Doprovet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
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Generic Name: erythromycin and sulfisoxazole (Oral route)
e-rith-roe-MYE-sin eth-il-SUX-i-nate, sul-fi-SOX-a-zole A-se-teel
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antibiotic Combination
Chemical Class: Erythromycin
Erythromycin and sulfisoxazole is a combination antibiotic used to treat ear infections in children. It also may be used for other problems as determined by your doctor. It will not work for colds, flu, or other virus infections.
Erythromycin and sulfisoxazole combination is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not specifically included in product labeling, erythromycin and sulfisoxazole combination is used in certain patients with the following medical condition:
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:
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.
This medicine has been tested in children over the age of 2 months and has not been shown to cause different side effects or problems than it does in adults. This medicine should not be given to infants under 2 months of age unless directed by the child's doctor, because it may cause unwanted effects.
This medicine is intended for use in children and is not generally used in adult patients.
| 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. |
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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.
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.
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.
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.
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:
This section provides information on the proper use of a number of products that contain erythromycin and sulfisoxazole. It may not be specific to Pediazole. Please read with care.
Erythromycin and sulfisoxazole combination is best taken with extra amounts of water and may be taken with food. Additional amounts of water should be taken several times every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects (e.g., kidney stones) of sulfa medicines.
Do not give this medicine to infants under 2 months of age, unless otherwise directed by your doctor. Sulfa medicines may cause liver problems in these infants.
Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.
Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.
To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.
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.
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.
Store in the refrigerator. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine, especially if you will be taking this medicine for a long time.
If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
Erythromycin and sulfisoxazole may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:
If you have a severe reaction from the sun, check with your doctor.
Erythromycin and sulfisoxazole combination may cause blood problems. These problems may result in a greater chance of infection, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.
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:
Check with your doctor as soon as possible if any of the following side effects occur:
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:
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: Pediazole side effects (in more detail)
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Cefazoline Sandoz may be available in the countries listed below.
Cefazolin is reported as an ingredient of Cefazoline Sandoz in the following countries:
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LITAK 2 mg/ml solution for injection
Each ml of solution contains 2 mg of cladribine (2
For a full list of excipients, see section 6.1.
Solution for injection.
Clear, colourless solution.
LITAK is indicated for the treatment of hairy cell leukaemia.
Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy.
Posology
The recommended posology for hairy cell leukaemia is a single course of LITAK given by subcutaneous bolus injection at a daily dose of 0.14 mg/kg body weight for 5 consecutive days.
Deviations from the posology indicated above are not advised.
Elderly
Experience with patients older than 65 years is limited. Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function. The risk requires assessment on a case-by-case basis (see section 4.4).
Renal and hepatic impairment
There are no data on the use of LITAK in patients with renal or hepatic impairment. LITAK is contraindicated in patients with moderate to severe renal impairment (creatinine clearance
Paediatric use
LITAK is contraindicated in patients less than 18 years of age (see section 4.3).
Method of administration
LITAK is supplied as a ready
Self-administration by the patient
LITAK can be self
Hypersensitivity to the active substance or any of the excipients.
Pregnancy and lactation.
Patients less than 18 years of age.
Moderate to severe renal impairment (creatinine clearance
Concomitant use of other myelosuppressive medicinal products.
Cladribine is an antineoplastic and immunosuppressive substance that can induce considerable toxic adverse reactions, such as myelo
Particular caution is advised and risks/benefits should be carefully evaluated if administration of cladribine is considered in patients with increased infection risk, manifested bone marrow failure or infiltration, myelosuppressive pre
If severe toxicity occurs, the physician should consider delaying or discontinuing the therapy with the medicinal product until serious complications resolve. In case of infections, antibiotic treatment should be initiated as required.
It is recommended that patients receiving cladribine should receive irradiated cellular blood components/products to prevent transfusion-related graft-versus-host disease (Ta-GVHD).
Secondary malignancies
Like other nucleoside analogues, treatment with cladribine is associated with myelosuppression and profound and prolonged immunosuppression. Treatment with these agents is associated with the occurrence of second malignancies. Secondary malignancies are expected to occur in patients with hairy cell leukaemia. Their frequency varies widely, ranging from 2% to 21%. The peak risk is at 2 years after diagnosis with a median between 40 and 66 months. The cumulative frequencies of second malignancy are 5%, 10-12% and 13-14% following 5, 10 and 15 years respectively after diagnosis of hairy cell leukaemia. Following cladribine, the incidence of second malignancies ranges from 0% to 9.5% after a median observation period of 2.8 to 8.5 years. The frequency of second malignancy following treatment with LITAK was 3.4% in all 232 hairy cell leukaemia patients treated, during a 10-year period. The highest incidence of second malignancy with LITAK was 6.5% after a median follow-up of 8.4 years. Therefore, patients treated with cladribine should be regularly monitored.
