Glicerolo + Sodio Cloruro Diaco may be available in the countries listed below.
Glycerol is reported as an ingredient of Glicerolo + Sodio Cloruro Diaco in the following countries:
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Oxaliplatina Actavis may be available in the countries listed below.
Oxaliplatin is reported as an ingredient of Oxaliplatina Actavis in the following countries:
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Suprofene may be available in the countries listed below.
Suprofene (DCIT) is known as Suprofen in the US.
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Glossary
| DCIT | Denominazione Comune Italiana |
Amikacin Bidiphar may be available in the countries listed below.
Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Amikacin Bidiphar in the following countries:
International Drug Name Search
Generic Name: treprostinil injection (tre PROS ti nil)
Brand Names: Remodulin
Treprostinil dilates (or widens) the arteries and decreases the amount of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs.
Treprostinil is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.
Treprostinil may also be used for other purposes not listed in this medication guide.
Before using this medication, tell your doctor if you have low blood pressure, liver disease, or a bleeding or blood clotting disorder.
Treprostinil is given as an continuous (around-the-clock) injection using an infusion pump. The medicine enters the body through a catheter placed under your skin or into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how to use an infusion pump and inject your medicine.
Your doctor may want you to be in a hospital when you start using treprostinil. This is so you can be watched for any signs of serious side effects from the medicine.
Use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup infusion pump and infusion sets available so as not to interrupt your treatment if one infusion pump stops working.
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication:
low blood pressure;
bleeding or blood clotting disorder.
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. Your doctor may occasionally change your dose to make sure you get the best results.
Treprostinil is given as an continuous (around-the-clock) injection using an infusion pump. The medicine enters the body through a catheter placed under your skin or into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how to use an infusion pump and inject your medicine. Do not give yourself an injection if you do not understand these instructions. Call your doctor, nurse, or pharmacist for help with injection instructions.
Your doctor may want you to be in a hospital when you start using treprostinil. This is so you can be watched for any signs of serious side effects from the medicine.
Use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup infusion pump and infusion sets available so as not to interrupt your treatment if one infusion pump stops working.
Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Call your doctor for instructions if you miss a dose of treprostinil.
Overdose symptoms may include warmth and redness or tingling under your skin, headache, feeling light-headed, fainting, nausea, vomiting, diarrhea, or seizure (convulsions).
new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;
swelling in your hands or feet; or
feeling like you might pass out.
Less serious side effects may include:
pain, swelling, redness, bleeding, or a hard lump where your catheter is placed;
dizziness;
mild skin rash;
headache or jaw pain;
flushing (warmth, redness or tingling); or
diarrhea or nausea.
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.
Tell your doctor about all other medicines you use, especially:
gemfibrozil (Lopid);
a blood thinner such as warfarin (Coumadin);
blood pressure medication such as a diuretic (water pill); or
medication used to prevent blood clots, such as alteplase (Activase), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine), ticlopidine (Ticlid), and urokinase (Abbokinase).
This list is not complete and other drugs may interact with treprostinil. 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: Remodulin side effects (in more detail)
Silibinine may be available in the countries listed below.
Silibinine (DCF) is also known as Silibinin (Rec.INN)
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Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
M05BA05
0089987-06-4
C7-H9-Cl-O6-P2-S
318
Calcium regulator
Phosphonic acid, [[(4-chlorophenyl)thio]methylene]bis-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Enat may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Enat in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Chloramphenicol is reported as an ingredient of Chlora Tabs in the following countries:
International Drug Name Search
Setron may be available in the countries listed below.
Azithromycin is reported as an ingredient of Setron in the following countries:
Granisetron hydrochloride (a derivative of Granisetron) is reported as an ingredient of Setron in the following countries:
Ondansetron is reported as an ingredient of Setron in the following countries:
Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Setron in the following countries:
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Omeprazolo Actavis may be available in the countries listed below.
Omeprazole is reported as an ingredient of Omeprazolo Actavis in the following countries:
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Oflodis may be available in the countries listed below.
