Je-Vax

DRUG DESCRIPTION

JE-VAX®, Japanese Encephalitis Virus Vaccine Inactivated, is a sterile,
lyophilized vaccine for subcutaneous use, prepared by inoculating mice intracerebrally
with Japanese encephalitis (JE) virus, "Nakayama-NIH" strain, manufactured
by The Research Foundation for Microbial Diseases of Osaka University ("BIKEN
® buffered saline, pH 8.0. The homogenate is centrifuged and the supernatant
inactivated with formaldehyde, then processed to yield a partially purified,
inactivated virus suspension. This is further purified by ultra-centrifugation
through 40% w/v sucrose. The suspension is then lyophilized in final containers
and sealed under dry nitrogen atmosphere. Thimerosal (mercury derivative) is
added as a preservative to a final concentration of 0.007%. The diluent, Sterile
Water for Injection, contains no preservative. Each 1.0 mL dose contains approximately
500 µg of gelatin, less than 100 µg of formaldehyde, less than 0.0007% v/v Polysorbate
80, and less than 50 ng of mouse serum protein. No myelin basic protein can
be detected at the detection threshold of the assay ( < 2 ng/mL). Prior to
reconstitution, the vaccine is a white caked powder, and after reconstitution
the vaccine is a colorless transparent liquid. The potency of JE vaccine is
determined by immunizing mice with either the test vaccine or the JE reference
vaccine. Neutralizing antibodies are measured in a plaque neutralization assay
performed on sera from the immunized mice. The potency of the test vaccine must
be no less than that of the reference vaccine.

What are the possible side effects of this vaccine (Je-Vax)?

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. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely...

Read All Potential Side Effects and See Pictures of Je-Vax »

Je-Vax Patient Information Including Side Effects

Brand Names: Je-Vax

Generic Name: Japanese encephalitis virus vaccine (Nakayama) (Pronunciation: JAP a NEEZ en CEF a LYE tis NA ka YA ma)

• What is Japanese encephalitis virus vaccine (Nakayama) (Je-Vax)?


• What are the possible side effects of this vaccine (Je-Vax)?


• What is the most important information I should know about this vaccine (Je-Vax)?


• What should I discuss with my healthcare provider before receiving this vaccine (Je-Vax)?


• How is this vaccine given (Je-Vax)?


• What happens if I miss a dose (Je-Vax)?


• What happens if I overdose (Je-Vax)?


• What should I avoid before or after receiving this vaccine (Je-Vax)?


• What other drugs will affect Japanese encephalitis virus vaccine (Nakayama) (Je-Vax)?


• Where can I get more information?

What is Japanese encephalitis virus vaccine (Nakayama) (Je-Vax)?

Japanese encephalitis is a serious disease caused by a virus. It is the leading cause of viral encephalitis (inflammation of the brain) in Asia. Encephalitis is an infection of the membrane around the brain and spinal cord. This infection often causes only mild symptoms, but prolonged swelling of the brain can cause permanent brain damage or death.

Japanese encephalitis virus is carried and spread by mosquitos.

The Japanese encephalitis Nakayama vaccine is used to help prevent this disease in adults and children who are at least 12 months old.

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

This vaccine is recommended for people who plan to spend 30 days or longer in areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred. The vaccine should also be given to people who will spend any amount of time in rural areas where Japanese encephalitis is endemic, or those who are otherwise at high risk of coming into contact with the virus.

You should receive this vaccine and all booster shots at least 10 days prior to your arrival in an area where you may be exposed to the virus.

Not everyone who travels to Asia needs to receive a Japanese encephalitis vaccine. Follow your doctor instructions or the recommendations of the Centers for Disease Control and Prevention (CDC).

This vaccine is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

Like any vaccine, the Japanese encephalitis Nakayama vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Je-Vax)?

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. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction (which may occur up to 17 days after you receive the shot): 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:

• feeling light-headed, fainting;


• high fever;


• behavior changes; or


• seizures (black-out or convulsions).

Less serious side include:

• redness, pain, or swelling where the shot was given;


• low fever, chills, flu symptoms;


• headache, tired feeling;


• muscle pain;


• nausea, vomiting, stomach pain; or


• mild itching or skin rash.

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 this vaccine (Je-Vax)?

