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Tuesday, 27 September 2016

Nalfon

Generic Name: fenoprofen (fen oh PROE fen)

Brand Names: Nalfon

What is Nalfon (fenoprofen)?

Fenoprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Fenoprofen works by reducing hormones that cause inflammation and pain in the body.

Fenoprofen is used to treat pain or inflammation caused by arthritis.

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

What is the most important information I should know about Nalfon (fenoprofen)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking fenoprofen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What should I discuss with my healthcare provider before taking Nalfon (fenoprofen)?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to fenoprofen, or if you have:

severe kidney disease;

a stomach ulcer or inflammatory bowel disease; or

a history of allergic reaction to aspirin or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take fenoprofen:

a history of heart attack, stroke, or blood clot;

heart disease, congestive heart failure, high blood pressure;

a history of stomach ulcers or bleeding, bowel problems, diverticulosis;

liver or kidney disease;

asthma;

polyps in your nose; or

if you smoke.

FDA pregnancy category C. It is not known whether fenoprofen is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking fenoprofen during the last 3 months of pregnancy may result in birth defects. Do not take fenoprofen during pregnancy unless your doctor has told you to. Fenoprofen 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. Do not give this medicine to a child younger than 14 years old without the advice of a doctor.

How should I take Nalfon (fenoprofen)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. The maximum amount of fenoprofen for adults is 3 grams (3000 mg) per day. Know the amount of fenoprofen in the specific product you are taking.

If you take fenoprofen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

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

Store fenoprofen 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, confusion, dizziness, drowsiness, black or bloody stools, coughing up blood, fever, urinating less than usual or not at all, shallow breathing, fainting, or coma.

What should I avoid while taking Nalfon (fenoprofen)?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain medicines similar to fenoprofen (such as aspirin, ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking fenoprofen. Alcohol can increase the risk of stomach bleeding. Fenoprofen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Nalfon (fenoprofen) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking fenoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

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

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

confusion, tremors or shaking;

urinating less than usual or not at all;

pain, burning, or bleeding when you urinate;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

dizziness, headache, nervousness;

skin itching or rash;

dry mouth;

increased sweating, runny nose;

blurred vision; or

ringing in your ears.

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 Nalfon (fenoprofen)?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with fenoprofen may cause you to bruise or bleed easily.

Before taking fenoprofen, tell your doctor if you are taking:

cyclosporine (Gengraf, Neoral, Sandimmune);

lithium (Eskalith, Lithobid);

diuretics (water pills) such as furosemide (Lasix);

aspirin or salicylates such as Doan's Pills, Dolobid, and others;

a blood thinner such as warfarin (Coumadin);

steroids (prednisone and others);

seizure medication such as phenobarbital (Luminal, Solfoton) or phenytoin (Dilantin);

a sulfa drug such as Bactrim or Septra;

oral diabetes medications such as glipizide (Glucotrol), glimepiride (Amaryl, Duetact, Avandaryl), and others; or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), nabumetone (Relafen), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others.

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

More Nalfon resources

Nalfon Side Effects (in more detail)
Nalfon Use in Pregnancy & Breastfeeding
Drug Images
Nalfon Drug Interactions
Nalfon Support Group
1 Review for Nalfon - Add your own review/rating

Nalfon Prescribing Information (FDA)

Nalfon Monograph (AHFS DI)

Nalfon Advanced Consumer (Micromedex) - Includes Dosage Information

Nalfon MedFacts Consumer Leaflet (Wolters Kluwer)

Fenoprofen Prescribing Information (FDA)

Fenoprofen MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Nalfon with other medications

Gout, Acute
Osteoarthritis
Pain
Rheumatoid Arthritis

Where can I get more information?

Your pharmacist can provide more information about fenoprofen.

See also: Nalfon side effects (in more detail)

Numorphan

oxymorphone hydrochloride

Dosage Form: Suppositories and Injection, USP CII

Numorphan Description

Numorphan (oxymorphone hydrochloride, USP), a semi-synthetic opioid substitute for morphine, is a potent analgesic.

Oxymorphone hydrochloride is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98.

Numorphan Injection is available in two concentrations, 1 mg/mL, 1 mL ampul and 1.5 mg/mL, 10 mL vial of oxymorphone hydrochloride. In addition, each 1 mg/mL ampul contains 8.0 mg/mL sodium chloride. Each 1.5 mg/mL vial contains 8.0 mg/mL sodium chloride, 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben. pH for both the ampul and vial is adjusted with hydrochloric acid.

The Numorphan Rectal Suppository is available in a concentration of 5 mg of oxymorphone hydrochloride in a base consisting of polyethylene glycol 1000 and polyethylene glycol 3350.

Numorphan - Clinical Pharmacology

Numorphan is a potent opioid analgesic. Administered parenterally, 1 mg of Numorphan is approximately equivalent in analgesic activity to 10 mg of morphine sulfate.

Many of the effects described below are common to the class of opioid analgesics, including Numorphan.

Central Nervous System (CNS)

Opioid analgesics exert their principal pharmacologic effects on the CNS and the gastrointestinal tract. The principal actions of therapeutic value are analgesia and sedation. The precise mechanism of the analgesic action is unknown. However, specific CNS opiate receptors have been identified and likely play a role in the expression of analgesic effects.

Opioids produce respiratory depression by direct action on brain stem respiratory centers. The mechanism of respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation. Opioids depress the cough reflex by direct action on the cough center in the medulla. Opioids cause miosis. Pinpoint pupils are a common sign of opioid overdose but are not pathognomonic. Marked mydriasis may be seen with worsening hypoxia.

Gastrointestinal Tract and Other Smooth Muscle

Opioids decrease gastric, biliary, and pancreatic secretions. These drugs cause a reduction in motility associated with an increase in tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased while tone is increased to the point of spasm. The end result is constipation. Opioids can cause a marked increase in biliary tract pressure as a result of spasm of the sphincter of Oddi.

Opioids increase smooth muscle tone in the urinary tract and can induce spasms. Urinary urgency and difficulty with urination may result. These effects, in conjunction with the central effect of these drugs on release of vasopressin, may produce oliguria.

Pharmacokinetics

The onset of action of parenterally administered Numorphan is rapid; initial effects are usually perceived within 5 to 10 minutes. Its duration of action is approximately 3 to 6 hours.

Distribution

After an IV dose, the steady state volume of distribution was 3.08 ± 1.14 L/kg in healthy male and female subjects.

Metabolism

Oxymorphone undergoes extensive hepatic metabolism in humans. After a 10 mg oral dose, 49% was excreted over a five-day period in the urine. Of this, 82% was excreted in the first 24 hours after administration. The recovered drug-related products contained the oxymorphone (1.9%), the conjugate of oxymorphone (44.1%), the 6β-carbinol produced by 6-keto reduction of oxymorphone (0.3%), and the conjugates of 6β-carbinol (2.6%) and 6α-carbinol (0.1%).