Ofloxacin is reported as an ingredient of Oflodis in the following countries:
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Perfan may be available in the countries listed below.
Enoximone is reported as an ingredient of Perfan in the following countries:
International Drug Name Search
Derasect may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Dimpylate is reported as an ingredient of Derasect in the following countries:
International Drug Name Search
Gabapentin Sandoz may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabapentin Sandoz in the following countries:
International Drug Name Search
Generic Name: Rufinamide
Class: Anticonvulsants, Miscellaneous
ATC Class: N03AF03
Chemical Name: 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide
Molecular Formula: C10H8F2N4O
CAS Number: 106308-44-5
REMS:
FDA approved a REMS for rufinamide to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
Anticonvulsant; a triazole derivative.1 6 7 9 10 11 12 13 14 15 17 18
Management (in combination with other anticonvulsants) of seizures associated with Lennox-Gastaut syndrome in adults and children ≥4 years of age.1 5 6 8 9 10 11 28 Designated an orphan drug by FDA for use in this condition.5 8 10
Has been studied with some success in the adjunctive management of refractory or inadequately controlled partial seizures† in adolescents and adults;6 7 10 11 12 13 16 17 18 19 21 22 24 25 29 30 further study needed to establish role in therapy.11 19
Withdraw rufinamide gradually to minimize the potential for increased seizure frequency or status epilepticus in patients with seizure disorders.1 (See Dosage under Dosage and Administration.) If abrupt discontinuance is necessary, closely supervise transition to another anticonvulsant.1
Closely monitor for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.1 2 3 4 20 (See Suicidality Risk under Cautions.)
Administer orally as tablets or oral suspension twice daily in equally divided doses with food.1
Administer scored tablets whole, as half tablets, or crushed.1 21
Scored tablets may not provide the exact mg/kg dosage that has been calculated for use in children; manufacturer's recommended dosages in children are therefore designated as approximate.1 21
Shake well prior to administration of each dose.1
Administer using bottle adapter and calibrated oral dosing syringe supplied by manufacturer.1
Firmly insert bottle adapter into neck of bottle before use; allow adapter to remain in place as long as bottle is in use (up to 90 days).1
To dispense dose, insert oral dosing syringe into adapter in upright bottle, then invert bottle and withdraw appropriate dose into oral dosing syringe.1 Replace cap over bottle adapter after each use.1 Consult manufacturer's patient information (medication guide) for detailed information on administration of oral suspension.1
Children ≥4 years of age: Initially, approximately 10 mg/kg daily administered in 2 equally divided doses.1 Increase daily dosage in increments of approximately 10 mg/kg every other day up to a target dosage of 45 mg/kg or 3.2 g daily, whichever is lower.1 Efficacy of dosages lower than the target dosage has not been established.1
Initiate therapy at a dosage lower than 10 mg/kg daily in children receiving valproic acid.1 11 (See Specific Drugs under Interactions.)
Reduce dosage gradually if discontinuing therapy.1 In clinical trials, rufinamide dosage was tapered by approximately 25% every other day.1
Initially, 400–800 mg daily administered in 2 equally divided doses.1 Increase dosage in increments of 400–800 mg daily every other day until a maximum dosage of 3.2 g daily is reached.1 Efficacy of dosages lower than 3.2 g daily has not been established.1
Initiate therapy at a dosage lower than 400 mg daily in adults receiving valproic acid.1 11 (See Specific Drugs under Interactions.)
Reduce dosage gradually if discontinuing therapy.1 In clinical trials, rufinamide dosage was tapered by approximately 25% every other day.1
Children ≥4 years of age: Maximum 45 mg/kg or 3.2 g daily, whichever is less.1
Maximum 3.2 g daily.1
Not studied in patients with hepatic impairment.1 21 Do not use in patients with severe hepatic impairment.1 21 (See Hepatic Impairment under Cautions.)
