Poly Hist HC Liquid

Generic Name: Hydrocodone/Phenylephrine/Pyrilamine (hye-droe-KOE-done/fen-ill-EF-rin/peer-IL-a-meen)
Brand Name: Examples include Codimal DH and Poly Hist HC

Poly Hist HC Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Poly Hist HC Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Poly Hist HC Liquid if:

• you are allergic to any ingredient in Poly Hist HC Liquid or any other codeine- or morphine-related medicine (eg, codeine)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Poly Hist HC Liquid:

Some medical conditions may interact with Poly Hist HC Liquid. 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, heart blood vessel problems, or other heart problems


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have or recently have had any head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Poly Hist HC Liquid's side effects


• Cimetidine, digoxin, or droxidopa because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone because it may decrease Poly Hist HC Liquid's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Poly Hist HC Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Poly Hist HC Liquid

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

Use Poly Hist HC Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Poly Hist HC Liquid 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.


• If you miss a dose of Poly Hist HC Liquid, 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 Poly Hist HC Liquid.

Important safety information:

• Poly Hist HC Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Poly Hist HC Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you take Poly Hist HC Liquid without checking with your doctor.


• Poly Hist HC Liquid has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


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


• Poly Hist HC Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Poly Hist HC Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Poly Hist HC Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Poly Hist HC Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Poly Hist HC Liquid in CHILDREN; they may be more sensitive to its effects.


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

When used for long periods of time or at high doses, Poly Hist HC Liquid 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 Poly Hist HC Liquid stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Poly Hist HC Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Poly Hist HC Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Poly Hist HC Liquid:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble sleeping; vision changes.

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: Poly Hist HC 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Poly Hist HC Liquid:

Store Poly Hist HC Liquid 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 Poly Hist HC Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Poly Hist HC Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Poly Hist HC Liquid 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 Poly Hist HC Liquid. 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 Poly Hist HC resources

• Poly Hist HC Side Effects (in more detail)
• Poly Hist HC Use in Pregnancy & Breastfeeding
• Poly Hist HC Drug Interactions
• Poly Hist HC Support Group
• 0 Reviews · Be the first to review/rate this drug

Ethacrynic Acid

Class: Loop Diuretics
Note: This monograph also contains information on Ethacrynate Sodium
VA Class: CV702
CAS Number: 58-54-8
Brands: Edecrin,, Sodium Edecrin

• 
  

  Ethacrynic acid is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion.¹²⁹ (See Electrolyte, Fluid, and Renal Effects under Cautions.)

  
  


• 
  

  Careful medical supervision is required; dosage selection and titration should be adjusted to the individual patient’s needs. (See Dosage and Administration.) ¹²⁹

  
  

Introduction

A loop-type diuretic¹²⁹ and antihypertensive agent.^b

Uses for Ethacrynic Acid

Edema

Management of edema associated with CHF, hepatic cirrhosis, and renal disease (e.g., nephrotic syndrome).¹²⁹

Considered a diuretic of choice for most patients with CHF.¹⁰⁸

Short-term management of ascites associated with malignancy, idiopathic edema, or lymphedema.¹²⁹

Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or nephrotic syndrome.¹²⁹ (See Pediatric Use under Cautions.)

In patients whose condition is refractory to diuretics, may use IV administration of a diuretic (e.g., ethacrynate sodium) or concomitant therapy with 2 or more diuretics (e.g., a loop diuretic and metolazone, a loop diuretic and a thiazide diuretic), or alternatively, short-term administration of a drug that increases blood flow (e.g., a positive inotropic agent such as dobutamine or dopamine) may be needed.¹⁰⁸

IV ethacrynate sodium is used when rapid onset of diuresis is needed (e.g., acute pulmonary edema).¹²⁹

Hypertension

Has been used in the management of hypertension† (alone or in combination with other classes of antihypertensive agents).^b

One of several preferred initial therapies in hypertensive patients with CHF or renal disease.†¹²⁶

Ethacrynic acid is the only orally available nonsulfonamide diuretic; may be particularly useful in patients hypersensitive to sulfonamides (e.g., other loop diuretics, thiazides).^{103 104}

Can be used as monotherapy for initial management of uncomplicated hypertension;† however, thiazide diuretics are preferred by JNC 7.¹²⁶

IV ethacrynate sodium has been used as an adjunct to hypotensive agents in the management of hypertensive crisis†, especially when accompanied by pulmonary edema.^b

Hypercalcemia

IV ethacrynate sodium has been used in the management of hypercalcemia†, alone or with sodium chloride 0.9% injection.^b

Ethylene Glycol or Bromide Poisoning

Has been used with mannitol in the management of ethylene glycol poisoning†.^b

Management of bromide intoxication†.^b

Diabetes Insipidus

Treatment of nephrogenic diabetes insipidus† that is refractory to vasopressin or chlorpropamide.^b

Ethacrynic Acid Dosage and Administration

General

Edema

• 
  

  Careful etiologic diagnosis should precede the use of any diuretic.^b

  
  


• 
  

  Hospitalization of the patient during initiation of therapy is advisable, especially for patients with hepatic cirrhosis and ascites or chronic renal failure.^b

  
  


• 
  

  Most experts state that all patients with symptomatic CHF who have evidence for, or a prior history of, fluid retention generally should receive diuretic therapy in conjunction with moderate sodium restriction (≤3 g of sodium daily), an ACE inhibitor, and usually a β-adrenergic blocking agent, with or without a cardiac glycoside.¹⁰⁸

  
  


• 
  

  In prolonged diuretic therapy, intermittent use of the drug (e.g., on 2-4 consecutive days each week) may be advisable.^b

