Web PLR Articles Directory Scotland: March 2012

Saturday, 31 March 2012

Genora 1/35

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Estrostep Fe, Femcon FE, Junel 1.5/30, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin 21 1.5/30, Loestrin 24 Fe, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin FE 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 7/7/7, Nortrel 0.5/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent

What is Genora 1/35 (ethinyl estradiol and norethindrone)?

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

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

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

What is the most important information I should know about Genora 1/35 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

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

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Genora 1/35 (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease, liver cancer, or a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Genora 1/35 (ethinyl estradiol and norethindrone)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Genora 1/35 (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Genora 1/35 (ethinyl estradiol and norethindrone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

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

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

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

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

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness.

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 other drugs will affect Genora 1/35 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

prednisolone (Orapred);

theophylline (Respbid, Theo-Dur);

St. John's wort;

an antibiotic;

seizure medication;

a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

HIV or AIDS medications.

There may be other drugs not listed that can affect this medication. 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.

More Genora 1/35 resources

Genora 1/35 Side Effects (in more detail)
Genora 1/35 Use in Pregnancy & Breastfeeding
Drug Images
Genora 1/35 Drug Interactions
Genora 1/35 Support Group
0 Reviews for Genora/35 - Add your own review/rating

Aranelle Prescribing Information (FDA)

Balziva Prescribing Information (FDA)

Brevicon Prescribing Information (FDA)

Briellyn Prescribing Information (FDA)

Cyclafem 1/35 Prescribing Information (FDA)

Cyclafem 7/7/7 Prescribing Information (FDA)

Estrostep Fe Prescribing Information (FDA)

Femcon FE Prescribing Information (FDA)

Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Femhrt Consumer Overview

Femhrt Prescribing Information (FDA)

Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)

Jevantique Prescribing Information (FDA)

Jinteli Prescribing Information (FDA)

Leena Prescribing Information (FDA)

Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)

Lo Loestrin Fe Consumer Overview

Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information

Lo Loestrin Fe Prescribing Information (FDA)

Loestrin 24 FE Prescribing Information (FDA)

Loestrin 24 Fe Consumer Overview

Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)

Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)

Tilia FE Prescribing Information (FDA)

Tri-Norinyl Prescribing Information (FDA)

Zenchent FE Prescribing Information (FDA)

Zeosa Prescribing Information (FDA)

Compare Genora 1/35 with other medications

Abnormal Uterine Bleeding
Acne
Birth Control
Endometriosis
Gonadotropin Inhibition
Menstrual Disorders
Polycystic Ovary Syndrome
Postmenopausal Symptoms
Prevention of Osteoporosis

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Genora/35 side effects (in more detail)

Thursday, 29 March 2012

Neosporin

Generic Name: neomycin, polymyxin b, and gramicidin (Ophthalmic route)

nee-oh-MYE-sin SUL-fate, pol-ee-MIX-in B SUL-fate, gram-i-SYE-din

Commonly used brand name(s)

In the U.S.

Neocidin

Neosporin

Ocu-Spor-G

Available Dosage Forms:

Solution

Therapeutic Class: Antibiotic Combination

Chemical Class: Neomycin

Uses For Neosporin

Neomycin, polymyxin B, and gramicidin is a combination antibiotic medicine used to treat infections of the eye.

Neomycin, polymyxin B, and gramicidin combination is available only with your doctor's prescription.

Before Using Neosporin

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this combination in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of neomycin, polymyxin B, and gramicidin combination in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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.

Proper Use of neomycin, polymyxin b, and gramicidin

This section provides information on the proper use of a number of products that contain neomycin, polymyxin b, and gramicidin. It may not be specific to Neosporin. Please read with care.

The bottle is only partially full to provide proper drop control.

To use:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.

If you think you did not get the drop of medicine into your eye properly, use another drop.

To keep the medicine as germ-free as possible, do not touch the applicator tip or dropper to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For eye infections:
- For eye drops dosage form:
  - Adults and children—Use one drop in the eye two to four times a day for seven to ten days. If you have a more serious infection, your doctor may want you to use one drop in the eye every fifteen to thirty minutes at first. Then your doctor may have you use the medicine less often.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Neosporin

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Neosporin 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 immediately if any of the following side effects occur:

More common

Itching, rash, redness, swelling, or other sign of irritation in or around the eye not present before use of this medicine

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:

Less common

Burning or stinging sensation in the eye

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: Neosporin 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 Neosporin resources

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

Neosporin Prescribing Information (FDA)

Neosporin topical Concise Consumer Information (Cerner Multum)

Neosporin Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Neosporin with other medications

Conjunctivitis, Bacterial

Friday, 23 March 2012

Icy Hot Arthritis Therapy Topical

Generic Name: capsaicin (Topical route)

kap-SAY-sin

Commonly used brand name(s)

In the U.S.