Haematologic toxicity
During the first month following treatment, myelosuppression is most notable and red blood cell or platelet transfusions may be required. Patients with symptoms of bone marrow depression should be treated with caution, since further suppression of bone marrow function should be anticipated. Therapeutic risks and benefits should be carefully evaluated in patients with active or suspected infections. The risk of severe myelotoxicity and long-lasting immunosuppression is increased in patients with a disease-related bone marrow infiltration or a previous myelosuppressive treatment. Dose reduction and regular monitoring of the patient is required in such cases. Pancytopenia is normally reversible and the intensity of bone marrow aplasia is dose-dependent. An increased incidence of opportunistic infections is expected during, and for 6 months following, therapy with cladribine. Careful and regular monitoring of peripheral blood counts is essential during, and for 2 to 4 months following, treatment with cladribine to detect potential adverse reactions and consequent complications (anaemia, neutropenia, thrombocytopenia, infections, haemolysis or bleedings), and to survey haematologic recovery. Fever of unknown origin frequently occurs in patients treated for hairy cell leukaemia and is manifested predominantly during the first 4 weeks of therapy. The origin of febrile events should be investigated by appropriate laboratory and radiologic tests. Less than a third of febrile events are associated with a documented infection. In case of fever related to infections or agranulocytosis, an antibiotic treatment is indicated.
Renal and hepatic impairment
There are no data on the use of LITAK in patients with renal or hepatic impairment. Clinical experience is very limited and safety of LITAK in these patients is not well established (see sections 4.3 and 5.2).
Careful treatment is required in patients with known or suspected renal or hepatic impairment. For all patients treated with LITAK, periodic assessment of renal and hepatic function is advised as clinically indicated.
Elderly
Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function. The risk requires assessment on a case
Prevention of tumour lysis syndrome
In patients with a high tumour burden, prophylactic allopurinol therapy to control serum levels of uric acid, together with adequate or increased hydration, should be commenced 24 hours before the start of chemotherapy. A daily oral dose of 100 mg of allopurinol is recommended for a period of 2 weeks. In case of an accumulation of the serum uric acid above the normal range, the dose of allopurinol may be increased to 300 mg/day.
Fertility
Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see sections 4.6 and 5.3).
Due to a potential increase of haematological toxicity and bone marrow suppression, cladribine must not be used concomitantly with other myelosuppressive medicinal products. An influence of cladribine on the activity of other antineoplastic agents has not been observed in vitro (e.g. doxorubicin, vincristine, cytarabine, cyclophosphamide) and in vivo. However, an in vitro study revealed cross-resistance between cladribine and nitrogen mustard (chlormethine); for cytarabine, one author has described an in vivo cross-reaction without loss of activity.
Due to the similar intracellular metabolism, cross-resistance with other nucleoside analogues, such as fludarabine or 2'-deoxycoformycin may occur. Therefore, simultaneous administration of nucleoside analogues with cladribine is not advisable.
Corticosteroids have been shown to enhance the risk for severe infections when used in combination with cladribine and should not be given concomitantly with cladribine.
Since interactions with medicinal products undergoing intracellular phosphorylation, such as antiviral agents, or with inhibitors of adenosine uptake may be expected, their concomitant use with cladribine is not recommended.
Pregnancy
Cladribine causes serious birth defects when administered during pregnancy. Animal studies and in vitro studies with human cell lines demonstrated the teratogenicity and mutagenicity of cladribine. Cladribine is contraindicated in pregnancy.
Women of childbearing potential must use effective contraception during treatment with cladribine and for 6 months after the last cladribine dose. In case of pregnancy during therapy with cladribine, the woman should be informed about the potential hazard to the foetus.
Lactation
It is unknown whether cladribine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, lactation is contraindicated during treatment with cladribine and for 6 months after the last cladribine dose.
Fertility
The effects of cladribine on fertility have not been studied in animals. However, a toxicity study conducted with cynomolgus monkeys has shown that cladribine suppresses maturation of rapidly generating cells, including testicular cells. The effect on human fertility is unknown. Antineoplastic agents, such as cladribine, which interfere with DNA, RNA and protein synthesis, might be expected to have adverse effects on human gametogenesis (see section 5.3).
Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see section 4.4).
LITAK has a major influence on the ability to drive and use machines. In case certain adverse reactions with a potential impact on performance occur (e.g. dizziness, very common, or drowsiness, which may occur due to anaemia, which is very common), patients should be advised not to drive or use machines.
Very common adverse reactions observed during the three most relevant clinical trials with cladribine in 279 patients treated for various indications and in 62 patients with hairy cell leukaemia (HCL) were myelosuppression, especially severe neutropenia (41% (113/279), HCL 98% (61/62)), severe thrombocytopenia (21% (58/279), HCL 50% (31/62)) and severe anaemia (14% (21/150), HCL 55% (34/62)), as well as severe immunosuppression/lymphopenia (63% (176/279), HCL 95% (59/62)), infections (39% (110/279), HCL 58% (36/62)) and fever (up to 64%).
Culture-negative fever following treatment with cladribine occurs in 10-40% of patients with hairy cell leukaemia and is rarely observed in patients with other neoplastic disorders. Skin rashes (2-31%) are mainly described in patients with other concomitantly administered medicinal products known to cause rash (antibiotics and/or allopurinol). Gastrointestinal adverse reactions like nausea (5-28%), vomiting (1-13%), and diarrhoea (3-12%) as well as fatigue (2-48%), headache (1-23%), and decreased appetite (1-22%) have been reported during treatment with cladribine. Cladribine is unlikely to cause alopecia; mild and transient alopecia for a few days was observed in 4/523 patients during the treatment, but could not clearly be associated with cladribine.
