Kentacef may be available in the countries listed below.
Cefatrizine comp. with propylene glycole (a derivative of Cefatrizine) is reported as an ingredient of Kentacef in the following countries:
International Drug Name Search
Apo-Trifluoperazine may be available in the countries listed below.
Trifluoperazine is reported as an ingredient of Apo-Trifluoperazine in the following countries:
Trifluoperazine hydrochloride (a derivative of Trifluoperazine) is reported as an ingredient of Apo-Trifluoperazine in the following countries:
International Drug Name Search
Generic Name: metronidazole vaginal (MET roe NYE da zole)
Brand Names: MetroGel-Vaginal, Vandazole
Metronidazole is an antibiotic that fights bacteria in the body.
Metronidazole vaginal is used to treat vaginal infections caused by bacteria.
Metronidazole vaginal may also be used for other purposes not listed in this medication guide.
Do not use metronidazole vaginal if you have ever had an allergic reaction to it.
Before using metronidazole vaginal, tell your doctor if you have liver disease, a seizure disorder, problems with circulation (such as Raynaud's syndrome), or if you have taken disulfiram (Antabuse) within the past 14 days.
Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.
Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.
Do not use metronidazole vaginal if you have ever had an allergic reaction to it.
Before using metronidazole vaginal, tell your doctor if you are allergic to any drugs, or if you have:
liver disease;
a seizure disorder; or
problems with circulation (such as Raynaud's syndrome).
If you have any of these conditions, you may need a dose adjustment or special tests to safely use metronidazole vaginal.
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.
Insert the cream into your vagina using the applicator as directed.
Your medication may come with disposable applicators. Use each applicator for only 1 day and then throw it away. If you use the medication twice daily, wash and rinse the applicator after your morning dose and use it again for your evening dose. Then throw it away and use a new applicator the next day.
Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.
You may need to use a sanitary napkin during treatment, but do not use a tampon.
Metronidazole vaginal can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using this medication.
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.
An overdose of metronidazole applied in the vagina is not expected to produce life-threatening symptoms.
Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.
Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.
Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.
Rare but serious side effects may include:
seizure (convulsions); or
numbness, burning, pain, or tingly feeling in your hands or feet.
Less serious side effects may include:
mild burning or stinging when the medication is applied;
pelvic pain or cramps;
loss of appetite, constipation, upset stomach, vomiting;
dizziness, sleep problems (insomnia);
runny nose;
urinating more than usual;
acne, increased sweating; or
breast discharge or enlargement.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor if you have taken disulfiram (Antabuse) within the past 14 days. Also tell your doctor if you are using:
cimetidine (Tagamet);
lithium (Eskalith, Lithobid, Lithonate); or
a blood thinner such as warfarin (Coumadin).
There may be other drugs that can interact with metronidazole vaginal. 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.
See also: Vandazole side effects (in more detail)
Blefamide may be available in the countries listed below.
Sulfacetamide sodium salt (a derivative of Sulfacetamide) is reported as an ingredient of Blefamide in the following countries:
International Drug Name Search
Fematrix
40
transdermal patch
Please read this leaflet before you take your medicine, and keep it safe because you may want to read it again. If you have any questions or are not sure about anything, ask your doctor or a pharmacist.
Fematrix belongs to a group of medicines known as Hormone Replacement Therapy or HRT.
Fematrix 40 is a self-adhesive transdermal patch containing 1.25 mg of estradiol. Each patch delivers approximately 40 micrograms of estradiol in 24 hours. The patch is rectangular in shape with rounded corners and comes in a sachet. Each box contains 8 sachets, each containing one patch.
The estradiol in Fematrix 40 is made from plant materials. The patch also contains: diethyltoluamide, acrylic adhesive (Dow Corning MG-0560) and acrylic thickener (Acrysol 33).
The marketing authorisation holder is
Fematrix 40 patches are manufactured by
Fematrix is an estrogen only HRT for peri and postmenopausal women, used to treat the symptoms of the menopause (change of life). These symptoms vary from woman to woman, and can include hot flushes, night sweats, sleeping difficulties, dryness of the vagina and urinary problems.
Fematrix is suitable for peri and postmenopausal women who may or may not still be having their periods and women switching from standard (cyclic or sequential) HRT on the advice of their doctor.
