformulated ethical drugs introduced after the PDR annual
`volume goes to press. Intended primarily for physicians, PDR's purpose is to make
`available essential prescription information on major pharmaceutical specialties, bio(cid:173)
`logicals, and antibiotics in convenient reference form.
`
`The function of the publisher is the compilation, organization, and distribution of this
`information. Each product description has been prepared by the manufacturer, and
`edited and approved by the manufacturer's medical department, medical director, or
`medical consultant. Manufacturers indicated the main headings in the Drug, Chemical,
`and Pharmacological Index (Yellow Section) and in the Therapeutic Indications Index
`(Blue Section) under which their products have been listed.
`
`In the course of obtaining product information, the publisher emphasized to manu(cid:173)
`facturers the necessity of describing products comprehensively so that physicians would
`have access to all the essential information needed to prescribe intelligently, including
`composition, action and uses, administration, dosage, contraindications, precautions,
`side effects, form in which supplied and other details concerning use. In organizing and
`presenting the material in PHYSICIANS' DESK REFERENCE, the publisher is providing all
`the information made available to PDR by manufacturers. Besides the information
`given here, additional information on any product may be obtained from the manu(cid:173)
`facturer. In addition the common name, generic composition or chemical name of each
`brand name prescription product will be found in the information for each product.
`
`In making this material available to the medical profession, it should be understood
`that the publisher is not advocating the Use of any product described herein.
`
`This edition has been distributed to over 180,000 medical doctors and doctors of oste(cid:173)
`opathy in the United States, and to various other segments of the health team.
`
`J. PAUL FoLsoM
`General Manager
`
`IPR2016-01033 SHIRE EX2038, p. 2
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`IPR2017-00011 SHIRE EX2038, p. 2
`
`

`
`children) intravenously or intramuscularly
`or 2 hours before surgery (repeat if neces(cid:173)
`sary)
`to
`reduce blood pressure, prevent
`paroxysmal hypertension due to anesthesia or
`stress, and
`improve the patient's general
`condition.
`Use During Operation: During surgery, give
`phentolamine methanesulfonate (5 mg. for
`adults, 1 mg. for children) intravenously as
`indicated to prevent paroxysms of hyper(cid:173)
`tension, tachycardia, respiratory depression,
`convulsions or other effects of epinephrine
`intoxication. Postoperatively, norepinephrine
`may be given to control the hypotension
`which commonly
`follows
`removal of a
`pheochromocytoma.
`PRECAUTIONS: Because phentolamine
`causes tachycardia, give cautiously to pa(cid:173)
`tients with coronary occlusive disease. It is
`preferable not to give cardiac glycosides fol(cid:173)
`lowing any untoward response to phentola(cid:173)
`mine until the patient has fully recovered
`from the reaction.
`HOW SUPPLIED: Ampuls, each contain(cid:173)
`ing 5 mg. phentolamine ni.ethanesulfonate
`and 5 mg. lactose in lyophilized form, ac(cid:173)
`companied by a 1-ml. ampul of Sterile Water
`for Injection; cartons of 1, boxes of 6
`cartons. Tablets, (white, scored), each con(cid:173)
`taining 50 mg. phentolamine hydrochloride;
`bottles of 100.
`[Shown it~ Product Iden-tification Section.]
`
`Il<
`
`RITALIN® hydrochloride
`{methylphenidate hydrochloride NND
`CIBA)
`ACTION AND USES: A mild stimulant
`and antidepressant, which
`improves mood
`and performance, usually without producing
`hyperexcitability or depressive rebound. In(cid:173)
`duces alertness, a brighter mental outlook
`and improved psychomotor performance. In(cid:173)
`dicated orally in chronic fatigue (associated
`with convalescence, debilitated states, etc.) ;
`drug-induced lethargy (such as produced by
`tranquilizers, barbiturates, antihistamines,
`anticonvulsants, etc.) ; psychoneuroses and
`psychoses
`(associated with exogenous de(cid:173)
`pression, apathy or· withdrawal) ; narcolepsy;
`apathetic or withdrawn senile behavior ;
`functional behavior problems
`in children
`(hyperactivity, stuttering, etc.). Parenter(cid:173)
`ally,
`the drug
`is
`indicated for stimulat(cid:173)
`ing freer verbalization during psychothera(cid:173)
`peutic interviews ; for marked sedation and
`acute barbiturate intoxication; for drowsi(cid:173)
`ness and lethargy due to tranquilizing agents
`and oversedation due to barbiturates ; for
`initiating therapy in selected psychiatric pa(cid:173)
`tients ; and for hastening recovery period
`surgical and/or dental
`anes(cid:173)
`following
`thesia.
`ADMINISTRATION AND DOSAGE:
`ORAL DOSAGE: Give orally in divided doses,
`preferably 30 to 45 minutes before meals.
`Many patients respond
`to 10 mg. b.i.d.
`or t.i.d. Others will require 20-mg. doses.
