Janacin may be available in the countries listed below.
Ingredient matches for Janacin
Norfloxacin
Norfloxacin is reported as an ingredient of Janacin in the following countries:
- Hong Kong
International Drug Name Search
Sunday 7 October 2012
Saturday 29 September 2012
Terbinafine Tablets 250mg (Actavis UK Ltd)
Terbinafine 250mg tablets
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1 What Terbinafine tablets are and what they are used for
2 Before you take Terbinafine tablets
3 How to take Terbinafine tablets
4 Possible side effects
5 How to store Terbinafine tablets
6 Further information
What Terbinafine tablets are and what they are used for
Terbinafine belongs to a group of medicines called antifungal drugs. Terbinafine tablets are used for the treatment of fungal infections of:
- the groin area.
- the skin (ringworm).
- toe and finger nails (yellow, opaque and thickened nails).
- the feet (athlete’s foot).
Before you take Terbinafine tablets
Do not take Terbinafine tablets and tell your doctor if you:
- are allergic (hypersensitive) to terbinafine (active substance) or any of the other ingredients of Terbinafine tablets (see section 6).
- suffer from severely impaired liver or kidney function.
Check with your doctor or pharmacist before taking Terbinafine tablets if you:
- have an autoimmune disease e.g. systemic lupus erythematosus.
- suffer from liver disease.
- suffer from psoriasis (scaling skin disease), as it may worsen whilst you are taking Terbinafine tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
- rifampicin (an antibiotic).
- cimetidine (used to treat stomach ulcers).
- tricyclic antidepressants, selective serotonin reuptake inhibitors and monoamine oxidase inhibitors (medicines for depression).
- beta blockers (heart medicines).
- ciclosporin (used to prevent and treat the rejection of transplants and also used in immune diseases).
- tolbutamine (used for diabetes).
- terfenadine (an antihistamine).
- triazolam (a sedative).
- oral contraceptives. Break-through bleeding and irregular periods may occur when Terbinafine tablets are taken with oral contraceptives.
Pregnancy and breast-feeding
If you are breast-feeding, you should not take Terbinafine tablets. If you are pregnant or planning to become pregnant, you should not take Terbinafine tablets unless your doctor decides it is necessary. You must only take Terbinafine tablets according to your doctor’s instructions.
Driving and using machines
Terbinafine tablets may affect your ability to drive or operate machines.
How to take Terbinafine tablets
Always take Terbinafine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets with water.
The usual dose is
Adults (including the elderly):
Duration of treatment depends on the type of fungal infection and the severity of the infection.
- Fungal infection of the groin area, skin and feet: 250mg (one 250mg Terbinafine tablet) once a day for 2-4 weeks. Some cases of athlete’s foot may require treatment for up to 6 weeks.
Complete healing of the infection may not occur until several weeks after completing the course of treatment.
- Fungal infection of the nails:
Fingernails: 250mg (one 250mg Terbinafine tablet) once a day for 6 weeks.
Toenails: 250mg (one 250mg Terbinafine tablet) once a day for 12 weeks. Some cases may require treatment for up to 6 months.
Complete healing of the infection may not occur until several weeks after completing the course of treatment. A healthy nail may take several months to grow back.
- Fungal infection of the groin area, skin and feet: 250mg (one 250mg Terbinafine tablet) once a day for 2-4 weeks. Some cases of athlete’s foot may require treatment for up to 6 weeks.
Children:
Use in children is not recommended.
Impaired kidney function:
If you have impaired kidney function, your doctor may prescribe you a lower dose. Please follow your doctor’s instructions.
If you take more Terbinafine tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include headache, feeling sick, pain in the upper part of the stomach (epigastric pain) and dizziness.
If you forget to take Terbinafine tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.
Possible side effects
Like all medicines, Terbinafine tablets can cause side effects, although not everybody gets them.
