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Dexmethylphenidate

Pronunciation: dex-METH-il-FEN-i-date
Generic Name: Dexmethylphenidate
Brand Name: Focalin

Use Dexmethylphenidate with caution if you have a history of emotional problems or alcohol or substance abuse. Abuse of Dexmethylphenidate may cause it to not work as well. Abuse may also lead to addiction and severe mental changes. Do not suddenly stop using Dexmethylphenidate. Depression or other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.

Dexmethylphenidate is used for:

Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

Dexmethylphenidate is a central nervous system stimulant. Exactly how it works is not known.

Do NOT use Dexmethylphenidate if:

you are allergic to any ingredient in Dexmethylphenidate or to methylphenidate

you have severe anxiety, agitation, or tension

you have glaucoma

you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome

you have serious heart problems (eg, heart defect, irregular heartbeat)

you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

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

Before using Dexmethylphenidate:

Some medical conditions may interact with Dexmethylphenidate. 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 a history of high blood pressure, heart problems (eg, heart failure, fast or irregular heartbeat), or recent heart attack, or if a family member has a history of irregular heartbeat or sudden death

if you have a history of seizures or abnormal electroencephalograms (EEGs)

if you have a history of overactive thyroid or chronic fatigue

if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems

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

MAOIs (eg, phenelzine) because severe high blood pressure may occur

Clonidine because serious side effects may occur

Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Dexmethylphenidate

Medicines for high blood pressure (eg, guanethidine, metoprolol) because their effectiveness may be decreased by Dexmethylphenidate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dexmethylphenidate 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 Dexmethylphenidate:

Use Dexmethylphenidate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Dexmethylphenidate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dexmethylphenidate refilled.

Take Dexmethylphenidate by mouth with or without food.

Take your doses at least 4 hours apart unless your doctor tells you otherwise.

You may have trouble sleeping while taking Dexmethylphenidate. If this occurs, taking your last dose earlier in the day may help. Check with your doctor before you change the way that you take Dexmethylphenidate. If trouble sleeping continues, talk with your doctor.

If you miss a dose of Dexmethylphenidate, 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 Dexmethylphenidate.

Important safety information:

Dexmethylphenidate may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Dexmethylphenidate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do NOT take more than the recommended dose without checking with your doctor.

If your symptoms do not get better within 1 month or if they get worse, check with your doctor.

Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or another serious problem, talk with your doctor about other therapies to treat your condition.

Tell your doctor or dentist that you take Dexmethylphenidate before you receive any medical or dental care, emergency care, or surgery.

Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Dexmethylphenidate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Dexmethylphenidate may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Dexmethylphenidate.

Caution is advised when using Dexmethylphenidate in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.

Dexmethylphenidate should not be used in CHILDREN younger than 6 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 Dexmethylphenidate while you are pregnant. It is not known if Dexmethylphenidate is found in breast milk. If you are or will be breast-feeding while you use Dexmethylphenidate, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Dexmethylphenidate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Dexmethylphenidate stops working well. Do not take more than prescribed.

Some people who use Dexmethylphenidate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Dexmethylphenidate. If you stop taking Dexmethylphenidate suddenly, you may have WITHDRAWAL symptoms. These may include depression or other mental problems.

Possible side effects of Dexmethylphenidate:

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:

Dizziness; drowsiness; headache; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping.

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; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility, restlessness); blurred vision or other vision problems; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression, irritability, panic attacks, persistent crying, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

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: Dexmethylphenidate 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. Symptoms may include confusion; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; muscle twitching; seizures; severe or persistent headache or vomiting; tremors; unusual sweating.

Proper storage of Dexmethylphenidate:

Store Dexmethylphenidate 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 Dexmethylphenidate out of the reach of children and away from pets.

General information:

If you have any questions about Dexmethylphenidate, please talk with your doctor, pharmacist, or other health care provider.

Dexmethylphenidate is 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 Dexmethylphenidate. 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

More Dexmethylphenidate resources

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

Dexmethylphenidate Prescribing Information (FDA)

dexmethylphenidate Advanced Consumer (Micromedex) - Includes Dosage Information

Dexmethylphenidate Hydrochloride Monograph (AHFS DI)

Focalin Consumer Overview

Focalin Prescribing Information (FDA)

Focalin XR Prescribing Information (FDA)

Compare Dexmethylphenidate with other medications

ADHD
Auditory Processing Disorder

Doxepin Hydrochloride

Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors
VA Class: CN601
Chemical Name: 1-Propamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride
Molecular Formula: C₁₉H₂₁NO HCL
CAS Number: 1229-29-4
Brands: Sinequan

Suicidality

Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.^h ⁱ Doxepin is not approved for use in pediatric patients <12 years of age.^a ^k ^l (See Pediatric Use under Cautions.)

In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.^h ⁱ

Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.^h ⁱ ^j

Appropriately monitor and closely observe all patients who are started on doxepin therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.^h ⁱ ^j (See Worsening of Depression and Suicidality Risk and Pediatric Use under Cautions.)

