Azmacort

DRUG DESCRIPTION

Proprietary name: Azmacort
Established name: Triamcinolone acetonide
Route of administration: RESPIRATORY (INHALATION) (C38216)
Active ingredients (moiety): Triamcinolone acetonide (Triamcinolone)

#	Strength	Form	Inactive ingredients
1	60 MILLIGRAM	AEROSOL, METERED (C42960)	Dehydrated alcohol, dichlorodifluoromethane

Triamcinolone acetonide, USP, the active ingredient in Azmacort® (triamcinolone acetonide inhalation aerosol) Inhalation
Aerosol, is a corticosteroid with a molecular weight of 434.5 and with the chemical
designation 9- Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
cyclic 16,17-acetal with acetone. (C₂₄H₃₁FO₆).

Azmacort (triamcinolone acetonide inhalation aerosol) Inhalation Aerosol is a metered-dose aerosol unit containing
a microcrystalline suspension of triamcinolone acetonide in the propellant dichlorodifluoromethane
and dehydrated alcohol USP 1% w/w. Each canister contains 60 mg triamcinolone
acetonide. The canister must be primed prior to the first use. After an initial
priming of 2 actuations, each actuation delivers 200 mcg triamcinolone acetonide
from the valve and 75 mcg from the spacer-mouthpiece under definedin vitro
test conditions. The canister will remain primed for 3 days. If the canister
is not used for more than 3 days, then it should be reprimed with 2 actuations.
There are at least 240 actuations in one Azmacort (triamcinolone acetonide inhalation aerosol) Inhalation

Aerosol canister. After 240 actuations, the amount delivered per actuation
may not be consistent and the unit should be discarded.

What are the possible side effects of triamcinolone inhalation (Azmacort)?

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.

Call your doctor at once if you have any of these serious side effects:

• weakness, tired feeling, nausea, loss of appetite, weight loss;


• wheezing or breathing problems after using this medication;


• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;


• pain or burning when you urinate;


• changes...

Read All Potential Side Effects and See Pictures of Azmacort »

What are the precautions when taking triamcinolone acetonide (inhalation aerosol) (Azmacort)?

Before using triamcinolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by mouth (such as...

Read All Potential Precautions of Azmacort »

Azmacort Consumer (continued)

SIDE EFFECTS: See also Precautions section.

Dry/sore throat, hoarseness, headache, or voice changes may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as ear pain, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush (yeast infection). Contact your doctor if you notice white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, increased thirst/urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using triamcinolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Triamcinolone may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

It is not known if triamcinolone passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.

Azmacort Patient Information Including Side Effects

Brand Names: Azmacort

Generic Name: triamcinolone inhalation (Pronunciation: trye am SIH no lone)

• What is triamcinolone inhalation (Azmacort)?


• What are the possible side effects of triamcinolone inhalation (Azmacort)?


• What is the most important information I should know about triamcinolone inhalation (Azmacort)?


• What should I discuss with my healthcare provider before using triamcinolone inhalation (Azmacort)?


• How should I use triamcinolone inhalation (Azmacort)?


• What happens if I miss a dose (Azmacort)?


• What happens if I overdose (Azmacort)?


• What should I avoid while using triamcinolone inhalation (Azmacort)?


• What other drugs will affect triamcinolone inhalation (Azmacort)?


• Where can I get more information?

What is triamcinolone inhalation (Azmacort)?

Triamcinolone is a steroid. It prevents the release of substances in the body that cause inflammation.

Triamcinolone inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

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

What are the possible side effects of triamcinolone inhalation (Azmacort)?

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.

Call your doctor at once if you have any of these serious side effects:

• weakness, tired feeling, nausea, loss of appetite, weight loss;


• wheezing or breathing problems after using this medication;


• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;


• pain or burning when you urinate;


• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);


• worsening asthma symptoms.

Less serious side effects may include:

• nausea, diarrhea, stomach pain;


• joint or muscle pain;


• dryness in your mouth, nose, or throat;


• white patches or sores inside your mouth or on your lips;


• stuffy nose, sinus pain, sore throat, cough; or


• hoarseness or deepened voice.