Elimination

In healthy subjects, the mean terminal half-life of oxymorphone was 1.3 ± 0.7 hours. The mean systemic clearance was 2.0 ± 0.5 L/min.

Indications and Usage for Numorphan

Numorphan Suppository is indicated for the relief of moderate to severe pain.

Numorphan Injection is indicated for the relief of moderate to severe pain. It is also indicated for preoperative medication, for support of anesthesia, for obstetrical analgesia, and for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction.

Contraindications

Numorphan should not be administered to patients who are hypersensitive to oxymorphone hydrochloride or to any of the other ingredients in Numorphan, or hypersensitive to morphine analogs.

Numorphan should not be administered to individuals during an acute asthmatic attack or to patients with severe respiratory depression, upper airway obstruction, or any patient who has or is suspected of having a paralytic ileus. Numorphan should not be used in the treatment of pulmonary edema secondary to a chemical respiratory irritant. Opioid analgesics cause pooling of blood in the extremities by decreasing peripheral vascular resistance. This effect results in decreases in venous return, cardiac work, and pulmonary venous pressure, and blood is shifted from the central to peripheral circulation which would not be beneficial in the treatment of pulmonary edema secondary to a chemical respiratory irritant.

Warnings

Interactions with Other Central Nervous System Depressants

Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics or other CNS depressants (including alcohol) concomitantly with Numorphan may exhibit an additive CNS depression (see PRECAUTIONS; Drug Interactions).

Respiratory Depression

Numorphan should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression or coma.

Head Injury and Increased Intracranial Pressure

The possible respiratory depressant effects of potent analgesics and their potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated in the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, potent analgesics can produce effects which may obscure the clinical course of patients with head injuries. Therefore, Numorphan should be used in these circumstances only when essential, and then should be administered with extreme caution.

Acute Abdominal Conditions

The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Drug Dependence

Numorphan, as with other opioid drugs, can produce tolerance, psychological dependence, and physical dependence and has the potential for being abused (see DRUG ABUSE AND DEPENDENCE).

Pregnancy

Safe use in pregnancy has not been established (relative to possible adverse effects on fetal development). As with other analgesics, the use of Numorphan in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child (see PRECAUTIONS).

Precautions

General

Special Risk Patients

Numorphan should be used with caution in elderly and debilitated patients and in patients who are known to be sensitive to central nervous system depressants, such as those with cardiovascular, pulmonary, renal or hepatic disease. Caution should also be exercised in patients with hypothyroidism, acute alcoholism, delirium tremens, convulsive disorders, Addison’s disease, gallbladder disease or gallstones, prostatic hypertrophy or urethral stricture, recent gastrointestinal or genitourinary tract surgery, inflammatory bowel disease, diarrhea secondary to poisoning until the toxin is eliminated, diarrhea secondary to pseudomembranous colitis, cardiac arrhythmias, increased ocular pressure, and toxic psychosis. Debilitated and elderly patients and those with severe liver disease should receive smaller doses of Numorphan.

Hypotensive Effect

Opioid analgesics may cause severe hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or coadministration of drugs such as phenothiazines or general anesthetics. Administer with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure. Orthostatic hypotension may occur in ambulatory patients.

Information for Patients

Patients should be cautioned regarding the following:

Drowsiness, dizziness, or lightheadedness related to the use of this medication may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car, operating machinery, etc.

This medication, like other opioid analgesics, will add to the effect of alcohol and other CNS depressants [such as antihistamines, sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, tricyclic antidepressants, and monoamine oxidase (MAO) inhibitors]. Alcohol should not be consumed while taking Numorphan.

Withdrawal side effects may be precipitated by suddenly stopping this drug after prolonged use (regular use for several weeks or more). The medication should be gradually reduced before completely discontinuing use.

Elderly patients are more sensitive to opioid analgesics, especially the respiratory depressant effects and opioid induced urinary retention. Lower doses or longer dosing intervals may be required.

Orthostatic hypotension may occur with the use of this medication, especially in ambulatory patients. Patients should get up slowly from a lying or sitting position.

Numorphan (oxymorphone hydrochloride, USP) may be habit forming and has the potential for being abused. Tolerance, psychological and physical dependence can occur.

Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence, and neonatal withdrawal may occur.

Laboratory Tests

Opioids may increase biliary tract pressure with resultant increases in plasma amylase or lipase.

Drug Interactions

The concomitant use of other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, and alcohol may produce additive CNS depressant effects. When such combined therapy is contemplated, the dose of one or both agents should be reduced (see WARNINGS).

Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

It has been reported that the incidence of bradycardia was increased when oxymorphone was combined with propofol for induction of anesthesia.

In addition, CNS toxicity has been reported (confusion, disorientation, respiratory depression, apnea, seizures) following coadministration of cimetidine with opioid analgesics; no clear-cut cause and effect relationship was established.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies have not been performed in animals to evaluate the carcinogenic potential of Numorphan. Studies to evaluate the mutagenic potential of Numorphan have not been conducted. There have been no studies to evaluate the effect of Numorphan on fertility.

Usage in Pregnancy

Teratogenic Effects: Pregnancy Category C: Numorphan was reported to produce malformations in offspring of hamsters that received 1,500 times the recommended human dose on Day 8 of gestation. There have been no adequate and well-controlled studies of reproductive toxicity in other laboratory animals or in pregnant women. It is not known whether Numorphan can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. As with other opioid analgesics, the use of Numorphan in pregnancy or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child.

Non-teratogenic Effects

Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence. Neonatal withdrawal may occur. Symptoms usually appear during the first days of life and may include convulsions, irritability, excessive crying, tremors, hyperactive reflexes, fever, vomiting, diarrhea, sneezing, yawning, and increased respiratory rate.

Labor and Delivery

Numorphan should be used with caution during labor. Sinusoidal fetal heart rate patterns may occur with the use of opioid analgesics.

Opioid analgesics in therapeutic doses may prolong labor. Generally, the effect of opioids on the pregnant uterus appears to depend on the time of administration; administration of the drugs during the latent phase of the first stage of labor, or before cervical dilation of 4-5 cm has occurred, may hamper the progress of labor.

Opioid analgesics, including Numorphan, may cause respiratory depression in the newborn. The effect of Numorphan, if any, on the later growth, development, and functional maturation of the child is unknown.

Nursing Mothers

It is not known whether Numorphan is excreted in human milk. Because many drugs, including some opioids, are excreted in human milk, caution should be exercised when Numorphan is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Numorphan in pediatric patients below the age of 18 years have not been established.

Adverse Reactions

As with all potent opioid analgesics, possible side effects when using Numorphan include:

Central Nervous System

Drowsiness, sedation, lightheadedness, unusual tiredness or weakness, headache, dysphoria, euphoria, miosis, diplopia, blurred vision, nervousness, restlessness, confusion, mental clouding, trouble sleeping, paradoxical CNS stimulation, hallucinations, mental depression.