The Japanese encephalitis Nakayama vaccine is given in a series of 3 shots. The booster shots are usually given 7 days and 2 weeks to 1 month after the first shot. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Japanese encephalitis Nakayama vaccine is for use in adults and children who are at least 12 months old.

This vaccine is recommended for people who plan to spend 30 days or longer in areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred. The vaccine should also be given to people who will spend any amount of time in rural areas where Japanese encephalitis is endemic, or those who are otherwise at high risk of coming into contact with the virus.

You should receive the vaccine and all booster doses at least 10 days prior to your arrival in an area where you may be exposed to the virus.

Not everyone who travels to Asia needs to receive a Japanese encephalitis vaccine. Follow your doctor instructions or the recommendations of the Centers for Disease Control and Prevention (CDC).

This vaccine is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Related Drug Centers

• Je-Vax

Vincasar PFS

(Generic versions may still be available.)

DRUG DESCRIPTION

VINCASAR PFS^® (vincristine sulfate injection, USP) is the salt of an alkaloid obtained from a common flowering herb, the periwinkle plant (Vinca rosea Linn.). Originally known as leurocristine, it has also been referred to as LCR and VCR.

Vincristine sulfate is a white to slightly yellow, amorphous powder. It is soluble in methanol, freely soluble in water, but only slightly soluble in 95% ethanol. In 98% ethanol, vincristine sulfate has an ultraviolet spectrum with maxima at 221 nm (e+ 47,100).

VINCASAR PFS (vincristine sulfate injection) ^®, a sterile, preservative-free, single use only solution, is available in 1 mg (1 mg/1 mL) and 2 mg (2 mg/2 mL) vials. Each mL contains vincristine sulfate, 1 mg (1.08 mmoL); mannitol, 100 mg; water for injection, q.s. Acetic acid and sodium acetate have been added for pH control. The pH of VINCASAR PFS (vincristine sulfate injection) ranges from 3.5 to 5.5. This product is a sterile solution for cancer/oncolytic use.

What are the possible side effects of vincristine (Oncovin, Vincasar PFS)?

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.

Call your doctor at once if you have a serious side effect such as:

• signs of infection such as fever, chills, sore throat, mouth pain, white patches or sores inside your mouth or on your lips;


• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;


• easy bruising, unusual bleeding (nose, mouth,...

Read All Potential Side Effects and See Pictures of Vincasar PFS »

What are the precautions when taking vincristine sulfate injection (Vincasar PFS)?

Before using vincristine, 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.

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 type of nerve/muscle disease (demyelinating form of Charcot-Marie-Tooth syndrome), radiation treatment to the liver.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other nerve/muscle problems (neuromuscular disease, neuropathy), liver disease, decreased bone marrow function, blood disorders, current...

Read All Potential Precautions of Vincasar PFS »

Vincasar PFS Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, weight loss, diarrhea, bloating, stomach/abdominal pain or cramps, mouth sores, dizziness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Vincristine may also affect the nerves in the intestines, causing gut movement to slow down. This effect can result in constipation, which in some cases may become serious. Consult your doctor or pharmacist about how you can prevent constipation (e.g., maintain a diet adequate in fiber, drink plenty of water, exercise, choose the right type of laxative with a stool softener, avoid bulk-forming laxatives). Tell your doctor or pharmacist promptly if you develop constipation.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication commonly affects the nerves and muscles in your body. Most of these side effects go away after this medication is stopped, however some effects may persist for a long time. Tell your doctor immediately if any of these serious side effects occur: painful/difficult urination, change in the amount of urine, pain (e.g., in the joints, back, muscles, jaw), numbness/tingling/pain of the arms/legs, weakness, difficulty walking, loss of coordination/balance, inability to move your muscles (e.g., muscles of the face, other parts of your body), drooping eyelids, hoarseness, trouble speaking, mental/mood changes (e.g., depression, hallucinations, confusion).

Tell your doctor right away if you have any other serious side effects, including: vision/hearing changes, seizures, unusual bleeding/bruising.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Trouble breathing may infrequently occur with vincristine treatment, especially when it is given with another chemotherapy drug, mitomycin-C. Patients with lung problems may be more sensitive to this side effect. Long-term treatment of this side effect may be required if it worsens. This effect may occur within minutes to several hours after vincristine is given and up to 2 weeks after the dose of mitomycin-C. Get medical help right away if you have shortness of breath or coughing. If you have this reaction, you should not receive vincristine again.

