Lortab 5

DRUG DESCRIPTION

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

WARNING: May be habit forming (see PRECAUTIONS, Information
for Patients, and DRUG ABUSE AND DEPENDENCE).

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:

C₁₈H₂₁NO₃ • C₄H₆0₆
• 2 ½ H₂0                
   M.W. 494.490

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:

C₈H₉NO₂     
           M.W. 151.16

Each Lortab 5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablet contains:

Hydrocodone Bitartrate........................................................5 mg

Acetaminophen...............................................................500 mg

In addition, each tablet contains the following inactive ingredients: cornstarch, FD & C Blue #1 Lake, gelatin, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, and sugar spheres. Meets USP dissolution test 1.

What are the precautions when taking hydrocodone bitartrate and acetaminophen tablets (Lortab 5)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (e.g., morphine, codeine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), severe diarrhea (e.g., pseudomembranous colitis, infectious diarrhea due to toxins).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, difficulty urinating (e.g., enlarged prostate, urethral stricture), alcohol use, drug dependency, heart problems (e.g., slow/irregular heartbeat, very low blood pressure),...

Read All Potential Precautions of Lortab 5 »

Lortab 5 Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, flushing, vision changes, or mental/mood 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular breathing, slow/irregular heartbeat, change in the amount of urine.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: impairment or loss of hearing (especially with high doses for long periods).

If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (e.g., morphine, codeine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), severe diarrhea (e.g., pseudomembranous colitis, infectious diarrhea due to toxins).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, difficulty urinating (e.g., enlarged prostate, urethral stricture), alcohol use, drug dependency, heart problems (e.g., slow/irregular heartbeat, very low blood pressure), abdominal/stomach problems (e.g., gallbladder disease), lung disease (e.g., asthma, chronic obstructive pulmonary disease), seizure disorders, serious head injury or brain disease, spinal problems (kyphoscoliosis), low thyroid disease (hypothyroidism), adrenal gland problems (Addison's disease), psychiatric problems (toxic psychosis).

This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of side effects of this drug.

This product contains acetaminophen which may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially the possible decreased breathing and drowsiness effects.

This medication should be used only when clearly needed during pregnancy. It is not recommended for use for long periods or in high doses near the expected delivery date because of the potential for harm to an unborn baby. Discuss the risks and benefits with your doctor.

Based on information from related drugs, this drug may pass into breast milk. Due to the potential risk to the infant, consult your doctor before breast-feeding.

FML

DRUG DESCRIPTION

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name:

Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.
Structural Formula:

Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium
chloride 0.004%.

Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%;
purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate,
monobasic; and sodium hydroxide to adjust the pH. FML® (fluorometholone ophthalmic suspension) suspension is formulated
with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.

What are the possible side effects of fluorometholone ophthalmic (Flarex, FML Forte Liquifilm, FML Liquifilm, FML S.O.P.)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• pain behind your eyes, sudden vision changes, severe headache;


• sudden eye irritation;


• blurred vision, tunnel vision, eye pain, or seeing halos around lights; or


• signs of...

Read All Potential Side Effects and See Pictures of FML »

FML Patient Information Including Side Effects

Brand Names: Flarex, FML Forte Liquifilm, FML Liquifilm, FML S.O.P.

Generic Name: fluorometholone ophthalmic (Pronunciation: FLURE oh METH oh lone)

• What is fluorometholone ophthalmic (FML)?


• What are the possible side effects of fluorometholone ophthalmic (FML)?


• What is the most important information I should know about fluorometholone ophthalmic (FML)?


• What should I tell my healthcare provider before using fluorometholone ophthalmic (FML)?


• How should I use fluorometholone ophthalmic (FML)?


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


• What happens if I overdose (FML)?


• What should I avoid while using fluorometholone ophthalmic (FML)?


• What other drugs will affect fluorometholone ophthalmic (FML)?


• Where can I get more information?

What is fluorometholone ophthalmic (FML)?

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

Fluorometholone ophthalmic (for the eyes) is used to treat eye swelling caused by infections, injury, surgery, or other conditions.

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

What are the possible side effects of fluorometholone ophthalmic (FML)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• pain behind your eyes, sudden vision changes, severe headache;


• sudden eye irritation;


• blurred vision, tunnel vision, eye pain, or seeing halos around lights; or


• signs of new eye infection, such as swelling, draining, or crusting of your eyes.

Less serious side effects may include:

• increased sensitivity to light; or


• mild stinging, burning, itching, or irritation in your eyes.

