Sunday, 18 March 2012

Sultrin Triple Sulfa


Generic Name: triple sulfa vaginal (TRIH pull SUL fa)

Brand Names: Gyne Sulf, Sultrin Triple Sulfa, Trysul, V.V.S.


What is Sultrin Triple Sulfa (triple sulfa vaginal)?

Triple sulfa is an antibacterial medication. It fights bacteria in the body.


Triple sulfa vaginal is used to treat vaginal infections caused by the bacteria Gardnerella vaginalis.


Triple sulfa vaginal may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Sultrin Triple Sulfa (triple sulfa vaginal)?


Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (such as pantyhose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.


Avoid getting this medication in the eyes, nose, or mouth.

What should I discuss with my healthcare provider before using Sultrin Triple Sulfa (triple sulfa vaginal)?


Do not use triple sulfa vaginal if you have ever had an allergic reaction to it or to another sulfa-based medicine.


Triple sulfa vaginal is in the FDA pregnancy category C. This means that it is not known whether triple sulfa vaginal will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. Triple sulfa passes into breast milk and may affect a nursing baby. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use Sultrin Triple Sulfa (triple sulfa vaginal)?


Use triple sulfa vaginal exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.


Insert the tablet or cream into the vagina using the applicator as directed. Triple sulfa vaginal is usually used twice a day, in the morning and evening.

Use this medication continuously for the prescribed amount of time, even during your menstrual period.


A sanitary napkin can be worn to prevent the medication from staining clothing but do not use a tampon.


If the infection does not clear up after one course of therapy has been finished, or if it appears to get worse, see your doctor. You may have another type of infection.


Avoid getting this medication in the eyes, nose, or mouth. Store triple sulfa vaginal at room temperature away from moisture and heat.

What happens if I miss a dose?


Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not use a double dose.


What happens if I overdose?


An overdose of triple sulfa vaginal is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that triple sulfa vaginal has been ingested, contact an emergency room or a poison control center.


What should I avoid while using Sultrin Triple Sulfa (triple sulfa vaginal)?


Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.


Avoid sexual intercourse or use a condom to prevent spreading the infection to a sexual partner.


Sultrin Triple Sulfa (triple sulfa vaginal) side effects


Stop using triple sulfa vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.


Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Sultrin Triple Sulfa (triple sulfa vaginal)?


Avoid using other vaginal creams or douches during treatment with triple sulfa, unless otherwise directed by your doctor.


Drugs other than those listed here may also interact with triple sulfa vaginal. Talk to your doctor and pharmacist before taking any prescription or over the counter medicines, including herbal products.



More Sultrin Triple Sulfa resources


  • Sultrin Triple Sulfa Support Group
  • 0 Reviews for Sultrin Triple Sulfa - Add your own review/rating


Compare Sultrin Triple Sulfa with other medications


  • Bacterial Vaginitis


Where can I get more information?


  • Your pharmacist has additional information about triple sulfa vaginal written for health professionals that you may read.

What does my medication look like?


Triple sulfa vaginal is available with a prescription under several brand names. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



  • Sultrin Triple Sulfa vaginal tablets




  • Sultrin Triple Sulfa vaginal cream




  • Dayto Sulfa vaginal cream




  • Gyne-Sulf vaginal cream




  • Trysul vaginal cream




  • V.V.S. vaginal cream




Saturday, 10 March 2012

Colofac Tablets 135mg







Colofac tablets 135 mg



mebeverine hydrochloride



What you should know about Colofac Tablets


This leaflet is about your medicine, Colofac Tablets 135 mg.


Please read it as it gives you some important information. Please keep this leaflet as you may want to read it again. If you have any questions or are not sure about anything, ask your doctor or a pharmacist.





What is in Colofac Tablets 135 mg?



The tablets are white, round, and sugar coated.



Each tablet contains 135 mg mebeverine hydrochloride. The tablets also contain lactose, starch, povidone, talc, magnesium stearate. The sugar coating contains talc, sucrose, gelatin, acacia, carnauba wax.



Each pack contains 100 tablets.



The marketing authorisation holder is




Solvay Healthcare Limited


Southampton

SO18 3JD



Manufactured by




Solvay Pharmaceuticals


01400 Chatillon-sur-Chalaronne


France


trade mark




What do Colofac Tablets 135 mg do?


Your medicine is one of a group of medicines called antispasmodics. This medicine is used as treatment for the symptoms of irritable bowel syndrome and other conditions usually included in this grouping, such as: chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. This is a very common condition which causes spasm and pain in the gut or intestine.


The intestine is a long muscular tube which squeezes rhythmically so that food can pass down it to be digested. If the intestine goes into spasm and squeezes too tightly, you get pain. The way anti-spasmodic medicines work is by relieving the spasm and pain.