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

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

In the US -

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

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

PRECAUTIONS: Before using vincristine, 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.

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 type of nerve/muscle disease (demyelinating form of Charcot-Marie-Tooth syndrome), radiation treatment to the liver.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other nerve/muscle problems (neuromuscular disease, neuropathy), liver disease, decreased bone marrow function, blood disorders, current infections.

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

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

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

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

Children may be more sensitive to the effects of this drug, especially slowed movement of the gut that may cause vomiting and constipation.

Elderly patients who also take drugs that may cause difficult urination as a side effect may be more sensitive to the effects of this drug on the kidneys (urinary retention). Consult your doctor for more details. See also Drug Interactions.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms, birth control pills) while using this medication and for some time afterwards. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Vincasar PFS Patient Information Including Side Effects

Brand Names: Oncovin, Vincasar PFS

Generic Name: vincristine (Pronunciation: vin KRIS teen)

• What is vincristine (Vincasar PFS)?


• What are the possible side effects of vincristine (Vincasar PFS)?


• What is the most important information I should know about vincristine (Vincasar PFS)?


• What should I discuss with my healthcare provider before receiving vincristine (Vincasar PFS)?


• How is vincristine given (Vincasar PFS)?


• What happens if I miss a dose (Vincasar PFS)?


• What happens if I overdose (Vincasar PFS)?


• What should I avoid while receiving vincristine (Vincasar PFS)?


• What other drugs will affect vincristine (Vincasar PFS)?


• Where can I get more information?

What is vincristine (Vincasar PFS)?

Vincristine is cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Vincristine is used to treat leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, rhabdomyosarcoma (soft tissue tumors), neuroblastoma (cancer that forms in nerve tissue), and Wilms' tumor.

Vincristine is sometimes used in combination with other cancer medications.

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

What are the possible side effects of vincristine (Vincasar PFS)?

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.

Call your doctor at once if you have a serious side effect such as:

• signs of infection such as fever, chills, sore throat, mouth pain, white patches or sores inside your mouth or on your lips;


• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;


• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;


• numbness, burning, pain, or tingly feeling;


• bronchospasm (wheezing, chest tightness, trouble breathing);


• stomach pain and tenderness, jaundice (yellowing of the skin or eyes);


• severe constipation;


• painful or difficult urination, urinating more or less than usual or not at all;


• spinning sensation, feeling like you might pass out;


• seizure (convulsions);


• problems with vision, hearing, speech, swallowing, balance, or daily activities;


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


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


• pain, burning, redness, swelling, or skin changes where the IV needle was placed.

Less serious side effects may include:

• temporary hair loss;


• decreased weight with loss of muscle tissue;


• jaw pain;


• tumor pain, bone pain;


• missed menstrual periods;


• nausea, vomiting, diarrhea, loss of appetite; or


• feeling weak or tired.

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 vincristine (Vincasar PFS)?

You should not use this medication if you are allergic to it, or if you have Charcot-Marie-Tooth syndrome.

Do not use vincristine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive vincristine, tell your doctor if you have liver disease, coronary artery disease, or a nerve-muscle disorder such as myasthenia gravis, Lou Gehrig's disease, multiple sclerosis, or muscular dystrophy.

Vincristine is sometimes used in combination with other cancer medications.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vincristine is injected.

Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments. Contact your doctor at once if you develop signs of infection.

Related Drug Centers

• Vincasar PFS

Unithroid

DRUG DESCRIPTION

UNITHROID™ (levothyroxine sodium tablets, USP ) contains synthetic crystalline L-3,3¹,5,5¹-tetraiodothyronine sodium salt [levothyroxine (T₄) sodium]. Synthetic T₄ is identical to that produced in the human thyroid gland. Levothyroxine (T₄) sodium has an empirical formula of C₁₅H₁₀I₄N NaO₄ x H₂O, molecular weight of798.86 g/mol (anhydrous).