Contact your doctor immediately if you develop:
impaired liver function including yellowing of the skin or whites of the eyes (jaundice),
inflammation of the liver (hepatitis) and blocked bile flow (cholestasis). Symptoms include itching, constantly feeling sick, loss of appetite, tiredness, being sick, fatigue, stomach pain, dark urine or pale stools.
an allergic (hypersensitivity) reaction with swelling of the face, lips, tongue or throat,
difficulty breathing or swallowing (anaphylaxis) or skin reactions such as a rash or pale or red irregular raised patches with severe itching (hives).
a skin reaction such as a severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis), sensitivity to sunlight or artificial light (e.g. sun beds).- fever or sore throat.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (they occur in between 1 and 10 per 100 patients who receive treatment)
Headache, feeling of fullness, loss of appetite, indigestion, feeling sick, mild stomach pain, diarrhoea.
Uncommon (they occur in between 1 and 10 per 1,000 patients who receive treatment)
Taste disturbances and loss of taste sense.
Rare (they occur in between 1 to 10 per 10,000 patients who receive treatment)
‘Pins and needles’ or tingling, reduced sense of touch, dizziness, a feeling of general discomfort and illness, tiredness, joint pain (arthralgia), muscle pain (myalgia).
Very rare (they occur in less than 1 per 10,000 patients who receive treatment, including isolated reports)
Changes in the blood count, if you notice increased bruising, nosebleeds, sore throats or infections you
should tell your doctor who may want you to have a blood test. Worsening of psoriasis (scaling skin disease), loss of hair, development or worsening of severe immune disease with skin symptoms (systemic lupus erythematosus), psychiatric symptoms such as depression and anxiety.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Terbinafine tablets
Keep out of the reach and sight of children.
Keep the blister in the outer carton.
Do not use Terbinafine tablets after the expiry date which is stated on the label/carton/bottle. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Terbinafine tablets contain
- The active substance is terbinafine as terbinafine hydrochloride. Each tablet contains 250mg of the active substance.
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose and magnesium stearate.
What Terbinafine tablets look like and contents of the pack
Terbinafine tablets are white, round, flat tablets.
Terbinafine tablets are available in the following pack sizes: 14 and 28.
Marketing Authorisation Holder and Manufacturer:
Actavis
Barnstaple
EX32 8NS
UK
This leaflet was last revised in November 2008.
If you would like a leaflet with larger text, please contact 01271 311257.
Actavis
Barnstaple
EX32 8NS
UK
Friday 28 September 2012
Glynase Pres-Tab
Generic Name: glyburide (Oral route)
GLYE-bure-ide
Commonly used brand name(s)
In the U.S.
- Diabeta
- Glycron
- Glynase Pres-Tab
- Micronase
In Canada
- Euglucon
Available Dosage Forms:
- Tablet
Therapeutic Class: Hypoglycemic
Chemical Class: 2nd Generation Sulfonylurea
Uses For Glynase Pres-Tab
Glyburide is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.
Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Glyburide belongs to a class of medicines called sulfonylureas. It causes your pancreas to release more insulin into the blood stream. This medicine may be used alone or with another oral medicine such as metformin.
This medicine is available only with your doctor's prescription.
