ABILIFY

ABILIFY

Indications for: Schizophrenia. Tourette's disorder, Psychosis.


Adult Dosage:Orally disintegrating tabs: Dissolve on tongue; take without liquids. Initially 10 mg or 15 mg once daily; may increase after at least 2 weeks; usual range 10–15 mg/day; max 30mg/day. Concomitant strong CYP3A4 or CYP2D6 inhibitors, or CYP2D6 poor metabolizer: reduce aripiprazole dose by 1⁄2. Concomitant strong CYP3A4 inducers: double aripiprazole dose (max 30mg/day) over 1–2 weeks. Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.


Children Dosage:Schizophrenia: 13–17yrs: initially 2mg daily, then increase to 5mg after 2 days, then increase to target dose of 10mg after 2 days. Subsequent doses may be adjusted by increments of 5mg/day; max 30mg/day. Tourette's disorder: 6–18yrs: <50kg: initially 2mg/day, then increase to target dose of 5mg/day after 2 days. May increase to 10 mg/day if optimal control of tics not achieved. Adjust doses at ≥1 week intervals. ≥50kg: initially 2 mg/day for 2 days, then increase to 5 mg/day for 5 days, then increase to target dose of 10mg/day on day 8. May increase to 20mg/day if optimal control of tics not achieved. Adjust dose by 5mg/day at ≥1 week intervals.


Boxed Warning: Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors with antidepressant drugs.


ABILIFY Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Cardio- or cerebrovascular disease. Risk of neuroleptic malignant syndrome, hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC/ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; consider discontinuation if clinically significant decline in WBC occurs. Discontinue if severe neutropenia occurs (ANC <1000/mm3). Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Suicidal tendencies. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. CYP2D6 poor metabolizers. Reevaluate periodically. Write ℞ for smallest practical amount. Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.


ABILIFY Classification: Atypical antipsychotic.


ABILIFY Interactions: See Adult. Potentiated by CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Antagonized by CYP3A4 inducers (eg, carbamazepine, rifampin). Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Monitor with lorazepam.


Adverse Reactions: Headache, anxiety, insomnia, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia (consider discontinuation if occurs), weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.


Note: Register patients in the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.


Generic Drug Availability: Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite (NO)


How Supplied: Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Prefilled Dual Chamber Syringe—1 (w. supplies); Single-use vials—1 (w. supplies); Oral soln, orally disintegrating tabs—contact supplier; MyCite kits (1-component patch)—30 tabs + 7 patches; MyCite kits (2-component patch)—Starter kit (30 tabs + 1 pod + 7 strips); Maintenance kit (30 tabs + 7 strips)



ACETAMINOPHEN

Warning

Introduction

Synthetic nonopiate derivative of p-aminophenol; produces analgesia and antipyresis.

Uses for Acetaminophen

Pain

Symptomatic relief of mild to moderate pain.

Recommended by many experts as initial analgesic for many patients; however, consider risk of inadvertent overdosage and resultant acute liver failure. (See Hepatic Effects and also see Pediatric Use under Cautions.)

Self-medication in children ≥6 years of age and adults for the temporary relief of minor aches and pain associated with headache, muscular aches, backache, minor arthritis pain, common cold, toothache, and menstrual cramps. Self-medication in infants and children for the temporary relief of minor aches and pain associated with the common cold, flu, headache, sore throat, immunizations, toothache, muscle aches, sprains, and overexertion.

Self-medication in fixed combination with aspirin and caffeine for the temporary relief of mild to moderate pain associated with migraine headache. This combination also can be used for the treatment of severe migraine headache if previous attacks have responded to similar nonopiate analgesics or NSAIAs.

Symptomatic treatment of pain associated with osteoarthritis; considered an initial drug of choice for pain management in osteoarthritis patients.

Used in fixed combination with other agents (e.g., chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, pseudoephedrine) for short-term relief of minor aches and pain, headache, fever, and/or other symptoms (e.g., rhinorrhea, sneezing, lacrimation, itching eyes, oronasopharyngeal itching, nasal congestion, cough) associated with seasonal allergic rhinitis (e.g., hay fever), other upper respiratory allergies, or the common cold.

Treatment of pain in various combinations with aspirin, caffeine, opiates, and/or other agents. Oral use in combination with an opiate (e.g., codeine, oxycodone) produces greater analgesic effect than that produced by either acetaminophen or higher doses of the opiate alone.

IV use in patients with moderate to severe postoperative pain reduces pain intensity and rescue opiate requirements compared with placebo, but clinical benefits of the lower opiate dosages (e.g., reduction in opiate-related adverse effects) not established.

Fever

Reduction of fever.

Self-medication to reduce fever in infants, children, and adults.

Acetaminophen Dosage and Administration

Administration

Usually administered orally; may be administered rectally as suppositories in patients who cannot tolerate oral therapy. Also may be administered IV.

Oral Administration

Swallow extended-release tablets whole; do not crush, chew, or dissolve in liquid.

Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.

Pediatric Administration

For liquid preparations (e.g., solution, suspension), use the calibrated dosing device provided by the manufacturer for measurement of the dose.

80-mg orally disintegrating tablets may be used in children ≥2 years of age.

160-mg orally disintegrating tablets or 325-mg conventional tablets commonly used in children ≥6 years of age.

Orally disintegrating tablets (e.g., Tylenol Meltaways) should be allowed to dissolve in the mouth or should be chewed before swallowing. Use caution to ensure that the correct number of tablets required for the intended dose is removed from the blister package.

Rectal Administration

Dividing suppositories in an attempt to administer lower dosages may not provide a predictable dose.

Some experts state that rectal acetaminophen preparations should not be used for self-medication in children unless such use is specifically discussed with a clinician and parents or caregivers are instructed to adhere to dosage and administration recommendations.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.

Monitor the end of the infusion to prevent possibility of air embolism, especially when acetaminophen solution is the primary infusion.

Commercially available 10-mg/mL injection may be administered without further dilution. Each vial (1 g/100 mL) is for single use only; discard any unused portions.

Dose of 1 g: Administer by inserting a vented IV set through the septum of the 100-mL vial.

Dose of <1 g: Dose must be withdrawn from vial and placed in a separate container for IV infusion to avoid inadvertent administration of the total volume of the vial. Aseptically withdraw the appropriate dose from an intact sealed vial and transfer to an empty sterile container (e.g., glass bottle, plastic container, syringe); draw small-volume (up to 60 mL) pediatric doses into a syringe and administer via syringe pump.

Administer within 6 hours after penetration of the vacuum seal of the vial or transfer of vial contents to another container.

Do not admix with any other drugs.

Rate of Administration

Administer by IV infusion over 15 minutes.