Arthricare For Women

Capsagel

Capsagesic-HP Arthritis Relief

Capsin

Double Cap

Icy Hot Arthritis Therapy

Pain Enz

Rid-A-Pain

Sportsmed

Therapatch Warm

Trixaicin

Zostrix

Available Dosage Forms:

Lotion

Cream

Gel/Jelly

Patch, Extended Release

Film

Ointment

Liquid

Stick

Therapeutic Class: Analgesic

Uses For Icy Hot Arthritis Therapy

Capsaicin is used to help relieve a certain type of pain known as neuralgia (shingles). Capsaicin is also used to help relieve minor pain associated with rheumatoid arthritis or muscle sprains and strains. This medicine will not cure any of these conditions.

Neuralgia is a pain that comes from the nerves near the surface of your skin. This pain may occur after an infection with herpes zoster (shingles or postherpetic neuralgia). Capsaicin will help relieve the pain of postherpetic neuralgia, but it will not cure the condition.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Icy Hot Arthritis Therapy

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of capsaicin in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of capsaicin in the elderly.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of capsaicin

This section provides information on the proper use of a number of products that contain capsaicin. It may not be specific to Icy Hot Arthritis Therapy. Please read with care.

A nurse or other trained healthcare professional will apply the topical Qutenza™ patch to the affected area.

If you are using the topical cream, gel, lotion, or ointment for neuralgia, muscle pain, or arthritis, follow the instructions on the medicine label.

Be careful not to get any of this medicine in your eyes, because it can cause severe eye irritation. If the medicine does get in your eyes, wash the eyes with water and check with your doctor right away.

If capsaicin gets on your face, scalp, or in your mouth, it may cause a burning sensation. Wash these areas with warm (not hot) soapy water.

If you are using the cream, gel, lotion, or ointment:

Do not put the medicine on wounds or irritated skin.

Apply a small amount of medicine and use your fingers to rub it in well so very little or no medicine is left on the skin.

Wash your hands with soap and water after applying the medicine to avoid getting it in your eyes or on other sensitive areas of the body.

If you are using capsaicin for arthritis in your hands, do not wash your hands for at least 30 minutes after applying it.

If a bandage is being used on the treated area, do not wrap it tightly.

Use the medicine regularly every day as directed. It may take a full 2 weeks before your pain goes away.

If your condition gets worse, or does not improve after one month, stop using the medicine and check with your doctor.

Dosing

For topical dosage form (cream, gel, lotion, or ointment):
- For arthritis, muscle pain, or neuralgia:
  - Adults and teenagers—Apply regularly 3 or 4 times a day and rub in well.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Icy Hot Arthritis Therapy

If you use the Qutenza™ patch:

Your doctor will check you closely for any problems or unwanted effects that may be caused by this medicine.

Your blood pressure will be measured while the patch is on your skin and after it has been removed. If you notice any change to your recommended blood pressure at home, call your doctor right away. If you have questions about this, talk to your doctor.

You may have some skin redness, burning, or a stinging sensation at the application site. Heat, humidity, bathing in warm water, or sweating may increase the burning sensation. If this irritation is severe or does not go away, call your doctor.

Your skin may be more sensitive to heat and sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Check with your doctor right away if you have coughing, shortness of breath, or any breathing problems after the patch is removed.

Your doctor might give you oral pain medicines (e.g., opioids, narcotics) while the patch is in place and after it is removed. These medicines may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

If you use the cream, gel, lotion, or ointment:

You may have some skin redness, burning, or a stinging sensation at the application site. Although this usually disappears after the first several days, it may last 2 to 4 weeks. Heat, humidity, bathing in warm water, or sweating may increase the burning sensation. If this irritation is severe or does not go away, call your doctor.

The burning sensation will not improve or go away if you reduce the number of doses you use each day. Using fewer doses may also reduce the amount of pain relief you get.

Your skin may be more sensitive to heat and sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Check with your doctor right away if you have coughing, shortness of breath, or any breathing problems after the medicine has dried on the skin.

Icy Hot Arthritis Therapy 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 immediately if any of the following side effects occur:

More common - all forms

Burning, itching, dryness, pain, redness, swelling, or soreness at the application site

Less common - all forms

Cough

cough-producing mucus

difficulty with breathing

shortness of breath or troubled breathing

sore throat

stuffy or runny nose

tightness in the chest or wheezing

Less common - patch only

Blurred vision

dizziness

headache

nervousness

pounding in the ears

slow or fast heartbeat

Incidence not known - patch only

Bloating or swelling of the face, arms, hands, lower legs, or feet

increased sensitivity to pain

increased sensitivity to touch

rapid weight gain

tingling in the hands and feet

unsteadiness or awkwardness

unusual weight gain or loss

weakness in the arms, hands, legs, or feet

Less common - patch only

Fever

muscle aches

nausea

pain or tenderness around the eyes and cheekbones

unusual tiredness or weakness

vomiting

Incidence not known - patch only

Abnormal skin color

change in taste

loss of taste

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: Icy Hot Arthritis Therapy Topical side effects (in more detail)

Compare Icy Hot Arthritis Therapy Topical with other medications

Burning Mouth Syndrome
Diabetic Nerve Damage
Osteoarthritis
Pain
Peripheral Neuropathy
Persisting Pain, Shingles

Thursday, 22 March 2012

Fluvoxamine Extended-Release Capsules

Pronunciation: floo-VOX-a-meen
Generic Name: Fluvoxamine
Brand Name: Luvox CR

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Fluvoxamine Extended-Release Capsules outweigh the risks.

