Librium

DRUG DESCRIPTION

Librium, the original chlordiazepoxide HCI and prototype for the benzodiazepine
compounds, was synthesized and developed at Hoffmann-La Roche Inc. It is a versatile
therapeutic agent of proven value for the relief of anxiety. Librium (chlordiazepoxide) is among
the safer of the effective psychopharmacologic compounds available, as demonstrated
by extensive clinical evidence.

Librium (chlordiazepoxide) is available as capsules containing 5 mg, 10 mg or 25 mg chlordiazepoxide
HCI. Each capsule also contains corn starch, lactose and talc. Gelatin capsule
shells may contain methyl.and propyl parabens and potassium sorbater with the
following dye systems: 5-mg capsules - FD&C Yellow No. 6 plus D&C Yellow
No. 10 and either FD&C Blue No. 1 or FD&C Green No. 3. 10-mg capsules
- D&C Yellow No. 10 and either FD&C Blue No. 1 plus FD&C Red No.
3 or FD&C Green No. 3 plus FD&C Red No. 40. 25-mg capsules- D&C
Yellow No. 10 and either FD&C Green No. 3 or FD&C Blue No. 1.

Chlordiazepoxide hydrochloride is 7-chloro-2- (methylamino) -5-phenyl-3H-1,4-benzodiazepine
4-oxide hydrochloride. A white to practically white crystalline substance, it
is soluble in water. It is unstable in solution and the powder must be protected
from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide
hydrochloride is as follows:

What are the possible side effects of chlordiazepoxide (Librium)?

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:

• confusion;


• depressed mood, thoughts of suicide or hurting yourself;


• restless muscle movements in your eyes, tongue, jaw, or neck;


• hyperactivity, agitation, hostility;


• hallucinations; or


• jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Librium »

What are the precautions when taking chlordiazepoxide (Librium)?

Before taking this medication, 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: liver disease, kidney disease, lung/breathing problems (e.g., COPD, sleep apnea), blood disorder (porphyria), drug or alcohol abuse.

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

Caution is advised when using this drug...

Read All Potential Precautions of Librium »

Librium Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, nausea, constipation, blurred vision, or headache 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: mental/mood changes, slurred speech, clumsiness, trouble walking, decreased/increased interest in sex, tremor, uncontrollable movements, facial or muscle twitching, trouble urinating, sleep disturbances.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fainting, stomach/abdominal pain, persistent nausea, vomiting, fatigue, yellowing eyes or skin, dark urine, 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, 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 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: liver disease, kidney disease, lung/breathing problems (e.g., COPD, sleep apnea), blood disorder (porphyria), drug or alcohol abuse.

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

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the drowsiness effect.

This medication is not recommended for use during pregnancy due to the potential for harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details.

Based on information from related drugs, this drug may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Librium Patient Information Including Side Effects

Brand Names: Librium

Generic Name: chlordiazepoxide (Pronunciation: klor dye az e POX ide)

• What is chlordiazepoxide (Librium)?


• What are the possible side effects of chlordiazepoxide (Librium)?


• What is the most important information I should know about chlordiazepoxide (Librium)?


• What should I discuss with my healthcare provider before taking chlordiazepoxide (Librium)?


• How should I take chlordiazepoxide (Librium)?


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


• What happens if I overdose (Librium)?


• What should I avoid while taking chlordiazepoxide (Librium)?


• What other drugs will affect chlordiazepoxide (Librium)?


• Where can I get more information?

What is chlordiazepoxide (Librium)?

Chlordiazepoxide is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Chlordiazepoxide affects chemicals in the brain that may become unbalanced and cause anxiety.

Chlordiazepoxide is used to treat anxiety disorders or alcohol withdrawal.

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

What are the possible side effects of chlordiazepoxide (Librium)?

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:

• confusion;


• depressed mood, thoughts of suicide or hurting yourself;


• restless muscle movements in your eyes, tongue, jaw, or neck;


• hyperactivity, agitation, hostility;


• hallucinations; or


• jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• drowsiness, tiredness;


• swelling;


• skin rash;


• nausea, vomiting, constipation; or


• irregular menstrual periods.