Dosage

To minimize risk of inadvertent overdosage, FDA recommends that health care providers stop prescribing and dispensing prescription combination preparations containing >325 mg of acetaminophen per dosage unit; doses consisting of either 1 or 2 dosage units (i.e., 325 or 650 mg of acetaminophen per dose) may be prescribed as clinically appropriate for the patient and in consideration of the strengths of each component (generally acetaminophen and an opiate analgesic) of the fixed combination. (See Preparations.)

FDA recommends that pharmacists receiving prescriptions for fixed-combination preparations containing >325 mg of acetaminophen per dosage unit contact the prescriber to discuss use of a preparation containing ≤325 mg of the drug per dosage unit.

Take care to avoid dosing errors when prescribing, preparing, and administering IV acetaminophen. (See Boxed Warning.)

Pediatric Patients

Dosage in children should be guided by body weight. (See Pediatric Use under Cautions.)

Pain

Oral

Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).

Age

Weight

Oral Dose

≤3 months

2.7–5 kg

40 mg

4–11 months

5–8 kg

80 mg

12–23 months

8–11 kg

120 mg

2–3 years

11–16 kg

160 mg

4–5 years

16–21 kg

240 mg

6–8 years

22–27 kg

320 mg

9–10 years

27–32 kg

400 mg

11 years

33–43 kg

480 mg

For self-medication in children ≥12 years of age, 650 mg every 4–6 hours or 1 g every 6 hours as necessary. (See Prescribing Limits under Dosage and Administration.)

Rectal

Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).

Age

Rectal Dose

2–4 years

160 mg

4–6 years

240 mg

6–9 years

320 mg

9–11 years

320–400 mg

11–12 years

320–480 mg

Individualize dosage in children <2 years of age.

For self-medication in children ≥12 years of age, 325–650 mg every 4 hours as necessary.

IV

Administer as single or repeated doses.

Children 2–12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours.

Adolescents ≥13 years of age and weighing <50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours.

Adolescents ≥13 years of age and weighing ≥50 kg: 1 g every 6 hours or 650 mg every 4 hours. May switch between oral and IV acetaminophen without dosage adjustment.

Fever

Oral

Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).

Age

Weight

Oral Dose

≤3 months

2.7–5 kg

40 mg

4–11 months

5–8 kg

80 mg

12–23 months

8–11 kg

120 mg

2–3 years

11–16 kg

160 mg

4–5 years

16–21 kg

240 mg

6–8 years

22–27 kg

320 mg

9–10 years

27–32 kg

400 mg

11 years

33–43 kg

480 mg

For self-medication in children ≥12 years of age, 650 mg every 4–6 hours or 1 g every 6 hours as necessary. (See Prescribing Limits under Dosage and Administration.)

Rectal

Dose may be given every 4 hours as necessary (up to 5 times in 24 hours).

Age

Rectal Dose

2–4 years

160 mg

4–6 years

240 mg

6–9 years

320 mg

9–11 years

320–400 mg

11–12 years

320–480 mg

Individualize dosage in children <2 years of age.

For self-medication in children ≥12 years of age, 325–650 mg every 4 hours as necessary.

IV

Administer as single or repeated doses.

Children 2–12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours.

Adolescents ≥13 years of age and weighing <50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours.

Adolescents ≥13 years of age and weighing ≥50 kg: 1 g every 6 hours or 650 mg every 4 hours. May switch between oral and IV acetaminophen without dosage adjustment.

Adults

Pain

Oral

For self-medication, 650 mg every 4–6 hours or 1 g every 6 hours as necessary. Alternatively, 1.3 g as extended-release tablets every 8 hours. (See Prescribing Limits under Dosage and Administration.)

Rectal

325–650 mg every 4 hours as necessary.

IV

Administer as single or repeated doses.

Adults weighing ≥50 kg: 1 g every 6 hours or 650 mg every 4 hours. May switch between oral and IV acetaminophen without dosage adjustment.

Adults weighing <50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours.

Pain Associated with Migraine Headache

Oral

Acetaminophen, aspirin, and caffeine for self-medication: 2 tablets (each containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) as a single dose.

Pain Associated with Osteoarthritis

Oral

1 g 4 times daily. Alternatively, 1.3 g as extended-release tablets every 8 hours.

Fever

Oral

For self-medication, 650 mg every 4–6 hours or 1 g every 6 hours as necessary. (See Prescribing Limits under Dosage and Administration.)

Rectal

325–650 mg every 4 hours as necessary.

IV

Administer as single or repeated doses.

Adults weighing ≥50 kg: 1 g every 6 hours or 650 mg every 4 hours. May switch between oral and IV acetaminophen without dosage adjustment.

Adults weighing <50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours.

Prescribing Limits

Pediatric Patients

Pain

Oral

Do not exceed recommended daily dosage. For self-medication in children ≥12 years of age, some manufacturers recommend a maximum dosage of 3 g daily. (See Prescribing Limits: Adults, under Dosage and Administration.)

Self-medication should not exceed 5 days (in children 2–11 years of age) or 10 days (in children ≥12 years of age).

IV

Children 2–12 years of age: Maximum single dose is 15 mg/kg, minimum dosing interval is 4 hours, and maximum daily dosage is 75 mg/kg per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Adolescents ≥13 years of age and weighing <50 kg: Maximum single dose is 15 mg/kg, minimum dosing interval is 4 hours, and maximum daily dosage is 75 mg/kg per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Adolescents ≥13 years of age and weighing ≥50 kg: Maximum single dose is 1 g, minimum dosing interval is 4 hours, and maximum daily dosage is 4 g per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Fever

Oral

Do not exceed recommended daily dosage. For self-medication in children ≥12 years of age, some manufacturers recommend a maximum dosage of 3 g daily. (See Prescribing Limits: Adults, under Dosage and Administration.)

Self-medication should not exceed 3 days.

IV

Children 2–12 years of age: Maximum single dose is 15 mg/kg, minimum dosing interval is 4 hours, and maximum daily dosage is 75 mg/kg per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Adolescents ≥13 years of age and weighing <50 kg: Maximum single dose is 15 mg/kg, minimum dosing interval is 4 hours, and maximum daily dosage is 75 mg/kg per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Adolescents ≥13 years of age and weighing ≥50 kg: Maximum single dose is 1 g, minimum dosing interval is 4 hours, and maximum daily dosage is 4 g per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Adults

Current limit is 4 g daily. Some experts recommend a maximum dosage of 3 g daily when used for long-term therapy (e.g., ≥2 weeks). FDA is evaluating whether data exist to support establishing a lower (i.e., <4 g daily) maximum daily dosage for certain patients (e.g., those who chronically ingest alcohol). Some manufacturers (e.g., McNeil, Tylenol) voluntarily revised their labeling and currently recommend a maximum dosage of 3 g daily.

