THE ACTIVE INGREDIENT IN PREVACID DELAYED-RELEASE CAPSULES AND PREVACID SOLUTAB DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS IS LANSOPRAZOLE, A SUBSTITUTED BENZIMIDAZOLE, 2-[[[3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)-2-PYRIDYL] METHYL] SULFINYL] BENZIMIDAZOLE, A COMPOUND THAT INHIBITS GASTRIC ACID SECRETION. ITS EMPIRICAL FORMULA IS C16H14F3N3O2S WITH A MOLECULAR WEIGHT OF 369.37. PREVACID HAS THE FOLLOWING STRUCTURE:
LANSOPRAZOLE IS A WHITE TO BROWNISH-WHITE ODORLESS CRYSTALLINE POWDER WHICH MELTS WITH DECOMPOSITION AT APPROXIMATELY 166°C. LANSOPRAZOLE IS FREELY SOLUBLE IN DIMETHYLFORMAMIDE; SOLUBLE IN METHANOL; SPARINGLY SOLUBLE IN ETHANOL; SLIGHTLY SOLUBLE IN ETHYL ACETATE, DICHLOROMETHANE AND ACETONITRILE; VERY SLIGHTLY SOLUBLE IN ETHER; AND PRACTICALLY INSOLUBLE IN HEXANE AND WATER.
LANSOPRAZOLE IS STABLE WHEN EXPOSED TO LIGHT FOR UP TO TWO MONTHS. THE RATE OF DEGRADATION OF THE COMPOUND IN AQUEOUS SOLUTION INCREASES WITH DECREASING PH. THE DEGRADATION HALF-LIFE OF THE DRUG SUBSTANCE IN AQUEOUS SOLUTION AT 25°C IS APPROXIMATELY 0.5 HOUR AT PH 5.0 AND APPROXIMATELY 18 HOURS AT PH 7.0.
PREVACID IS SUPPLIED IN DELAYED-RELEASE CAPSULES AND IN DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS FOR ORAL ADMINISTRATION.
THE DELAYED-RELEASE CAPSULES ARE AVAILABLE IN TWO DOSAGE STRENGTHS: 15 MG AND 30 MG OF LANSOPRAZOLE PER CAPSULE. EACH DELAYED-RELEASE CAPSULE CONTAINS ENTERIC-COATED GRANULES CONSISTING OF 15 MG OR 30 MG OF LANSOPRAZOLE (ACTIVE INGREDIENT) AND THE FOLLOWING INACTIVE INGREDIENTS: SUGAR SPHERE, SUCROSE, METHACRYLIC ACID COPOLYMER, LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE, STARCH, MAGNESIUM CARBONATE, TALC, POLYETHYLENE GLYCOL, TITANIUM DIOXIDE, POLYSORBATE 80, HYDROXYPROPYL CELLULOSE, COLLOIDAL SILICON DIOXIDE, D&C RED NO. 28, FD&C BLUE NO. 1, FD&C GREEN NO. 31, AND FD&C RED NO. 40.
PREVACID SOLUTAB DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS ARE AVAILABLE IN TWO DOSAGE STRENGTHS: 15 MG AND 30 MG OF LANSOPRAZOLE PER TABLET. EACH DELAYED-RELEASE ORALLY DISINTEGRATING TABLET CONTAINS ENTERIC-COATED MICROGRANULES CONSISTING OF 15 MG OR 30 MG OF LANSOPRAZOLE (ACTIVE INGREDIENT) AND THE FOLLOWING INACTIVE INGREDIENTS: MANNITOL, METHACRYLIC ACID, HYDROXYPROPYL CELLULOSE, LACTOSE MONOHYDRATE-MICROCRYSTALLINE CELLULOSE SPHERE, TRIETHYL CITRATE, CROSPOVIDONE, POLYACRYLATE, MAGNESIUM CARBONATE, ASPARTAME2, GLYCERYL MONOSTEARATE, HYPROMELLOSE, MAGNESIUM STEARATE, CITRIC ACID, TITANIUM DIOXIDE, TALC, ARTIFICIAL STRAWBERRY FLAVOR, POLYETHYLENE GLYCOL, POLYSORBATE 80 AND FERRIC OXIDE.
INDICATIONS
SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER
PREVACID IS INDICATED FOR SHORT-TERM TREATMENT (FOR 4 WEEKS) FOR HEALING AND SYMPTOM RELIEF OF ACTIVE DUODENAL ULCER [SEE CLINICAL STUDIES].
H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
TRIPLE THERAPY: PREVACID/AMOXICILLIN/CLARITHROMYCIN
PREVACID IN COMBINATION WITH AMOXICILLIN PLUS CLARITHROMYCIN AS TRIPLE THERAPY IS INDICATED FOR THE TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE (ACTIVE OR ONE-YEAR HISTORY OF A DUODENAL ULCER) TO ERADICATE H. PYLORI. ERADICATION OF H. PYLORI HAS BEEN SHOWN TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE [SEE CLINICAL STUDIES].
PLEASE REFER TO THE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLARITHROMYCIN.
DUAL THERAPY: PREVACID/AMOXICILLIN
PREVACID IN COMBINATION WITH AMOXICILLIN AS DUAL THERAPY IS INDICATED FOR THE TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE (ACTIVE OR ONE-YEAR HISTORY OF A DUODENAL ULCER) WHO ARE EITHER ALLERGIC OR INTOLERANT TO CLARITHROMYCIN OR IN WHOM RESISTANCE TO CLARITHROMYCIN IS KNOWN OR SUSPECTED (SEE THE CLARITHROMYCIN PACKAGE INSERT, MICROBIOLOGY SECTION). ERADICATION OF H. PYLORI HAS BEEN SHOWN TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE [SEE CLINICAL STUDIES].
PLEASE REFER TO THE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN.
MAINTENANCE OF HEALED DUODENAL ULCERS
PREVACID IS INDICATED TO MAINTAIN HEALING OF DUODENAL ULCERS. CONTROLLED STUDIES DO NOT EXTEND BEYOND 12 MONTHS [SEE CLINICAL STUDIES].
SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
PREVACID IS INDICATED FOR SHORT-TERM TREATMENT (UP TO 8 WEEKS) FOR HEALING AND SYMPTOM RELIEF OF ACTIVE BENIGN GASTRIC ULCER [SEE CLINICAL STUDIES].
HEALING OF NSAID-ASSOCIATED GASTRIC ULCER
PREVACID IS INDICATED FOR THE TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS WHO CONTINUE NSAID USE. CONTROLLED STUDIES DID NOT EXTEND BEYOND 8 WEEKS [SEE CLINICAL STUDIES].