Families land caregivers must closely watch patients who take Fluvoxamine Extended-Release Capsules. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Fluvoxamine Extended-Release Capsules are used for:

Treating obsessive-compulsive disorder (OCD). It may also be used for other conditions as determined by your doctor.

Fluvoxamine Extended-Release Capsules are a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to decrease anxiety and obsessive or compulsive behavior.

Do NOT use Fluvoxamine Extended-Release Capsules if:

you are allergic to any ingredient in Fluvoxamine Extended-Release Capsules

you are taking or have taken linezolid, methylene blue, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or St. John's wort within the last 14 days

you are taking alosetron, astemizole, a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, ramelteon, sibutramine, terfenadine, thioridazine, or tizanidine

you are taking any other medicine that contains fluvoxamine

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

Video: Treatment for Depression

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

Before using Fluvoxamine Extended-Release Capsules:

Some medical conditions may interact with Fluvoxamine Extended-Release Capsules. 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 or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse

if you have a history of seizures, stroke, high blood pressure, heart problems, liver or kidney problems, stomach or bowel bleeding, diabetes, blood or bone marrow problems, or metabolism problems

if you are dehydrated, have low blood sodium levels, or drink alcohol or smoke

if you will be having electroconvulsive therapy (ECT)

if you are taking medicine for depression or any other mental or mood problem

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

Anorexiants (eg, phentermine), fenfluramine derivatives (eg, dexfenfluramine), linezolid, lithium, MAOIs (eg, phenelzine), medicines for mental problems (eg, quetiapine), methylene blue, metoclopramide, nefazodone, quinidine, rasagiline, selegiline, serotonin 5-HT₁ receptor agonists (eg, sumatriptan), sibutramine, St. John's wort, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur

Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased

Tramadol because the risk of seizures may be increased

Astemizole, cisapride, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, or terfenadine because severe heart problems, including irregular heartbeat, may occur

Cyproheptadine because it may decrease Fluvoxamine Extended-Release Capsules's effectiveness

Alosetron , aripiprazole, benzodiazepines (eg, alprazolam, diazepam), beta-blockers (eg, metoprolol, propranolol), carbamazepine, clozapine, diltiazem, methadone, mexiletine, phenytoin, ramelteon, risperidone, other SSRIs (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, venlafaxine), tacrine, theophylline, tizanidine, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Fluvoxamine Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluvoxamine Extended-Release Capsules 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 Fluvoxamine Extended-Release Capsules:

Use Fluvoxamine Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Fluvoxamine Extended-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fluvoxamine Extended-Release Capsules refilled.

Take Fluvoxamine Extended-Release Capsules by mouth with or without food.

Swallow Fluvoxamine Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.

Take Fluvoxamine Extended-Release Capsules at bedtime unless your doctor tells you otherwise.

Continue to take Fluvoxamine Extended-Release Capsules even if you feel well. Do not miss any doses.

Do not suddenly stop taking Fluvoxamine Extended-Release Capsules without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Fluvoxamine Extended-Release Capsules and whenever a change in dose is made.

If you miss a dose of Fluvoxamine Extended-Release Capsules, 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 Fluvoxamine Extended-Release Capsules.

Important safety information:

Fluvoxamine Extended-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fluvoxamine Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol while you are using Fluvoxamine Extended-Release Capsules.

Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fluvoxamine Extended-Release Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Fluvoxamine Extended-Release Capsules for longer than prescribed without checking with your doctor.

Children, teenagers, and young adults who take Fluvoxamine Extended-Release Capsules may be at increased risk of suicidal thoughts or actions. Watch patients who take Fluvoxamine Extended-Release Capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; 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.

If your doctor tells you to stop taking Fluvoxamine Extended-Release Capsules, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Fluvoxamine Extended-Release Capsules.

Serotonin syndrome is a possibly fatal syndrome that can be caused by Fluvoxamine Extended-Release Capsules. Your risk may be greater if you take Fluvoxamine Extended-Release Capsules with certain other medicines (eg, MAOIs, "triptans"). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.

Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can rarely be caused by Fluvoxamine Extended-Release Capsules. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.

Fluvoxamine Extended-Release Capsules may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.

Caution is advised when using Fluvoxamine Extended-Release Capsules in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.

Fluvoxamine Extended-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. They may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.

Fluvoxamine Extended-Release Capsules may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Fluvoxamine Extended-Release Capsules.

PREGNANCY and BREAST-FEEDING: Fluvoxamine Extended-Release Capsules may cause harm to the fetus if it is taken during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Fluvoxamine Extended-Release Capsules while you are pregnant. Fluvoxamine Extended-Release Capsules are found in breast milk. Do not breast-feed while taking Fluvoxamine Extended-Release Capsules.

Possible side effects of Fluvoxamine Extended-Release Capsules:

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; decreased sexual ability; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; increased sweating; loss of appetite; nausea; nervousness; sore throat; stomach upset; trouble sleeping; vomiting; weakness; yawning.

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); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory loss; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; painful or unusually heavy menstrual periods; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or trouble sleeping; stiff muscles; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes.