`In a few cases, 5-mg. doses will be ade(cid:173)
`quate. The few patients who are unable
`to sleep if medication is taken late in the
`day should take the ·last dose before 6 p.m.
`Psychiatric conditions associated with de(cid:173)
`pression generally require several days to
`weeks to show benefit and occasionally re(cid:173)
`quire larger oral doses.
`PARENTERAL DOSAGE: Can be given intra(cid:173)
`venously, intramuscularly, or subcutaneously.
`Emergency Use: In cases of acute overdos(cid:173)
`age of barbiturates, tranquilizers, anticon(cid:173)
`vulsants or other sedative drugs, 30 to 50
`mg. parenterally. Repeat every 30 minutes as
`indicated.
`Drttg-induced Lethargy: For lethargy caused
`by
`tranquilizers, barbiturates, anticonvul(cid:173)
`sants or other sedative drugs, 10 mg. 1 to 3
`times daily is generally sufficient.
`Marked Oversedation
`(or where a more
`rapid effect is desired) : For overcoming the
`signs and symptoms of acute overdosage of
`barbiturates,
`tranquilizers, anticonvulsants,
`
`Professio.nal Products
`etc., 20 to 30 mg. parenterally. In cases of
`severe barbiturate intoxication where full
`consciousness is not immediately restored,
`marked
`improvement
`in
`respiration and
`cardiovascular status has been noted. Sup(cid:173)
`portive therapy is necessary, although the
`need for strenuous measures is markedly
`lessened with methylphenidate.
`Recover)'
`from Postoperative Anesthesia:
`For hastening the recovery period following
`surgical and/or dental barbiturate anes(cid:173)
`thesia, 10 to 30 mg. parenterally at comple(cid:173)
`tion of surgery or on arrival at the recovery
`room.
`Psychiatric Conditlons Associated with De(cid:173)
`pression: For initiating therapy in patients
`with selected psychiatric conditions, 10 to
`20 mg. parenterally, repeated every 30 min(cid:173)
`utes as required.
`Psychotlzerapetttic Adjunct: For stimulating
`freer verbalization during psychotherapeutic
`interviews, 10 to 20 mg.
`intramuscularly,
`10 to 15 minutes before interview.
`CONTRAINDICATIONS: ORAL: Marked
`anxiety, tension, and agitation are probably
`the only contraindications to methylphenidate
`alone, since the drug may aggravate these
`symptoms.
`PRECAUTIONS: ORAL: Rarely, methyl(cid:173)
`phenidate has been associated with overt
`psychotic behavior. Patients with an ele(cid:173)
`ment of agitation may also react adversely ;
`discontinue therapy if necessary.
`Because
`the drug may mask normal
`fatigue states induced by overexertion, it
`should not be used to increase mental or
`physical
`capacities
`beyond physiological
`limits.
`While oral methylphenidate has little or no
`effect on blood pressure, effects of pressor
`agents have been potentiated in pharmaco(cid:173)
`logical experiments. Use cautiously with
`epinephrine,
`levarterenol
`(norepinephrine),
`or angiotensin amide.
`SIDE EFFECTS: oRAL: Nervousness and
`insomnia are the most common side effects
`but are readily controlled by reducing dosage
`and omitting drug in afternoon or evening.
`Other side effects: anorexia, nausea, dizzi(cid:173)
`ness,
`palpitation,
`headache,
`drowsiness.
`Rarely, blood pressure and pulse changes,
`both up and down, occur.
`PARENTERAL: An occasional moderate rise in
`blood pressure. When repeated doses are
`given by injection, especially intravenously,
`careful check of the blood pressure before
`each dose is recommended.
`Other reactions may occur with parenteral
`administration and are reviewed under ORAL
`CAUTIONS and ORAL SIDE EFFECTS.
`PREPARATION FOR INJECTION: To prepare
`solution for intramuscular, intravenous, or
`subcutaneous injection, add only the special
`solvent which is supplied. Gently rotate until
`crystals are completely dissolved. To facili(cid:173)
`tate the administration of large doses, as
`little as 1 ml. of solution may be used to dis(cid:173)
`solve the contents of one vial. The concen(cid:173)
`tration should be written on the vial at the
`time of preparation.
`Caution: Methylphenidate is stable indefi(cid:173)
`nitely in lyophilized form but should be used
`within 2 months after solution is prepared.
`Do not inject Parenteral Solution through
`tubing or a syringe which contains a barbitu(cid:173)
`rate or strongly alkaline solution, since a
`heavy precipitate is formed.
`HOW SUPPLIED: Tablets, 5 mg. (pale
`yellow) and 10 mg. (pale blue) ; bottles of
`100, 500 and 1000. Tablets, 20 mg. (pale
`orange) ; bottles of 100 and 1000. Pare1~teral
`Soltttfmz.: Multiple-dose Vials, 10 ml., each
`vial containing 100 mg. methylphenidate hy(cid:173)
`drochloride and 100 mg. lactose in lyophilized
`form ; cartons of 1 and 6. Each vial is ac(cid:173)
`companied by a 1 0-ml. vial of sterile solvent,
`each ml. containing 5 mg. chlorobutanol as a
`preservative, 4.81 mg. citric acid, 10.36 mg.