No dosage adjustment necessary in patients with renal impairment (Clcr <30 mL/minute).1 11 21
Consider dosage adjustment in hemodialysis patients; hemodialysis within 3 hours after a dose may reduce drug exposure to a limited extent (by about 30%).1 11 21
Select dosage carefully, usually initiating therapy at lower end of usual dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1 10
Familial short QT syndrome.1 21 (See Shortening of QT Interval under Cautions and see Drugs that Shorten QT Interval under Interactions.)
Increased risk of suicidality (suicidal behavior or ideation) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%).1 2 3 4 20 Increased suicidality risk was observed ≥1 week after initiation of anticonvulsant therapy and continued through 24 weeks.1 2 3 4 Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.1 2 4
Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression.1 2 3 4 20 Anxiety, agitation, hostility, hypomania, and mania may be precursors to emerging suicidality.2
Balance risk of suicidality with risk of untreated illness.1 2 Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality.1 20 If suicidal thoughts or behavior emerges during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself.1 20 (See Advice to Patients.)
Two general categories of adverse CNS effects reported: 1) somnolence or fatigue, and 2) coordination abnormalities, dizziness, gait disturbances, and ataxia.1 (See Suicidality Risk under Cautions.)
Multiorgan hypersensitivity syndrome reported with rufinamide and other anticonvulsants; presentation is variable but typically includes fever and rash associated with other organ system involvement.1 32
One case with rash, urticaria, facial edema, fever, elevated eosinophils, stuporous state, and severe hepatitis began on day 29 of rufinamide therapy;1 other possible cases (with rash accompanied by fever, elevated liver function test results, hematuria, and/or lymphadenopathy) reported in children <12 years of age within 4 weeks of treatment initiation.1 Cases resolved or improved following drug discontinuance.1
If multiorgan hypersensitivity reaction is suspected, discontinue rufinamide and initiate alternative treatment.1 21 Closely monitor patients who develop a rash.1 21
Shortening of QT interval reported;1 reported degree of shortening (mean of 20 msec at dosages ≥2.4 mg twice daily) is without known clinical risk.1 11
Familial short QT syndrome is associated with increased risk of sudden death and ventricular arrhythmias, particularly ventricular fibrillation, primarily when the corrected QT (QTc) interval is <300 msec.1 Nonclinical data indicate QT-interval shortening is associated with ventricular fibrillation.1
Manufacturer and some clinicians state that patients with familial short QT syndrome should not receive rufinamide; caution advised when administering rufinamide with other drugs that shorten the QT interval.1 11 21 28 Some clinicians recommend using rufinamide with caution in patients with a history of an abnormal ECG demonstrating QT-interval shortening or a family history of unexplained cardiac arrhythmia or sudden death.28 (See Contraindications under Cautions and also see Drugs that Shorten QT Interval under Interactions.)
Abrupt withdrawal of anticonvulsants may result in increased seizure frequency or status epilepticus in patients with seizure disorders.1 If discontinuing therapy, withdraw rufinamide gradually (see Dosage under Dosage and Administration).1 If abrupt discontinuance is necessary, closely supervise transition to another anticonvulsant.1
Incidence of treatment-emergent status epilepticus in rufinamide-treated patients is difficult to estimate because standard definitions were not employed in studies.1 9 Incidence of possible status epilepticus with rufinamide treatment was 4.1% in one study of Lennox-Gastaut syndrome and 0.9% across all controlled clinical trials of the drug.1
Category C.1
UCB AED Pregnancy Registry at 888-537-7734 (for clinicians and patients) and North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients); NAAED registry information also available on the website .1
Effect on labor and delivery is unknown.1
Likely to be distributed into milk.1 21 Discontinue nursing or the drug.1 21
Safety and efficacy not established in children <4 years of age.1 21
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.1 No clinically important differences in pharmacokinetics between healthy geriatric individuals and younger healthy adults.1
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1
Not studied in hepatic impairment.1 Use with caution in patients with mild to moderate hepatic impairment.1 Use in severe hepatic impairment not recommended.1
Renal impairment (Clcr <30 mL/minute) does not substantially alter pharmacokinetics; hemodialysis may reduce exposure.1 (See Renal Impairment under Dosage and Administration and also see Absorption: Special Populations and Elimination: Special Populations, under Pharmacokinetics.)