  
  

Hypertension†

• 
  

  If added to regimen of a patient stabilized on a potent hypotensive agent, consider dosage reduction of preexisting therapy to avoid severe hypotension.^b

  
  

Administration

Administer ethacrynic acid orally. ^{129 b} Administer ethacrynate sodium by IV infusion or slow IV injection.^{129 b} Do not administer ethacrynate sodium sub-Q or IM because of local pain and irritation.^{129 b}

IV Administration

Use IV administration when a rapid onset of diuresis is desired (e.g., acute pulmonary edema, impaired GI absorption, in patients unable to take the drug orally).^{129 b}

Reconstitution

Reconstitute vial containing ethacrynate sodium equivalent to 50 mg of ethacrynic acid with 50 mL of 5% dextrose injection or 0.9% sodium chloride injection to provide a solution containing 1 mg of ethacrynic acid per mL.^{129 b}

Do not use if solution is hazy or opalescent, which may occur if reconstituted with 5% dextrose injection having a pH <5. ¹²⁹

Rate of Administration

Infuse slowly over 20–30 minutes through the tubing of a running IV infusion^b or by direct IV injection over several minutes.^{129 b}

Dosage

Available as ethacrynic acid and ethacrynate sodium; dosage expressed in terms of ethacrynic acid.^{129 b}

Select dosage carefully to prevent a more rapid or substantial loss of fluid or electrolyte than is indicated or necessary.¹²⁹ (See Electrolyte, Fluid, and Renal Effects under Cautions.)

Weigh patients under standard conditions before initiating and during diuretic therapy.¹²⁹

Adjust dosage according to patient’s requirements and response.^b In adults, use smallest dosage required to produce gradual weight loss of 0.45–0.9 kg (1–2 pounds) daily.¹²⁹

Some clinicians suggest not to give the drug for more than 2 consecutive days until the patient’s responsiveness is known.^b

Pediatric Patients

Edema

Oral

Hospitalized pediatric patients excluding infants: Initially 25mg.¹²⁹ Increase with caution in 25-mg increments daily until desired effect is achieved.¹²⁹ Once desired response is obtained, may reduce dosage to the minimum required for maintenance.^b (See Pediatric Use under Cautions.)

Hypertension†

IV†

Although manufacturer does not recommend IV use in pediatric patients,^{129 b} some clinicians consider 1-mg/kg doses safe and effective in such patients.^b

Adults

Edema

Oral

Day 1: 50 mg after a meal¹²⁹ (preferably in the morning).^b

Day 2: 50 mg twice daily after meals, if needed.¹²⁹

Day 3: 100 mg in the morning and 50–100 mg after the noon or evening meal, depending on response to the morning dose.^{129 b}

Some clinicians recommend a dosage of 50 mg daily for several days and then increasing dosage only if necessary.^b

Adjust dosage gradually in increments of 25–50 mg daily to avoid alterations in electrolyte and water excretion.^{129 b} Some patients (usually those with severe, refractory edema) may require up to 200 mg twice daily.¹²⁹

When added to existing diuretic regimen, initial dose should be 25 mg; increase in increments of 25 mg. ^b

For maintenance therapy, use smallest effective dose once or twice daily.^b May reduce frequency of administration after effective diuresis (dry weight) is achieved (usually with doses of 50–100 mg);¹²⁹ may administer drug intermittently (e.g., on alternate days or less frequently).^{129 b}

IV

Average size adults: 50 mg or 0.5–1 mg/kg; single IV doses should not exceed 100 mg. ¹²⁹ Usually only one dose is necessary; if a second dose is needed, use a new injection site to avoid possible thrombophlebitis. ¹²⁹

Hypertension†

Oral

Initially: 25 mg daily;^{101 102 103 104} if necessary, increase dosage gradually until desired response is achieved or a usual maximum dosage of 100 mg daily, in 2 or 3 divided doses is attained.^{102 104}

In patients with renal insufficiency or CHF, may increase dosage until desired therapeutic response is achieved, adverse effects become intolerable, or suggested maximum dosage of 200 mg daily, in divided doses, is attained.¹⁰¹

Usually administered in 2 or 3 divided doses daily for the management of hypertension.^{103 104}

Prescribing Limits

Adults

Edema

Oral

Maximum 200 mg twice daily.¹²⁹

IV

Maximum 100 mg per dose. ^b

Hypertension†

Oral

Maximum 100mg daily, in divided doses; ^b in patients with renal insufficiency or CHF, 200 mg daily, in divided doses.¹⁰¹

Special Populations

Hepatic Impairment

Initiate therapy in a hospital in cirrhotic patients with ascites. ¹²⁹

Renal Impairment

Higher dosages (>100 mg) may be necessary for management of hypertension† in adults with renal insufficiency.^{101 102} May increase dosage until desired therapeutic response is achieved, adverse effects become intolerable, or suggested maximum dosage of 200 mg daily, in divided doses, is attained.¹⁰¹

CHF

Higher dosages (>100 mg) may be necessary for management of hypertension† in adults with CHF. ^{101 102} May increase dosage until desired therapeutic response is achieved, adverse effects become intolerable, or suggested maximum dosage of 200 mg daily, in divided doses, is attained.¹⁰¹

Geriatric Patients

Select dosage with caution because of age-related decreases in renal function.¹²⁹

Cautions for Ethacrynic Acid

Contraindications

• 
  

  Anuria, hypotension, dehydration with low serum sodium concentrations, or metabolic alkalosis with hypokalemia.^{129 b}

  
  