Fematrix 40 is not a contraceptive. If you need contraception you should use a non-hormonal method.
Fematrix contains estradiol. This hormone replaces the estradiol you produce in your ovaries from puberty until the menopause. Your body's natural estrogen is also called estradiol.
Estradiol replaces your body's natural estrogen, controlling your menopausal symptoms. Women who still have a womb should normally take some form of progesterone (a progestagen), because estrogen alone can cause problems due to a build up of the womb lining. When needed, a progestagen such as dydrogesterone 10 mg should normally be added to Fematrix for 12 - 14 days each month. Taking dydrogesterone for part of each monthly cycle (with Fematrix) helps prevent a build up of the womb lining by inducing a regular monthly bleed (see ‘endometrial cancer’).
Before you take your medicine, you should make sure that it is safe for you to do so. If you answer yes to any of the following questions, do not take Fematrix:
If any of the following apply to you, you should check with your doctor before you start taking Fematrix:
Before you start taking HRT, your doctor should ask about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.
Once you’ve started on HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.
Be sure to:
If you have (or had in the past, or are at risk of getting) any of the following conditions, your doctor may want to see you more often for check-ups:
As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.
Effects on your heart or circulation
Heart disease
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have had heart disease, talk to your doctor to see if you should take HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing conjugated estrogen plus the progestagen MPA), have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.
If you get:
Stroke
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:
If you are worried about any of these things,
or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.
Compare
Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT, the figure would be 4 in 1000.
Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.
For women in their 60s who are taking HRT, the figure would be 15 in 1000.
If you get:
Blood clots
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.
These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous thromboembolism, or VTE.
You are more likely to get a blood clot:
If any of these things apply to you,
talk to your doctor to see if you should take HRT.
Compare
Looking at women in their 50s who are not taking HRT — on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.
For women in their 50s who are taking HRT, the figure would be 7 in 1000.
Looking at women in their 60s who are not taking HRT — on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.
For women in their 60s who are taking HRT, the figure would be 17 in 1000.
If you get:
If you’re going to have surgery,
make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.
Effects on your risk of developing cancer
Breast cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT. Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestagen HRT is higher than for estrogen-only HRT (but estrogen plus progestagen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ below).
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping.
Your risk of breast cancer is also higher:
Compare
Looking at women aged 50 who are not taking HRT — on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.
For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be 33 and 34 in 1000 (ie an extra 1-2 cases).
If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (an extra 5 cases).
For women who start taking estrogen plus progestagen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (ie an extra 6 cases).
If they take estrogen plus progestagen HRT for 10 years, the figure will be 51 in 1000 (ie an extra 19 cases).
If you notice
any changes in your breast, such as:
Endometrial cancer (cancer of the lining of the womb)
Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestagen as well as the estrogen helps to lower the extra risk.
If you still have your womb, your doctor may prescribe a progestagen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product.
If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestagen.
If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestagen as well as an estrogen.
Your product, Fematrix is an estrogen-only product
Compare
Looking at women who still have a uterus and who are not taking HRT – on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.
For women who take estrogen-only HRT the number will be 2 to 12 times higher, depending on the dose and how long you take it.
The addition of a progestagen to estrogen-only HRT substantially reduces the risk of endometrial cancer.
If you get
breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that taking estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
If you are taking anticonvulsants (eg. phenobarbital, phenytoin, carbamazepine), anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz), ritonavir, nelfinavir or herbal preparations containing St John’s wort (Hypericum perforatum), talk to your doctor or a pharmacist. These other medicines may stop Fematrix working properly.
Generally your doctor will start you on Fematrix 40. Your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms. The dose can then be increased, by your doctor, if necessary. One Fematrix patch should be applied twice weekly on a continuous basis. Each patch should be removed after 3 to 4 days and replaced with a new patch applied to a slightly different site. Patches should be applied to clean, dry and intact areas of skin below the waist on the lower back or buttocks. Fematrix should not be applied on or near the breasts.
In women with a uterus, a progestagen such as dydrogesterone 10 mg should normally be added to Fematrix for 12-14 days each month.
If you are having regular periods you should apply the first patch within five days of the start of bleeding. If you are not having regular periods and are not taking any other HRT preparations, or you are switching from a combined continuous HRT product, you can apply the patch on any convenient day.