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: Fluvoxamine 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 chest pain; coma; fast, slow, or irregular heartbeat; seizures; severe or persistent dizziness, drowsiness, diarrhea, nausea, or vomiting; tremor; trouble breathing.

Proper storage of Fluvoxamine Extended-Release Capsules:

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

General information:

If you have any questions about Fluvoxamine Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

Fluvoxamine Extended-Release Capsules are 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 summary only. It does not contain all information about Fluvoxamine Extended-Release Capsules. 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

More Fluvoxamine resources

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

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Anxiety and Stress
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Wednesday, 21 March 2012

Flumazenil 0.1mg / ml Injection (hameln)

1. Name Of The Medicinal Product

Flumazenil 0.1 mg/ml Injection

2. Qualitative And Quantitative Composition

Each ml contains 0.1 mg flumazenil.

1 ampoule with 5 ml contains 0.5 mg flumazenil.

1 ampoule with 10 ml contains 1 mg flumazenil.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

solution for injection

concentrate for solution for infusion

clear colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

Flumazenil is indicated for the complete or partial reversal of the central sedative effects of benzodiazepines. It may therefore be used in anaesthesia and in intensive care in the following situations:

In anaesthesia

- Termination of hypnosedative effects in general anaesthesia induced and/or maintained with benzodiazepines in hospitalized patients

- Reversal of benzodiazepine sedation in short-term diagnostic and therapeutic procedures in ambulatory patients and hospitalized patients

In intensive care situations

- For the specific reversal of the central effects of benzodiazepines, in order to restore spontaneous respiration

- For diagnosis and treatment of intoxication or overdose with only or mainly benzodiazepines

4.2 Posology And Method Of Administration

Flumazenil should be administered intravenously by an anaesthetist or experienced physician.

Flumazenil may be administered as an infusion (see 6.6).

Flumazenil may be used concomitantly with other resuscitative measures.

Adults:

Anaesthesia

The recommended starting dose is 0.2 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, up to a maximum dose of 1.0 mg. The usual dose required lies between 0.3 and 0.6 mg, but may deviate depending on the patient's characteristics and the benzodiazepine used.

Intensive Care

The recommended starting dose is 0.2 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, up to a total dose of 2 mg or until the patient awakes. If drowsiness recurs, an intravenous infusion of 0.1 – 0.4 mg/h may be useful. The rate of infusion should be adjusted individually to achieve the desired level of consciousness.

If no clear effect on awareness and respiration is obtained after repeated dosing, it should be considered that the intoxication is not due to benzodiazepines.

Infusion should be discontinued every 6 hours to verify whether resedation occurs.

To avoid withdrawal symptoms in patients treated for a long period of time with high doses of benzodiazepines in the intensive care unit, the dosage of flumazenil has to be titrated individually and the injection has to be administered slowly (see 4.4).

Elderly

In the absence of data on the use of flumazenil in elderly patients, it should be noted that this population is generally more sensitive to the effects of medicinal products and should be treated with due caution.

Children and adolescents (from 1 to 17 years)

For the reversal of conscious sedation induced by benzodiazepines in children older than 1 year the recommended starting dose is 0.01 mg/kg (up to 0.2 mg), administered intravenously over a period of 15 seconds. If, after a waiting period of 45 seconds, the required level of consciousness is not obtained, a follow-up injection of 0.01 mg/kg (up to 0.2 mg) may be administered and where necessary repeated at 60-second intervals (up to a maximum of 4 times) to a maximum dose of 0.05 mg/kg or 1 mg, depending on which is the lowest dose. The dose should be adjusted to the patient's response. There are no data on safety and efficacy of repeated flumazenil administration in children in case of resedation.

Children under the age of 1 year

There are insufficient data on the use of flumazenil in children under 1 year. Therefore flumazenil should only be administered in children under 1 year if the potential benefits to the patient outweigh the possible risk.

Patients with renal or hepatic impairment

In patients with impaired hepatic function, the elimination of flumazenil may be delayed (see section 5.2) and therefore careful titration of dosage is recommended. No dosage adjustments are required in patients with renal impairment.

4.3 Contraindications

- Hypersensitivity to flumazenil or to any of the excipients.

- Patients receiving benzodiazepines for control of a potentially life-threatening condition (e.g. control of intracranial pressure or status epilepticus).

- In mixed intoxications with benzodiazepines and tricyclic and/or tetracyclic antidepressants, the toxicity of the antidepressants can be masked by protective benzodiazepine effects. In the presence of autonomic (anticholinergic), neurological (motor abnormalities) or cardiovascular symptoms of severe intoxication with tricyclics/ tetracyclics, Flumazenil should not be used to reverse the benzodiazepine effect.

4.4 Special Warnings And Precautions For Use

Use in children for indications other than reversal of conscious sedation is not recommended as no controlled studies are available. The same applies for children below the age of 1 year.

- The patient should be monitored for an adequate period of time (ECG, pulse, oximetry, patient alertness and other vital signs such as heart rate, respiratory rate and blood pressure).

- Flumazenil specifically reverses benzodiazepines. Therefore if the patient does not wake up, another aetiology should be considered.

- When used in anaesthesiology at the end of surgery, flumazenil should not be given until the effects of peripheral muscle relaxants have been fully reversed.