REMS:

FDA approved a REMS for doxepin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of doxepin and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Dibenzoxepin-derivative tricyclic antidepressant (TCA).^a ^b ^c ^k ^l ^p

Uses for Doxepin Hydrochloride

Depressive and Anxiety Disorders

Treatment of depression and/or anxiety in psychoneurotic patients.^a ^k ^l Psychoneurosis symptoms that respond well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension, and worry.^a ^k ^l

Treatment of depression and/or anxiety associated with alcoholism.^a ^k ^l (See Specific Drugs under Interactions.)

Treatment of depression and/or anxiety associated with organic disease; consider possible drug interactions if receiving other drugs concomitantly.^a ^k ^l

Treatment of psychotic depressive disorders with associated anxiety, including involutional depression and manic-depressive disorders.^a ^k ^l

Chronic Idiopathic Urticaria

Has been effective in the management of chronic idiopathic urticaria† and may be used as an alternative to antihistamines, which are generally considered first-line therapy in patients with this condition.ⁿ ^o ^v ^w

Doxepin Hydrochloride Dosage and Administration

General

Depressive and Anxiety Disorders

Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of doxepin and vice versa.^a ^c ^k ^l Also allow at least 5 weeks to elapse when switching from fluoxetine.^a ^c ^k ^l

Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.^a ^h ⁱ ^j ^k (See Worsening of Depression and Suicidality Risk under Cautions.)

Avoid abrupt discontinuance of therapy in patients receiving high dosages for prolonged periods.^a ^c ^k ^l To avoid withdrawal reactions, taper dosage gradually.^a ^k ^l (See Withdrawal of Therapy under Cautions.)

Administration

Oral Administration

Administer orally in up to 3 divided doses or as a single daily dose (if ≤150 mg); may administer once-daily doses at bedtime to reduce daytime sedation.^a ^b ^k ^l

Dilute each dose of oral concentrate with 120 mL of water, whole or skim milk, or orange, grapefruit, tomato, prune, or pineapple juice just prior to administration; solution is physically incompatible with many carbonated beverages.^a ^b Patients on methadone maintenance may mix doxepin oral concentrate and methadone syrup with Gatorade, lemonade, orange juice, sugar water, Tang, or water but not with grape juice.^a ^b Bulk dilution and storage not recommended by manufacturer.^a

Dosage

Available as doxepin hydrochloride; dosage expressed in terms of doxepin.^a ^b ^k ^l

Individualize dosage carefully according to individual requirements and response.^a ^b ^k ^l

When administered as a single daily dose, the maximum daily dose recommended is 150 mg.^a ^k ^l Commercially available 150-mg capsules of doxepin are intended for maintenance therapy only and are not recommended for initial therapy.^a ^b ^k

Pediatric Patients

Depressive and Anxiety Disorders

Oral

Adolescents ≥12 years of age should receive dosage recommended for adults.^a ^k ^l (See Adults under Dosage.)

Adults

Depressive and Anxiety Disorders

Oral

Patients with illness of mild to moderate severity: Initially, 75 mg daily.^a ^b ^k ^l May adjust dosage as necessary based on response.^a ^k ^l Usual maintenance dosage: 75–150 mg daily.^a ^k ^l

More seriously ill patients: Higher dosages may be necessary; gradually increase dosage to ≤300 mg daily, if necessary.^a ^k ^l

Dosages >300 mg daily rarely provide additional therapeutic effect.^a ^b ^k ^l

Patients with very mild symptomatology or emotional symptoms associated with organic brain syndrome: Lower dosages may be adequate; some patients respond to 25–50 mg daily.^a ^b ^k ^l

Prescribing Limits

Pediatric Patients

Depressive and Anxiety Disorders

Oral

Adolescents ≥12 years of age: Maximum 300 mg daily.^a ^b ^k ^l

Adults

Oral

Maximum 300 mg daily.^a ^b ^k ^l

Special Populations

Geriatric Patients

Select dosage at the lower end of recommended range since decreased hepatic, renal, or cardiac function and concomitant illness and medications are more frequent; increase dosage more gradually and monitor closely.^a ^k ^l May administer before bedtime.^a (See Geriatric Use under Cautions.)

Cautions for Doxepin Hydrochloride

Contraindications

Although the manufacturers do not state that doxepin is contraindicated in patients receiving MAO inhibitors, concurrent or recent (i.e., within 2 weeks) therapy with MAO inhibitors generally is contraindicated in patients receiving TCAs. ^a ^c ^k ^l (See MAO Inhibitors under Interactions.)