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 chlordiazepoxide (Librium)?

Do not use this medication if you are allergic to chlordiazepoxide or to other benzodiazepines, such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).

This medication can cause birth defects in an unborn baby. Do not use chlordiazepoxide if you are pregnant.

Before taking chlordiazepoxide, tell your doctor if you have any breathing problems, glaucoma, porphyria, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking chlordiazepoxide. This medication can increase the effects of alcohol.

Tell your doctor if you regularly use other medicines that make you sleepy. They can add to sleepiness caused by chlordiazepoxide.

Chlordiazepoxide may be habit-forming and should be used only by the person it was prescribed for. Chlordiazepoxide should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Related Drug Centers

• Librium

Merrem I.V.

DRUG DESCRIPTION

MERREM® I.V. (meropenem for injection) is a sterile, pyrogen-free, synthetic,
broad-spectrum, carbapenem antibiotic for intravenous administration. It is
(4R,5S,6S)-3-[[(3S,5S)-5- (Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-
azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula
is C₁₇H₂₅N₃O₅S•3H₂O
with a molecular weight of 437.52. Its structural formula is:

MERREM I.V. (meropenem) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether.

When constituted as instructed (see DOSAGE AND ADMINISTRATION;
PREPARATION OF SOLUTION), each 1 g MERREM I.V. vial will deliver 1 g of
meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg
MERREM I.V. vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium
carbonate (1.96 mEq).

What are the possible side effects of meropenem (Merrem)?

If you experience a rare but serious side effects, stop taking meropenem and seek emergency medical attention or contact your doctor immediately:

• allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)


• seizures;


• severe or watery diarrhea;


• a skin rash;


• unusual tiredness or weakness; or


• unusual bleeding or bruising.

Other less serious side effects may be more likely to occur. Continue to use meropenem and...

Read All Potential Side Effects and See Pictures of Merrem I.V. »

What are the precautions when taking meropenem (Merrem I.V.)?

Before using meropenem, tell your doctor or pharmacist if you are allergic to it; or to penicillins or cephalosporins; 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: brain disorders (e.g., seizures, head injury, tumor), kidney disease, stomach/intestinal diseases (e.g., colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

Tell your doctor if you are pregnant before using this medication.

It is not known...

Read All Potential Precautions of Merrem I.V. »

Merrem I.V. Consumer (continued)

SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause upset stomach, headache, nausea, vomiting, constipation, or diarrhea. 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, hearing changes (e.g., decreased hearing, ringing in the ears), mental/mood changes (e.g., confusion), swollen tongue.

Get medical help right away if any of these rare but very serious side effects occur: seizures, unusual weakness.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of these 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.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

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 using meropenem, tell your doctor or pharmacist if you are allergic to it; or to penicillins or cephalosporins; 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: brain disorders (e.g., seizures, head injury, tumor), kidney disease, stomach/intestinal diseases (e.g., colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Merrem I.V. Patient Information Including Side Effects

Brand Names: Merrem

Generic Name: meropenem (Pronunciation: mer oh PEH nem)

• What is meropenem (Merrem I.V.)?


• What are the possible side effects of meropenem (Merrem I.V.)?


• What is the most important information I should know about meropenem (Merrem I.V.)?


• What should I discuss with my healthcare provider before taking meropenem (Merrem I.V.)?


• How should I take meropenem (Merrem I.V.)?


• What happens if I miss a dose (Merrem I.V.)?


• What happens if I overdose (Merrem I.V.)?


• What should I avoid while taking meropenem (Merrem I.V.)?


• What other drugs will affect meropenem (Merrem I.V.)?


• Where can I get more information?

What is meropenem (Merrem I.V.)?

Meropenem is an antibiotic. It fights bacteria in the body.

Meropenem is used in the treatment of infections of the abdomen, such as appendicitis and peritonitis, bacterial meningitis (infection of the lining of the brain), and skin infections.