Pain

Oral or Rectal

Maximum 4 g daily. Some manufacturers recommend a maximum oral dosage of 3 g daily. (See Prescribing Limits: Adults, under Dosage and Administration.)

Self-medication should not exceed 10 days.

IV

Adults weighing ≥50 kg: Maximum single dose is 1 g, minimum dosing interval is 4 hours, and maximum daily dosage is 4 g per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Adults weighing <50 kg: Maximum single dose is 15 mg/kg, minimum dosing interval is 4 hours, and maximum daily dosage is 75 mg/kg per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Pain Associated with Migraine Headache

Oral

Acetaminophen, aspirin, and caffeine: Maximum for self-medication is 2 tablets (each containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) in 24 hours unless otherwise directed by a clinician.

Pain Associated with Osteoarthritis

Oral

Maximum 4 g daily.

Fever

Oral or Rectal

Maximum 4 g daily. Some manufacturers recommend maximum oral dosage of 3 g daily. (See Prescribing Limits: Adults, under Dosage and Administration.)

Self-medication should not exceed 3 days.

IV

Adults weighing ≥50 kg: Maximum single dose is 1 g, minimum dosing interval is 4 hours, and maximum daily dosage is 4 g per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Adults weighing <50 kg: Maximum single dose is 15 mg/kg, minimum dosing interval is 4 hours, and maximum daily dosage is 75 mg/kg per 24-hour period (including all routes of administration and all acetaminophen-containing preparations, including fixed combinations).

Special Populations

Hepatic Impairment

Reduction of total daily dosage may be warranted in patients with hepatic impairment or active liver disease. (See Hepatic Impairment under Cautions.)

Renal Impairment

Longer dosing intervals and reduced total daily dosage may be warranted in patients with severe renal impairment (Clcr ≤30 mL/minute).

Detailed Acetaminophen dosage information

Cautions for Acetaminophen

Contraindications

Warnings/Precautions

Warnings

Hepatic Effects

Ingestion of a single toxic dose or multiple excessive doses can result in hepatotoxicity. (See Boxed Warning.) About 50% of cases of acute liver failure in the US result from inadvertent overdosage. (See Advice to Patients.) Following suspected overdosage, evaluate necessity of antidote (acetylcysteine) therapy.

Increased serum ALT concentrations reported in healthy individuals receiving oral acetaminophen 4 g daily for 14 days in 1 study. Increased AST or hepatic enzyme concentrations reported in patients receiving IV acetaminophen in clinical studies.

Use with caution in patients with hepatic impairment, active liver disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., resulting from dehydration or blood loss), or severe renal impairment (Clcr ≤30 mL/minute). Contraindicated in those with severe hepatic impairment or severe active liver disease.

Sensitivity Reactions

Hypersensitivity Reactions

Sensitivity reactions (e.g., anaphylaxis, urticaria, rash, pruritus, respiratory distress, swelling of the face, mouth, or throat) reported rarely. If such reactions occur, immediately discontinue the drug.

Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.

Other Warnings/Precautions

Dermatologic Reactions

Serious, potentially fatal dermatologic reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) reported rarely. May occur at any time during therapy. Although NSAIAs may cause similar reactions, cross-sensitivity with acetaminophen does not appear to occur.

Discontinue at the first appearance of rash or any other manifestation of hypersensitivity.

Use of Multiple Acetaminophen-containing Preparations

Do not use multiple acetaminophen-containing preparations concomitantly. (See Boxed Warning.)

Use of Fixed Combinations

When used in fixed combination with other agents (e.g., aspirin, caffeine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, opiate agonists, phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).

Because many OTC and prescription preparations contain acetaminophen, concomitant use of more than one acetaminophen-containing preparation can result in adverse consequences (e.g., acetaminophen overdosage). Avoid such concomitant use. (See Advice to Patients.)

When used in fixed combination with an opiate analgesic, an increase in dosage of the fixed combination (because of tolerance to the opiate) may increase risk of inadvertent acetaminophen overdosage. To minimize such risk, FDA has requested manufacturers to reformulate prescription combination preparations to limit the amount of acetaminophen to 325 mg per dosage unit. FDA recommends that health care providers stop prescribing and dispensing prescription combination preparations containing >325 mg of acetaminophen per dosage unit. (See Preparations and also see Dosage under Dosage and Administration.)

Masking of Fever

Antipyretic effects may mask the presence of fever.

Specific Populations

Pregnancy

Epidemiologic data regarding oral acetaminophen use in pregnant women have shown no increased risk of major congenital malformations in infants exposed in utero.

Commonly used during all stages of pregnancy for analgesia and antipyresis. Although thought not to be associated with risk in offspring, some recent reports have questioned this assessment, especially with frequent maternal use or in cases involving genetic variability. FDA reviewed data on a possible association between acetaminophen use during pregnancy and risk of ADHD in children and announced in January 2015 that the data were inclusive. Some experts state that as with all drug use during pregnancy, avoid routine acetaminophen use.

Manufacturer states IV acetaminophen should be used during pregnancy only when clearly needed; IV acetaminophen not studied in pregnant women or in animal reproduction studies.

Use IV acetaminophen during labor and delivery only after careful assessment of potential benefits and risks; IV acetaminophen not studied in this setting.

Lactation

Distributed into milk in small quantities after oral administration; data suggest approximately 1–2% of maternal daily dosage is ingested by nursing infant.

Maculopapular rash reported in a breast-fed infant; rash resolved when mother discontinued acetaminophen use and recurred when she resumed such use.

AAP and other experts state acetaminophen is an acceptable choice for use in nursing women. Manufacturer states IV acetaminophen should be used with caution in nursing women.

Pediatric Use

Severe hepatotoxicity and death reported in children who apparently received acetaminophen dosages exceeding those recommended (10–15 mg/kg per dose with a maximum of 5 doses per day) for children. Contributing factors include improper interpretation of dosing information or failure to read such information, use of adult-strength preparations, use of excessive dosing because of the perception that desired therapeutic effects had not been achieved, and lack of knowledge about the potential toxicity of acetaminophen in excessive dosage.

Inadvertent overdosage, possibly resulting in hepatic failure and death, reported following confusion over different concentrations of acetaminophen (e.g., 80 mg/0.8 mL, 80 mg/mL, 160 mg/5 mL) contained in various pediatric preparations. To minimize dosing confusion, FDA recommended that only one concentration of liquid acetaminophen be available for OTC use in all pediatric patients. Some manufacturers voluntarily changed the concentration of the infants' formulation to be the same as that of the children's formulation (i.e., from 80 mg/0.8 mL or 80 mg/mL to 160 mg/5 mL). However, older, more-concentrated infants' preparations (80 mg/0.8 mL or 80 mg/mL) may remain available. To avoid confusion and potential for dosing errors, advise patients to carefully read the product labeling to identify the concentration of acetaminophen (in mg/mL), dosage, and directions for use. (See Advice to Patients.)