Gastrointestinal System

Nausea, vomiting, dry mouth, constipation, biliary tract spasm, cramps or pain, loss of appetite, paralytic ileus or toxic megacolon in patients with inflammatory bowel disease.

Cardiovascular System

Hypotension, orthostatic hypotension particularly in ambulatory patients, tachycardia, bradycardia, palpitations, flushing.

Respiratory System

Respiratory depression, atelectasis, allergic bronchospastic reaction, allergic laryngeal edema, allergic laryngospasm.

Genitourinary System

Ureteral spasm, urinary hesitancy or retention, antidiuretic effect.

Dermatologic

Itching, sweating, injection site reaction, allergic reaction (such as skin rash, hives, and/or itching, swelling of the face).

Drug Abuse and Dependence

Numorphan is a Schedule II opioid and is subject to the Federal Controlled Substances Act.

Numorphan, as with other opioid drugs, can produce tolerance, psychological dependence, and physical dependence and has the potential for being abused. The addiction potential of the drug appears to be about the same as for morphine.

Withdrawal symptoms may occur when opioids are abruptly discontinued after prolonged use. Withdrawal symptoms may be characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, gooseflesh, restless sleep, and mydriasis during the first 24 hours. These symptoms often increase in severity and over the next 72 hours may be accompanied by increasing irritability, anxiety, weakness, twitching, and spasms of muscles; kicking movements; severe backaches; abdominal and leg pains; abdominal and muscle cramps; hot and cold flashes; insomnia; nausea, anorexia, vomiting, intestinal spasm, diarrhea, coryza, and repetitive sneezing; increase in body temperature, blood pressure, respiratory rate and heart rate. Because of excessive loss of fluids through sweating, vomiting and diarrhea, there is usually marked weight loss, dehydration, ketosis, and disturbances in acid-base balance. Cardiovascular collapse can occur. Without treatment most observable symptoms disappear in 5-14 days; however, there appears to be a phase of secondary or chronic abstinence which may last for 2-6 months characterized by decreasing insomnia, irritability, and muscular aches. In addition, the patient may have miosis and a slight lowering of blood pressure, pulse rate, and body temperature; respiratory centers exhibit a decreased response to the stimulatory effects of carbon dioxide.

The dose of Numorphan should be gradually reduced before discontinuation in those patients who require treatment for physical dependence.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms (see PRECAUTIONS; Usage in Pregnancy).

Overdosage

Signs and Symptoms

Serious overdosage with Numorphan is characterized by respiratory depression, (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride (NARCAN®) is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids including oxymorphone. Therefore, an appropriate dose of naloxone hydrochloride should be administered (usual initial adult dose 0.4 mg-2 mg) preferably by the intravenous route and simultaneously with efforts at respiratory resuscitation. Since the duration of action of oxymorphone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.

Naloxone hydrochloride should not be administered in the absence of clinically significant respiratory or cardiovascular depression. In addition, it should be considered that the use of an opioid antagonist in patients physically dependent on opioids may precipitate an acute withdrawal syndrome that cannot be readily suppressed while the action of the antagonist persists. If respiratory depression is associated with muscular rigidity, administration of a neuromuscular blocking agent may be necessary to facilitate assisted or controlled ventilation. Muscular rigidity may also respond to opioid antagonist therapy.

Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.

Numorphan Dosage and Administration

Smaller doses of Numorphan than those recommended below should be used for debilitated and elderly patients and those with severe liver disease.

Usual Adult Dosage of Numorphan Injection

Subcutaneous or intramuscular administration: initially 1 mg to 1.5 mg, repeated every 4 to 6 hours as needed. Intravenous: 0.5 mg initially. In non debilitated patients the dose can be cautiously increased until satisfactory pain relief is obtained. For analgesia during labor 0.5 mg to 1 mg intramuscularly is recommended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Usual Adult Dosage of Numorphan Rectal Suppositories

One suppository, 5 mg, every 4 to 6 hours. In non debilitated patients the dose can be cautiously increased until satisfactory pain relief is obtained.

How is Numorphan Supplied

For Injection

DEA Order Form Required

1 mg/mL 1 mL ampuls

(paraben/sodium dithionite-free) (box of 10) NDC 63481-444-10

1.5 mg/mL 10 mL multiple dose vials

(sodium dithionite-free) (box of 1) NDC 63481-445-01

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

Protect from light.

For Rectal Suppositories

DEA Order Form Required

5 mg Wrapped in gold foil (box of 6) NDC 63481-761-06

Store under refrigeration 2° - 8°C (36°- 46°F).

Manufactured for:

Endo Pharmaceuticals Inc.

Chadds Ford, Pennsylvania 19317

Numorphan® is a Registered Trademark of Endo Pharmaceuticals Inc.

NARCAN® is a Registered Trademark of Endo Pharmaceuticals Inc.

Printed in U.S.A.

542789/April, 2004

Numorphan
oxymorphone hydrochloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	63481-444
Route of Administration	PARENTERAL	DEA Schedule	CII

INGREDIENTS
Name (Active Moiety)	Type	Strength
oxymorphone hydrochloride (oxymorphone)	Active	1 MILLIGRAM In 1 MILLILITER
sodium chloride	Inactive	8.0 MILLIGRAM In 1 MILLILITER
hydrochloric acid	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	63481-444-10	10 AMPULE In 1 BOX	contains a AMPULE
1		1 mL (MILLILITER) In 1 AMPULE	This package is contained within the BOX (63481-444-10)

Numorphan
oxymorphone hydrochloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	63481-445
Route of Administration	PARENTERAL	DEA Schedule	CII

INGREDIENTS
Name (Active Moiety)	Type	Strength
oxymorphone hydrochloride (oxymorphone)	Active	1.5 MILLIGRAM In 1 MILLILITER
sodium chloride	Inactive	8 MILLIGRAM In 1 MILLILITER
methylparaben	Inactive	1.8 MILLIGRAM In 1 MILLILITER
propylparaben	Inactive	0.2 MILLIGRAM In 1 MILLILITER
hydrochloric acid	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	63481-445-01	1 VIAL In 1 BOX	contains a VIAL, MULTI-DOSE
1		10 mL (MILLILITER) In 1 VIAL, MULTI-DOSE	This package is contained within the BOX (63481-445-01)

Numorphan
oxymorphone hydrochloride suppository

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	63481-761
Route of Administration	RECTAL	DEA Schedule	CII

INGREDIENTS
Name (Active Moiety)	Type	Strength
oxymorphone hydrochloride (oxymorphone)	Active	5 MILLIGRAM In 1 SUPPOSITORY
polyethylene glycol 1000	Inactive
polyethylene glycol 3350	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	63481-761-06	6 SUPPOSITORY In 1 BOX	None

Revised: 05/2006Endo Pharmaceuticals Inc.

