Clobetasol Solution

Pronunciation: kloe-BAY-ta-sol
Generic Name: Clobetasol
Brand Name: Examples include Embeline and Temovate

Clobetasol Solution is used for:

Treating inflammation and itching of the scalp due to certain skin conditions. It is also used to treat moderate to severe psoriasis. It may also be used for other conditions as determined by your doctor.

Clobetasol Solution is a topical adrenocortical steroid. It works by reducing skin inflammation (eg, redness, swelling, itching, irritation) in a way that is not clearly understood.

Do NOT use Clobetasol Solution if:

• you are allergic to any ingredient in Clobetasol Solution or to other corticosteroids (eg, prednisone)

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

Before using Clobetasol Solution:

Some medical conditions may interact with Clobetasol Solution. 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 any kind of skin infection of the scalp, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Clobetasol Solution. Because little, if any, of Clobetasol Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Clobetasol Solution 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 Clobetasol Solution:

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

• Wash and completely dry the affected area before applying Clobetasol Solution.


• Apply a small amount of Clobetasol Solution to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Clobetasol Solution.


• If applying to an area with hair, part the hair when applying so that Clobetasol Solution reaches the skin.


• Do not bandage or cover the treated skin area unless directed by your doctor. Do not wear tight-fitting clothes over the treated area.


• If you miss a dose of Clobetasol Solution, apply 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 apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Clobetasol Solution.

Important safety information:

• Clobetasol Solution is for external use only. Do not get Clobetasol Solution in your eyes, nose, mouth, or on your lips. If contact is made with the eyes, flush them immediately with tap water.


• Use Clobetasol Solution with extreme caution if treating the face, groin, diaper area, or underarms.


• Do not use Clobetasol Solution to treat rosacea or conditions around the mouth.


• Do NOT take more than the recommended dose or use for longer than 2 weeks without checking with your doctor.


• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Do not use Clobetasol Solution to treat large areas of your body without first checking with your doctor.


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


• Check with your doctor before having vaccinations while using Clobetasol Solution.


• Do not use Clobetasol Solution for other skin conditions at a later time.


• Clobetasol Solution has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Clobetasol Solution is flammable. Do not store or use near an open flame or while smoking.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Clobetasol Solution.


• Clobetasol Solution should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clobetasol Solution while you are pregnant. It is not known if Clobetasol Solution is found in breast milk after topical use. If you are or will be breast-feeding while you use Clobetasol Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Clobetasol Solution:

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:

Dryness; itching; mild burning or stinging.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Clobetasol Solution; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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: Clobetasol 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Clobetasol Solution:

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

General information:

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


• Clobetasol Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Clobetasol Solution. 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 Clobetasol resources

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

Compare Clobetasol with other medications

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AVC

Generic Name: sulfanilamide vaginal (sul fa NILL a mide)

Brand Names: AVC

What is AVC (sulfanilamide vaginal)?

Sulfanilamide is an antibacterial medication. It fights bacteria in your body.

Sulfanilamide vaginal is used to treat vaginal candida (yeast) infections.

Sulfanilamide vaginal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about AVC (sulfanilamide vaginal)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use AVC (sulfanilamide vaginal)?

Do not use sulfanilamide vaginal if you have had an allergic reaction to it or to any other sulfa-based medicine in the past.

Do not use sulfanilamide vaginal if you have a fever, abdominal pain, foul-smelling discharge, diabetes, HIV, or AIDS. Consult your doctor.

Sulfanilamide vaginal is in the FDA pregnancy category C. This means that it is not known whether sulfanilamide vaginal will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. Sulfanilamide passes into breast milk. Do not use sulfanilamide vaginal without first talking to your doctor if you are breast-feeding a baby.

How should I use AVC (sulfanilamide vaginal)?

Use sulfanilamide vaginal exactly as directed by your doctor, or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Insert the suppository or cream into the vagina using the applicator as directed, usually once or twice daily.

Use this medication continuously for the prescribed amount of time, even during your menstrual period.

You can use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.

If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.

Avoid getting this medication in your eyes, nose, or mouth. Store sulfanilamide topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of sulfanilamide vaginal is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that sulfanilamide vaginal has been ingested, contact an emergency room or a poison control center.

What should I avoid while using AVC (sulfanilamide vaginal)?

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid sexual intercourse or use a condom to prevent the infection from spreading to your partner.