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

What is the most important information I should know about triamcinolone inhalation (Azmacort)?

Do not use triamcinolone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using triamcinolone inhalation for 2 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack.

If you were switched from an oral (taken by mouth) steroid to triamcinolone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

Related Drug Centers

• Azmacort

MDP Multidose Kit

DRUG DESCRIPTION

Each kit contains 10 multidose reaction vials, each containing 10 mg of medronic acid, 0.17 mg (minimum) stannous chloride (maximum stannous and stannic chloride 0.29 mg), and 2 mg ascorbic acid. The contents of the vial are sterile, pyrogen-free, lyophilized and sealed under nitrogen. The pH has been adjusted to 4.0-7.8 with hydrochloric acid and sodium hydroxide.

Administration is by intravenous injection for diagnostic use, after reconstitution with oxidant-free sodium pertechnetate Tc99m injection. The product as supplied is sterile and pyrogen-free.

The precise structure of stannous technetium Tc99m medronate complex is unknown at this time.

Physical Characteristics

Technetium Tc99m decays by isomeric transition with a physical half-life of
6.02 hours.¹ The principal photon that is useful for detection and
imaging studies is listed in Table 1.

Table 1. Principal Radiation Emission Data¹

Radiation	Mean %/Disintegration	Mean Energy (keV)
Gamma-2	89.07	140.5
1Kocher, David C, “Radioactive Decay Data Tables,” DOE/TIC-11026, 108 (1981).

External Radiation

The specific gamma ray constant for Tc99m is 0.78 R/hr-mCi at 1 cm. The first half-value layer is 0.017 cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of 1,000.

Table 2. Radiation Attenuation of Lead (Pb) Shielding

Shield Thickness (Pb) cm	Coefficient of Attenuation
0.017	0.5
0.08	10-1
0.16	10-2
0.25	10-3
0.33	10-4

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

Table 3. Physical Decay Chart: Tc99m, half-life 6.02 hours

Hours	Fraction Remaining	Hours	Fraction Remaining
0*	1.000	5	0.562
1	0.891	6	0.501
2	0.794	8	0.398
3	0.708	10	0.316
4	0.631	12	0.251
*Calibration Time

Priftin

DRUG DESCRIPTION

PRIFTIN (rifapentine) for oral administration contains 150 mg of the active ingredient rifapentine per tablet.

The 150 mg tablets also contain, as inactive ingredients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cellulose, hypromellose USP, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, synthetic red iron oxide, and titanium dioxide.

Rifapentine is a rifamycin derivative antibiotic and has a similar profile of microbiological activity to rifampin (rifampicin). The molecular weight is 877.04.

The molecular formula is C₄₇H₆₄N₄O₁₂.

The chemical name for rifapentine is rifamycin, 3-[[(4-cyclopentyl-1-piperazinyl)imino]methyl]-or 3-[N-(4-Cyclopentyl - 1-piperazinyl)formimidoyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-cyclopentyl-l-piperazinyl)-formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. It has the following structure:

What are the possible side effects of rifapentine (Priftin)?

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.

Call your doctor at once if you have any of these serious side effects:

• blood in your urine;


• pale skin, weakness, easy bruising or bleeding; or


• fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or...

Read All Potential Side Effects and See Pictures of Priftin »

What are the precautions when taking rifapentine (Priftin)?

Before taking rifapentine, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (such as rifampin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, a certain blood disorder (porphyria), liver disease, alcohol use.

Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Rifapentine may cause...

Read All Potential Precautions of Priftin »

Priftin Consumer (continued)

SIDE EFFECTS: Stomach upset, nausea, vomiting, loss of appetite, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication may cause urine, sweat, saliva, or tears to turn reddish. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may be permanently stained.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: symptoms of liver disease (such as persistent nausea/vomiting, unusual tiredness/weakness, severe stomach/abdominal pain, yellowing eyes/skin, dark urine), painful/swollen joints, dark/bloody urine, easy bleeding/bruising, unusual tiredness, signs of a new infection (such as fever, persistent sore throat).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking rifapentine, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (such as rifampin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, a certain blood disorder (porphyria), liver disease, alcohol use.

Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Rifapentine may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

During pregnancy, this medication should be used only when clearly needed. When this drug is taken during the last few weeks of pregnancy, the risk of bleeding in both mother and infant may be increased. Tell your doctor immediately if you notice any bleeding in your newborn. Discuss the risks and benefits with your doctor.

It is unknown if rifapentine passes into breast milk. However, similar drugs pass into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

Priftin Patient Information Including Side Effects

Brand Names: Priftin

Generic Name: rifapentine (Pronunciation: RIF a PEN teen)

• What is rifapentine (Priftin)?


• What are the possible side effects of rifapentine (Priftin)?


• What is the most important information I should know about rifapentine (Priftin)?


• What should I discuss with my healthcare provider before taking rifapentine (Priftin)?


• How should I take rifapentine (Priftin)?


• What happens if I miss a dose (Priftin)?


• What happens if I overdose (Priftin)?


• What should I avoid while taking rifapentine (Priftin)?


• What other drugs will affect rifapentine (Priftin)?


• Where can I get more information?

What is rifapentine (Priftin)?

Rifapentine is an antibiotic. It prevents bacteria from multiplying in your body.

Rifapentine is used together with other antibiotics to treat tuberculosis.

Rifapentine must always be used in combination with other antibiotics.

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

What are the possible side effects of rifapentine (Priftin)?

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.

Call your doctor at once if you have any of these serious side effects:

• blood in your urine;


• pale skin, weakness, easy bruising or bleeding; or


• fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools;


• nausea, vomiting, diarrhea, loss of appetite;


• stomach pain;


• headache;


• joint pain; or


• mild skin rash or itching.

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

What is the most important information I should know about rifapentine (Priftin)?

You should not take this medication if you are allergic to rifapentine, rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rimactane, Rifamate).

Before taking rifapentine, tell your doctor if you have porphyria.

Rifapentine should not be used without other antibiotics. Be sure to take all your medications as prescribed by your doctor.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Rifapentine can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rifapentine.

Do not wear dentures or contact lenses while taking rifapentine. This medicine may discolor certain body fluids (including tears and saliva) with a red, orange, or brown color. While this is a harmless side effect, it may permanently stain a pair of contact lenses.

Related Drug Centers

• Priftin

Deconsal DM

DRUG DESCRIPTION

Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets are an antihistamine/nasal decongestant/antitussive combination for oral administration as a chewable tablet. Each Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablet in a grape-flavored, dye-free, mottled brown-colored, scored tablet for oral administration contains:

Phenylephrine HCl.................10 mg

Pyrilamine Maleate................16 mg

Dextromethorphan HBr...........15 mg

Inactive ingredients: Citric acid, calcium phosphate dibasic, hypromellose, grape flavor, magnesium aluminum silicate, magnesium stearate, compressible
sugar, corn starch, mannitol, sucralose, talc, tannic acid, and xanthan gum.

See DOSAGE AND ADMINISTRATION section for
further descriptive composition.

What are the precautions when taking phenylephrine, pyrilamine maleate, and dextromethorphan hbr (Deconsal DM)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to pseudoephedrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had a bad reaction to similar drugs (sympathomimetics such as ephedrine, phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus, high blood pressure, heart disease (such as chest pain, heart failure, heart attack), fast/slow/irregular heartbeat, diabetes, a certain eye...

Read All Potential Precautions of Deconsal DM »

Deconsal DM Consumer (continued)

SIDE EFFECTS: Nausea or headache may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness, fainting, fast/irregular/pounding heartbeat, mental/mood changes (such as anxiety, confusion, nervousness, irritability), shaking (tremor), trouble sleeping, difficult/painful urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to pseudoephedrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had a bad reaction to similar drugs (sympathomimetics such as ephedrine, phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus, high blood pressure, heart disease (such as chest pain, heart failure, heart attack), fast/slow/irregular heartbeat, diabetes, a certain eye problem (glaucoma), difficulty urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Caution is advised when using this product in children because they may be more sensitive to its side effects, especially nervousness, irritability, and high blood pressure. (See also Uses Section.)

