Dexlansoprazole Delayed-Release Capsules

Pronunciation: DEX-lan-SOE-pra-zole
Generic Name: Dexlansoprazole
Brand Name: Dexilant

Dexlansoprazole Delayed-Release Capsules are used for:

Healing and maintaining healing of irritation of the esophagus. It is also used to treat symptoms of gastroesophageal reflux disease (GERD) (eg, heartburn). It may also be used for other conditions as determined by your doctor.

Dexlansoprazole Delayed-Release Capsules are a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

Do NOT use Dexlansoprazole Delayed-Release Capsules if:

• you are allergic to any ingredient in Dexlansoprazole Delayed-Release Capsules


• you are taking atazanavir or dasatinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dexlansoprazole Delayed-Release Capsules:

Some medical conditions may interact with Dexlansoprazole Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have low blood potassium or magnesium levels, liver problems, or stomach or bowel cancer


• if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Dexlansoprazole Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased


• Voriconazole because it may increase the risk of Dexlansoprazole Delayed-Release Capsules's side effects


• Anticoagulants (eg, warfarin), digoxin, saquinavir, or tacrolimus because the risk of their side effects may be increased by Dexlansoprazole Delayed-Release Capsules


• Ampicillin, azole antifungals (eg, ketoconazole), clopidogrel, dasatinib, erlotinib, HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Dexlansoprazole Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dexlansoprazole Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dexlansoprazole Delayed-Release Capsules:

Use Dexlansoprazole Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Dexlansoprazole Delayed-Release Capsules. Talk to your pharmacist if you have questions about this information.


• Take Dexlansoprazole Delayed-Release Capsules by mouth with or without food.


• Swallow Dexlansoprazole Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.


• Continue to take Dexlansoprazole Delayed-Release Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Dexlansoprazole Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dexlansoprazole Delayed-Release Capsules.

Important safety information:

• Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds; or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.


• Dexlansoprazole Delayed-Release Capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Dexlansoprazole Delayed-Release Capsules in high doses, for longer than a year, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information.


• Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Dexlansoprazole Delayed-Release Capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).


• Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Dexlansoprazole Delayed-Release Capsules.


• Use Dexlansoprazole Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.


• Dexlansoprazole Delayed-Release Capsules should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dexlansoprazole Delayed-Release Capsules while you are pregnant. It is not known if Dexlansoprazole Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Dexlansoprazole Delayed-Release Capsules.

Possible side effects of Dexlansoprazole Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; gas; nausea; stomach pain; upper respiratory tract infection; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; calf pain, swelling, or tenderness; chest pain, numbness of an arm or leg, sudden severe vomiting or dizziness, or vision changes; depression; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint pain, tenderness, swelling, or warmth; red, swollen, blistered, or peeling skin; seizures; shortness of breath; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dexlansoprazole side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Dexlansoprazole Delayed-Release Capsules:

Store Dexlansoprazole Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dexlansoprazole Delayed-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Dexlansoprazole Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Dexlansoprazole Delayed-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dexlansoprazole Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dexlansoprazole resources

• Dexlansoprazole Side Effects (in more detail)
• Dexlansoprazole Dosage
• Dexlansoprazole Use in Pregnancy & Breastfeeding
• Dexlansoprazole Drug Interactions
• Dexlansoprazole Support Group
• 61 Reviews for Dexlansoprazole - Add your own review/rating

Compare Dexlansoprazole with other medications

• Barrett's Esophagus
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DepoCyt

Generic Name: Cytarabine
Class: Antineoplastic Agents
VA Class: AN300
CAS Number: 147-94-4

• Experience of Supervising Clinician


• 
  

  Conventional cytarabine: Use only under supervision of qualified clinicians experienced in therapy with antineoplastic agents.^{a b c c j} Consider possible benefits vs known risks of cytarabine treatment.^{a b c j}

  
  


• 
  

  Liposomal cytarabine: Use only under supervision of qualified clinicians experienced in intrathecal therapy with antineoplastic agents; adequate diagnostic and treatment facilities must be readily available for management of complications.^d

  
  

• Induction Therapy with Conventional Cytarabine


• 
  

  Patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity.^{a b c j}

  
  


• 
  

  Risk of serious adverse effects, including myelosuppression with leukopenia, thrombocytopenia, and anemia.^{a b c j} Less serious adverse effects include nausea, vomiting, diarrhea, abdominal pain, oral ulceration, and hepatic dysfunction.^{a b c j} (See Cautions.)

  
  

• Chemical Arachnoiditis with Intrathecal Liposomal Cytarabine


• 
  

  Chemical arachnoiditis, a syndrome manifested principally by nausea, vomiting, headache, and fever, commonly occurs.^d If left untreated, may be fatal.^d (See Chemical Arachnoiditis Related to Liposomal Cytarabine under Cautions.)

  
  


• 
  

  Administer dexamethasone to ameliorate symptoms and reduce incidence.^d (See Liposomal Cytarabine under Dosage and Administration.)

  
  

Introduction

Antimetabolite antineoplastic agent; synthetic pyrimidine antagonist.^{d f i}

Uses for DepoCyt

Acute Myeloid Leukemia (AML)

Conventional cytarabine: Remission induction (in combination with other antineoplastic agents) in AML (acute nonlymphocytic leukemia) in children and adults.^{237 a b c j}

Conventional cytarabine and either idarubicin or daunorubicin (with or without thioguanine) are currently preferred components of induction regimens.^{g h} However, various regimens have been used in combination therapy, and comparative efficacy is continually being evaluated.^g

Conventional cytarabine: Has been used with other antineoplastic agents in regimens of consolidation following induction of a complete remission†; ^{239 242 243 f g} role of such therapy in prolonging remissions and optimal dosage, schedules, and duration of consolidation chemotherapy regimens not established.^g

Conventional cytarabine: Has been used with other antineoplastic agents in the treatment of erythroleukemia.^f

Conventional cytarabine: Also has been used alone in high-dose† regimens to induce remissions in some patients with refractory AML or with secondary AML.^f