Before you take Colofac Tablets 135 mg


Do not take if:


You are allergic to lactose (also found in dairy products) or any of the other tablet ingredients. Talk to your doctor if:


  • You are pregnant, or planning to become pregnant

  • You have had any diseases of the bowel, apart from irritable bowel syndrome (IBS)


Other important information


This medicine contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine




Questions you may have about Colofac Tablets 135 mg


Can I continue to drink alcohol? Yes


Will the tablets make me drowsy? No - your responses will not be affected - you may still drive or operate machinery.





How to take Colofac Tablets 135 mg


Follow your doctor's instructions. The normal starting dose for adults (including the elderly), and children over 10 years, is one tablet three times a day. This may be gradually reduced after a few weeks when the desired effect has been obtained. Do not give to children under 10 years.


The tablets are best taken 20 minutes before meals as some patients find their symptoms are strongest after they have eaten. Swallow the tablets with water: do not chew them.


If you miss a dose, take it when you remember. If the next dose is nearly due, ignore the missed dose and carry on as normal with the next dose.


Do not stop taking the tablets without consulting your doctor, even if you feel better.


If you, or someone else, takes too many Colofac Tablets 135 mg, you should contact a doctor immediately or go to the nearest hospital casualty department. Take the Colofac Tablets 135 mg packaging with you.




After taking your Colofac Tablets 135 mg


Very rarely, people taking this medicine may develop allergic reactions. These may include inflamed or reddened skin, itching or skin rashes. If you develop swelling of the face, lips and/or tongue, stop taking your tablets and contact your doctor immediately. If you notice these or any other side effects not mentioned in this leaflet, tell your doctor or a pharmacist.




How to store Colofac Tablets 135 mg


Do not store above 30°C. Store in original container.


Do not take your medicine after the expiry date on the carton or blister.


Keep all medicines where children cannot see or reach them.


Return any unused tablets to a pharmacist.



This leaflet was revised in July 2006.



Remember


This medicine is for you. Please do not offer it to your family and friends, even if they have the same symptoms as you.


1034148 CL450





Friday, 9 March 2012

Ampyra


Generic Name: Dalfampridine
Class: Other Miscellaneous Therapeutic Agents
Chemical Name: 4-aminopyridine
Molecular Formula: C5H6N2
CAS Number: 504-24-5


REMS:


FDA approved a REMS for dalfampridine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of dalfampridine and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Dalfampridine was formerly known as fampridine (4-aminopyridine; 4-AP);1 13 14 broad spectrum potassium channel blocker.1 13 14 22


Uses for Ampyra


Multiple Sclerosis


Used to improve walking in patients with multiple sclerosis (MS) (designated an orphan drug by FDA for this use).1 23


In clinical studies in MS patients who received the recommended dalfampridine dosage, walking improvement was demonstrated by increased walking speed in a timed 25-foot walk (T25FW).1 2 3 20 In those who responded to dalfampridine (approximately 35–43%), walking speed increased 25–29%2 3 20 and was maintained until the drug was discontinued.2 20


Although only a portion of MS patients respond to dalfampridine treatment with walking improvement, improved walking during such treatment has been demonstrated in all MS disease types (relapsing remitting, primary progressive, secondary progressive, progressive relapsing).2 20 It is not clear what magnitude of improvement in walking speed results in improved walking ability or quality of life.20 Although consistent improvements in walking speed were shown to be associated with improvements on patient self-assessment of ambulatory disability (12-item Multiple Sclerosis Walking Scale; MSWS-12), the average MSWS-12 score during dalfampridine treatment was not different than that reported with placebo.1 20


The magnitude of walking improvement reported with dalfampridine is independent of concomitant therapy with biologic response modifiers used for the management of MS (interferon, glatiramer acetate, natalizumab).1 2


Data insufficient regarding safety and efficacy for management of other MS symptoms (e.g., motor function assessed using manual muscle testing, visual function, cognitive function, fatigue).6 12 14 18 20


Ampyra Dosage and Administration


General



  • Determine estimated Clcr prior to initiation of dalfampridine.1 (See Renal Impairment under Cautions.)



Restricted Distribution



  • Distribution of dalfampridine is restricted; the drug is available only through certain specialty pharmacies.21 22 Specific information regarding the dalfampridine distribution process is available from the manufacturer at 888-881-1918 or .21




  • FDA required and approved a Risk Evaluation and Mitigation Strategy (REMS) for dalfampridine;22 goals of the dalfampridine REMS are to inform patients and health-care providers about serious risks associated with dalfampridine (e.g., risk of seizures) (see Cautions) and to inform health-care providers about the change in the established name from fampridine to dalfampridine.22 The REMS requires that a dalfampridine medication guide be provided to patient each time the drug is dispensed and outlines a communication plan requiring initial and periodic communications from manufacturer to certain targeted groups of prescribers and pharmacists.22



Administration


Oral Administration


Administer orally with or without food.1 (See Food under Pharmacokinetics.)