Risk of overdosage and toxicity (including death) in children <2 years of age receiving preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these cold and cough preparations in this age group; appropriate dosages not established. FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns.

Use of IV acetaminophen for analgesia or antipyresis in pediatric patients ≥2 years of age supported by controlled studies in adults and additional safety and pharmacokinetic data from 355 pediatric patients (age range: premature neonates to adolescents). Efficacy of IV acetaminophen for analgesia and antipyresis not established in children <2 years of age.

Geriatric Use

In studies of IV acetaminophen, no substantial differences in safety or efficacy relative to younger patients, but increased sensitivity cannot be ruled out.

Hepatic Impairment

Use with caution in patients with hepatic impairment or active liver disease; dosage reduction may be warranted. (See Hepatic Impairment under Dosage and Administration.) Contraindicated in those with severe hepatic impairment or severe active liver disease.

Renal Impairment

Use with caution in patients with severe renal impairment (Clcr ≤30 mL/minute); dosage reduction may be warranted. (See Renal Impairment under Dosage and Administration.)

Interactions for Acetaminophen

Drugs Affecting Hepatic Microsomal Enzymes

Drugs that induce or regulate CYP2E1 may alter metabolism of acetaminophen and increase its hepatotoxic potential. (See Metabolism under Pharmacokinetics.) Clinical importance not established.

Specific Drugs

Drug

Interaction

Comments

Alcohol

Increased risk of acetaminophen-induced hepatotoxicity

Complex effects on acetaminophen pharmacokinetics; excessive alcohol use can induce hepatic cytochromes, but alcohol also competitively inhibits acetaminophen metabolism

Avoid regular or excessive use of acetaminophen; alternatively, avoid chronic ingestion of alcohol (see Prescribing Limits: Adults, under Dosage and Administration)

Anticonvulsants (barbiturates, carbamazepine, phenytoin)

Increased conversion of acetaminophen to hepatotoxic metabolites; increased risk of hepatotoxicity

Limit acetaminophen self-medication; dosage adjustment not required

Anticoagulants, oral

Possible increased PT

Effects of IV acetaminophen not established

Clinical importance questioned; monitor anticoagulant activity if large doses of acetaminophen used

Manufacturer of acetaminophen injection states more frequent INR monitoring also may be appropriate during short-term concomitant IV acetaminophen use

Aspirin

No inhibition of antiplatelet effect of aspirin


Isoniazid

Possible increased risk of hepatotoxicity

Limit acetaminophen self-medication

Phenothiazines

Possible increased risk of severe hypothermia


Acetaminophen drug interactions (more detail)

Acetaminophen Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration, with peak plasma concentration attained within 10–60 minutes (immediate-release preparations) or 60–120 minutes (extended-release preparations).

Poor or variable absorption following rectal administration; considerable variation in peak plasma concentrations attained; time to reach peak plasma concentration is substantially longer than after oral administration.

Pharmacokinetics of IV acetaminophen are dose proportional at doses of 0.5–1 g.

Systemic exposure is similar following IV or oral administration, but peak plasma concentration at end of 15-minute IV infusion is up to 70% higher than peak concentration following oral administration of same dose.

Following single-dose IV administration in pediatric patients (15-mg/kg dose) or adults (1-g dose), systemic exposure in children and adolescents is similar to that in adults, but exposure is higher in neonates and infants. Simulations suggest that dose reductions of 33% in infants 1 month to <2 years of age and 50% in neonates up to 28 days of age, with a minimum dosing interval of 6 hours, would result in systemic exposures similar to those observed in children ≥2 years of age.

Food

Food may delay absorption following administration as extended-release tablets.

Distribution

Extent

Rapidly distributed to most body tissues except fat. Crosses placenta and is distributed into breast milk in small quantities.

Plasma Protein Binding

10–25%.

Elimination

Metabolism

Metabolized principally by sulfate and glucuronide conjugation; small amounts (5–10%) oxidized by CYP-dependent pathways (mainly CYP2E1) to a toxic metabolite, N-acetyl-p-benzoquinoneimine (NAPQI). NAPQI is detoxified by glutathione and eliminated; any remaining toxic metabolite may bind to hepatocytes and cause cellular necrosis.

Elimination Route

Mainly excreted in urine as conjugates.

Half-life

Reportedly 1.25–3 hours.

Following IV administration, 2.4 hours in adults, 2.9–3 hours in children and adolescents, 4.2 hours in infants, and 7 hours in neonates.

Special Populations

Following toxic doses or in patients with liver damage, plasma half-life may be prolonged.

In patients with moderate to severe renal impairment, acetaminophen conjugates may accumulate.

Stability

Storage

Oral

Tablets

Room temperature. Protect orally disintegrating tablets (Tylenol Meltaways) from high humidity. Protect grape-flavored orally disintegrating tablets from light.

Suspension/Solution

Room temperature.

Parenteral

Injection

20–25°C; do not refrigerate or freeze. Use within 6 hours after penetration of vacuum seal of vial or transfer of vial contents to another container.

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility301

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility

Compatible

Ketamine HCl


Compatible

Buprenorphine HCl

Butorphanol tartrate

Cefoxitin sodium

Ceftriaxone sodium

Clindamycin phosphate

Dexamethasone sodium phosphate

Diphenhydramine HCl

Dolasetron mesylate

Droperidol

Fentanyl citrate

Granisetron HCl

Heparin sodium

Hydrocortisone sodium succinate

Hydromorphone HCl

Hydroxyzine HCl

Ketorolac tromethamine

Lidocaine HCl

Lorazepam

Mannitol

Meperidine HCl

Methylprednisolone sodium succinate

Metoclopramide HCl

Midazolam HCl

Morphine sulfate

Nalbuphine HCl

Ondansetron HCl

Piperacillin sodium-tazobactam sodium

Potassium chloride

Prochlorperazine edisylate

Ranitidine HCl

Sufentanil citrate

Vancomycin HCl

Incompatible

Acyclovir sodium

Chlorpromazine HCl

Diazepam

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

To minimize the risk of inadvertent acetaminophen overdosage in pediatric patients, FDA has recommended that only one concentration of liquid acetaminophen be available for OTC use in all pediatric patients. Some manufacturers have voluntarily changed the concentration of the infants' formulation to be the same as that of the children's formulation. (See Pediatric Use under Cautions.) However, older, more-concentrated infants' preparations may remain available.