Meropenem may also be used for purposes other than those listed here.

What are the possible side effects of meropenem (Merrem I.V.)?

If you experience a rare but serious side effects, stop taking meropenem and seek emergency medical attention or contact your doctor immediately:

• allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)


• seizures;


• severe or watery diarrhea;


• a skin rash;


• unusual tiredness or weakness; or


• unusual bleeding or bruising.

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

• nausea or vomiting;


• diarrhea or constipation;


• headache; or


• soreness, redness, or mild swelling at the injection site.

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 meropenem (Merrem I.V.)?

Do not take meropenem without first talking to your doctor if you have an allergy to meropenem, imipenem (Primaxin), a penicillin antibiotic, or a cephalosporin antibiotic.

Related Drug Centers

• Merrem IV

Enjuvia

DRUG DESCRIPTION

ENJUVIA™ (synthetic conjugated estrogens, B) tablets contain a blend
of ten (10) synthetic estrogenic substances. The estrogenic substances are:
sodium estrone sulfate, sodium equilin sulfate, sodium 17α-dihydroequilin
sulfate, sodium 17α-estradiol sulfate, sodium 17β-dihydroequilin sulfate,
sodium 17α-dihydroequilenin sulfate, sodium 17β-dihydroequilenin
sulfate, sodium equilenin sulfate, sodium 17β-estradiol sulfate, and sodium
Δ^8,9-dehydroestrone sulfate.

The structural formulae for these estrogens are:

ENJUVIA (synthetic conjugated estrogens, b) tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, B. These tablets contain the following inactive ingredients: ascorbyl palmitate, butylated hydroxyanisole, colloidal silicon dioxide, edetate disodium dehydrate, plasticized ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, purified water, iron oxide red, titanium dioxide, polyethylene glycol, polysorbate 80, triacetate and triacetin/glycerol. In addition, the 0.45 mg tablets contain iron oxide black and iron oxide yellow; the 0.9 mg tablets also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake and FD&C yellow no. 6 aluminum lake; and the 1.25 mg tablets contain iron oxide yellow.

What are the precautions when taking synthetic conjugated estrogens, b (Enjuvia)?

Before taking this medication, 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: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels,...

Read All Potential Precautions of Enjuvia »

Enjuvia Consumer (continued)

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes 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: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product 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 this medication, 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: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression).

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking an estrogen product. You may need to stop this medication for a time or take special precautions.

This drug may cause blotchy, dark areas of the skin on the face (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

Children may be more sensitive to the side effects of this drug. It may affect their growth/development. Discuss the possible effects of this medication with the doctor, and monitor your child's growth periodically.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

Taclonex

DRUG DESCRIPTION

Taclonex® (calcipotriene and betamethasone dipropionate) Ointment contains calcipotriene hydrate and betamethasone dipropionate.

It is intended for topical use.

Calcipotriene hydrate is a synthetic vitamin D₃ analogue.

• Chemically, calcipotriene hydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(α),3(β),24-triol,hydrate,
  with the empirical formula


• C₂₇H₄₀O₃,H₂O, a molecular weight
  of 430.6, and the following structural formula:

Calcipotriene hydrate is a white to almost white crystalline compound.

Betamethasone dipropionate is a synthetic corticosteroid.

Betamethasone dipropionate has the chemical name 9-fluoro-11(β),17,21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate,
with the empirical formula C₂₈H₃₇FO₇, a molecular
weight of 504.6, and the following structural formula:

Betamethasone dipropionate is a white to almost white odorless powder.

Each gram of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.

What are the possible side effects of betamethasone and calcipotriene (Taclonex, Taclonex Scalp)?

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

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

• severe skin irritation on treated areas;


• worsened symptoms or no improvement in psoriasis;


• pus, swelling, redness, increased itching, or other signs of skin infection;


• confusion,...

Read All Potential Side Effects and See Pictures of Taclonex »

What are the precautions when taking calcipotriene and betamethasone dipropionate (Taclonex)?