Adverse reactions that have been reported are listed in the table below by frequency category and system organ class. The frequencies are defined as follows: Very common (
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* see descriptive section below.
Non-haematological adverse reactions
Non
Blood counts
Since patients with an active hairy cell leukaemia mostly present with low blood counts, especially low neutrophil counts, more than 90% of the cases have transient severe neutropenias (< 1.0 x 109/l). The use of haematopoietic growth factors neither improves the recovery of neutrophil counts nor decreases the incidence of fever. Severe thrombocytopenias (< 50 x 109/l) are observed in about 20% to 30% of all patients. Lymphocytopenia lasting for several months and immunosuppression with an increased risk of infections are expected. The recovery of cytotoxic T
Infections
Severe long-term lymphocytopenias have been reported rarely which, however, could not be associated with late infectious complications. Very common severe complications, in some cases with fatal outcome, are opportunistic infections (e.g. Pneumocystis carinii, Toxoplasma gondii, listeria, candida, herpes viruses, cytomegalovirus and atypical mycobacteria). Forty percent of the patients who were treated with LITAK at a dose of 0.7 mg/kg body weight per cycle suffered from infections. These were on average more severe than the infections manifested in 27% of all patients receiving a reduced dose of 0.5 mg/kg body weight per cycle. Forty-three percent of patients with hairy cell leukaemia experienced infectious complications at standard dose regimen. One third of these infections have to be considered as severe (e.g. septicaemia, pneumonia). At least 10 cases with acute autoimmune haemolytic anaemia have been reported. All patients were successfully treated with corticosteroids.
Rare serious adverse reactions
Serious adverse reactions like ileus, severe hepatic failure, renal failure, cardiac failure, atrial fibrillation, cardiac decompensation, apoplexy, neurological disturbances in speech and swallowing, tumour lysis syndrome with acute renal failure, transfusion-related graft-versus-host disease, Stevens
Fatal outcome
The majority of deaths related to the medicinal product are due to infectious complications. Further rare cases with fatal outcome, reported in association with LITAK chemotherapy, were second malignancy, cerebro
Frequently observed symptoms of overdose are nausea, vomiting, diarrhoea, severe bone marrow depression (including anaemia, thrombocytopenia, leukopenia, and agranulocytosis), acute renal insufficiency, as well as irreversible neurologic toxicity (paraparesis/quadriparesis), Guillain
No specific antidote exists. Immediate discontinuation of therapy, careful observation, and initiation of appropriate supportive measures (blood transfusions, dialysis, haemofiltration, anti
Pharmacotherapeutic group: Purine analogues, ATC code: L01BB04
Cladribine is a purine nucleoside analogue acting as an antimetabolite. The single substitution of hydrogen for chlorine at position 2 distinguishes cladribine from its natural counterpart 2'
Mechanism of action
Cladribine is a prodrug which is taken up rapidly in cells after parenteral administration, and is phosphorylated intracellularly to the active nucleotide 2
Unlike other nucleoside analogues, cladribine is toxic in rapidly proliferating cells as well as in resting cells. No cytotoxic effect of cladribine could be observed in cell lines of solid tumours. The mechanism of action of cladribine is attributed to the incorporation of CdATP into DNA strands: the synthesis of new DNA in dividing cells is blocked and the DNA repair mechanism is inhibited, resulting in an accumulation of DNA strand breaks and a decrease of NAD (nicotinamide adenine dinucleotide) and ATP concentration, even in resting cells. Furthermore, CdATP inhibits ribonucleotide reductase, the enzyme responsible for the conversion of ribonucleotides into deoxyribonucleotides. Cell death occurs from energy depletion and apoptosis.
Clinical efficacy
In the clinical trial using LITAK subcutaneously, 63 patients with hairy cell leukaemia (33 newly diagnosed patients and 30 patients with relapsed or progressive disease) were treated. The overall response rate was 97% with long-lasting remission, with 73% of patients staying in complete remission after four years follow
Absorption
Cladribine shows complete bioavailability after parenteral administration; the mean area under the plasma concentration versus time curve (AUC) is comparable after continuous or intermittent 2
Distribution
After subcutaneous bolus injection of a 0.14 mg/kg cladribine dose, a Cmax of 91 ng/ml is reached on average after 20 minutes only. In another study using a dose of 0.10 mg/kg body weight/day, the maximum plasma concentration Cmax after continuous intravenous infusion was 5.1 ng/ml (tmax: 12 hours) compared to 51 ng/ml after subcutaneous bolus injection (tmax: 25 minutes).
Intracellular concentration of cladribine exceeds its plasma concentration by 128 to 375 times.