AVC (sulfanilamide vaginal) side effects

Stop using sulfanilamide vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. Continue to use sulfanilamide vaginal and talk to your doctor if you experience

• 
  

  burning,

  
  


• 
  

  itching,

  
  


• 
  

  irritation of the skin, or

  
  


• 
  

  an increased need to urinate.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect AVC (sulfanilamide vaginal)?

Avoid using other vaginal creams or douches at the same time as sulfanilamide vaginal unless your doctor approves.

Drugs other than those listed here may also interact with sulfanilamide vaginal. Ask your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More AVC resources

• AVC Side Effects (in more detail)
• AVC Use in Pregnancy & Breastfeeding
• 0 Reviews for AVC - Add your own review/rating

• AVC Prescribing Information (FDA)


• AVC MedFacts Consumer Leaflet (Wolters Kluwer)

Compare AVC with other medications

• Vaginal Yeast Infection

Where can I get more information?

• Your pharmacist has additional information about sulfanilamide vaginal written for health professionals that you may read.

See also: AVC side effects (in more detail)

Zydone

hydrocodone bitartrate and acetaminophen

Dosage Form: tablet
Zydone®

(Hydrocodone Bitartrate and

Acetaminophen Tablets, USP)

CIII

Rx only

WARNING

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.  Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.

Zydone Description

Zydone (hydrocodone bitartrate and acetaminophen tablets), for oral administration, contain hydrocodone bitartrate and acetaminophen in the following strengths:

Hydrocodone Bitartrate, USP	5 mg
Acetaminophen, USP	400 mg

Hydrocodone Bitartrate, USP	7.5 mg
Acetaminophen, USP	400 mg

Hydrocodone Bitartrate, USP	10 mg
Acetaminophen, USP	400 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. The 5 mg/400 mg strength contains FD&C Yellow No. 10; 7.5 mg/400 mg contains FD&C Blue No. 2; and 10 mg/400 mg contains FD&C Red No. 40.

Zydone Tablets meet USP Dissolution Test 1.

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Acetaminophen, 4’-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Zydone - Clinical Pharmacology

Hydrocodone is a semisynthetic opioid analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, opioids may produce drowsiness, changes in mood and mental clouding.

The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat-regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

Pharmacokinetics

The behavior of the individual components is described below.

Hydrocodone: Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolites.

See OVERDOSAGE for toxicity information.

Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

See OVERDOSAGE for toxicity information.

Indications and Usage for Zydone

Zydone (hydrocodone bitartrate and acetaminophen tablets) is indicated for the relief of moderate to moderately severe pain.

Contraindications

Zydone tablets should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product.

Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

Warnings

Respiratory Depression

At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

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

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.  Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.  The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen.  Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity / anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.  Clinical signs including swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting.  There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention.  Instruct patients to discontinue Zydone immediately and seek medical care if they experience these symptoms.  Do not prescribe Zydone for patients with acetaminophen allergy.

Precautions

General

Special Risk Patients: As with any opioid analgesic agent, Zydone tablets should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Cough Reflex: Hydrocodone suppresses the cough reflex; as with all opioids, caution should be exercised when Zydone tablets are used postoperatively and in patients with pulmonary disease.

Information for Patients/Caregivers

·      Do not take Zydone if you are allergic to any of its ingredients.

·      If you develop signs of allergy such as a rash or difficulty breathing stop taking Zydone and contact your healthcare provider immediately.

·      Do not take more than 4000 milligrams of acetaminophen per day.  Call your doctor if you took more than the recommended dose.

·      Hydrocodone, like all opioids, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly.

·      Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

·      Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

Patients receiving opioids, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Drug/Laboratory Test Interactions

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy

Teratogenic Effects; Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Zydone tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

Labor and Delivery

As with all opioids, administration of this product to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical Studies of hydrocodone bitartrate and acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen tablets and observed closely.

Adverse Reactions

The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

Gastrointestinal System: Prolonged administration of Zydone (hydrocodone bitartrate and acetaminophen tablets) may produce constipation.

Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on brain stem respiratory center (see OVERDOSAGE).

Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

Dermatological: Skin rash, pruritus.

The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Potential effects of high dosage are listed in the OVERDOSAGE section.

Drug Abuse and Dependence

Controlled Substance

Zydone tablets are classified as a Schedule III controlled substance.

Abuse and Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.

Overdosage

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.

