Clonazepam

Pronunciation: kloe-NAZ-e-pam
Generic Name: Clonazepam
Brand Name: Klonopin

Clonazepam is used for:

Controlling certain types of seizures in the treatment of epilepsy and for the treatment of panic disorders. It may also be used for other conditions as determined by your doctor.

Clonazepam is a benzodiazepine. It works by increasing the activity of a naturally occurring chemical in the brain.

Do NOT use Clonazepam if:

• you are allergic to any ingredient in Clonazepam or to another benzodiazepine (eg, diazepam)


• you have a severe mental disorder, acute angle glaucoma, or severe liver disease


• you are taking sodium oxybate (GHB)

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

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Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Clonazepam:

Some medical conditions may interact with Clonazepam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of alcohol or substance abuse or dependence, or if you consume more than 3 alcohol-containing drinks per day


• if you have a history of mental or mood problems (eg, depression, suicidal thoughts or attempts)


• if you have myasthenia gravis (a condition in which the muscles become progressively weakened)


• if you have angle-closure glaucoma, kidney or liver problems, or the blood disorder porphyria


• if you have chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, or other breathing problems

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

• Methadone or sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe may occur


• Paroxetine or tricyclic antidepressants (eg, amitriptyline) because side effects, including confusion, excessive sweating, fever, restlessness, seizures, and twitching, which can rarely be life-threatening, may occur


• Antifungals (eg, fluconazole), cimetidine, disulfiram, hormonal contraceptives (eg, birth control pills), nefazodone, omeprazole, or valproic acid because they may increase the risk of Clonazepam's side effects


• Rifampin or St. John's wort because they may decrease Clonazepam's effectiveness


• Valproic acid because the effectiveness of both drugs may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clonazepam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Clonazepam:

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

• Take Clonazepam by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Clonazepam whole with a full glass of water (8 oz/240 mL).


• If you are taking Clonazepam for the prevention of seizures, taking Clonazepam at the same times each day will help you remember to take it.


• Continue to take Clonazepam even if you feel well. Do not miss any doses. Clonazepam works best when there is a constant level of Clonazepam in your body.


• If you miss a dose of Clonazepam and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

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

Important safety information:

• Clonazepam may cause drowsiness, dizziness, lightheadedness, blurred vision, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use Clonazepam with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Clonazepam may cause you to lose consciousness if you have a history of seizures. Use Clonazepam with caution. Do not perform tasks that could be unsafe for you or others if you should lose consciousness (eg, driving, swimming, running heavy machinery).


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Clonazepam; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Patients who take Clonazepam may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Clonazepam closely. Contact the doctor at once if new, worsened, or sudden symptoms such as anxious, restless, or irritable behavior; depressed mood; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Notify your doctor if seizure control worsens.


• Carry an ID card at all times that says you take Clonazepam if it is used for seizures.


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


• Use Clonazepam with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion and drowsiness.


• Clonazepam should not be used in CHILDREN younger than 18 years old with panic disorder; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Clonazepam may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clonazepam while you are pregnant. Clonazepam is found in breast milk. Do not breast-feed while taking Clonazepam.

When used for long periods of time or at high doses, Clonazepam may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Clonazepam stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Clonazepam. This is known as DEPENDENCE or addiction. If you stop taking Clonazepam suddenly, you may have WITHDRAWAL symptoms. These may include abnormal thoughts or behavioral disorder, anxiety, depression, hallucinations, personality changes, or loss of contact with reality; convulsions (seizures); insomnia; stomach and muscle cramps; tremor. Do not suddenly stop taking Clonazepam. If you need to stop Clonazepam, your doctor will lower your dose over time.