If you are currently using a 'cyclic’ or ‘sequential' HRT preparation (which involves taking an estrogen tablet or patch for part of the month, followed by both estrogen and progestagen tablet or patch for up to 14 days) you should apply the first Fematrix patch the day after you finish the pack i.e. at the end of the progestagen phase.
If you forget to change your patch at the right time you should change it as soon as possible. But remember to follow your normal schedule for sticking on the next one. If you normally change your patch on a Monday and Thursday and you forget to change your Monday patch until Tuesday or Wednesday, then you must still change your next patch on Thursday. If a patch is missed or applied late, it is more likely that you will have irregular bleeds.
If your patch comes off before the day when you regularly change it and you cannot stick it back on, put a new patch on. You should then change this patch on your normal change day and carry on as usual.
You should stick the patch on dry, unbroken areas of your skin below the waistline such as your lower back or buttocks. Do not put the patch on or near the breasts.
When you have chosen the area where you want to put the patch, make sure the area is not red or irritated. Before you apply the patch, wash and dry the area where you are going to put it. Do not put any powder, oil or cream on your skin before you stick the patch on as this might prevent it from sticking properly.
Take one sachet out of the box and carefully tear it open. Take out the patch, take off the smaller piece of shiny backing covering the sticky side (see Figure 1) and put the patch on the area of skin you have chosen.
Gently peel off the rest of the backing and flatten the surface of the patch with your other hand as you pull (Figure 2). This should give a smooth and wrinkle-free surface.
Pressing it for a few seconds will make it stick firmly (Figure 3). As long as you have stuck the patch on correctly, you can bathe or shower with little risk of it coming off.
When the time comes to change the patch, take off the old one. Place your new patch on a fresh area of skin.
After use, fold the Fematrix patch in two with the adhesive surface to the inside and dispose with the normal household waste. Do not flush the patch down the toilet.
It is almost impossible to get an overdose of estradiol from Fematrix 40, but if you think you have, take off the patch(es) and tell a doctor.
Some women may have side effects when taking Fematrix, but they usually disappear after the first few months. In the list of possible side effects given below, we give an indication of how likely it is that you will get these side effects: ‘common’ means less than one in ten patients may experience this side effect; ‘uncommon’ means less than one in a hundred; ‘rarely’ means less than one in a thousand; and ‘very rarely’ means less than one in ten thousand patients.
Some patients may experience a mild and brief local rash at the site of application with or without itching; this usually disappears rapidly on removal of the patch.
Tumours related to estrogens (both benign and malignant) have been associated with HRT (see ‘Effect on your risk of developing cancer’ above).
Dementia: HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.
Usually, side effects are not common and do not usually last long. If any of these side effects do last for a long time or you notice any other side effects and you are worried about them, please contact your doctor or a pharmacist for advice.
You should stop taking Fematrix 40 and contact your doctor if:
Do not store above 25°C. Store in the original package. Do not use the patches after the expiry date shown on the pack. Store all medicines where children cannot see or reach them.
Take any unused patches back to a pharmacy (chemist).
This leaflet was revised in January 2006.
Remember
This medicine is for you. Please do not offer it to your family and friends, even if they have the same symptoms as you.
registered trade mark
Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory tract infections, or allergies. It may also be used for other conditions as determined by your doctor.
Phenylephrine/Pyrilamine/Dihydrocodeine Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Phenylephrine/Pyrilamine/Dihydrocodeine Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Phenylephrine/Pyrilamine/Dihydrocodeine Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine/Pyrilamine/Dihydrocodeine Liquid 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.
Use Phenylephrine/Pyrilamine/Dihydrocodeine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Phenylephrine/Pyrilamine/Dihydrocodeine Liquid.
When used for long periods of time or at high doses, Phenylephrine/Pyrilamine/Dihydrocodeine Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Phenylephrine/Pyrilamine/Dihydrocodeine Liquid stops working well. Do not take more than prescribed.
Some people who use Phenylephrine/Pyrilamine/Dihydrocodeine Liquid for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.
If you suddenly stop taking Phenylephrine/Pyrilamine/Dihydrocodeine Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
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; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; lightheadedness; loss of appetite; nausea; nervousness or anxiety; sweating; trouble sleeping; upset stomach or mild stomach pain; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); persistent trouble sleeping; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe or persistent stomach pain; slow or shallow breathing; tremor; trouble urinating or inability to urinate; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or blurred vision.