Inactive Ingredients

Colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, corn starch, acacia and sodium starch glycolate. The following are the coloring additives per tablet strength:

Strength (mcg)	Color Additive(s)
25	FD&C Yellow No. 6 Aluminum Lake
50	None
75	FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake
88	D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake
100	D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake
112	D&C Red No. 27 Aluminum Lake
125	FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake
150	FD&C Blue No. 2 Aluminum Lake
175	FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 Aluminum Lake
200	FD&C Red No. 40 Aluminum Lake
300	D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake

What are the possible side effects of levothyroxine (Levothroid, Levoxyl, Synthroid, Unithroid)?

Stop using levothyroxine and 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:

• headache;


• sleep problems (insomnia);


• nervous or irritable feeling;


• fever, hot flashes, sweating;


• changes in your menstrual periods;


• appetite changes, weight...

Read All Potential Side Effects and See Pictures of Unithroid »

What are the precautions when taking levothyroxine sodium (Unithroid)?

Before taking levothyroxine, 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: increased thyroid hormones (thyrotoxicosis), decreased adrenal gland function, heart disease (such as coronary artery disease, irregular heartbeat), high blood pressure, diabetes.

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

Current information shows that this drug may be used during pregnancy....

Read All Potential Precautions of Unithroid »

Unithroid Consumer (continued)

SIDE EFFECTS: Hair loss may occur during the first few months of treatment. This effect is usually temporary as your body adjusts to this medication. If this effect persists or worsens, 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 effects of high thyroid hormone levels occur: increased sweating, sensitivity to heat, mental/mood changes (such as nervousness, mood swings), tiredness, diarrhea, shaking (tremor), headache, shortness of breath.

Get medical help right away if any of these rare but serious effects of high thyroid hormone levels occur: chest pain, fast/pounding/irregular heartbeat, swelling hands/ankles/feet, seizures.

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 levothyroxine, 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: increased thyroid hormones (thyrotoxicosis), decreased adrenal gland function, heart disease (such as coronary artery disease, irregular heartbeat), high blood pressure, diabetes.

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

Current information shows that this drug may be used during pregnancy. Tell your doctor if you are pregnant because your dose may need to be adjusted.

Levothyroxine passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Unithroid Patient Information Including Side Effects

Brand Names: Levothroid, Levoxyl, Synthroid, Unithroid

Generic Name: levothyroxine (Pronunciation: LEE voe thye ROX een)

• What is levothyroxine (Unithroid)?


• What are the possible side effects of levothyroxine (Unithroid)?


• What is the most important information I should know about levothyroxine (Unithroid)?


• What should I discuss with my healthcare provider before taking levothyroxine (Unithroid)?


• How should I take levothyroxine (Unithroid)?


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


• What happens if I overdose (Unithroid)?


• What should I avoid while taking levothyroxine (Unithroid)?


• What other drugs will affect levothyroxine (Unithroid)?


• Where can I get more information?

What is levothyroxine (Unithroid)?

Levothyroxine is a replacement for a hormone that is normally produced by your thyroid gland to regulate the body's energy and metabolism. Levothyroxine is given when the thyroid does not produce enough of this hormone on its own.

Levothyroxine treats hypothyroidism (low thyroid hormone). Levothyroxine is also used to treat or prevent goiter (enlarged thyroid gland), which can be caused by hormone imbalances, radiation treatment, surgery, or cancer.

Levothyroxine should not be used to treat obesity or weight problems.

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

What are the possible side effects of levothyroxine (Unithroid)?

Stop using levothyroxine and 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:

• headache;


• sleep problems (insomnia);


• nervous or irritable feeling;


• fever, hot flashes, sweating;


• changes in your menstrual periods;


• appetite changes, weight changes;

Less serious side effects may include mild hair loss.

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 levothyroxine (Unithroid)?

Since thyroid hormone occurs naturally in the body, almost anyone can take levothyroxine. You should not use this medication if you have had a heart attack, a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

Before taking this medication, tell your doctor if you have heart disease, coronary artery disease, anemia (lack of red blood cells), diabetes, problems with your pituitary or adrenal glands, or a history of blood clots.

If you use insulin or take diabetes medicine by mouth, ask your doctor if your dose needs to be changed when you start using levothyroxine.