Possible side effects of Clonazepam:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; dizziness; drowsiness; dry mouth; headache; increased saliva production; lightheadedness; loss of coordination; nausea; runny nose; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes; blurred vision or other vision changes; change in appetite; change in the amount of urine produced or painful urination; changes in sexual function; confusion; dark urine; excessive hair growth or loss; fever, chills, or sore throat; hallucinations; irregular heartbeat; memory loss or problems; muscle aches or weakness; new or worsening mental or mood changes (eg, agitation, aggression, anxiety, behavior changes, depression, hostility, irritability, nervousness); new or worsening seizures; painful menstrual periods; pale stools; severe drowsiness; severe or persistent tiredness or weakness; shortness of breath; slow or shallow breathing; slurred speech or other speech problems; suicidal thoughts or actions; tremor; unusual bruising or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Clonazepam side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include clumsiness; confusion; difficult or slow breathing; dizziness; drowsiness leading to unresponsiveness or coma; lightheadedness, especially upon standing; loss of consciousness.

Proper storage of Clonazepam:

Store Clonazepam at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clonazepam out of the reach of children and away from pets.

General information:

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


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


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


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

This information is a summary only. It does not contain all information about Clonazepam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Clonazepam resources

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

• Clonazepam Prescribing Information (FDA)


• Clonazepam Professional Patient Advice (Wolters Kluwer)


• Clonazepam Monograph (AHFS DI)


• Klonopin Consumer Overview


• Klonopin Prescribing Information (FDA)


• clonazepam Advanced Consumer (Micromedex) - Includes Dosage Information

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NovoSeven RT

Pronunciation: koe-AG-yoo-lay-shun FAK-tor
Generic Name: Coagulation Factor VIIa (Recombinant) (RT)
Brand Name: NovoSeven RT

NovoSeven RT is used for:

Treating or preventing bleeding episodes in certain patients with bleeding problems such as hemophilia A or B, acquired hemophilia, or congenital FVII deficiency.

NovoSeven RT is a clotting factor. It works by activating the body's clotting system.

Do NOT use NovoSeven RT if:

• you are allergic to any ingredient in NovoSeven RT, unless your doctor tells you otherwise

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

Before using NovoSeven RT:

Some medical conditions may interact with NovoSeven RT. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• you are allergic to mouse, hamster, or cow proteins


• if you have kidney problems, hardening of the arteries, disseminated intravascular coagulation (DIC), an infection of the blood or tissues, or blood conditions other than hemophilia


• if you have a blood clot or history of blood clots


• if you have a crush injury


• if you are also using another type of coagulation factor VIIa

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

• Activated or nonactivated prothrombin complex concentrates because the risk of blood clots may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if NovoSeven RT may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use NovoSeven RT:

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

• NovoSeven RT is usually given as an injection at your doctor's office, hospital, or clinic.


• If you miss a dose of NovoSeven RT, contact your doctor right away.

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

Important safety information:

• Lab tests, including bleeding time, may be performed while you use NovoSeven RT. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using NovoSeven RT while you are pregnant. It is not known if NovoSeven RT is found in breast milk. Do not breast-feed while taking NovoSeven RT.

Possible side effects of NovoSeven RT:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; joint aches; mild fever; mild pain, swelling, or redness at the injection site; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding at the injection site; bloody stools; calf or stomach pain, tenderness, or swelling; chest pain; confusion; dizziness; fainting; numbness of an arm or leg; one-sided weakness; shortness of breath; sudden severe headache or vomiting; swelling; uncontrolled bleeding; vision or speech changes; vomiting blood or material that looks like coffee grounds; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: NovoSeven RT side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of NovoSeven RT:

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

General information:

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


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


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


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

This information is a summary only. It does not contain all information about NovoSeven RT. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More NovoSeven RT resources

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

• NovoSeven RT Prescribing Information (FDA)


• NovoSeven RT injection Concise Consumer Information (Cerner Multum)


• NovoSeven RT Monograph (AHFS DI)


• NovoSeven RT Advanced Consumer (Micromedex) - Includes Dosage Information

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Trimox

Pronunciation: a-MOX-i-SIL-in
Generic Name: Amoxicillin
Brand Name: Examples include Amoxil and Trimox

Trimox is used for:

Treating infections caused by certain bacteria. It is also used with other medicines to treat Helicobacter pylori infection and ulcers of the small intestines.