• 
  

  Increasing azotemia and/or oliguria, electrolyte imbalance, or severe, watery diarrhea that occurs during use.^{129 b}

  
  


• 
  

  Known hypersensitivity to ethacrynic acid or any ingredient in the formulation.^{129 b}

  
  


• 
  

  Use in infants.¹²⁹

  
  

Warnings/Precautions

Warnings

Electrolyte, Fluid, and Renal Effects

Excessive diuresis may cause fluid and electrolyte (chloride, calcium, magnesium, sodium) depletion; these effects likely to occur with large doses of the drug, in patients on restricted salt intake,^b those with secondary hyperaldosteronism (associated with cirrhosis and nephrosis),^b or use of digoxin.^b Resultant hypovolemia may result in dehydration, blood volume reduction leading to circulatory collapse and thromboembolic episodes (e.g., cerebral vascular thrombosis, pulmonary emboli [may be fatal]), particularly in geriatric patients.^{129 b}

Fatal arrhythmias associated with hypokalemia reported in patients with severe myocardial disease receiving digitalis.¹²⁹ Hypokalemia and hypochloremia may result in metabolic alkalosis, especially in patients with other losses of potassium and chloride resulting from vomiting, diarrhea, GI drainage, excessive sweating, paracentesis, or potassium-losing renal diseases.^b To reduce or prevent potassium depletion, administer drug intermittently and/or give potassium-rich foods or a potassium-sparing diuretic.^b Potassium supplements may be necessary in patients whose serum potassium concentration is less than approximately 3 mEq/L or those receiving digitalis glycosides.^b

Risk of orthostatic hypotension or acute hypotensive episodes, especially with brisk diuresis (evidenced by rapid and excessive weight loss) or in patients receiving other antihypertensive agents; monitor BP closely.^{129 b}

Rapid or excessive diuresis may cause an abrupt fall in GFR and renal blood flow.^b

Transient rise in BUN may occur, especially in patients with chronic renal disease; usually reversible upon discontinuance. ^b

If excessive diuresis occurs, discontinue the drug until homeostasis is restored.¹²⁹

If excessive electrolyte depletion occurs, reduce dosage or withdraw drug temporarily.¹²⁹

Adequate Patient Evaluation and Monitoring

Monitor serum electrolytes, BUN, and CO₂ early in therapy and periodically thereafter; discontinue or reduce dosage if excessive diuresis and/or electrolyte abnormalities occur.^{129 b} Correct electrolyte abnormalities as appropriate.^{129 b}

Observe carefully for manifestations of fluid and electrolyte depletion (e.g., thirst, weakness, lethargy, dizziness, faintness, mental confusion, lassitude, restlessness, muscle pains or cramps, muscular fatigue, headache, paresthesia, anorexia, hypotension, oliguria, arrhythmia, nausea, vomiting).^b

Ototoxicity

Tinnitus, vertigo with a sense of fullness in the ears, and temporary (lasting 1–24 hours) or permanent deafness have occurred, usually after IV administration in patients with severe renal impairment or in those concomitantly receiving ototoxic drugs or in those who received ethacrynic acid or ethacrynate sodium doses larger than those recommended.¹²⁹ (See Specific Drugs under Interactions.)

Sensitivity Reactions

Rash has been reported. ¹²⁹

General Precautions

Metabolic Effects

Hyperglycemia and alterations in glucose tolerance reported.¹²⁹

Specific Populations

Pregnancy

Category B.¹²⁹

Lactation

Not known whether ethacrynic acid is distributed into milk.^{129 b} Discontinue nursing or the drug.^{129 b}

Pediatric Use

Safety and efficacy not established in infants; do not administer to infants until further accumulation of data.^{129 109} (See Contraindications under Cautions.)

The manufacturer states that dosage recommendations for short-term management of hospitalized pediatric patients (excluding infants) with edema associated with congenital heart disease or nephrotic syndrome, are empiric, since no well-controlled studies have been published.^{109 129}

Safety and efficacy of ethacrynate sodium in pediatric patients not established. ^b

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out. ¹²⁹ Other reported clinical experience has not identified differences in responses between geriatric and younger patients.¹²⁹

Assess renal function periodically, since ethacrynic acid is substantially eliminated by kidneys and geriatric patients are more likely to have decreased renal function.¹²⁹ Select dosage with caution.¹²⁹

Hepatic Impairment

Manufacturer recommends initiating therapy in a hospital in cirrhotic patients with ascites.¹²⁹

Administer with caution in patients with advanced cirrhosis, especially those with a history of previous episodes of electrolyte imbalance or hepatic encephalopathy.¹²⁹

In patients with hepatic cirrhosis, rapid alterations in fluid and electrolyte balance may precipitate hepatic pre-coma or coma.¹²⁹ Deaths have occurred in patients with severely decompensated hepatic cirrhosis with ascites, with or without encephalopathy as a result of intensification of preexisting electrolyte imbalance.¹²⁹

Potassium depletion possible; consider supplemental potassium and/or potassium-sparing agents in cirrhotic patients.¹²⁹

Renal Impairment

When used in the treatment of renal edema, hypoproteinemia may reduce responsiveness to ethacrynic acid and the use of albumin human should be considered.^{129 b}

Potassium depletion possible; consider supplemental potassium and/or potassium-sparing agents in nephrotic patients. ¹²⁹

Common Adverse Effects

Anorexia, malaise, abdominal pain/discomfort, dysphagia, nausea, vomiting, diarrhea, reversible hyperuricemia, hyperglycemia, acute gout, deafness, tinnitus, vertigo, headache, fatigue, apprehension, confusion, rash, fever, chills, hematuria; local irritation and pain has been occasionally reported after IV use. ¹²⁹