The mean volume of distribution of cladribine is 9.2 l/kg. Plasma protein binding of cladribine is 25% on average, with a wide interindividual variation (5
Metabolism
The prodrug cladribine is metabolised intracellularly, predominantly by deoxycytidine kinase, to 2
Elimination
Pharmacokinetic studies in humans showed that the plasma concentration curve of cladribine fits a 2in vivo is clearly prolonged as compared to the retention time in the plasma: Half1/2 of initially 15 hours and subsequently more than 30 hours were measured in leukaemic cells.
Cladribine is eliminated mainly by the kidneys. The renal excretion of unmetabolised cladribine occurs within 24 hours and accounts for 15% and 18% of the dose after 2
Special populations
Renal and hepatic impairment
There are no studies available using cladribine in patients with renal or hepatic impairment (see also section 4.2 and section 4.4). Clinical experience is very limited and safety of LITAK in these patients is not well established. LITAK is contraindicated in patients with moderate to severe renal impairment or with moderate to severe hepatic impairment (see section 4.3).
Paediatric use
The use of LITAK in children has not been investigated (see section 4.2).
Elderly
Experience with patients older than 65 years is limited. Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function.
Cladribine is moderately acutely toxic to mice, with an LD50 of 150 mg/kg by intraperitoneal administration.
In 7
Cladribine is teratogenic in mice (at doses of 1.5
Carcinogenesis/mutagenesis
Long-term studies in animals to evaluate the carcinogenic potential of cladribine have not been conducted. On the basis of available data, no evaluation can be made of the carcinogenic risk of cladribine to humans.
Cladribine is a cytotoxic medicinal product, which is mutagenic to cultured mammalian cells. Cladribine is incorporated into DNA strands and inhibits DNA synthesis and repair. Exposure to cladribine induces DNA fragmentation and cell death in various normal and leukaemic cells and cell lines at concentrations of 5 nM to 20 µM.
Fertility
The effects of cladribine on fertility have not been studied in animals. However, a toxicity study conducted with cynomolgus monkeys has shown that cladribine suppresses maturation of rapidly generating cells, including testicular cells. The effect on human fertility is unknown. Antineoplastic agents, such as cladribine, which interfere with DNA, RNA and protein synthesis, might be expected to have adverse effects on human gametogenesis (see sections 4.4 and 4.6).
Sodium chloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections
LITAK must not be mixed with other medicinal products.
4 years.
From a microbiological point of view, unless the opening precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in
Store in a refrigerator (2°C
Do not freeze.
10 ml type I glass vial with rubber stopper (bromobutyl) and flip
Packs contain 1 or 5 vials, each with 5 ml of solution. Not all pack
Procedures for proper handling and disposal of antineoplastic medicinal products should be used. Cytotoxic medicinal products should be handled with caution. Avoid contact by pregnant women.
The use of disposable gloves and protective garments is recommended when handling and administering LITAK. If LITAK contacts the skin or mucous membranes, rinse the area immediately with copious amounts of water.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
The vials are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Lipomed GmbH
Hegenheimer Strasse 2
D
Germany
EU/1/04/275/001
EU/1/04/275/002
Date of first authorisation: 14/04/2004
Date of last renewal: 19/04/2009
December 2009
Bicalutamid Fresenius may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Bicalutamid Fresenius in the following countries:
International Drug Name Search
Balsalazide Sodium may be available in the countries listed below.
Balsalazide Sodium (BANM) is known as Balsalazide in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
Treating inflammatory lesions caused by rosacea.
Doxycycline Capsules is a tetracycline. Tetracyclines are often used to treat infections; however, Doxycycline Capsules will not treat infection. It works by reducing skin inflammation caused by rosacea.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Doxycycline Capsules. 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 Doxycycline Capsules. 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 Doxycycline Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Doxycycline Capsules 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 Doxycycline Capsules.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; nose or throat irritation; sensitivity to sunlight.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; chest pain; dark urine; decreased urination; fever, chills, or sore throat; moderate to severe sunburn; red, swollen, blistered, or peeling skin; severe diarrhea; severe or persistent headache; stomach pain or cramps; throat irritation; trouble swallowing; unusual bruising or bleeding; unusual joint pain; unusual tiredness; vaginal irritation or discharge; vision changes; 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.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Doxycycline Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Doxycycline Capsules out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Doxycycline Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Biperideno Dosa may be available in the countries listed below.
Biperiden hydrochloride (a derivative of Biperiden) is reported as an ingredient of Biperideno Dosa in the following countries:
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Buspiron may be available in the countries listed below.
Buspirone hydrochloride (a derivative of Buspirone) is reported as an ingredient of Buspiron in the following countries:
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Molsidomine is reported as an ingredient of Molicor in the following countries:
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Loratadine 10 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
if you have ever had an allergic reaction to this product or any of its ingredients
liver or kidney disease. Your doctor should determine if you need a different dose.
do not take more than directed. Taking more than directed may cause drowsiness.
an allergic reaction to this product occurs. Seek medical help right away.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
| adults and children 6 years and over | 1 tablet daily; not more than 1 tablet in 24 hours |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
lactose monohydrate, magnesium stearate, povidone, pregelatinized starch
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Loratadine Tablets, 10 mg
Antihistamine
Compare to Claritin® Tablets active ingredient
24 Hour
Non-Drowsy*
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Actual Size
*When taken as directed. See Drug Facts Panel.