Trimox is a penicillin antibiotic. It works by killing sensitive bacteria.

Do NOT use Trimox if:

• you are allergic to any ingredient in Trimox or another penicillin antibiotic (eg, ampicillin)


• you have recently received or will be receiving live oral typhoid vaccine


• you have infectious mononucleosis (mono)

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

Before using Trimox:

Some medical conditions may interact with Trimox. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of allergies, asthma, hay fever, or hives


• if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to a cephalosporin (eg, cephalexin) or another beta-lactam antibiotic (eg, imipenem)


• if you have kidney problems or gonorrhea

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

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased


• Probenecid because it may increase the amount of Trimox in your blood


• Chloramphenicol, macrolide antibiotics (eg, erythromycin), sulfonamides (eg, sulfamethoxazole), or tetracycline antibiotics (eg, doxycycline) because they may decrease Trimox's effectiveness


• Methotrexate because the risk of its side effects may be increased by Trimox


• Live oral typhoid vaccine or hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Trimox

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trimox may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trimox:

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

• Take Trimox by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• To clear up your infection completely, take Trimox for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Trimox, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Trimox may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Trimox with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Trimox only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Trimox for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Trimox may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Trimox. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Brown, yellow, or gray tooth discoloration has occurred rarely in some patients taking Trimox. It occurred most often in children. The discoloration was reduced or removed by brushing or dental cleaning in most cases. Contact your doctor if you experience this effect.


• Diabetes patients - Trimox may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.


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


• Use Trimox with caution in the ELDERLY; they may be more sensitive to its effects, especially patients with kidney problems.


• Use Trimox with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• Caution is advised when using Trimox in CHILDREN younger than 3 months old; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trimox while you are pregnant. Trimox is found in breast milk. If you are or will be breast-feeding while you use Trimox, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Trimox:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; stomach pain or cramps; unusual bruising or bleeding; vaginal discharge or irritation; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

See also: Trimox side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Trimox:

Store Trimox at or below 68 degrees F (20 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trimox out of the reach of children and away from pets.

General information:

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


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


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


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

This information is a summary only. It does not contain all information about Trimox. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Trimox resources

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

• Trimox Advanced Consumer (Micromedex) - Includes Dosage Information


• Trimox Consumer Overview


• Amoxicillin Prescribing Information (FDA)


• Amoxicillin Professional Patient Advice (Wolters Kluwer)


• Amoxicillin Monograph (AHFS DI)


• Amoxicillin and Clavulanate Potassium Monograph (AHFS DI)


• Amoxil Consumer Overview


• Amoxil Prescribing Information (FDA)


• Amoxil Advanced Consumer (Micromedex) - Includes Dosage Information


• Biomox Prescribing Information (FDA)


• DisperMox Prescribing Information (FDA)


• Moxatag Prescribing Information (FDA)


• Moxatag Consumer Overview

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Nafarelin

Pronunciation: NAF-a-REL-in
Generic Name: Nafarelin
Brand Name: Synarel

Nafarelin is used for:

Treating endometriosis, including relieving pain and reducing lesions. It is also used to treat early puberty (central precocious puberty [CPP]) in children of both sexes. It may also be used for other conditions as determined by your doctor.

Nafarelin is a gonadotropin-releasing hormone (GnRH) agonist analog. It works by decreasing production of certain steroids in the body, which decreases the symptoms of endometriosis or early puberty.

Do NOT use Nafarelin if:

• you are allergic to any ingredient in Nafarelin or to GnRH


• you are pregnant, may become pregnant, or are breast-feeding


• you have undiagnosed abnormal vaginal bleeding

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

Before using Nafarelin:

Some medical conditions may interact with Nafarelin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• you are planning to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a runny or stuffy nose, osteoporosis (weak bones), or a family history of osteoporosis


• if you regularly use alcohol or tobacco


• if the patient is a child with endometriosis

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

• Anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone) because the risk of decreased bone density (weak bones) may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nafarelin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nafarelin:

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

• An extra patient leaflet is available with Nafarelin. Talk to your pharmacist if you have questions about this information.