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
PREVACID IS INDICATED FOR REDUCING THE RISK OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS WITH A HISTORY OF A DOCUMENTED GASTRIC ULCER WHO REQUIRE THE USE OF AN NSAID. CONTROLLED STUDIES DID NOT EXTEND BEYOND 12 WEEKS [SEE CLINICAL STUDIES].
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
SHORT-TERM TREATMENT OF SYMPTOMATIC GERD
PREVACID IS INDICATED FOR THE TREATMENT OF HEARTBURN AND OTHER SYMPTOMS ASSOCIATED WITH GERD [SEE CLINICAL STUDIES].
SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS
PREVACID IS INDICATED FOR SHORT-TERM TREATMENT (UP TO 8 WEEKS) FOR HEALING AND SYMPTOM RELIEF OF ALL GRADES OF EROSIVE ESOPHAGITIS. FOR PATIENTS WHO DO NOT HEAL WITH PREVACID FOR 8 WEEKS (5 TO 10%), IT MAY BE HELPFUL TO GIVE AN ADDITIONAL 8 WEEKS OF TREATMENT. IF THERE IS A RECURRENCE OF EROSIVE ESOPHAGITIS AN ADDITIONAL 8-WEEK COURSE OF PREVACID MAY BE CONSIDERED [SEE CLINICAL STUDIES].
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (EE)
PREVACID IS INDICATED TO MAINTAIN HEALING OF EROSIVE ESOPHAGITIS. CONTROLLED STUDIES DID NOT EXTEND BEYOND 12 MONTHS [SEE CLINICAL STUDIES].
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME (ZES)
PREVACID IS INDICATED FOR THE LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS, INCLUDING ZOLLINGER-ELLISON SYNDROME [SEE CLINICAL STUDIES].
DOSAGE AND ADMINISTRATION
PREVACID IS AVAILABLE AS A CAPSULE AND AN ORALLY DISINTEGRATING TABLET, AND IS AVAILABLE IN 15 MG AND 30 MG STRENGTHS. DIRECTIONS FOR USE SPECIFIC TO THE ROUTE AND AVAILABLE METHODS OF ADMINISTRATION FOR EACH OF THESE DOSAGE FORMS IS PRESENTED BELOW. PREVACID SHOULD BE TAKEN BEFORE EATING. PREVACID PRODUCTS SHOULD NOT BE CRUSHED OR CHEWED. IN THE CLINICAL TRIALS, ANTACIDS WERE USED CONCOMITANTLY WITH PREVACID.
RECOMMENDED DOSE
INDICATION
RECOMMENDED DOSE
FREQUENCY
DUODENAL ULCERS
  SHORT-TERM TREATMENT
15 MG
ONCE DAILY FOR 4 WEEKS
  MAINTENANCE OF HEALED
15 MG
ONCE DAILY
H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE*
  TRIPLE THERAPY:
    PREVACID
30 MG
TWICE DAILY (Q12H) FOR 10 OR 14 DAYS
    AMOXICILLIN
1 GRAM
TWICE DAILY (Q12H) FOR 10 OR 14 DAYS
    CLARITHROMYCIN
500 MG
TWICE DAILY (Q12H) FOR 10 OR 14 DAYS
  DUAL THERAPY:
    PREVACID
30 MG
THREE TIMES DAILY (Q8H) FOR 14 DAYS
    AMOXICILLIN
1 GRAM
THREE TIMES DAILY (Q8H) FOR 14 DAYS
BENIGN GASTRIC ULCER
  SHORT-TERM TREATMENT
30 MG
ONCE DAILY FOR UP TO 8 WEEKS
NSAID-ASSOCIATED GASTRIC ULCER
  HEALING
30 MG
ONCE DAILY FOR 8 WEEKSâ
  RISK REDUCTION
15 MG
ONCE DAILY FOR UP TO 12 WEEKSâ
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
  SHORT-TERM TREATMENT OF SYMPTOMATIC GERD
15 MG
ONCE DAILY FOR UP TO 8 WEEKS
  SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS
30 MG
ONCE DAILY FOR UP TO 8 WEEKS*
PEDIATRIC (1 TO 11 YEARS OF AGE)
SHORT-TERM TREATMENT OF SYMPTOMATIC GERD AND SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS
  = 30 KG
15 MG
ONCE DAILY FOR UP TO 12 WEEKS§
  > 30 KG
30 MG
ONCE DAILY FOR UP TO 12 WEEKS§
(12 TO 17 YEARS OF AGE) SHORT-TERM TREATMENT OF SYMPTOMATIC GERD
  NONEROSIVE GERD
15 MG
ONCE DAILY FOR UP TO 8 WEEKS
  EROSIVE ESOPHAGITIS
30 MG
ONCE DAILY FOR UP TO 8 WEEKS
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
15 MG
ONCE DAILY
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME
60 MG
ONCE DAILY¶
*PLEASE REFER TO AMOXICILLIN AND CLARITHROMYCIN FULL PRESCRIBING INFORMATION FOR CONTRAINDICATIONS AND WARNINGS, AND FOR INFORMATION REGARDING DOSING IN ELDERLY AND RENALLY-IMPAIRED PATIENTS.
â CONTROLLED STUDIES DID NOT EXTEND BEYOND INDICATED DURATION.
âĄFOR PATIENTS WHO DO NOT HEAL WITH PREVACID FOR 8 WEEKS (5 TO 10%), IT MAY BE HELPFUL TO GIVE AN ADDITIONAL 8 WEEKS OF TREATMENT. IF THERE IS A RECURRENCE OF EROSIVE ESOPHAGITIS, AN ADDITIONAL 8 WEEK COURSE OF PREVACID MAY BE CONSIDERED.
§ THE PREVACID DOSE WAS INCREASED (UP TO 30 MG TWICE DAILY) IN SOME PEDIATRIC PATIENTS AFTER 2 OR MORE WEEKS OF TREATMENT IF THEY REMAINED SYMPTOMATIC. FOR PEDIATRIC PATIENTS UNABLE TO SWALLOW AN INTACT CAPSULE PLEASE SEE ADMINISTRATION OPTIONS.
¶ VARIES WITH INDIVIDUAL PATIENT. RECOMMENDED ADULT STARTING DOSE IS 60 MG ONCE DAILY. DOSES SHOULD BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS AND SHOULD CONTINUE FOR AS LONG AS CLINICALLY INDICATED. DOSAGES UP TO 90 MG TWICE DAILY HAVE BEEN ADMINISTERED. DAILY DOSE OF GREATER THAN 120 MG SHOULD BE ADMINISTERED IN DIVIDED DOSES. SOME PATIENTS WITH ZOLLINGER-ELLISON SYNDROME HAVE BEEN TREATED CONTINUOUSLY WITH PREVACID FOR MORE THAN 4 YEARS.