Loratadine Tablets, 10 mg Carton
| Members Mark Loratadine loratadine tablet | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA076301 | 05/21/2007 | |
| Labeler - Sam's West Inc (051957769) |
Generic Name: Micafungin Sodium
Class: Echinocandins
VA Class: AM700
Chemical Name: Pneumocandin A0, 1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy)phenyl]-3-isoxazolyl]benzoyl]- L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt
Molecular Formula: C56H70N9NaO23S
CAS Number: CAS-208538-73-2; CAS-235114-32-6
Antifungal; echinocandin; lipopeptide synthesized from a fermentation product of Coleophoma empetri.1 2 3 4 5 8
Treatment of candidemia, acute disseminated candidiasis, and certain other invasive Candida infections (peritonitis, abscesses).1 10 29 A drug of choice.10 23
For treatment of candidemia in nonneutropenic patients or for empiric treatment of suspected invasive candidiasis in such patients, IDSA recommends fluconazole or an echinocandin (caspofungin, micafungin, anidulafungin) for initial therapy;23 amphotericin B (conventional or lipid formulation) is the preferred alternative.23 An echinocandin may be preferred for initial treatment in those who have moderately severe to severe candidemia, are allergic to or intolerant of azole antifungals, have recently received an azole, or have or are likely to have infections caused by C. glabrata or C. krusei.23 Fluconazole may be preferred for initial treatment in those who are less critically ill and have not recently received an azole and for infections caused by C. parapsilosis.23 If an echinocandin is used initially, transition to fluconazole is recommended for patients who are clinically stable and have isolates likely to be susceptible to fluconazole (e.g., C. albicans).23
For treatment of candidemia in neutropenic patients, IDSA recommends an echinocandin (caspofungin, micafungin, anidulafungin) or amphotericin B (a lipid formulation) for initial therapy;23 fluconazole is the preferred alternative in those who are less critically ill or have not recently received an azole;23 voriconazole can be used as an alternative when broader antifungal coverage is required.23 An echinocandin is preferred for C. glabrata infections;23 fluconazole or amphotericin B (a lipid formulation) is preferred for C. parapsilosis infections;23 an echinocandin, amphotericin B (a lipid formulation), or voriconazole is recommended for C. krusei infections.23 For initial empiric treatment of suspected invasive candidiasis in neutropenic patients, amphotericin B (a lipid formulation), caspofungin, or voriconazole is recommended;23 alternatives are fluconazole or itraconazole.23
Safety and efficacy not established for treatment of endocarditis, osteomyelitis, or meningitis caused by Candida.1
Treatment of esophageal candidiasis.1 2 3 4 7 10 23 43 A drug of choice.10 23
Esophageal candidiasis requires treatment with a systemic antifungal (not a topical antifungal).23 43 44
IDSA recommends oral fluconazole as the preferred drug of choice for treatment of esophageal candidiasis;23 if oral therapy is not tolerated, IV fluconazole, IV amphotericin B (conventional formulation), or an IV echinocandin (caspofungin, micafungin, anidulafungin) is recommended.23 For fluconazole-refractory infections, preferred alternatives are itraconazole oral solution, oral posaconazole, or IV or oral voriconazole;23 other alternatives are an IV echinocandin (caspofungin, micafungin, anidulafungin) or IV amphotericin B (conventional formulation).23
For treatment of esophageal candidiasis in HIV-infected adults and adolescents†, CDC, National Institutes of Health (NIH), and IDSA recommend IV or oral fluconazole as the preferred drug of choice and itraconazole oral solution as the preferred alternative.43 Other alternatives include an IV echinocandin (caspofungin, micafungin, anidulafungin), oral or IV voriconazole, oral posaconazole, or IV amphotericin B (conventional formulation).43 For refractory esophageal candidiasis, including fluconazole-refractory infections, itraconazole oral solution or oral posaconazole is preferred;43 alternatives include IV amphotericin B (conventional or lipid formulation), an IV echinocandin (caspofungin, micafungin, anidulafungin), or oral or IV voriconazole.43
Patients with frequent or severe recurrences of esophageal candidiasis, including HIV-infected patients, may benefit from long-term suppressive or maintenance therapy (secondary prophylaxis) with oral fluconazole or oral posaconazole;23 43 however, the potential for azole resistance should be considered.23 43 Echinocandins not in recommendations for secondary prophylaxis of esophageal candidiasis.23 43 44 Patients with fluconazole-refractory esophageal candidiasis who responded to an echinocandin should receive voriconazole or posaconazole for secondary prophylaxis until antiretroviral therapy produces immune reconstitution.43
Treatment of oropharyngeal candidiasis†.10 23 43 Considered an alternative, not a drug of choice.23 43
IDSA recommends topical clotrimazole or topical nystatin for mild oropharyngeal candidiasis;23 oral fluconazole is recommended for moderate to severe disease.23 For refractory oropharyngeal candidiasis, including fluconazole-refractory infections, itraconazole oral solution, oral posaconazole, or oral voriconazole is recommended.23 An IV echinocandin (caspofungin, micafungin, anidulafungin) or IV amphotericin B (conventional formulation) also are recommended as alternatives for refractory infections.23