• To use a nose spray, gently blow your nose. Sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for at least 30 seconds between sprays.


• After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.


• If you are also using a decongestant nasal spray, do not use it within 2 hours after using Nafarelin. Check with your doctor if you have questions about using Nafarelin along with your other medicines.


• It may take 4 to 8 weeks for Nafarelin to work. Continue to use Nafarelin even if you feel well. Do not miss any doses.


• If you miss a dose of Nafarelin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.


• If you miss more than 1 dose of Nafarelin, contact your doctor.

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

Important safety information:

• Avoid sneezing during or immediately after using Nafarelin, if possible, because Nafarelin's effectiveness may be decreased.


• Do not exceed the recommended dose or use Nafarelin for longer than prescribed without checking with your doctor.


• If you are using Nafarelin for CPP, you may experience some signs of puberty (eg, vaginal bleeding, breast enlargement, increased pubic hair) or temporary body odor during the first month of treatment. This is normal. If these side effects persist or are severe, contact your doctor.


• If you are using Nafarelin for endometriosis, you may experience irregular or unusual vaginal bleeding during the first 2 months you use Nafarelin. This is normal. If you experience severe or persistent vaginal bleeding or if you have unusual vaginal bleeding that lasts longer than 2 months after you start Nafarelin, contact your doctor.


• If you are using Nafarelin for endometriosis, your menstrual period should stop while you use Nafarelin. Contact your doctor if your regular menstrual period continues while you are using Nafarelin.


• Women who may become pregnant must have a negative pregnancy test before beginning treatment with Nafarelin.


• Women of childbearing age should avoid becoming pregnant while using Nafarelin. To prevent pregnancy, use a nonhormonal form of birth control (eg, condoms) while using Nafarelin.


• Women who miss more than one dose of Nafarelin in a row may experience breakthrough vaginal bleeding and ovulation, with the possibility of pregnancy. Contact your doctor if you miss more than one dose of Nafarelin.


• Nafarelin may interfere with certain lab tests, including diagnostic tests of pituitary gonadotropic and gonadal function. Be sure your doctor and lab personnel know you are using Nafarelin.


• Lab tests, including gonadal sex steroid levels and growth rate, may be performed while you use Nafarelin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Nafarelin should be used with extreme caution in CHILDREN younger than 18 years old who have endometriosis; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Nafarelin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Nafarelin is found in breast milk. Do not breast-feed while taking Nafarelin.

Possible side effects of Nafarelin:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; dandruff; decreased sexual desire; headache; hot flashes; mood swings; muscle pain; nasal irritation; runny nose; temporary increase or decrease in breast size; trouble sleeping; vaginal dryness; weight change.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal pain; chest pain; continued menstrual periods; depression; irregular heartbeat; mental or mood changes; severe, persistent, or unusual vaginal bleeding; shortness of breath; sudden headache or vomiting; swelling of the hands or feet; vision changes; whitish or brownish vaginal discharge.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nafarelin side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Nafarelin:

Store Nafarelin upright at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Nafarelin out of the reach of children and away from pets.

General information:

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


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


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


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

This information is a summary only. It does not contain all information about Nafarelin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nafarelin resources

• Nafarelin Side Effects (in more detail)
• Nafarelin Use in Pregnancy & Breastfeeding
• Nafarelin Support Group
• 2 Reviews for Nafarelin - Add your own review/rating

• nafarelin Nasal Advanced Consumer (Micromedex) - Includes Dosage Information


• Nafarelin Acetate Monograph (AHFS DI)


• Synarel Prescribing Information (FDA)


• Synarel Concise Consumer Information (Cerner Multum)

Compare Nafarelin with other medications

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Vigamox

Generic Name: moxifloxacin hydrochloride

Dosage Form: ophthalmic solution
FULL PRESCRIBING INFORMATION

INDICATIONS AND USAGE

Vigamox® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Corynebacterium species*

Micrococcus luteus*

Staphylococcus aureus

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus warneri*

Streptococcus pneumoniae

Streptococcus viridans group

Acinetobacter lwoffii*

Haemophilus influenzae

Haemophilus parainfluenzae*

Chlamydia trachomatis

*Efficacy for this organism was studied in fewer than 10 infections.