- As the action of flumazenil is usually shorter than that of benzodiazepines and sedation may possibly recur, the patient should remain closely monitored, preferably in the intensive care unit, until the effect of flumazenil has presumably worn off.

- In patients at increased risk, the advantages of sedation by means of benzodiazepines should be weighed against the drawbacks of rapid awakening. In patients (e.g. with cardiac problems) maintenance of a certain level of sedation may be preferable to being fully awake.

- Rapid injection of high doses (more than 1 mg) flumazenil should be avoided in patients who receive chronic treatment with benzodiazepines as this may cause withdrawal symptoms.

- In patients suffering from preoperative anxiety or having a history of chronic or episodic anxiety, the dosage of flumazenil should be adjusted carefully.

- Postoperative pain must be taken into account.

- In patients treated for long periods with high doses of benzodiazepines, the advantages of the use of flumazenil should be weighed against the risk of withdrawal symptoms. If withdrawal symptoms occur despite careful dosing, an individually titrated dose of 5 mg diazepam or 5 mg midazolam should be given by slow intravenous injection.

- Because of the potential for resedation and respiratory depression, children previously sedated with midazolam should be monitored for at least 2 hours after flumazenil administration. In case of other sedating benzodiazepines, the monitoring time must be adjusted according to their expected duration.

- Until sufficient data are available flumazenil should not be used in children of 1 year or younger unless the risks for the patient (especially in case of accidental overdose) have been weighed against the advantages of the therapy.

- The use of the antagonist is not recommended in patients with epilepsy, who have been treated with benzodiazepines for a prolonged period of time. Although flumazenil has some intrinsic anti-epileptic effects, the abrupt antagonising effect can cause convulsions in patients with epilepsy.

- In patients with serious brain damage (and/or unstable intracranial pressure) receiving flumazenil – to reverse the effects of benzodiazepines – an increased intracranial pressure may develop.

- Flumazenil is not recommended for the treatment of benzodiazepine-dependence or for the treatment of long-term benzodiazepine-abstinence-syndromes.

- Panic attacks have been reported after the use of flumazenil in patients with a history of panic disorder.

- Due to the increased frequency of benzodiazepine tolerance and dependence in patients with alcoholism and other drug dependencies, flumazenil should be used with caution in this population.

- This medicinal product contains approximately 3.7 mg sodium per ml of flumazenil solution for injection. This should be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Flumazenil reverses the central effects of benzodiazepines by means of competitive interaction at receptor level: the effects of non-benzodiazepine agonists acting via the benzodiazepine receptor, such as zopiclone, triazolopyridazine and others, are also antagonised by flumazenil. However, flumazenil does not block the effect of medicines that do not operate via this route. Interaction with other central nervous system depressants has not been observed. Particular caution is necessary when using flumazenil in cases of accidental overdose since the toxic effects of other psychotropic medicinal products (especially tricyclic antidepressants) taken concurrently may increase with the subsidence of the benzodiazepine effect.

No change in the pharmacokinetics of flumazenil has been observed in combination with the benzodiazepines midazolam, flunitrazepam and lormetazepam. Flumazenil does not affect the pharmacokinetics of these benzodiazepines.

4.6 Pregnancy And Lactation

Although studies in animals have not shown evidence of embryo toxicity or teratogenicity, the possible risk to humans caused by flumazenil during pregnancy has not been determined (see section 5.3). Therefore, flumazenil should only be used during pregnancy if the possible benefit to the patient outweighs the potential risks for the foetus.

It is not known whether flumazenil is excreted in human milk. For this reason, breast-feeding should be interrupted for 24 hours when flumazenil is used during lactation.

Emergency use of flumazenil during pregnancy and lactation is not contraindicated.

4.7 Effects On Ability To Drive And Use Machines

Patients who have received flumazenil to reverse the effects of benzodiazepine sedation should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the benzodiazepine may return.

4.8 Undesirable Effects

Immune systems disorders	Allergic reactions.	Common (
Psychiatric disorders	Anxiety*, emotional lability, insomnia, somnolence.	Common (
Nervous system disorders	Vertigo, headache, agitation*, tremor, dry mouth, hyperventilation, speech disorder, paresthesia.	Common (
Convulsions (in patients suffering epilepsy or severe hepatic insufficiency, mainly after long-term treatment with benzodiazepines or multiple medicinal product abuse).	Uncommon (
Ear disorders	Abnormal hearing.	Uncommon (
Eye disorders	Diplopia, strabismus, lacrimation increased.	Common (
Cardiac disorders	Palpitations*.	Common (
Tachycardia or bradycardia, extrasystole.	Uncommon (
Vascular disorders	Flushing, hypotension, orthostatic hypotension, transient increased blood pressure (on awakening).	Common (
Respiratory, thoracic and mediastinal disorders	Dyspnoea, cough, nasal congestion, chest pain.	Uncommon (
Gastrointestinal disorders	Nausea (during anaesthesia).	Very common (
Vomiting (during anaesthesia), hiccup.	Common (
Skin and subcutaneous tissue disorders	Sweating.	Common (
General disorders and administration site conditions	Fatigue, injection site pain.	Common (
Shivering.	Uncommon (

*: after rapid injection, not requiring treatment

In patients treated for long periods with benzodiazepines flumazenil can induce withdrawal symptoms. The symptoms are: tension, agitation, anxiety, confusion, hallucinations, tremor and convulsions.