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

The pseudoephedrine in this product passes into breast milk and may have undesirable effects on a nursing infant. It is unknown if guaifenesin passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

Dilantin

DRUG DESCRIPTION

Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the
barbiturates in chemical structure, but has a five-membered ring. The chemical
name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural
formula:

Each Dilantin (phenytoin) — 100 mg Extended Oral Capsule—contains 100 mg phenytoin
sodium. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc,
USP; and magnesium stearate, NF. The capsule body contains titanium dioxide,
USP and gelatin, NF. The capsule cap contains FD&C red No. 28; FD&C
yellow No. 6; and gelatin NF. Product in vivo performance is characterized
by a slow and extended rate of absorption with peak blood concentrations expected
in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP
with a rapid rate of absorption with peak blood concentration expected in 1%
to 3 hours.

What are the possible side effects of phenytoin?

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.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• swollen glands, easy bruising or bleeding;,...

Read All Potential Side Effects and See Pictures of Dilantin »

What are the precautions when taking phenytoin (Dilantin)?

Before taking phenytoin, tell your doctor or pharmacist if you are allergic to it; or to other anti-seizure medications (e.g., ethotoin, phenobarbital, ethosuximide, trimethadione); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, certain blood conditions (porphyria), diabetes, liver disease, lupus, folate or vitamin B-12 deficiency (megaloblastic anemia).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit...

Read All Potential Precautions of Dilantin »

Dilantin Consumer (continued)

SIDE EFFECTS: Headache, nausea, vomiting, constipation, dizziness, drowsiness, trouble sleeping, or nervousness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Phenytoin may cause swelling and bleeding of the gums. Massage your gums and brush and floss your teeth regularly to minimize this problem. See your dentist regularly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual eye movements, loss of coordination, slurred speech, confusion, muscle twitching, double or blurred vision, tingling of the hands/feet, facial changes (e.g., swollen lips, butterfly-shaped rash around the nose/cheeks), excessive hair growth, increased thirst or urination, unusual tiredness, bone or joint pain, easily broken bones.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: uncontrolled muscle movements, swollen glands (lymph nodes), stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, easy bruising/bleeding, signs of infection (e.g., persistent sore throat or fever).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, high fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking phenytoin, tell your doctor or pharmacist if you are allergic to it; or to other anti-seizure medications (e.g., ethotoin, phenobarbital, ethosuximide, trimethadione); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, certain blood conditions (porphyria), diabetes, liver disease, lupus, folate or vitamin B-12 deficiency (megaloblastic anemia).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Alcohol may also affect your blood levels of this drug.

Tell your doctor you are using phenytoin prior to surgery or any procedure that makes you unable to take it by mouth.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood (or urine) glucose level frequently, as directed by your doctor. Promptly report any abnormal results as directed. Your medicine, exercise plan, or diet may need to be adjusted.

Vitamin D supplements may be necessary to prevent weakening of the bones (osteomalacia). Discuss this with your doctor.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.

Phenytoin passes into breast milk. Consult your doctor before breast-feeding.

Dilantin Patient Information Including Side Effects

Brand Names: Dilantin, Dilantin Infatabs, Dilantin Kapseals, Dilantin-125, Phenytek, Phenytoin Sodium, Prompt

Generic Name: phenytoin (oral) (Pronunciation: FEN i toyn)

• What is phenytoin (Dilantin)?


• What are the possible side effects of phenytoin?


• What is the most important information I should know about phenytoin?


• What should I discuss with my healthcare provider before taking phenytoin?


• How should I take phenytoin?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while taking phenytoin?


• What other drugs will affect phenytoin?


• Where can I get more information?

What is phenytoin (Dilantin)?

Phenytoin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures.

Phenytoin is used to control seizures. Phenytoin is not made to treat all types of seizures, and your doctor will determine if it is the right medication for you.