DOSAGE AND ADMINISTRATION

Instill one drop in the affected eye 3 times a day for 7 days.

DOSAGE FORMS AND STRENGTHS

4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin hydrochloride, 0.5% as base.

Contraindications

Vigamox® solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.

Warnings and Precautions

Topical Ophthalmic Use Only

NOT FOR INJECTION. Vigamox® solution is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.

Hypersensitivity Reaction

In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

Growth of Resistant Organisms with Prolonged Use

As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.

Avoidance of Contact Lens Wear

Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients.

Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

Drug Interactions

Drug-drug interaction studies have not been conducted with Vigamox® solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C.

Teratogenic Effects: Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day.

Since there are no adequate and well-controlled studies in pregnant women, Vigamox® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Vigamox® solution is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of Vigamox® solution in infants below 1 year of age have not been established.

There is no evidence that the ophthalmic administration of Vigamox® solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Vigamox Description

Vigamox® (moxifloxacin hydrochloride ophthalmic solution) 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position.

Chemical Name:

1 - Cyclopropyl - 6 - fluoro - 1,4 - dihydro - 8 - methoxy - 7 - [(4aS,7aS) - octahydro - 6H - pyrrolol[3,4 - b]pyridin - 6 - yl] - 4 - oxo - 3 - quinoline carboxylic acid, monohydrochloride. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of Vigamox® solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base.

Contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8.

Vigamox® solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg.

Vigamox - Clinical Pharmacology

Mechanism of Action

Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs (See 12.4 Microbiology).

Pharmacokinetics

Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of Vigamox® solution 3 times a day. The mean steady-state Cmax (2.7 ng/mL) and estimated daily exposure AUC (45 ng•hr/mL) values were 1,600 and 1,000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

Microbiology

The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.

In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10-9 to < 1 x 10-11 for Gram-positive bacteria.

Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:

Aerobic Gram-positive microorganisms:

Corynebacterium species*

Micrococcus luteus*

Staphylococcus aureus

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus warneri*

Streptococcus pneumoniae

Streptococcus viridans group

Aerobic Gram-negative microorganisms:

Acinetobacter lwoffii*

Haemophilus influenzae

Haemophilus parainfluenzae*

Other microorganisms:

Chlamydia trachomatis

*Efficacy for this organism was studied in fewer than 10 infections.

The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of Vigamox® solution in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials.

The following organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 μg/ml or less (systemic susceptible breakpoint) against most (≥ 90%) strains of the following ocular pathogens.

Aerobic Gram-positive microorganisms:

Listeria monocytogenes

Staphylococcus saprophyticus

Streptococcus agalactiae

Streptococcus mitis

Streptococcus pyogenes

Streptococcus Group C, G and F

Aerobic Gram-negative microorganisms:

Acinetobacter baumannii

Acinetobacter calcoaceticus

Citrobacter freundii

Citrobacter koseri

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli

Klebsiella oxytoca

Klebsiella pneumoniae

Moraxella catarrhalis

Morganella morganii

Neisseria gonorrhoeae

Proteus mirabilis

Proteus vulgaris

Pseudomonas stutzeri

Anaerobic microorganisms:

Clostridium perfringens

Fusobacterium species

Prevotella species

Propionibacterium acnes

Other microorganisms:

Chlamydia pneumoniae

Legionella pneumophila

Mycobacterium avium

Mycobacterium marinum

Mycoplasma pneumoniae

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis).

Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice.

Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose. At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.

Clinical Studies

In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, Vigamox® solution produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of baseline pathogens ranged from 84% to 94%. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

How Supplied/Storage and Handling

Vigamox® solution is supplied as a sterile ophthalmic solution in Alcon’s DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

3 mL in a 4 mL bottle - NDC 0065-4013-03

Storage: Store at 2°C- 25°C (36°F - 77°F).