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.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; cold and clammy skin; coma; confusion; hallucinations; limp muscles; seizures; severe dizziness, drowsiness, lightheadedness, or headache; slow or shallow breathing; small pupils; unusually fast, slow, or irregular heartbeat; vomiting.
Store Phenylephrine/Pyrilamine/Dihydrocodeine Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine/Pyrilamine/Dihydrocodeine Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Phenylephrine/Pyrilamine/Dihydrocodeine Liquid. 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.
Venlafaxin AbZ may be available in the countries listed below.
Venlafaxine hydrochloride (a derivative of Venlafaxine) is reported as an ingredient of Venlafaxin AbZ in the following countries:
International Drug Name Search
Candistat may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Candistat in the following countries:
Itraconazole is reported as an ingredient of Candistat in the following countries:
Nystatin is reported as an ingredient of Candistat in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Pentobarbital sodium salt (a derivative of Pentobarbital) is reported as an ingredient of Combuthal in the following countries:
Thiopental Sodium is reported as an ingredient of Combuthal in the following countries:
International Drug Name Search
Cytarabine Injection Solution 20 mg/ml and 100 mg/ml
For Cytarabine Injection Solution 100 mg/ml: Cytarabine BP 100 mg/ml
For Cytarabine Injection Solution 20 mg/ml: Cytarabine BP 20 mg/ml
There is no overage for these formulations.
Cytarabine Injection Solution 100 mg/ml: Aqueous, sterile solution for injection.
Cytarabine Injection Solution 20 mg/ml: Aqueous, sterile, isotonic solution for injection.
Cytarabine may be used alone or in combination with other antineoplastic agents. It is indicated alone or in combination for induction of remission and/or maintenance in patients with acute myeloid leukaemia, acute non-lymphoblastic leukaemias, acute lymphoblastic leukaemias, acute lymphocytic leukaemia, erythroleukaemia, blast crises of chronic myeloid leukaemia, diffuse histiocytic lymphomas (non-Hodgkin's lymphomas of high malignancy), meningeal leukaemia and meningeal neoplasms. Clinicians should refer to the current literature on combination therapy before initiating treatment.
Cytarabine Injection Solution is a ready to use solution with a concentration of 20 mg/ml and 100 mg/ml. The 20 mg/ml presentation is suitable for intravenous, subcutaneous and intrathecal use.
Cytarabine Injection Solution 100 mg/ml can be administered by the intravenous and subcutaneous routes. Cytarabine Injection Solution 100 mg/ml should not be administered by the intrathecal route due to the slight hypertonicity of this formulation. (See side effects section).
Cytarabine Injection Solution can be diluted with Sterile Water for Injection BP, Glucose Injection BP or Sodium Chloride 0.9% Injection BP. Prepared infusions, in the recommended diluents should be used immediately. Alternatively, the diluted infusion fluids may be stored at 2-8°C, protected from light, but portions remaining unused after 24 hours must be discarded.
Remission Induction: Adults.
Continuous Dosing: The usual dose in leukaemia, is 2 mg/kg by rapid intravenous injection daily for ten days. If after ten days neither therapeutic response nor toxicity has been observed, the dose may be increased to 4 mg per kg until a therapeutic response or toxicity is evident. Daily blood counts should be taken. Almost all patients can be carried to toxicity with these doses.
Alternatively, 0.5 to 1 mg/kg may be infused daily in 1-24 hours for ten days, and then at a rate of 2 mg/kg/day until toxicity is observed. Continue to toxicity or until remission occurs. Results from one hour infusions have been satisfactory in the majority of patients.
Intermittent dosing: Cytarabine may be given as intermittent IV doses of 3-5 mg/kg daily, for Five consecutive days This course of treatment can be repeated after an interval of 2 to 9 days, and repeated until the therapeutic response or toxicity is exhibited.
Evidence of bone marrow improvement has been reported to occur 7-64 days after the beginning of therapy.
In general, if a patient shows neither remission nor toxicity after a trial period, then cautiously administered higher doses can be administered. Generally patients tolerate higher doses given by rapid intravenous injection rather than slow infusion.