For treatment of oropharyngeal candidiasis in HIV-infected adults and adolescents†, CDC, NIH, and IDSA recommend oral fluconazole as the preferred drug of choice for initial episodes;43 alternatives for initial episodes include topical clotrimazole or topical nystatin.43 For fluconazole-refractory infections, itraconazole oral solution or oral posaconazole is preferred;43 alternatives include IV amphotericin B (conventional or a lipid formulation), an IV echinocandin (caspofungin, micafungin, anidulafungin), or oral or IV voriconazole.43
Patients with frequent or severe recurrences of oropharyngeal candidiasis, including HIV-infected patients, may benefit from long-term suppressive or maintenance therapy (secondary prophylaxis) with oral fluconazole or itraconazole oral solution;23 43 however, the potential for azole resistance should be considered.23 43 Echinocandins not included in recommendations for secondary prophylaxis of oropharyngeal candidiasis.23 43 Patients with fluconazole-refractory oropharyngeal candidiasis who responded to an echinocandin should receive voriconazole or posaconazole for secondary prophylaxis until antiretroviral therapy produces immune reconstitution.43
Prophylaxis of Candida infections in hematopoietic stem cell transplant (HSCT) recipients.1 2 3 4 6 23 A drug of choice.23
For antifungal prophylaxis in HSCT recipients with neutropenia, IDSA recommends fluconazole, posaconazole, or micafungin.23
Has been used with some success as primary or salvage therapy, alone or in conjunction with other antifungals, for treatment of invasive aspergillosis†.2 5 12 25 27 30 31 32 33 34 39 40 The role of micafungin in treatment of invasive aspergillosis remains to be defined.2 3 4 5 11 25 37
IDSA and other clinicians consider voriconazole the drug of choice for treatment of invasive aspergillosis and amphotericin B (a lipid formulation) the preferred alternative for initial treatment.10 45 For salvage therapy in patients refractory to or intolerant of primary antifungal therapy, IDSA and others recommend amphotericin B (a lipid formulation), caspofungin, micafungin, posaconazole, or itraconazole.10 45 For empiric or preemptive therapy, IDSA recommends amphotericin B (a lipid formulation), caspofungin, itraconazole, or voriconazole as drugs of choice.45
Administer by slow IV infusion.1 Do not administer by rapid IV injection.1
Do not admix or infuse concomitantly with other drugs.1
If administered via an existing IV line; flush line with 0.9% sodium chloride injection prior to infusing micafungin.1
Reconstituted and diluted solutions should be protected from light, but covering the IV tubing or infusion drip chamber not necessary.1
Reconstitute 50- or 100-mg vials of lyophilized micafungin by adding 5 mL of 0.9% sodium chloride injection to provide a solution containing approximately 10 or 20 mg/mL, respectively.1 Alternatively, 5 mL of 5% dextrose injection can be used.1 Gently swirl to avoid foam formation; do not shake.1
Use strict aseptic technique since drug contains no preservative.1
Add contents of appropriate number of reconstituted 50- or 100-mg vials to 100 mL of 0.9% sodium chloride injection or, alternatively, 100 mL of 5% dextrose injection.1 Discard partially used vials.1
IV infusions are given over 1 hour.1 More rapid infusion may increase risk of histamine-mediated reactions.1 (See Hypersensitivity Reactions under Cautions.)
Available as micafungin sodium; dosage expressed in terms of the salt.1
A loading dose is not required.1
100 mg once daily by slow IV infusion.1 10 43
IDSA and others recommend that antifungal treatment for candidemia (without persistent fungemia or metastatic complications) be continued for 14 days after first negative blood culture and resolution of signs and symptoms of candidemia.10 23 Mean duration of successful micafungin treatment in clinical trials was 15 days (range: 10–47 days).1
150 mg once daily by slow IV infusion.1 10
HIV-infected adults: 150 mg once daily by slow IV infusion.43
IDSA and others recommend that antifungal treatment be continued for 14–21 days.10 23 43 Mean duration of successful micafungin treatment in clinical trials was 15 days (range: 10–30 days).1
100 or 150 mg once daily by slow IV infusion.10 23
HIV-infected adults: 150 mg once daily by slow IV infusion.43
IDSA and others recommended that antifungal treatment be continued for 7–14 days.23 43
50 mg once daily by slow IV infusion.1 23
Optimum duration of antifungal prophylaxis not known;23 continue prophylaxis throughout the period of risk of neutropenia.23 Mean duration of effective prophylaxis in clinical trials was 19 days (range: 6–51 days).1
100 or 150 mg once daily by slow IV infusion has been recommended as salvage therapy;45 optimum dosage and duration of antifungal treatment not established.45
Dosage adjustment not required in adults with mild to moderate hepatic impairment (Child-Pugh score 7–9).1 2 5
Data not available regarding use in adults with severe hepatic impairment (Child-Pugh score >9);1 select dosage with caution.20
Dosage adjustment not required.1 3 5 Not dialyzable; supplemental doses not required following dialysis.1 3 5
Dosage adjustment not required in adults ≥65 years of age.1 3 5
Known hypersensitivity to micafungin, other echinocandin antifungals (e.g., anidulafungin, caspofungin), or any ingredient in the formulation.1
Serious hypersensitivity reactions (e.g., anaphylaxis and anaphylactoid reactions, including shock) have occurred.1 4 6 7 8
Possible histamine-mediated symptoms (e.g., rash, pruritus, facial swelling) have occurred.1 Rapid IV infusion may increase risk of histamine-mediated reactions.1 (See Rate of Administration under Dosage and Administration.)