Before Using Glynase Pres-Tab
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
Appropriate studies have not been performed on the relationship of age to the effects of glyburide in the pediatric population. 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 glyburide in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment in the dose for patients receiving glyburide.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bosentan
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acarbose
- Alatrofloxacin
- Balofloxacin
- Ciprofloxacin
- Clinafloxacin
- Disopyramide
- Enoxacin
- Fleroxacin
- Flumequine
- Gatifloxacin
- Gemifloxacin
- Grepafloxacin
- Levofloxacin
- Lomefloxacin
- Moxifloxacin
- Norfloxacin
- Ofloxacin
- Pefloxacin
- Prulifloxacin
- Rufloxacin
- Sparfloxacin
- Temafloxacin
- Tosufloxacin
- Trovafloxacin Mesylate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Aceclofenac
- Acemetacin
- Alclofenac
- Alprenolol
- Apazone
- Aspirin
- Atenolol
- Benoxaprofen
- Betaxolol
- Bevantolol
- Bisoprolol
- Bitter Melon
- Bromfenac
- Bucindolol
- Bufexamac
- Carprofen
- Carteolol
- Carvedilol
- Celiprolol
- Clarithromycin
- Clometacin
- Clonixin
- Clorgyline
- Colesevelam
- Cyclosporine
- Dexketoprofen
- Diclofenac
- Diflunisal
- Dilevalol
- Dipyrone
- Droxicam
- Esmolol
- Etodolac
- Etofenamate
- Felbinac
- Fenbufen
- Fenoprofen
- Fentiazac
- Fenugreek
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
- Gemfibrozil
- Glucomannan
- Ibuprofen
- Indomethacin
- Indoprofen
- Iproniazid
- Isocarboxazid
- Isoxicam
- Ketoprofen
- Ketorolac
- Labetalol
- Levobunolol
- Lornoxicam
- Meclofenamate
- Mefenamic Acid
- Meloxicam
- Mepindolol
- Metipranolol
- Metoprolol
- Moclobemide
- Nabumetone
- Nadolol
- Naproxen
- Nebivolol
- Nialamide
- Niflumic Acid
- Nimesulide
- Oxaprozin
- Oxprenolol
- Oxyphenbutazone
- Pargyline
- Penbutolol
- Phenelzine
- Phenylbutazone
- Pindolol
- Pirazolac
- Piroxicam
- Pirprofen
- Procarbazine
- Propranolol
- Propyphenazone
- Proquazone
- Psyllium
- Rifampin
- Rifapentine
- Selegiline
- Sotalol
- Sulfamethoxazole
- Sulindac
- Suprofen
- Talinolol
- Tenidap
- Tenoxicam
- Tertatolol
- Tiaprofenic Acid
- Timolol
- Tolmetin
- Toloxatone
- Tranylcypromine
- Voriconazole
- Warfarin
- Zomepirac
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol intoxication or
- Underactive adrenal glands or
- Underactive pituitary gland or
- Undernourished condition or
- Weakened physical condition or
- Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking glyburide.
- Diabetic ketoacidosis (ketones in the blood) or
- Type I diabetes—Should not be used in patients with these conditions.
- Fever or
- Infection or
- Surgery or
- Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (a blood disorder) in patients with this condition.
- Heart disease—Use with caution. May make this condition worse.
- Kidney disease or
- Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
Proper Use of glyburide
This section provides information on the proper use of a number of products that contain glyburide. It may not be specific to Glynase Pres-Tab. Please read with care.
Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
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 type 2 diabetes:
- For oral dosage form (tablets):
- Adults—At first, 2.5 to 5 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (micronized tablets):
- Adults—At first, 1.5 to 3 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. The dose is usually not more than 12 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
Missed Dose
If you miss a dose of this medicine, take 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. Do not double doses.
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 Glynase Pres-Tab
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
It is very important to follow carefully any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
- Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
- In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.
Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, including a heart attack.
Too much glyburide can cause low blood sugar (hypoglycemia) when it is used under certain conditions. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly and call someone on your health care team right away when you need advice.
Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.
If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.
Do not take this medicine if you are also using bosentan (Tracleer®). Also, make sure your doctor knows about all other medicines you are using for diabetes, including insulin.