In general the undesirable effect profile in children does not differ much from that in adults. When using flumazenil for the reversal of conscious sedation abnormal crying, agitation and aggressive reactions have been reported.

4.9 Overdose

Even when administered intravenously at doses of 100 mg, no symptoms of overdose attributable to flumazenil have been observed.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antidotes.

ATC code: V03A B25

Flumazenil, an imidazobenzodiazepine, is a benzodiazepine antagonist which, by competitive interaction, blocks the effects of substances acting via the benzodiazepine-receptor. Neutralisation of paradoxical reactions of benzodiazepines has been reported.

According to experiments in animals, the effects of substances, which are not acting via the benzodiazepine-receptor (like barbiturates, GABA-mimetics and adenosine-receptor agonists), are not blocked by flumazenil. Non-benzodiazepine-agonists, like cyclopyrrolones (zopiclone) and triazolopyridazines, are blocked by flumazenil. The hypnosedative effects of benzodiazepines are blocked rapidly (within 1-2 minutes) after intravenous administration. Depending on the difference in elimination time between agonist and antagonist, the effect can recur after several hours. Flumazenil has possibly a slight agonistic, anticonvulsive effect. Flumazenil caused benzodiazepine withdrawal symptoms, including convulsions, in animals receiving long-term flumazenil treatment.

5.2 Pharmacokinetic Properties

Distribution

Flumazenil is a lipophilic weak base. Flumazenil is bound by approximately 50 % to plasma proteins, from which two thirds are bound to albumin. Flumazenil is extensively distributed across the extra vascular space. During the distribution phase plasma concentration of flumazenil decreases with a half life of 4-15 minutes. The distribution volume under steady-state conditions (Vss) is 0.9 – 1.1 L/kg.

Metabolism

Flumazenil is mainly eliminated through hepatic metabolism. The carboxylic acid metabolite was shown in plasma (in free form) and in urine (in free and conjugated form) to be the most important metabolite.

In pharmacological tests this metabolite has proved to be inactive as a benzodiazepine agonist or antagonist.

Elimination

Almost no unchanged flumazenil is excreted in the urine. This indicates a complete metabolic degradation of the active substance in the body. Radiolabelled medicinal product is completely eliminated within 72 hours, with 90 to 95 % of the radioactivity appearing in the urine and 5 to 10 % in the faeces. Elimination is rapid, as is shown by the short half life of 40 to 80 minutes. The total plasma clearance of flumazenil is 0.8 to 1.0 L/hour/kg and can almost completely be attributed to hepatic metabolism.

The pharmacokinetics of flumazenil are dose-proportional within the therapeutic dose-range and up to 100 mg.

The intake of food during the intravenous infusion of flumazenil results in an increase of 50 % of the clearance probably due to postprandial increase in liver perfusion.

Pharmacokinetics in special patient groups

Elderly

The pharmacokinetics of flumazenil in the elderly are not different from that in young adults.

Patients with impaired hepatic function

In patients with a moderately to severely impaired liver function the half life of flumazenil is increased (increase of 70 – 210 %) and the total clearance is lower (between 57 and 74 %) compared to normal healthy volunteers.

Patients with impaired renal function

The pharmacokinetics of flumazenil are not different in patients with impaired renal function or patients undergoing haemodialysis compared to normal healthy volunteers.

Children

The half life of flumazenil in children over the age of one is a little shorter and varies more than in adults and amounts to an average of 40 minutes (in general varying from 20 to 75 minutes). The clearance and the distribution volume, corrected for body weight, are the same as in adults.

5.3 Preclinical Safety Data

Late prenatal as well as per- and postnatal exposure to flumazenil induced both behavioural alterations and an increase of hippocampal benzodiazepine receptor density in the rat offspring. The effect of these findings is not considered relevant if the product is used for a very short time as instructed.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Disodium edetate

Glacial acetic acid

Sodium chloride

Sodium hydroxide for pH adjustment

Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except for those mentioned in section 6.6.

6.3 Shelf Life

3 years.

Shelf life after first opening:

After first opening the medicinal product should be used immediately.

Shelf life after dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Carton boxes with 5 or 10 ampoules (glass Type I) containing 5 ml solution for injection.

Carton boxes with 5 or 10 ampoules (glass Type I) containing 10 ml solution for injection.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

This medicinal product is for single use only and any unused solution should be discarded.

Please inspect the medicinal product visually. It should only be used if the solution is clear and practically free from particles.

When flumazenil is to be used in infusion, it must be diluted prior to infusion. Flumazenil should only be diluted with sodium chloride 9 mg/ml (0.9 %) solution, dextrose 50 mg/ml (5 %) solution or sodium chloride 4.5 mg/ml (0.45 %) + dextrose 25 mg/ml (2.5 %) solution (10, 20, 50 ml Flumazenil 0.1 mg/ml in 500 ml solution). Compatibility between flumazenil and other solutions for injection has not been established.