More Numorphan resources

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

Compare Numorphan with other medications

Labor Pain
Pain

Thursday, 22 September 2016

Dexedrine Spansules

Generic Name: dextroamphetamine (Oral route)

dex-troe-am-FET-a-meen

Oral route(Tablet;Capsule, Extended Release)

Amphetamines have a high potential for abuse, and administration for prolonged periods of time may lead to drug dependence and must be avoided. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events .

Commonly used brand name(s)

In the U.S.

Dexedrine

Dexedrine Spansules

Dextrostat

Liquadd

ProCentra

Available Dosage Forms:

Capsule, Extended Release

Solution

Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine (class)

Uses For Dexedrine Spansules

Dextroamphetamine belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep) .

Dextroamphetamine increases attention and decreases restlessness in patients who are overactive, cannot concentrate for very long or are easily distracted, and have unstable emotions. It is also used as part of a total treatment program that also includes social, educational, and psychological treatment .

This medicine is available only with a doctor's prescription. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you or your child needs this medicine .

Before Using Dexedrine Spansules

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 have not been performed on the relationship of age to the effects of dextroamphetamine in children with attention-deficit hyperactivity disorder below 3 years of age. Safety and efficacy have not been established .

Dextroamphetamine sustained-release capsule is not recommended in children below 6 years of age .

Geriatric

No information is available on the relationship of age to the effects of dextroamphetamine in geriatric patients .

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

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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.

Clorgyline

Furazolidone

Iproniazid

Isocarboxazid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Selegiline

Sibutramine

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.

Citalopram

Venlafaxine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of dextroamphetamine

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

Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence) .

If you or your child think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Instead, check with your doctor .

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions .

If you or your child use the tablet form of this medicine, and you take it two or three times a day. Take the first dose in the morning. The other doses may be taken during the day with 4 to 6 hours between doses .

It is best to take the sustained-release capsule in the morning. Taking this medicine in the afternoon or evening could make it harder for you to fall asleep .

Swallow the sustained-release capsule whole. Do not crush, break, or chew it .

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 attention-deficit hyperactivity disorder (ADHD):):
- For oral dosage form (tablets):
  - Adults and children 6 years of age and older—At first, 5 milligrams (mg) one or two times a day. Your doctor may adjust your dose if needed.
  - Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may adjust your dose if needed.
  - Children younger than 3 years of age—Use and dose must be determined by your doctor .
- For oral dosage form (sustained-release capsules):
  - Adults and children 6 years of age and older—At first, 5 milligrams (mg) one or two times a day. Your doctor may adjust your dose if needed.
  - Children younger than 6 years of age—Use and dose must be determined by your doctor .

For narcolepsy:
- For oral dosage form (tablets or sustained-release capsules):
  - Adults and children 12 years of age and older—At first, 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
  - Children 6 to 12 years of age—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
  - Children younger than 6 years of age—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 Dexedrine Spansules

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

If you or your child will be taking this medicine in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely .

Do not take dextroamphetamine within 14 days of taking an MAO inhibitor such as Eldepryl®, Marplan®, Nardil®, or Parnate®.

This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor) .

If you or your child have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs that you may be dependent on dextroamphetamine are:

A strong desire or need to continue taking the medicine.

A need to increase the dose to receive the effects of the medicine.

Withdrawal effects (for example, mental depression, nausea or vomiting, stomach cramps or pain, trembling, unusual tiredness or weakness) that occur after the medicine is stopped .

This medicine may cause slow growth in children. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly .

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 .

Dexedrine Spansules 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:

Rare

Agitation

delusions

hallucinations

Incidence not known

Blurred vision

chest discomfort or pain

difficulty breathing

dizziness

faintness

false or unusual sense of well-being

fast, pounding, or irregular heartbeat or pulse

headache

nervousness

pounding in the ears

restlessness

shakiness in legs, arms, hands, or feet

shortness of breath

sleeplessness

swelling of feet or lower legs

trembling or shaking of hands or feet

trouble sleeping

troubled breathing

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

unable to sleep

uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)

unusual tiredness or weakness

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

Symptoms of overdose

Change in consciousness

dark-colored urine

diarrhea

discouragement

feeling sad or empty

fever

irritability

lack of appetite

loss of consciousness

loss of interest or pleasure

mood or mental changes

muscle cramps or spasms

muscle pain or stiffness

nausea

panic state

physical attempt to injure

rapid breathing

seizures

stomach cramps

sweating

trouble concentrating

trouble sleeping

violent actions

vomiting

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:

Incidence not known

Bad, unusual, or unpleasant (after)taste

change in taste

constipation

decreased interest in sexual intercourse

dry mouth

hives or welts

inability to have or keep an erection

indigestion

itching

loss in sexual ability, desire, drive, or performance

passing of gas

redness of skin

skin rash

weight loss

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: Dexedrine Spansules side effects (in more detail)

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Nystatin

Class: Polyenes
VA Class: AM700
CAS Number: 1400-61-9
Brands: Mycostatin, Mykacet, Nystat-Rx, Nystop, Pedi-Dri

Introduction

Antifungal; polyene antibiotic.¹²⁸ ¹²⁹ ¹³⁰ ¹³¹ ¹³³ ¹³⁴ ¹⁵⁰

Uses for Nystatin

Cutaneous and Mucocutaneous Candidiasis

Treatment of cutaneous infections caused by Candida,¹²⁸ ¹³⁰ ¹³³ ¹⁴⁷ ¹⁴⁸ ¹⁴⁹ including perlèche, intertriginous candidiasis, and paronychia.^e Used topically alone¹²⁸ ¹³³ ¹⁴⁷ ¹⁴⁹ or in fixed combination with a corticosteroid (triamcinolone acetonide).¹³⁰

Treatment of candidal diaper dermatitis.¹¹⁴ ¹¹⁵ ¹⁴⁹ ¹⁵⁰ Treatment of choice is a topical antifungal (e.g., nystatin, clotrimazole, miconazole);¹¹⁵ may be used in conjunction with a topical corticosteroid.¹³⁰ ^e ¹⁴⁹ The majority of infants with candidal diaper dermatitis harbor C. albicans in their intestines and infected feces appear to be an important source of the cutaneous infection.¹¹⁵ Some clinicians recommend that an oral antifungal agent (e.g., oral nystatin) be administered concomitantly to treat the intestinal infection,¹¹⁵ but studies have not provided evidence that concomitant oral and topical therapy is more effective than topical therapy alone.¹¹⁴ ¹¹⁵

Oropharyngeal Candidiasis

Treatment of oropharyngeal candidiasis (thrush).¹¹¹ ¹²⁶ ¹³¹ ¹⁴⁶ ¹⁴⁹

Uncomplicated oropharyngeal candidiasis usually can be treated using oral topical therapy (clotrimazole lozenge or nystatin oral suspension); systemic oral antifungals (fluconazole, itraconazole, ketoconazole) usually are reserved for treatment of oropharyngeal candidiasis unresponsive to oral topical antifungals or for severe oropharyngeal candidiasis with esophageal involvement.¹¹¹ ¹²⁶ Some clinicians prefer to use systemic oral azole antifungals for initial therapy of oropharyngeal candidiasis in HIV-infected individuals.¹¹¹ ¹¹²

Nystatin is ineffective for treatment of esophageal candidiasis in HIV-infected individuals.¹¹¹ ¹¹²

Intestinal Candidiasis

Oral treatment of mucous membrane (nonesophageal) GI candidiasis.¹³¹ ¹³⁴

Has been used orally in conjunction with an intravaginal antifungal to treat coexisting intestinal candidiasis and vulvovaginal candidiasis.¹⁰⁰ ¹⁰¹ (See Vulvovaginal Candidiasis under Uses.)

