Ampyra

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Common Side Effects of Ampyra

Tell your doctor if any of the following side effects are severe or don't go away:

• Headache
• Nausea
• Dizziness
• Difficulty falling or staying asleep
• Heartburn
• Weakness
• Constipation
• Mild back pain
• Pain or irritation of the nose or throat

Serious Side Effects of Ampyra

Tell your doctor right away if you experience any of the following serious side effects:

• Seizures
• Difficult, painful, or frequent urination
• Fever or chills
• Severe pain in the back, side, or stomach
• Worsening of MS symptoms
• Problems with balance
• Burning, tingling, or itching of the skin
• Signs of a severe allergic reaction (may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat)

The most common side effects of Ampyra include:

• urinary tract infection
• trouble sleeping (insomnia)
• dizziness
• headache
• nausea
• weakness
• back pain
• problems with balance
• multiple sclerosis relapse
• burning, tingling or itching of your skin
• irritation in your nose and throat
• constipation
• indigestion
• pain in your throat

This is not a complete list of Ampyra side effects. Ask your doctor or pharmacist for more information. 

Before you receive Ampyra, tell your doctor about all of your medical conditions. Especially tell your doctor if you have kidney disease or if you have ever had a seizure.

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Take Ampyra exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The maximum recommended dose of Ampyra is one 10 mg tablet twice daily, taken with or without food, and should not be exceeded. Doses should be taken approximately 12 hours apart. You should not take double or extra doses if a dose is missed.

If you take too much Ampyra call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Ampyra is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Ampyra at 59ºF to 86ºF (15ºC to 30ºC).
• Safely throw away Ampyra that is out of date or no longer needed.
• Keep Ampyra and all medicines out of the reach of children.

Mechanism of Action

Mechanism not completely understood, but in animal studies shown to block potassium channels, to delay repolarization and to increase duration of action potentials in demyelinated axons

Does not prolong QTc interval

Pharmacokinetics

Half-life elimination: 5-7 hr (prolonged up to 3 times longer in severe renal impairment)

Absorption: rapid and completely absorbed from GI tract; 96% relative bioavailability to aqueous oral solution; extended-release tablet

Vd: 2.6 L/kg

Peak Plasma Time: 3-4 hr  

Peak Plasma Concentration: 17.3 ng/mL-21.6 ng/mL (slight increase with food, 12-17%)

Protein Bound: 1-3%  

Metabolism: Minimal, 90.3% eliminated unchanged; 2 inactive metabolites (3-hydroxy-4-aminopyridine and 3-hydroxy-4-aminopyridine sulfate)

Excretion: feces (0.5%), urine (95.9%)  

Before you start treatment with dalfampridine, your doctor may perform tests to check your kidney function.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. High doses of dalfampridine may increase your risk of seizure.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Dalfampridine is usually taken once every 12 hours. Follow your doctor's dosing instructions very carefully.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Do not dissolve the tablet in liquid. Breaking or dissolving the pill may cause too much of the drug to be released at one time which can increase your risk of a seizure.

Dalfampridine may be taken with or without food.

Do not take more than 2 tablets in a 24-hour period.

To be sure this medicine is not causing harmful effects, your kidney function may need to be checked often.

Store at room temperature away from moisture and heat.

Throw away any leftover medicine after the expiration date on the label has passed.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Storage

Oral

25°C (may be exposed to 15–30°C).1

The maximum recommended dose of Ampyra is one 10 mg tablet twice daily, taken with or without food, and should not be exceeded. Doses should be taken approximately 12 hours apart. Tablets should only be taken whole; do not divide, crush, chew, or dissolve. Patients should not take double or extra doses if a dose is missed.

Estimated creatinine clearance (CrCl) should be known before initiating treatment with Ampyra, and monitored at least annually during treatment with Ampyra. CrCl can be estimated using the following equation (multiply by 0.85 for women):

In patients with mild renal impairment (CrCl 51–80 mL/min), Ampyra plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures. As mild renal impairment is common after age 50, estimating CrCl is particularly important in these patients. The potential benefits of Ampyra should be carefully considered against the risk of seizures in these patients [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.4)].

No additional benefit was demonstrated at doses greater than 10 mg twice daily and adverse reactions and discontinuations because of adverse reactions were more frequent at higher doses.

Take Ampyra exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. High doses of dalfampridine may increase your risk of seizure.

Before you start your treatment, your doctor may perform tests to check your kidney function.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Ampyra is usually taken once every 12 hours. Follow your doctor's dosing instructions very carefully.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Do not dissolve the tablet in liquid. Breaking or dissolving the pill may cause too much of the drug to be released at one time which can increase your risk of a seizure.

Ampyra may be taken with or without food.

Do not take more than 2 tablets in a 24-hour period.

To be sure this medicine is not causing harmful effects, your kidney function may need to be checked often.

Store at room temperature away from moisture and heat.

Throw away any leftover medicine after the expiration date on the label has passed.

Usual Adult Dose for Multiple Sclerosis:

Maximum recommended dose: 10 mg every 12 hours, taken with or without food

Patients should not take double or extra doses if a dose is missed.

Tablets should only be taken whole. Tablets should not be divided, crushed, chewed, or dissolved.

Usual Geriatric Dose for Multiple Sclerosis:

Maximum recommended dose: 10 mg every 12 hours, taken with or without food

Patients should not take double or extra doses if a dose is missed.

Tablets should only be taken whole. Tablets should not be divided, crushed, chewed, or dissolved.

A population pharmacokinetic analysis showed that dalfampridine clearance modestly decreased with increasing age, but not sufficiently to necessitate a modification of dose.

Applies to dalfampridine: oral tablet extended release

Renal

Renal side effects including urinary tract infection (12%) have been reported.[Ref]

General

General side effects including insomnia (9%) and asthenia (7%) have been reported.[Ref]

Nervous system

Nervous system side effects including dizziness (7%), headache (7%), balance disorder (5%), multiple sclerosis relapse (4%), and paresthesia (4%) have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea (7%), constipation (3%), dyspepsia (2%), and pharyngolaryngeal pain (2%) have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including back pain (5%) have been reported.[Ref]

Respiratory

Respiratory side effects including nasopharyngitis (4%) have been reported.[Ref]

Genitourinary

Genitourinary side effects have been have reported in animal studies which noted a significant increase in uterine polyps at the highest dose tested.[Ref]

Some side effects of Ampyra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Dalfampridine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of decreased offspring viability and growth. There are no controlled data in human pregnancy. Dalfampridine should only be given during pregnancy when potential benefit justifies the potential risk to the fetus.