Acute Lymphocytic Leukemia (ALL)

Conventional cytarabine: Has been used alone or with other antineoplastic agents for remission induction in ALL;^{237 a b c j} however, combinations containing other antineoplastic agents are more effective.^{f h}

Conventional cytarabine: Generally has been limited to use with other antineoplastics for remission induction in some patients who do not achieve a complete remission with combinations containing other agents or who relapse during maintenance therapy.^f

Conventional cytarabine: Also has been used occasionally in regimens of consolidation and/or maintenance therapy following induction of a complete remission by combinations containing other agents.^{f h}

Conventional cytarabine: Has been used alone in high-dose† regimens to induce remissions in some patients with refractory ALL.^f

Meningeal Leukemia and Other Meningeal Neoplasms

Conventional cytarabine: Has been used effectively alone or with other chemotherapeutic agents in treatment, maintenance, and prophylactic therapy of meningeal leukemia and other meningeal neoplasms (e.g., lymphoma).^{a c f j}

Many clinicians consider intrathecal conventional cytarabine and intrathecal methotrexate to have similar efficacy in the treatment of these conditions; however, intrathecal conventional cytarabine produces less systemic toxicity than intrathecal methotrexate.^f

Liposomal cytarabine: Treatment of lymphomatous meningitis.^d

Intrathecal liposomal cytarabine appears to have greater efficacy in the treatment of neoplastic meningitis and less systemic toxicity compared with intrathecal conventional cytarabine;ⁱ however, further study is needed.^{d i}

Chronic Myelogenous Leukemia (CML)

Conventional cytarabine: Used with other antineoplastic agents (e.g., daunorubicin) in the treatment of accelerated or blast phase of CML;^{a b c f j} however, various regimens have been used in combination therapy, and comparative efficacy is continually being evaluated.^{237 246 247 253 254}

Non-Hodgkin’s Lymphomas†

Conventional cytarabine: Has been used with other antineoplastic agents for maintenance therapy of non-Hodgkin’s lymphoma in children†.^f

Conventional cytarabine: Has been used with other antineoplastic agents for remission induction and/or maintenance therapy in adults with non-Hodgkin’s lymphomas, principally advanced diffuse histiocytic lymphoma†.^f

Conventional cytarabine: Has been used alone in high-dose† regimens with some success for the treatment of refractory non-Hodgkin’s lymphomas†.^f

DepoCyt Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastics.^{a b c d j}

  
  

Premedication before Intrathecal Liposomal Cytarabine

• 
  

  Initiate dexamethasone therapy on the day of the intrathecal administration of liposomal cytarabine to prevent or ameliorate chemical arachnoiditis.^{d i} Administer 4 mg of dexamethasone twice daily orally or IV for 5 days.^d

  
  

Administration

Conventional cytarabine: Administer by rapid IV injection or continuous IV infusion, sub-Q injection, or intrathecal injection; ^{a b c j} also has been administered by IM injection† and by continuous sub-Q infusion†.^f

Liposomal cytarabine: Administer only by intrathecal injection.^d

IV Administration

For solution compatibility information for conventional cytarabine see Compatibility under Stability.

Higher total doses of conventional cytarabine may be given by rapid IV injection compared with continuous IV infusion with no increase in hematologic toxicity; most effective method of administration not established.^{a b c f j}

Cytarabine injection solution containing benzyl alcohol may be used for IV administration but should not be used in high-dose regimens†.²⁵¹

Cytarabine injection solution containing benzyl alcohol should not be used in neonates.^{a b c f}

Cytarabine injection in pharmacy bulk packages is not intended for direct IV infusion; individual doses can be withdrawn with a sterile dispensing set or transfer device and used undiluted or further diluted in a compatible IV solution.^{252 f}

Reconstitution of Conventional Cytarabine

Add 5, 10, 10, or 20 mL of bacteriostatic water for injection containing 0.945% benzyl alcohol to a vial containing 100, 500, 1000, or 2000 mg cytarabine powder; resultant solutions contain 20, 50, 100, or 100 mg of cytarabine per mL, respectively.^j

Diluents containing benzyl alcohol should not be used in neonates^{f j} or in high-dose† regimens.^{a b c j} (See Benzyl Alcohol under Cautions.)

The desired dose of reconstituted solution may be given by rapid IV injection or may be further diluted with 5% dextrose or 0.9% sodium chloride injection for IV infusion.^{f j}

Dilution of Conventional Cytarabine

Cytarabine injection solution (containing 20 or 100 mg/mL) may be diluted with a compatible IV solution (e.g., 5% dextrose injection, 0.9% sodium chloride injection) for direct IV injection, rapid IV injection, or IV infusion.^{250 b c j}

Cytarabine injection in pharmacy bulk package solution (containing 20 mg/mL) should be diluted with a compatible IV solution (e.g., 5% dextrose injection, 0.9% sodium chloride injection) for IV infusion.^c

Alternatively, desired dose of the solution reconstituted from powder may be further diluted with 5% dextrose or 0.9% sodium chloride injection for IV infusion.^j

Rate of Administration of Conventional Cytarabine

Has been given over 1–3 hours when used for treatment of refractory or secondary acute leukemia and refractory non-Hodgkin’s lymphomas.^f

Also administered by rapid IV injection or continuous IV infusion.^{a b c j}

Sub-Q Administration

For solution compatibility information on conventional cytarabine see Compatibility under Stability. Consult specialized references for information on continuous sub-Q infusion†.

Cytarabine injection solution containing benzyl alcohol may be used for sub-Q administration but should not be used in high-dose regimens†.²⁵¹

Reconstitution of Conventional Cytarabine

Add 5, 10, 10, or 20 mL of bacteriostatic water for injection containing 0.945% benzyl alcohol to a vial containing 100, 500, 1000, or 2000 mg cytarabine powder; resultant solutions contain 20, 50, 100, or 100 mg of cytarabine per mL, respectively.^j

Diluents or drug solutions containing benzyl alcohol should not be used in neonates^{a b c f j} or in high-dose† regimens.^{a b c j} (See Benzyl Alcohol under Cautions.)