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

What are the possible side effects of phenytoin?

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.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• swollen glands, easy bruising or bleeding;, swollen or tender gums;


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


• the first sign of any skin rash, no matter how mild;


• confusion, hallucinations, unusual thoughts or behavior;


• slurred speech, loss of balance or coordination;


• tremor (uncontrolled shaking), restless muscle movements in your eyes, tongue, jaw, or neck;


• extreme thirst or hunger, urinating more than usual;


• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or


• changes in the shape of your face or lips.

Less serious side effects may include:

• mild skin rash or itching;


• dizziness, nervousness, sleep problems (insomnia);


• nausea, vomiting, constipation; or


• headache, joint pain.

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 is the most important information I should know about phenytoin?

If you are taking phenytoin to prevent seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking phenytoin.

Do not change your dose of phenytoin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Related Drug Centers

• Dilantin


• Dilantin 125


• Dilantin Infatabs

Zenapax

DRUG DESCRIPTION

ZENAPAX (daclizumab) is an immunosuppressive, humanized IgG1 monoclonal antibody produced by recombinant DNA technology that binds specifically to the alpha subunit (p55 alpha, CD25, or Tac subunit) of the human high-affinity interleukin-2 (IL-2) receptor that is expressed on the surface of activated lymphocytes.

Daclizumab is a composite of human (90%) and murine (10%) antibody sequences. The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody. The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody. The molecular weight predicted from the DNA sequence is 144 kilodaltons.

ZENAPAX (daclizumab) 25 mg/5 mL is supplied as a clear, sterile, colorless concentrate for further dilution and intravenous administration. Each milliliter of ZENAPAX contains 5 mg of daclizumab and 3.6 mg sodium phosphate monobasic monohydrate, 11 mg sodium phosphate dibasic heptahydrate, 4.6 mg sodium chloride, 0.2 mg polysorbate 80, and may contain hydrochloric acid or sodium hydroxide to adjust the pH to 6.9. No preservatives are added.

What are the possible side effects of daclizumab (Zenapax)?

There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

If you experience a serious...

Read All Potential Side Effects and See Pictures of Zenapax »

What are the precautions when taking daclizumab (Zenapax)?

Before using daclizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: serious infection, cancer.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may...

Read All Potential Precautions of Zenapax »

Zenapax Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, or diarrhea may commonly occur during treatment with daclizumab. However, these side effects are probably caused by other drugs you are taking at the same time (e.g., cyclosporine, corticosteroids). If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: redness/pain/swelling at the injection site.

This medication can lower your body's ability to fight an infection. Use of drugs that weaken the immune system may also infrequently increase your risk of developing certain types of cancer (e.g., lymphoma) years after treatment. Your doctor should monitor you closely for signs of these problems. Tell your doctor immediately if you develop any of the following signs: signs of infection (e.g., fever, persistent sore throat, cough, painful urination), poor wound healing, unusual growths/lumps, swollen glands (e.g., on the neck, in the armpits), unexplained weight loss, night sweats, easy bruising/bleeding, abdominal pain/swelling, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain, slow/fast/irregular heartbeat, increased sweating.

In a heart transplant study, use of daclizumab in combination with cyclosporine, mycophenolate mofetil, and corticosteroids may have infrequently caused an increased risk of serious (sometimes fatal) reactions. Consult your doctor or pharmacist for more details.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using daclizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: serious infection, cancer.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

Caution is advised when using this drug in children because they may be more sensitive to its side effects, especially diarrhea, vomiting, infection, and worsening high blood pressure.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially infection.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is recommended that women of childbearing age should use effective birth control before, during, and for 4 months after completion of treatment with this medication. Talk to your doctor about reliable forms of birth control.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, consult your doctor before breast-feeding.

Zenapax Patient Information Including Side Effects

Brand Names: Zenapax

Generic Name: daclizumab (Pronunciation: dah KLIH zyoo mab)

• What is daclizumab (Zenapax)?