Give doses approximately 12 hours apart.1


Swallow whole tablet; do not divide, crush, chew, or dissolve.1


If a dose is missed, do not double dosage or take extra doses.1 Take the next dose at the regularly scheduled time.1


Dosage


Adults


Multiple Sclerosis

Treatment to Improve Walking

Oral

10 mg twice daily.1 Give doses approximately 12 hours apart.1


Has been used for up to 9–14 weeks in clinical studies.1 2 3


Prescribing Limits


Adults


Oral

Maximum 10 mg twice daily with doses given approximately 12 hours apart.1 Higher dosage does not result in additional therapeutic benefit and is associated with increased risk of adverse reactions (e.g., seizures).1 (See Seizures under Cautions.)


Special Populations


Hepatic Impairment


Pharmacokinetics not evaluated in adults with hepatic impairment.1 Hepatic impairment not expected to affect pharmacokinetics or dosage recommendations.1


Renal Impairment


Contraindicated in patients with moderate or severe renal impairment (Clcr ≤50 mL/minute).1


In patients with mild renal impairment (Clcr 51–80 mL/minute), total body clearance of dalfampridine is reduced by about 45% and plasma concentrations may approach those seen with doses that may be associated with an increased risk of seizures.1 (See Renal Impairment under Cautions.) Manufacturer does not provide dosage recommendations for such patients.1 Only available as a preparation containing 10 mg of dalfampridine.1


Geriatric Patients


Dosage modification not necessary in patients ≥65 years of age based solely on age.1 Eliminated by kidneys;1 consider that geriatric patients are more likely to have decreased renal function.1 (See Renal Impairment under Dosage and Administration.)


Cautions for Ampyra


Contraindications



  • History of seizures.1 (See Seizures under Cautions.)




  • Moderate or severe renal impairment (Clcr ≤50 mL/minute).1 (See Renal Impairment under Cautions.)



Warnings/Precautions


Seizures


Seizures reported in patients receiving dalfampridine.1 2 3 4 8 Incidence of seizures appears to be dose-related.1 3 4 12


Altered mental state, confusion, and seizures (including status epilepticus requiring intensive supportive care) reported following overdosage.1 8


Seizures reported rarely with recommended dosage (10 mg twice daily);1 2 increased risk of seizures at higher dosage (e.g., 15 or 20 mg twice daily).1 In open-label extension studies in MS patients, incidence of seizures was more than 4 times greater at a dosage of 15 mg twice daily compared with a dosage of 10 mg twice daily.1


Contraindicated in patients with prior history of seizures.1 Has not been evaluated in patients with a history of seizures or with evidence of epileptiform activity on EEG; such patients were excluded from clinical trials.1 Risk of seizures in patients with epileptiform activity on EEG is unknown and could be substantially higher than that observed in clinical trials.1


Risk of seizures in patients with mild renal impairment (Clcr 51–80 mL/minute) who receive usual dosage is unknown.1 (See Renal Impairment under Cautions.)


If a seizure occurs, discontinue dalfampridine and do not restart the drug.1


Concurrent Treatment with Other Aminopyridines


Because of increased risk of dose-related adverse effects, do not use in patients receiving other aminopyridines, including extemporaneously prepared formulations; dalfampridine formerly was known as fampridine (4-aminopyridine, 4-AP), since the active ingredient is the same.1


Prior to initiation of dalfampridine, discontinue use of any product containing 4-aminopyridine.1


Urinary Tract Infections


Urinary tract infections reported more frequently in patients receiving dalfampridine (12%) than in patients receiving placebo (8%).1


Specific Populations


Pregnancy

Category C.1


In animal studies, decreased offspring viability and growth reported at a dosage similar to maximum recommended human dosage.1


Lactation

Not known whether distributed into human milk.1 Discontinue nursing or the drug.1


Pediatric Use

Safety and efficacy not established in patients <18 years of age.1


Geriatric Use

Insufficient experience with dalfampridine in geriatric patients ≥65 years of age to determine whether such individuals respond differently than younger individuals.1


Substantially eliminated by kidneys;1 11 geriatric patients are more likely to have decreased renal function.1 Because risk of adverse reactions (including seizures) may be greater in patients with impaired renal function,1 it is particularly important to determine estimated Clcr in this age group prior to initiation of dalfampridine.1 (See Renal Impairment under Cautions.)