Intrathecal Administration

Conventional Cytarabine

Usually administered in 5–15 mL of solution, after removing an equivalent volume of CSF.^f

Only preservative-free injection solutions are suitable for intrathecal administration.^{250 a b c j}

Injection in pharmacy bulk packages should not be used for preparation of solutions for intrathecal administration.²⁵²

Reconstitution of Conventional Cytarabine

Do not use diluents containing benzyl alcohol for preparation of solutions.^{b c j}

Reconstitute cytarabine powder with preservative-free 0.9% sodium chloride injection, Elliott’s B solution, other isotonic buffered diluents that do not contain a preservative (e.g., lactated Ringer’s injection), or the patient’s spinal fluid.^{f j}

Liposomal Cytarabine

Only use for intrathecal administration.^d

Administer directly into CSF via an intraventricular reservoir or by direct injection into lumbar sac; do not use inline filters.^d

Following intrathecal administration by lumbar puncture, patient should lie flat for 1 hour.^d

Preparing Dose of Liposomal Cytarabine

Allow vials to warm to room temperature; immediately prior to withdrawing dose, gently agitate or invert to ensure resuspension of liposomes.^d Avoid aggressive agitation.^d

Withdraw dose from the vial immediately before administration.^d

Do not dilute or mix with any other drugs.^d

Rate of Administration of Liposomal Cytarabine

Inject slowly over a period of 1–5 minutes.^d

Dosage

Conventional cytarabine: Optimize results and minimize adverse effects by basing dose on clinical and hematologic response, patient tolerance, and other therapy being used.^f

Consult published protocols for dosages used in combination regimens and method and sequence of administration.

Pediatric Patients

The manufacturers make no specific dosage recommendations for pediatric patients; consult published protocols for dosages used in children.^{a b c j}

Adults

Acute Leukemia

Induction with Conventional Cytarabine

IV

Monotherapy: 200 mg/m² daily by continuous IV infusion for 5 days at approximately 2-week intervals.^f

Combination therapy: 2–6 mg/kg daily or 100–200 mg/m² daily by continuous IV infusion or in 2 or 3 divided doses by rapid IV injection or IV infusion for 5–10 days in a course of therapy or daily until a remission is attained.^f

Maintenance with Conventional Cytarabine

Initiate appropriate maintenance therapy after induction of a complete remission.^f

Dosage and schedule vary according to regimen used.^f

IV

70–200 mg/m² daily by rapid IV injection or continuous IV infusion for 2–5 days at monthly intervals.^f

IM† or Sub-Q

1 or 1.5 mg/kg IM at intervals of 1–4 weeks.^f

Refractory or Secondary Acute Leukemia†

Treatment with Conventional Cytarabine

IV

3 g/m² by IV infusion (usually over 1–3 hours) every 12 hours for up to 12 doses has been used.^f

Meningeal Leukemia and Other Meningeal Neoplasms

Treatment and Maintenance with Conventional Cytarabine

Dosage schedule usually determined by the type and severity of CNS manifestations and prior response to therapy.^{a b c j}

Intrathecal

5–75 mg/m² or 30–100 mg administered at frequencies ranging from once every 2–7 days to once daily for 4 or 5 days.^{a b c f j}

Alternatively, 30 mg/m² once every 4 days until CSF findings are normal, followed by 1 additional dose.^{a b c j}

Lymphomatous Meningitis

Induction with Liposomal Cytarabine

Intrathecal

50 mg every 14 days for 2 doses (weeks 1 and 3).^d

Consolidation with Liposomal Cytarabine

Intrathecal

50 mg every 14 days for 3 doses (weeks 5, 7, and 9) followed by 1 additional dose after 28 days (week 13).^d

Maintenance with Liposomal Cytarabine

Intrathecal

50 mg every 28 days for 4 doses (weeks 17, 21, 25, and 29).^d

Refractory Non-Hodgkin’s Lymphomas†

Treatment with Conventional Cytarabine

IV

3 g/m² by IV infusion (usually over 1–3 hours) every 12 hours for up to 12 doses has been used.^f

Dosage Modification for Toxicity

Conventional Cytarabine

Consider suspension or modification of therapy if polymorphonuclear granulocyte count <1000/mm³ or platelet count <50,000/mm³;^{a b c j} however, during remission induction therapy in acute leukemia, the drug usually is administered in a short course and therapy is not discontinued or adjusted based on peripheral blood counts.^f

When indicated, resume therapy when definite signs of marrow recovery appear (on successive bone marrow studies).^{a b c j} Withholding therapy until peripheral blood values normalize may permit escape from control.^{a b c j}

Intrathecal Liposomal Cytarabine

If drug-related neurotoxicity develops, reduce dose to 25 mg.^d If toxicity persists, discontinue therapy.^d

Special Populations

Hepatic Impairment

Conventional Cytarabine

Select dosage with caution.^{a b c j} (See Hepatic Impairment under Cautions.)

Renal Impairment

Conventional Cytarabine

Select dosage with caution.^{a b c j} (See Renal Impairment under Cautions.)

Cautions for DepoCyt

Contraindications

• 
  

  Liposomal or Conventional Cytarabine: Hypersensitivity to cytarabine or any ingredient in the formulation.^{a b c d j}

  
  


• 
  

  Liposomal Cytarabine: Active meningeal infection.^d

  
  

Warnings/Precautions

Warnings

Hematologic Effects

Conventional cytarabine: Potent myelosuppressant.^{a b c j} Initiate with caution in patients with preexisting drug-induced myelosuppression.^{a b c j} Patients must be under close medical supervision and facilities should be available for management of serious complications, possibly fatal, of myelosuppression (e.g., infection resulting from granulocytopenia, hemorrhage secondary to thrombocytopenia).^{a b c j} (See Boxed Warning.)