Signs and Symptoms

Hydrocodone: Serious overdose with hydrocodone 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.

Acetaminophen: In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment

A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.  Assisted or controlled ventilation should also be considered.

For hydrocodone overdose, 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 is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, including hydrocodone. Since the duration of action of hydrocodone 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.  An opioid antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation.  Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading.  To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected.  Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication.  Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

Zydone Dosage and Administration

Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

5 mg/400 mg: The usual adult dose is one or two tablets every four to six hours as needed for pain.

The total daily dosage should not exceed eight tablets.

7.5 mg/400 mg: The usual adult dosage is one tablet every four to six hours as needed for pain.

The total daily dosage should not exceed six tablets.

10 mg/400 mg: The usual adult dosage is one tablet every four to six hours as needed for pain.

The total daily dosage should not exceed six tablets.

How is Zydone Supplied

Zydone (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:

5 mg/400 mg

Yellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.

Bottles of 100         NDC 63481-668-70

7.5 mg/400 mg

Blue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.

Bottles of 100         NDC 63481-669-70

10 mg/400 mg

Red, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other.

Bottles of 100         NDC 63481-698-70

Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

A Schedule III Opioid. Oral prescription where permitted by state law.

Manufactured for:

Endo Pharmaceuticals Inc.

Chadds Ford, Pennsylvania 19317

Zydone® is a Registered Trademark of Endo Pharmaceuticals Inc.

© 2011 Endo Pharmaceuticals

Printed in U.S.A.

May 2011

Package Label - Principal Display Panel - Zydone 5 mg/400 mg Bottle Label

Package Label - Principal Display Panel - Zydone 7.5 mg/400 mg Bottle Label

Package Label - Principal Display Panel - Zydone 10 mg/400 mg Bottle Label

Zydone  hydrocodone bitartrate and acetaminophen  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63481-668 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 400 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSCARMELLOSE SODIUM   CROSPOVIDONE   CELLULOSE, MICROCRYSTALLINE   POVIDONE   STARCH, CORN   STEARIC ACID

Product Characteristics Color YELLOW Score no score Shape OCTAGON (8 SIDED) Size 8mm Flavor Imprint Code E;5 Contains

Packaging # NDC Package Description Multilevel Packaging 1 63481-668-70 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040288	12/01/1998

Zydone  hydrocodone bitartrate and acetaminophen  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63481-669 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 7.5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 400 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSCARMELLOSE SODIUM   CROSPOVIDONE   CELLULOSE, MICROCRYSTALLINE   POVIDONE   STARCH, CORN   STEARIC ACID   FD&C BLUE NO. 2

Product Characteristics Color BLUE Score no score Shape OCTAGON (8 SIDED) Size 17mm Flavor Imprint Code E;7;5 Contains

Packaging # NDC Package Description Multilevel Packaging 1 63481-669-70 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040288	12/01/1998

Zydone  hydrocodone bitartrate and acetaminophen  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63481-698 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 10 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 400 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSCARMELLOSE SODIUM   CROSPOVIDONE   CELLULOSE, MICROCRYSTALLINE   POVIDONE   STARCH, CORN   STEARIC ACID   FD&C RED NO. 40

Product Characteristics Color RED Score no score Shape OCTAGON (8 SIDED) Size 17mm Flavor Imprint Code E;10 Contains

Packaging # NDC Package Description Multilevel Packaging 1 63481-698-70 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040288	12/01/1998

Labeler - Endo Pharmaceuticals Inc. (178074951)

Revised: 07/2011Endo Pharmaceuticals Inc.

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Gallium

Dosage Form: Injection

Rx Only.

Diagnostic – For Intravenous Use

Gallium Description

Gallium Citrate Ga 67 Injection is supplied in a 10 milliliter vial as an isotonic, sterile, non-pyrogenic solution. Each milliliter of the isotonic solution contains 74 megabecquerels (2 millicuries) of Gallium Ga 67 on the calibration date as a complex formed from 8.3 nanograms Gallium chloride Ga 67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride and 0.9 percent benzyl alcohol (v/v) as a preservative. The pH is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution.

Gallium Ga 67, with a half-life of 78.26 hours, is cyclotron produced by the proton irradiation of enriched zinc. At the time of calibration the drug contains no more than 0.02% Gallium Ga 66 and no more than 0.2% Zinc Zn 65. The concentration of each radionuclidic impurity changes with time. At expiration, the drug contains no more than 0.001% Gallium Ga 66 and no more than 1.0% Zinc Zn 65. No carrier has been added.