Hepatic Impairment

Pharmacokinetics not evaluated in patients with hepatic impairment.1 Hepatic impairment not expected to affect pharmacokinetics or dosage recommendations.1


Renal Impairment

Clearance of dalfampridine is decreased in patients with renal impairment and is correlated with Clcr.1


Prior to initiation of dalfampridine, determine estimated Clcr (e.g., Cockcroft-Gault equation).1


Contraindicated in patients with moderate or severe renal impairment (Clcr ≤50 mL/minute).1


In patients with mild renal impairment (Clcr 51–80 mL/minute), plasma concentrations attained with usual dosage (10 mg twice daily) may approach those seen with 15 mg twice daily, a dosage that may be associated with an increased risk of seizures.1 (See Seizures under Cautions.) Manufacturer does not provide dosage recommendations for patients with mild renal impairment.1 Only available as a preparation containing 10 mg of dalfampridine.1


Common Adverse Effects


Urinary tract infections,1 2 3 insomnia,1 2 3 5 12 dizziness,1 2 3 5 9 12 headache,1 2 3 9 12 nausea,1 2 3 5 12 asthenia,1 2 3 9 12 tremor,12 fatigue,2 3 upper respiratory tract infection,2 3 back pain,1 2 balance disorder,1 2 3 MS relapse or worsening,1 3 paresthesia,1 3 5 12 muscle spasm,3 peripheral edema,3 nasopharyngitis,1 constipation,1 dyspepsia,1 pharyngolaryngeal pain.1


Interactions for Ampyra


Metabolized by CYP isoenzyme 2E1 and, possibly, other unidentified CYP isoenzymes.1


Does not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4/5;1 does not induce 1A2, 2B6, 2C9, 2C19, 2E1, or 3A4/5.1


Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes


Pharmacokinetic interactions unlikely with drugs metabolized by CYP isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5.1


Drugs Affecting or Affected by P-glycoprotein Transport


Not an inhibitor or substrate of the P-glycoprotein transport system; pharmacokinetic interactions unlikely with drugs that are inhibitors or substrates of this transport system.1


Specific Drugs












Drug



Interaction



Comments



Baclofen



Concomitant use does not affect pharmacokinetics of either drug1



Interferon beta



Concomitant use of sub-Q interferon beta-1b does not affect pharmacokinetics of dalfampridine1


Ampyra Pharmacokinetics


Absorption


Bioavailability


Rapidly and completely absorbed from GI tract.1 9 10 11


Bioavailability of dalfampridine (formerly known as fampridine [4-aminopyridine; 4-AP]) extended-release tablets is 96% compared with an extemporaneously prepared aqueous oral solution of the drug.1


Extended-release dalfampridine tablets result in delayed absorption and a slower increase to lower peak plasma concentrations compared with an aqueous oral solution of the drug; extent of absorption (AUC) is not affected.1 9 11


Plasma concentrations and AUC increase proportionally with dose.1 9 12 13


Pharmacokinetics in adults with MS similar to that reported in healthy adults.1 9


In adults 29–56 years of age with MS who received a single 10-mg dalfampridine extended-release tablet, mean peak plasma concentration was 25.23 ng/mL and was attained 3.92 hours after the dose.9 In healthy fasting adults, a single 10-mg extended-release tablet of the drug resulted in peak concentrations of 17.3–21.6 ng/mL occurring 3–4 hours after the dose.1 11


Food


Administration of a dalfampridine extended-release tablet with food results in a 12–17% increase in peak plasma concentrations and a 4–7% decrease in AUC of the drug; not considered clinically important.1


Distribution


Extent


Studies using IV dalfampridine indicate the drug is distributed into CSF.13


Not known whether distributed into human milk.1


Plasma Protein Binding


1–3% bound to plasma proteins.1


Elimination


Metabolism


A small portion of a dalfampridine dose is metabolized by CYP isoenzymes to 3-hydroxy-4-aminopyridine and 3-hydroxy-4-aminopyridine sulfate.1 These metabolites have no pharmacologic activity on potassium channels.1 In vitro studies indicate CYP2E1 is the major enzyme responsible for 3-hydroxylation of dalfampridine; other unidentified CYP enzymes play a minor role in 3-hydroxylation of the drug.1


Elimination Route


Following oral administration, 95.9% of a dalfampridine dose is eliminated in urine and 0.5% is eliminated in feces.1


The majority of the dose is eliminated in urine (90.3%) as unchanged dalfampridine;1 4.3% is eliminated as 3-hydroxy-4-aminopyridine and 2.6% is eliminated as 3-hydroxy-4-aminopyridine sulfate.1


Half-life


Dalfampridine: 5.2–6.5 hours.1 9 11


3-Hydroxy-4-aminopyridine sulfate: 7.6 hours.1


Special Populations


Geriatric adults: Clearance of dalfampridine is modestly decreased with increasing age; age-related decrease in clearance not considered clinically important.1


Females: Females may have higher maximum dalfampridine plasma concentrations than males;1 9 not considered clinically important.1