Different brands of levothyroxine may not work the same. If you get a prescription refill and your new pills look different, talk with your pharmacist or doctor.

It may take several weeks before your body starts to respond to this medication. Do not stop taking this medication suddenly. Even if you feel well, you may still need to take this medicine every day for the rest of your life to replace the thyroid hormone your body cannot produce.

There are many other medicines that can affect levothyroxine. 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.

Related Drug Centers

• Levoxyl


• Unithroid


• Synthroid


• Levothroid

Tubersol

DRUG DESCRIPTION

Tuberculin Purified Protein Derivative¹ (Mantoux) - TUBERSOL (tuberculin purified protein) ®
for intradermal (Mantoux) tuberculin testing is available in a stabilized solution
bio-equivalent to 5 U.S. units (TU) PPD-S per test dose (0.1 mL).

TUBERSOL (tuberculin purified protein) ® is prepared by Aventis Pasteur Limited from a large Master Batch,
Connaught Tuberculin (CT68) and is a cell-free purified protein fraction obtained
from a human strain of Mycobacterium tuberculosis grown on a protein-free
synthetic medium, and inactivated.²

TUBERSOL (tuberculin purified protein) ® is a sterile isotonic solution of Tuberculin in phosphate buffered
saline containing Tween 80 (0.0005%) as a stabilizer. Phenol 0.28% is added
as a preservative.^3,4,5

Prior to release, each successive lot is tested for potency in sensitized guinea
pigs in comparison with the U.S. Standard Tuberculin PPD-S.⁶

Accuzyme

DRUG DESCRIPTION

ACCUZYME (papain and urea) enzymatic debriding ointment contains papain, USP (8.3 x 105 USP units of activity per gram) and urea, USP 10% in a hydrophilic ointment base composed of emulsifying wax, fragrance, glycerin, isopropyl palmitate, lactose, methylparaben, potassium phosphate monobasic, propylparaben, and purified water.

What are the possible side effects of papain-urea topical?

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 be more likely to occur, such as mild stinging or burning of the skin where the medicine is applied.

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...

Read All Potential Side Effects and See Pictures of Accuzyme »

Accuzyme Patient Information Including Side Effects

Brand Names: Accuzyme, AllanEnzyme, Ethezyme 650, Ethezyme 830, Gladase, Kovia, Pap-Urea

Generic Name: papain-urea topical (Pronunciation: PA pane yoo REE ah)

• What is papain-urea topical (Accuzyme)?


• What are the possible side effects of papain-urea topical?


• What is the most important information I should know about papain-urea topical?


• What should I discuss with my healthcare provider before using papain-urea topical?


• How should I use papain-urea topical?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while using papain-urea topical?


• What other drugs will affect papain-urea topical?


• Where can I get more information?

What is papain-urea topical (Accuzyme)?

Papain is a substance from the papaya fruit. Papain breaks down certain proteins.

Urea also breaks down protein.

Papain-urea topical is used to break down dead skin or tissues in wounds such as bed sores, ulcers, burns, surgical wounds, cysts, and carbuncles. This process is sometimes called debridement (de-BREED-ment). The broken-down tissues can then be more easily removed.

Papain-urea topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of papain-urea topical?

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 be more likely to occur, such as mild stinging or burning of the skin where the medicine is applied.

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.

What is the most important information I should know about papain-urea topical?

Wash your hands before and after applying papain-urea topical.

Clean the wound as directed by your doctor. Use only the type of cleanser your doctor has recommended.

Apply papain-urea topical directly to the wound. Then cover the treated area with bandaging or other dressing recommended by your doctor. Keep the wound covered at all times, because this medication will cause the dead tissues to slough and peel off.

Avoid using hydrogen peroxide to clean your wound before applying papain-urea topical. Hydrogen peroxide can make the papain-urea less effective in breaking down the tissues of your wound.

Do not use other medicated skin products unless your doctor has told you to.