Gallium Citrate has the following chemical structure:

PHYSICAL CHARACTERISTICS

Gallium Ga 67 with a physical half-life of 78.26 hours1 decays by electron capture to stable Zinc Zn 67. Photons that are useful for imaging studies are listed in Table 1.

Table 1. Principal Radiation Emission Data1

Radiation	Mean % Per Disintegration	Energy
Gamma-2	2.9	91.3
Gamma-3	35.7	93.3
Gamma-4	19.7	184.6
Gamma-5	2.2	209.0
Gamma-6	16.0	300.2
Gamma-7	4.5	393.5

1

Kocher, D.C., Radioactive Decay Tables, Health and Safety Research Division, National Technical Information Service, DOE/TIC-11026, pg. 80, 1981.

EXTERNAL RADIATION

The specific gamma ray constant for Gallium Ga 67 is 1.6 R/mCi-hour at 1 cm. The first half-value thickness of lead (Pb) is 0.066 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead is shown in Table 2. For example, the use of 1.2 cm of lead will decrease the radiation exposure by a factor of about 100.

Table 2. Radiation Attenuation by Lead Shielding

Shield Thickness (Pb), cm	Coefficient of Attenuation
0.066	0.5
0.41	10-1
1.2	10-2
2.5	10-3
4.8	10-4

To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.

Table 3. Physical Decay Chart Gallium Ga 67 Half-Life 78.26 Hours

*Calibration Time
Hours	Fraction Remaining	Hours	Fraction Remaining
0*	1.000	72 (3d)	0.529
6	0.948	78	0.501
12	0.899	84	0.475
18	0.853	90	0.451
24 (1d)	0.809	96 (4d)	0.427
30	0.767	108	0.384
36	0.727	120 (5d)	0.345
42	0.689	132	0.311
48 (2d)	0.654	144 (6d)	0.279
54	0.620	156	0.251
60	0.588	168 (7d)	0.226
66	0.557

Gallium - Clinical Pharmacology

Gallium Citrate Ga 67, with no carrier added, has been found to concentrate in certain viable primary and metastatic tumors as well as focal sites of infection. The mechanism of concentration is unknown, but investigational studies have shown that Gallium Ga 67 accumulates in lysosomes and is bound to a soluble intracellular protein.

It has been reported in the scientific literature that following intravenous injection, the highest tissue concentration of Gallium Ga 67 - other than tumors and sites of infection - is the renal cortex. After the first day, the maximum concentration shifts to bone and lymph nodes and after the first week, to liver and spleen. Gallium Ga 67 is excreted relatively slowly from the body. The average whole body retention is 65 percent after seven days, with 26 percent having been excreted in the urine and 9 percent in the stools.

Indications and Usage for Gallium

Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive Gallium Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.

Contraindications

None.

Warnings

None known.

Precautions

General

A thorough knowledge of the normal distribution of intravenously administered Gallium Citrate Ga 67 Injection is essential in order to accurately interpret pathologic states. The finding of an abnormal Gallium Ga 67 concentration usually implies the existence of underlying pathology, but further diagnostic studies should be done to distinguish benign from malignant lesions. Gallium Citrate Ga 67 Injection is intended for use as an adjunct in the diagnosis of certain neoplasms as well as focal areas of infection. Certain pathologic conditions may yield up to 40 percent false negative Gallium Ga 67 studies. Therefore, a negative study cannot be definitely interpreted as ruling out the presence of disease.

Lymphocytic lymphoma frequently does not accumulate Gallium Ga 67 sufficiently for unequivocal imaging and the use of Gallium with this histologic type of lymphoma is not recommended at this time.

Gallium Ga 67 localization cannot differentiate between tumor and acute inflammation, and other diagnostic studies must be added to define the underlying pathology.

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper management and to insure minimum radiation exposure to occupational workers.

The vial contents are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether this drug affects fertility in males or females.

Pregnancy Category C

Animal reproductive studies have not been conducted with Gallium Citrate Ga 67. It is also not known whether Gallium Citrate Ga 67 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gallium Citrate Ga 67 should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature of women of childbearing capability, should be performed during the first few (approximately ten) days following the onset of menses.

Nursing Mothers

This drug is known to be excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feedings.