Intravenous infusion solutions should be discarded after 24 hours.

7. Marketing Authorisation Holder

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

8. Marketing Authorisation Number(S)

PL 25215/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

17/02/2006

10. Date Of Revision Of The Text

October 2007

Tuesday, 20 March 2012

Prolixin Oral Concentrate

Generic Name: fluphenazine hydrochloride

Dosage Form: Oral Concentrate

Prolixin Description

Prolixin (fluphenazine hydrochloride) is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Prolixin Oral Concentrate (Fluphenazine Hydrochloride Oral Solution) contains 5 mg fluphenazine hydrochloride per mL. Inactive ingredients: alcohol 14%, glycerin, purified water, and sodium benzoate.

Prolixin - Clinical Pharmacology

Prolixin has activity at all levels of the central nervous system as well as on multiple organ systems. The mechanism whereby its therapeutic action is exerted is unknown.

Indications and Usage for Prolixin

Prolixin is indicated in the management of manifestations of psychotic disorders.

Prolixin has not been shown effective in the management of behavioral complications in patients with mental retardation.

Contraindications

Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Prolixin (fluphenazine hydrochloride) is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

Warnings

Tardive Dyskinesia

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with neuroleptic (antipsychotic) drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown.

Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if neuroleptic treatment is withdrawn. Neuroleptic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long- term course of the syndrome is unknown.

Given these considerations, neuroleptics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic neuroleptic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to neuroleptic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatment are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.

(For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PRECAUTIONS, Information for Patients and ADVERSE REACTIONS, Tardive Dyskinesia.)

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

The use of this drug may impair the mental and physical abilities required for driving a car or operating heavy machinery.

Potentiation of the effects of alcohol may occur with the use of this drug.

Since there is no adequate experience in children who have received this drug, safety and efficacy in children have not been established.

Usage in Pregnancy

The safety for the use of this drug during pregnancy has not been established; therefore, the possible hazards should be weighed against the potential benefits when administering this drug to pregnant patients.

Precautions

General

Because of the possibility of cross-sensitivity, fluphenazine hydrochloride should be used cautiously in patients who have developed cholestatic jaundice, dermatoses or other allergic reactions to phenothiazine derivatives.

Psychotic patients on large doses of a phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena. Moreover, it should be remembered that reduced amounts of anesthetics or central nervous system depressants may be necessary.

The effects of atropine may be potentiated in some patients receiving fluphenazine because of added anticholinergic effects.

Fluphenazine hydrochloride should be used cautiously in patients exposed to extreme heat or phosphorus insecticides; in patients with a history of convulsive disorders, since grand mal convulsions have been known to occur; and in patients with special medical disorders, such as mitral insufficiency or other cardiovascular diseases and pheochromocytoma.

The possibility of liver damage, pigmentary retinopathy, lenticular and corneal deposits, and development of irreversible dyskinesia should be remembered when patients are on prolonged therapy.

Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

Information for Patients

Given the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.

Abrupt Withdrawal

In general, phenothiazines do not produce psychic dependence; however, gastritis, nausea and vomiting, dizziness, and tremulousness have been reported following abrupt cessation of high dose therapy. Reports suggest that these symptoms can be reduced if concomitant antiparkinsonian agents are continued for several weeks after phenothiazine is withdrawn.

Facilities should be available for periodic checking of hepatic function, renal function and the blood picture. Renal function of patients on long-term therapy should be monitored; if BUN (blood urea nitrogen) becomes abnormal, treatment should be discontinued.

As with any phenothiazine, the physician should be alert to the possible development of “silent pneumonias” in patients under treatment with fluphenazine hydrochloride.

Adverse Reactions

Central Nervous System

The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see below). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants.

Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually be controlled by administration of antiparkinsonian drugs such as Benztropine Mesylate or intravenous Caffeine and Sodium Benzoate injection, and by subsequent reduction in dosage.

Tardive Dyskinesia

See WARNINGS. The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk and extremities. The severity of the syndrome and the degree of impairment produced vary widely.

The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of neuroleptic drugs should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder. This maneuver is critical, since neuroleptic drugs may mask the signs of the syndrome.

Other CNS Effects

Occurrences of neuroleptic malignant syndrome (NMS) have been reported in patients on neuroleptic therapy (see WARNINGS, Neuroleptic Malignant Syndrome); leukocytosis, elevated CPK, liver function abnormalities, and acute renal failure may also occur with NMS.

Drowsiness or lethargy, if they occur, may necessitate a reduction in dosage; the induction of a catatonic-like state has been known to occur with dosages of fluphenazine far in excess of the recommended amounts. As with other phenothiazine compounds, reactivation or aggravation of psychotic processes may be encountered.

Phenothiazine derivatives have been known to cause, in some patients, restlessness, excitement, or bizarre dreams.

Autonomic Nervous System

Hypertension and fluctuation in blood pressure have been reported with fluphenazine hydrochloride.