Related Drug Centers

• Accuzyme

Follistim AQ

DRUG DESCRIPTION

Follistim® AQ (follitropin beta injection) contains human follicle-stimulating
hormone (hFSH), a glycoprotein hormone which is manufactured by recombinant
DNA (rDNA) technology. The active drug substance, follitropin beta, has a dimeric
structure containing two glycoprotein subunits (alpha and beta). Both the 92
amino acid alpha-chain and the 111 amino acid beta-chain have complex heterogeneous
structures arising from two N-linked oligosaccharide chains. Follitropin beta
is synthesized in a Chinese hamster ovary (CHO) cell line that has been transfected
with a plasmid containing the two subunit DNA sequences encoding for hFSH. The
purification process results ina highly purified preparation with a consistent
hFSH isoform profile and high specific activity¹. The biological
activity is determined by measuring the increase in ovary weight in female rats.
The intrinsic luteinizing hormone (LH) activity in follitropin beta is less
than 1 IU per 40,000 IU FSH. The compound is considered to contain no LH activity.

The amino acid sequence and tertiary structure of the product are indistinguishable
from that of human follicle-stimulating hormone (hFSH) of urinary source. Also,
based on available data derived from physio-chemical tests and bioassay, follitropin
beta and follitropin alfa, another recombinant follicle-stimulating hormone
product, are indistinguishable.

Follistim® AQ (follitropin beta) is presented as a sterile aqueous solution intended for SUBCUTANEOUS
or INTRAMUSCULAR administration. Each single-use vial of Follistim® AQ (follitropin beta) contains
the following per 0.5 mL: 75 IU or 150 IU of FSH activity; 25 mg sucrose, NF;
7.35 mg sodium citrate (dihydrate), USP; 0.25 mg L-methionine, USP; 0.1 mg polysorbate
20, NF; and water for injection, USP. Hydrochloric acid, NF and/or sodium hydroxide,
NF are used to adjust the pHto 7.

The recombinant protein in Follistim® AQ (follitropin beta) has been standardized for FSH in
vivo bioactivity in terms of the First International Reference Preparation
for human menopausal gonadotropins (code 70/45), issued by the World Health
Organization Expert Committee on Biological Standardization (1982). Under current
storage conditions, Follistim® AQ (follitropin beta) may contain up to 11% of oxidized follitropin
beta.

In clinical trials with Follistim®, serum antibodies to FSH or anti-CHO
cell derived proteins were not detected in any of the treated patients after
exposure to Follistim®for up to three cycles.

Therapeutic Class: Infertility.

What are the possible side effects of follicle stimulating hormone (Follistim, Follistim AQ, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen)?

Stop using follicle stimulating hormone and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

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


• pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);


• confusion, severe dizziness, severe headache; or

...

Read All Potential Side Effects and See Pictures of Follistim AQ »

What are the precautions when taking follitropin beta (Follistim AQ)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH), or to streptomycin, or neomycin; 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: abnormal bleeding from the vagina or uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary, testis), tumors in the brain (e.g., pituitary tumor), ovarian cysts or enlargement, other fertility problems (e.g., primary...

Read All Potential Precautions of Follistim AQ »

What are the possible side effects of follicle stimulating hormone (Follistim, Follistim AQ, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen)?

Stop using follicle stimulating hormone and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

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


• pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);


• confusion, severe dizziness, severe headache; or

...

Read All Potential Side Effects and See Pictures of Follistim AQ »

What are the precautions when taking follitropin beta (Follistim AQ)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH), or to streptomycin, or neomycin; 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: abnormal bleeding from the vagina or uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary, testis), tumors in the brain (e.g., pituitary tumor), ovarian cysts or enlargement, other fertility problems (e.g., primary...

Read All Potential Precautions of Follistim AQ »

What are the possible side effects of follicle stimulating hormone (Follistim, Follistim AQ, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen)?

Stop using follicle stimulating hormone and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

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


• pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);


• confusion, severe dizziness, severe headache; or

...

Read All Potential Side Effects and See Pictures of Follistim AQ »

What are the precautions when taking follitropin beta (Follistim AQ)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH), or to streptomycin, or neomycin; 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: abnormal bleeding from the vagina or uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary, testis), tumors in the brain (e.g., pituitary tumor), ovarian cysts or enlargement, other fertility problems (e.g., primary...

Read All Potential Precautions of Follistim AQ »

Follistim AQ Consumer (continued)

SIDE EFFECTS: Headache, stomach pain, bloating, redness/pain at the injection site, breast tenderness/pain, and dizziness 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 serious side effects occur: flu-like symptoms (e.g., fever, chills, muscle aches, tiredness), swelling of ankles/hands/feet, bleeding from the vagina.