PATIENTS SHOULD BE INSTRUCTED THAT IF A DOSE IS MISSED, IT SHOULD BE TAKEN AS SOON AS POSSIBLE. HOWEVER, IF THE NEXT SCHEDULED DOSE IS DUE, THE PATIENT SHOULD NOT TAKE THE MISSED DOSE, AND SHOULD BE INSTRUCTED TO TAKE THE NEXT DOSE ON TIME. PATIENTS SHOULD BE INSTRUCTED NOT TO TAKE 2 DOSES AT ONE TIME TO MAKE UP FOR A MISSED DOSE.
SPECIAL POPULATIONS
RENAL IMPAIRMENT PATIENTS AND GERIATRIC PATIENTS DO NOT REQUIRE DOSAGE ADJUSTMENT. HOWEVER, CONSIDER DOSE ADJUSTMENT IN PATIENTS WITH SEVERE LIVER IMPAIRMENT [SEE USE IN SPECIFIC POPULATIONS].
IMPORTANT ADMINISTRATION INFORMATION
ADMINISTRATION OPTIONS
PREVACID DELAYED-RELEASE CAPSULES â ORAL ADMINISTRATION
PREVACID DELAYED-RELEASE CAPSULES SHOULD BE SWALLOWED WHOLE.
ALTERNATIVELY, FOR PATIENTS WHO HAVE DIFFICULTY SWALLOWING CAPSULES, PREVACID DELAYED-RELEASE CAPSULES CAN BE OPENED AND ADMINISTERED AS FOLLOWS:
OPEN CAPSULE.
SPRINKLE INTACT GRANULES ON ONE TABLESPOON OF EITHER APPLESAUCE, ENSURE PUDDING, COTTAGE CHEESE, YOGURT OR STRAINED PEARS.
SWALLOW IMMEDIATELY.
PREVACID DELAYED-RELEASE CAPSULES MAY ALSO BE EMPTIED INTO A SMALL VOLUME OF EITHER APPLE JUICE, ORANGE JUICE OR TOMATO JUICE AND ADMINISTERED AS FOLLOWS:
OPEN CAPSULE.
SPRINKLE INTACT GRANULES INTO A SMALL VOLUME OF EITHER APPLE JUICE, ORANGE JUICE OR TOMATO JUICE (60 ML â APPROXIMATELY 2 OUNCES).
MIX BRIEFLY.
SWALLOW IMMEDIATELY.
TO ENSURE COMPLETE DELIVERY OF THE DOSE, THE GLASS SHOULD BE RINSED WITH TWO OR MORE VOLUMES OF JUICE AND THE CONTENTS SWALLOWED IMMEDIATELY.
PREVACID DELAYED-RELEASE CAPSULES â NASOGASTRIC TUBE ( = 16 FRENCH) ADMINISTRATION
FOR PATIENTS WHO HAVE A NASOGASTRIC TUBE IN PLACE, PREVACID DELAYED-RELEASE CAPSULES CAN BE ADMIN ISTERED AS FOLLOWS:
OPEN CAPSULE.
MIX INTACT GRANULES INTO 40 ML OF APPLE JUICE. DO NOT USE OTHER LIQUIDS.
INJECT THROUGH THE NASOGASTRIC TUBE INTO THE STOMACH.
FLUSH WITH ADDITIONAL APPLE JUICE TO CLEAR THE TUBE.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
PREVACID SOLUTAB DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS
PREVACID SOLUTAB SHOULD NOT BE BROKEN OR CUT.
PREVACID SOLUTAB SHOULD NOT BE CHEWED.
PLACE THE TABLET ON THE TONGUE AND ALLOW IT TO DISINTEGRATE, WITH OR WITHOUT WATER, UNTIL THE PARTICLES CAN BE SWALLOWED.
THE TABLET TYPICALLY DISINTEGRATES IN LESS THAN 1 MINUTE.
ALTERNATIVELY, FOR CHILDREN OR OTHER PATIENTS WHO HAVE DIFFICULTY SWALLOWING TABLETS, PREVACID SOLUTAB CAN BE DELIVERED IN TWO DIFFERENT WAYS.
PREVACID SOLUTAB â ORAL SYRINGE
FOR ADMINISTRATION VIA ORAL SYRINGE, PREVACID SOLUTAB CAN BE ADMINISTERED AS FOLLOWS:
PLACE A 15 MG TABLET IN ORAL SYRINGE AND DRAW UP 4 ML OF WATER, OR PLACE A 30 MG TABLET IN ORAL SYRINGE AND DRAW UP 10 ML OF WATER.
SHAKE GENTLY TO ALLOW FOR A QUICK DISPERSAL.
AFTER THE TABLET HAS DISPERSED, ADMINISTER THE CONTENTS WITHIN 15 MINUTES.
REFILL THE SYRINGE WITH APPROXIMATELY 2 ML (5 ML FOR THE 30 MG TABLET) OF WATER, SHAKE GENTLY, AND ADMINISTER ANY REMAINING CONTENTS.
PREVACID SOLUTAB â NASOGASTRIC TUBE ( = 8 FRENCH) ADMINISTRATION
FOR ADMINISTRATION VIA A NASOGASTRIC TUBE, PREVACID SOLUTAB CAN BE ADMINISTERED AS FOLLOWS:
PLACE A 15 MG TABLET IN A SYRINGE AND DRAW UP 4 ML OF WATER, OR PLACE A 30 MG TABLET IN A SYRINGE AND DRAW UP 10 ML OF WATER.
SHAKE GENTLY TO ALLOW FOR A QUICK DISPERSAL.
AFTER THE TABLET HAS DISPERSED, INJECT THROUGH THE NASOGASTRIC TUBE INTO THE STOMACH WITHIN 15 MINUTES.
REFILL THE SYRINGE WITH APPROXIMATELY 5 ML OF WATER, SHAKE GENTLY, AND FLUSH THE NASOGASTRIC TUBE.
HOW SUPPLIED
DOSAGE FORMS AND STRENGTHS
15 MG CAPSULES ARE OPAQUE, HARD GELATIN, COLORED PINK AND GREEN WITH THE TAP LOGO AND âPREVACID 15â IMPRINTED ON THE CAPSULE.
30 MG CAPSULES ARE OPAQUE, HARD GELATIN, COLORED PINK AND BLACK WITH THE TAP LOGO AND âPREVACID 30â IMPRINTED ON THE CAPSULE.
15 MG TABLETS ARE WHITE TO YELLOWISH WHITE, UNCOATED, COLORED ORANGE TO DARK BROWN SPECKLES WITH â15â DEBOSSED ON ONE SIDE OF THE TABLET.
30 MG TABLETS ARE WHITE TO YELLOWISH WHITE, UNCOATED, COLORED ORANGE TO DARK BROWN SPECKLES WITH â30â DEBOSSED ON ONE SIDE OF THE TABLET.