Glynase Pres-Tab 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:
Less common
- Difficulty with swallowing
- dizziness
- fast heartbeat
- hives
- itching
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shortness of breath
- skin rash
- tightness in the chest
- unusual tiredness or weakness
- wheezing
- Abdominal or stomach pain
- chills
- clay-colored stools
- dark urine
- diarrhea
- fever
- headache
- light-colored stools
- loss of appetite
- nausea and vomiting
- rash
- unpleasant breath odor
- upper right abdominal pain
- vomiting of blood
- yellow eyes and skin
- Agitation
- back, leg, or stomach pains
- bleeding gums
- blood in the urine or stools
- bloody, black, or tarry stools
- blurred vision
- change in near or distance vision
- chest pain
- coma
- confusion
- convulsions
- cough or hoarseness
- decreased urine output
- depression
- difficulty in focusing eyes
- difficulty with breathing
- fast or irregular heartbeat
- fluid-filled skin blisters
- general body swelling
- high fever
- hostility
- increased thirst
- irritability
- itching of the skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lethargy
- lower back or side pain
- muscle pain or cramps
- muscle twitching
- nosebleeds
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- seizures
- sensitivity to the sun
- skin thinness
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stupor
- swelling of the face, ankles, or hands
- swollen or painful glands
- unusual bleeding or bruising
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Anxiety
- cold sweats
- cool, pale skin
- increased hunger
- nervousness
- nightmares
- shakiness
- slurred speech
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
- Indigestion
- passing of gas
- Difficulty with moving
- itching
- joint pain
- redness or other discoloration of the skin
- severe sunburn
- swollen joints
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: Glynase Pres-Tab side effects (in more detail)
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More Glynase Pres-Tab resources
- Glynase Pres-Tab Side Effects (in more detail)
- Glynase Pres-Tab Use in Pregnancy & Breastfeeding
- Drug Images
- Glynase Pres-Tab Drug Interactions
- Glynase Pres-Tab Support Group
- 0 Reviews for Glynase Pres-Tab - Add your own review/rating
Compare Glynase Pres-Tab with other medications
- Diabetes, Type 2
Thursday 27 September 2012
Excedrin
Pronunciation: ah-seet-ah-MIN-oh-fen /ka-FEEN
Generic Name: Acetaminophen/Caffeine
Brand Name: Excedrin
Excedrin is used for:
Relieving fever and minor aches and pains caused by headache, toothache, colds, sinus swelling, muscle aches, menstrual cramps, and arthritis. It may also be used for other conditions as determined by your doctor.
Excedrin is an analgesic and antipyretic combination. It works by raising the pain threshold and acting on the heat control center in the brain.
Do NOT use Excedrin if:
- you are allergic to any ingredient in Excedrin
Contact your doctor or health care provider right away if any of these apply to you.
Before using Excedrin:
Some medical conditions may interact with Excedrin. Tell your health care provider 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 anxiety or sleeplessness, liver disease, viral hepatitis, severe heart disease, or kidney problems
Some MEDICINES MAY INTERACT with Excedrin. Tell your health care provider if you are taking any of the following medicines, especially any of the following:
- Isoniazid or quinolones (eg, ciprofloxacin) because side effects of Excedrin may be increased
- Oral blood thinners (eg, warfarin) because side effects, including risk of bleeding, may be increased by Excedrin
- Theophyllines (eg, aminophylline) because the risk of side effects may be increased by Excedrin
This may not be a complete list of all interactions that may occur. Ask your health care provider if Excedrin 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 Excedrin:
Use Excedrin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Excedrin may be taken with or without food.
- If you miss a dose of Excedrin and you are using it regularly, 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 Excedrin.
Important safety information:
- Excedrin contains acetaminophen. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your doctor or pharmacist if you have any questions about which medicines contain acetaminophen.
- Acetaminophen may cause liver damage. If you drink 3 or more alcoholic drinks every day, do not take Excedrin without first discussing it with your doctor. Alcohol use combined with acetaminophen may increase your risk for liver damage.
- Adults should not take more than a total of 4 grams (4,000 mg) of acetaminophen per day (3 grams [3,000 mg] if you have liver disease). Maximum dosage in children varies according to weight.
- Avoid large amounts of caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate.