Patient Counseling Information

Patients should be advised not to touch the dropper tip to any surface to avoid contaminating the contents.

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Patients should be told to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.

Rx Only

Licensed to Alcon by Bayer Pharma AG.

U.S. PAT. NO. 5,607,942; 6,716,830; 7,671,070

© 2003-2011 Novartis

Manufactured by

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA


9007343-1011

PRINCIPAL DISPLAY PANEL

NDC 0065 - 4013 - 03               STERILE

Vigamox®

(moxifloxacin hydrochloride

ophthalmic solution)

0.5% as base

3 mL

ALCON®

Vigamox   moxifloxacin hydrochloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-4013 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN) MOXIFLOXACIN 5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BORIC ACID   SODIUM CHLORIDE   WATER   HYDROCHLORIC ACID   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-4013-03 3 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021598	05/07/2003

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 07/2011Alcon Laboratories, Inc.

More Vigamox resources

• Vigamox Side Effects (in more detail)
• Vigamox Dosage
• Vigamox Use in Pregnancy & Breastfeeding
• Vigamox Support Group
• 4 Reviews for Vigamox - Add your own review/rating

• Vigamox eent Monograph (AHFS DI)


• Vigamox Advanced Consumer (Micromedex) - Includes Dosage Information


• Vigamox Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Vigamox Consumer Overview


• Moxeza Consumer Overview

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• Conjunctivitis, Bacterial
• Ophthalmic Surgery

human papillomavirus vaccine Intramuscular

HUE-man pap-ah-LOH-mah-VYE-rus ree-KOM-bi-nant VAX-een kwa-drah-VAY-lent (types 6,11,16,18)

Commonly used brand name(s)

In the U.S.

• Gardasil

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

Uses For human papillomavirus vaccine

Human papillomavirus (HPV) recombinant quadrivalent vaccine is an active immunizing agent used to prevent infection caused by human papillomavirus (types 6, 11, 16, and 18). It works by causing your body to produce its own protection (antibodies) against the virus.

HPV infection is usually a sexually transmitted disease (STD) and is easily spread by having sex with an infected person. This vaccine helps prevent anal, cervical, vulvar, or vaginal cancer; genital warts; and abnormal or precancerous diseases of the anus, cervix, vagina, and vulva in girls and women 9 to 26 years of age. This vaccine also helps prevent abnormal or precancerous diseases of the anus, anal cancer, and genital warts in boys and men 9 to 26 years of age. This vaccine will not treat these diseases or protect you against diseases that are caused by other HPV types. The vaccine will also not protect you against other sexually transmitted diseases that are not caused by HPV.

This vaccine is available only with your doctor's prescription.

Before Using human papillomavirus vaccine

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to human papillomavirus vaccine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of human papillomavirus recombinant quadrivalent vaccine in children younger than 9 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of human papillomavirus recombinant quadrivalent vaccine have not been performed in the geriatric population. Safety and efficacy have not been established.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Immune deficiency condition, or family history of—This condition may increase the chance and severity of side effects with the vaccine and/or may decrease the useful effects of the vaccine.

• Severe illness with fever—The symptoms of this condition may be confused with the possible side effects of the vaccine.

Proper Use of human papillomavirus vaccine

A nurse or other trained health professional will give you this vaccine. It is given as a shot in the muscle of your upper arm or upper leg.

To get the best possible protection against infection with the HPV virus, you should complete the vaccine dosing schedule, even if you are not directly exposed to HPV.

This vaccine is usually given as three shots. You will need another dose at 2 months and 6 months after the first dose, unless your doctor tells you otherwise.

Missed Dose

human papillomavirus vaccine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using human papillomavirus vaccine

It is very important that you return to your doctor's office at the right time for all of the doses. Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble with breathing after you get the injection.

This vaccine does not replace your routine screening tests for anal cancer or cervical cancer (pap test). You will need to see your doctor for screening tests even after receiving this vaccine.