STORAGE AND HANDLING
PREVACID DELAYED-RELEASE CAPSULES, 15 MG, ARE OPAQUE, HARD GELATIN, COLORED PINK AND GREEN WITH âTAPâ AND âPREVACID 15â IMPRINTED ON THE CAPSULES. THE 30 MG CAPSULES ARE OPAQUE, HARD GELATIN, COLORED PINK AND BLACK WITH âTAPâ AND âPREVACID 30â IMPRINTED ON THE CAPSULES. THEY ARE AVAILABLE AS FOLLOWS:
NDC 64764-541-30 UNIT OF USE BOTTLES OF 30: 15-MG CAPSULES
NDC 64764-541-19 BOTTLES OF 1000: 15-MG CAPSULES
NDC 64764-541-11 UNIT DOSE PACKAGE OF 100: 15-MG CAPSULES
NDC 64764-046-13 BOTTLES OF 100: 30-MG CAPSULES
NDC 64764-046-19 BOTTLES OF 1000: 30-MG CAPSULES
NDC 64764-046-11 UNIT DOSE PACKAGE OF 100: 30-MG CAPSULES
PREVACID SOLUTAB DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS, 15 MG, ARE WHITE TO YELLOWISH WHITE UNCOATED TABLETS WITH ORANGE TO DARK BROWN SPECKLES, WITH â15â DEBOSSED ON ONE SIDE OF THE TABLET. THE 30 MG ARE WHITE TO YELLOWISH WHITE UNCOATED TABLETS WITH ORANGE TO DARK BROWN SPECKLES, WITH â30â DEBOSSED ON ONE SIDE OF THE TABLET. THE TABLETS ARE AVAILABLE AS FOLLOWS:
NDC 64764-543-11 UNIT DOSE PACKAGES OF 100: 15-MG TABLETS
NDC 64764-544-11 UNIT DOSE PACKAGES OF 100: 30-MG TABLETS
STORE AT 25°C (77°F); EXCURSIONS PERMITTED TO 15-30°C (59-86°F)[SEE USP CONTROLLED ROOM TEMPERATURE].
SIDE EFFECTS
CLINICAL
WORLDWIDE, OVER 10,000 PATIENTS HAVE BEEN TREATED WITH PREVACID IN PHASE 2 OR PHASE 3 CLINICAL TRIALS INVOLVING VARIOUS DOSAGES AND DURATIONS OF TREATMENT. IN GENERAL, PREVACID TREATMENT HAS BEEN WELL-TOLERATED IN BOTH SHORT-TERM AND LONG-TERM TRIALS.
BECAUSE CLINICAL TRIALS ARE CONDUCTED UNDER WIDELY VARYING CONDITIONS, ADVERSE REACTION RATES OBSERVED IN THE CLINICAL TRIALS OF A DRUG CANNOT BE DIRECTLY COMPARED TO RATES IN THE CLINICAL TRIALS OF ANOTHER DRUG AND MAY NOT REFLECT THE RATES OBSERVED IN CLINICAL PRACTICE.
THE FOLLOWING ADVERSE REACTIONS WERE REPORTED BY THE TREATING PHYSICIAN TO HAVE A POSSIBLE OR PROBABLE RELATIONSHIP TO DRUG IN 1% OR MORE OF PREVACID-TREATED PATIENTS AND OCCURRED AT A GREATER RATE IN PREVACID-TREATED PATIENTS THAN PLACEBO-TREATED PATIENTS IN TABLE 1.
TABLE 1: INCIDENCE OF POSSIBLY OR PROBABLY TREATMENT-RELATED ADVERSE REACTIONS IN SHORT-TERM, PLACEBO-CONTROLLED PREVACID STUDIES
BODY SYSTEM/ADVERSE EVENT
PREVACID
(N= 2768)
%
PLACEBO
(N= 1023)
%
BODY AS A WHOLE
  ABDOMINAL PAIN
2.1
1.2
DIGESTIVE SYSTEM
  CONSTIPATION
1.0
0.4
  DIARRHEA
3.8
2.3
  NAUSEA
1.3
1.2
HEADACHE WAS ALSO SEEN AT GREATER THAN 1% INCIDENCE BUT WAS MORE COMMON ON PLACEBO. THE INCIDENCE OF DIARRHEA WAS SIMILAR BETWEEN PATIENTS WHO RECEIVED PLACEBO AND PATIENTS WHO RECEIVED 15 MG AND 30 MG OF PREVACID, BUT HIGHER IN THE PATIENTS WHO RECEIVED 60 MG OF PREVACID (2.9%, 1.4%, 4.2%, AND 7.4%, RESPECTIVELY).
THE MOST COMMONLY REPORTED POSSIBLY OR PROBABLY TREATMENT-RELATED ADVERSE EVENT DURING MAINTENANCE THERAPY WAS DIARRHEA.
IN THE RISK REDUCTION STUDY OF PREVACID FOR NSAID-ASSOCIATED GASTRIC ULCERS, THE INCIDENCE OF DIARRHEA FOR PATIENTS TREATED WITH PREVACID, MISOPROSTOL, AND PLACEBO WAS 5%, 22%, AND 3%, RESPECTIVELY.
ANOTHER STUDY FOR THE SAME INDICATION, WHERE PATIENTS TOOK EITHER A COX-2 INHIBITOR OR LANSOPRAZOLE AND NAPROXEN, DEMONSTRATED THAT THE SAFETY PROFILE WAS SIMILAR TO THE PRIOR STUDY. ADDITIONAL REACTIONS FROM THIS STUDY NOT PREVIOUSLY OBSERVED IN OTHER CLINICAL TRIALS WITH PREVACID INCLUDED CONTUSION, DUODENITIS, EPIGASTRIC DISCOMFORT, ESOPHAGEAL DISORDER, FATIGUE, HUNGER, HIATAL HERNIA, HOARSENESS, IMPAIRED GASTRIC EMPTYING, METAPLASIA, AND RENAL IMPAIRMENT.