As a single agent for induction of remissions in patients with acute leukaemia, Cytarabine has been given in doses of 200 mg/m2 by continuous IV Infusion for five days at approximately 2 week intervals.
Maintenance therapy: To maintain remission, doses of 1-1.5 mg/kg may be given intravenously or subcutaneously, once or twice weekly.
Leukaemic Meningitis: Therapy for established meningitis employs a wide variety of dose regimens but a recommended total daily dose not exceeding 100 mg, alternating with Methotrexate (given either systemically or intrathecally) is recommended. Cytarabine Injection has been given intrathecally at doses of 10-30 mg per m2 three times a week until CSF findings return to normal. Cytarabine Injection Solution 100mg/mL should not be administered by the intrathecal route due to the slight hypertonicity of this formulation. (See side effects section).
Myelosuppression, anaemia and thrombocytopenia occur almost to all patients given daily infusions or injections. Myelosuppression is biphasic and nadirs at 7-9 and 15-24 days. Evidence of bone marrow improvement may be expected 7-64 (mean 28) days after the beginning of treatment.
Children: Children appear to tolerate higher doses of Cytarabine than adults, and where the range of doses is given, children should receive the higher dose.
Elderly: No data is available to suggest that a change in dose is necessary in the elderly. However, the elderly patient is more susceptible to toxic reactions and therefore particular attention should be paid to drug induced leucopenia, thrombocytopenia and anaemia.
Cytarabine is contraindicated in patients with known hypersensitivity to the drug. Therapy with Cytarabine should not be considered in patients with pre-existing drug-induced bone marrow suppression, unless in the opinion of the physician the potential benefits outweigh the hazards. Cytarabine should not be used in the management of non-malignant disease, except for immunosuppression.
Special Warnings and Precautions:
Cytarabine is a potent bone marrow suppressant. Patients receiving the drug should be kept under close medical supervision. Leucocyte and platelet counts should be performed frequently and daily during induction. One case of anaphylaxis that resulted in cardiopulmonary arrest and necessitated resuscitation has been reported. This occurred immediately after intravenous Cytarabine was administered.
Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of dosage schedules). These reactions include reversible corneal toxicity; cerebral and cerebellar dysfunction, usually reversible; severe gastrointestinal ulceration including pneumatosis cysteroides intestinalis, leading to peritonitis; sepsis and liver abscess; and pulmonary oedema.
Cytarabine has been shown to be mutagenic and carcinogenic in animals.
Cytarabine should only be used under the constant supervision by physicians experienced in therapy with cytotoxic agents. Hyperuricaemia secondary to lysis of neoplastic cells may occur in patients receiving Cytarabine; serum uric acid concentrations should be monitored.
Periodic determinations of renal and hepatic functions and bone marrow should also be performed and the drug should be used with caution in patients with impaired hepatic function.
However, dosage reduction does not appear to be necessary in patients with impaired renal function. The human liver apparently detoxifies a substantial fraction of the administered dose. The drug should be used with caution and at a reduced dose when liver function is poor. Frequent platelet and leucocyte counts are mandatory. Therapy should be suspended or modified when drug-induced bone marrow depression results in a platelet count of less than 50,000 or a polymorphonuclear count of under 1000 per cubic mm. Counts may continue to fall after the therapy has been discontinued and may reach lowest values after five to seven days. Therapy may be restarted when the bone marrow appears to be recovering on successive bone marrow studies. Therapy should not wait until the normal blood values are obtained to be re-initiated.
When intravenous doses are given quickly, patients may become nauseated and may vomit for several hours afterwards. The problem tends to be less severe when infused.
The safety of the drug has not been established in infants.
i) Cardiac Glycosides
G.I. absorption of oral digoxin tablets may be substantially reduced in patients receiving combination chemotherapy regimens (including regimens containing cytarabine), possibly as a result of temporary damage to intestinal mucosa caused by the cytotoxic agents. Limited data suggest that the extent of G.I. absorption of digitoxin is not substantially affected by concomitant administration of combination chemotherapy regimens known to decrease absorption of digoxin.
ii) Anti-Infective Agents
One in vitro study indicates that cytarabine may antagonise the activity of gentamicin against Klebsiella pneumoniae. Limited data may suggest that cytarabine may antagonise the anti-infective activity of flucytosine, possibly by competitive inhibition of the anti-infective uptake by fungi.