To minimize the risk of inadvertent acetaminophen overdosage, FDA has requested manufacturers to reformulate prescription combination preparations containing the drug to limit the acetaminophen amount to ≤325 mg per dosage unit. FDA no longer considers prescription combination preparations containing >325 mg of acetaminophen to be safe. As of March 26, 2014, all manufacturers of such preparations had discontinued marketing of the preparations, but some had not withdrawn the drug applications. FDA intends to withdraw approval of those applications if they are not voluntarily withdrawn. Therefore, availability of combination preparations with higher concentrations of acetaminophen per dose will diminish over time. Some prescription combination preparations that previously contained >325 mg of acetaminophen per dosage unit may have been reformulated to contain smaller amount of acetaminophen. Pharmacists are encouraged to return any prescription combination preparations containing >325 mg of acetaminophen per dosage unit to the wholesaler or manufacturer. FDA intends to address OTC acetaminophen-containing preparations in a separate regulatory action.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, gel-coated

500 mg*

Acetaminophen Extra Strength Gel-coated Capsules



Solution

167 mg/5 mL*

Tylenol Extra-Strength Adult

McNeil


Suspension

160 mg/5 mL*

Tylenol Oral Suspension Children’s

McNeil




Tylenol Oral Suspension Infant's

McNeil


Tablets

325 mg*

Tylenol Regular Strength (scored)

McNeil


Tablets, extended-release, film-coated

650 mg*

Tylenol Arthritis Pain Extended-Release Caplets

McNeil




Tylenol 8 HR Extended-Release Caplets

McNeil


Tablets, film-coated

500 mg*

Tylenol Extra Strength Caplets

McNeil


Tablets, orally disintegrating

80 mg*

Tylenol Meltaways Children’s

McNeil



160 mg*

Tylenol Meltaways Junior Strength

McNeil

Parenteral

Injection, for IV infusion

10 mg/mL (1 g)

Ofirmev

Mallinckrodt

Rectal

Suppositories

80 mg

FeverAll Infants’

Taro



120 mg*

Acephen

G&W




FeverAll Children’s

Taro



325 mg

Acephen

G&W




FeverAll Junior Strength

Taro



650 mg*

Acephen

G&W


Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For solution

325 mg/packet Acetaminophen and Aspirin 500 mg/packet

Goody's Back & Body Pain Powder

Prestige


Tablets, film-coated

250 mg Acetaminophen, Aspirin 250 mg, and buffer

Excedrin Back and Body Caplets

Novartis

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, gel-coated

250 mg Acetaminophen, Aspirin 250 mg, and Caffeine 65 mg*

Excedrin Menstrual Complete Gelcaps

Novartis


For solution

260 mg/packet Acetaminophen, Aspirin 520 mg/packet, and Caffeine 32.5 mg/packet

Goody’s Extra Strength Headache Powder

Prestige



325 mg/packet Acetaminophen, Aspirin 500 mg/packet, and Caffeine 65 mg/packet

Goody’s Cool Orange Extra Strength Powder

Prestige


Tablets, film-coated

194 mg Acetaminophen, Aspirin 227 mg, Caffeine 33 mg, and buffers

Vanquish Caplets

Moberg



250 mg Acetaminophen, Aspirin 250 mg, and Caffeine 65 mg

Excedrin Extra Strength Caplets

Novartis




Excedrin Migraine Caplets

Novartis




Goody's Extra Strength Caplets

Prestige




Pamprin Max

Chattem

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL*

Acetaminophen and Codeine Phosphate Oral Solution ( C-V)



Suspension

120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL

Capital and Codeine ( C-V)

Valeant


Tablets

300 mg Acetaminophen and Codeine Phosphate 15 mg*

Acetaminophen and Codeine Phosphate Tablets ( C-III)




300 mg Acetaminophen and Codeine Phosphate 30 mg*

Tylenol with Codeine No. 3 ( C-III)

Janssen



300 mg Acetaminophen and Codeine Phosphate 60 mg*

Tylenol with Codeine No. 4 ( C-III)

Janssen

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For solution

500 mg/packet Acetaminophen and Diphenhydramine Citrate 38 mg/packet

Goody's PM Powder

Prestige


Tablets, film-coated

500 mg Acetaminophen and Diphenhydramine Citrate 38 mg*

Excedrin PM Caplets

Novartis




Excedrin PM Geltabs

Novartis




Midol PM Caplets

Bayer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

5 mg/5 mL Oxycodone Hydrochloride and Acetaminophen 325 mg/5 mL

Roxicet ( C-II)

Roxane


Tablets

2.5 mg Oxycodone Hydrochloride and Acetaminophen 300 mg*

Oxycodone Hydrochloride and Acetaminophen Tablets ( C-II)




2.5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg*

Percocet ( C-II)

Endo



5 mg Oxycodone Hydrochloride and Acetaminophen 300 mg*

Primlev ( C-II)

Akrimax



5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg*

Endocet ( C-II; scored)

Qualitest




Percocet ( C-II; scored)

Endo



7.5 mg Oxycodone Hydrochloride and Acetaminophen 300 mg*

Primlev ( C-II)

Akrimax



7.5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg*

Endocet ( C-II)

Qualitest




Percocet ( C-II)

Endo



10 mg Oxycodone Hydrochloride and Acetaminophen 300 mg*

Primlev ( C-II)

Akrimax



10 mg Oxycodone Hydrochloride and Acetaminophen 325 mg*

Endocet ( C-II)

Qualitest




Percocet ( C-II)

Endo

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

300 mg with Butalbital 50 mg and Caffeine 40 mg*

Fioricet

Actavis



300 mg with Butalbital 50 mg, Caffeine 40 mg, and Codeine Phosphate 30 mg*

Fioricet with Codeine ( C-III)

Actavis



320.5 mg with Caffeine 30 mg and Dihydrocodeine Bitartrate 16 mg

Trezix ( C-III)

WraSer



325 mg with Butalbital 50 mg and Caffeine 40 mg*

Capacet

Magna



325 mg with Butalbital 50 mg, Caffeine 40 mg, and Codeine Phosphate 30 mg*

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules ( C-III)



Capsules, gel-coated

500 mg with Caffeine 60 mg and Pyrilamine Maleate 15 mg

Midol Complete Gelcaps

Bayer



500 mg with Caffeine 65 mg*

Acetaminophen with Caffeine Gelcaps



Solution

83 mg/5 mL with Caffeine 5.4 mg/5 mL

Goody's Headache Relief Shot

Prestige



100 mg/5 mL with Hydrocodone Bitartrate 3.3 mg/5 mL*

Lortab Elixir ( C-II)