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 fluorometholone ophthalmic (FML)?

Do not use this medication if you are allergic to fluorometholone, or if you have any type of viral or fungal eye infection, ocular herpes, tuberculosis, or an untreated infection in your eye or elsewhere, including chickenpox.

Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, if you have herpes, or if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

Do not use fluorometholone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using fluorometholone before putting your contact lenses in.

Shake the eye drops gently before each use.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not stop using fluorometholone suddenly without first talking to your doctor. Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.

Related Drug Centers

• Fluorometholone


• Fluorometholone Forte

Lodine

(Generic versions may still be available.)

DRUG DESCRIPTION

Lodine® (etodolac) is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol.

The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic
acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an
n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula
for etodolac is C₁₇H₂₁NO₃, and it has the following
structural formula:

The inactive ingredients in Lodine (etodolac) include:

-in capsules: cellulose, gelatin, iron oxides, lactose, magnesium stearate,
povidone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.

-in tablets: cellulose, hypromellose, lactose, magnesium stearate, polyethylene
glycol, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide.
The 400 mg tablets contain D&C Yellow #10, FD&C Blue #2, and FD&C
Yellow #6 as color additives. The 500 mg tablets contain FD&C Blue #2 only.

What are the possible side effects of etodolac (Lodine, Lodine XL)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking etodolac and seek medical attention or call your doctor at once if you have any of these serious side effects:

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


• black, bloody, or tarry stools;


• coughing up blood or vomit that looks like coffee grounds;


• swelling or rapid...

Read All Potential Side Effects and See Pictures of Lodine »

What are the precautions when taking etodolac (Lodine)?

Before taking etodolac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, severe loss of body water (dehydration),...

Read All Potential Precautions of Lodine »

Lodine Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, diarrhea, drowsiness, or dizziness may occur. 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: easy bruising/bleeding, difficult/painful swallowing, hearing changes (such as ringing in the ears), mental/mood changes, swelling of the ankles/feet/hands, sudden/unexplained weight gain, change in the amount of urine, unexplained stiff neck, vision changes.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.

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.

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 etodolac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, severe loss of body water (dehydration), stroke, throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers).

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.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

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

Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Lodine Patient Information Including Side Effects

Brand Names: Lodine, Lodine XL

Generic Name: etodolac (Pronunciation: ee toe DOE lak)

• What is etodolac (Lodine)?


• What are the possible side effects of etodolac (Lodine)?


• What is the most important information I should know about etodolac (Lodine)?


• What should I discuss with my healthcare provider before taking etodolac (Lodine)?


• How should I take etodolac (Lodine)?


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


• What happens if I overdose (Lodine)?


• What should I avoid while taking etodolac (Lodine)?


• What other drugs will affect etodolac (Lodine)?


• Where can I get more information?

What is etodolac (Lodine)?

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

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

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

What are the possible side effects of etodolac (Lodine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking etodolac and seek medical attention or call your doctor at once if you have any of these serious side effects:

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


• black, bloody, or tarry stools;


• coughing up blood or vomit that looks like coffee grounds;


• swelling or rapid weight gain;


• urinating less than usual or not at all;


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


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


• bruising, severe tingling, numbness, pain, muscle weakness; or


• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation;


• bloating, gas;


• dizziness, headache, nervousness;


• skin itching or rash;


• sore throat, stuffy nose;


• blurred vision; or


• ringing in your ears.

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 etodolac (Lodine)?

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

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

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

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

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to etodolac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking etodolac. Alcohol can increase the risk of stomach bleeding caused by etodolac.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Etodolac can make your skin more sensitive to sunlight and sunburn may result.

Related Drug Centers

• Lodine

Beconase-AQ

DRUG DESCRIPTION

Beclomethasone dipropionate, monohydrate, the active component of BECONASE AQ Nasal Spray, is an anti-inflammatory steroid having the chemical name 9-chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, monohydrate and the following chemical structure:

Beclomethasone 17,21-dipropionate is a diester of beclomethasone, a synthetic
halogenated corticosteroid. Beclomethasone dipropionate, monohydrate is a white
to creamy-white, odorless powder with a molecular weight of 539.06. It is very
slightly soluble in water, very soluble in chloroform, and freely soluble in
acetone and in ethanol.

BECONASE AQ Nasal Spray is a metered-dose, manual pump spray unit containing
a microcrystalline suspension of beclomethasone dipropionate, monohydrate equivalent
to 42 mcg of beclomethasone dipropionate, calculated on the dried basis, in
an aqueous medium containing microcrystalline cellulose, carboxymethylcellulose
sodium, dextrose, benzalkonium chloride, polysorbate 80, and 0.25% v/w phenylethyl
alcohol. The pH through expiry is 5.0 to 6.8.