Renal impairment: Total body clearance reduced about 45% in adults with mild renal impairment (Clcr 51–80 mL/minute), about 50% in those with moderate renal impairment (Clcr 30–50 mL/minute), and about 75% in those with severe renal impairment (Clcr <30 mL/minute).1 Mean half-life in otherwise healthy adults with mild or moderate renal impairment is 7.4 or 8.1 hours, respectively; mean half-life in those with severe renal impairment is 14.3 hours.11


Hepatic impairment: Pharmacokinetics not evaluated in patients with hepatic impairment.1 Hepatic impairment not expected to have a clinically important effect on dalfampridine pharmacokinetics.1


Stability


Storage


Oral


Extended-release Tablets

25°C (may be exposed to 15–30°C).1


Actions



  • Aminopyridine;1 13 14 broad spectrum potassium channel blocker.1 13 14




  • Dalfampridine was formerly known as fampridine (4-aminopyridine; 4-AP),1 13 and is commercially available as extended-release tablets.1 Dalfampridine has been prepared extemporaneously as immediate-release capsules or oral solution.4 7 10 13 17




  • Dalfampridine has a relatively narrow therapeutic index with concentration-dependent adverse effects.2 5 9 10 11 14 Compared with the immediate-release preparations, commercially available extended-release dalfampridine tablets provide an improved pharmacokinetic profile (e.g., lower peak plasma concentrations, more stable and sustained plasma concentrations) and allow use of a twice-daily dosage regimen.1 2 9 10 11




  • Mechanism of action responsible for improved walking in MS patients not fully elucidated.1 14 16 19




  • Selectively blocks fast, voltage-gated potassium channels (Kv) in excitable tissues and nonexcitable cells such as B cells and T lymphocytes.13 14 20 In vitro and animal studies indicate increased conduction of action potentials in demyelinated axons;1 13 14 16 20 this effect appears to be dose dependent.13 16 20 Other mechanisms of action (e.g., potentiation of synaptic transmission and skeletal muscle twitch tension, immunomodulatory effects on Kv channels in microglia, macrophages, dendritic cells, and/or T lymphocytes) also may be involved.13 14 16 20




  • Does not prolong QTc interval;1 7 10 does not have a clinically important effect on QRS duration.1 10



Advice to Patients



  • Dalfampridine medication guide must be provided to patient each time the drug is dispensed (see Restricted Distribution under Dosage and Administration);22 importance of patient reading the medication guide prior to initiating dalfampridine therapy and each time the prescription is refilled.1




  • Importance of taking dalfampridine exactly as prescribed.1




  • Advise patients not to take a double dose if they miss a dose.1 Importance of not taking more than 2 tablets in a 24-hour period and ensuring that there is an interval of approximately 12 hours between doses.1




  • Importance of storing dalfampridine at 25°C, although the drug may be exposed to 15–30°C.1




  • Advise patients that dalfampridine can cause dose-dependent seizures, especially if dosage higher than recommended is used or if patient has renal impairment.1 Importance of immediately informing clinician if patient has a history of seizures or has renal impairment.1 Importance of discontinuing the drug and contacting clinician if a seizure occurs during treatment.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.1 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


Distribution of dalfampridine is restricted;21 22 available only through certain specialty pharmacies.21 22 (See Restricted Distribution under Dosage and Administration.)













Dalfampridine

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, extended-release, film-coated



10 mg



Ampyra



Acorda



Disclaimer

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.




References



1. Acorda Therapeutics Inc. Ampyra (dalfampridine) extended-release tablets prescribing information. Hawthorne, NY; 2010 Jan.



2. Goodman AD, Brown TR, Krupp LB et al. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009; 373:732-8. [PubMed 19249634]



3. Goodman AD, Brown TR, Cohen JA et al. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology. 2008; 71:1134-41. [PubMed 18672472]



4. Bever CT, Young D, Anderson PA et al. The effects of 4-aminopyridine in multiple sclerosis patients: results of a randomized, placebo-controlled, double-blind, concentration-controlled, crossover trial. Neurology. 1994; 44:1054-9. [PubMed 8208399]



5. Schwid SR, Petrie MD, McDermott MP et al. Quantitative assessment of sustained-release 4-aminopyridine for symptomatic treatment of multiple sclerosis. Neurology. 1997; 48:817-21. [PubMed 9109861]



6. Solari A, Uitdehaag B, Giuliani G et al. Aminopyridines for symptomatic treatment in multiple sclerosis. Cochrane Database Syst Rev. 2002; :CD001330. [PubMed 12804404]



7. Isoda WC, Segal JL. Effects of 4-aminopyridine on cardiac repolarization, PR interval, and heart rate in patients with spinal cord injury. Pharmacotherapy. 2003; 23:133-6. [PubMed 12587799]



8. Burton JM, Bell CM, Walker SE et al. 4-aminopyridine toxicity with unintentional overdose in four patients with multiple sclerosis. Neurology. 2008; 71:1833-4. [PubMed 19029525]