ADDITIONAL ADVERSE EXPERIENCES OCCURRING IN LESS THAN 1% OF PATIENTS OR SUBJECTS WHO RECEIVED PREVACID IN DOMESTIC TRIALS ARE SHOWN BELOW:
BODY AS A WHOLE â ABDOMEN ENLARGED, ALLERGIC REACTION, ASTHENIA, BACK PAIN, CANDIDIASIS, CARCINOMA, CHEST PAIN (NOT OTHERWISE SPECIFIED), CHILLS, EDEMA, FEVER, FLU SYNDROME, HALITOSIS, INFECTION (NOT OTHERWISE SPECIFIED), MALAISE, NECK PAIN, NECK RIGIDITY, PAIN, PELVIC PAIN
CARDIOVASCULAR SYSTEM â ANGINA, ARRHYTHMIA, BRADYCARDIA, CEREBROVASCULAR ACCIDENT/CEREBRAL INFARCTION, HYPERTENSION/HYPOTENSION, MIGRAINE, MYOCARDIAL INFARCTION, PALPITATIONS, SHOCK (CIRCULATORY FAILURE), SYNCOPE, TACHYCARDIA, VASODILATION
DIGESTIVE SYSTEM â ABNORMAL STOOLS, ANOREXIA, BEZOAR, CARDIOSPASM, CHOLELITHIASIS, COLITIS, DRY MOUTH, DYSPEPSIA, DYSPHAGIA, ENTERITIS, ERUCTATION, ESOPHAGEAL STENOSIS, ESOPHAGEAL ULCER, ESOPHAGITIS, FECAL DISCOLORATION, FLATULENCE, GASTRIC NODULES/FUNDIC GLAND POLYPS, GASTRITIS, GASTROENTERITIS, GASTROINTESTINAL ANOMALY, GASTROINTESTINAL DISORDER, GASTROINTESTINAL HEMORRHAGE, GLOSSITIS, GUM HEMORRHAGE, HEMATEMESIS, INCREASED APPETITE, INCREASED SALIVATION, MELENA, MOUTH ULCERATION, NAUSEA AND VOMITING, NAUSEA AND VOMITING AND DIARRHEA, GASTROINTESTINAL MONILIASIS, RECTAL DISORDER, RECTAL HEMORRHAGE, STOMATITIS, TENESMUS, THIRST, TONGUE DISORDER, ULCERATIVE COLITIS, ULCERATIVE STOMATITIS
ENDOCRINE SYSTEM â DIABETES MELLITUS, GOITER, HYPOTHYROIDISM
HEMIC AND LYMPHATIC SYSTEM â ANEMIA, HEMOLYSIS, LYMPHADENOPATHY
METABOLISM AND NUTRITIONAL DISORDERS â AVITAMINOSIS, GOUT, DEHYDRATION, HYPERGLYCEMIA/HYPOGLYCEMIA, PERIPHERAL EDEMA, WEIGHT GAIN/LOSS
MUSCULOSKELETAL SYSTEM â ARTHRALGIA, ARTHRITIS, BONE DISORDER, JOINT DISORDER, LEG CRAMPS, MUSCULOSKELETAL PAIN, MYALGIA, MYASTHENIA, PTOSIS, SYNOVITIS
NERVOUS SYSTEM â ABNORMAL DREAMS, AGITATION, AMNESIA, ANXIETY, APATHY, CONFUSION, CONVULSION, DEMENTIA, DEPERSONALIZATION, DEPRESSION, DIPLOPIA, DIZZINESS, EMOTIONAL LABILITY, HALLUCINATIONS, HEMIPLEGIA, HOSTILITY AGGRAVATED, HYPERKINESIA, HYPERTONIA, HYPESTHESIA, INSOMNIA, LIBIDO DECREASED/INCREASED, NERVOUSNESS, NEUROSIS, PARESTHESIA, SLEEP DISORDER, SOMNOLENCE, THINKING ABNORMALITY, TREMOR, VERTIGO
RESPIRATORY SYSTEM â ASTHMA, BRONCHITIS, COUGH INCREASED, DYSPNEA, EPISTAXIS, HEMOPTYSIS, HICCUP, LARYNGEAL NEOPLASIA, LUNG FIBROSIS, PHARYNGITIS, PLEURAL DISORDER, PNEUMONIA, RESPIRATORY DISORDER, UPPER RESPIRATORY INFLAMMATION/INFECTION, RHINITIS, SINUSITIS, STRIDOR
SKIN AND APPENDAGES â ACNE, ALOPECIA, CONTACT DERMATITIS, DRY SKIN, FIXED ERUPTION, HAIR DISORDER, MACULOPAPULAR RASH, NAIL DISORDER, PRURITUS, RASH, SKIN CARCINOMA, SKIN DISORDER, SWEATING, URTICARIA
SPECIAL SENSES â ABNORMAL VISION, AMBLYOPIA, BLEPHARITIS, BLURRED VISION, CATARACT, CONJUNCTIVITIS, DEAFNESS, DRY EYES, EAR/EYE DISORDER, EYE PAIN, GLAUCOMA, OTITIS MEDIA, PAROSMIA, PHOTOPHOBIA, RETINAL DEGENERATION/DISORDER, TASTE LOSS, TASTE PERVERSION, TINNITUS, VISUAL FIELD DEFECT
UROGENITAL SYSTEM â ABNORMAL MENSES, BREAST ENLARGEMENT, BREAST PAIN, BREAST TENDERNESS, DYSMENORRHEA, DYSURIA, GYNECOMASTIA, IMPOTENCE, KIDNEY CALCULUS, KIDNEY PAIN, LEUKORRHEA, MENORRHAGIA, MENSTRUAL DISORDER, PENIS DISORDER, POLYURIA, TESTIS DISORDER, URETHRAL PAIN, URINARY FREQUENCY, URINARY RETENTION, URINARY TRACT INFECTION, URINARY URGENCY, URINATION IMPAIRED, VAGINITIS.
POSTMARKETING EXPERIENCE
ADDITIONAL ADVERSE EXPERIENCES HAVE BEEN REPORTED SINCE PREVACID HAS BEEN MARKETED. THE MAJORITY OF THESE CASES ARE FOREIGN-SOURCED AND A RELATIONSHIP TO PREVACID HAS NOT BEEN ESTABLISHED. BECAUSE THESE REACTIONS WERE REPORTED VOLUNTARILY FROM A POPULATION OF UNKNOWN SIZE, ESTIMATES OF FREQUENCY CANNOT BE MADE. THESE EVENTS ARE LISTED BELOW BY COSTART BODY SYSTEM.
BODY AS A WHOLE â ANAPHYLACTIC/ANAPHYLACTOID REACTIONS; DIGESTIVE SYSTEM â HEPATOTOXICITY, PANCREATITIS, VOMITING; HEMIC AND LYMPHATIC SYSTEM â AGRANULOCYTOSIS, APLASTIC ANEMIA, HEMOLYTIC ANEMIA, LEUKOPENIA, NEUTROPENIA, PANCYTOPENIA, THROMBOCYTOPENIA, AND THROMBOTIC THROMBOCYTOPENIC PURPURA; METABOLISM AND NUTRITIONAL DISORDERS â HYPOMAGNESEMIA; MUSCULOSKELETAL SYSTEM â BONE FRACTURE, MYOSITIS; SKIN AND APPENDAGES â SEVERE DERMATOLOGIC REACTIONS INCLUDING ERYTHEMA MULTIFORME, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS (SOME FATAL); SPECIAL SENSES â SPEECH DISORDER; UROGENITAL SYSTEM â INTERSTITIAL NEPHRITIS, URINARY RETENTION.