After initial priming (6 actuations), each actuation of the pump delivers from
the nasal adapter 100 mg of suspension containing beclomethasone dipropionate,
monohydrate equivalent to 42 mcg of beclomethasone dipropionate. If the pump
is not used for 7 days, it should be primed until a fine spray appears. Each
25-g bottle of BECONASE AQ Nasal Spray provides 180 metered sprays.

What are the possible side effects of beclomethasone nasal (Beconase AQ)?

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:

• severe or ongoing nose bleed;


• sores in the nose that won't heal;


• wheezing, trouble breathing;


• vision problems; or


• fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• sneezing,...

Read All Potential Side Effects and See Pictures of Beconase-AQ »

What are the precautions when taking beclomethasone dipropionate, monohydrate (Beconase-AQ)?

Before using nasal beclomethasone, 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 problems (such as glaucoma, cataracts), infections (including tuberculosis), recent nose problems (such as injury, ulcers, surgery).

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.

Rarely, using corticosteroid medications for a long time can make it more...

Read All Potential Precautions of Beconase-AQ »

Beconase-AQ Consumer (continued)

SIDE EFFECTS: Nose/throat dryness or irritation, sneezing, nosebleeds, and unpleasant taste/smell may occur. If any of these side 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 immediately if any of these rare but serious side effects occur: loss of taste or smell, pain/sores in your nose.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as beclomethasone). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor immediately if you have any signs of infection (such as ear pain, persistent sore throat, fever, chills, white patches inside the nose or on the back of the throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/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 nasal beclomethasone, 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 problems (such as glaucoma, cataracts), infections (including tuberculosis), recent nose problems (such as injury, ulcers, surgery).

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.

Rarely, using corticosteroid medications for a long time can make it 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 this medication within the past few months.

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

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. However, many doctors consider this drug to be safe to use during pregnancy. Rarely, infants born to mothers who have been using corticosteroids (including beclomethasone) for a long 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. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Beconase-AQ Patient Information Including Side Effects

Brand Names: Beconase AQ

Generic Name: beclomethasone nasal (Pronunciation: BE kloe METH a sone)

• What is beclomethasone nasal (Beconase-AQ)?


• What are the possible side effects of beclomethasone nasal (Beconase-AQ)?


• What is the most important information I should know about beclomethasone nasal (Beconase-AQ)?


• What should I discuss with my healthcare provider before using beclomethasone nasal (Beconase-AQ)?


• How should I use beclomethasone nasal (Beconase-AQ)?


• What happens if I miss a dose (Beconase-AQ)?


• What happens if I overdose (Beconase-AQ)?


• What should I avoid while using beclomethasone nasal (Beconase-AQ)?


• What other drugs will affect beclomethasone nasal (Beconase-AQ)?


• Where can I get more information?

What is beclomethasone nasal (Beconase-AQ)?

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

Beclomethasone nasal is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Beclomethasone is also used to keep nasal polyps from coming back after surgery to remove them.

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

What are the possible side effects of beclomethasone nasal (Beconase-AQ)?

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:

• severe or ongoing nose bleed;


• sores in the nose that won't heal;


• wheezing, trouble breathing;


• vision problems; or


• fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• sneezing, runny or stuffy nose;


• dryness or irritation in your nose or throat;


• nausea, headache, feeling light-headed;


• unpleasant taste or smell; or


• sores or white patches inside or around your nose.

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 beclomethasone nasal (Beconase-AQ)?

Before using beclomethasone, tell your doctor if you have been sick or had an infection of any kind. Also tell your doctor if you have glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Beclomethasone nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using beclomethasone nasal.

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using beclomethasone nasal.

Related Drug Centers

• Beconase-AQ


• Beconase

Lomotil

DRUG DESCRIPTION

Each Lomotil (diphenoxylate and atropine) tablet and each 5 ml of Lomotil (diphenoxylate and atropine) liquid for oral use contains:
diphenoxylate hydrochloride 2.5 mg atropine sulfate ..............0.025 mg

Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate
monohydrochloride and has the following structural formula:

Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl)
benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1)
(salt) monohydrate and has the following structural formula:

A subtherapeutic amount of atropine sulfate is present to discourage deliberate
overdosage.