Seek immediate medical attention if any of these unlikely but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, pain/swelling of the calf muscles, chest pain, rapid breathing.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during therapy or after treatment has been discontinued. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, nausea/vomiting, sudden/rapid weight gain, or a change in the amount of urine.

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 medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH), or to streptomycin, or neomycin; 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: abnormal bleeding from the vagina or uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary, testis), tumors in the brain (e.g., pituitary tumor), ovarian cysts or enlargement, other fertility problems (e.g., primary ovarian failure).

Tell your doctor your medical history, especially of: blood clots, stroke, certain heart diseases (e.g., heart attacks), lung problems (e.g., asthma).

Multiple births may occur because of this treatment.

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

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

Follistim AQ Patient Information Including Side Effects

Brand Names: Follistim, Follistim AQ, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen

Generic Name: follicle stimulating hormone (injectable) (Pronunciation: PAH lich cull STIM u lay ting HORE moan)

• What is follicle stimulating hormone (Follistim AQ)?


• What are the possible side effects of follicle stimulating hormone (Follistim AQ)?


• What is the most important information I should know about follicle stimulating hormone (Follistim AQ)?


• What should I discuss with my healthcare provider before using follicle stimulating hormone (Follistim AQ)?


• How should I use follicle stimulating hormone (Follistim AQ)?


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


• What happens if I overdose (Follistim AQ)?


• What should I avoid while using follicle stimulating hormone (Follistim AQ)?


• What other drugs will affect follicle stimulating hormone (Follistim AQ)?


• Where can I get more information?

What is follicle stimulating hormone (Follistim AQ)?

Follicle stimulating hormone (FSH) is a naturally occurring hormone. FSH is important in the development of follicles (eggs) produced by the ovaries. FSH is also important in the development of sperm.

Follicle stimulating hormone is used to stimulate a follicle (egg) to develop and mature. It is used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature. Follicle stimulating hormone is also used to stimulate the development of multiple eggs for in vitro fertilization. Follicle stimulating hormone can be used by men to increase the production of sperm.

Follicle stimulating hormone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of follicle stimulating hormone (Follistim AQ)?

Stop using follicle stimulating hormone and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

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


• pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);


• confusion, severe dizziness, severe headache; or


• difficulty breathing.

Approximately 5% of patients treated with follicle stimulating hormone develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms.

Other side effects may also occur. Notify your doctor if you experience

• ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;


• nausea, vomiting, diarrhea, or flatulence (gas);


• fever or chills;


• headache;


• dizziness;


• rapid pulse or heart rate;


• muscle or joint weakness or aching;


• breast tenderness;


• spotting or menstrual changes;


• pain, swelling, or irritation at the injection site; or


• dry skin, a rash, or hair loss.

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 follicle stimulating hormone (Follistim AQ)?

Treatment with follicle stimulating hormone increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.

Related Drug Centers

• Gonal-F


• Gonal-f RFF


• Follistim


• Follistim AQ Cartridge

Bepreve

DRUG DESCRIPTION

BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of BEPREVE™ contains 15 mg bepotastine besilate.

Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha
-2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical
structure for bepotastine besilate is:

Bepotastine besilate is a white or pale yellowish crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. BEPREVE™ (bepotastine besilate ophthalmic solution 1.5%) ophthalmic solution is supplied as a sterile, aqueous 1.5% solution, with a pH of 6.8.

The osmolality of BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% is approximately 290 mOsm/kg.

Each mL of BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% contains:

Active: Bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine)

Preservative: benzalkonium chloride 0.005%

Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium
hydroxide to adjust pH, and water for injection, USP.

What are the precautions when taking bepotastine besilate ophthalmic solution 1.5% (Bepreve)?

Before using bepotastine, 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: contact lens use.

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

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

If you develop a new eye...

Read All Potential Precautions of Bepreve »

Bepreve Consumer (continued)

SIDE EFFECTS: A mild taste in the mouth, headache, eye irritation, or sore throat 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.

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), 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 bepotastine, 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: contact lens use.

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

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

If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of bepotastine eye drops or start a new bottle.

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

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