As adjunctive therapy in pediatric patients: Somnolence, headache, fatigue, dizziness, influenza, nasopharyngitis, nausea, vomiting, decreased appetite.1 6 9 10 11 13 14 15 21
As adjunctive therapy in adults: Headache, dizziness, fatigue, somnolence, diplopia, tremor, nystagmus, blurred vision, nausea, vomiting.1 6 9 10 11 13 14 15 21
Metabolized by carboxylesterases.1
Demonstrates little or no inhibition of most CYP isoenzymes.1 8 Weak inhibitor of CYP2E1;1 21 weak inducer of CYP3A4.1 11 14 21
Unlikely to be involved in clinically important pharmacokinetic interactions.1
Substrates of CYP2E1: Potential pharmacokinetic interaction (increased plasma substrate concentrations).1 21 (See Specific Drugs under Interactions.)
Substrates of CYP3A4: Potential pharmacokinetic interaction (decreased exposure of substrates).1 11 14 21 (See Specific Drugs under Interactions.)
Inducers of carboxylesterases: Potential pharmacokinetic interaction (increased rufinamide clearance); broad-spectrum inducers may have minor effects on rufinamide metabolism via this mechanism.1 (See Specific Drugs under Interactions.)
Inhibitors of carboxylesterases: Potential pharmacokinetic interaction (decreased rufinamide metabolism).1 8
Typical average steady-state plasma rufinamide concentrations generally have little effect on the pharmacokinetics of other anticonvulsants.1 Effects, when present, are more marked in pediatric patients.1 (See Specific Drugs under Interactions.)
Clinical importance of drug interactions between rufinamide and potentially interacting anticonvulsants is unknown; some clinicians recommend monitoring plasma concentrations of other anticonvulsants and rufinamide following initiation or withdrawal of anticonvulsant therapy if clinically warranted.28
Potential pharmacologic interaction; use concomitantly with caution.1 21 23 (See Specific Drugs under Interactions and see Shortening of QT Interval under Cautions.)
Pharmacokinetic interaction unlikely; not highly bound to plasma proteins.1
Drug | Interaction | Comments |
|---|---|---|
Benzodiazepines | Clinically important pharmacokinetic interactions with benzodiazepines unlikely; possible additive CNS effects1 13 21 24 Clonazepam: Pharmacokinetic interaction unlikely6 13 24 Triazolam: Decreased triazolam AUC (by 37%) and peak plasma concentrations (by 23%)1 11 12 | |
Carbamazepine | Decreased plasma carbamazepine concentrations (by 7–13%)1 Decreased plasma rufinamide concentrations (by 19–26% depending on carbamazepine dosage)1 | |
Chlorzoxazone | Possible increased plasma chlorzoxazone concentrations1 21 | |
CNS agents (e.g., alcohol, benzodiazepines) | Possible additive CNS effects (e.g., sedation)1 21 | |
Contraceptives, oral | Decreased AUC and peak plasma concentrations of ethinyl estradiol (by 22 and 31%, respectively) and norethindrone (by 14 and 18%, respectively)1 8 10 11 12 14 15 18 23 | Additional nonhormonal contraceptive methods recommended1 10 21 |
Digoxin | Possible additive effect on shortening of QT-interval1 21 23 | Use concomitantly with caution1 21 23 |
Lamotrigine | Decreased plasma lamotrigine concentrations (by 7–13%)1 Possible additive effect on shortening of QT-interval1 21 23 | Use concomitantly with caution1 21 23 |
Magnesium | Possible additive effect on shortening of QT-interval1 21 23 | Use concomitantly with caution1 21 23 |
Mexiletine | Possible additive effect on shortening of QT-interval1 21 23 | Use concomitantly with caution1 21 23 |
Olanzapine | Pharmacokinetic interaction unlikely1 8 12 14 18 | |
Oxcarbazepine | Pharmacokinetic interaction unlikely6 13 24 | |
Phenobarbital | Increased plasma phenobarbital concentrations (by 8–13%)1 Decreased plasma rufinamide concentrations (by 25–46% independent of phenobarbital dosage or concentration)1 | |
Phenytoin | Increased plasma phenytoin concentrations (by 7–21%)1 Decreased plasma rufinamide concentrations (by 25–46% independent of phenytoin dosage or concentration)1 | US manufacturer states routine dosage adjustment not recommended;1 others state reduction in phenytoin dosage may be considered33 |