Before using this product, tell your doctor or pharmacist if you are allergic to betamethasone or calcipotriene; 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: a certain mineral imbalance (high calcium blood level), thin skin in the areas to be treated.

If you have a skin infection or a skin reaction other than psoriasis (e.g., bacterial skin infection, chickenpox, herpes simplex), it should be treated before you start this medication. Betamethasone and other corticosteroid drugs can slow down...

Read All Potential Precautions of Taclonex »

Taclonex Consumer (continued)

SIDE EFFECTS: Itching, burning, redness, or irritation of the skin 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: skin thinning/discoloration/"stretch marks", swelling/inflammation of the hair pores (folliculitis), worsening of psoriasis.

This product may infrequently cause an increase in the level of calcium in your blood. Tell your doctor immediately if you notice any of the following unlikely but serious side effects: mental/mood changes, unexplained constipation.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. 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.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 this product, tell your doctor or pharmacist if you are allergic to betamethasone or calcipotriene; 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: a certain mineral imbalance (high calcium blood level), thin skin in the areas to be treated.

If you have a skin infection or a skin reaction other than psoriasis (e.g., bacterial skin infection, chickenpox, herpes simplex), it should be treated before you start this medication. Betamethasone and other corticosteroid drugs can slow down your body's response to antibiotic drugs and make it more difficult to clear an infection.

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

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Your doctor may direct you to limit or avoid phototherapy while you use this product. Discuss this further with your doctor.

Rarely, using corticosteroid medications for a long time or over large areas of skin 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.

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.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Taclonex Patient Information Including Side Effects

Brand Names: Taclonex, Taclonex Scalp

Generic Name: betamethasone and calcipotriene (topical) (Pronunciation: BAY ta METH a sone and KAL si poe TRYE een)

• What is betamethasone and calcipotriene (Taclonex)?


• What are the possible side effects of betamethasone and calcipotriene (Taclonex)?


• What is the most important information I should know about betamethasone and calcipotriene (Taclonex)?


• What should I discuss with my healthcare provider before using betamethasone and calcipotriene (Taclonex)?


• How should I use betamethasone and calcipotriene (Taclonex)?


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


• What happens if I overdose (Taclonex)?


• What should I avoid while using betamethasone and calcipotriene (Taclonex)?


• What other drugs will affect betamethasone and calcipotriene (Taclonex)?


• Where can I get more information?

What is betamethasone and calcipotriene (Taclonex)?

Betamethasone is a topical corticosteroid. It reduces swelling, relieves itching, and constricts blood vessels.

Calcipotriene is a form of vitamin D. It works by decreasing the rate of skin cell reproduction.

Betamethasone and calcipotriene is a combination drug used to treat psoriasis vulgaris.

Betamethasone and calcipotriene may also be used for other purposes not listed in this medication guide.

What are the possible side effects of betamethasone and calcipotriene (Taclonex)?

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

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

• severe skin irritation on treated areas;


• worsened symptoms or no improvement in psoriasis;


• pus, swelling, redness, increased itching, or other signs of skin infection;


• confusion, thirst, extreme tiredness, lost appetite, weight loss;


• adrenal insufficiency--nausea, vomiting, lost appetite, tiredness, trouble breathing, joint/muscle pain, feeling light-headed, fainting;


• Cushing syndrome--weight gain (especially in your face), thinning muscles in your arms or legs, easy bruising, thinning skin, acne, increased facial hair, darkened skin; or


• high blood sugar (hyperglycemia)--increased urination and thirst, nausea, vomiting.

Less serious side effects may include:

• burning or mild itching;


• red or scaly rash;


• swollen hair follicles; or


• changes in the color of treated skin areas.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about betamethasone and calcipotriene (Taclonex)?