Risk of increased frequency of infections (e.g., viral, bacterial, fungal), as well as possible hemorrhagic complications; potentially fatal.^{a b c j}

During induction therapy, perform leukocyte and platelet counts daily.^{a b c j} (See Dosage Modification for Toxicity under Dosage and Administration.)

Perform bone marrow examinations frequently after blasts have disappeared from peripheral blood.^{a b c f j} Counts of formed elements in peripheral blood may continue to fall after drug discontinuance and reach lowest values after drug-free intervals of 12–24 days.^{a b c j}

Liposomal cytarabine: Clinically important systemic exposure to unencapsulated cytarabine unlikely following intrathecal administration.^d However, careful hematologic monitoring recommended since myelosuppression cannot be completely ruled out.^d

High-dose Regimens with Conventional Cytarabine

Severe and sometimes fatal CNS, GI, and pulmonary toxicities reported following experimental dosage regimens for refractory or secondary acute leukemia or refractory non-Hodgkin’s lymphomas; differ from reactions seen with regimens employing lower dosages.^{a b c f j}

Cerebral and cerebellar dysfunction (e.g., somnolence, coma, personality changes) reported; usually reversible.^{a b c j} Reversible, acute aseptic meningitis, combined with cerebellar dysfunction, reported in at least 1 patient.²⁰⁵

Peripheral motor and sensory neuropathies have occurred occasionally.^{202 203 204 a b c j}

Patients with renal or hepatic impairment may be at increased risk of CNS toxicity associated with high-dose cytarabine therapy.^{a b c j}

Monitor patients receiving high-dose therapy closely for signs of central or peripheral neurotoxicity.^{202 203 204 a b c j} Dosage schedule adjustment may be necessary to avoid irreversible neurologic toxicity.^{202 a b c j}

Severe GI ulceration (including pneumatosis cystoides intestinalis leading to peritonitis), bowel necrosis, necrotizing colitis, hepatic abscess or hepatic damage with increased hyperbilirubinemia reported.^{a b c j}

Pancreatitis reported in patients previously treated with asparaginase and those receiving high-dose cytarabine therapy.^{212 218 a b c j}

Pulmonary edema reported.^{a b c j} Diffuse interstitial pneumonitis reported occasionally in patients receiving relatively high doses (e.g., 1 g/m²) of cytarabine alone or in combination with other antineoplastic agents.^{213 214 215 216 217 218 219 220 221 a b c j}

A syndrome of acute respiratory distress, rapidly progressing to pulmonary edema and radiographically pronounced cardiomegaly, which was sometimes fatal, has been reported in patients with refractory acute leukemia receiving high-dose therapy.^{a b c j}

Severe skin rash leading to desquamation has been reported rarely.^{a b c j} Complete alopecia occurs more commonly with high-dose regimens.^{a b c j}

Fatal cardiomyopathy reported in patients receiving high-dose cytarabine in combination with cyclophosphamide in preparation for bone marrow transplantation; this cardiac toxicity may be schedule dependent.^{a b c j}

Hemorrhagic conjunctivitis and reversible corneal toxicity (e.g., keratitis) reported; may be minimized or prevented by prophylaxis with ophthalmic corticosteroid preparations.^{a b c j}

Intrathecal Administration of Conventional Cytarabine

Possible systemic toxicity; carefully monitor hematologic status.^{a b c j} Dosage adjustment of concurrently administered antineoplastic agents may be necessary.^{a b c j}

Concurrent (within a few days) IV chemotherapy or cranial/spinal irradiation and intrathecal treatment with conventional cytarabine may be associated with increased risk of neurotoxicity (e.g., spinal cord toxicity).^{a b c d j}

Progressive ascending paralysis reported.^{200 a b c j} Occurred in 2 children 4–6 months after intrathecal and IV therapy with conventional cytarabine at usual doses in combination with other drugs and CNS irradiation; fatal in one patient.^{200 a b c j}

Permanent neurologic deficits reported rarely.^d

Intrathecal Administration of Liposomal Cytarabine

Observe closely for acute toxic reactions.^d

Neurotoxicity may occur after a single dose or repeated administration; most likely to occur within 5 days of intrathecal administration.^d Monitor continuously and reduce subsequent doses if neurotoxicity occurs; discontinue if neurotoxicity persists.^d CSF flow obstruction may result in increased CSF concentrations and increased risk of neurotoxicity.^d (See Dosage Modification for Toxicity under Dosage and Administration.)

At least 2 fatalities attributed to liposomal cytarabine have occurred.^d One patient died after developing encephalopathy 36 hours after receiving intraventricular liposomal cytarabine;^{d i} the other patient developed focal seizures that progressed to status epilepticus and died approximately 8 weeks after the last intraventricular dose of liposomal cytarabine.^d

Possible increased risk of adverse events in patients receiving concurrent radiation or chemotherapy.^d

Chemical Arachnoiditis Related to Liposomal Cytarabine

Common complication of intrathecal liposomal cytarabine; in clinical studies, generally occurred ≤48 hours after intrathecal administration.^{d i}

Defined in clinical studies as occurrence of any 1 of certain manifestations (i.e., neck rigidity, neck pain, meningism) or any 2 of the following: nausea, vomiting, headache, fever, back pain, or CSF pleocytosis.^{d i}

Administer dexamethasone to ameliorate symptoms and reduce incidence.^{d i} (See Intrathecal Administration under Dosage and Administration and also Chemical Arachnoiditis in Boxed Warning.)