Inactive ingredients of Lomotil (diphenoxylate and atropine) tablets include acacia, corn starch, magnesium
stearate, sorbitol, sucrose, and talc. Inactive ingredients of Lomotil (diphenoxylate and atropine) liquid
include cherry flavor, citric acid, ethyl alcohol 15%, FD&C Yellow No. 6,
glycerin, sodium phosphate, sorbitol, and water.

What are the possible side effects of atropine and diphenoxylate (Lomotil, Lonox, Vi-Atro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• stomach pain or bloating;


• ongoing or worsening diarrhea;


• diarrhea that is watery or bloody;


• numbness in your hands or feet;


• depressed mood;


• confusion, unusual thoughts or...

Read All Potential Side Effects and See Pictures of Lomotil »

What are the precautions when taking diphenoxylate and atropine (Lomotil)?

Before taking diphenoxylate with atropine, tell your doctor or pharmacist if you are allergic to either drug; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease (e.g., obstructive jaundice, cirrhosis), diarrhea caused by certain types of infections (Clostridium difficile-associated diarrhea following recent antibiotic therapy, bacterial infection of the gut caused by E. coli, Salmonella, Shigella).

Before using this medication, tell your doctor or pharmacist your medical history,...

Read All Potential Precautions of Lomotil »

Lomotil Consumer (continued)

SIDE EFFECTS: See also Precautions for side effects seen in children.

Drowsiness, dizziness, headache, tiredness, blurred vision, dry mouth, and loss of appetite may occur. 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 immediately if any of these unlikely but serious side effects occur: stomach/abdominal pain or swelling, severe nausea, vomiting, mental/mood changes (e.g., confusion, depression), restlessness, numbness/tingling of arms/legs.

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 diphenoxylate with atropine, tell your doctor or pharmacist if you are allergic to either drug; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease (e.g., obstructive jaundice, cirrhosis), diarrhea caused by certain types of infections (Clostridium difficile-associated diarrhea following recent antibiotic therapy, bacterial infection of the gut caused by E. coli, Salmonella, Shigella).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current dehydration or mineral imbalance, a certain type of bowel disease (acute ulcerative colitis).

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.

Liquid forms of this product may contain alcohol. Caution is advised if you have alcohol dependence or liver disease. Ask your doctor or pharmacist about using this product safely.

This drug is not recommended for use in children younger than 2 years. Caution is advised when using this drug in children, particularly those with Down's syndrome, because they may be more sensitive to the following side effects: high fever, fast heartbeat, decreased urination, flushing, dry skin/mouth, thirst. Very serious (possibly life-threatening) effects may occur if too much of this medication is taken by children.

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

This medication passes into breast milk. Consult your doctor before breast-feeding.

Lomotil Patient Information Including Side Effects

Brand Names: Lomotil, Lonox, Vi-Atro

Generic Name: atropine and diphenoxylate (Pronunciation: A troe peen and DYE fen OX i late)

• What is atropine and diphenoxylate (Lomotil)?


• What are the possible side effects of atropine and diphenoxylate (Lomotil)?


• What is the most important information I should know about atropine and diphenoxylate (Lomotil)?


• What should I discuss with my healthcare provider before taking atropine and diphenoxylate (Lomotil)?


• How should I take atropine and diphenoxylate (Lomotil)?


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


• What happens if I overdose (Lomotil)?


• What should I avoid while taking atropine and diphenoxylate (Lomotil)?


• What other drugs will affect atropine and diphenoxylate (Lomotil)?


• Where can I get more information?

What is atropine and diphenoxylate (Lomotil)?

Atropine affects the body in many different ways, such as reducing spasms in the bladder, stomach, and intestines.

Diphenoxylate is an antidiarrheal medication.

The combination of atropine and diphenoxylate is used to treat diarrhea.

Atropine and diphenoxylate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of atropine and diphenoxylate (Lomotil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• stomach pain or bloating;


• ongoing or worsening diarrhea;


• diarrhea that is watery or bloody;


• numbness in your hands or feet;


• depressed mood;


• confusion, unusual thoughts or behavior;


• fast heart rate; or


• urinating less than usual or not at all.

Less serious side effects may include:

• drowsiness, dizziness, headache;


• tired or restless feeling;


• nausea, vomiting, upset stomach, loss of appetite; or


• 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 atropine and diphenoxylate (Lomotil)?

If you are giving this medication to a child, pay close attention to the dose. An atropine and diphenoxylate overdose is more likely to occur in a child, and can cause breathing problems or result in death or permanent brain damage.