If serious hypersensitivity reaction occurs, discontinue infusion and initiate appropriate therapy as indicated.1
Clinically important hemolysis and hemolytic anemia reported rarely.1 Transient acute intravascular hemolysis and hemoglobinuria (without clinically important anemia) reported in a healthy volunteer receiving micafungin and prednisolone concomitantly.1 20
If clinical or laboratory evidence of hemolysis or hemolytic anemia occurs, monitor closely for evidence of worsening of these conditions and evaluate benefits versus risks of continuing micafungin.1
Abnormal liver function test results reported.1 Clinically important hepatic dysfunction, hepatitis, and hepatic failure reported in patients with serious underlying conditions receiving multiple drugs concomitantly.1
If abnormal liver function test results occur, monitor for development of worsening hepatic function and evaluate benefits versus risks of continuing micafungin.1
Increased BUN and Scr reported.1 Clinically important renal dysfunction or acute renal failure reported rarely.1
If abnormal renal function test results occur, monitor for development of worsening renal function.1
The manufacturer states that efficacy not established for treatment of infections caused by fungi other than Candida.1
Category C.1
Distributed into milk in rats;21 not known whether distributed into human milk.1 Use caution.1
Safety and efficacy not established in children ≤16 years of age.1
Has been used in some neonates and children <16 years of age† for treatment of candidemia or other invasive Candida infections and generally was well tolerated.20 35
Some experts state data are insufficient to date to recommend use of micafungin for first-line treatment of invasive candidiasis or for treatment of esophageal or oropharyngeal candidiasis in children (including HIV-infected children).44
Safety and efficacy in those ≥65 years of age similar to that reported in younger adults, but possibility of increased sensitivity cannot be ruled out.1
Moderate hepatic impairment (Child-Pugh score 7–9): Peak plasma concentration and AUC of micafungin decreased by approximately 22%;1 dosage adjustments not necessary.1
Severe hepatic impairment (Child-Pugh score >9): Pharmacokinetics not evaluated.1 Evaluate benefits versus risks of continued therapy if abnormal liver function test results occur.1
GI effects (diarrhea,1 42 nausea,1 vomiting,1 42 constipation,1 abdominal pain,1 dyspepsia,1 anorexia1 ), pyrexia,1 mucosal inflammation,1 rigors,1 peripheral edema,1 fatigue,1 hypokalemia,1 40 hypomagnesemia,1 42 hypocalcemia,1 hyperglycemia,1 fluid overload,1 bacteremia,1 sepsis,1 cough,1 dyspnea,1 epistaxis,1 hematologic effects (thrombocytopenia,1 neutropenia1 anemia,1 febrile neutropenia1 ), increased AST,1 42 increased ALT,1 42 increased alkaline phosphatase,1 42 rash,1 pruritus,1 headache,1 insomnia,1 anxiety,1 hypotension,1 hypertension,1 back pain,1 tachycardia,1 injection site reactions (inflammation, phlebitis, thrombophlebitis).1 2 4 6 42
Substrate for and weak inhibitor of CYP3A in vitro; CYP3A plays minor role in metabolism in vivo.1 4 8
Pharmacokinetic interactions unlikely with drugs metabolized by CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4.1 4 5 18 19
Not an inhibitor or substrate of the P-glycoprotein transport system; pharmacokinetic interactions unlikely.1 4
Drug | Interaction | Comments |
|---|---|---|
Amphotericin | No effect on micafungin pharmacokinetics1 In vitro evidence of additive or synergistic antifungal effects against Aspergillus; no in vitro evidence of antagonism2 | Micafungin dosage adjustment not necessary1 |
Corticosteroids (prednisolone) | No evidence of pharmacokinetic interactions 1 | Micafungin dosage adjustment not necessary1 |
Fluconazole | No evidence of pharmacokinetic interactions with oral or IV fluconazole1 2 | Micafungin dosage adjustment not necessary1 |
Immunosuppressive agents (cyclosporine, mycophenolate, sirolimus, tacrolimus) | Cyclosporine: Decreased oral clearance and increased half-life of cyclosporine; no effect on micafungin pharmacokinetics17 Mycophenolate: No evidence of pharmacokinetic interactions1 Sirolimus: Increased sirolimus AUC; no effect on peak sirolimus plasma concentrations; no effect on micafungin pharmacokinetics1 Tacrolimus: No evidence of pharmacokinetic interactions 1 16 | Cyclosporine: Monitor cyclosporine concentrations when micafungin initiated or discontinued; adjust cyclosporine dosage as needed;17 20 40 micafungin dosage adjustment not necessary1 Mycophenolate: Micafungin dosage adjustment not necessary1 Sirolimus: Monitor for sirolimus toxicity and reduce sirolimus dosage if necessary;1 micafungin dosage adjustment not necessary1 Tacrolimus: Micafungin dosage adjustment not necessary1 |
