PAREMYD®
(HYDROXYAMPHETAMINE HYDROBROMIDE 1% AND TROPICAMIDE 0.25%)
CONVENIENT ONE-DROP SOLUTION FOR DILATION
· CONVENIENT ONE-DROP FORMULATION IS EASIER TO ADMINISTER THAN MANY CURRENT REGIMENS CONSISTING OF A DROP FROM TWO SEPARATE PRODUCTS.
FOR PATIENT AND PRACTITIONER CONVENIENCE
· FORMULATED TO WORK QUICKLY TO FIT BUSY PATIENTS' SCHEDULES AND YOUR PATIENT FLOW.
· ONLY PARTIAL LOSS OF ACCOMMODATION , DUE TO LOWER (0.25%) CONCENTRATION OF TROPICAMIDE.
· MINIMIZES INCONVENIENCE: RECOVERY BEGINS WITHIN 90 MINUTES, WITH COMPLETE RECOVERY TYPICALLY IN 6 TO 8 HOURS.
PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) SOLUTION SHOULD NOT BE USED IN PATIENTS WITH ANGLE-CLOSURE GLAUCOMA OR IN THOSE WITH NARROW ANGLES IN WHOM DILATION OF THE PUPIL MAY PRECIPITATE AN ATTACK OF ANGLE-CLOSURE GLAUCOMA. THIS PRODUCT IS ALSO CONTRAINDICATED IN PATIENTS WHO ARE HYPERSENSITIVE TO ANY OF ITS COMPONENTS.
DESCRIPTION
HYDROXYAMPHETAMINE IS A DERIVATIVE OF AMPHETAMINES. HYDROXYAMPHETAMINE IS INTENDED MAINLY AS LOCAL EYE DROPS FOR DIAGNOSTIC PURPOSES. IT IS INDIRECT SYMPATHOMIMETIC AGENT WHICH CAUSE DILATION OF THE EYE PUPIL BEFORE DIAGNOSTIC TEST. AMONG THE MINOR SIDE EFFECTS FROM ITS USE ARE: CHANGE IN COLOR VISION, DIFFICULTY SEEING AT NIGHT, DRY MOUTH, HEADACHE, INCREASED SENSITIVITY OF EYES TO SUNLIGHT, MUSCLE STIFFNESS OR TIGHTNESS AND TEMPORARY STINGING IN THE EYES. THE MAIN USE OF HYDROXYAMPHETAMINES AS EYE DROPS IS THE DIAGNOSIS OF HORNER'S SYNDROME WHICH IS CHARACTERIZED BY NERVE LESIONS.
PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) STERILE OPHTHALMIC SOLUTION IS A TOPICAL MYDRIATIC COMBINATION PRODUCT FOR OPHTHALMIC USE.
INDICATIONS & DOSAGE
INDICATIONS
PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) SOLUTION IS INDICATED FOR MYDRIASIS IN ROUTINE DIAGNOSTIC PROCEDURES AND IN CONDITIONS WHERE SHORT-TERM PUPIL DILATION IS DESIRED. PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) PROVIDES CLINICALLY SIGNIFICANT MYDRIASIS WITH PARTIAL CYCLOPLEGIA.
DOSAGE AND ADMINISTRATION
ONE TO TWO DROPS IN THE CONJUNCTIVAL SAC. THE ONSET OF ACTION WITH PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) SOLUTION OCCURS WITHIN 15 MINUTES FOLLOWED BY MAXIMUM EFFECT WITHIN 60 MINUTES. CLINICALLY SIGNIFICANT DILATION, INHIBITION OF PUPILLARY LIGHT RESPONSE, AND PARTIAL CYCLOPLEGIA LAST 3 HOURS. MYDRIASIS WILL REVERSE SPONTANEOUSLY WITH TIME, TYPICALLY IN 6 TO 8 HOURS. HOWEVER, IN SOME CASES, COMPLETE RECOVERY MAY TAKE UP TO 24 HOURS.
HOW SUPPLIED
PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) (HYDROXYAMPHETAMINE HYDROBROMIDE/TROPICAMIDE OPHTHALMIC SOLUTION) 1%/0.25% AS A 15 ML SOLUTION IN A 15 ML OPAQUE WHITE, LOW DENSITY POLYETHYLENE BOTTLE WITH A NATURAL LOW DENSITY POLYETHYLENE DROPPER TIP AND A RED POLYPROPYLENE CAP. 15 ML - NDC 17478-704-12
NOTE: PROTECT FROM LIGHT. STORE BETWEEN 15° C TO 25° C (59° F TO 77° F).