Interactions for Ethacrynic Acid

Specific Drugs

Drug	Interaction	Comments
Alcohol	May augment effects of alcoholb
Antidiabetic agents (e.g., insulin, oral agents)	Possible antagonism of hypoglycemic effect as result of hypokalemiab	Observe for possible decreased diabetic control; correct potassium deficit and/or adjust dosage of antidiabetic agentb
Antihypertensive agents	Additive antihypertensive effect; orthostatic hypotension may occurb	Reduce dosage of both drugsb
Carbonic anhydrase inhibitors (e.g., acetazolamide, dichlorphenamide, methazolamide)	May potentiate action of carbonic anhydrase inhibitors; augmentation of natriuresis and kaliuresis129	Cautiously dose ethacrynic acid 129
Cardiac glycosides (e.g., digoxin)	Possible electrolyte disturbances (e.g., hypokalemia, hypomagnesemia), increased risk of cardiac glycoside toxicity and/or fatal cardiac arrhythmiasb	Periodically monitor electrolytes; correct hypokalemiab
Corticosteroids	Possible increased risk of gastric hemorrhage associated with corticosteroids129 (See also Drugs that Cause Potassium Loss)
Diuretics	Enhanced therapeutic effect129 b	Reduce ethacrynic acid dosage when it is added to an existing diuretic regimenb
Diuretics, loop (e.g., bumetanide, furosemide, torsemide)	Share similar mechanisms of actionb	No therapeutic rationale for concomitant useb
Diuretics, potassium-sparing (e.g., amiloride, spironolactone, triamterene)	Possible reduction in potassium loss129	May be used for therapeutic advantage129
Diuretics, thiazides	Additive diuretic effectb	Use reduced dosage of ethacrynic acid when added to existing diuretic regimenb
Drugs that cause potassium loss (e.g., corticosteroids, corticotropin, amphotericin B)	Additive hypokalemic effectsb	Monitor electrolytes; correct hypokalemiab
Lithium	Reduced renal clearance of lithium and increased risk of lithium toxicity129 b	Avoid concomitant use; if concomitant therapy is necessary, hospitalize patient and monitor for lithium toxicity129 b
Neuromuscular blocking agents, nondepolarizing (e.g., tubocurarine chloride)	Potential for prolonged neuromuscular blockade, associated with potassium depletionb
NSAIAs	Possible decreased diuretic, natriuretic effect, and antihypertensive effects.108 119 129 b Increased risk of developing renal failure associated with decreased renal blood flow, resulting from prostaglandin inhibition by NSAIAs117 118	Monitor closely for desired diuretic effect129
Ototoxic drugs (e.g., aminoglycosides, some cephalosporins)	Possible additive ototoxic effect (transient or permanent deafness), especially with IV ethacrynate sodium 129 b	Avoid concomitant use129 b
Uricosuric drugs (probenecid, sulfinpyrazone)	Urinary excretion and efficacy of ethacrynic acid may decrease.b Possible antagonism of uricosuric effectsb	Monitor serum uric acid concentrations; dosage of uricosuric agents may need to be increasedb
Warfarin	Possible potentiation of anticoagulant effect (because of displacement of warfarin from protein-binding sites)129 b	Monitor INR closely; consider reducing warfarin dose129 b

Ethacrynic Acid Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from the GI tract.^b

Onset

Following oral administration, diuretic effect occurs within 30 minutes and peaks in about 2 hours.^{129 b}

Following IV administration of ethacrynate sodium, diuresis usually occurs within 5 minutes and reaches a maximum within 15–30 minutes.^{129 b}

Duration

Diuretic effect persists 6–8 hours (up to 12 hours) following oral administration, and about 2 hours following IV administration of ethacrynate sodium.^{129 b}

Distribution

Extent

In animals, substantial amounts accumulate only in the liver.^b

Does not enter the CSF.^{129 b}

Not known whether ethacrynic acid crosses the placenta^b or is distributed into human milk.^{129 b}

Elimination

Metabolism

Metabolized to a cysteine conjugate (which may contribute to the pharmacologic effects of the drug) and to an unstable, unidentified compound.^b

Elimination Route

IV Ethacrynate sodium: Excreted in urine (about 30–65%) and in bile (about 35–40%); partially as the cysteine conjugate.^b

Rate of urinary excretion increases as urinary pH increases. ^b

Stability

Storage

Oral

Tablets

Tight containers at 25°C (may be exposed to 15–30°C).^{120 129}

Parenteral

Powder for Injection

25°C (may be exposed to 15–30°C).^{120 129}

Use reconstituted solutions within 24 hours of preparation.^{129 b}

Reconstituted solutions stable for short periods of time at pH 7 at room temperature; less stable as pH and/or temperature increase.^b Some 5% dextrose solutions have pH <5, which may result in a hazy or opalescent solution that should not be used.¹²⁹

Compatibility

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

Parenteral

Solution Compatibility^b

Compatible
Dextran 75 6% in sodium chloride 0.9%
Dextrose 5% in water
Dextrose 5% in sodium chloride 0.9%
Normosol-R (pH 7.4)
Ringer’s injection
Ringer’s injection, lactated
Sodium chloride 0.9%
Water for injection
Incompatible
Normosol-M

Drug Compatibility^b

Admixture Compatibility

Incompatible
Hydralazine HCl
Procainamide HCl
Reserpine
Tolazoline HCl in sodium chloride injection

ActionsActions

• 
  

  Loop diuretic with rapid onset of action.^{129 b}

  
  