Benzyl Alcohol

Do not use conventional cytarabine injection solution containing benzyl alcohol in neonates.^{a b c j f} Do not use diluents containing benzyl alcohol to reconstitute or dilute conventional cytarabine for use in neonates.^{a b c j} Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity in neonates.^{a b c f j}

Do not use conventional cytarabine injection solution containing benzyl alcohol for intrathecal administration.^{a b c} Do not use diluents containing benzyl alcohol to reconstitute conventional cytarabine for intrathecal administration.^j

Because of potential neurotoxicity, conventional cytarabine injection solution containing benzyl alcohol or cytarabine powder reconstituted or diluted with diluents containing benzyl alcohol should not be used for high-dose regimens.^{a b c j}

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; upper and lower distal limb defects, extremity and ear deformities, low birth weight, premature delivery, and adverse hematologic effects reported.^{a b c d j}

Avoid pregnancy during therapy with conventional or liposomal cytarabine; especially avoid cytarabine use during first trimester.^{a b c d j} If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.^{a b c d j} Follow-up monitoring of infants exposed to cytarabine in utero is advised.^{a b c j}

Sensitivity Reactions

Anaphylaxis

At least one case of anaphylaxis that resulted in acute cardiopulmonary arrest and required resuscitation has been reported after IV administration of conventional cytarabine.^d

General Precautions

Cytarabine (Ara-C) Syndrome

Cytarabine syndrome reported; may manifest as fever, myalgia, bone pain, maculopapular rash, conjunctivitis, malaise, and occasionally chest pain.^{a b c j} Generally occurs 6–12 hours after administration of conventional cytarabine.^{a b c j}

Corticosteroids are beneficial in treatment and prevention.^{a b c j} If symptoms require treatment, consider administration of corticosteroids, as well as continuation of conventional cytarabine therapy.^{a b c j}

GI Effects

Nausea and vomiting are more frequent and severe following rapid IV administration of conventional cytarabine than with continuous IV infusion.^{a b c j}

Pancreatitis

Pancreatitis reported in patients receiving conventional cytarabine and in those previously treated with asparaginase.^{a b c j} (Also see High-dose Regimens with Conventional Cytarabine under Cautions.)

Hyperuricemia

Hyperuricemia may occur in patients receiving conventional cytarabine because of extensive purine catabolism accompanying rapid cellular destruction.^{a b c f j}

Monitor serum uric acid concentrations in patients receiving conventional cytarabine.^{a b c j} Hyperuricemia may be minimized or prevented by adequate hydration, alkalinization of urine, and/or administration of allopurinol.^{a b c f j}

Alterations in CSF

Transient increases in CSF protein concentration and WBC counts reported in patients following intrathecal administration of liposomal or conventional cytarabine.^d

Specific Populations

Pregnancy

Category D.^{a b c d j} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether cytarabine is distributed into milk; discontinue nursing or the drug.^{a b c d j}

Pediatric Use

Do not use conventional cytarabine injection solution or diluents containing benzyl alcohol in neonates.^{b 250} (See Benzyl Alcohol under Cautions.)

Safety and efficacy of liposomal cytarabine not established in children.^d

Hepatic Impairment

Use with caution; increased risk of CNS toxicity after high-dose therapy with conventional cytarabine because of decreased clearance.^{a b c j} Assess hepatic function prior to and periodically during prolonged therapy.^{a b c j}

Renal Impairment

Use with caution; increased risk of CNS toxicity after high-dose therapy with conventional cytarabine because of decreased clearance.^{a b c j} Assess renal function prior to and periodically during prolonged therapy.^{a b c j}

Common Adverse Effects

IV, sub-Q, or IM administration of conventional cytarabine: Myelosuppression, anorexia, nausea, vomiting, diarrhea, oral and anal inflammation or ulceration, hepatic dysfunction, fever, rash, thrombophlebitis, bleeding (all sites).^{a b c j}

Intrathecal administration of conventional cytarabine: Nausea, vomiting, fever, transient headaches.^{a b c d f j}

Intrathecal administration of liposomal cytarabine: Chemical arachnoiditis (neck rigidity, neck pain, meningism, nausea, vomiting, headache, fever, back pain, and/or CSF pleocytosis), asthenia, pain, confusion, somnolence.^{d i}

Interactions for DepoCyt

No formal drug interaction studies conducted with liposomal cytarabine to date.^d

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Antineoplastic agents, intrathecally administered	Possible enhanced neurotoxicity when intrathecal conventional cytarabine used concomitantly with other intrathecal cytotoxic agentsd	Concomitant intrathecal use of liposomal cytarabine and other antineoplastic agents not studiedd
Digoxin	GI absorption of oral digoxin tablets may be substantially reduced when used concomitantly with conventional cytarabine207 208 a b c j	Monitor plasma digoxin concentrations closely; use of digoxin oral elixir or liquid-filled capsules may improve absorption207 208 210 a b c j
Flucytosine	Possible inhibition of anti-infective activity by competitive inhibition of uptake by fungi when flucytosine was used concomitantly with conventional cytarabinea b c j
Gentamicin	In vitro evidence of inhibition of antibacterial activity against Klebsiella pneumoniae with conventional cytarabine211 a b c j	Monitor closely; if therapeutic response is not achieved, reevaluate anti-infective therapy211 a b c j
Test, for WBC in CSF	Liposomal cytarabine vesicles are similar in size and appearance to WBC d	Interpret CSF analysis with care d

DepoCyt Pharmacokinetics

Absorption

Bioavailability

Conventional cytarabine: <20% of dose is absorbed after oral administration; not effective when administered orally.^{a b c j}

Conventional cytarabine: Continuous IV infusions produce relatively constant plasma concentrations of the drug in 8–24 hours.^{a b c f j}

Following sub-Q or IM injection of radioactively labeled conventional cytarabine, peak plasma concentrations of radioactivity occur within 20–60 minutes and are considerably lower than those attained after IV administration.^{a b c j}

Liposomal cytarabine: Negligible systemic exposure expected after intrathecal administration.^d

Liposomal cytarabine: Limited data indicate peak cytarabine concentrations occur within 5 hours in both ventricle and lumbar sac after intrathecal administration into lumbar sac or by intraventricular reservoir.^{d i}

Distribution

Extent

Conventional cytarabine: Rapidly and widely distributed into tissues and fluids, including liver, plasma, and peripheral granulocytes;^{a b c f j} crosses blood-brain barrier to a limited extent.^{a b c i j}

Conventional cytarabine: CSF concentrations are higher during continuous IV or sub-Q infusion than after rapid IV injection and are approximately 40–60% of plasma concentrations.^{a b c f j}

Conventional cytarabine: Apparently crosses placenta;^{a b}

Dayquil Pressure and Pain Caplet

Generic Name: ibuprofen and pseudoephedrine (EYE bue pro fen and SOO doe ee FED rin)

Brand Names: Advil Cold & Sinus, Advil Cold and Sinus Liqui-Gel, Children's Ibuprofen Cold Relief, Dristan Sinus, Motrin Childrens Cold

What is Dayquil Pressure and Pain Caplet (ibuprofen and pseudoephedrine)?