9. Vollmer T, Henney HR. Pharmacokinetics and tolerability of single escalating doses of fampridine sustained-release tablets in patients with multiple sclerosis: a Phase I-II, open-label trial. Clin Ther. 2009; 31:2206-14. [PubMed 19922891]



10. Vollmer T, Blight AR, Henney HR. Steady-state pharmacokinetics and tolerability of orally administered fampridine sustained-release 10-mg tablets in patients with multiple sclerosis: a 2-week, open-label, follow-up study. Clin Ther. 2009; 31:2215-23. [PubMed 19922892]



11. Smith W, Swan S, Marbury T et al. Single-Dose pharmacokinetics of sustained-release fampridine (Fampridine-SR) in healthy volunteers and adults with renal impairment. J Clin Pharmacol. 2010; 50:151-9. [PubMed 19966074]



12. Goodman AD, Cohen JA, Cross A et al. Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study. Mult Scler. 2007; 13:357-68. [PubMed 17439905]



13. Hayes KC. The use of 4-aminopyridine (fampridine) in demyelinating disorders. CNS Drug Rev. 2004; 10:295-316. [PubMed 15592580]



14. Judge SI, Bever CT. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006; 111:224-59. [PubMed 16472864]



15. van Diemen HA, Polman CH, van Dongen MM et al. 4-Aminopyridine induces functional improvement in multiple sclerosis patients: a neurophysiological study. J Neurol Sci. 1993; 116:220-6. [PubMed 8336169]



16. Smith KJ, Felts PA, John GR. Effects of 4-aminopyridine on demyelinated axons, synapses and muscle tension. Brain. 2000; 123 ( Pt 1):171-84. [PubMed 10611131]



17. Blight AR, Henney HR. Pharmacokinetics of 14C-radioactivity after oral intake of a single dose of 14C-labeled fampridine (4-aminopyridine) in healthy volunteers. Clin Ther. 2009; 31:328-35. [PubMed 19302905]



18. Smits RC, Emmen HH, Bertelsmann FW et al. The effects of 4-aminopyridine on cognitive function in patients with multiple sclerosis: a pilot study. Neurology. 1994; 44:1701-5. [PubMed 7936300]



19. Davis FA, Stefoski D, Quandt FN. Mechanism of action of 4-aminopyridine in the symptomatic treatment of multiple sclerosis. Ann Neurol. 1995; 37:684. [PubMed 7755367]



20. US Food and Drug Administration, Center for Drug Evaluation and Research. Medical review(s) NDA application number 22-250s000. From FDA website.



21. Ampyra distribution guide. From website. Accessed 2010 Apr 20.



22. Ampyra (dalfampridine) extended-release tablets risk evaluation and mitigation strategy (REMS). From FDA website.



23. 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 web site. Accessed 2010 Jun 8.



More Ampyra resources


  • Ampyra Side Effects (in more detail)
  • Ampyra Dosage
  • Ampyra Use in Pregnancy & Breastfeeding
  • Ampyra Drug Interactions
  • Ampyra Support Group
  • 17 Reviews for Ampyra - Add your own review/rating


  • Ampyra Prescribing Information (FDA)

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Sylatron


Generic Name: peginterferon alfa-2b (Subcutaneous route)


peg-in-ter-FEER-on AL-fa-2b


Subcutaneous route(Powder for Solution)

PegIntron(R): May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of these conditions. Ribavirin may cause birth defects and fetal death, and extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia, which may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen .


Subcutaneous route(Powder for Solution)

Sylatron(TM): The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons, including peginterferon alfa-2b. Permanently discontinue peginterferon alfa-2b in patients with persistently severe or worsening signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not resolve after stopping peginterferon alfa-2b .



Commonly used brand name(s)

In the U.S.


  • PEG-Intron

  • Peg Intron RP

  • Sylatron

Available Dosage Forms:


  • Powder for Solution

  • Kit

Therapeutic Class: Antineoplastic Agent


Pharmacologic Class: Interferon, Alfa (class)


Uses For Sylatron


Peginterferon alfa-2b injection is a synthetic (man-made) version of substances normally produced in the body to fight infection. Peginterferon alfa-2b injection is used alone or together with ribavirin and another drug called a hepatitic C virus (HCV) NS3/4A protease inhibitor (such as telaprevir or boceprevir) to treat chronic hepatitis C infection. It is used for patients who have never been treated by alpha interferons. The combination treatment of peginterferon alfa-2b and ribavirin is used to treat adults and children 3 years of age and older who show symptoms of liver damage.


Peginterferon alfa-2b injection is also used to prevent malignant melanoma (a type of skin cancer) from coming back after it has been removed by surgery. This medicine should be started within 84 days of surgery to remove lymph nodes containing cancer.


This medicine is available only with your doctor's prescription.