Vulvovaginal Candidiasis

Treatment of vulvovaginal candidiasis.¹⁰² ¹⁰⁸ ¹¹⁹ ¹²² ¹²⁹ CDC and other clinicians recommend that uncomplicated vulvovaginal candidiasis (defined as vulvovaginal candidiasis that is mild to moderate, sporadic or infrequent, most likely caused by C. albicans, or occurring in immunocompetent women) be treated with an intravaginal azole antifungal (e.g., butoconazole, clotrimazole, miconazole, terconazole, tioconazole) or, alternatively, oral fluconazole.¹⁰² ¹⁰⁸ ¹¹⁶ ¹¹⁸ ¹¹⁹ ¹²² ¹²³ ¹²⁷ Intravaginal nystatin can be used for uncomplicated vulvovaginal candidiasis,¹⁰² ¹⁰⁸ ¹²⁷ but generally is less effective than intravaginal azole antifungals.¹⁰² ¹²⁷

Has been used orally in conjunction with an intravaginal antifungal to treat coexisting intestinal candidiasis and vulvovaginal candidiasis.¹⁰⁰ ¹⁰¹ While early studies provided some limited evidence that reducing intestinal candidal colonization could improve the mycologic response and reduce the recurrence rate of vulvovaginal candidiasis,¹⁰⁰ ¹⁰¹ most evidence suggests that combined oral and intravaginal therapy does not substantially reduce the risk of recurrence compared with intravaginal therapy alone.¹⁰³ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶

Topical treatment of male sexual partners of women with recurrent vulvovaginal candidiasis who have symptomatic balanitis or penile dermatitis.¹⁰² Routine treatment of asymptomatic male sexual partners of women with recurrent vulvovaginal candidiasis is not recommended but may be considered when the woman has recurrent infections.¹⁰² ¹²⁰ ¹²⁴

Prevention of Candida Infections

Oral nystatin has been used for prevention of initial or recurrent mucocutaneous candidiasis (including oropharyngeal candidiasis) in HIV-infected individuals†,¹¹⁰ but is no longer included in the prophylaxis guidelines of the Prevention of Opportunistic Infections Working Group of the US Public Health Service and Infectious Diseases Society of America (USPHS/IDSA).¹⁰⁹ If prophylaxis of mucocutaneous candidiasis is indicated in HIV-infected individuals with history of frequent or severe episodes of oropharyngeal, esophageal, or vaginal candidiasis, USPHS/IDSA recommends fluconazole or, alternatively, itraconazole.¹⁰⁹

Oral nystatin has been used in various regimens for prophylaxis† against candida infections during periods of iatrogenic neutropenia in patients receiving immunosuppressive therapy (e.g., patients with malignancies, transplant recipients).¹³⁵ ¹³⁶ ¹³⁷ ¹³⁸ ¹³⁹ ¹⁴⁰ ¹⁴⁴ Routine primary antifungal prophylaxis in neutropenic patients is not recommended, but may be considered in certain carefully selected high-risk patients (e.g., solid organ transplant recipients, patients in institutions that have a high incidence of fungal infections).¹⁴¹ ¹⁴³ ¹⁴⁵ If primary prophylaxis against candida infections is used in cancer or transplant recipients, many clinicians recommend oral fluconazole.¹⁴¹ ¹⁴³

Nystatin Dosage and Administration

Administration

Apply topically to the skin as a cream, ointment, or powder.¹²⁸ ¹³⁰ ¹³³ ¹⁴⁷ ¹⁴⁸ Administer topically to the oral cavity as an oral suspension.¹³¹ ¹⁴⁶ Administer intravaginally as a vaginal tablet.¹²⁹ Administer orally as film-coated tablets.¹³⁴

Topical creams, ointments, or powders should not be ingested, applied to the eye, or administered intravaginally.¹²⁸ ¹³⁰ ¹³³ ^e

Topical Administration

When treating cutaneous candidiasis, use proper hygiene and skin care measures to prevent spread of infection and reinfection; keep affected areas dry and exposed to air if possible.^e

Cream may be preferred instead of ointment in intertriginous areas; powder may be preferred if lesions are very moist.¹⁴⁷

Avoid occlusive dressings.^e

Cream or Ointment

Apply cream or ointment to affected area and gently and thoroughly massage into the skin.¹²⁸ ¹³⁰ ¹⁴⁷ ¹⁴⁸

Powder

Apply powder to affected areas.¹³³

For treatment of candidal foot infections, dust powder onto feet and into shoes and stockings.¹²⁸ ¹³³

Oral Topical Administration

For Oral Suspension

The powder for oral suspension is used by the patient to extemporaneously prepare each individual dose at the time of administration.¹³¹ Add the appropriate dose of powder (units of nystatin) to the volume of water recommended by the manufacturer (e.g., 118–177 mL) and stir well until suspended.¹³¹

Place one-half of the oral suspension in one side of the mouth and retain in the mouth for as long as possible before swallowing.¹³¹ Repeat using the remainder of the oral suspension in the other side of the mouth.¹³¹

Suspension

Shake suspension well before using.¹⁴⁶

Place one-half of the dose in each side of the mouth (use a dropper in infants and young children) and retain in the mouth as long as possible before swallowing.¹⁴⁶ Do not feed infants for 5–10 minutes after the dose.¹⁴⁶

Intravaginal Topical Administration

Insert vaginal tablet high in the vagina using the applicator provided by the manufacturer.¹²⁹

Continue intravaginal nystatin during menstruation.¹²⁹ Cleansing douches may be used by nonpregnant patients; adjunctive anti-infective douches are unnecessary.¹²⁹

Dosage

Pediatric Patients

Cutaneous Candidiasis

Topical

Cream, ointment, or powder: Apply to affected areas 2 or 3 times daily for ≥2 weeks.¹²⁸ ¹³³ ¹⁴⁷ ¹⁴⁸ ^e

Candidal Diaper Dermatitis

Topical

Cream, ointment, or powder: Apply to affected areas several times daily for 7–10 days.¹¹⁴ ¹⁵⁰

Fixed-combination cream or ointment containing nystatin and triamcinolone acetonide: Apply to affected area in the morning and evening.¹³⁰ ^e

Oral

Oral suspension: As an adjunct to topical nystatin, some clinicians recommend oral administration of 100,000 units of nystatin 4 times daily.^e ¹³²