- Stop using Excedrin and ask your doctor if pain gets worse or lasts more than 10 days, if fever gets worse or lasts more than 3 days, or if new symptoms occur or redness or swelling is present.
- Excedrin may cause false results with some in-home test kits for blood cholesterol. Check with your doctor or pharmacist if you are taking Excedrin and need to check your blood cholesterol at home.
- PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Excedrin during pregnancy. Excedrin is excreted in breast milk. If you are or will be breast-feeding while you are using Excedrin, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of Excedrin:
All medicines may cause side effects, but many people have no, or minor, side effects. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; unusual tiredness; 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: Excedrin 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 dark urine; excessive sweating; extreme fatigue; irregular heartbeat; low blood pressure; stomach pain; vomiting; yellowing of the skin or eyes.
Proper storage of Excedrin:
Store Excedrin at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Excedrin out of the reach of children and away from pets.
General information:
- If you have any questions about Excedrin, please talk with your doctor, pharmacist, or other health care provider.
- Excedrin 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 Excedrin. 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.
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Monday 24 September 2012
HYDREX SURGICAL SCRUB CHLORHEXIDINE 4% W / V SKIN CLEANSER
1. Name Of The Medicinal Product
HYDREX SURGICAL SCRUB CHLORHEXIDINE 4% W/V SKIN CLEANSER
2. Qualitative And Quantitative Composition
Chlorhexidine Gluconate 4% w/v
3. Pharmaceutical Form
Solution.
4. Clinical Particulars
4.1 Therapeutic Indications
For use as an antiseptic hand wash, a pre-operative hand scrub and a pre-operative skin preparation to surgery.
4.2 Posology And Method Of Administration
Antiseptic Hand Wash - wet the hands and forearms, apply 5 ml of skin cleanser and wash for one minute. Rinse thoroughly and dry.
Pre-operative Surgical Scrub - wet hands and forearms, apply 5 ml of skin cleanser and wash for one minute, cleaning the finger nails with a brush. Rinse and repeat the procedure using a further 5 ml of skin cleanser and wash for 2 minutes. Rinse thoroughly and dry.
Pre-operative Skin Preparation - the patient should wash his whole body with 25 ml of the cleanser on at least two occasions, usually the day before and on the day of the operation.
4.3 Contraindications
Avoid contact with eyes, middle ear, brain and meninges.
4.4 Special Warnings And Precautions For Use
For external use only.
Keep out of the reach and sight of children.
Do not use in body cavities.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
No special precautions need to be taken when used in pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Some users may be hypersensitive to chlorhexidine gluconate or amine oxide, particularly on repeated use.
4.9 Overdose
Chlorhexidine is poorly absorbed. If swallowed treat with gastric lavage. Employ supportive measures as appropriate.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Chlorhexidine is a bisbiguanide disinfectant which is active against a wide range of Gram-positive and Gram-negative vegetative bacteria. It is also active against some viruses and fungi. It is most active at neutral or slightly acid pH
5.2 Pharmacokinetic Properties
Percutaneous absorption of chlorhexidine gluconate is negligible and leads to clinically insignificant plasma concentrations.
5.3 Preclinical Safety Data
Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, carcinogenic potential and toxicity to reproduction.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Ponceau 4R
Dialkylamine Oxide
Glycerine
Industrial Methylated Spirit
Cellosize
Purified Water
Perfume
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
Hydrex Surgical Scrub is packaged in HDPE containers in the following sizes: 100 ml, 250 ml, 500 ml, 2000 ml and 5000 ml.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.
8. Marketing Authorisation Number(S)
PL 04509/0020
9. Date Of First Authorisation/Renewal Of The Authorisation
1 March 2003
10. Date Of Revision Of The Text
June 2003 / August 2006
Sunday 23 September 2012
Myocet
1. Name Of The Medicinal Product
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion
2. Qualitative And Quantitative Composition
Liposome–encapsulated doxorubicin–citrate complex corresponding to 50 mg doxorubicin hydrochloride (HCl).