Primidone | Decreased plasma rufinamide concentrations (by 25–46% independent of primidone dosage or concentration)1 | |
Ranolazine | Possible additive effect on shortening of QT-interval1 21 23 | Use concomitantly with caution1 21 23 |
Topiramate | Pharmacokinetic interaction unlikely1 | |
Valproate | Increased plasma rufinamide concentrations (by <16 to 70% depending on valproate concentration); may be more pronounced in pediatric patients1 10 11 12 13 14 16 18 21 23 24 26 27 | In patients stabilized on rufinamide, initiate valproic acid at low dosage and titrate to clinically effective dosage1 In patients receiving valproic acid, initiate rufinamide at dosage <400 mg daily in adults and <10 mg/kg daily in children1 11 |
Well absorbed following oral administration; peak plasma concentrations occur 4–6 hours after a dose.1 Extent of absorption decreases with increasing doses.1
Food increased the extent of absorption and peak exposure of a single 400-mg dose by 34 and 56%, respectively.1
Under fed conditions, ≥85% of a single 600-mg dose was absorbed.1
Peak plasma concentrations and AUC are decreased by 16 and 29%, respectively, at 3 hours after a hemodialysis session.1
34% (mainly albumin).1 6
Extensively metabolized, primarily via carboxylesterase-mediated hydrolysis of the carboxylamide group to an inactive acid derivative (GCP 47292).1 6 8 10 11 12 13 14 15 16 17 18 21 Metabolic pathways do not involve CYP isoenzymes and glutathione.1 6 8 10 12 16 18
Eliminated principally in urine (85%), mostly as metabolites (≥66% as CGP 47292); only 2% of dose is excreted as unchanged drug.1 6 8 10 11 12 13 15 16 17 18 21
Approximately 6–10 hours.1 6
Effect of hepatic impairment on pharmacokinetics not evaluated.1
Renal impairment (Clcr <30 mL/minute) does not substantially alter pharmacokinetics; hemodialysis may reduce exposure (see Absorption: Special Populations under Pharmacokinetics).1
Pharmacokinetics in pediatric patients 4–17 years of age similar to pharmacokinetics in adults.1
No clinically important pharmacokinetic differences between healthy geriatric individuals and younger healthy adults.1
25°C (may be exposed to 15–30°C).1
25°C (may be exposed to 15–30°).1 Protect from moisture.1
Triazole-derivative anticonvulsant; structurally unrelated to other currently available anticonvulsants.1 6 7 9 10 11 12 13 14 15 16 17 18 21 28
Exact mechanism(s) of anticonvulsant action is unknown, but may involve modulation of sodium channel activity and, in particular, prolongation of the inactive state of the channel.1 6 7 9 10 11 12 13 14 15 16 17 18 21
Does not appear to substantially interact with monoaminergic, cholinergic, histaminergic, glycine, GABA, or glutamate receptors or systems.6 7 10 13 14 17 18
Importance of providing copy of written patient information (medication guide) each time rufinamide is dispensed.1 20 31 Importance of patients reading this information prior to taking the drug.1 31
Risk of suicidality (anticonvulsants, including rufinamide, may increase risk of suicidal thoughts or actions in about 1 in 500 people).1 2 20 34 Importance of patients, family members, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one's life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).1 2 34
Risk of multiorgan hypersensitivity reactions.1 34 Importance of notifying clinician if rash (with or without fever) occurs.1 34
Importance of taking rufinamide only as prescribed.1 34
Importance of taking rufinamide with food.1 31 Importance of informing patients that rufinamide scored tablets may be swallowed whole, broken in half, or crushed.1 31 Importance of instructing patients in proper techniques for administration of the oral suspension, including use of the bottle adapter and oral dosing syringe.1
When applicable, advise patients that rufinamide oral suspension does not contain lactose, gluten, or carbohydrates and is dye-free.1
Risk of sleepiness, difficulty with coordination, and dizziness; importance of advising patients to avoid driving or operating machinery until they gain experience with the drug's effects.1 21 Risk of additive CNS effects (e.g., sedation) if used with alcohol or other drugs that affect the CNS.1 21 34