Ibuprofen is nonsteroidal anti-inflammatory drugs (NSAID) that reduces hormones that cause inflammation and pain in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of ibuprofen and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

Ibuprofen and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Dayquil Pressure and Pain Caplet (ibuprofen and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) within the past 14 days.

Ibuprofen may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use this medication just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Ibuprofen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking ibuprofen, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds. Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines.

What should I discuss with my doctor before taking Dayquil Pressure and Pain Caplet (ibuprofen and pseudoephedrine)?

Do not use this medication just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Ibuprofen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking ibuprofen, especially in older adults.

Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to ibuprofen or pseudoephedrine, or if you have:

• 
  

  a stomach ulcer or active bleeding in your stomach or intestines;

  
  


• 
  

  polyps in your nose; or

  
  


• 
  

  a history of allergic reaction to aspirin or other NSAIDs.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  a history of stomach ulcers or bleeding;

  
  


• 
  

  heart disease, congestive heart failure, high blood pressure;

  
  


• 
  

  systemic lupus erythematosus (SLE);

  
  


• liver or kidney disease;


• 
  

  a thyroid disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  enlarged prostate or problems with urination;

  
  


• 
  

  a bleeding or blood clotting disorder; or

  
  


• 
  

  if you smoke.

  
  

Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not take this medication without medical advice if you are pregnant. It is not known whether ibuprofen and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Dayquil Pressure and Pain Caplet (ibuprofen and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

An overdose of ibuprofen can damage your stomach or intestines. Adults should not take more than 800 milligrams per dose or 3200 mg per day (4 maximum doses).

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medication for 7 days.

If you need surgery, tell the surgeon ahead of time that you are using ibuprofen and pseudoephedrine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, stomach pain, dizziness, feeling restless or nervous, blurred vision, sweating, breathing problems, or seizure (convulsions).

What should I avoid while taking Dayquil Pressure and Pain Caplet (ibuprofen and pseudoephedrine)?

Ask a doctor or pharmacist before using any other cough, cold, or pain medicine. Ibuprofen and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains ibuprofen or pseudoephedrine. Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Dayquil Pressure and Pain Caplet (ibuprofen and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  
  


• 
  

  bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  dangerously high blood pressure (severe headache, buzzing in your ears, confusion, chest pain, shortness of breath);

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  skin rash, severe tingling, numbness, pain, muscle weakness; or

  
  


• 
  

  fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  upset stomach, nausea, heartburn, diarrhea, constipation;

  
  


• 
  

  bloating, gas, loss of appetite;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  dizziness, headache, feeling excited or restless;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  mild itching or skin rash.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Dayquil Pressure and Pain Caplet (ibuprofen and pseudoephedrine)?

Tell your doctor about all other medicines you use, especially:

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  diuretics (water pills), or medicines to treat high blood pressure;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others; or

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with ibuprofen and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Dayquil Pressure and Pain Caplet resources

• Dayquil Pressure and Pain Caplet Use in Pregnancy & Breastfeeding
• Dayquil Pressure and Pain Caplet Drug Interactions
• Dayquil Pressure and Pain Caplet Support Group
• 3 Reviews for Dayquil Pressure and Pain Caplet - Add your own review/rating

Compare Dayquil Pressure and Pain Caplet with other medications

• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about ibuprofen and pseudoephedrine.

Differin

Generic Name: Adapalene
Class: Skin and Mucous Membrane Agents, Miscellaneous
VA Class: DE752
Chemical Name: 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Molecular Formula: C₂₈H₂₈O₃
CAS Number: 106685-40-9

Introduction

Retinoid; synthetic naphthoic acid-derivative.^{7 8 10 11 12 13 14 15 16 17 18 19 20 22}

Uses for Differin

Acne Vulgaris

Treatment of acne vulgaris.^{1 4 5 6 7 11 12 13 14 16 17 18 19 20 21 22 31 32}

Differin Dosage and Administration

Administration

Topical Administration

Apply a thin film to skin as a cream, gel, or solution.^{1 4 5 7 11 12 13 16 17 18 19 20 21 22 31 32}

Cleanse and dry the affected areas prior to application.^{1 31 32}

Do not apply to eye(s), lips, angles of nose, or mucous membranes.^{1 31 32}

A transient feeling of pruritus or burning may occur immediately after application.^{1 12 31 32} If increased sensitivity or irritation occurs, reduce frequency of application or, depending on the severity, discontinue use.^{1 31 32}

Apparent exacerbation of acne that may occur during early weeks of therapy is attributable to the drug’s action on previously unseen lesions; do not discontinue.^{1 31 32}

Excessive use does not increase therapeutic effects and may produce marked erythema, peeling, and discomfort.^{1 31 32}

Pledgets

Remove single-use pledget applicators from foil immediately before use, use once, and then discard; do not use if seal is broken.³¹

Dosage

Pediatric Patients

Acne Vulgaris

Topical

Children and adolescents ≥12 years of age: Apply once daily in the evening at bedtime.^{1 12 31 32}

Improvement usually detectable within 8–12 weeks.^{1 31 32}

Adults

Acne Vulgaris

Topical

Apply once daily in the evening at bedtime.^{1 12 31 32}

Improvement usually detectable within 8–12 weeks.^{1 31 32}

Prescribing Limits

Pediatric Patients

Acne Vulgaris

Topical

Children and adolescents ≥12 years of age: most reported experience to date has been for treatment periods that did not exceed 12 weeks.^{4 5 6 12 22}