Excipient(s): The reconstituted medicinal product contains approximately 108 mg sodium for a 50 mg doxorubicin HCl dose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Myocet is supplied as a three-vial system:
Myocet doxorubicin HCl is a red lyophilised powder.
Myocet liposomes is a white to off-white, opaque and homogeneous dispersion.
Myocet buffer is a clear colourless solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Myocet, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in adult women.
4.2 Posology And Method Of Administration
The use of Myocet should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy.
Posology
When Myocet is administered in combination with cyclophosphamide (600 mg/m2) the initial recommended dose of Myocet is 602 every three weeks.
Elderly patients
Safety and efficacy of Myocet have been assessed in 61 patients with metastatic breast cancer, age 65 and over. Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet in this population was comparable to that observed in patients less than 65 years old.
Patients with impaired hepatic function
As metabolism and excretion of doxorubicin occurs primarily by the hepatobiliary route, evaluation of hepatobiliary function should be performed before and during therapy with Myocet.
Based on limited data in patients with liver metastases, it is recommended that the initial dose of Myocet is reduced in accordance with the following table
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If possible, Myocet should be avoided in patients with bilirubin> 50 μmol/l as the recommendation is based mainly on extrapolations.
For dose reductions due to other toxicity, see section 4.4.
Patients with impaired renal function
Doxorubicin is metabolised largely by the liver and excreted in the bile. Therefore dose modification is not required for patients with renal function impairment.
Paediatric population
The safety and efficacy of Myocet in children aged up to 17 years has not been established. No data are available.
Method of administration
Myocet must be reconstituted and further diluted prior to administration (see section 6.6). A final concentration of between 0.4 mg/ml to 1.2 mg/ml doxorubicin HCl, is required. Myocet is administered by intravenous infusion over a period of 1 hour.
Myocet must not be administered by the intramuscular or subcutaneous route or as a bolus injection.
4.3 Contraindications
Hypersensitivity to the active substance, to the pre-admixtures or to any of the excipients.
4.4 Special Warnings And Precautions For Use
Myelosuppression
Therapy with Myocet causes myelosuppression. Myocet should not be administered to individuals with absolute neutrophil counts (ANC) lower than 1,500 cells/μl or platelets less than 100,000/μl prior to the next cycle. Careful haematological monitoring (including white blood cell and platelet count, and haemoglobin) should be performed during therapy with Myocet.
Haematological as well as other toxicity may require dose reductions or delays. The following dosage modifications are recommended during therapy and should be performed in parallel for both Myocet and cyclophosphamide. Dosing subsequent to a dose reduction is left to the discretion of the physician in charge of the patient.
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If myelotoxicity delays treatment to greater than 35 days after the first dose of the previous cycle, then consideration should be given to stopping treatment.
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For dose reduction of Myocet due to liver function impairment, see section 4.2.
Cardiac toxicity
Doxorubicin and other anthracyclines can cause cardiotoxicity. The risk of toxicity rises with increasing cumulative doses of those medicinal products and is higher in individuals with a history of cardiomyopathy, or mediastinal irradiation or pre-existing cardiac disease.
Analyses of cardiotoxicity in clinical trials have shown a statistically significant reduction in cardiac events in patients treated with Myocet compared to patients treated with conventional doxorubicin at the same dose in mg. The full clinical relevance of these findings is currently unclear.
In a phase III study in combination with cyclophosphamide (CPA) comparing Myocet (60 mg/m2) + CPA (600 mg/m2) versus doxorubicin (60 mg/m2) + CPA (600 mg/m2), 6% versus 21% of patients, respectively, developed a significant decrease in left ventricular ejection fraction (LVEF). In a phase III study comparing single-agent Myocet (75 mg/m2) versus single-agent doxorubicin (75 mg/m2), 12% versus 27% of patients, respectively developed a significant decrease in LVEF. The corresponding figures for congestive heart failure (CHF), which was less accurately assessed, were 0% for Myocet + CPA versus 3% for doxorubicin + CPA, and 2% for Myocet versus 8% for doxorubicin. The median lifetime cumulative dose of Myocet in combination with CPA to a cardiac event was> 1260 mg/m2, compared to 480 mg/m2 for doxorubicin combination with CPA.