Oropharyngeal Candidiasis

Oral Topical

Oral suspension: 200,000 units 4 times daily in infants or 400,000–600,000 units 4 times daily in children.¹³¹ ¹⁴⁶ Limited data indicate that 100,000 units 4 times daily is effective in premature and low birthweight infants.¹⁴⁶

Continue treatment for 14 days or for ≥48 hours after perioral symptoms have disappeared and cultures have returned to normal.¹³¹ ¹⁴⁶ If symptoms persist, confirm the diagnosis of candidiasis and rule out other pathogens before initiating another course of nystatin therapy.¹³¹

Adults

Cutaneous Candidiasis

Topical

Cream, ointment, or powder: Apply to affected areas 2 or 3 times daily for ≥2 weeks.¹²⁸ ¹³³ ¹⁴⁷ ¹⁴⁸ ^e

Fixed combination cream or ointment containing nystatin and triamcinolone acetonide: Apply to affected area in the morning and evening.¹³⁰

Symptomatic improvement of cutaneous or mucocutaneous candidal infections usually occurs within 1–3 days; however, continue therapy for ≥2 weeks.^e Discontinue therapy only after 2 successive negative tests for Candida.^e

Clinical and mycologic cure for chronic paronychia may require several months of therapy.^e

Oropharyngeal Candidiasis

Oral Topical

Oral suspension: 400,000 to 600,000 units 4 times daily.¹³¹ ¹⁴⁶ In HIV-infected individuals, 500,000 to 1,000,000 units 3–5 times daily.¹¹¹

Continue treatment for 14 days or for ≥48 hours after perioral symptoms have disappeared and cultures have returned to normal.¹³¹ If symptoms persist, confirm the diagnosis of candidiasis and rule out other pathogens before initiating another course of nystatin therapy.¹³¹

Intestinal Candidiasis

Oral

Oral suspension prepared using the powder for oral suspension: 500,000 to 1 million units 3 times daily for ≥48 hours after clinical cure.¹³¹

Film-coated tablets: 2 tablets (500,000 to 1 million units) 3 times daily for ≥48 hours after clinical cure.¹³¹

Vulvovaginal Candidiasis

Intravaginal

Vaginal tablet: 1 tablet (100,000 units) once daily for 14 days.¹⁰² ¹²⁹

Cautions for Nystatin

Contraindications

Hypersensitivity to nystatin or any ingredient in the formulation.¹²⁸ ¹²⁹ ¹³⁰ ¹³¹ ¹³³ ¹³⁴ ¹⁴⁶ ¹⁴⁷ ¹⁴⁸

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Irritation or sensitization may occur.¹²⁹ Rash, urticaria, and Stevens-Johnson syndrome reported rarely.¹²⁸ ¹³³ ¹³⁴

Discontinue therapy if irritation or sensitization occurs.¹²⁸ ¹²⁹ ¹³¹ ¹³³ ¹³⁴ ¹⁴⁶ ¹⁴⁷ ¹⁴⁸

General Precautions

Selection and Use of Antifungals

Nystatin topical creams, ointments, or powders should not be used for treatment of systemic, oral, ophthalmic, or intravaginal infections.¹²⁸ ¹³³

Nystatin oral suspension or film-coated oral tablets should not be used for treatment of systemic fungal infections.¹³⁴ ¹⁴⁶

Prior to use of topical nystatin for treatment of cutaneous or mucocutaneous Candida infections¹²⁸ ¹³³ and prior to use of intravaginal nystatin tablets for treatment of vulvovaginal candidiasis, diagnosis should be confirmed by microscopic examination (saline or potassium hydroxide [KOH] wet mount or Gram stain) and/or culture.¹⁰² ¹¹⁹ ¹²⁸ ¹²⁹ ¹³³

If symptoms persist after initial treatment, confirm the diagnosis and rule out other pathogens before initiating another course of nystatin.¹²⁸ ¹³⁰ ¹³³

Use of Fixed Combinations Containing Corticosteroids

When nystatin is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with topical corticosteroid therapy.¹³⁰ ^e ⁱ

Specific Populations

Pregnancy

Category A (vaginal tablets).¹²⁹

Category C (topical creams, ointments, and powders).¹²⁸ ¹³³

Category C (oral suspension and film-coated oral tablets).¹³⁴ ¹⁴⁶

Category C (topical creams containing fixed combination of nystatin and triamcinolone acetonide).¹³⁰

Lactation

Not known whether nystatin distributed into milk; use with caution.¹²⁸ ¹³⁰ ¹³³ ¹³⁴ ¹⁴⁶

Not known whether triamcinolone acetonide distributed into milk; use fixed-combination preparations containing nystatin and triamcinolone acetonide with caution.¹³⁰

Pediatric Use

Topical cream and topical powder may be used in pediatric patients, including neonates.¹²⁸ ¹³³

Safety and efficacy of vaginal tablets not established in pediatric patients.¹²⁹

Fixed-combination preparations containing nystatin and triamcinolone acetonide have been used effectively for treatment of cutaneous candidiasis in a limited number of children 2 months to 12 years of age.¹³⁰ Pediatric patients may be more susceptible to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature individuals because of the greater skin surface area-to-body weight ratio.¹³⁰ ¹³⁴ ^e

Common Adverse Effects

Topical creams, ointments, or powders: Hypersensitivity reactions (burning, itching, rash, eczema, pain).¹²⁸ ¹³³

Oral suspension or film-coated oral tablets: Mild and transitory GI effects (nausea, vomiting, diarrhea, GI distress); hypersensitivity reactions.¹³¹ ¹⁴⁶

Nystatin Pharmacokinetics

Absorption

Bioavailability

Not absorbed following topical application to intact skin or mucous membranes.¹²⁸ ¹²⁹ ¹³⁰ ¹³³

Insignificant absorption occurs in most patients following oral administration.¹³¹ ¹³⁴ ¹⁴⁶ Usually undetectable in plasma when given in usual oral doses,¹³¹ but clinically important plasma concentrations may occur occasionally in patients with renal impairment.¹³⁴ ¹⁴⁶

Elimination

Elimination Route

Following oral administration, majority of nystatin dose is excreted unchanged in feces.¹³¹ ¹³⁴ ¹⁴⁶

Stability

Storage

Topical

Cream or Ointment

15–30°C; avoid freezing and excessive heat (40°C).¹²⁸ ¹³³ ¹⁴⁷ ¹⁴⁸

Powder

Tight container at 15–30°C; avoid excessive heat (40°C).¹²⁸ ¹³³

Oral Topical

Powder For Oral Suspension

Tight, light resistant container at 2–8°C.¹³¹ Potency of the powder can only be assured for up to 90 days after the container is first opened.¹³¹

Contains no preservative; use oral suspension immediately after the powder is mixed in water.¹³¹