MANUFACTURED BY: AKORN BUFFALO GROVE, IL 60089. FOR PRODUCT ENQUIRY CALL: 800-932-5676 OR FAX 800-943-3694 • WWW.AKORN.COM
SIDE EFFECTS & DRUG INTERACTIONS
SIDE EFFECTS
INCREASED INTRAOCULAR PRESSURE HAS BEEN REPORTED FOLLOWING USE OF MYDRIATICS. TRANSIENT STINGING, DRYNESS OF THE MOUTH , BLURRED VISION , PHOTOPHOBIA WITH OR WITHOUT CORNEAL STAINING, TACHYCARDIA , HEADACHE, ALLERGIC REACTIONS, NAUSEA , VOMITING, PALLOR, AND MUSCLE RIGIDITY HAVE BEEN REPORTED WITH THE USE OF TROPICAMIDE AND/OR HYDROXYAMPHETAMINE HYDROBROMIDE, AND THUS MAY OCCUR WITH PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) SOLUTION. CENTRAL NERVOUS SYSTEM DISTURBANCES HAVE ALSO BEEN REPORTED. PSYCHOTIC REACTIONS, BEHAVIORAL DISTURBANCES, AND VASOMOTOR OR CARDIORESPIRATORY COLLAPSE HAVE BEEN REPORTED WITH THE USE OF ANTICHOLINERGIC DRUGS. RARE BUT SERIOUS CARDIOVASCULAR EVENTS, INCLUDING DEATH DUE TO MYOCARDIALINFARCTION, VENTRICULAR FIBRILLATION AND SIGNIFICANT HYPOTENSIVE EPISODES HAVE OCCURRED SHORTLY FOLLOWING PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) INSTILLATION.
DRUG INTERACTIONS
3-ISOBUTYL-1-METHYL-7H-XANTHINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH 3-ISOBUTYL-1-METHYL-7H-XANTHINE.
6-O-BENZYLGUANINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH 6-O-BENZYLGUANINE.
7-DEAZAGUANINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH 7-DEAZAGUANINE.
7,9-DIMETHYLGUANINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH 7,9-DIMETHYLGUANINE.
8-AZAGUANINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH 8-AZAGUANINE.
8-CHLOROTHEOPHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH 8-CHLOROTHEOPHYLLINE.
9-DEAZAGUANINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH 9-DEAZAGUANINE.
9-METHYLGUANINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH 9-METHYLGUANINE.
ACEFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH ACEFYLLINE.
AMINOPHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH AMINOPHYLLINE.
BAMIFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH BAMIFYLLINE.
BROMOTHEOPHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH BROMOTHEOPHYLLINE.
BUFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH BUFYLLINE.
CAFEDRINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH CAFEDRINE.
CAFFEINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH CAFFEINE.
DOXOFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH DOXOFYLLINE.
DYPHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH DYPHYLLINE.
ESCITALOPRAM THE RISK OR SEVERITY OF SEROTONIN SYNDROME CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH ESCITALOPRAM.
ETAMIPHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH ETAMIPHYLLINE.
FENETHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH FENETHYLLINE.
FLUOXETINE THE RISK OR SEVERITY OF SEROTONIN SYNDROME CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH FLUOXETINE.
FORMOTEROL HYDROXYAMPHETAMINE MAY INCREASE THE SYMPATHOMIMETIC ACTIVITIES OF FORMOTEROL.
FURAFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH FURAFYLLINE.
GLYBURIDE THE THERAPEUTIC EFFICACY OF GLYBURIDE CAN BE DECREASED WHEN USED IN COMBINATION WITH HYDROXYAMPHETAMINE.
GUANINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH GUANINE.
HYPOXANTHINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH HYPOXANTHINE.
LASMIDITAN THE RISK OR SEVERITY OF SEROTONIN SYNDROME CAN BE INCREASED WHEN LASMIDITAN IS COMBINED WITH HYDROXYAMPHETAMINE.
LISOFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH LISOFYLLINE.
LOBUCAVIR THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH LOBUCAVIR.
MERCAPTOPURINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH MERCAPTOPURINE.
OXTRIPHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH OXTRIPHYLLINE.
PCS-499 THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH PCS-499.
PELDESINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH PELDESINE.
PENTIFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH PENTIFYLLINE.
PENTOXIFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH PENTOXIFYLLINE.
PROPENTOFYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH PROPENTOFYLLINE.
PROXYPHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH PROXYPHYLLINE.
THEOBROMINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH THEOBROMINE.
THEODRENALINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH THEODRENALINE.
THEOPHYLLINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH THEOPHYLLINE.
TRAMADOL THE RISK OR SEVERITY OF SEROTONIN SYNDROME CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH TRAMADOL.
TRAZODONE THE RISK OR SEVERITY OF SEROTONIN SYNDROME CAN BE INCREASED WHEN TRAZODONE IS COMBINED WITH HYDROXYAMPHETAMINE.
URIC ACID THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH URIC ACID.
VALOMACICLOVIR THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH VALOMACICLOVIR.
XANTHINE THE RISK OR SEVERITY OF ADVERSE EFFECTS CAN BE INCREASED WHEN HYDROXYAMPHETAMINE IS COMBINED WITH XANTHINE.