`propylene glycol, and 5.12 mg. sodium citrate
`in water.
`[Shown in Product I den.tification Section]
`
`It<
`RITONIC®
`COMPOSITION: Each Ritonic Capsule
`contains 5 mg. Ritalin® hydrochloride
`(methylphenidate hydrochloride CIBA), 1.25
`mg. methyltestosterone, 5 meg. ethinyl estra(cid:173)
`diol, 5 mg. thiamin (vitamin B1 ), 1 mg. ribo(cid:173)
`flavin (vitamin B2 ), 2 mg. pyridoxine hydro(cid:173)
`chloride (vitamin B6 ), 2 meg. vitamin B12
`activity, 25 mg. nicotinamide, and 250 mg.
`dicalcium ·phosphate.
`ACTION AND USES: Ritonic is designed
`to improve mood and maintain vitality. It
`contains Ritalin (methylphenidate)-a mild,
`safe, nonamphetamine stimulant-and a bal(cid:173)
`anced complement of vitamins, calcium, and
`hormones. Patients benefit· from the mental
`and physical alerting effects of methylpheni(cid:173)
`date as well as anabolic stimulation and nu(cid:173)
`tritional support. For patients who are losing
`their drive, alertness, vitality and zest for
`living because of the natural degenerative
`changes of advancing years; for those de(cid:173)
`bilitated or depressed by chronic illness, over(cid:173)
`those recuperating
`work, etc., as well as
`from
`illness or surgery. Ritonic ·elevates
`mood quickly, smoothly; effects last about
`4 hours without extreme letdown or rebound.
`It rarely, if ever, affects blood pressure,
`pulse, sleep or appetite.
`ADMINISTRATION AND DOSAGE:
`Dosage will depend upon
`indication and
`individual response. Average dosage is one
`capsule after breakfast and one after lunch.
`SIDE EFFECTS: Rarely,· nausea occurs.
`If nervousness, palpitation or insomnia oc(cid:173)
`cur, reduce dosage.
`CONTRAINDICATIONS: None.
`PRECAUTIONS: None.
`HOW SUPPLIED: Capsules, bottles of
`100.
`[Shown in Product Identification Section]
`It<
`SER-AP-ES@
`COMPOSITION: Ser-Ap-Es combines the
`antihypertensive effects of 0.1 mg. Serpasil®
`(reserpine CIBA), 25 mg. Apresoline® hy(cid:173)
`drochloride
`(hydralazine
`hydrochloride
`CIBA), and 15 mg. Esidrix® (hydrochloro(cid:173)
`thiazide CIBA) in one convenient tablet.
`ACTION AND USES: This triple combi(cid:173)
`nation lowers blood pressure uniformly, con(cid:173)
`sistently, and safely while it relieves many
`of the complicating symptoms of hyperten(cid:173)
`sion:'. Ser-Ap-Es is recommended for all cases
`of hypertension, except the mildest and the
`most severe.
`ADMINISTRATION AND DOSAGE:
`One or 2 tablets t.i.d. To initiate therapy,
`1 tablet t .. i.d. is recommended.
`Since the antihypertensive effects of reser(cid:173)
`pine are not immediately apparent, maximal
`reduction in blood pressure from a given
`dosage of Ser-Ap-Es may not occur for 2
`weeks. For maintenance, adjust dosage to
`lowest patient requirement.
`SIDE EFFECTS: See product descriptions
`under SERPASIL (reserpine), APRESO(cid:173)
`LINE (hydralazine), and ESIDRIX (hydro(cid:173)
`chlorothiazide).
`PRECAUTIONS: Use cautiously
`in pa(cid:173)
`tients with coronary artery disease, ad(cid:173)
`vanced renal damage and cerebral vascular
`accidents.
`HOvV SUPPLIED: Tablets (salmon pink),
`each containing 0.1 mg. reserpine, 25 mg.
`hydralazine hydrochloride, and 15 mg. hy(cid:173)
`drochlorothiazide; bottles of 100 and 1000.
`[Shown in Product IdentificationS ection]
`
`:tr<
`
`SERPASIL®
`(reserpine USP CIBA)
`ACTION AND USES: Antihypertensive
`and calming agent. Produces a gradual, sus(cid:173)
`tained lowering of blood pressure, especially
`the neurogenic type of hypertension ; a calm(cid:173)
`ing effect ; a slowing of the pulse rate. Also
`indicated for hypertensive emergencies ; for
`toxemia of pregnancy.
`ADAfiNISTRATION AND DOSAGE:
`It is preferable to administer reserpine after
`continued on next page
`
`IPR2016-01033 SHIRE EX2038, p. 3
`
`IPR2017-00011 SHIRE EX2038, p. 3