Pediatric Use

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

Adverse Reactions

Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.

Gallium Dosage and Administration

The recommended adult (70 kg) dose of Gallium Citrate Ga 67 Injection is 74 to 185 megabecquerels (2 to 5 millicuries). Gallium Citrate Ga 67 Injection is intended for intravenous administration only.

Approximately 10 percent of the administered dose is excreted in the feces during the first week after injection. Daily laxatives and/or enemas are recommended from the day of injection until the final images are obtained in order to cleanse the bowel of radioactive material and minimize the possibility of false positive studies.

Studies indicate the optimal tumor to background concentration ratios are often obtained 48 hours post injection. However, considerable biological variability may occur in individuals and acceptable images may be obtained as early as 6 hours and as late as 120 hours after injection.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if contents are turbid.

Instructions for the handling of Gallium Citrate Ga 67:

1. Waterproof gloves should be used during the entire handling and administration procedure.
   


2. Using proper shielding, the vial containing the Gallium Citrate Ga 67 should be visually inspected to insure that it is free of particulate matter and discoloration prior to use.
   


3. Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the preparation.

RADIATION DOSIMETRY

The estimated absorbed radiation doses2 from an intravenous injection of 185 megabecquerels (5 millicuries) of Gallium Citrate Ga 67 are shown in Table 4.

Table 4. Absorbed Radiation Doses

Tissue	mGy/ 185MBq	rads/ 5mCi
Whole Body	13.0	1.30
Skeleton	22.0	2.20
Liver	23.0	2.30
Bone Marrow	29.0	2.90
Spleen	26.5	2.65
Kidney	20.5	2.05
Ovaries	14.0	1.40
Testes	12.0	1.20
Gastrointestinal Tract
Stomach	11.0	1.10
Small Intestine	18.0	1.80
Upper Large Intestine	28.0	2.80
Lower Large Intestine	45.0	4.50

2

MIRD Dose Estimate Report No. 2, J. Nucl. Med. 14; 755-6 (1973).

How is Gallium Supplied

Catalog Number 180.

Gallium Citrate Ga 67 Injection is supplied sterile and non-pyrogenic for intravenous use. Each milliliter contains 74 megabecquerels (2 millicuries) of Gallium Ga 67 on the calibration date, as a complex formed from 8.3 nanograms Gallium chloride Ga 67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride, and 0.9 percent benzyl alcohol (v/v) as a preservative. The pH is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution.

Gallium Citrate Ga 67 Injection is available in vials containing 111 MBq, 222 MBq and 444 MBq (3 mCi, 6 mCi and 12 mCi) on the calibration date.

STORAGE AND HANDLING

The contents of the vial are radioactive, and adequate shielding and handling precautions must be maintained. Store at controlled room temperature 20-25°C (68-77°F) [see USP].

Storage and disposal of Gallium Citrate Ga 67 Injection should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.

Revised 4/2005

Mallinckrodt Inc.

St. Louis, MO 63134

MALLINCKRODT

A180I0

Gallium CITRATE GA-67  Gallium citrate, ga-67  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0019-N180 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Gallium Citrate, Ga-67 (Gallium Citrate, Ga-67) Active 2 MILLICURIE  In 1 MILLILITER sodium citrate dihydrate Inactive 1.9 MILLIGRAM  In 1 MILLILITER sodium chloride Inactive 7.8 MILLIGRAM  In 1 MILLILITER benzyl alcohol Inactive   hydrochloric acid Inactive   sodium hydroxide Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0019-N180-D0 1 VIAL In 1 CAN contains a VIAL, MULTI-DOSE 1 1.65 mL (MILLILITER) In 1 VIAL, MULTI-DOSE This package is contained within the CAN (0019-N180-D0) 2 0019-N180-G0 1 VIAL In 1 CAN contains a VIAL, MULTI-DOSE 2 3.3 mL (MILLILITER) In 1 VIAL, MULTI-DOSE This package is contained within the CAN (0019-N180-G0) 3 0019-N180-M0 1 VIAL In 1 CAN contains a VIAL, MULTI-DOSE 3 6.6 mL (MILLILITER) In 1 VIAL, MULTI-DOSE This package is contained within the CAN (0019-N180-M0)

Revised: 03/2007Mallinckrodt Inc.