Importance of informing patients not to stop taking rufinamide without first talking to their clinician since stopping the drug suddenly can cause serious problems, including seizures.1 31 34
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Importance of clinicians informing women about the existence of and encouraging enrollment in pregnancy registries (see Pregnancy under Cautions).1 Potential increased risk of pregnancy in women taking hormonal contraceptives; importance of discussing use of additional contraceptive methods.1 10 21
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., hepatic disease, depression, bipolar disorder), family history of suicidality or bipolar disorder, or current diagnosis or history of familial short QT syndrome.1 31 34
Importance of advising patients of other important precautionary information.1 (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 |
|---|---|---|---|---|
Oral | Suspension | 40 mg/mL | Banzel | Eisai |
Tablets, film-coated | 200 mg | Banzel (scored) | Eisai | |
400 mg | Banzel (scored) | Eisai |
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 October 27, 2011. 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.
1. Eisai Co., Ltd. Banzel (rufinamide) tablets prescribing information. Woodcliff Lake, NJ; 2011 Mar.
2. Food and Drug Administration. FDA Alert: Information for healthcare professionals: suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.
3. Food and Drug Administration. FDA News: FDA alerts health care providers to risk of suicidal thoughts and behavior with antiepileptic medications. Rockville, MD; 2008 Jan 31. From the FDA website.
4. Food and Drug Administration. FDA Alert: Suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.
5. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97 414). Rockville, MD. From FDA website. Accessed 2009 Apr 22.
6. Heaney D, Walker MC. Rufinamide. Drugs Today (Barc). 2007; 43:455-60. [PubMed 17728846]
7. Rogawski MA. Diverse mechanisms of antiepileptic drugs in the development pipeline. Epilepsy Res. 2006; 69:273-94. [PubMed 16621450]
8. Perucca E, Cloyd J, Critchley D et al. Rufinamide: clinical pharmacokinetics and concentration-response relationships in patients with epilepsy. Epilepsia. 2008; 49:1123-41. [PubMed 18503564]
9. Glauser T, Kluger G, Sachdeo R et al. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology. 2008; 70:1950-8. [PubMed 18401024]
10. Cheng-Hakimian A, Anderson GD, Miller JW. Rufinamide: pharmacology, clinical trials, and role in clinical practice. Int J Clin Pract. 2006; 60:1497-501. [IDIS 564203] [PubMed 17073844]
11. . Rufinamide (Banzel) for epilepsy. Med Lett Drugs Ther. 2009; 51:18-20. [PubMed 19265777]
12. Deeks ED, Scott LJ. Rufinamide. CNS Drugs. 2006; 20:751-60; discussion 761. [PubMed 16953653]
13. Hakimian S, Cheng-Hakimian A, Anderson GD et al. Rufinamide: a new anti-epileptic medication. Expert Opin Pharmacother. 2007; 8:1931-40. [PubMed 17696794]
14. Johannessen Landmark C, Johannessen SI. Pharmacological management of epilepsy: recent advances and future prospects. Drugs. 2008; 68:1925-39. [PubMed 18778117]
15. Chung AM, Eiland LS. Use of second-generation antiepileptic drugs in the pediatric population. Paediatr Drugs. 2008; 10:217-54. [PubMed 18590343]
16. Bialer M, Johannessen SI, Kupferberg HJ et al. Progress report on new antiepileptic drugs: a summary of the Eighth Eilat Conference (EILAT VIII). Epilepsy Res. 2007; 73:1-52. [PubMed 17158031]
17. Bialer M, Johannessen SI, Kupferberg HJ et al. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001; 43:11-58. [PubMed 11137386]
18. Arroyo S. Rufinamide. Neurotherapeutics. 2007; 4:155-62. [PubMed 17199032]
19. Pålhagen S, Canger R, Henriksen O et al. Rufinamide: a double-blind, placebo-controlled proof of principle trial in patients with epilepsy. Epilepsy Res. 2001; 43:115-24. [PubMed 11164700]
20. Food and Drug Administration. Suicidal behavior and ideation and antiepileptic drugs: update 5/5/2009. Rockville, MD; 2009 May 5. From the FDA website.