Hypotension has rarely presented a problem with fluphenazine. However, patients with pheochromocytoma, cerebral vascular or renal insufficiency, or a severe cardiac reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensive reactions with phenothiazine compounds, and should therefore be observed closely when the drug is administered. If severe hypotension should occur, supportive measures including the use of intravenous vasopressor drugs should be instituted immediately. Levarterenol Bitartrate Injection is the most suitable drug for this purpose; epinephrine should not be used since phenothiazine derivatives have been found to reverse its action, resulting in a further lowering of blood pressure.

Autonomic reactions including nausea and loss of appetite, salivation, polyuria, perspiration, dry mouth, headache, and constipation may occur. Autonomic effects can usually be controlled by reducing or temporarily discontinuing dosage.

In some patients, phenothiazine derivatives have caused blurred vision, glaucoma, bladder paralysis, fecal impaction, paralytic ileus, tachycardia, or nasal congestion.

Metabolic and Endocrine

Weight change, peripheral edema, abnormal lactation, gynecomastia, menstrual irregularities, false results on pregnancy tests, impotency in men and increased libido in women have all been known to occur in some patients on phenothiazine therapy.

Allergic Reactions

Skin disorders such as itching, erythema, urticaria, seborrhea, photosensitivity, eczema and even exfoliative dermatitis have been reported with phenothiazine derivatives. The possibility of anaphylactoid reactions occurring in some patients should be borne in mind.

Hematologic

Routine blood counts are advisable during therapy since blood dyscrasias including leukopenia, agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura, eosinophilia, and pancytopenia have been observed with phenothiazine derivatives. Furthermore, if any soreness of the mouth, gums, or throat, or any symptoms of upper respiratory infection occur and confirmatory leukocyte count indicates cellular depression, therapy should be discontinued and other appropriate measures instituted immediately.

Hepatic

Liver damage as manifested by cholestatic jaundice may be encountered, particularly during the first months of therapy; treatment should be discontinued if this occurs. An increase in cephalin flocculation, sometimes accompanied by alterations in other liver function tests, has been reported in patients receiving fluphenazine hydrochloride who have had no clinical evidence of liver damage.

Others

Sudden, unexpected and unexplained deaths have been reported in hospitalized psychotic patients receiving phenothiazines. Previous brain damage or seizures may be predisposing factors; high doses should be avoided in known seizure patients. Several patients have shown sudden flare-ups of psychotic behavior patterns shortly before death. Autopsy findings have usually revealed acute fulminating pneumonia or pneumonitis, aspiration of gastric contents, or intramyocardial lesions.

Although this is not a general feature of fluphenazine, potentiation of central nervous system depressants (opiates, analgesic, antihistamines, barbiturates, alcohol) may occur.

The following adverse reactions have also occurred with phenothiazine derivatives: systemic lupus erythematosus-like syndrome, hypotension severe enough to cause fatal cardiac arrest, altered electrocardiographic and electroencephalographic tracings, altered cerebrospinal fluid proteins, cerebral edema, asthma, laryngeal edema, and angioneurotic edema; with long-term use — skin pigmentation, and lenticular and corneal opacities.

Prolixin Dosage and Administration

Depending on the severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 to 10.0 mg and should be divided and given at six- to eight-hour intervals.

The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately two to three times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses.

When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1.0 or 5.0 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient's requirements.

For psychotic patients who have been stabilized on a fixed daily dosage of orally administered Prolixin (fluphenazine hydrochloride) dosage forms, conversion to the long-acting injectable Prolixin Decanoate may be indicated [see package insert for Prolixin Decanoate (Fluphenazine Decanoate Injection) for conversion information].

For geriatric patients, the suggested starting dose is 1.0 to 2.5 mg daily, adjusted according to the response of the patient.

When the Oral Concentrate dosage form is to be used, the desired dose (measured by a calibrated device only) should be added to at least 60 mL (2 fl oz) of a suitable diluent just prior to administration to insure palatability and stability. Suggested diluents include tomato or fruit juice, milk, and uncaffeinated soft drinks. The Oral Concentrate should not be mixed with beverages containing caffeine (coffee, cola), tannics (tea), or pectinates (apple juice) because of potential incompatibility.

Prolixin Injection (Fluphenazine Hydrochloride Injection USP) is useful when psychotic patients are unable or unwilling to take oral therapy.

How is Prolixin Supplied

120 mL bottle with a 1 mL safety-cap dropper calibrated at 0.1 mL and in 0.2 mL increments. 5 mg fluphenazine hydrochloride per mL. NDC 0003-0801-10.

Prolixin (Fluphenazine Hydrochloride) is also available as a sterile aqueous solution for intramuscular use, plus tablets and elixir for oral administration. See specific package insert for complete information.

Storage

Store at room temperature; avoid freezing. Protect from light. Keep tightly closed.

Bristol-Myers Squibb Company

Princeton, NJ 08540

1017856A1

P5369-01

Prolixin
fluphenazine hydrochloride solution, concentrate

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0003-0801
Route of Administration	ORAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
fluphenazine hydrochloride (fluphenazine)	Active	5 MILLIGRAM In 1 MILLILITER
alcohol	Inactive
glycerin	Inactive
water	Inactive
sodium benzoate	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0003-0801-10	120 mL (MILLILITER) In 1 BOTTLE, DROPPER	None

Revised: 01/2006Bristol-Myers Squibb Company

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