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Zidovudine

Pronunciation: zye-DOE-vue-deen
Generic Name: Zidovudine
Brand Name: Retrovir

Severe bone marrow problems (eg, low white blood cell levels, anemia) have been reported with Zidovudine. The risk may be greater in patients with advanced HIV infection. Tell your doctor right away if you have symptoms of anemia (eg, severe or persistent tiredness or weakness) or an infection (eg, fever, chills, persistent cough or sore throat, decreased or painful urination).

Muscle pain or aches have occurred with long-term use of Zidovudine. Tell your doctor if you develop these effects.

A severe and sometimes fatal effect called lactic acidosis has been reported with this type of medicine. Tell your doctor right away if you experience fast breathing; fast or irregular heartbeat; nausea; severe or unusual drowsiness; shortness of breath; sluggishness; vomiting; dizziness or light-headedness; feeling of being unusually cold; or unusual muscle pain or cramps.

Severe and sometimes fatal liver problems have been reported with this type of medicine. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent loss of appetite, nausea, or stomach pain).

Zidovudine is used for:

Treating HIV infection when used along with other medicines. It is also used with other medicines to help prevent women from passing the HIV virus to the fetus during pregnancy.

Zidovudine is an antiviral. It works by blocking the reproduction of the HIV virus.

Do NOT use Zidovudine if:

• you are allergic to any ingredient in Zidovudine


• you are taking doxorubicin, ribavirin, stavudine, or any other medicine that contains zidovudine

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

Before using Zidovudine:

Some medical conditions may interact with Zidovudine. 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 bone marrow problems (eg, low white blood cell or hemoglobin levels) or lactic acidosis


• if you have a history of alcohol abuse or dependence, kidney problems, pancreatitis, or hepatitis C virus (HCV) infection or other liver problems (eg, cirrhosis)


• if you are on dialysis, you are at risk for liver problems, or you are very overweight

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

• Zalcitabine because severe pancreas problems may occur


• Ganciclovir, interferon alfa, probenecid, valproic acid, or any other medicine that contains zidovudine because they may increase the risk of Zidovudine's side effects


• Ribavirin because it may decrease Zidovudine's effectiveness or increase the risk of Zidovudine's side effects


• Doxorubicin or stavudine because they may decrease Zidovudine's effectiveness

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

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

• Zidovudine is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Zidovudine at home, a health care provider will teach you how to use it. Be sure you understand how to use Zidovudine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Zidovudine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• Use Zidovudine on a regular schedule around the clock, unless your doctor tells you otherwise.


• Continue to use Zidovudine even if you feel well. Do not miss any doses.


• It is important not to miss doses of Zidovudine. If you miss a dose of Zidovudine, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Zidovudine.

Important safety information:

• Zidovudine may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Do NOT take more than the recommended dose or stop using Zidovudine without checking with your doctor.


• Zidovudine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• Zidovudine does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• The risk of certain severe side effects (lactic acidosis, severe liver problems) may be greater in patients who are overweight (obese), women, and patients who have taken certain HIV medicines for a long time. Talk with your doctor if you have questions about your risk for severe side effects from Zidovudine.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Zidovudine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


• Zidovudine may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Zidovudine.


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


• PREGNANT WOMEN: Zidovudine may not always prevent you from passing the HIV virus to the fetus. It is not known how Zidovudine may affect the baby later in life. Discuss any questions or concerns with your doctor.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zidovudine while you are pregnant. Zidovudine is found in breast milk. Do not breast-feed while taking Zidovudine. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Zidovudine to the baby.

Possible side effects of Zidovudine:

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; headache; loss of appetite; nausea; unusual tiredness; 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); muscle pain, aches, cramps, or weakness; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; symptoms of infection (eg, fever, chills, persistent cough or sore throat, decreased or painful urination); symptoms of lactic acidosis (eg, fast breathing; fast or irregular heartbeat; severe or unusual nausea, drowsiness, or vomiting; shortness of breath; sluggishness; dizziness or light-headedness; feeling of being unusually cold); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent loss of appetite, nausea, or stomach pain); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting).

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: Zidovudine side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Zidovudine:

Zidovudine is usually handled and stored by a health care provider. If you are using Zidovudine at home, store Zidovudine as directed by your pharmacist or health care provider. Keep Zidovudine out of the reach of children and away from pets.

General information:

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


• Zidovudine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

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

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• HIV Infection
• Nonoccupational Exposure
• Occupational Exposure
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