• 
  

  In vitro, inhibits active transport of chloride in the lumen of the ascending limb of the loop of Henle and thereby, diminishes reabsorption of sodium and chloride at that site.^b

  
  


• 
  

  Increases potassium excretion in the distal renal tubule, and exerts a direct effect on electrolyte transport at the proximal tubule. ^b

  
  


• 
  

  Does not inhibit carbonic anhydrase and is not an aldosterone antagonist.^b Aldosterone secretion may increase during therapy and may contribute to hypokalemia.^b

  
  


• 
  

  Enhances excretion of sodium, chloride, potassium, hydrogen, calcium, and magnesium.^b

  
  


• 
  

  Initially, sodium and chloride excretion is substantial, and chloride loss exceeds that of sodium.¹²⁹

  
  


• 
  

  With prolonged administration, sodium and chloride excretion declines, and excretion of potassium and hydrogen may increase.^{129 b} Excessive losses of potassium, hydrogen, and chloride may result in metabolic alkalosis.

  
  


• 
  

  Maximum diuresis and electrolyte loss are greater with ethacrynic acid than with the thiazides or most other diuretics except furosemide.^b

  
  


• 
  

  Has little or no direct effect on GFR or renal blood flow; however, a fall in GFR may accompany pronounced reductions in plasma volume associated with rapid or excessive diuresis.¹²⁹

  
  


• 
  

  A hypotensive effect may result from decreased plasma volume.^b

  
  

Advice to Patients

• 
  

  Importance of reporting manifestations of fluid and electrolyte depletion (e.g., dryness of mouth, thirst, weakness, dizziness, faintness, mental confusion, lassitude, lethargy, drowsiness, restlessness, muscle pains or cramps, paresthesia, muscular fatigue, hypotension, headache, oliguria, tachycardia, arrhythmia, anorexia, nausea, vomiting).^{129 b}

  
  


• 
  

  Importance of discussing dietary measures and supplementation to prevent or correct hypokalemia.^b

  
  


• 
  

  Importance of informing patients with diabetes mellitus that blood glucose and urine glucose concentrations may increase.^b

  
  


• 
  

  Importance of immediately reporting severe diarrhea.^b

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.¹²⁹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹²⁹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹²⁹ (See Cautions.)

  
  

Preparations

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

Ethacrynic Acid

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	25 mg	Edecrin (scored)	Aton Pharma

Ethacrynate Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV use only	equivalent to ethacrynic acid 50 mg	Sodium Edecrin (with mannitol 62.5 mg)	Aton Pharma

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.

Edecrin 25MG Tablets (VALEANT): 100/$354 or 300/$997

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 March 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Fischer AF, Parker BR, Stevenson DK. Nephrolithiasis following in utero diuretic exposure: an unusual case. Pediatrics. 1988; 81:712-4. [IDIS 241064] [PubMed 3282218]

101. The Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

102. 1988 Joint National Committee. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

103. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

104. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health. (NIH publication No. 98-4080.)

105. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

106. Psaty BM, Smith NL, Siscovich DS et al. Health outcomes associated with antihypertensive therapies used as first-line agents: a systematic review and meta-analysis. JAMA. 1997; 277:739-45. [IDIS 380501] [PubMed 9042847]

107. Whelton PK, Appel LJ, Espeland MA et al. for the TONE Collaborative Research Group. Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). JAMA. 1998; 279:839-46. [PubMed 9515998]

108. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9A-38A.

109. Merck. Edecrin (ethacrynic acid) tablets and Intravenous Sodium Edecrin (ethacrynate sodium) prescribing information (dated 1997 Jun). In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999:1790-1.

110. Leary WP, Reyes AJ. Drug interactions with diuretics. S Afr Med J. 1984; 65:455-61. [IDIS 186610] [PubMed 6701709]

111. The Captopril-Digoxin Multicenter Research Group. Comparative effects of therapy with captopril and digoxin in patients with mild to moderate heart failure. JAMA. 1988; 259:539-44. [IDIS 237362] [PubMed 2447297]

112. Richardson A, Bayliss J, Scriven AJ et al. Double-blind comparison of captopril alone against frusemide plus amiloride in mild heart failure. Lancet. 1987; 2:709-11. [IDIS 234108] [PubMed 2888942]

113. Sherman LG, Liang CS, Baumgardner S et al. Piretanide, a potent diuretic with potassium-sparing properties, for the treatment of congestive heart failure. Clin Pharmacol Ther. 1986; 40:587-94. [IDIS 224725] [PubMed 3533372]

114. Patterson JH, Adams KF Jr, Applefeld MM et al. Oral torsemide in patients with chronic congestive heart failure: effects on body weight, edema, and electrolyte excretion. Pharmacotherapy. 1994; 14:514-21. [IDIS 336083] [PubMed 7997385]

115. Wilson JR, Reichek N, Dunkman WB et al. Effect of diuresis on the performance of the failing left ventricle in man. Am J Med. 1981;70:234-9.

116. Parker JO. The effects of oral ibopamine in patients with mild heart failure—a double blind placebo controlled comparison to furosemide. Int J Cardiol. 1993; 40:221-7. [PubMed 8225657]

117. Hansten PD, Horn JR. Diuretics and non-steroidal anti-inflammatory drugs. Drug Interact Newsl. 1986; 6:27-9.

118. O’Brien WM. Pharmacology of nonsteroidal anti-inflammatory drugs: practical review for clinicians. Am. J Med. 1983; 10:32-9.