ECR



108 mg/5 mL with Butalbital 16.7 mg/5 mL and Caffeine 13.3 mg/5 mL*

Alagesic LQ

Poly Pharmaceuticals



108 mg/5 mL with Hydrocodone Bitartrate 2.5 mg/5 mL*

Hydrocodone Bitartrate and Acetaminophen Oral Solution ( C-II)




108 mg/5 mL with Hydrocodone Bitartrate 3.3 mg/5 mL*

Hydrocodone Bitartrate and Acetaminophen Oral Solution ( C-II)



Tablets

300 mg with Butalbital 50 mg

Bupap

ECR



300 mg with Hydrocodone Bitartrate 5 mg*

Vicodin ( C-II; scored)

AbbVie



300 mg with Hydrocodone Bitartrate 7.5 mg

Vicodin ES ( C-II; scored)

AbbVie



300 mg with Hydrocodone Bitartrate 10 mg

Vicodin HP ( C-II; scored)

AbbVie



325 mg with Butalbital 50 mg

Butapap

Mikart




Phrenilin (scored)

Valeant



325 mg with Butalbital 50 mg and Caffeine 40 mg*

Butalbital, Acetaminophen, and Caffeine Tablets




325 mg with Hydrocodone Bitartrate 2.5 mg*

Hydrocodone and Acetaminophen Tablets ( C-II)




325 mg with Hydrocodone Bitartrate 5 mg*

Lortab ( C-II; scored)

UCB




Norco ( C-II; scored)

Actavis



325 mg with Hydrocodone Bitartrate 7.5 mg*

Lortab ( C-II; scored)

UCB




Norco ( C-II; scored)

Actavis



325 mg with Hydrocodone Bitartrate 10 mg*

Lortab ( C-II; scored)

UCB




Norco ( C-II; scored)

Actavis


Tablets, film-coated

325 mg with Diphenhydramine Hydrochloride 12.5 mg*

Percogesic Original Strength

Prestige



325 mg with Tramadol Hydrochloride 37.5 mg*

Ultracet ( C-IV)

Janssen



500 mg with Caffeine 60 mg and Pyrilamine Maleate 15 mg*

MidolComplete Caplets

Bayer



500 mg with Caffeine 65 mg*

Excedrin Tension Headache Caplets

Novartis



500 mg with Diphenhydramine Hydrochloride 12.5 mg

Percogesic Extra Strength Caplets

Prestige



500 mg with Diphenhydramine Hydrochloride 25 mg*

Tylenol PM Extra Strength Caplets

McNeil




Tylenol PM Extra Strength Geltabs

McNeil



500 mg with Pamabrom 25 mg

Midol Teen Caplets

Bayer



500 mg with Pamabrom 25 mg and Pyrilamine Maleate 15 mg

Pamprin Multi-Symptom Caplets

Chattem




Premsyn PMS Caplets

Chattem

Acetaminophen also is commercially available in combination with other drugs, including analgesics, antihistamines, antimuscarinics, antitussives, barbiturates, decongestants, and expectorants.

AHFS DI Essentials™. © Copyright 2024, Selected Revisions February 1, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

Reload page with references included



ACIPHEX

ACIPHEX ® (a-se-feks) (rabeprazole sodium) delayed-release tablets. 


This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about ACIPHEX?

ACIPHEX may help your acid-related symptoms, but you could still have serious stomach problems.

Talk with your doctor.

ACIPHEX can cause serious side effects, including:


You should take

ACIPHEX exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take ACIPHEX.


What is ACIPHEX?

ACIPHEX is a prescription medicine called a Proton Pump Inhibitor (PPI).

ACIPHEX reduces the amount of acid in your stomach.

ACIPHEX is used in adults: for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) and to relieve symptoms, such as heartburn pain.

If needed, your doctor may decide to prescribe another 8 weeks of ACIPHEX. to maintain the healing of the esophagus and relief of symptoms related to EE.

It is not known if ACIPHEX is safe and effective if used longer than 12 months (1 year). for up to 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD).

GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach.

This may cause a burning feeling in your chest or throat, sour taste, or burping. for up to 4 weeks for the healing and relief of duodenal ulcers.

The duodenal area is the area where food passes when it leaves the stomach, for 7 days with certain antibiotic medicines to treat an infection caused by bacteria called H. pylori . Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back. for the long-term treatment of conditions where your stomach makes too much acid.

This includes a rare condition called Zollinger-Ellison syndrome. ACIPHEX is used in adolescents 12 years of age and older to treat symptoms of Gastroesophageal Reflux Disease (GERD) for up to 8 weeks.

It is not known if ACIPHEX is safe and effective in children to: heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE)  maintain the healing of the esophagus and relief of symptoms related to EE treat symptoms that happen with Gastroesophageal Reflux Disease (GERD)  heal duodenal ulcers  treat an infection caused by bacteria called H. pylori to reduce the risk of duodenal ulcers from coming back  treat conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome. ACIPHEX delayed-release tablets should not be used in children under 12 years of age.


Who should not take ACIPHEX?

Do not take ACIPHEX if you: are allergic to rabeprazole or any of the other ingredients in ACIPHEX.

See the end of this Medication Guide for a complete list of ingredients in ACIPHEX. are allergic to any other Proton Pump Inhibitor (PPI) medicine

are taking a medicine that contains rilpivirine (Edurant, Complera) used to treat HIV-1 (Human Immunodeficiency Virus)


What should I tell my doctor before taking ACIPHEX?

Before you take ACIPHEX tell your doctor if you: have been told that you have low magnesium levels in your blood, have liver problems, have any allergies, have any other medical conditions, are pregnant or plan to become pregnant. It is not known if ACIPHEX can harm your unborn baby. Talk to your doctor about the possible risks to an unborn baby if ACIPHEX is taken during pregnancy. are breastfeeding or plan to breastfeed.

It is not known if ACIPHEX passes into your breast milk or if it will affect your baby or your breast milk. Talk to your doctor about the best way to feed your baby if you take ACIPHEX.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ACIPHEX may affect how other medicines work, and other medicines may affect how ACIPHEX works.  Especially tell your doctor if you take an antibiotic that contains clarithromycin or amoxicillin or if you take warfarin (COUMADIN, JANTOVEN) or methotrexate (Otrexup, Rasuvo, Trexall).

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take ACIPHEX?

Take ACIPHEX exactly as prescribed. Your doctor will prescribe the dose that is right for you and your medical condition. Do not change your dose or stop taking ACIPHEX unless you talk to your doctor. Take ACIPHEX for as long as it is prescribed even if you feel better. ACIPHEX is usually taken 1 time each day. Your doctor will tell you the time of day to take ACIPHEX, based on your medical condition. 