There is no experience with Myocet in patients with a history of cardiovascular disease, e.g. myocardial infarction within 6 months prior to treatment. Thus, caution should be exercised in patients with impaired cardiac function. The cardiac function of the patients treated concomitantly with Myocet and trastuzumab must be appropriately monitored as described below.
The total dose of Myocet should also take into account any previous, or concomitant, therapy with other cardiotoxic compounds, including anthracyclines and anthraquinones.
Before initiation of Myocet therapy a measurement of left ventricular ejection fraction (LVEF) is routinely recommended, either by Multiple Gated Arteriography (MUGA) or by echocardiography. These methods should also be applied routinely during Myocet treatment. The evaluation of left ventricular function is considered mandatory before each additional administration of Myocet once a patient exceeds a lifetime cumulative anthracycline dose of 550 mg/m2 or whenever cardiomyopathy is suspected. If LVEF has decreased substantially from baseline e.g. by> 20 points to a final value> 50% or by> 10 points to a final value of < 50%, the benefit of continued therapy must be carefully evaluated against the risk of producing irreversible cardiac damage. However, the most definitive test for anthracycline myocardial injury, i.e., endomyocardial biopsy, should be considered.
All patients receiving Myocet should also routinely undergo ECG monitoring. Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the cessation of Myocet therapy. However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Congestive heart failure due to cardiomyopathy may occur suddenly, and may also be encountered after discontinuation of therapy.
Injection site reactions
Myocet should be considered an irritant and precautions should be taken to avoid extravasation. If extravasation occurs, the infusion should be immediately terminated. Ice may be applied to the affected area for approximately 30 minutes. Subsequently, the Myocet infusion should be restarted in a different vein than that in which the extravasation has occurred. Note that Myocet may be administered through a central or peripheral vein. In the clinical program, there were nine cases of accidental extravasation of Myocet, none of which were associated with severe skin damage, ulceration or necrosis.
Infusion associated reactions
When infused rapidly acute reactions associated with liposomal infusions have been reported. Reported symptoms have included flushing, dyspnoea, fever, facial swelling, headache, back pain, chills, tightness in the chest and throat, and/or hypotension. These acute phenomena may be avoided by using a 1-hour infusion time.
Other
For precautions regarding the use of Myocet with other medicinal products, see section 4.5.
Efficacy and safety of Myocet in the adjuvant treatment of breast cancer have not been determined. The importance of apparent differences in tissue distribution between Myocet and conventional doxorubicin has not been elucidated with respect to long-term antitumour efficacy.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Specific medicinal product compatibility studies have not been performed with Myocet. Myocet is likely to interact with substances that are known to interact with conventional doxorubicin. Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit P-glycoprotein (P
4.6 Pregnancy And Lactation
Women of childbearing potential
Women of childbearing potential should use an effective contraceptive during treatment with Myocet and up to 6 months following discontinuation of therapy.
Pregnancy
Due to the known cytotoxic, mutagenic and embryotoxic properties of doxorubicin, Myocet should not be used during pregnancy unless clearly necessary.
Breastfeeding
Women receiving Myocet should not breastfeed.
4.7 Effects On Ability To Drive And Use Machines
Myocet has been reported to cause dizziness. Patients who suffer from this should avoid driving and operating machinery.
4.8 Undesirable Effects
During clinical trials, the most frequently reported adverse reactions were nausea/vomiting (73%), leucopoenia (70%), alopecia (66%), neutropenia (46%), asthenia/fatigue (46%), stomatitis/mucositis (42%), thrombocytopenia (31%) and anaemia (30%).