Adults

Acne Vulgaris

Topical

Most reported experience to date has been for treatment periods that did not exceed 12 weeks.^{4 5 6 12 22}

Cautions for Differin

Contraindications

• 
  

  Known hypersensitivity to adapalene or any ingredient in the formulation.^{1 31 32}

  
  

Warnings/Precautions

Sensitivity Reactions

Photosensitivity

Increased risk for sunburn; minimize exposure to sunlight or artificial UV irradiation sources (e.g., sunlamps).^{1 31 32}

Use caution in patients subjected to considerable occupational sun exposure or with inherent sun sensitivity; use of sunscreen products (SPF 15 or greater) and protective clothing over treated areas recommended when exposure cannot be avoided.^{1 31 32}

Avoid concomitant use of photosensitizing agents.³³ (See Interactions.)

Use not recommended in patients with sunburn until full recovery occurs.^{1 31}

Other Sensitivity Reactions

Discontinue therapy if sensitivity reaction or chemical irritation occurs.^{1 31 32}

General Precautions

Dermatologic Effects

Erythema, dryness, scaling, burning, or pruritus may occur.^{1 31 32} If increased sensitivity or irritation occurs, use less frequently or, depending on the severity of the reaction, discontinue.^{1 31 32}

Do not apply to cuts, abrasions, or eczematous or sunburned skin.^{1 31 32} (See Photosensitivity under Cautions.)

Facial Cleansing

Use of mild or soapless cleanser is recommended; use medicated or drying soaps and abrasive soaps and cleansers with caution.^{1 31 32}

Cosmetic Agents or Processes

Avoid use of irritating cosmetics, other preparations, or processes (e.g., electrolysis) that might dry or irritate the skin.³³ (See Interactions.)

Environmental Stimuli

Possible increased skin irritation in patients exposed to environmental extremes (e.g., wind, cold).^{1 31 32}

Dry Skin

Use moisturizers if necessary; avoid preparations containing alpha hydroxy or glycolic acids.³²

Specific Populations

Pregnancy

Category C.^{1 31 32}

Lactation

Not known whether adapalene is distributed into milk.^{1 31 32} Use caution.^{1 31 32}

Pediatric Use

Safety and efficacy not established in children <12 years of age.^{1 31 32}

Geriatric Use

Insufficient experience in controlled clinical studies in patients ≥65 years of age to determine whether geriatric patients respond differently to adapalene than younger adults.³² However, clinical experience generally has not revealed age-related differences.³²

Common Adverse Effects

Erythema, scaling, dryness, pruritus, burning/stinging.^{1 31 32}

Interactions for Differin

Specific Drugs

Drug	Interaction	Comments
Keratolytic agents (e.g., resorcinol, salicylic acid, sulfur)	Possible additive effects1 31 32	Allow sufficient time for the effects of the keratolytic agent to subside before initiating adapalene1 31 32
Photosensitizing agents (e.g., fluoroquinolone anti-infectives, phenothiazines, sulfonamides, thiazide diuretics)	Possible increased phototoxicity33	Avoid concomitant use33

Other Topical Preparations

Potential pharmacodynamic interaction (increased skin irritation).^{1 31 32} Avoid concurrent use of topical preparations with high concentrations of alcohol, menthol, spices, or lime (e.g., lotions, astringents, perfume); irritating cosmetics (e.g., toners, peeling [desquamating] agents); permanent wave solutions; or hair depilatories or waxes.^{1 31 32 33}

Differin Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following topical application.^{1 31 32}

Elimination

Elimination Route

Eliminated principally by biliary excretion.^{1 31 32}

Stability

Storage

Topical

Cream, Gel, Solution

20–25°C.^{1 31 32}

Protect cream from freezing.³²

Store solution upright in tight container.³¹

ActionsActions

• 
  

  Actions similar to those of other retinoids (e.g., isotretinoin, tretinoin) but more potent anti-inflammatory activity in vitro and in vivo.^{1 4 5 6 9 13 15 16 17 19 23 24 31}

  
  


• 
  

  Relatively selective affinity for specific nuclear retinoic acid receptor (RAR) proteins (e.g., RARβ, RARγ) that appear to enhance gene transcription.^{5 6 7 23 24}

  
  


• 
  

  Exact mechanism(s) of action not elucidated.^{1 4 5 6 9 13 15 16 17 19 31} Appears to affect expression of genes that modulate follicular keratinization^{5 19 22} and cell (e.g., epithelial) differentiation,^{1 4 5 6 9 10 13 15 19 22 23 31} which result in inhibition of corneocyte accumulation and cohesion and reduction in inflammatory and noninflammatory acne lesions.^{1 6 11 12 22 23 24 31}

  
  

Advice to Patients

• 
  

  Importance of clinicians instructing patients about proper use of the drug.^{1 31 32}

  
  


• 
  

  Importance of continuing therapy in early weeks, even if acne initially appears to worsen.^{1 31 32}

  
  


• 
  

  Risk of photosensitivity; importance of using sunscreens and wearing protective clothing over treated areas.^{1 31 32}

  
  


• 
  

  Importance of avoiding contact with eyes, lips, angles of nose, or mucous membranes.^{1 31 32}

  
  


• 
  

  Importance of not applying adapalene to cuts, abrasions, or eczematous or sunburned skin.^{1 31 32}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.^{1 31 32}

  
  


• 
  

  Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{1 31 32}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 31 32} (See Cautions.)

  
  

Preparations

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

Adapalene

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Cream	0.1%	Differin (with parabens)	Galderma
	Gel	0.1%	Differin (with methylparaben and propylene glycol)	Galderma
	Pledgets (saturated with solution)	0.1%	Differin (with SD alcohol 40-B 30% w/v)	Galderma
	Solution	0.1%	Differin (with SD alcohol 40-B 30% w/v)	Galderma

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Differin 0.1% Cream (GALDERMA): 45/$280 or 135/$829.96

Differin 0.1% Gel (GALDERMA): 45/$280 or 135/$829.96

Differin 0.3% Gel (GALDERMA): 45/$222 or 135/$630.01

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Galderma. Differin (adapalene) gel 0.1% prescribing information. Fort Worth, TX; 1996 May.