Before Using Sylatron


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of Pegintron® in children younger than 3 years of age. Safety and efficacy have not been established.


Appropriate studies have not been performed on the relationship of age to the effects of Sylatron™ in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of peginterferon alfa-2b injection in the elderly. However, elderly patients are likely to be more sensitive to the effects of this medicine, and are more likely to have age-related kidney problems, which may require caution in patients receiving this medicine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Allergic reactions (e.g., anaphylaxis, bronchoconstriction, Stevens-Johnson syndrome) or

  • Autoimmune hepatitis (liver inflammation) or

  • Decompensated liver disease—Should not be used in patients with these conditions.

  • Angina (severe chest pain) or

  • Heart attack, history of or

  • Heart or blood vessel disease or

  • Heart rhythm problems (e.g., arrhythmia , tachycardia), history of or

  • Hypotension (low blood pressure)—Use with caution. Patients with these conditions should be closely monitored while using this medicine.

  • Bone marrow problems (e.g., aplastic anemia) or

  • Brain disease (e.g., encephalopathy) or

  • Breathing problems or other lung diseases (e.g., chronic obstructive pulmonary disease or COPD, pneumonia, pulmonary infiltrates, sarcoidosis), or history of or

  • Depression or mental illness, history of or

  • Diabetes mellitus (sugar diabetes) or

  • Diabetic retinopathy (eye problem caused by diabetes) or

  • Eye or vision problems (e.g., retinopathy, optic neuritis) or

  • Hyperglycemia (high blood sugar level) or

  • Hypertensive retinopathy (eye problem caused by hypertension or high blood pressure) or

  • Hypertriglyceridemia (high triglyceride levels or fats in the blood) or

  • Kidney disease or

  • Liver disease (including cirrhosis), severe or

  • Psoriasis or

  • Psychiatric problems, history of or

  • Rheumatoid arthritis or

  • Systemic lupus erythematosus or

  • Thyroid disease or

  • Type 1 diabetes—Use with caution. May make these conditions worse.

  • Colitis (inflammation of the bowel) or

  • Pancreatitis (inflammation of the pancreas)—Peginterferon alfa-2b should be stopped in patients with these conditions.

  • Heart disease (severe and unstable), or history of or

  • Kidney disease, severe or

  • Sickle cell anemia (red blood cell disorder) or

  • Thalassemia major (genetic blood disorder)—Peginterferon alfa-2b together with ribavirin should not be used in patients with these conditions.

  • Organ transplant (e.g., liver)—Use of peginterferon alfa-2b alone or in combination with ribavirin have not been studied in patients with this condition.

Proper Use of peginterferon alfa-2b

This section provides information on the proper use of a number of products that contain peginterferon alfa-2b. It may not be specific to Sylatron. Please read with care.


A nurse or other trained health professional may give you or your child this medicine. This medicine is given as a shot under your skin. You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.


Each package of peginterferon alfa-2b contains a patient instruction sheet. Read this sheet carefully and make sure you understand:


  • How to prepare the injection.

  • Proper use of disposable syringes.

  • How to give the injection.

  • How long the injection is stable.

If you have any questions about any of this, check with your doctor.


This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.


Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.


Pegintron® is available in 2 dosage forms: a vial (glass container) or a prefilled syringe. If you switch from using the vial to using the prefilled syringe, double-check that you are giving yourself the correct amount of medicine.


If you are using this medicine, your doctor will tell you to inject this medicine at bedtime and take medicines (e.g., acetaminophen, Tylenol®) 30 minutes before using this medicine. This helps prevent common "flu-like" symptoms such as fever, chills, headaches, muscle or joint pain, or tiredness. Also, drink extra fluids if you experience these symptoms.


You might not use all of the medicine in each vial (glass container) or prefilled syringe. Use each vial or syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For injection dosage form:
    • For hepatitis C virus infection:
      • Adults—Dose is based on body weight and must be determined by your doctor. It is usually between 40 and 150 micrograms (mcg) injected under the skin once a week. The medicine should be taken on the same day each week.

      • Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor.

      • Children younger than 3 years of age—Use and dose must be determined by your doctor.


    • For hepatitis C virus infection, in combination with ribavirin:
      • Adults—Dose is based on body weight and must be determined by your doctor. It is usually between 50 and 150 micrograms (mcg) injected under the skin once weekly (same time and day each week) and should be taken together with ribavirin twice daily.

      • Children 3 years of age and older—Dose is based on body surface area and must be determined by your doctor. The dose is usually 60 microgram per square meter (mcg/m[2]) of body surface area injected under the skin once weekly (same time and day each week) and should be taken together with ribavirin twice daily.

      • Children younger than 3 years of age—Use and dose must be determined by your doctor.