Glaucoma or urinary retention.^a ^k ^l

Known hypersensitivity to doxepin or other dibenzoxepin-derivative TCAs.^a ^k ^l

Warnings/Precautions

Warnings

Shares the toxic potentials of other TCAs; observe the usual precautions of TCA therapy.^a ^b ^c ^k ^l

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.^g ^h ⁱ ^j However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.^h ⁱ ^j

Appropriately monitor and closely observe patients receiving doxepin for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.^h ⁱ ^j (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.ⁱ ^j Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.^h ⁱ ^j (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.^a ^c ^d ⁱ ^k ^l

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder [OCD]) or nonpsychiatric disorders.ⁱ

Bipolar Disorder

May unmask bipolar disorder.ⁱ (See Activation of Mania or Hypomania under Cautions.) Doxepin is not approved for use in treating bipolar depression.^k ^l

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.^a ⁱ ^k ^l

Sensitivity Reactions

Possible sensitivity reactions including skin rash, photosensitization, edema, and pruritus.^a ^k

General Precautions

Activation of Mania or Hypomania

Possible activation of mania and hypomania, particularly in patients with bipolar disorder; decrease dosage and/or administer an antipsychotic agent concomitantly.^a ^c ^k ^l (See Bipolar Disorder under Cautions.)

Cognitive/Physical Impairment

Mental alertness or physical coordination required for performing hazardous tasks (e.g., driving, operating machinery) may be impaired.^a ^c ^k ^l

Response to alcohol may be potentiated.^a ^c ^k ^l

Anticholinergic Effects

Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased IOP).^a ^c ^k ^l (See Contraindications under Cautions.)

Withdrawal of Therapy

Possibly severe withdrawal reactions; avoid abrupt discontinuance of therapy and taper dosage gradually.^a ^c ^k ^l

Psychosis

Possible exacerbation of psychosis in patients with schizophrenia; decrease dosage or administer an antipsychotic agent concomitantly.^a ^c ^k ^l

Specific Populations

Pregnancy

Category C.^e

Lactation

Distributes into milk;¹⁰⁰ ¹⁰¹ ^a ^c ^e ^k ^l ^r ^s some clinicians recommend that breast-feeding be avoided during doxepin therapy.^e ^r ^s

Pediatric Use

Safety of doxepin in pediatric patients <12 years of age has not been established.^a ^c ^k ^l

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).^a ⁱ ^k However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.^g No suicides occurred in these pediatric trials.^a ^g ⁱ ^k

Carefully consider these findings when assessing potential benefits and risks of doxepin in a child or adolescent for any clinical use.^a ^g ^h ⁱ ^j ^k ^l (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^a ^k ^l

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.^h ⁱ (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Doxepin generally is well tolerated in geriatric patients.^a ^k ^l Possible increased sensitivity to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, orthostatic hypotension, and sedative effects of TCAs.^k ^l

Titrate dosage carefully.^a ^k ^l (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Drowsiness, anticholinergic effects (e.g., dry mouth, constipation, blurred vision), GI effects (e.g., nausea, vomiting, diarrhea).^a ^c ^k ^l ^m ⁿ ^o

Interactions for Doxepin Hydrochloride

Metabolized in the liver by various CYP isoenzymes (e.g., CYP1A2, CYP2D6, CYP3A4).^a ^k ^l

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP2D6: potential pharmacokinetic interaction (increased plasma doxepin concentrations) with concomitant use of CYP2D6 inhibitors; use with caution.^a ^k ^l Consider doxepin dosage adjustment whenever a CYP2D6 inhibitor is added or discontinued.^a ^k ^l

Specific Drugs

Drug	Interaction	Comments
Alcohol	Potentiates the effects of alcohol^c ^k ^l	Avoid concomitant use^a ^k ^l Increased risks if overdose or suicide attempt occurs^a ^k ^l
Antiarrhythmics: class 1C (e.g., flecainide, propafenone); quinidine	Potential for decreased doxepin metabolism^a ^c ^k ^l	Monitor for TCA toxicity; dosage adjustment may be needed^a ^c ^k ^l
Anticholinergic agents	Hyperthermia, particularly during hot weather, and paralytic ileus possible ^c	Use with caution; dosage adjustment may be needed^c
Antipsychotics (e.g., phenothiazines)	Potential for decreased doxepin metabolism^a ^c ^k ^l	Dosage adjustment may be needed^a ^c ^k ^l
Cimetidine	Possible increased plasma doxepin concentrations^a ^k ^l ^t ^u Potential for tricyclic toxicity, particularly anticholinergic adverse effects^a ^c ^k ^l ^t ^u	Monitor for TCA toxicity; dosage adjustment may be needed^c ^u
CNS depressants (e.g., analgesics, antihistamines, barbiturates, general anesthetics, opiates)	Potentiates the effects of CNS depressants^c
Guanethidine and related compounds	Antagonizes the antihypertensive effects of guanethidine and related compounds at doxepin dosages >150 mg daily; at dosages ≤150 mg daily, antagonism of antihypertensive effects not reported^a ^c ^k ^l
Levodopa	May interfere with levodopa absorption^c	Monitor levodopa dosage carefully^c
MAO inhibitors	Potentially life-threatening serotonin syndrome ^a ^c ^k ^l	Concomitant use with TCAs generally contraindicated^a ^c ^k ^l Allow at least 2 weeks to elapse when switching to or from these drugs^a ^c ^k ^l
Methylphenidate	Potential for decreased metabolism and increased therapeutic efficacy and toxicity of TCAs^c
SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)	Possible serotonin syndrome^c Potential for decreased doxepin metabolism and increased plasma concentrations^a ^c ^k ^l	Use with caution and monitor for TCA toxicity; dosage adjustment may be needed^a ^c ^k ^l Allow at least 5 weeks to elapse when switching from fluoxetine^a ^c ^k ^l
Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine)	Increased vasopressor and/or cardiac effects^c	Use with caution; dosage adjustment may be required^c
Thyroid agents	Possible cardiac arrhythmias^c	Use with caution ^c
Tolazamide	Severe hypoglycemia reported in at least one patient^a ^k ^l