2. Hurwitz S. Acne vulgaris: current concepts of pathogenesis and treatment. Am J Dis Child. 1979; 133:536-44. [PubMed 155397]

3. Chandraratna RAS. Tazarotene—first of a new generation of receptor-selective retinoids. Br J Dermatol. 1996; 135:18-25.

4. Verschoore M, Langner A, Wolska H et al. Efficacy and safety of CD 271 alcoholic gels in the topical treatment of acne vulgaris. Br J Dermatol. 1991; 124:368-71. [IDIS 280987] [PubMed 1827344]

5. Shalita A, Weiss JS, Chalker DK et al. A comparison of the efficacy and safety of adapalene gel 0.1% and tretinoin gel 0.025% in the treatment of acne vulgaris: a multicenter trial. J Am Acad Dermatol. 1996; 34:482-5. [IDIS 364859] [PubMed 8609263]

6. Bernard BA. Adapalene, a new chemical entity with retinoid activity. Skin Pharmacol. 1993; 6(Suppl 1):61-9. [PubMed 8142113]

7. Griffiths CEM, Elder JT, Bernard BA et al. Comparison of CD271 (Adapalene) and all- trans retinoic acid in human skin: dissociation of epidermal effects and CRABP-II mRNA expression. J Invest Dermatol. 1993; 101:325-28. [PubMed 8396608]

8. Jamoulle JC, Grandjean L, Lamaud E et al. Follicular penetration and distribution of topically applied CD 271, a new naphthoic acid derivative intended for topical acne treatment. J Invest Dermatol. 1990; 94:731-2. [PubMed 2139085]

9. Hensby C, Cavey D, Bouclier M et al. The in vivo and in vitro anti- inflammatory activity of CD271: a new retinoid-like modulator of cell differentiation. Agents Actions. 1990; 29:56-8. [PubMed 2109510]

10. Bernerd F, Ortonne JP, Bouclier M et al. The rhino mouse model: the effects of topically applied all-trans retinoic acid and CD271 on the fine structure of the epidermis and utricle wall of pseudocomedones. Arch Dermatol Res. 1991; 283:100-7. [PubMed 2069410]

11. Leyden JJ. Therapy for acne vulgaris. N Engl J Med. 1997; 336:1156-62. [IDIS 388309] [PubMed 9099661]

12. Brogden RN, Goa KL. Adapalene: a review of its pharmacological properties and clinical potential in the management of mild to moderate acne. Drugs. 1997; 53:511-9. [PubMed 9074847]

13. Verschoore M. Adapalene: a novel topical retinoid receptor agonist for acne—overview. J Am Acad Dermatol. 1997; 36:S91.

14. Kligman AM. The treatment of acne with topical retinoids: one man’s opinions. J Am Acad Dermatol. 1997; 36:S92-5.

15. Shroot B, Michel S. Pharmacology and chemistry of adapalene. J Am Acad Dermatol. 1997; 36:S96-103. [PubMed 9204085]

16. Verschoore M, Poncet M, Czernielewski J et al. Adapalene 0.1% gel has low skin- irritation potential. J Am Acad Dermatol. 1997; 36:S104-9.

17. Caron D, Sorba V, Kerrouche N et al. Split-face comparison of adapalene 0.1% gel and tretinoin 0.025% gel in acne patients. J Am Acad Dermatol. 1997; 36:S110-12. [IDIS 389401] [PubMed 9204087]

18. Caron D, Sorba V, Clucas A et al. Skin tolerance of adapalene 0.1% gel in combination with other topical antiacne treatments. J Am Acad Dermatol. 1997; 36:S113-5.

19. Clucas A, Verschoore M, Sorba V et al. Adapalene 0.1% gel is better tolerated than tretinoin 0.025% gel in acne patients. J Am Acad Dermatol. 1997; 36:S116-8.

20. Allec J, Chatelus A, Wagner N. Skin distribution and pharmaceutical aspects of adapalene gel. J Am Acad Dermatol. 1997; 36:S119-25. [PubMed 9204090]

21. Cunliffe WJ, Caputo R, Dreno B et al. Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials. J Am Acad Dermatol. 1997; 36:S126-34. [IDIS 389404] [PubMed 9204091]

22. Anon. Adapalene for acne. Med Lett Drugs Ther. 1997; 39:19-20. [PubMed 9057779]

23. Thiboutot DM. Acne: an overview of clinical research findings. Dermatol Clin. 1997; 15:97-109. [PubMed 9001864]

24. Gibson JR. Rationale for the development of new topical treatments for acne vulgaris. Cutis. 1996; 57:13-9. [PubMed 8654127]

25. Anon. Update on birth defects with isotretinoin. FDA Drug Bull. 1984; 14:15-6. [PubMed 6592122]

26. Benke PJ. The isotretinoin teratogen syndrome. JAMA. 1984; 251:3267-9. [IDIS 186330] [PubMed 6587131]

27. de la Cruz E, Sun S, Vangvanichyakorn K et al. Multiple congenital malformations associated with maternal isotretinoin therapy. Pediatrics. 1984; 74:428-30. [IDIS 189774] [PubMed 6591112]

28. Lammer EJ, Chen DT, Hoar RM et al. Retinoic acid embryopathy. N Engl J Med. 1985; 313:837-41. [IDIS 204599] [PubMed 3162101]

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31. Galderma. Differin (adapalene) solution 0.1% prescribing information. Fort Worth, TX; 1997 Jul.

32. Galderma Laboratories. Differin cream 0.1% (adapalene) prescribing information. Fort Worth, TX; 2000 May.

33. Galderma Laboratories, Fort Worth, TX: Personal Communication.

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