    • For prevention of melanoma:
      • Adults—Dose is based on body weight and must be determined by your doctor. It is usually 6 micrograms (mcg) per kilogram (kg) of body weight injected under the skin per week for 8 doses. This should be followed by 3 mcg/kg of body weight per week injected under the skin for up to 5 years.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Store the medicine that has been mixed in the refrigerator. You may use it immediately but also may be stored in the refrigerator for 24 hours. Throw away any mixed medicine that has not been used within this time. Do not freeze the solution.


Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.


Precautions While Using Sylatron


It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.


Using peginterferon alfa-2b together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.


A negative pregnancy test is needed in women who are of childbearing age before starting treatment with this medicine and ribavirin. Two forms of birth control must be used during treatment and for 6 months after treatment ends. You will need to have pregnancy tests done regularly to make sure you are not pregnant while being treated with these medicines and after your treatment ends.


This medicine can increase thoughts of suicide in people with or without a history of a mental illness. This medicine may also cause relapse in people with a history of substance abuse. Tell your doctor right away if you start to feel more depressed or exhibit aggressive behavior. Also tell your doctor right away if you have thoughts of hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects during treatment and up to 6 months after treatment, tell your doctor or your child's doctor right away.


This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble with breathing, trouble with swallowing, or any swelling of the hands, face, or mouth while you or your child are using this medicine.


Serious allergic reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; fever or chills; hives or welts; red skin lesions; severe acne or skin rash; or sores or ulcers on the skin while you or your child are using this medicine.


Stop using this medicine and check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).


Peginterferon alfa-2b injection combined with ribavirin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this occurs, there are certain precautions you or your child can take, especially when your blood count is low, to reduce the risk of infection or bleeding:


  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.

  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

  • Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


Peginterferon alfa-2b injection when used together with ribavirin may cause teeth and gum problems. These medicines may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take these medicines for a long time. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.


Stop using this medicine and check with your doctor right away if you or your child have symptoms that could lead to pancreatitis. This includes sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.


This medicine when used together with ribavirin may affect your child's growth. Your doctor may need to check your child's height and weight during and after treatment with these medicines.


Peripheral neuropathy may occur if you use this medicine together with telbivudine (Tyzeka®). Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Sylatron Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Abdominal or stomach pain

  • anxiety

  • black, tarry stools

  • blood in the urine or stools

  • bloody diarrhea

  • chills

  • cloudy urine

  • cough or hoarseness

  • depression

  • difficult or labored breathing

  • fever

  • infection

  • irritability

  • lower back or side pain

  • mood swings

  • nausea

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on the skin

  • shortness of breath

  • tightness in the chest

  • trouble with sleeping

  • troubled breathing with exertion

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • vomiting

  • wheezing

Less common
  • Changes in menstrual cycle

  • constipation

  • drowsiness

  • dry hair and skin

  • sensitivity to cold

  • weight gain

Rare
  • Aching, pain, or stiffness in the joints

  • aggressive behavior

  • attempt to kill yourself

  • backache

  • chest pain (severe)

  • cool, pale skin

  • decrease in vision

  • diarrhea

  • difficulty with speaking

  • dizziness

  • drug addiction or overdose

  • eye pain

  • fast or irregular heartbeat

  • feeling of constant movement of self or surroundings

  • headache

  • hives or skin rash

  • itching of the skin

  • loss of appetite

  • muscle weakness

  • nervousness

  • numbness or loss of feeling in one or both limbs on the same side of the body

  • palpitations

  • paralysis

  • possible decrease in the amount of urine

  • restlessness

  • sensation of spinning

  • sensitivity to heat

  • sensitivity to sunlight

  • sweating (excessive)

  • thick, scaly skin

  • thoughts of killing someone

  • thoughts of killing yourself

  • warm, smooth, or moist skin

  • weight loss

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:


More common
  • Aching, fullness, or tension in the sinuses

  • bruising, irritation, or itching at the injection site

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • change in taste

  • difficulty with moving

  • flushing of the skin

  • hair loss

  • indigestion

  • loss of taste

  • muscle pain or stiffness

  • pain in the bones or muscles

  • runny nose

  • sneezing

  • sore throat

  • thinning of the hair

Less common
  • Muscle rigidity or stiffness

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: Sylatron side effects (in more detail)



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More Sylatron resources


  • Sylatron Side Effects (in more detail)
  • Sylatron Use in Pregnancy & Breastfeeding
  • Sylatron Drug Interactions
  • Sylatron Support Group
  • 0 Reviews for Sylatron - Add your own review/rating


  • Sylatron Prescribing Information (FDA)

  • Sylatron Consumer Overview

  • Sylatron MedFacts Consumer Leaflet (Wolters Kluwer)

  • Peginterferon Alfa-2b Professional Patient Advice (Wolters Kluwer)

  • Peginterferon alfa-2b MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pegintron Prescribing Information (FDA)



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