Use in Pregnancy:
Cytarabine is teratogenic in some animal species. It should not be used in pregnant women (especially during the first trimester), or in those who may become pregnant, unless the possible benefits outweigh the potential risks. Women who are, or become, pregnant during treatment with Cytarabine should be informed of the risks.
Use in Lactation:
It is not known if Cytarabine or its metabolite is distributed into breast milk, and it should not be used.
No documented effect on ability to drive or operate machinery.
Haematological Effects:
The major adverse effect of Cytarabine is the haematological toxicity. Myelosuppression is manifested by megaloblastosis, reticulocytopenia, thrombocytopenia and anaemia.
These appear to be more evident after high doses and continuous infusions; the severity depends on the dose of the drug and schedule of administration.
GI Effects:
Nausea and vomiting occur and are generally more frequent following rapid IV administration than with continuous IV infusion of the drug.
Diarrhoea, anorexia, oral and anal inflammation or ulceration and less frequently abdominal pain, sore throat, oesophagitis, oesophageal ulceration and gastrointestinal haemorrhage may also occur.
Other reported adverse effects of Cytarabine include fever, rash, alopecia, skin ulceration, conjunctivitis, chest pain, urinary retention, dizziness, neuritis or neural toxicity and pain, cellulitis or thrombophlebitis at the site of injection. Cytarabine has also been associated with renal dysfunction, hepatic dysfunction and jaundice in some patients. It has also been associated with sepsis, irritation or sepsis at the injection site, neuritis or neurotoxicity rash, freckling, skin and mucosal bleeding, chest pain, joint pain and reduction in reticulocytes.
A Cytarabine reaction is characterised by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis and malaise. It usually occurs 6-12 hours after administration. Corticosteroids have been shown to be beneficial in treating or preventing this syndrome. If the symptoms of the syndrome are serious enough to warrant treatment, corticosteroids should be contemplated as well as continuation of Cytarabine therapy.
Cessation of therapy followed by management of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics as required.
Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits DNA polymerase and may also inhibit certain acid kinase enzymes. Primarily the drug acts as a false nucleoside and competes for enzymes involved in the conversion of Cytidine nucleotide to deoxycytidine nucleotide and also incorporation into the DNA.
Cytarabine has no effect on non proliferating cells nor on proliferating cells unless in the S phase. It is a cell cycle specific antineoplastic drug.
Oral administration is ineffective due to rapid deamination in the gut. Cytidine deaminase is concentrated in the liver and intravenous doses show biphasic elimination with half lives of approximately 10 minutes and 1-3 hours.
After 24 hours 80% of a dose has been eliminated either as the inactive metabolite or as the unchanged Cytarabine, mostly in urine but some in bile.
CSF levels of 50% of plasma levels are achieved with IV infusion. Intrathecal dosing results in slower elimination (T1/2 2-11 hours).
Cytarabine is rapidly and widely distributed into tissues, crosses the blood brain barrier and also the placenta.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Cytarabine Injection Solution 100 mg/ml: Water for Injections BP
Cytarabine Injection Solution 20 mg/ml: Sodium Chloride BP
Water for Injections BP
Solutions of Cytarabine have been reported to be incompatible with various drugs, i.e. Carbenicillin Sodium, Cephalothin Sodium, Fluorouracil, Gentamicin Sulphate, Heparin Sodium, Hydrocortisone Sodium Succinate, Insulin-regular, Methylprednisolone Sodium Succinate, Nafacillin Sodium, Oxacillin Sodium, Penicillin G Sodium. However, the incompatibility depends on several factors (e.g. concentrations of the drug, specific diluents used, resulting pH, temperature). Specialised references should be consulted for specific compatibility information.
36 months.
Store below 25°C. Protect from Light.
In diluted infusion fluids store at 2-8°C and protect from light for a maximum of 24 hours.