COMBINATION THERAPY WITH AMOXICILLIN AND CLARITHROMYCIN
IN CLINICAL TRIALS USING COMBINATION THERAPY WITH PREVACID PLUS AMOXICILLIN AND CLARITHROMYCIN, AND PREVACID PLUS AMOXICILLIN, NO ADVERSE REACTIONS PECULIAR TO THESE DRUG COMBINATIONS WERE OBSERVED. ADVERSE REACTIONS THAT HAVE OCCURRED HAVE BEEN LIMITED TO THOSE THAT HAD BEEN PREVIOUSLY REPORTED WITH PREVACID, AMOXICILLIN, OR CLARITHROMYCIN.
TRIPLE THERAPY: PREVACID/AMOXICILLIN/CLARITHROMYCIN
THE MOST FREQUENTLY REPORTED ADVERSE REACTIONS FOR PATIENTS WHO RECEIVED TRIPLE THERAPY FOR 14 DAYS WERE DIARRHEA (7%), HEADACHE (6%), AND TASTE PERVERSION (5%). THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN THE FREQUENCY OF REPORTED ADVERSE REACTIONS BETWEEN THE 10- AND 14-DAY TRIPLE THERAPY REGIMENS. NO TREATMENT-EMERGENT ADVERSE REACTIONS WERE OBSERVED AT SIGNIFICANTLY HIGHER RATES WITH TRIPLE THERAPY THAN WITH ANY DUAL THERAPY REGIMEN.
DUAL THERAPY: PREVACID/AMOXICILLIN
THE MOST FREQUENTLY REPORTED ADVERSE REACTIONS FOR PATIENTS WHO RECEIVED PREVACID THREE TIMES DAILY PLUS AMOXICILLIN THREE TIMES DAILY DUAL THERAPY WERE DIARRHEA (8%) AND HEADACHE (7%). NO TREATMENT-EMERGENT ADVERSE REACTIONS WERE OBSERVED AT SIGNIFICANTLY HIGHER RATES WITH PREVACID THREE TIMES DAILY PLUS AMOXICILLIN THREE TIMES DAILY DUAL THERAPY THAN WITH PREVACID ALONE.
FOR INFORMATION ON ADVERSE REACTIONS WITH AMOXICILLIN OR CLARITHROMYCIN, REFER TO THEIR FULL PRESCRIBING INFORMATION, ADVERSE REACTIONS SECTIONS.
LABORATORY VALUES
THE FOLLOWING CHANGES IN LABORATORY PARAMETERS IN PATIENTS WHO RECEIVED PREVACID WERE REPORTED AS ADVERSE REACTIONS:
ABNORMAL LIVER FUNCTION TESTS, INCREASED SGOT (AST), INCREASED SGPT (ALT), INCREASED CREATININE, INCREASED ALKALINE PHOSPHATASE, INCREASED GLOBULINS, INCREASED GGTP, INCREASED/DECREASED/ABNORMAL WBC, ABNORMAL AG RATIO, ABNORMAL RBC, BILIRUBINEMIA, BLOOD POTASSIUM INCREASED, BLOOD UREA INCREASED, CRYSTAL URINE PRESENT, EOSINOPHILIA, HEMOGLOBIN DECREASED, HYPERLIPEMIA, INCREASED/DECREASED ELECTROLYTES, INCREASED/DECREASED CHOLESTEROL, INCREASED GLUCOCORTICOIDS, INCREASED LDH, INCREASED/DECREASED/ABNORMAL PLATELETS, INCREASED GASTRIN LEVELS AND POSITIVE FECAL OCCULT BLOOD. URINE ABNORMALITIES SUCH AS ALBUMINURIA, GLYCOSURIA, AND HEMATURIA WERE ALSO REPORTED. ADDITIONAL ISOLATED LABORATORY ABNORMALITIES WERE REPORTED.
IN THE PLACEBO CONTROLLED STUDIES, WHEN SGOT (AST) AND SGPT (ALT) WERE EVALUATED, 0.4% (4/978) AND 0.4% (11/2677) PATIENTS, WHO RECEIVED PLACEBO AND PREVACID, RESPECTIVELY, HAD ENZYME ELEVATIONS GREATER THAN THREE TIMES THE UPPER LIMIT OF NORMAL RANGE AT THE FINAL TREATMENT VISIT. NONE OF THESE PATIENTS WHO RECEIVED PREVACID REPORTED JAUNDICE AT ANY TIME DURING THE STUDY.
IN CLINICAL TRIALS USING COMBINATION THERAPY WITH PREVACID PLUS AMOXICILLIN AND CLARITHROMYCIN, AND PREVACID PLUS AMOXICILLIN, NO INCREASED LABORATORY ABNORMALITIES PARTICULAR TO THESE DRUG COMBINATIONS WERE OBSERVED.
FOR INFORMATION ON LABORATORY VALUE CHANGES WITH AMOXICILLIN OR CLARITHROMYCIN, REFER TO THEIR FULL PRESCRIBING INFORMATION, ADVERSE REACTIONS SECTIONS.
READ THE PREVACID (LANSOPRAZOLE) SIDE EFFECTS CENTER FOR A COMPLETE GUIDE TO POSSIBLE SIDE EFFECTS »
DRUG INTERACTIONS
DRUGS WITH PH-DEPENDENT ABSORPTION KINETICS
PREVACID CAUSES LONG-LASTING INHIBITION OF GASTRIC ACID SECRETION. PREVACID AND OTHER PPIS ARE LIKELY TO SUBSTANTIALLY DECREASE THE SYSTEMIC CONCENTRATIONS OF THE HIV PROTEASE INHIBITOR ATAZANAVIR, WHICH IS DEPENDENT UPON THE PRESENCE OF GASTRIC ACID FOR ABSORPTION, AND MAY RESULT IN A LOSS OF THERAPEUTIC EFFECT OF ATAZANAVIR AND THE DEVELOPMENT OF HIV RESISTANCE. THEREFORE, PREVACID AND OTHER PPIS SHOULD NOT BE CO-ADMINISTERED WITH ATAZANAVIR [SEE CLINICAL PHARMACOLOGY].
PREVACID AND OTHER PPIS MAY INTERFERE WITH THE ABSORPTION OF OTHER DRUGS WHERE GASTRIC PH IS AN IMPORTANT DETERMINANT OF ORAL BIOAVAILABILITY (E.G., AMPICILLIN ESTERS, DIGOXIN, IRON SALTS, KETOCONAZOLE) [SEE CLINICAL PHARMACOLOGY].