ACIPHEX can be taken with or without food. Your doctor will tell you whether to take this medicine with or without food based on your medical condition. Swallow each ACIPHEX tablet whole. Do not chew, crush, or split ACIPHEX tablets. Tell your doctor if you cannot swallow tablets whole. If you miss a dose of ACIPHEX, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule.

Do not take 2 doses at the same time. If you take too much ACIPHEX, call your doctor or your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room. Your doctor may prescribe antibiotic medicines with ACIPHEX to help treat a stomach infection and heal stomach (duodenal) ulcers that are caused by bacteria called H. pylori. Make sure you read the patient information that comes with an antibiotic before you start taking it.

What are the possible side effects of ACIPHEX?

ACIPHEX may cause serious side effects, including:  See “What is the most important information I should know about ACIPHEX?”

Interaction with warfarin. Taking warfarin with a Proton Pump Inhibitor (PPI) may lead to an increased risk of bleeding and death.

If you take warfarin, your doctor may check your blood to see if you have an increased risk of bleeding.

If you take warfarin during treatment with ACIPHEX, tell your doctor right away if you have any signs or symptoms of bleeding, including unexpected bleeding or bleeding that lasts a long time, such as: nosebleeds that happen often unusual bleeding from the gums, menstrual bleeding that is heavier than normal or unusual vaginal bleeding, bleeding that is severe or that you cannot control, red, pink or brown urine bright red or black stools (looks like tar) coughing up blood or blood clots  vomiting blood or your vomit looks like “coffee grounds” headaches, feel dizzy or weak,  Vitamin B-12 deficiency. ACIPHEX reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on ACIPHEX for a long time (more than 3 years). Low magnesium levels in your body.  this problem can be serious. Low magnesium can happen in some people who take a Proton Pump inhibitor (PPI) medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away and get medical care if you have any of these symptoms: seizures, dizziness, abnormal or fast heart beat jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, spasm of the voice box


Your doctor may check the level of magnesium in your body before you start taking ACIPHEX, during treatment, or if you will be taking ACIPHEX for a long period of time. The most common side effects of ACIPHEX in adults include: pain,  sore throat, gas, infection, constipation. The most common side effects of ACIPHEX in adolescents 12 years of age and older include: headache, diarrhea, nausea,  vomiting, stomach-area (abdomen) pain 


Other side effects: Serious allergic reactions.


Tell your doctor if you get any of the following symptoms with ACIPHEX: rash. face swelling, throat tightness, difficulty breathing.


Your doctor may stop ACIPHEX if these symptoms happen.

These are not all of the possible side effects of ACIPHEX.  Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.


How should I store ACIPHEX?

Store ACIPHEX Tablets in a dry place at room temperature between 68° F to 77° F (20° C to 25° C). 

Keep ACIPHEX and all medicines out of the reach of children.



What are the ingredients in ACIPHEX?

Active ingredient:

rabeprazole sodium

Inactive ingredients : carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium stearate, mannitol, propylene glycol, sodium hydroxide, sodium stearyl fumarate, talc, and titanium dioxide. Iron oxide yellow is the coloring agent for the tablet coating.  Iron oxide red is the ink pigment.


Distributed by Eisai Inc., Woodcliff Lake, NJ 07677

All brand names are the trademarks of their respective owners.

For more information, go to http://www.aciphex.com/ or call 1-888-4-ACIPHEX.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: April 2016



ABILIFY - MYCITE


MEDICATION GUIDE


ABILIFY MYCITE®  (a BIL ĭ fī - Mi SIHYT)  (aripiprazole tablets with sensor), for oral use


Important: If you are taking ABILIFY MYCITE with other medicines for treatment of major depressive disorder (MDD), you should also read the Medication Guides or Patient Information that comes with the other medicines.



The ABILIFY MYCITE System has 4 parts: 



Download the MYCITE App before using the ABILIFY MYCITE System. Always follow the instructions provided within the MYCITE App when using the ABILIFY MYCITE System. 

Your healthcare provider should show you how to use the ABILIFY MYCITE System before you use it for the first time. 



What is the most important information I should know about ABILIFY MYCITE?

ABILIFY MYCITE may cause serious side effects, including:


Increased risk of death in elderly people with dementia-related psychosis. Medicines like

ABILIFY MYCITE can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY MYCITE is not approved for the treatment of people who have lost touch with reality (psychosis) due to confusion or memory loss (dementia).


Increased risk of suicidal thoughts or actions in children and young adults. Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. It is not known if ABILIFY MYCITE is safe and effective for use in children.


How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?


Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.


Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.


Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

 

What is ABILIFY MYCITE?

ABILIFY MYCITE is a prescription medicine of aripiprazole tablets with an Ingestible Event Marker (IEM) sensor inside it used:

To treat adults with schizophrenia.

To treat bipolar I disorder: short-term (acute) treatment of adults with manic or mixed episodes alone or when used with the medicine lithium or valproate maintenance treatment of adults alone or when used with the medicine lithium or valproate. To treat adults with major depressive disorder (MDD) along with other antidepressant medicines   The ABILIFY MYCITE System is meant to track if you have taken your ABILIFY MYCITE.


It is not known if ABILIFY MYCITE can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole. 


There may be a delay in the detection of the ABILIFY MYCITE tablet and sometimes the detection of the tablet might not happen at all. ABILIFY MYCITE is not for use as real-time or emergency  monitoring.  


It is not known if ABILIFY MYCITE is safe or effective for use in children. 


Do not take ABILIFY MYCITE if you are allergic to aripiprazole or any of the ingredients in ABILIFY MYCITE. See the end of this Medication Guide for a complete list of ingredients in ABILIFY MYCITE.


Before taking ABILIFY MYCITE, tell your healthcare provider about all your medical conditions, including if you:


Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with ABILIFY MYCITE. 


If you become pregnant during treatment with ABILIFY MYCITE, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.


If you are breastfeeding or plan to breastfeed. ABILIFY MYCITE can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ABILIFY MYCITE.


Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


ABILIFY MYCITE and other medicines may affect each other causing possible serious side effects. ABILIFY MYCITE may affect the way other medicines work, and other medicines may affect how ABILIFY MYCITE works.


Your healthcare provider can tell you if it is safe to take ABILIFY MYCITE with your other medicines. Do not start or stop any other medicines during treatment with ABILIFY MYCITE without talking to your healthcare provider first. 


Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

 

How should I take ABILIFY MYCITE?

See the MYCITE App for instructions about how to apply and wear the MYCITE Patch and how to use the ABILIFY MYCITE System the right way.


 

What should I avoid while taking ABILIFY MYCITE?



What are the possible side effects of ABILIFY MYCITE?