The following adverse reactions have been reported with Myocet during clinical studies and post marketing experience. Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common
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4.9 Overdose
Acute overdose with Myocet will worsen toxic side effects. Treatment of acute overdose should focus on supportive care for expected toxicity and may include hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmaco-therapeutic group: Antineoplastic agents, anthracyclines and related substances, ATC code: L01DB01
The active substance in Myocet is doxorubicin HCl. Doxorubicin may exert its antitumour and toxic effects by a number of mechanisms including inhibition of topoisomerase II, intercalation with DNA and RNA polymerases, free radical formation and membrane binding. Liposomal-encapsulated compared with conventional doxorubicin was not found more active in doxorubicin resistant cell lines in vitro. In animals, liposome-encapsulated doxorubicin reduced the distribution to heart and gastrointestinal mucosa compared with conventional doxorubicin, while antitumoural efficacy in experimental tumours was maintained.
Myocet (60 mg/m2) + CPA (600 mg/m2) was compared with conventional doxorubicin + CPA (at the same doses) and Myocet (75 mg/m2) + CPA (600 mg/m2) was compared to epirubicin + CPA (at the same doses). In a third trial, Myocet (75 mg/m2) monotherapy was compared with conventional doxorubicin monotherapy (at the same dose). Findings regarding response rate and progression-free survival are provided in Table 3.
Table 3
Antitumour efficacy summary for combination and single-agent studies
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Abbreviations: PFS, progression-free survival; Dox, doxorubicin; Epi, epirubicin; Relative Risk, comparator taken as reference; Risk Ratio, Myocet taken as reference
a Secondary endpoint
5.2 Pharmacokinetic Properties
The plasma pharmacokinetics for total doxorubicin in patients receiving Myocet shows a high degree of inter-patient variability. In general however, the plasma levels of total doxorubicin are substantially higher with Myocet than with conventional doxorubicin, while the data indicate that peak plasma levels of free (not liposome-encapsulated) doxorubicin are lower with Myocet than with conventional doxorubicin. Available pharmacokinetic data preclude conclusions regarding the relationship between plasma levels of total/free doxorubicin and its influence on the efficacy/safety of Myocet. The clearance of total doxorubicin was 5.1 ± 4.8 l/h and the volume of distribution at steady state (Vd) was 56.6 ± 61.5 l whereas after conventional doxorubicin, clearance and Vd were 46.7 ± 9.6 l/h and 1,451 ± 258 l, respectively. The major circulating metabolite of doxorubicin, doxorubicinol, is formed via aldo-keto-reductase. The peak levels of doxorubicinol occur in the plasma later with Myocet than with conventional doxorubicin.
The pharmacokinetics of Myocet have not been specifically studied in patients with renal insufficiency. Doxorubicin is known to be eliminated in large part by the liver. A dose reduction of Myocet has been shown to be appropriate in patients with impaired hepatic function (see section 4.2 for dosage recommendations).
Substances that inhibit P-glycoprotein (P-Gp) have been shown to alter the disposition of doxorubicin and doxorubicinol (see also section 4.5).
5.3 Preclinical Safety Data
Studies of genotoxicity, carcinogenicity and reproductive toxicity of Myocet have not been performed but doxorubicin is known to be both mutagenic and carcinogenic and may cause toxicity to reproduction.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Myocet doxorubicin HCl
• lactose
Myocet liposomes
• egg phosphatidylcholine
• cholesterol
• citric acid
• sodium hydroxide
• water for injections
Myocet buffer
• sodium carbonate
• water for injections
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf Life
18 months
Chemical and physical in-use stability after reconstitution has been demonstrated for up to 8 hours at 25°C, and for up to 5 days at 2°C – 8°C.
From a microbiological point of view, the medicinal 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 long
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