Cytarabine Injection Solution 20mg/ml is supplied in the following packs in both conventional glass vials and ONCO-TAIN® vials:
100 mg in 5 ml vial: Pack of 5
500 mg in 25 ml vial: Singles
1 gram in 50 ml vial: Singles
Cytarabine Injection Solution 100mg/ml is supplied in the following packs in conventional glass vials and ONCO-TAIN® vials:
100 mg in 1ml vial: Pack of 5
500 mg in 5 ml vial: Pack of 5 and Singles
1 g in 10 ml vial: Singles
2 g in 20 ml vial: Singles
Cytarabine Injection Solution 100mg/ml is also supplied in the following packs in ONCO•VIALS®:
100mg in 1ml vial: Pack of 5 and Singles
500mg in 5ml vial: Pack of 5 and Singles
1g in 10ml vial: Pack of 5 and Singles
2g in 20ml vial: Pack of 5 and Singles
Not applicable.
Faulding Pharmaceuticals Plc
Queensway
Royal Leamington Spa
Warwickshire, CV31 3RW
United Kingdom
Cytarabine Injection Solution 100 mg/ml: PL 04515/0057
Cytarabine Injection Solution 20 mg/ml: PL 04515/0040
Cytarabine Injection Solution 100 mg/ml: 7th July 1992/ 9th September 1997
Cytarabine Injection Solution 20 mg/ml: 7th July 1992/ 10 September 1997
14 August 2001
POM
Mebutit may be available in the countries listed below.
Trimebutine maleate (a derivative of Trimebutine) is reported as an ingredient of Mebutit in the following countries:
International Drug Name Search
Uresix may be available in the countries listed below.
Furosemide is reported as an ingredient of Uresix in the following countries:
International Drug Name Search
Generic Name: albuterol and ipratropium (inhalation) (al BYOO ter ol and ip ra TRO pee um)
Brand Names: Combivent, DuoNeb
Albuterol and ipratropium are bronchodilators that relax muscles in the airways and increase air flow to the lungs.
The combination of albuterol and ipratropium is used as an inhaled medication to prevent bronchospasm in people with chronic obstructive pulmonary disease (COPD) who are also using other medicines to control their condition.
Albuterol and ipratropium inhalation may also be used for purposes not listed in this medication guide.
Before you use this medicine, tell your doctor if you have heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, seizures, diabetes, overactive thyroid, an enlarged prostate, urination problems, liver disease, or kidney disease.
To make sure you can safely use this medication, tell your doctor if you have any of these other conditions:
heart disease, high blood pressure, coronary artery disease, or heart rhythm disorder;
a seizure disorder such as epilepsy;
diabetes;
overactive thyroid;
glaucoma;
enlarged prostate, problems with urination; or
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Albuterol and ipratropium inhalation comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
To use the inhaler (Combivent):
Shake the canister vigorously for at least 10 seconds before each spray.
Uncap the mouthpiece of the inhaler. Breathe out fully. Put the mouthpiece into your mouth and close your lips. Keep your eyes closed to prevent spraying any medicine into your eyes. Breathe in slowly while pushing down on the canister. Hold your breath for 10 seconds, then breathe out slowly.
If you use more than one inhalation at a time, wait at least 2 minutes before using the second inhalation.
Keep your inhaler clean and dry, and store it with the cap on the mouthpiece. Clean your inhaler once a week by removing the canister and placing the mouthpiece under warm running water for at least 30 seconds. Allow the parts to dry before putting the inhaler back together.
To use the solution with a nebulizer (Duoneb):
Open the foil pouch and remove one vial. Squeeze all of the medicine out into the chamber of the nebulizer.
Attach the mouthpiece or face mask to the drug chamber. Then, attach the drug chamber to the compressor. Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth.
Breathe in slowly and evenly until you have inhaled all of the medicine (usually 5 to 15 minutes). The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.
Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.
To be sure this medication is helping your condition and not causing harmful effects, your lung function will need to be tested often. You may also need blood tests at your doctor's office. Visit your doctor regularly.
Use albuterol and ipratropium inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Keep track of the number of sprays you have used and throw away the inhaler canister after 200 sprays, even if it feels like there is still medicine in it.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
chest pain and fast, pounding, or uneven heart beats;
swelling of your ankles or feet;
vision problems, eye pain, or seeing halos around lights;
pain or burning with urination; or
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
hoarse voice, sore throat, cough, runny or stuffy nose;
constipation, diarrhea;
nausea, upset stomach;
headache; or
leg cramps.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:
2 puffs by metered dose inhaler 4 times a day. Patients may take an extra dose as warranted by symptomatology. The maximum recommended dose is 12 puffs/day.
or
One 3 mL vial by nebulization 4 times a day. Patients may take extra doses as warranted by symptomatology. The maximum recommended dose is 6 vials (18 mL)/ day.