ABILIFY MYCITE may cause serious side effects, including:


See “What is the most important information I should know about ABILIFY MYCITE?” 


Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.  

Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:


Uncontrolled body movements (tardive dyskinesia). ABILIFY MYCITE may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ABILIFY MYCITE. Tardive dyskinesia may also start after you stop taking ABILIFY MYCITE.


Problems with your metabolism such as:


high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take ABILIFY MYCITE. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start and during your treatment with ABILIFY MYCITE. 


Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with ABILIFY MYCITE:

feel very thirsty

need to urinate more than usual

feel very hungry

feel weak or tired

feel sick to your stomach

feel confused, or your breath smells fruity o   increased fat levels (cholesterol and triglycerides) in your blood.

weight gain. You and your healthcare provider should check your weight regularly.


Unusual urges. Some people taking ABILIFY MYCITE have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.

 

Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

Falls

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with ABILIFY MYCITE.

Seizures (convulsions)

Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking ABILIFY MYCITE?”

Difficulty swallowing 


The most common side effects of ABILIFY MYCITE in adults include:


These are not all the possible side effects of ABILIFY MYCITE. 


Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.


How should I store ABILIFY MYCITE?



General information about the safe and effective use of ABILIFY MYCITE.


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY MYCITE for a condition for which it was not prescribed. Do not give ABILIFY MYCITE to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ABILIFY MYCITE that was written for healthcare professionals.


What are the ingredients in ABILIFY MYCITE?


Active ingredient: aripiprazole


Inactive ingredients: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose, and Ingestible Event Marker (IEM). Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate.

Manufactured by:


Tablets with embedded IEM sensors Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan MYCITE Patches Manufactured for Otsuka America Pharmaceutical, Inc. 3956 Point Eden Way, Hayward, CA 94545 USA Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA ABILIFY MYCITE®  and MYCITE®  are registered trademarks of Otsuka Pharmaceutical Company.

      

© 2020, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan For more information about ABILIFY MYCITE go to www.abilifymycite.com or call 1-844-692-4834.  


APITOM


MEDICATION GUIDE

APTIOM (ap tee' om) (eslicarbazepine acetate) tablets

 

What is the most important information I should know about APTIOM?

Do not stop taking APTIOM without first talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems.

Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).

Like other antiepileptic drugs, APTIOM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying

attempt to commit suicide

new or worse depression

new or worse anxiety

feeling agitated or restless

panic attacks o trouble sleeping (insomnia)

new or worse irritability

acting aggressive, being angry, or violent

acting on dangerous impulses

an extreme increase in activity and talking (mania)

other unusual changes in behavior or mood

 

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

 

APTIOM may cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells.

You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following:

swelling of your face, eyes, lips, or tongue

trouble swallowing or breathing

a skin rash

hives

fever, swollen glands, or sore throat that do not go away or come and go

painful sores in the mouth or around your eyes

yellowing of your skin or eyes

unusual bruising or bleeding

severe fatigue or weakness

severe muscle pain

frequent infections or infections that do not go away

 

APTIOM may cause the level of sodium in your blood to be low.

Symptoms of low blood sodium include:

nausea

tiredness, lack of energy

irritability

confusion

muscle weakness or muscle spasms

more frequent or more severe seizures Some medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.

 

What is APTIOM?

APTIOM is a prescription medicine used to treat partial-onset seizures. It is not known if APTIOM is safe and effective in children under 4 years of age.

Who should not take APTIOM?

Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the other ingredients in APTIOM, or oxcarbazepine. See the end of this Medication Guide for a complete list of ingredients in APTIOM.

What should I tell my healthcare provider before taking APTIOM?

Before taking APTIOM, tell your healthcare provider about all your medical conditions, including if you:

have or have had suicidal thoughts or actions, depression or mood problems

have liver, kidney, or blood problems

are allergic to oxcarbazepine. Some people who are allergic to oxcarbazepine may also be allergic to APTIOM.

use birth control medicine. APTIOM may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use.

 

If you are pregnant or plan to become pregnant. APTIOM may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking APTIOM. You and your healthcare provider will decide if you should take APTIOM while you are pregnant.

 

If you become pregnant while taking APTIOM, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

If you are breastfeeding or plan to breastfeed. APTIOM passes into breast milk. You and your healthcare provider should discuss whether you should take APTIOM or breastfeed.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking APTIOM with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you take:

oxcarbazepine

carbamazepine

simvastatin

omeprazole

clobazam

phenobarbital

phenytoin

birth control medicine

rosuvastatin

primidone

 

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take APTIOM?

Take APTIOM exactly as your healthcare provider tells you to take it.

Do not stop taking APTIOM without talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems, including seizures that will not stop (status epilepticus).

Your healthcare provider may change your dose.

Your healthcare provider will tell you how much APTIOM to take.

APTIOM can be taken with or without food.

APTIOM can be taken as a whole tablet or crushed.

If you take too much APTIOM, call your healthcare provider or go to the nearest hospital emergency room right away.

Talk with your healthcare provider about what you should do if you miss a dose.

 

What should I avoid while taking APTIOM?

Do not drive, operate heavy machinery, or do dangerous activities until you know how APTIOM affects you. APTIOM may slow your thinking and motor skills.

 

What are the possible side effects of APTIOM? See “What is the most important information I should know about APTIOM?”

APTIOM may cause other serious side effects including:

Nervous system problems. APTIOM may cause problems that can affect your nervous system.

Symptoms of nervous system problems include:

dizziness

trouble walking or with coordination

feeling sleepy and tired

trouble concentrating

vision problems

 

Liver problems. APTIOM may affect your liver.

Symptoms of liver problems include:

yellowing of your skin or the whites of your eyes

nausea or vomiting

loss of appetite

stomach pain

dark urine

 

Get medical help right away if you have any of the symptoms listed above or listed in

 

“What is the most important information I should know about APTIOM?”

The most common side effects of APTIOM include:

dizziness

sleepiness

nausea

headache

double vision

vomiting

feeling tired

blurred vision

shakiness

problems with coordination

 

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of APTIOM. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

How should I store APTIOM?

Store APTIOM at 68o F to 77o F (20o C to 25o C).  Safely throw away medicine that is out of date or no longer needed. Keep APTIOM and all medicines out of reach of children.

What are the ingredients in APTIOM?

Active ingredient: eslicarbazepine acetate

Inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone

General information about the safe and effective use of APTIOM. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use APTIOM for a condition for which it was not prescribed.

Do not give APTIOM to other people, even if they have the same symptoms that you have. It may harm them.

 

This Medication Guide summarizes the most important information about APTIOM. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about APTIOM that is written for health professionals. For more information, go to www.aptiom.com or call 1-888-394-7377.

Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough, MA 01752 USA