Use this medication exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Before using betamethasone and calcipotriene, tell your doctor if you are pregnant or breast-feeding.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can affect betamethasone and calcipotriene. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Related Drug Centers

• Taclonex


• Taclonex Scalp

Fluarix

DRUG DESCRIPTION

FLUARIX, Influenza Virus Vaccine, for intramuscular injection, is a sterile
colorless to slightly opalescent suspension. FLUARIX is a vaccine prepared from
influenza viruses propagated in embryonated chicken eggs. Each of the influenza
viruses is produced and purified separately. After harvesting the virus-containing
fluids, each influenza virus is concentrated and purified by zonal centrifugation
using a linear sucrose density gradient solution containing detergent to disrupt
the viruses. Following dilution, the vaccine is further purified by diafiltration.
Each influenza virus solution is inactivated by the consecutive effects of sodium
deoxycholate and formaldehyde leading to the production of a “split virus.”
Each split inactivated virus is then suspended in sodium phosphate-buffered
isotonic sodium chloride solution. The vaccine is formulated from the 3 split
inactivated virus solutions.

FLUARIX has been standardized according to USPHS requirements for the 2011-2012
influenza season and is formulated to contain 45 micrograms (mcg) hemagglutinin
(HA) per 0.5-mL dose, in the recommended ratio of 15 mcg HA of each of the following
3 strains: A/California/7/2009 NYMC X-181 (H1N1), A/Victoria/210/2009 NYMC X-187
(H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008.

FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal.
Each 0.5-mL dose also contains octoxynol-10 (TRITON® X-100) ≤ 0.085 mg,
α-tocopheryl hydrogen succinate ≤ 0.1 mg, and polysorbate 80 (Tween
80) ≤ 0.415 mg. Each dose may also contain residual amounts of hydrocortisone
≤ 0.0016 mcg, gentamicin sulfate ≤ 0.15 mcg, ovalbumin ≤ 0.05 mcg, formaldehyde
≤ 5 mcg, and sodium deoxycholate ≤ 50 mcg from the manufacturing process.

The tip caps of the prefilled syringes may contain natural rubber latex. The
rubber plungers do not contain latex.

What are the possible side effects of influenza virus injectable vaccine?

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to...

Read All Potential Side Effects and See Pictures of Fluarix »

What are the precautions when taking influenza virus vaccine (Fluarix)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to eggs or chicken products; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in some brands), 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: any fever, uncontrolled seizures or other nervous system disorder (e.g., encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, thrombocytopenia), history of...

Read All Potential Precautions of Fluarix »

Fluarix Consumer (continued)

SIDE EFFECTS: Soreness/redness/swelling/bruising at the injection site may occur and may last for up to 1-2 days. Fever, muscle aches, headache or weakness may also occur. If any of these effects continue beyond 2 days or become bothersome, inform your doctor.

If your doctor has directed you to receive this vaccine, 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 rare but very serious side effects occur: mental/mood changes, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

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 Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to eggs or chicken products; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in some brands), 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: any fever, uncontrolled seizures or other nervous system disorder (e.g., encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, thrombocytopenia), history of Guillain-Barre syndrome, immune system disorders (e.g., autoimmune disorders, radiation treatment), seizures (e.g., epilepsy controlled by medication, febrile seizures) or history of other nervous system disorders, vaccination history including previous reactions to any vaccines.

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

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Fluarix Patient Information Including Side Effects

Brand Names: Afluria, Fluarix, FluLaval, Fluvirin, Fluvirin Preservative-Free, Fluzone, Fluzone Preservative-Free, Fluzone Preservative-Free Pediatric

Generic Name: influenza virus vaccine (injectable) (Pronunciation: in floo ENZ a VYE rus VAK seen)

• What is influenza virus injectable vaccine (Fluarix)?


• What are the possible side effects of influenza virus injectable vaccine?


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


• What should I discuss with my healthcare provider before receiving this vaccine?


• How is this given?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid before or after receiving this vaccine?


• What other drugs will affect influenza virus injectable vaccine?


• Where can I get more information?

What is influenza virus injectable vaccine (Fluarix)?

Influenza virus (commonly known as "the flu") is a serious disease caused by a virus. Influenza virus can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The virus can also be passed through contact with objects the infected person has touched, such as a door handle or other surfaces.