Suspension

15–30°C; avoid freezing.¹⁴⁶

Oral

Tablets, Film-coated

15–30°C.¹³⁴

Intravaginal

Tablets

15–30°C.¹²⁹

Actions and SpectrumActions

Fungistatic or fungicidal in action.¹²⁸ ¹²⁹ ¹³³ ¹³⁴ ¹⁴⁶

Binds to sterols in the fungal cell membrane, which no longer functions as a selective barrier and allows the loss of potassium and other cellular constituents.¹²⁸ ¹²⁹ ¹³⁰ ¹³¹ ¹³³ ¹³⁴ ¹⁴⁶ ¹⁵⁰

Active against a variety of pathogenic and nonpathogenic yeasts and fungi.¹²⁸ ¹²⁹ ¹³³ ¹³⁴ ¹⁴⁶ Inactive against organisms that do not contain sterols in their cell membrane (e.g., bacteria, protozoa, viruses).¹²⁸ ¹²⁹ ¹³³ ¹³⁴ ¹⁴⁶

Candida: Active against C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. pseudotropicalis, C. guilliermondi, and C. tropicalis.¹²⁸ ¹³³ ^e

Dermatophytes: Active against Trichophyton rubrum and T. mentagrophytes.¹²⁸ ¹³³

Nystatin resistance has been reported in some strains of C. albicans, C. glabrata, C. guilliermondi, C. krusei, and C. tropicalis.¹²⁸ ¹³³ ¹³⁴ ¹⁵⁰ ^e

Advice to Patients

Importance of not interrupting or discontinuing oral or topical nystatin therapy until the prescribed regimen is completed even though symptomatic relief may occur within a few days.¹²⁸ ¹³³ ^e

Importance of not interrupting or discontinuing vaginal nystatin therapy during a prescribed regimen, even during menstruation or if symptomatic relief occurs after only a few days of therapy, unless otherwise instructed by clinician.¹²⁹

Importance of discontinuing treatment and consulting clinician if irritation or sensitization (redness, itching, burning, blistering, swelling, oozing) occurs at the treatment site.¹²⁸ ¹²⁹ ¹³³ ^e

Advise patients of preventive measures to prevent reinfection.¹³⁰

Importance of instructing patient on proper preparation and use of extemporaneous oral suspensions prepared from powder for oral suspension.¹³¹ Advise patient that extemporaneously prepared oral suspensions do not contain a preservative and should be used immediately after preparation and should not be stored.¹³¹

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

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

Nystatin
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For suspension	50 million units*	Nystatin Powder	Paddock
			Nystat-Rx	X-GEN
		150 million units*	Nystatin Powder	Paddock
			Nystat-Rx	X-GEN
		500 million units*	Nystatin Powder	Paddock
			Nystat-Rx	X-GEN
		1 billion units	Nystat-Rx	X-GEN
		2 billion units*	Nystatin Powder	Paddock
			Nystat-Rx	X-GEN
	Suspension	100,000 units/mL*	Nystatin Suspension (with ≤1% alcohol parabens and sucrose 50%)	Actavis, Fougera, Morton Grove, Taro
	Tablets, film-coated	500,000 units*	Nystatin Tablets	Teva, United Research Laboratories
Topical	Cream	100,000 units/g*	Mycostatin (with propylene glycol)	Bristol-Myers Squibb
			Nystatin Cream	Actavis, Fougera, Perrigo, Taro
	Ointment	100,000 units/g*	Nystatin Ointment	Actavis, Fougera, Perrigo
	Powder	100,000 units/g*	Mycostatin (dispersed in talc)	Bristol-Myers Squibb
			Nystatin Topical Powder (dispersed in talc)	Par, Upsher-Smith
			Nystop (dispersed in talc)	Paddock
			Pedi-Dri (dispersed in talc)	Pedinol
Vaginal	Tablets	100,000 units*	Nystatin Vaginal Tablets (available with applicator)	Odyssey

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

Nystatin Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Cream	100,000 units/g with Triamcinolone Acetonide 0.1%*	Mykacet	Actavis
			Nystatin and Triamcinolone Acetonide Cream	Fougera, Taro
	Ointment	100,000 units/g with Triamcinolone Acetonide 0.1%*	Mykacet	Actavis
			Nystatin and Triamcinolone Acetonide Ointment	Fougera, Taro

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.

Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (TARO): 60/$14.99 or 120/$19.98

Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (FOUGERA): 30/$13.99 or 60/$20.98

Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (FOUGERA): 15/$12.99 or 45/$20.99

Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Ointment (TARO): 15/$17.77 or 45/$32.29

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.

† 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. Nystatin Multicenter Study Group. Therapy of candidal vaginitis: the effect of eliminating intestinal Candida. Am J Obstet Gynecol. 1986; 155:651-5. [IDIS 221446] [PubMed 3529970]

101. Dennerstein GJ, Langley R. Vulvovaginal candidiasis: treatment and recurrence. Aust NZ J Obstet Gynaecol. 1982; 22:231-3.

102. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2006. MMWR Recomm Rep. 2006; 55(No. RR-11):1-85.

103. Holmes KK, Handsfield HH. Vulvovaginal candidiasis. In: Braunwald E, Isselbacher KJ, Petersdorf RG et al, eds. Harrison’s principles of internal medicine. 11th ed. New York: McGraw-Hill Book Company; 1987:513.

104. Velupillai S, Thin RN. Treatment of vulvovaginal yeast infection with nystatin. Practitioner. 1977; 219:897-901.

105. Milne JD, Warnock DW. Effect of simultaneous oral and vaginal treatment of the rate of cure and relapse in vaginal candidosis. Br J Vener Dis. 1979; 55:362-5. [PubMed 389354]

106. Sobel JD. Epidemiology and pathogenesis of recurrent vulvovaginal candidiasis. Am J Obstet Gynecol. 1985; 152:924-935. [PubMed 3895958]

107. Sobel JD. Pathogenesis and treatment of recurrent vulvovaginal candidiasis. Clin Infect Dis. 1992; 14(Suppl 1):S148-53.

108. Anon. Drugs for sexually transmitted diseases. Med Lett Treat Guid. 2004; 2:67-74.

109. US Public Health Service (USPHS) and Infectious Diseases Society of America (IDSA) Prevention of Opportunistic Infections Working Group. 2001 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons with human immunodeficiency virus. From HIV/AIDS Treatment Information Services (ATIS) website ().

