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