119. Brater DC. Drug-drug and drug-disease interactions with nonsteroidal anti-inflammatory drugs. Am J Med. 1986; 80(Suppl 1A):62-77. [IDIS 212035] [PubMed 3511686]

120. Edecrin (ethacrynic acid and ethacrynate sodium) tablets and injection. In: MedWatch: summary of safety-related drug labeling changes approved by FDA. Rockville, MD: US Food and Drug Administration; 1999 Oct.

121. The United States pharmacopeia, 24th rev, and The national formulary, 19th ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 2000:689.

122. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

123. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

124. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

125. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

126. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289.

127. Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. J Am Coll Cardiol. 2001;38:2101-2113.

128. The Guidelines Subcommittee of the WHO/ISH Mild Hypertension Liaison Committee. 1999 guidelines for the management of hypertension. J Hypertension. 1999; 17:392-403.

129. Aton Pharma, Inc. Edecrin and Sodium Edecrin (ethacrynic acid and ethacrynate sodium) tablets and injection prescribing information. Lawrenceville, NJ; 2007 Oct. Accessed 2/27/08.

b. AHFS Drug Information. McEvoy GK, ed. Ethacrynic Acid, Ethacrynate Sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2753-2756.

More Ethacrynic Acid resources

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

• Ethacrynic Acid MedFacts Consumer Leaflet (Wolters Kluwer)


• ethacrynic acid Concise Consumer Information (Cerner Multum)


• ethacrynic acid Advanced Consumer (Micromedex) - Includes Dosage Information


• Edecrin Prescribing Information (FDA)


• Edecrin Sodium Advanced Consumer (Micromedex) - Includes Dosage Information

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Prozac

Generic Name: fluoxetine (Oral route)

floo-OX-e-teen hye-droe-KLOR-ide

Oral route(Capsule;Capsule, Delayed Release;Solution)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PROZAC(R) is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD) .

Oral route(Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SARAFEM(R) is not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

• Prozac


• Prozac Weekly


• Rapiflux


• Sarafem


• Selfemra

In Canada

• Alti-Fluoxetine Hydrochloride


• Fluoxetine

Available Dosage Forms:

• Capsule


• Capsule, Delayed Release


• Tablet


• Syrup


• Solution

Therapeutic Class: Antidepressant

Pharmacologic Class: Fluoxetine

Uses For Prozac

Fluoxetine is used to treat mental depression, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder.

Fluoxetine is used with olanzapine to treat depression that is a part of bipolar disorder. These medicines are also used together to treat treatment resistant depression in patients who have been treated with other antidepressants that did not work well. This medicine may also be used for other conditions as determined by your doctor.

Fluoxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, fluoxetine is used in certain patients with the following medical conditions:

• Premature ejaculation.

Before Using Prozac

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with depression. However, safety and efficacy have not been established in children younger than 8 years of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with obsessive-compulsive disorder. However, safety and efficacy have not been established in children younger than 7 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of fluoxetine in children with bulimia nervosa and panic disorder. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine and fluoxetine combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluoxetine in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood), which may require caution and an adjustment in the dose for patients receiving fluoxetine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Levomethadyl