Doxepin Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from the GI tract following oral administration; bioavailability averages approximately 30%.^b ^c ^m ^p ^q

Peak plasma concentrations usually occur within 2 hours after oral administration.^b ^m ^p ^q

Onset

Anxiolytic effect occurs prior to antidepressant effect; antidepressant effect usually occurs within 2–3 weeks.^a ^k ^l

Distribution

Extent

Doxepin and its active N-demethylated metabolite are distributed into milk in concentrations ranging from about 30–140% and 10–115%, respectively, of those in maternal serum.¹⁰⁰ ¹⁰¹ ^a ^c ^e ^k ^l ^r ^s Substantial concentrations of the active metabolite have been detected in the serum and urine of nursing infants whose mothers were receiving 75–150 mg of doxepin daily.¹⁰⁰ ¹⁰¹

Plasma Protein Binding

Highly bound to plasma protein.^c ^p

Elimination

Metabolism

Extensively metabolized in the liver by various CYP isoenzymes (principally CYP2D6; also CYP1A2, CYP3A4); undergoes demethylation to pharmacologically active metabolite, N-desmethyldoxepin.^a ^b ^k ^m ^p ^q Poor metabolizers of CYP2D6 metabolize the drug more slowly than normal metabolizers.^a ^k ^l

Elimination Route

Excreted principally in urine.^c

Half-life

6–24.5 hours.^b ^m ⁿ ^p ^x

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 15–30°C.^b ^k

Oral Concentrate

Tight, light-resistant containers at 20–25°C.^b ^l

Actions

Mechanism of action in the management of depressive and anxiety disorders is unknown but may involve inhibition of reuptake of norepinephrine.^a ^k ^l

Exhibits anticholinergic, antihistaminic, antiserotonergic, and antiadrenergic activity.^a ^c ^f ^k ^l ⁿ ^o

Associated with more frequent anticholinergic, sedative, and cardiovascular effects and weight gain than SSRIs.^c

Advice to Patients

Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.^a ^d ^h ⁱ ^j ^k ^l FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.^a ^h ⁱ ^j ^k ^l

Importance of avoiding certain activities (e.g., operating machinery, driving a motor vehicle) until effects on the individual are known.^a ^k ^l

Risk of concomitant use with alcohol.^a ^k ^l

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a ^k ^l

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or planned surgery.^a ^k ^l

Importance of informing patients of other important precautionary information.^a ^k ^l (See Cautions.)

Preparations

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

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

Doxepin Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	10 mg (of doxepin)*	Sinequan (with parabens)	Pfizer
			Doxepin Hydrochloride Capsules	Watson
		25 mg (of doxepin)*	Sinequan (with parabens)	Pfizer
			Doxepin Hydrochloride Capsules	Watson
		50 mg (of doxepin)*	Sinequan (with parabens)	Pfizer
			Doxepin Hydrochloride Capsules	Watson
		75 mg (of doxepin)*	Sinequan (with parabens)	Pfizer
			Doxepin Hydrochloride Capsules	Watson
		100 mg (of doxepin)*	Sinequan (with parabens)	Pfizer
			Doxepin Hydrochloride Capsules	Watson
		150 mg (of doxepin)*	Sinequan (with parabens)	Pfizer
	Solution, concentrate	10 mg (of doxepin) per mL*	Sinequan Oral Concentrate (with parabens)	Pfizer
			Doxepin Hydrochloride Oral Solution (Concentrate) (with parabens)	Teva

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Doxepin HCl 10MG Capsules (MYLAN): 90/$28.99 or 180/$39.97

Doxepin HCl 10MG/ML Concentrate (TEVA PHARMACEUTICALS USA): 120/$23.99 or 360/$49.97

Doxepin HCl 100MG Capsules (MYLAN): 30/$25.99 or 60/$37.97

Doxepin HCl 150MG Capsules (PAR): 30/$25.99 or 90/$55.96

Doxepin HCl 25MG Capsules (PAR): 60/$13.99 or 120/$19.98

Doxepin HCl 50MG Capsules (MYLAN): 60/$24.99 or 180/$52.97

Doxepin HCl 75MG Capsules (MYLAN): 30/$22.99 or 90/$43.97

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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Matheson I, Pande H, Alertsen AR. Respiratory depression caused by N-desmethyldoxepin in breast milk. Lancet. 1985; 2:1124. [IDIS 207267] [PubMed 2865592]

101. Kemp J, Ilett KF, Booth J et al. Excretion of doxepin and N-desmethyldoxepin in human milk. Br J Clin Pharmacol. 1985; 20:497-9. [IDIS 210580] [PubMed 4074620]

102. Pfizer Roerig. Sinequan (doxepin hydrochloride) capsules and oral concentrate prescribing information. New York, NY; 2000 Apr.

103. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website: ().

104. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA website: ().

105. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA website: ().

a. Pfizer Inc. Sinequan(doxepin hydrochloride) capsules and oral concentrate prescribing information. New York, NY; 2005 Jan.

b. AHFS drug information 2007. McEvoy GK, ed. Doxepin hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2373-74.

c. AHFS drug information 2007. McEvoy GK, ed. Tricyclic antidepressant general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2353-60.

d. American Psychiatric Association Practice Guidelines. Practice guideline for the treatment of patients with major depressive disorder, second edition. From the APA website ().

e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:513-16.

f. Neittaanmaki H, Myohanen T, Fraki JE. Comparison of cinnarizine, cyproheptadine, doxepin, and hydroxyzine in treatment of idiopathic cold urticaria: usefulness of doxepin. J Am Acad Dermatol. 1984; 11:483-9. [PubMed 6480953]

g. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007; 297:1683-96. [PubMed 17440145]

h. Food and Drug Administration. FDA news: FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. Rockville, MD; 2007 May 2. From the FDA web site: .

i. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Rockville, MD; 2007 May 2. From the FDA web site: .

j. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site:

k. Watson Laboratories, Inc. Doxepin hydrochloride capsule prescribing information. Corona, CA; 2005 May.

l. Teva Pharmaceuticals USA. Doxepin hydrochloride oral concentrate prescribing information. Sellersville, PA; 2005 Jul.

m. Yan JH, Hubbard JW, McKay G et al.. Absolute bioavailability and stereoselective pharmacokinetics of doxepin. Xenobiotica. 2002; 32:615-23. [PubMed 12162857]

n. Greene SL, Reed CE, Schroeter AL. Double-blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. J Am Acad Dermatol. 1985; 12:669-75. [PubMed 3886724]

o. Goldsobel AB, Rohr AS, Siegel SC et al. Efficacy of doxepin in the treatment of chronic idiopathic urticaria. J Allergy Clin Immunol. 1986; 78:867-73. [PubMed 3782654]

p. Amsterdam J, Brunswick D, Mendels J. The clinical application of tricyclic antidepressant pharmacokinetics and plasma levels. Am J Psychiatry. 1980; 137:653-62. [PubMed 6990798]

q. Rudorfer MV, Potter WZ. Metabolism of tricyclic antidepressants.Cell Mol Neurobiol. 1999; 19:373-409. [PubMed 10319193]

r. Frey OR, Scheidt P, von Brenndorff AI. Adverse effects in a newborn infant breast-fed by a mother treated with doxepin. Ann Pharmacother. 1999; 33:690-3. [PubMed 10410181]

s. Pons G, Rey E, Matheson I et al. Excretion of psychoactive drugs into breast milk: pharmacokinetic principles and recommendations. Clin Pharmacokinet. 1994; 27:270-89. [PubMed 7834964]

t. Sutherland DL, Remillard AJ, Haight KR et al. The influence of cimetidine versus ranitidine on doxepin pharmacokinetics. Eur J Clin Pharmacol. 1987; 32:159-64. [IDIS 229491] [PubMed 3582480]

u. Abernethy DR, Todd EL. The influence of cimetidine versus ranitidine on doxepin pharmacokinetics. Eur J Clin Pharmacol. 1987; 32:159-64. [IDIS 229491] [PubMed 3582480]

v. Ormerod AD. Urticaria: recognition, causes and treatment. Drugs. 1994; 48:717-30. [IDIS 359176] [PubMed 7530629]

w. Pons G, Greene SL, Reed CE, Schroeter AL. Double-blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. J Am Acad Dermatol. 1985; 12:669-75. [PubMed 3886724]

x. Ziegler VE, Biggs JT, Wylie LT et al. Doxepin kinetics. Clin Pharmacokinet. 1978; 23:573-9.

Daptacel (DTaP)

Generic Name: diphtheria, tetanus, acellular pertussis vaccine (DTaP) (dif THEER ee uh, TET a nus, ay SEL yoo ler per TUS iss)

Brand Names: Daptacel (DTaP), Infanrix (DTaP), Infanrix (DTaP) Preservative Free, Tripedia (DTaP)

What is diphtheria, tetanus, acellular pertussis vaccine?

Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, tetanus acellular, and pertussis pediatric vaccine (also called DTaP) is used to help prevent these diseases in children who are ages 6 weeks to 6 years old (before the child has reached his or her 7th birthday).

This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the DTaP vaccine may not provide protection from disease in every person.

What is the most important information I should know about diphtheria, tetanus, acellular pertussis vaccine?

This vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months, 6 months, 15 months, and 18 months of age, and again between 4 and 6 years of age. Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Be sure your child receives all recommended doses of this vaccine. Your child may not be fully protected against disease if he or she does not receive the full series.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to any vaccine containing diphtheria, pertussis, or tetanus, or if the child has:

severe or uncontrolled epilepsy or other seizure disorder; or

if the child has received cancer chemotherapy or radiation treatment in the past 3 months.

Your child may not be able to receive this vaccine if he or she has ever received a similar vaccine that caused any of the following:

a very high fever (over 104 degrees);

a neurologic disorder or disease affecting the brain;

excessive crying for 3 hours or longer;

fainting or going into shock;

seizure (convulsions); or

Guillain-Barré syndrome (within 6 weeks after receiving a vaccine containing tetanus).

Before receiving this vaccine, tell the doctor if your child has:

a bleeding or blood clotting disorder such as hemophilia or easy bruising;

a history of seizures;

a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);

a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

if the child is taking a blood thinner such as warfarin (Coumadin); or

if it has been less than 4 weeks since the child last received a DTaP vaccine.

The pediatric version of this vaccine (Daptacel, Infanrix, Tripedia) should not be given to anyone over the age of 6 years old. Another vaccine is available for use in older children and adults.

How is this vaccine given?

This vaccine is injected into a muscle. Your child will receive this injection in a doctor's office or clinic setting.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. Your child may not be fully protected if he or she does not receive the full series.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Diphtheria, tetanus, acellular pertussis vaccine side effects

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the child's doctor if the previous shot caused any side effects.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if the child has a serious side effect such as:

extreme drowsiness, fainting;

fussiness, irritability, crying for an hour or longer;

seizure (black-out or convulsions); or

high fever.

Less serious side effects include:

mild fever or chills;

redness, pain, tenderness, or swelling where the shot was given;

mild fussiness or crying;

joint pain, body aches;

loss of appetite; or

mild nausea, diarrhea, or vomiting.

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect diphtheria, tetanus, acellular pertussis vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

an oral, nasal, inhaled, or injectable steroid medicine;

medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and other drugs may interact with this vaccine. 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 Daptacel (DTaP) resources

Daptacel (DTaP) Use in Pregnancy & Breastfeeding
Daptacel (DTaP) Drug Interactions
Daptacel (DTaP) Support Group
0 Reviews for Daptacel (DTaP) - Add your own review/rating

Compare Daptacel (DTaP) with other medications

Diphtheria Prophylaxis
Pertussis Prophylaxis
Tetanus Prophylaxis

Where can I get more information?

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Thursday, October 27, 2016

Darpaz

Generic Name: hyoscyamine, methenamine, methylene blue, and phenyl salicylate (HYE oh SYE a meen, meth EN a meen, METH il een BLUE, FEEN il sa LIS il ate)

Brand Names: Darpaz, Hyophen, Phosenamine, Phosphasal, Prosed/DS, Urelle, Uribel, Uro Blue, Ustell, Uta, UTICAP, Utira, Utira-C

What is Darpaz (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Methenamine and methylene blue work as mild antiseptics that fight bacteria in the urine and bladder.

Phenyl salicylate is a mild pain reliever.

The combination of hyoscyamine, methenamine, methylene blue, and phenyl salicylate is used to treat bladder irritation (pain, burning, inflammation) caused by urinary tract infection. This medication is also used to prevent bladder discomfort during a medical procedure.

Hyoscyamine, methenamine, methylene blue, and phenyl salicylate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Darpaz (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

You should not use hyoscyamine, methenamine, methylene blue, and phenyl salicylate if you are allergic to it.

Before taking this medication, tell your doctor if you have any type of heart problem (congestive heart failure, coronary heart disease, a heart valve or heart rhythm disorder), glaucoma, an enlarged prostate, bladder obstruction, myasthenia gravis, a stomach ulcer or obstruction, or if you are allergic to belladonna (Donnatal and others).

Drink plenty of liquids while you are taking this medication. If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and phenyl salicylate.

Many drugs can interact with this medicine. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all other medicines you use.

What should I discuss with my healthcare provider before taking Darpaz (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

You should not use hyoscyamine, methenamine, methylene blue, and phenyl salicylate if you are allergic to it.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

heart disease;

a heart rhythm disorder;

congestive heart failure;

coronary heart disease;

a heart valve disorder;

glaucoma;

an enlarged prostate or bladder obstruction;

myasthenia gravis;

an ulcer or obstruction in your stomach; or

if you are allergic to belladonna (Donnatal and others).

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine, methenamine, methylene blue, and phenyl salicylate can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hyoscyamine, methenamine, methylene blue, and phenyl salicylate should not be given to a child younger than 7 years old. Older adults may be more likely to have side effects from this medication.

How should I take Darpaz (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Hyoscyamine, methenamine, methylene blue, and phenyl salicylate is usually taken 4 times daily. Follow your doctor's instructions.