WARFARIN
IN A STUDY OF HEALTHY SUBJECTS, CO-ADMINISTRATION OF SINGLE OR MULTIPLE 60 MG DOSES OF PREVACID AND WARFARIN DID NOT AFFECT THE PHARMACOKINETICS OF WARFARIN NOR PROTHROMBIN TIME [SEE CLINICAL PHARMACOLOGY]. HOWEVER, THERE HAVE BEEN REPORTS OF INCREASED INR AND PROTHROMBIN TIME IN PATIENTS RECEIVING PPIS AND WARFARIN CONCOMITANTLY. INCREASES IN INR AND PROTHROMBIN TIME MAY LEAD TO ABNORMAL BLEEDING AND EVEN DEATH. PATIENTS TREATED WITH PPIS AND WARFARIN CONCOMITANTLY MAY NEED TO BE MONITORED FOR INCREASES IN INR AND PROTHROMBIN TIME [SEE CLINICAL PHARMACOLOGY].
TACROLIMUS
CONCOMITANT ADMINISTRATION OF LANSOPRAZOLE AND TACROLIMUS MAY INCREASE WHOLE BLOOD LEVELS OF TACROLIMUS, ESPECIALLY IN TRANSPLANT PATIENTS WHO ARE INTERMEDIATE OR POOR METABOLIZERS OF CYP2C19.
THEOPHYLLINE
A MINOR INCREASE (10%) IN THE CLEARANCE OF THEOPHYLLINE WAS OBSERVED FOLLOWING THE ADMINISTRATION OF PREVACID CONCOMITANTLY WITH THEOPHYLLINE. ALTHOUGH THE MAGNITUDE OF THE EFFECT ON THEOPHYLLINE CLEARANCE IS SMALL, INDIVIDUAL PATIENTS MAY REQUIRE ADDITIONAL TITRATION OF THEIR THEOPHYLLINE DOSAGE WHEN PREVACID IS STARTED OR STOPPED TO ENSURE CLINICALLY EFFECTIVE BLOOD LEVELS [SEE CLINICAL PHARMACOLOGY].
CLOPIDOGREL
CONCOMITANT ADMINISTRATION OF LANSOPRAZOLE AND CLOPIDOGREL IN HEALTHY SUBJECTS HAD NO CLINICALLY IMPORTANT EFFECT ON EXPOSURE TO THE ACTIVE METABOLITE OF CLOPIDOGREL OR CLOPIDOGREL-INDUCED PLATELET INHIBITION [SEE CLINICAL PHARMACOLOGY]. NO DOSE ADJUSTMENT OF CLOPIDOGREL IS NECESSARY WHEN ADMINISTERED WITH AN APPROVED DOSE OF PREVACID.
METHOTREXATE
CASE REPORTS, PUBLISHED POPULATION PHARMACOKINETIC STUDIES, AND RETROSPECTIVE ANALYSES SUGGEST THAT CONCOMITANT ADMINISTRATION OF PPIS AND METHOTREXATE (PRIMARILY AT HIGH DOSE; SEE METHOTREXATE PRESCRIBING INFORMATION) MAY ELEVATE AND PROLONG SERUM LEVELS OF METHOTREXATE AND/OR ITS METABOLITE HYDROXYMETHOTREXATE. HOWEVER, NO FORMAL DRUG INTERACTION STUDIES OF HIGH DOSE METHOTREXATE WITH PPIS HAVE BEEN CONDUCTED [SEE WARNINGS AND PRECAUTIONS].
IN A STUDY OF RHEUMATOID ARTHRITIS PATIENTS RECEIVING LOW-DOSE METHOTREXATE, PREVACID AND NAPROXEN, NO EFFECT ON PHARMACOKINETICS OF METHOTREXATE WAS OBSERVED [SEE CLINICAL PHARMACOLOGY].
FOR INFORMATION ON DRUG INTERACTIONS FOR AMOXICILLIN OR CLARITHROMYCIN, REFER TO THEIR FULL PRESCRIBING INFORMATION, DRUG INTERACTIONS SECTIONS.
WARNINGS
INCLUDED AS PART OF THE PRECAUTIONS SECTION.
PRECAUTIONS
GASTRIC MALIGNANCY
SYMPTOMATIC RESPONSE TO THERAPY WITH LANSOPRAZOLE DOES NOT PRECLUDE THE PRESENCE OF GASTRIC MALIGNANCY.
BONE FRACTURE
SEVERAL PUBLISHED OBSERVATIONAL STUDIES SUGGEST THAT PROTON PUMP INHIBITOR (PPI) THERAPY MAY BE ASSOCIATED WITH AN INCREASED RISK FOR OSTEOPOROSIS-RELATED FRACTURES OF THE HIP, WRIST OR SPINE. THE RISK OF FRACTURE WAS INCREASED IN PATIENTS WHO RECEIVED HIGH-DOSE, DEFINED AS MULTIPLE DAILY DOSES, AND LONG-TERM PPI THERAPY (A YEAR OR LONGER). PATIENTS SHOULD USE THE LOWEST DOSE AND SHORTEST DURATION OF PPI THERAPY APPROPRIATE TO THE CONDITION BEING TREATED. PATIENTS AT RISK FOR OSTEOPOROSIS-RELATED FRACTURES SHOULD BE MANAGED ACCORDING TO ESTABLISHED TREATMENT GUIDELINES [SEE DOSAGE AND ADMINISTRATION AND ADVERSE REACTIONS].
FOR INFORMATION ON WARNINGS AND PRECAUTIONS FOR AMOXICILLIN OR CLARITHROMYCIN, REFER TO THEIR FULL PRESCRIBING INFORMATION, WARNINGS AND PRECAUTIONS SECTIONS.
HYPOMAGNESEMIA
HYPOMAGNESEMIA, SYMPTOMATIC AND ASYMPTOMATIC, HAS BEEN REPORTED RARELY IN PATIENTS TREATED WITH PPIS FOR AT LEAST THREE MONTHS, IN MOST CASES AFTER A YEAR OF THERAPY. SERIOUS ADVERSE EVENTS INCLUDE TETANY, ARRHYTHMIAS, AND SEIZURES. IN MOST PATIENTS, TREATMENT OF HYPOMAGNESEMIA REQUIRED MAGNESIUM REPLACEMENT AND DISCONTINUATION OF THE PPI.
FOR PATIENTS EXPECTED TO BE ON PROLONGED TREATMENT OR WHO TAKE PPIS WITH MEDICATIONS SUCH AS DIGOXIN OR DRUGS THAT MAY CAUSE HYPOMAGNESEMIA (E.G., DIURETICS), HEALTH CARE PROFESSIONALS MAY CONSIDER MONITORING MAGNESIUM LEVELS PRIOR TO INITIATION OF PPI TREATMENT AND PERIODICALLY [SEE ADVERSE REACTIONS].