You or your child may feel faint, lightheaded, or dizzy right after you receive this vaccine. Sitting or lying down for 15 minutes after you receive the vaccine may help. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert. If this problem continues or gets worse, check with your doctor.

human papillomavirus vaccine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Fever

Less common

• Black, tarry stools


• bleeding gums


• blood in urine or stools


• blurred vision


• body aches or pain


• chills


• constipation


• cough


• depressed mood


• difficulty with breathing


• dry mouth


• dry skin and hair


• ear congestion


• feeling cold


• flushed, dry skin


• fruit-like breath odor


• headache


• hoarseness or husky voice


• increased hunger


• increased thirst


• increased urination


• loss of consciousness


• loss of voice


• muscle cramps and stiffness


• nasal congestion


• nausea


• pinpoint red spots on skin


• runny nose


• slowed heartbeat


• sneezing


• sore throat


• stomachache


• sweating


• troubled breathing


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

Rare

• Difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


• noisy breathing


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• shortness of breath


• skin rash


• tightness in the chest


• wheezing

Incidence not known

• Anxiety


• back pain, sudden and severe


• back, leg, or stomach pains


• bloating


• chest pain


• convulsions (seizures)


• dark urine


• fainting


• general body swelling


• hives or welts


• hoarseness


• inability to move the arms and legs


• indigestion


• irritation


• joint pain, stiffness, or swelling


• loss of appetite


• loss of bladder control


• muscle spasm or jerking of all extremities


• muscle weakness, sudden and progressing


• nosebleeds


• pain in the stomach, side, or abdomen, possibly radiating to the back


• pain, redness, or swelling in the arm or leg


• pale skin


• paralysis


• rash


• redness of the skin


• shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination


• sudden loss of consciousness


• sudden numbness and weakness in the arms and legs


• sudden shortness of breath or troubled breathing


• swelling of the eyelids, face, lips, hands, or feet


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Red streaks on the skin, swelling, tenderness, pain, or itching at the injection site

Less common

• Changes in skin coloring


• cloudy urine


• diarrhea


• difficulty with moving


• general feeling of discomfort or illness


• hair loss, thinning of hair


• muscle pain or stiffness


• pain in the joints


• sleeplessness


• toothache


• trouble with sleeping


• unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: human papillomavirus vaccine Intramuscular side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More human papillomavirus vaccine Intramuscular resources

• Human papillomavirus vaccine Intramuscular Side Effects (in more detail)
• Human papillomavirus vaccine Intramuscular Use in Pregnancy & Breastfeeding
• Human papillomavirus vaccine Intramuscular Drug Interactions
• Human papillomavirus vaccine Intramuscular Support Group
• 13 Reviews for Human papillomavirus vaccine Intramuscular - Add your own review/rating

Compare human papillomavirus vaccine Intramuscular with other medications

• Human Papillomavirus Prophylaxis

Nicorette Drugs Facts

Dosage Form: lozenge
Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 4 mg

Nicotine polacrilex, 2 mg

Purpose

Stop smoking aid

Uses

• reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• stomach ulcer or diabetes

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth problems occur


• persistent indigestion or severe sore throat occurs


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions 4mg Lozenge

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other important information


• stop smoking completely when you begin using the lozenge


• if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge


• if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge according to the following 12 week schedule:

Weeks 1to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

• nicotine lozenge is a medicine and must be used a certain way to get the best results


• place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 10 minutes). Minimize swallowing. Do not chew or swallow lozenge.


• you may feel a warm or tingling sensation


• occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 10 minutes)


• do not eat or drink 15 minutes before using or while the lozenge is in your mouth


• to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks


• do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects


• do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.


• stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Directions 2mg Lozenge

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other important information


• stop smoking completely when you begin using the lozenge


• if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge


• if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge according to the following 12 week schedule:


• 
  
  
  
  
  
  
  

  Weeks 1to 6	Weeks 7 to 9	Weeks 10 to 12
  1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours



• nicotine lozenge is a medicine and must be used a certain way to get the best results


• place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 10 minutes). Minimize swallowing. Do not chew or swallow lozenge.