• Linezolid


• Mesoridazine


• Methylene Blue


• Metoclopramide


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Pimozide


• Procarbazine


• Selegiline


• Terfenadine


• Thioridazine


• Toloxatone


• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Acecainide


• Aceclofenac


• Acemetacin


• Acenocoumarol


• Ajmaline


• Alclofenac


• Almotriptan


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Ancrod


• Anisindione


• Antithrombin III Human


• Apazone


• Aprindine


• Ardeparin


• Arsenic Trioxide


• Aspirin


• Astemizole


• Azimilide


• Benoxaprofen


• Bivalirudin


• Bretylium


• Bromfenac


• Bufexamac


• Carprofen


• Certoparin


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Cilostazol


• Citalopram


• Clarithromycin


• Clometacin


• Clonixin


• Clopidogrel


• Dalteparin


• Danaparoid


• Defibrotide


• Dermatan Sulfate


• Desipramine


• Desirudin


• Desvenlafaxine


• Dexfenfluramine


• Dexketoprofen


• Dextromethorphan


• Dibenzepin


• Diclofenac


• Dicumarol


• Diflunisal


• Dipyridamole


• Dipyrone


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Droxicam


• Duloxetine


• Eletriptan


• Enflurane


• Enoxaparin


• Eptifibatide


• Erythromycin


• Escitalopram


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenfluramine


• Fenoprofen


• Fentiazac


• Flecainide


• Floctafenine


• Fluconazole


• Flufenamic Acid


• Fluoxetine


• Flurbiprofen


• Fluvoxamine


• Fondaparinux


• Foscarnet


• Frovatriptan


• Gemifloxacin


• Halofantrine


• Haloperidol


• Halothane


• Heparin


• Hydroquinidine


• Ibuprofen


• Ibutilide


• Imipramine


• Indomethacin


• Indoprofen


• Isoflurane


• Isoxicam


• Isradipine


• Ketoprofen


• Ketorolac


• Lidoflazine


• Lorcainide


• Lornoxicam


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Mefloquine


• Meloxicam


• Meperidine


• Milnacipran


• Mirtazapine


• Nabumetone


• Nadroparin


• Naproxen


• Naratriptan


• Nepafenac


• Niflumic Acid


• Nimesulide


• Nortriptyline


• Octreotide


• Oxaprozin


• Oxyphenbutazone


• Parnaparin


• Paroxetine


• Pentamidine


• Pentosan Polysulfate Sodium


• Phenindione


• Phenprocoumon


• Phenylbutazone


• Pirazolac


• Pirmenol


• Piroxicam


• Pirprofen


• Prajmaline


• Prasugrel


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Propyphenazone


• Proquazone


• Quetiapine


• Rasagiline


• Reviparin


• Rizatriptan


• Salicylic Acid


• Salsalate


• Sematilide


• Sertindole


• Sertraline


• Sibutramine


• Sotalol


• Spiramycin


• St John's Wort


• Sulfamethoxazole


• Sulindac


• Sultopride


• Sumatriptan


• Suprofen


• Tamoxifen


• Tapentadol


• Tedisamil


• Telithromycin


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Ticlopidine


• Tinzaparin


• Tirofiban


• Tolmetin


• Tramadol


• Trazodone


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Tryptophan


• Vasopressin


• Venlafaxine


• Vilazodone


• Warfarin


• Ziprasidone


• Zolmitriptan


• Zomepirac


• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam


• Bupropion


• Buspirone


• Carbamazepine


• Clozapine


• Cyclobenzaprine


• Cyproheptadine


• Delavirdine


• Digoxin


• Fluphenazine


• Fosphenytoin


• Galantamine


• Ginkgo


• Iloperidone


• Lithium


• Metoprolol


• Nebivolol


• Paroxetine


• Pentazocine


• Phenytoin


• Risperidone


• Ritonavir


• Tetrabenazine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or


• Bleeding problems or


• Diabetes or


• Glaucoma, narrow angle or


• Hyponatremia (low sodium in the blood) or


• Mania, history of or


• Seizures, history of—Use with caution. May make these conditions worse.

• Diseases affecting metabolism or diseases involving blood circulation—Caution should be used in patients with these medical problems.

• Drug abuse, history of—Potential for increased dependence on this medicine.

• Electroconvulsive therapy (ECT)—Use with caution. May cause prolonged seizures in patients receiving ECT treatment with fluoxetine.

• Heart attack, recent history of or


• Heart disease, unstable—The effects of fluoxetine in patients with these conditions are not known.

• Kidney disease or


• Liver disease—Use with caution. Higher blood levels of fluoxetine may occur, increasing the chance of side effects.

• Weight loss—Fluoxetine may cause weight loss. This weight loss is usually small, but if a large weight loss occurs, it may be harmful in some patients especially in depressed or bulimic patients.

Proper Use of fluoxetine

This section provides information on the proper use of a number of products that contain fluoxetine. It may not be specific to Prozac. Please read with care.

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

If this medicine upsets your stomach, it may be taken with food.

If you are taking fluoxetine for depression, it may take 4 weeks or longer before you begin to feel better. Also, you may need to keep taking this medicine for 6 months or longer to stop the depression from returning.

If you are taking fluoxetine for obsessive-compulsive disorder, it may take 5 weeks or longer before you begin to get better. Your doctor should check your progress at regular visits during this time.

If you are taking fluoxetine for bulimia nervosa, you may begin to get better after 1 week. However, it may take 4 weeks or longer before you get better.

If you are using the oral liquid, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (delayed-release capsules, pulvules, or solution):
  
  • For depression:
    
    • Adults—At first, 20 milligrams (mg) once a day, taken as a single dose in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per day. Once your depression is under control, your doctor may wish to change you to a weekly dose. In this case, you will usually take a 90-mg capsule as a single dose one day per week.
    
    
    • Children 8 years of age and older—At first, 10 to 20 mg once a day, taken as a single dose in the morning. Your doctor may increase your dose as needed.
    
    
    • Children younger than 8 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For depression that occurs with bipolar disorder or treatment resistant depression:
    
    • Adults—At first, one capsule of 20 mg fluoxetine and 5 mg oral olanzapine once a day in the evening. Your doctor may increase your dose as needed. However, the dose is usually not more than 18 mg of oral olanzapine and 75 mg of fluoxetine per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For bulimia nervosa:
    
    • Adults—60 milligrams (mg) once a day, taken as a single dose in the morning. Your doctor may start with a lower dose and increase it gradually. The dose is usually not more than 60 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For obsessive-compulsive disorder:
    
    • Adults—At first, usually 20 milligrams (mg) once a day, taken as a single dose in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per day.
    
    
    • Children 7 years of age and older—At first, 10 mg once a day, taken as a single dose in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
    
    
    • Children younger than 7 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For panic disorder:
    
    • Adults—At first, 10 milligrams (mg) once a day, taken as a single dose in the morning or evening for one week. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For premenstrual dysphoric disorder:
    
    • Adults—At first, usually 20 milligrams (mg) once a day, taken as a single dose in the morning. Your doctor may have you take 20 mg every day of your menstrual cycle or for only 14 days out of your cycle. Your doctor will determine the use and dose that is right for you. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Prozac

It is important that your doctor check your progress at regular visits, to allow changes in your dose and help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Do not take fluoxetine within 2 weeks of taking an monoamine oxidase (MAO) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor for at least 5 weeks after taking fluoxetine. If you do, you may develop extremely high blood pressure or seizures.

Do not take thioridazine (Mellaril®) while you are taking fluoxetine or less than 5 weeks after you have stopped taking fluoxetine. You should not use pimozide (Orap®) while you are taking this medicine. Using these medicines together can cause very serious heart problems.

You should not take other medicines that also contain fluoxetine. This includes Symbyax®, Sarafem®, or Prozac® Weekly. Using these medicines together may increase your chance for more serious side effects.

If you develop a skin rash or hives, stop taking fluoxetine and check with your doctor as soon as possible.

Fluoxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not stop suddenly taking this medicine without checking first with your doctor. If you have been instructed to stop taking fluoxetine, ask your doctor how to slowly decrease the dose. This is to decrease the chance of having symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, a fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble with sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Make sure your doctor knows about all the other medicines you are using. Fluoxetine may cause serious conditions such as serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as linezolid [Zyvox®], lithium, tryptophan, St. John's Wort, or some pain medicines (e.g., tramadol [Ultram®], rizatriptan [Maxalt®], sumatriptan [Imitrex®], or zolmitriptan [Zomig®]). Check with your doctor first before taking any other medicines.

Fluoxetine may increase your risk for bleeding problems. Make sure your doctor knows if you are also using other medicines that thin the blood, such as aspirin, pain or arthritis medicines, sometimes called “NSAIDs” (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or warfarin (Coumadin®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Stop using the medicine and check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Avoid drinking alcohol while you are taking fluoxetine.

For diabetic patients:

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

This medicine may cause some people to become drowsy or less able to think clearly, or to have poor muscle control. Make sure you know how you react to fluoxetine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well able to control your movements.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Prozac Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Inability to sit still


• restlessness


• skin rash, hives, or itching

Less common

• Chills or fever


• joint or muscle pain

Rare

• Anxiety


• cold sweats


• confusion


• convulsions (seizures)


• cool pale skin


• diarrhea


• difficulty with concentration


• drowsiness


• dryness of the mouth


• excessive hunger


• fast or irregular heartbeat


• headache


• increased sweating


• increased thirst


• lack of energy


• mood or behavior changes


• overactive reflexes


• purple or red spots on the skin


• racing heartbeat


• shakiness or unsteady walk


• shivering or shaking


• talking, feeling, and acting with excitement and activity you cannot control


• trouble with breathing


• unusual or incomplete body or facial movements


• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain


• agitation


• back or leg pains


• bleeding gums


• blindness


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine or stools


• bloody, black, or tarry stools


• blue-yellow color blindness


• blurred vision


• chest pain or discomfort


• clay-colored stools


• constipation


• continuing vomiting


• cough or dry cough


• dark urine


• decreased urine output


• decreased vision


• depression


• difficulty with breathing


• difficulty with swallowing


• dizziness or lightheadedness


• eye pain


• fainting


• fast, pounding, or irregular heartbeat or pulse


• general body swelling


• high fever


• high or low blood pressure


• hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• hostility


• indigestion


• irregular or slow heart rate


• irritability


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of appetite


• loss of bladder control


• muscle twitching


• nausea


• nightmares


• no blood pressure or pulse


• noisy breathing


• nosebleeds


• pain in the ankles or knees


• painful, red lumps under the skin, mostly on the legs


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pinpoint red spots on the skin


• rapid weight gain


• red or irritated eyes


• red skin lesions, often with a purple center


• redness, tenderness, itching, burning, or peeling of the skin


• severe muscle stiffness


• severe sleepiness


• shortness of breath


• skin rash


• slurred speech


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stopping of heart


• sudden shortness of breath or troubled breathing


• sudden weakness in the arms or legs


• sudden, severe chest pain


• swelling of the face, ankles, or hands


• swollen or painful glands


• thoughts of killing oneself


• tightness in the chest


• tiredness


• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs


• unconsciousness


• unpleasant breath odor


• unusual bleeding or bruising


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• unusually pale skin


• use of extreme physical or emotional force


• vomiting of blood


• wheezing


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Actions that are out of control


• change in consciousness


• change in near or distance vision


• change in walking and balance


• clumsiness or unsteadiness


• confusion as to time, place, or person


• decreased awareness or responsiveness


• decreased interest in sexual intercourse


• difficulty in focusing eyes


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• feeling of constant movement of self or surroundings


• hallucinations


• high or low blood pressure


• holding false beliefs that cannot be changed by fact


• inability to have or keep an erection


• irregular heartbeat recurrent


• loss in sexual ability, desire, drive, or performance


• loss of bladder control


• loss of consciousness


• sensation of spinning


• severe muscle stiffness


• severe sleepiness


• shakiness in the legs, arms, hands, or feet


• sweating


• talking, feeling, and acting with excitement


• tiredness


• trembling or shaking of the hands or feet


• unresponsiveness


• unusual excitement, nervousness, or restlessness


• unusual or incomplete body or facial movements


• unusually pale skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decreased appetite

Less common or rare

• Abnormal dreams


• breast enlargement or pain


• change in sense of taste


• changes in vision


• feeling of warmth or heat


• flushing or redness of the skin, especially on face and neck


• frequent urination


• hair loss


• increased appetite


• increased sensitivity of the skin to sunlight


• menstrual pain


• stomach cramps, gas, or pain


• unusual secretion of milk, in females


• weight loss


• yawning

Incidence not known

• Cracks in the skin


• loss of heat from the body


• painful or prolonged erections of the penis


• scaly skin


• swelling of the breasts or breast soreness in both females and males


• unusual milk production

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Actions that are out of control


• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling


• crying


• depersonalization


• dizziness


• euphoria


• feeling of distress


• feeling that body or surroundings are turning


• general feeling of discomfort or illness


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• sleeplessness


• sweating


• unable to sleep


• vaginal bleeding

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Prozac side effects (in more detail)

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More Prozac resources

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

• Prozac Consumer Overview


• Prozac MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluoxetine Prescribing Information (FDA)


• Fluoxetine Hydrochloride Monograph (AHFS DI)


• Prozac Weekly Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Prozac Weekly Prescribing Information (FDA)


• Sarafem MedFacts Consumer Leaflet (Wolters Kluwer)


• Sarafem Prescribing Information (FDA)


• Selfemra Prescribing Information (FDA)

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