CONCOMITANT USE OF PREVACID WITH METHOTREXATE
LITERATURE SUGGESTS THAT CONCOMITANT USE OF PPIS WITH METHOTREXATE (PRIMARILY AT HIGH DOSE; SEE METHOTREXATE PRESCRIBING INFORMATION) MAY ELEVATE AND PROLONG SERUM LEVELS OF METHOTREXATE AND/OR ITS METABOLITE, POSSIBLY LEADING TO METHOTREXATE TOXICITIES. IN HIGH-DOSE METHOTREXATE ADMINISTRATION, A TEMPORARY WITHDRAWAL OF THE PPI MAY BE CONSIDERED IN SOME PATIENTS [SEE DRUG INTERACTIONS AND CLINICAL PHARMACOLOGY].
PATIENT COUNSELING INFORMATION
[SEE FDA-APPROVED PATIENT LABELING]
PATIENT SHOULD BE INFORMED OF THE FOLLOWING:
ADVISE PATIENTS TO IMMEDIATELY REPORT AND SEEK CARE FOR ANY CARDIOVASCULAR OR NEUROLOGICAL SYMPTOMS INCLUDING PALPITATIONS, DIZZINESS, SEIZURES, AND TETANY AS THESE MAY BE SIGNS OF HYPOMAGNESEMIA [SEE WARNINGS AND PRECAUTIONS].
INFORMATION FOR PATIENTS
PREVACID IS AVAILABLE AS A CAPSULE AND AN ORALLY DISINTEGRATING TABLET, AND IS AVAILABLE IN 15 MG AND 30 MG STRENGTHS. DIRECTIONS FOR USE SPECIFIC TO THE ROUTE AND AVAILABLE METHODS OF ADMINISTRATION FOR EACH OF THESE DOSAGE FORMS IS PRESENTED BELOW [SEE DOSAGE AND ADMINISTRATION].
PREVACID SHOULD BE TAKEN BEFORE EATING.
PREVACID PRODUCTS SHOULD NOT BE CRUSHED OR CHEWED.
PHENYLKETONURICS: CONTAINS PHENYLALANINE 2.5 MG PER 15 MG TABLET AND 5.1 MG PER 30 MG TABLET.
ADMINISTRATION OPTIONS
1. PREVACID DELAYED-RELEASE CAPSULES â ORAL ADMINISTRATION
PREVACID DELAYED-RELEASE CAPSULES SHOULD BE SWALLOWED WHOLE.
ALTERNATIVELY, FOR PATIENTS WHO HAVE DIFFICULTY SWALLOWING CAPSULES, PREVACID DELAYED-RELEASE CAPSULES CAN BE OPENED AND ADMINISTERED AS FOLLOWS:
OPEN CAPSULE.
SPRINKLE INTACT GRANULES ON ONE TABLESPOON OF EITHER APPLESAUCE, ENSURE PUDDING, COTTAGE CHEESE, YOGURT OR STRAINED PEARS.
SWALLOW IMMEDIATELY.
PREVACID DELAYED-RELEASE CAPSULES MAY ALSO BE EM PTIED INTO A SMALL VOLUME OF EITHER APPLE JUICE, ORANGE JUICE OR TOMATO JUICE AND ADMINISTERED AS FOLLOWS:
OPEN CAPSULE.
SPRINKLE INTACT GRANULES INTO A SMALL VOLUME OF EITHER APPLE JUICE, ORANGE JUICE OR TOMATO JUICE (60 ML â APPROXIMATELY 2 OUNCES).
MIX BRIEFLY.
TO ENSURE COMPLETE DELIVERY OF THE DOSE, THE GLASS SHOULD BE RINSED WITH TWO OR MORE VOLUMES OF JUICE AND THE CONTENTS SWALLOW IMMEDIATELY.
PREVACID DELAYED-RELEASE CAPSULES â NASOGASTRIC TUBE ( = 16 FRENCH) ADMINISTRATION
FOR PATIENTS WHO HAVE A NASOGASTRIC TUBE IN PLACE, PREVACID DELAYED-RELEASE CAPSULES CAN BE ADMINISTERED AS FOLLOWS:
OPEN CAPSULE.
MIX INTACT GRANULES INTO 40 ML OF APPLE JUICE. DO NOT USE OTHER LIQUIDS.
INJECT THROUGH THE NASOGASTRIC TUBE INTO THE STOMACH.
FLUSH WITH ADDITIONAL APPLE JUICE TO CLEAR THE TUBE.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
2. PREVACID SOLUTAB DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS
PREVACID SOLUTAB SHOULD NOT BE BROKEN OR CUT.
PREVACID SOLUTAB SHOULD NOT BE CHEWED.
PLACE THE TABLET ON THE TONGUE AND ALLOW IT TO DISINTEGRATE, WITH OR WITHOUT WATER, UNTIL THE PARTICLES CAN BE SWALLOWED.
THE TABLET TYPICALLY DISINTEGRATES IN LESS THAN 1 MINUTE.
ALTERNATIVELY, FOR CHILDREN OR OTHER PATIENTS WHO HAVE DIFFICULTY SWALLOWING TABLETS, PREVACID SOLUTAB CAN BE DELIVERED IN TWO DIFFERENT WAYS.
PREVACID SOLUTAB â ORAL SYRINGE
FOR ADMINISTRATION VIA ORAL SYRINGE, PREVACID SOLUTAB CAN BE ADMINISTERED AS FOLLOWS:
PLACE A 15 MG TABLET IN ORAL SYRINGE AND DRAW UP 4 ML OF WATER, OR PLACE A 30 MG TABLET IN ORAL SYRINGE AND DRAW UP 10 ML OF WATER.
SHAKE GENTLY TO ALLOW FOR A QUICK DISPERSAL.
AFTER THE TABLET HAS DISPERSED, ADMINISTER THE CONTENTS WITHIN 15 MINUTES.
REFILL THE SYRINGE WITH APPROXIMATELY 2 ML (5 ML FOR THE 30 MG TABLET) OF WATER, SHAKE GENTLY, AND ADMINISTER ANY REMAINING CONTENTS.
PREVACID SOLUTAB â NASOGASTRIC TUBE ( = 8 FRENCH) ADMINISTRATION
FOR ADMINISTRATION VIA A NASOGASTRIC TUBE, PREVACID SOLUTAB CAN BE ADMINISTERED AS FOLLOWS:
PLACE A 15 MG TABLET IN A SYRINGE AND DRAW UP 4 ML OF WATER, OR PLACE A 30 MG TABLET IN A SYRINGE AND DRAW UP 10 ML OF WATER.
SHAKE GENTLY TO ALLOW FOR A QUICK DISPERSAL.
AFTER THE TABLET HAS DISPERSED, INJECT THROUGH THE NASOGASTRIC TUBE INTO THE STOMACH WITHIN 15 MINUTES.
REFILL THE SYRINGE WITH APPROXIMATELY 5 ML OF WATER, SHAKE GENTLY, AND FLUSH THE NASOGASTRIC TUBE.
NONCLINICAL TOXICOLOGY