Tell your doctor about all other medications you use, especially:
atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
clidinium (Quarzan);
glycopyrrolate (Robinul);
hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);
dicyclomine (Bentyl);
mepenzolate (Cantil);
methantheline (Provocholine);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
irritable bowel medications such as dicyclomine (Bentyl) or propantheline (Pro Banthine);
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), metoprolol (Lopressor), propranolol (Inderal), and others;
a diuretic (water pill);
an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);
a stimulant, ADHD medication, diet pills, or over-the-counter cold or allergy medicines; or
medicines used to treat Parkinson's disease such as benztropine (Cogentin), orphenadrine (Norflex), trihexyphenidyl (Artane, Trihexane), and others.
This list is not complete and other drugs may interact with albuterol and ipratropium inhalation. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: albuterol and ipratropium side effects (in more detail)
Losacor Plus may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Losacor Plus in the following countries:
Losartan is reported as an ingredient of Losacor Plus in the following countries:
International Drug Name Search
Tanapress may be available in the countries listed below.
Imidapril hydrochloride (a derivative of Imidapril) is reported as an ingredient of Tanapress in the following countries:
International Drug Name Search
Bonalon may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Bonalon in the following countries:
International Drug Name Search
Blugat may be available in the countries listed below.
Gabapentin is reported as an ingredient of Blugat in the following countries:
International Drug Name Search
Bicalutamide Arrow may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Bicalutamide Arrow in the following countries:
International Drug Name Search
Bisacodyl GSK may be available in the countries listed below.
Bisacodyl is reported as an ingredient of Bisacodyl GSK in the following countries:
International Drug Name Search
Inderal Retard may be available in the countries listed below.
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Inderal Retard in the following countries:
International Drug Name Search
Quick-dissolve tablets.
| Nutrition Facts: | Per Tablet |
Vitamin D3 (cholecalciferol) | 1750 IU |
Vitamin C (ascorbic acid) | 100 mg |
Folate (folic acid/B9) | 1 mg |
Thiamin (B1) | 1.5 mg |
Riboflavin (B2) | 1.7 mg |
Niacin (B3) | 20 mg |
Pantothenic Acid (B5) | 5 mg |
Pyridoxine HCl (B6) | 10 mg |
Biotin (B7) | 150 mcg |
Vitamin B12 (cyanocobalamin) | 6 mcg |
Other ingredients: Mannitol, Crospovidone, Stearic Acid, Flavor, Magnesium Stearate, Sucralose, Polyvinyl Acetate.
Under the supervision of a physician for dietary management of patients with chronic renal failure; uremia; impaired metabolic functions of the kidney, and to maintain nutrient levels when dietary intake of vitamins is inadequate or excretion or loss is excessive.
Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurologic manifestations remain progressive.
One tablet daily, or as directed by a physician. If on dialysis, take after treatment.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep container tightly closed and protected from heat and moisture.
To report a serious adverse event or obtain product information contact 1-800-343-9497.
PATENT PENDING
Bottles of 90 (NDC 0256-0233-02)
Bottles of 30 (NDC 0256-0233-01)
Bottles of 5 (NDC 0256-0233-03), 12 bottles in a tray
NDC 0256-0233-02
Rx Only
NEPHROCAPS® QT
QUICK-DISSOLVE TABLETS
DIALYSIS/RENAL Vitamin
90 QUICK-DISSOLVE TABLETS
Manufactured by Fleming Pharmaceuticals.
Lot No.
Exp. Date
L742 Rev.0111
Bottle Label
| Nephrocaps-QT cholecalciferol, ascorbic acid, folic acid, thiamin, riboflavin, niacin, pantothenic acid, pyridoxine hcl, biotin, cyanocobalamin tablet, orally disintegrating | ||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 03/01/2011 | ||
| Labeler - Fleming & Company, Pharmaceuticals (006491351) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Fleming & Company, Pharmaceuticals | 006491351 | MANUFACTURE | |