• What are the possible side effects of daclizumab (Zenapax)?


• What is the most important information I should know about daclizumab (Zenapax)?


• What should I discuss with my healthcare provider before using daclizumab (Zenapax)?


• How should I use daclizumab (Zenapax)?


• What happens if I miss a dose (Zenapax)?


• What happens if I overdose (Zenapax)?


• What should I avoid while using daclizumab (Zenapax)?


• What other drugs will affect daclizumab (Zenapax)?


• Where can I get more information?

What is daclizumab (Zenapax)?

Daclizumab is an immunosuppressant. Immunosuppressants decrease the actions of the body's immune system.

Daclizumab is used to prevent the body from rejecting a transplanted kidney. Daclizumab is usually used as part of a treatment regimen including other medications.

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

What are the possible side effects of daclizumab (Zenapax)?

There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

If you experience a serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to daclizumab, seek emergency medical attention.

Other, less serious side effects may also occur. Continue to use daclizumab and notify your doctor if you experience

• upset stomach, nausea, or vomiting;


• diarrhea or constipation;


• tremor or dizziness;


• headache; or


• swelling of the hands, feet or legs.

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 is the most important information I should know about daclizumab (Zenapax)?

Because it may cause serious side effects, daclizumab should only be prescribed by a doctor experienced in immunosuppressive therapy and the management of organ transplant patients. Discuss the risks and benefits of using this medication with your doctor.

There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

Related Drug Centers

• Zenapax

Pulmicort Turbuhaler

DRUG DESCRIPTION

Budesonide, the active component of PULMICORT TURBUHALER (budesonide) 200 mcg, is a corticosteroid
designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione
cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture
of two epimers (22R and 22S). The empirical formula of budesonide is C₂₅H₃₄O₆
and its molecular weight is 430.5. Its structural formula is:

Budesonide is a white to off-white, tasteless, odorless powder that is practically
insoluble in water and in heptane, sparingly soluble in ethanol, and freely
soluble in chloroform. Its partition coefficient between octanol and water at
pH 7.4 is 1.6 x 10³.

PULMICORT TURBUHALER (budesonide) is an inhalation-driven multi-dose dry powder inhaler
that contains only micronized budesonide. Each actuation of PULMICORT TURBUHALER
provides 200 mcg budesonide per metered dose, which delivers approximately 160
mcg budesonide from the mouthpiece (based on in vitro testing at 60 L/min
for 2 sec).

In vitro testing has shown that the dose delivery for PULMICORT TURBUHALER (budesonide)
is substantially dependent on airflow through the device. Patient factors such
as inspiratory flow rates will also affect the dose delivered to the lungs of
patients in actual use (see Patient's Instructions
for Use). In adult patients with asthma (mean FEV₁ 2.9 L
[0.8 - 5.1 L]) mean peak inspiratory flow (PIF) through PULMICORT TURBUHALER (budesonide)
was 78 (40-111) L/min. Similar results (mean PIF 82 [43-125] L/min) were obtained
in asthmatic children (6 to 15 years, mean FEV₁ 2.1 L [0.9 - 5.4
L]). Patients should be carefully instructed on the use of this drug product
to assure optimal dose delivery.

What are the precautions when taking budesonide (Pulmicort Turbuhaler)?

Before using budesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose, milk proteins found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), high blood pressure, liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety,...

Read All Potential Precautions of Pulmicort Turbuhaler »

Pulmicort Turbuhaler Consumer (continued)

SIDE EFFECTS: See also Precautions section.

Dry/irritated throat, hoarseness, voice changes, bad taste in the mouth, runny nose, or nosebleeds may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as ear pain, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush (yeast infection). Contact your doctor if you notice white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but serious side effects occur: unusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, increased thirst/urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using budesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose, milk proteins found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), high blood pressure, liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Budesonide may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

Tell your doctor if you are pregnant before using this medication. Infants born to mothers who have used corticosteroids for a long time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness.

This drug passes into breast milk and may have undesirable effects in a nursing infant. Consult your doctor before breast-feeding.