Itraconazole | Increased itraconazole peak plasma concentration and AUC;1 no effect on micafungin pharmacokinetics1 | Monitor for itraconazole toxicity and reduce itraconazole dosage if necessary;1 micafungin dosage adjustment not necessary1 |
Nifedipine | Increased nifedipine peak plasma concentration and AUC; no effect on micafungin pharmacokinetics1 | Monitor for nifedipine toxicity and reduce nifedipine dosage if necessary; micafungin dosage adjustment not necessary1 |
Rifampin | No effect on micafungin pharmacokinetics1 | Micafungin dosage adjustment not necessary1 |
Ritonavir | No effect on micafungin pharmacokinetics1 | Micafungin dosage adjustment not necessary1 |
Voriconazole | No effect on pharmacokinetics of voriconazole or micafungin1 In vitro evidence of additive antifungal effects against Aspergillus;2 indifferent antifungal effects reported against Candida46 | Micafungin dosage adjustment not necessary1 |
Linear relationship between dose and AUC over dosage range of 50–150 mg daily and 3–8 mg/kg daily.1
85% of steady-state concentration usually achieved after 3 once-daily doses.1
AUC is approximately 23% larger in women compared with men, presumably because of lower body weight.1
Distributed into milk of lactating rats;21 not known whether distributed into human milk.1
>99%.1
Binds principally to albumin and to a lesser extent to α1-acid-glycoprotein; does not competitively displace bilirubin from albumin.1
Metabolized principally by arylsulfatase and catechol-O-methyltransferase;1 CYP3A plays only a minor role.1
Excreted principally in feces;1 71% of a dose eliminated in feces within 28 days.1
Adults: 13.4–17.2 hours.1
Geriatric adults: Pharmacokinetics in those 66–78 years of age similar to that reported in adults 20–24 years of age.1
Adults with moderate hepatic impairment (Child-Pugh score 7–9): Peak plasma concentration and AUC 22% lower than those reported with normal hepatic function.1 Pharmacokinetics not evaluated in patients with severe hepatic impairment.1
25°C (may be exposed to 15–30°C).1
Reconstituted solution may be stored in original vial for up to 24 hours at 25°C.1 Following dilution, protect from light and store for up to 24 hours at 25°C.1
Echinocandins (e.g., anidulafungin, caspofungin, micafungin) differ structurally and pharmacologically from other available antifungals.1 2 3 4
Inhibits synthesis of β-D-glucan an essential component of fungal cell walls that is not present in mammalian cells.1 2 3 5 6
May be fungistatic or fungicidal in action.2 3 4 24 27 28 36 37 38 39 40 41 Depending on the concentration, may be fungicidal against some Candida, but usually fungistatic against Aspergillus.24 27 28 36 37 38 39 40 41
Active in vitro against Candida, including C. albicans,1 2 27 28 C. dubliniensis,2 27 28 C. glabrata,1 2 27 28 C. guilliermondii,1 2 27 28 C. krusei,1 2 27 28 C. lusitaniae,2 27 28 C. metapsilosis,48 C. orthopsilosis,48 C. parapsilosis,1 2 27 28 47 48 and C. tropicalis.1 2 27 28
Active in vitro against Aspergillus, including A. fumigatus, A. flavis, A. niger, and A. terreus.2 3 4 5 8 14 25 27 28
Like other echinocandins, not active against Cryptococcus neoformans, Trichosporon, or zygomycetes.24 27 28 36 39 40 41
Potential for development of resistance not known.1 5 C. albicans with reduced susceptibility to micafungin reported after long-term treatment with the drug.1 22 27 41 Resistance also has developed in C. parapsilosis.47
Some C. albicans with reduced susceptibility to micafungin also have reduced susceptibility to caspofungin.22
Importance of informing patients about the possible benefits and risks associated with micafungin.1
Importance of informing patients about adverse potential effects associated with micafungin, including hypersensitivity reactions, hematologic effects, hepatic effects, and renal effects.1
Importance of informing the clinician if any unusual symptoms develop or if known symptoms persist or worsen.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, for IV infusion | 50 mg | Mycamine | Astellas |
100 mg | Mycamine | Astellas |
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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21. Astellas Pharma US. Mycamine (micafungin sodium) for injection. Deerfield, IL; 2005 Dec.
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35. Queiroz-Telles F, Berezin E, Leverger G et al. Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial. Pediatr Infect Dis J. 2008; 27:820-6. [PubMed 18679151]
36. Fromtling RA. Micafungin sodium (FK-463). Drugs Today (Barc). 2002; 38:245-57. [PubMed 12532193]
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43. Kaplan JE, Benson