Influenza virus vaccine is used to prevent infection caused by influenza virus. The vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year.

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine.

Influenza virus vaccine works by exposing you to a small dose of the virus, which helps your body to develop immunity to the disease. Influenza virus vaccine will not treat an active infection that has already developed in the body.

Influenza virus vaccine is for use in adults and children who are at least 6 months old.

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

What are the possible side effects of influenza virus injectable vaccine?

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

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

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

• severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);


• high fever; or


• unusual bleeding.

Less serious side effects may include:

• low fever, chills;


• redness, bruising, pain, swelling, or a lump where the vaccine was injected;


• headache, tired feeling; or


• joint or muscle pain.

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 this vaccine?

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine. This medication guide addresses only the injectable form of this vaccine.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Related Drug Centers

• Fluarix


• Fluzone


• Fluvirin


• Afluria

Amphadase

DRUG DESCRIPTION

Amphadase (hyaluronidase inj) is a preparation of purified bovine testicular hyaluronidase, a protein
enzyme. The exact chemical structure of this enzyme is unknown. However, the
amino acid sequence for the primary structure of the enzyme has been deduced
from the sequence of purified peptides.

Amphadase (hyaluronidase injection) is supplied as a sterile, colorless, ready
for use solution. Each vial contains 150 USP units of hyaluronidase per mL with
8.5 mg sodium chloride, 1 mg edetate disodium, 0.4 mg calcium chloride, monobasic
sodium phosphate buffer, and not more than 0.1 mg thimerosal (mercury derivative).

The ready for use solution is clear and colorless with an approximate pH of
6.8 and an osmolality of 295 to 355 mOsm.

What are the possible side effects of hyaluronidase (Amphadase, Hydase, Hylenex, Vitrase)?

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.

Less serious side effects may include:

• pain or tenderness where the medication was injected; or


• swelling in any part of your body.

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...

Read All Potential Side Effects and See Pictures of Amphadase »

Amphadase Patient Information Including Side Effects

Brand Names: Amphadase, Hydase, Hylenex, Vitrase

Generic Name: hyaluronidase (injectable) (Pronunciation: HYE al ure ON i dase)

• What is hyaluronidase (Amphadase)?


• What are the possible side effects of hyaluronidase (Amphadase)?


• What is the most important information I should know about hyaluronidase (Amphadase)?


• What should I discuss with my health care provider before receiving hyaluronidase (Amphadase)?


• How should I use hyaluronidase (Amphadase)?


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


• What happens if I overdose (Amphadase)?


• What should I avoid while receiving hyaluronidase (Amphadase)?


• What other drugs will affect hyaluronidase (Amphadase)?


• Where can I get more information?

What is hyaluronidase (Amphadase)?

Hyaluronidase is a genetically designed protein.

Hyaluronidase is used as an aid in helping your body absorb other injected medications.

Hyaluronidase is also used to help contrast dyes in your body show more clearly on certain types of x-rays or scans.

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

What are the possible side effects of hyaluronidase (Amphadase)?

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.

Less serious side effects may include:

• pain or tenderness where the medication was injected; or


• swelling in any part of your body.

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 hyaluronidase (Amphadase)?

Your doctor may perform a skin test to see if you are allergic to hyaluronidase before you receive the medication.

Before receiving hyaluronidase, tell your doctor if you are using any of the following drugs: furosemide (Lasix); phenytoin (Dilantin); a sedative or anxiety medication (such as Valium, Xanax, Tranxene); aspirin or salicylates; cortisone or ACTH (Corticotropin); estrogens; or an antihistamine (such as a cold or allergy medicine).