21. Hussar DA, Bilbow C. New drugs: Febuxostat, lacosamide, and rufinamide. J Am Pharm Assoc. 2009; 49:460-3.
22. Glauser T, Kluger G, Sachdeo R et al. Open-label study of the efficacy and safety of rufinamide adjunctive therapy in patients with Lennox-Gastaut syndrome. Epilepsia. 2005; 46 (Suppl. 6):408. Abstr. p1356.
23. Eisai Inc., Woodcliff Lake, NJ: Personal communication.
24. Luszczki JJ. Third-generation antiepileptic drugs: mechanisms of action, pharmacokinetics and interactions. Pharmacol Rep. 2009 Mar-Apr; 61:197-216. [PubMed 19443931]
25. Herman ST. Adopting an orphan drug: rufinamide for lennox-gastaut syndrome. Epilepsy Curr. 2009 May-Jun; 9:72-4. [PubMed 19471615]
26. Kluger G, Bauer B. Role of rufinamide in the management of Lennox-Gastaut syndrome (childhood epileptic encephalopathy). Neuropsychiatr Dis Treat. 2007; 3:3-11. [PubMed 19300535]
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Mycocin may be available in the countries listed below.
Nystatin is reported as an ingredient of Mycocin in the following countries:
International Drug Name Search
Brisking may be available in the countries listed below.
Aripiprazole is reported as an ingredient of Brisking in the following countries:
International Drug Name Search
Picetam may be available in the countries listed below.
Piracetam is reported as an ingredient of Picetam in the following countries:
International Drug Name Search
Chloortalidon A may be available in the countries listed below.
Chlortalidone is reported as an ingredient of Chloortalidon A in the following countries:
International Drug Name Search
Doxycyclin Chevita may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Doxycycline hyclate (a derivative of Doxycycline) is reported as an ingredient of Doxycyclin Chevita in the following countries:
International Drug Name Search
Masti-Safe may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cefapirin benzathine (a derivative of Cefapirin) is reported as an ingredient of Masti-Safe in the following countries:
International Drug Name Search
Gabapentina Ratiopharm may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabapentina Ratiopharm in the following countries:
International Drug Name Search
Zamoxy may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Zamoxy in the following countries:
International Drug Name Search
Oxaliplatine Mylan may be available in the countries listed below.
Oxaliplatin is reported as an ingredient of Oxaliplatine Mylan in the following countries:
International Drug Name Search
Generic Name: estradiol injection (ess tra DYE ol)
Brand Names: Clinagen LA 40, Delestrogen, Dep Gynogen, Depo-Estradiol, Estragyn LA 5, Gynogen LA 20, Menaval-20
Estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.
Estradiol injection is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to treat a lack of estrogen that is caused by ovarian failure or a condition called hypogonadism. Some forms of estradiol injection are used in men to treat the symptoms of prostate cancer.
Estradiol injection may also be used for other purposes not listed in this medication guide.
Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol injection.
Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol.
a bleeding or blood-clotting disorder;
a history of stroke or circulation problems;
abnormal vaginal bleeding that a doctor has not checked; or
any type of breast, uterine, or hormone-dependent cancer.
Before using estradiol injection, tell your doctor if you have:
high blood pressure, angina, or heart disease;
high cholesterol or triglycerides;
asthma;
epilepsy or other seizure disorder;
migraines;
diabetes;
depression;
gallbladder disease; or
if you have had your uterus removed (hysterectomy).
If you have any of these conditions, you may need a dose adjustment or special tests to safely use estradiol injection.
Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol injection.
Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
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. Follow the directions on your prescription label.
Estradiol injection is given as an shot into a muscle. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
This medicine is usually given once every 4 weeks. Follow your doctor's instructions.
Do not draw your estradiol dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol injection.
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.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using estradiol injection.
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
pain or swelling in your lower leg;
abnormal vaginal bleeding;
pain, swelling, or tenderness in your stomach;
jaundice (yellowing of the skin or eyes); or
a lump in your breast.
Less serious side effects may include:
nausea, vomiting, loss of appetite;
swollen breasts;
acne or skin color changes;
decreased sex drive, impotence, or difficulty having an orgasm;
migraine headaches or dizziness;
vaginal pain, dryness, or discomfort;
swelling of your ankles or feet;
depression; or
changes in your menstrual periods, break-through bleeding.
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.
Before using estradiol injection, tell your doctor if you are using any of the following drugs:
St. John's wort;
phenobarbital (Luminal, Solfoton);
a blood thinner such as warfarin (Coumadin);
ritonavir (Norvir);
carbamazepine (Carbatrol, Tegretol);
rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox).
This list is not complete and there may be other drugs that can interact with estradiol injection. 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: Depo-Estradiol side effects (in more detail)
Gabrilen may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Gabrilen in the following countries:
International Drug Name Search
Desamon may be available in the countries listed below.
Didecyldimethylammonium Chloride is reported as an ingredient of Desamon in the following countries:
Isopropyl Alcohol is reported as an ingredient of Desamon in the following countries:
International Drug Name Search
Volon A may be available in the countries listed below.
Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Volon A in the following countries:
Triamcinolone 16α,17α-acetonide 21-phosphate dipotassium salt (a derivative of Triamcinolone) is reported as an ingredient of Volon A in the following countries:
International Drug Name Search
Xylapan may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Xylazine hydrochloride (a derivative of Xylazine) is reported as an ingredient of Xylapan in the following countries:
International Drug Name Search
Fluconazol axcount may be available in the countries listed below.
Fluconazole is reported as an ingredient of Fluconazol axcount in the following countries:
International Drug Name Search
Nolvac may be available in the countries listed below.
Amlodipine maleate (a derivative of Amlodipine) is reported as an ingredient of Nolvac in the following countries:
International Drug Name Search
Gaspron may be available in the countries listed below.
Omeprazole is reported as an ingredient of Gaspron in the following countries:
International Drug Name Search
Treating certain bacterial infections. It may be used in combination with other medicines to treat acne or certain amoeba infections. It may be used to prevent certain types of malaria in travelers who will be visiting malaria-infected areas for less than 4 months. It may also be used to prevent or slow the progression of anthrax after exposure.
Doryx Delayed-Release Tablets are a tetracycline antibiotic. It works by slowing the growth of bacteria. Slowing the bacteria's growth allows the body's immune system to destroy the bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Doryx Delayed-Release Tablets. 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 Doryx Delayed-Release Tablets. 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 Doryx Delayed-Release Tablets 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 Doryx Delayed-Release Tablets 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 Doryx Delayed-Release Tablets.
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:
Loss of appetite; nausea; sensitivity to sunlight; vomiting.
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.
See also: Doryx side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Doryx Delayed-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Doryx Delayed-Release Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Doryx Delayed-Release Tablets. 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.