Do not crush, chew, or break an enteric coated pill. Swallow it whole. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating. Drink plenty of liquids while you are taking this medication. If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and phenyl salicylate. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

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 severe dizziness or rapid pulse.

What should I avoid while taking Darpaz (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Avoid taking an antacid or anti-diarrhea medicine within 1 hour before or after you take hyoscyamine, methenamine, methylene blue, and phenyl salicylate. Antacids or anti-diarrhea medicine can make it harder for your body to absorb hyoscyamine.

If you also take ketoconazole (Nizoral), wait at least 2 hours after taking it before you take hyoscyamine, methenamine, methylene blue, and phenyl salicylate.

Darpaz (hyoscyamine, methenamine, methylene blue, and phenyl salicylate) side effects

Methylene blue will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm.

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

severe dizziness, blurred vision, fast heart rate;

agitation, confusion, feeling restless or excited;

painful or difficult urination; or

feeling short of breath.

Less serious side effects may include:

mild dizziness;

drowsiness; or

flushing (warmth, redness, or tingly feeling).

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 Darpaz (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Many drugs can interact with this medicine. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all other medicines you use, especially:

atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

a diuretic (water pill);

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

glycopyrrolate (Robinul);

homatropine (Hycodan, Tussigon);

methantheline;

neostigmine (Prostigmin) or pyridostigmine (Mestinon);

bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or

an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);

medicines to treat symptoms of Alzheimer's disease such as donepezil (Aricept), galantamine (Razadyne), memantine (Namenda), rivastigmine (Exelon), or tacrine (Cognex);

narcotic pain medication such as codeine (Tylenol #3, Cheratuss, Guaiatuss), fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid), methadone (Dolophine, Methadose), morphine (Avinza, Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Endocet, Percocet), propoxyphene (Darvocet, Propacet), and others;

sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra);

sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or

ulcer or irritable bowel medications such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Hyomax), mepenzolate (Cantil), or propantheline (Pro Banthine).

This list is not complete and there are many other drugs that can interact with hyoscyamine, methenamine, methylene blue, and phenyl salicylate. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Darpaz resources

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

Darpaz Prescribing Information (FDA)

Darcalma Prescribing Information (FDA)

Phosenamine Prescribing Information (FDA)

Phosphasal Prescribing Information (FDA)

Phosphasal Advanced Consumer (Micromedex) - Includes Dosage Information

Prosed EC Advanced Consumer (Micromedex) - Includes Dosage Information

Prosed/DS MedFacts Consumer Leaflet (Wolters Kluwer)

Urelle Prescribing Information (FDA)

Uribel Prescribing Information (FDA)

Urimax Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Urised MedFacts Consumer Leaflet (Wolters Kluwer)

Uritact-EC Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Ustell Prescribing Information (FDA)

Uta MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Darpaz with other medications

Urinary Tract Infection

Where can I get more information?

Your pharmacist can provide more information about hyoscyamine, methenamine, methylene blue, and phenyl salicylate.

See also: Darpaz side effects (in more detail)

Dytan Suspension

Generic Name: Diphenhydramine (dye-fen-HYE-dra-meen)
Brand Name: Ben-Tann and Dytan

Dytan Suspension is used for:

Preventing or treating symptoms of hay fever and other upper respiratory allergies or the common cold, such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes, and relieving cough. It may also be used for other conditions as determined by your doctor.

Dytan Suspension is an antihistamine and anticholinergic. It works by blocking the action of histamine, reducing the symptoms of an allergic reaction. It also works in the brain to cause sedation.

Do NOT use Dytan Suspension if:

you are allergic to any ingredient in Dytan Suspension or other similar medicines

you are taking sodium oxybate (GHB)

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

Before using Dytan Suspension:

Some medical conditions may interact with Dytan Suspension. 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 a fast, slow, or irregular heartbeat

if you have a history of asthma; chronic obstructive pulmonary disease (COPD); chronic bronchitis; lung problems (eg, emphysema); shortness of breath; sleep apnea; heart blood vessel problems; stroke; seizures; a blockage of your stomach, intestine, or bladder; difficulty urinating; diabetes; ulcers; an enlarged prostate or other prostate problems; glaucoma; heart problems; high blood pressure; porphyria; phenylketonuria; or an overactive thyroid

Some MEDICINES MAY INTERACT with Dytan Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur

Monoamine oxidase (MAO) inhibitors (eg, phenelzine) because they may increase the risk of Dytan Suspension's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dytan Suspension 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 Dytan Suspension:

Use Dytan Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Dytan Suspension by mouth with or without food.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

Use Dytan Suspension exactly as directed on the package, unless instructed differently by your doctor. If you are taking Dytan Suspension without a prescription, follow any warnings and precautions on the label.

If you miss a dose of Dytan Suspension and you are taking it regularly, 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 Dytan Suspension.

Important safety information:

Dytan Suspension may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Dytan Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dytan Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Dytan Suspension may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Do not become overheated in hot weather or while you are being active; heatstroke may occur.

Dytan Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Dytan Suspension for a few days before the tests.

Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

Dytan Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Dytan Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Dytan Suspension has diphenhydramine in it. Before you start any new medicine, check the label to see if it has diphenhydramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not use Dytan Suspension for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

If your symptoms persist for more than 1 week or if you develop a fever, contact your health care provider.

Use Dytan Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, sedation, and lightheadedness upon standing.

Different brands of Dytan Suspension may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dytan Suspension while you are pregnant. Dytan Suspension is found in breast milk. If you are or will be breast-feeding while you use Dytan Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Dytan Suspension:

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:

Dizziness; drowsiness; itching; dry mouth, throat, and nose; excitability; thickening of mucus in nose or throat.

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); convulsions; fast heartbeat or pounding in the chest; decreased alertness; hallucinations; tremor; wheezing.

See also: Dytan 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. Symptoms may include coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness.

Proper storage of Dytan Suspension:

Store Dytan Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dytan Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Dytan Suspension, please talk with your doctor, pharmacist, or other health care provider.

Dytan Suspension is 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.

This information is a summary only. It does not contain all information about Dytan Suspension. 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

More Dytan resources

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

Compare Dytan with other medications

Allergic Reactions
Cold Symptoms
Cough
Extrapyramidal Reaction
Hay Fever
Insomnia
Motion Sickness
Nausea/Vomiting
Pruritus
Urticaria

Retavase

Generic Name: retaplase (RE te plase)

Brand Names: Retavase

What is Retavase (retaplase)?

Retaplase is a thrombolytic (THROM-bo-LIT-ik) drug that is used to dissolve blood clots.

Retaplase is used to improve heart function and prevent congestive heart failure or death in people who have had a heart attack.

Retaplase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Retavase (retaplase)?

You should not receive this medication if you are allergic to retaplase, or if you have a bleeding disorder, a brain tumor or aneurysm, uncontrolled high blood pressure, a history of stroke or blood clots, or recent brain or spinal injury or surgery.

Before using retaplase, tell your doctor if you have kidney or liver disease, eye complications caused by diabetes, an infection of the lining of your heart, or if you have had any recent surgery, injury, or major bleeding.

Tell your doctor if you take aspirin, a blood thinner such as warfarin (Coumadin), or any medications to prevent blood clots, such as abciximab (ReoPro), dipyridamole (Persantine), and others.

Tell your doctor at once if you have a serious side effect such as sudden numbness or weakness, confusion, problems with speech or vision, chest pain, sudden cough, wheezing, rapid breathing, fast or slow heart rate, darkening or purple discoloration of your fingers or toes, blood in your urine or stools, pale skin, easy bruising, or any bleeding that will not stop.

What should I discuss with my health care provider before I receive Retavase (retaplase)?

You should not receive this medication if you are allergic to retaplase, or if you have certain conditions. Be sure your doctor knows if you have:

any active bleeding;

a bleeding or blood clotting disorder;

a brain tumor, aneurysm, or blood vessel disorder;

untreated or uncontrolled high blood pressure;

a history of stroke or blood clot; or

recent spine or brain injury or surgery.

Before you receive retaplase, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;

liver disease;

eye complications caused by diabetes;

an infection of the lining of your heart (also called bacterial endocarditis); or

if you have had any recent surgery, injury, or major bleeding.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive this medicaiton.

FDA pregnancy category C. Retaplase may be harmful to an unborn baby. Before receiving this medication, tell your doctor if you are pregnant. It is not known whether retaplase passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is retaplase given?

Retaplase is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

Retaplase is usually given in two quick injections through an IV line. These injection are given 30 minutes apart.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you have received retaplase.

What happens if I miss a dose?

Since retaplase is given only when needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

An overdose of retaplase is not likely to occur.

What should I avoid after receiving Retavase (retaplase)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using retaplase.

Retavase (retaplase) 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. Tell your doctor at once if you have a serious side effect such as:

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

chest pain, sudden cough, wheezing, rapid breathing;

fast, slow, or uneven heart rate;

feeling like you might pass out;

weak pulse, fainting, slow breathing (breathing may stop);

darkening or purple discoloration of your fingers or toes;

blood in your urine;

black, bloody, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

bleeding from needle punctures (such as from needles used in blood tests or in giving injection) injections; or

pale skin, easy bruising, or any bleeding that will not stop.

Less serious side effects may include:

nausea;

vomiting; or

fever.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Retavase (retaplase)?

The following drugs can interact with retaplase. Tell your doctor if you are using any of these:

a blood thinner such as warfarin (Coumadin);

aspirin; or

medication used to prevent blood clots, such as abciximab (ReoPro), dipyridamole (Persantine), and others.

This list is not complete and there may be other drugs that can interact with retaplase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Retavase resources

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

Retavase Prescribing Information (FDA)

Retavase Monograph (AHFS DI)

Retavase Advanced Consumer (Micromedex) - Includes Dosage Information

Retavase MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Retavase with other medications

Heart Attack

Where can I get more information?

Your doctor or pharmacist can provide more information about retaplase.

See also: Retavase side effects (in more detail)