Use only the liquid form of this medicine in a child younger than 13 years old. Do not give atropine and diphenoxylate tablets to a child under 13.

Drink extra water while you are taking this medication to keep from getting dehydrated.

It may take up to 48 hours of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 10 days of treatment.

Related Drug Centers

• Lomotil

Lortab 2.5

DRUG DESCRIPTION

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral
administration.

WARNING: May be habit forming (see PRECAUTIONS, Information
for Patients, and DRUG ABUSE AND DEPENDENCE).

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:

C₁₈H₂₁NO₃• C₄H₆0₆
• 2 ½ H₂0                M.W.
494.50

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:

C₈H₉NO₂     
                    M.W. 151.17

Each Lortab 2.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablet contains:

Hydrocodone Bitartrate............................2.5 mg

Acetaminophen.....................................500 mg

In addition, each tablet contains the following inactive ingredients: colloidal
silicon dioxide, croscarmellose sodium, crospovidone, micro-crystalline cellulose,
povidone, pregelatinized starch, stearic acid and sugar spheres which are composed
of starch derived from corn, sucrose, and FD&C Red #3.

What are the precautions when taking hydrocodone bitartrate and acetaminophen tablets (Lortab 2.5)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (e.g., morphine, codeine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), severe diarrhea (e.g., pseudomembranous colitis, infectious diarrhea due to toxins).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, difficulty urinating (e.g., enlarged prostate, urethral stricture), alcohol use, drug dependency, heart problems (e.g., slow/irregular heartbeat, very low blood pressure),...

Read All Potential Precautions of Lortab 2.5 »

Lortab 2.5 Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, flushing, vision changes, or mental/mood 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular breathing, slow/irregular heartbeat, change in the amount of urine.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: impairment or loss of hearing (especially with high doses for long periods).

If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (e.g., morphine, codeine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), severe diarrhea (e.g., pseudomembranous colitis, infectious diarrhea due to toxins).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, difficulty urinating (e.g., enlarged prostate, urethral stricture), alcohol use, drug dependency, heart problems (e.g., slow/irregular heartbeat, very low blood pressure), abdominal/stomach problems (e.g., gallbladder disease), lung disease (e.g., asthma, chronic obstructive pulmonary disease), seizure disorders, serious head injury or brain disease, spinal problems (kyphoscoliosis), low thyroid disease (hypothyroidism), adrenal gland problems (Addison's disease), psychiatric problems (toxic psychosis).

This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of side effects of this drug.

This product contains acetaminophen which may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially the possible decreased breathing and drowsiness effects.

This medication should be used only when clearly needed during pregnancy. It is not recommended for use for long periods or in high doses near the expected delivery date because of the potential for harm to an unborn baby. Discuss the risks and benefits with your doctor.

Based on information from related drugs, this drug may pass into breast milk. Due to the potential risk to the infant, consult your doctor before breast-feeding.

Ixiaro

DRUG DESCRIPTION

IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension
for intramuscular injection. Each dose of vaccine contains approximately 6 mcg
of purified, inactivated JEV proteins and 250 mcg of aluminum hydroxide. The
appearance of the liquid is a white, opaque, non-uniform suspension which becomes
homogeneous upon shaking. As IXIARO (japanese encephalitis vaccine) is inactivated, it cannot cause Japanese
Encephalitis.

IXIARO (japanese encephalitis vaccine) is a vaccine prepared by propagating JEV strain SA₁₄-14-2
in Vero cells. Multiple viral harvests are performed, which are pooled, clarified
and concentrated. The virus suspension is treated with protamine sulfate to
remove contaminating DNA and proteins. The resulting partially purified virus
is processed through a sucrose density gradient centrifugation step and fractionated.
Each fraction is analyzed for the presence of virus, and fractions with the
highest virus activity are pooled to give a purified virus suspension. The purified
virus is then inactivated by treatment with formaldehyde. The preparation is
adjusted to a specified protein concentration and formulated by addition of
aluminum hydroxide.

The formulated bulk vaccine is filled into syringes, at a volume of 0.5 mL
per syringe. From the manufacturing process, IXIARO (japanese encephalitis vaccine) also contains: formaldehyde
(not more than 200 ppm), bovine serum albumin (not more than 100 ng/mL), host cell DNA (not more than 200 pg/mL), sodium metabisulphite (not more than 200
ppm), host cell proteins (not more than 300 ng/mL), and protamine sulfate (not
more than 1μg/mL). No preservatives, stabilizers, or antibiotics are added
to the formulation.