WARNINGS & PRECAUTIONS
WARNINGS
FOR TOPICAL OPHTHALMIC USE ONLY; NOT FOR INJECTION. THERE IS EVIDENCE THAT MYDRIATICS MAY PRODUCE A TRANSIENT ELEVATION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN-ANGLE GLAUCOMA . THIS PREPARATION RARELY MAY CAUSE CNS DISTURBANCES WHICH MAY BE PARTICULARLY DANGEROUS IN INFANTS, CHILDREN, OR THE AGED. PSYCHOTIC REACTIONS, BEHAVIORAL DISTURBANCES, AND VASOMOTOR OR CARDIORESPIRATORY COLLAPSE HAVE BEEN REPORTED WITH THE USE OF ANTICHOLINERGIC DRUGS.
PRECAUTIONS
GENERAL
PATIENTS WITH HYPERTENSION , HYPERTHYROIDISM, DIABETES , OR CARDIAC DISEASE (I.E., ARRHYTHMIAS OR CHRONIC ISCHEMIC HEART DISEASE ) SHOULD BE MONITORED AFTER INSTILLATION. THE ELDERLY AND OTHERS IN WHOM GLAUCOMA OR INCREASED INTRAOCULAR PRESSURE MAY BE ENCOUNTERED FOLLOWING ADMINISTRATION OF PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) SOLUTION SHOULD ALSO BE MONITORED CLOSELY. TO AVOID INDUCING ANGLE-CLOSURE GLAUCOMA , AN ESTIMATION OF THE DEPTH OF THE ANGLE OF THE ANTERIOR CHAMBER SHOULD BE MADE.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
NO STUDIES HAVE BEEN PERFORMED TO EVALUATE THE CARCINOGENIC , MUTAGENIC OR IMPAIRMENT OF FERTILITY POTENTIAL OF PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) .
PREGNANCY
PREGNANCY CATEGORY C: ANIMAL REPRODUCTION STUDIES HAVE NOT BEEN CONDUCTED WITH PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) . IT IS ALSO NOT KNOWN WHETHER PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN OR CAN AFFECT REPRODUCTION CAPABILITY. PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) SHOULD BE GIVEN TO A PREGNANT WOMAN ONLY IF CLEARLY NEEDED.
NURSING MOTHERS
IT IS NOT KNOWN WHETHER THIS DRUG IS EXCRETED IN HUMAN MILK. BECAUSE MANY DRUGS ARE EXCRETED IN HUMAN MILK, CAUTION SHOULD BE EXERCISED WHEN PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) IS ADMINISTERED TO A NURSING WOMAN.
PEDIATRIC USE
SAFETY AND EFFECTIVENESS IN PEDIATRIC PATIENTS HAVE NOT BEEN ESTABLISHED. PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) MAY RARELY CAUSE CNS DISTURBANCES WHICH MAY BE DANGEROUS IN INFANTS AND CHILDREN. PSYCHOTIC REACTIONS, BEHAVIORAL DISTURBANCES, AND VASOMOTOR OR CARDIORESPIRATORY COLLAPSE IN CHILDREN HAVE BEEN REPORTED WITH THE USE OF ANTICHOLINERGIC DRUGS. (SEE WARNINGS.) KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
GERIATRIC USE
NO OVERALL DIFFERENCES IN SAFETY AND EFFECTIVENESS HAVE BEEN OBSERVED BETWEEN ELDERLY AND YOUNGER PATIENTS.
OVERDOSAGE & CONTRAINDICATIONS
OVERDOSE
OCULAR OVERDOSAGE WILL CAUSE DILATION OF THE PUPILS. SYSTEMIC OVERDOSAGE OR INGESTION OF LARGE DOSES MAY RESULT IN HYPERTENSION , CARDIAC ARRHYTHMIAS, SUB- STERNAL DISCOMFORT, HEADACHE, SWEATING , NAUSEA , VOMITING, AND GASTROINTESTINAL IRRITATION. PATIENTS WITH SYSTEMIC OVERDOSAGE SHOULD BE CAREFULLY MONITORED AND TREATED SYMPTOMATICALLY.
CONTRAINDICATIONS
PAREMYD® (HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE) SOLUTION (HYDROXYAMPHETAMINE HYDROBROMIDE/TROPICAMIDE OPHTHALMIC SOLUTION)1%/0.25% SHOULD NOT BE USED IN PATIENTS WITH ANGLE-CLOSURE GLAUCOMA OR IN THOSE WITH NARROW ANGLES IN WHOM DILATION OF THE PUPIL MAY PRECIPITATE AN ATTACK OF ANGLE-CLOSURE GLAUCOMA . THIS PRODUCT IS ALSO CONTRAINDICATED IN PATIENTS WHO ARE HYPERSENSITIVE TO ANY OF ITS COMPONENTS.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
NO INFORMATION PROVIDED.
MECHANISM OF ACTION
HYDROXYAMPHETAMINE HYDROBROMIDE IS AN INDIRECT ACTING SYMPATHOMIMETIC AGENT WHICH CAUSES THE RELEASE OF NOREPINEPHRINE FROM ADRENERGIC NERVE TERMINALS, RESULTING IN MYDRIASIS.
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