110. MacPhail LA, Hilton JF, Dodd CL et al. Prophylaxis with nystatin pastilles for HIV-associated oral candidiasis. J Acquir Immune Defic Syndr Hum Retrovirol. 1996; 12:470-6. [PubMed 8757423]

111. Anon. Drugs for AIDS and associated infections. Med Lett Drugs Ther. 1995; 37:87-94. [PubMed 7565297]

112. American Thoracic Society. Fungal infection in HIV-infected persons. Am J Respir Crit Care Med. 1995; 152:816-22. [IDIS 352046] [PubMed 7633749]

113. Bristol-Myers Squibb. Mycostatin (nystatin lozenges) pastilles prescribing information. Princeton, NJ; 1999 Aug.

114. Munz D, Powell KR, Pai CH. Treatment of candidal diaper dermatitis: a double-blind placebo-controlled comparison of topical nystatin with topical plus oral nystatin. J Pediatr. 1982; 101:1022-5. [IDIS 162522] [PubMed 6754898]

115. Hoppe JE. Treatment of oropharyngeal candidiasis and candidal diaper dermatitis in neonates and infants: review and reappraisal. Pediatr Infect Dis J. 1997; 16:885-94. [IDIS 392887] [PubMed 9306485]

116. Hay RJ. Yeast infections. Dermatol Clin. 1996; 14:113-24. [PubMed 8821164]

117. Doering PL, Santiago TM. Drugs for the treatment of vulvovaginal candidiasis: comparative efficacy of agents and regimens. DICP. 1990; 24:1078-83. [IDIS 274670] [PubMed 2275233]

118. Sobel JD. Vaginitis. N Engl J Med. 1997; 337:1896-903. [IDIS 401347] [PubMed 9407158]

119. Sobel JD, Faro S, Force RW et al. Vulvovaginal candidiasis: epidemiologic, diagnostic, and therapeutic considerations. Am J Obstet Gynecol. 1998; 178:203-11. [IDIS 402301] [PubMed 9500475]

120. Bisschop MPJM, Merkus JMWM, Scheygrond H et al. Co-treatment of the male partner in vaginal candidosis: a double-blind randomized control study. Br J Obstet Gynecol. 1986; 93:79-81.

121. Bohannon NJV. Treatment of vulvovaginal candidiasis in patients with diabetes. Diabetes Care. 1998; 21:451-6. [IDIS 402373] [PubMed 9540031]

122. Tobin MJ. Vulvovaginal candidiasis: topical vs. oral therapy. Am Fam Physician. 1995; 51:1715-24. [IDIS 348350] [PubMed 7754931]

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124. Reviewers’ comments (personal observations) on Tioconazole 84:04.08.

125. Roxane Laboratories. Nystatin oral suspension USP 100,000 USP units/mL prescribing information. Columbus, OH; 1991 Dec.

126. Powderly WG, Mayer KH, Perfect JR. Diagnosis and treatment of oropharyngeal candidiasis in patients infected with HIV: a critical reassessment. AIDS Res Hum Retroviruses. 1999; 15:1405-12. [PubMed 10555102]

127. Anon. Drugs for vulvovaginal candidiasis. Med Lett Drugs Ther. 2001; 43:3-4. [PubMed 11151090]

128. Bristol-Myers Squibb. Mycostatin (nystatin) cream and topical powder prescribing information. Princeton, NJ. April 1997.

129. Odyssey Pharmaceuticals. Nystatin vaginal tablets USP 100,000 units prescribing information. East Hanover, NJ. 2003 March.

130. Fougera. Nystatin-triamcinolone acetonide cream USP prescribing information. Melville, NY; 1989 March.

131. Paddock Laborotories, Inc. Nystatin USP for extemporaneous preparation of oral suspension prescribing information. Minneapolis, MN.

132. Hoppe JE. Treatment of oropharyngeal candidiasis and candidal diaper dermatitis in neonates and infants: review and reappraisal. Pediatr Infant Dis J. 1997; 16:885-94.

133. Paddock Laborotories, Inc. Nystop (nystatin) topical powder, USP prescribing information. Minneapolis, MN. 2003 May

134. Teva. Nystatin tablets, USP prescribing information. Sellersville, PA. 1998 Jun.

135. Williams C, Whitehouse JM, Lister TA et al. Oral anticandidal prophylaxis in patients undergoing chemotherapy for acute leukemia. Med Pediatr Oncol. 1977; 3:275-80. [PubMed 311410]

136. Carpentieri U, Haggard ME, Lockhart LH et al. Clinical experience in prevention of candidiasis by nystatin in children with acute lymphocytic leukemia. J Pediatr. 1978; 92:593-5. [IDIS 103783] [PubMed 273087]

137. Pizzuto J, Conte G, Ambriz R et al. Nystatin prophylaxis in leukemia and lymphoma. N Engl J Med. 1978; 298:279-80. [PubMed 619271]

138. Wade JC, Schimpff SC, Hargadon MT et al. A comparison of trimethoprim-sulfamethoxazole plus nystatin with gentamicin plus nystatin in the prevention of infections in acute leukemia. N Engl J Med. 1981; 304:1057-62. [IDIS 130741] [PubMed 6782486]

139. Groll AH, Just-Nuebling G, Kurz M et al. Fluconazole versus nystatin in the prevention of candida infections in children and adolescents undergoing remission induction or consolidation chemotherapy for cancer. J Antimicrob Chemother. 1997; 40:855-62. [IDIS 399161] [PubMed 9462438]

140. Lumbreras C, Cuervas-Mons V, Jara P et al. Randomized trial of fluconazole versus nystatin for the prophylaxis of Candida infection following liver transplantation. J Infect Dis. 1996; 174:583-8. [IDIS 374439] [PubMed 8769617]

141. Hughes WT, Armstrong D, Bodey GP et al. 1997 guidelines for the use of antimicrobial agents in neutropenic patients with unexplained fever. Clin Infect Dis. 1997; 25:551-73. [IDIS 393722] [PubMed 9314442]

142. Reviewers’ comments (personal observations) on fluconazole 8:14.08.

143. Edwards JE, Bodey GP, Bowden RA et al. International conference for the development of a consensus on the management and prevention of severe candidal infections. Clin Infect Dis. 1997; 25:43-59. [IDIS 387869] [PubMed 9243032]

144. Walsh TJ, Lee JW. Prevention of invasive fungal infections in patients with neoplastic diseases. Clin Infect Dis. 1993; 17(Suppl 2):S468-80. [IDIS 323669] [PubMed 8274613]

145. Perfect JR. Antifungal prophylaxis: to prevent or not. Am J Med. 1993; 92:233-4.

146. Alpharma. Nystatin oral suspension, USP 100,000 units per mL prescribing information. Baltimore, MD. 1996 Sept.

147. Alpharma. Nystatin cream, USP (100,000 units/g) prescribing information. Baltimore, MD. 2000 Nov.

148. Alpharma. Nystatin ointment, USP (100,000 units/g) prescribing information. Baltimore, MD. 2000 Nov.

149. Edwards JE, Jr. Candida species. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practice of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000: 2656-74.

150. Kucers A, Crowe S, Grayson ML et al, eds. The use of antibiotics. A clinical review of antibacterial, antifungal, and antiviral drugs. 5th ed. Jordan Hill, Oxford: Butterworth-Heinemann; 1997: 1295-300.

e. AHFS Drug Information 2004. McEvoy GK, ed. Nystatin. American Society of Health-System Pharmacists; 2004:3363-6.

i. AHFS Drug Information 2003. McEvoy GK, ed. Topical Corticosteroids Statement. American Society of Health-System Pharmacists; 2003:page 3403-6.

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