• you may feel a warm or tingling sensation


• occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 10 minutes)


• do not eat or drink 15 minutes before using or while the lozenge is in your mouth


• to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks


• do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects


• do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.


• stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Other information

• Each lozenge contains: sodium, 5 mg


• store at 20 – 25oC (68 – 77oF)


• keep vial tightly closed and protect from light

Inactive ingredients

acesulfame potassium, calcium polycarbophil, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-888-569-1743 (English/Spanish) weekdays (9:00 am – 4:30 pm ET)

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in the U.K.

©2009 GlaxoSmithKline

Flip open for Directions and additional information

Retain this package for complete product information

• not for sale to those under 18 years of age


• proof of age required


• not for sale in vending machines or from any source where proof of age cannot be verified

NICORETTE®, COMMITTED QUITTERS®, and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to the GlaxoSmithKline group of companies.

Opening Direction:

Push in child resistant tab on the vial with thumb. Flip up the top of vial. Turn upside down and shake to remove lozenge.

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.


2. Use Enough – Use at least 9 Nicorette mini  lozenges per day during the first six weeks.


3. Use Long Enough – Use Nicorette mini lozenges for the full 12 weeks.


4. Use With a Support Program as directed in the enclosed User’s Guide.

TAMPER EVIDENT FEATURE: Do not use if clear neckband printed "SEALED FOR SAETY" is missing or broken. Retain outer carton for full product uses, directions and warnings.

go to www.nicorette.com for online support program

Principal Display Panel

Nicorette®

Nicotine polacrilex lozenge, 4mg

stop smoking aid

24 LOZENGES

mini Lozenge

4mg EACH (1 vial of 24)

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2mg Lozenge

Principal Display Panel

Nicorette®

Nicotine polacrilex lozenge, 2mg

stop smoking aid

24 LOZENGES

mini Lozenge

2mg EACH (1 Vial of 24)

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette® 4mg Lozenge

NICORETTE  nicotine  lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0508 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 2 mg

Inactive Ingredients Ingredient Name Strength POLACRILIN   ACESULFAME POTASSIUM   CALCIUM POLYCARBOPHIL   MAGNESIUM STEARATE   MANNITOL   POTASSIUM BICARBONATE   SODIUM ALGINATE   SODIUM CARBONATE   XANTHAN GUM

Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 10mm Flavor MINT Imprint Code M Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0508-01 24 LOZENGE In 1 CONTAINER None 2 0135-0508-02 3 CONTAINER In 1 CARTON contains a CONTAINER 2 27 LOZENGE In 1 CONTAINER This package is contained within the CARTON (0135-0508-02) 3 0135-0508-03 5 CONTAINER In 1 CARTON contains a CONTAINER 3 27 LOZENGE In 1 CONTAINER This package is contained within the CARTON (0135-0508-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022360	03/01/2010

NICORETTE  nicotine  lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0509 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 4 mg

Inactive Ingredients Ingredient Name Strength POLACRILIN   ACESULFAME POTASSIUM   CALCIUM POLYCARBOPHIL   MAGNESIUM STEARATE   MANNITOL   POTASSIUM BICARBONATE   SODIUM ALGINATE   SODIUM CARBONATE   XANTHAN GUM

Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 10mm Flavor MINT Imprint Code F Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0509-01 24 LOZENGE In 1 CONTAINER None 2 0135-0509-02 3 CONTAINER In 1 CARTON contains a CONTAINER 2 27 LOZENGE In 1 CONTAINER This package is contained within the CARTON (0135-0509-02) 3 0135-0509-03 5 CONTAINER In 1 CARTON contains a CONTAINER 3 27 LOZENGE In 1 CONTAINER This package is contained within the CARTON (0135-0509-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022360	03/01/2010

Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625)

Revised: 05/2010GlaxoSmithKline Consumer Healthcare LP

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