Related Drug Centers

• Hylenex


• Amphadase

Trivora-28

DRUG DESCRIPTION

Each Trivora cycle of 28 tablets consists of three different drug phases as
follows: Phase 1 comprised of 6 blue tablets, each containing 0.050 mg of levonorgestrel
(d(-)-13 beta-ethyl-17-alpha- ethinyl-17-beta-hydroxygon-4-en-3-one), a totally
synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,
17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel
and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 pink tablets, each
containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed
by 7 peach inert tablets. The inactive ingredients present in the blue, white
and pink tablets are lactose monohydrate, magnesium stearate, povidone and starch
(corn). Each blue tablet also contains FD&C Blue #1. Each pink tablet also
contains FD&C Red #40. Each inactive peach tablet contains the following
inactive ingredients: anhydrous lactose, FD&C Yellow #6, lactose monohydrate,
magnesium stearate and microcrystalline cellulose.

What are the possible side effects of ethinyl estradiol and levonorgestrel?

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:

• sudden numbness or weakness, especially on one side of the body;


• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;


• chest pain or heavy feeling, pain spreading to the arm or shoulder,...

Read All Potential Side Effects and See Pictures of Trivora-28 »

What are the precautions when taking levonorgestrel and ethinyl estradiol (Trivora-28)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to any estrogens (e.g., ethinyl estradiol, mestranol) or any progestins (e.g., norethindrone, desogestrel); 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 product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease,...

Read All Potential Precautions of Trivora-28 »

Trivora-28 Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, or breast tenderness/enlargement may occur. Acne may improve or get worse. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, notify your doctor promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

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 serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet, weight changes (gain or loss).

This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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: See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to any estrogens (e.g., ethinyl estradiol, mestranol) or any progestins (e.g., norethindrone, desogestrel); 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 product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, liver problems (e.g., liver tumor, active liver disease), current or suspected pregnancy, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (e.g., pills, patch), unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over).

Before using this product, tell your doctor your medical history, especially of: high blood pressure, high cholesterol or triglyceride (blood fat) levels, depression, diabetes, swelling (edema), gallbladder problems, kidney disease, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems.

Do not smoke cigarettes or use tobacco. Hormonal birth control (e.g., pills, injections, devices) combined with smoking significantly increases your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist, or consult the Patient Information Leaflet that comes with this product.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions.

This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

This medication passes into breast milk. This may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Trivora-28 Patient Information Including Side Effects

Brand Names: Alesse, Aviane, Enpresse, Lessina, Levlen, Levlite, Levora, Lutera, Lybrel, Nordette, Portia, Sronyx, Tri-Levlen, Triphasil-21, Triphasil-28, Trivora-28

Generic Name: ethinyl estradiol and levonorgestrel (Pronunciation: ETH in ill ess tra DYE ol and LEE vo nor JESS trel)

• What is ethinyl estradiol and levonorgestrel (Trivora-28)?


• What are the possible side effects of ethinyl estradiol and levonorgestrel?


• What is the most important information I should know about ethinyl estradiol and levonorgestrel?


• What should I discuss with my healthcare provider before taking ethinyl estradiol and levonorgestrel?


• How should I take ethinyl estradiol and levonorgestrel?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while taking ethinyl estradiol and levonorgestrel?


• What other drugs will affect ethinyl estradiol and levonorgestrel?


• Where can I get more information?

What is ethinyl estradiol and levonorgestrel (Trivora-28)?

Ethinyl estradiol and levonorgestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and levonorgestrel are used as contraception to prevent pregnancy.

Ethinyl estradiol and levonorgestrel may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ethinyl estradiol and levonorgestrel?

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:

• sudden numbness or weakness, especially on one side of the body;


• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;


• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;


• a change in the pattern or severity of migraine headaches;


• nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);


• swelling in your hands, ankles, or feet; or


• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;


• breast pain, tenderness, or swelling;


• freckles or darkening of facial skin;


• increased hair growth, loss of scalp hair;


• changes in weight or appetite;


• problems with contact lenses;


• vaginal itching or discharge;


• changes in your menstrual periods, decreased sex drive; or


• headache, nervousness, dizziness, tired feeling.

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 ethinyl estradiol and levonorgestrel?

Do not use ethinyl estradiol and levonorgestrel if you are pregnant or if you recently had a baby.

Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Related Drug Centers

• Alesse


• Lutera


• Trivora


• Levora


• Aviane


• Lybrel