Ruzurgi

Generic name: Amifampridine
Drug class: Cholinergic muscle stimulants

Usage of Ruzurgi

Amifampridine is used to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disease, wherein the immune system attacks the connection between the nerve and muscle (neuromuscular junction) and blocks the ability of the nerve cells to send signals to the muscle cells, leading to muscle weakness of the arms or legs.

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

Ruzurgi 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

Arm or leg pain

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

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

chest pain or tightness

chills

cough

cough producing mucus

diarrhea

difficult, burning, or painful urination

difficulty breathing or swallowing

dizziness

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

hoarseness

joint pain

loss of appetite

lower back or side pain

muscle pains, spasms, or weakness

nausea

nervousness

pounding in the ears

rapid weight gain

runny nose

shivering

slow or fast heartbeat

sneezing

sore throat

sweating

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trouble sleeping

unusual tiredness or weakness

unusual weight gain or loss

vomiting

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

Back pain

blindness

constipation

decreased vision

discouragement

falls

feeling cold

feeling sad or empty

heartburn

irritability

lack or loss of strength

loss of interest or pleasure

pale skin

stomach pain

trouble concentrating

trouble breathing

unusual bleeding or bruising

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.

Before taking Ruzurgi

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 amifampridine in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of Ruzurgi® in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Firdapse® in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetophenazine

Aclidinium

Acrivastine

Alcaftadine

Alfentanil

Amantadine

Ambenonium

Amdinocillin

Amdinocillin Pivoxil

Amineptine

Aminophylline

Amitriptylinoxide

Amoxapine

Amphetamine

Ampicillin

Anisotropine

Antazoline

Atropine

Azatadine

Azelastine

Azlocillin

Bacampicillin

Baclofen

Belladonna Alkaloids

Benperidol

Benzhydrocodone

Benzphetamine

Bepotastine

Bornaprine

Bromodiphenhydramine

Bromperidol

Brompheniramine

Buclizine

Bupivacaine

Butorphanol

Butriptyline

Butylscopolamine

Carbenicillin

Carbinoxamine

Chlorambucil

Chlorotrianisene

Chlorpheniramine

Chlorphenoxamine

Cimetropium

Cinnarizine

Clemastine

Clemizole

Clidinium

Cloxacillin

Cocaine

Codeine

Conjugated Estrogens

Cyclacillin

Cyclizine

Cyclopentolate

Cyclosporine

Cyproheptadine

Darifenacin

Demecarium

Dexbrompheniramine

Dexchlorpheniramine

Dextroamphetamine

Dibenzepin

Dicloxacillin

Dicyclomine

Dienestrol

Diethylstilbestrol

Difenoxin

Dihydrocodeine

Dimenhydrinate

Dimethindene

Diphenhydramine

Diphenylpyraline

Distigmine

Dixyrazine

Donepezil

Dothiepin

Doxylamine

Echothiophate

Edrophonium

Emedastine

Enflurane

Epinastine

Esterified Estrogens

Estradiol

Estramustine

Estriol

Estrone

Estropipate

Ethinyl Estradiol

Ethopropazine

Fentanyl

Fesoterodine

Flavoxate

Floxacillin

Flunarizine

Glycopyrrolate

Guanidine

Hetacillin

Homatropine

Hydrocodone

Hydromorphone

Hydroxyamphetamine

Hyoscyamine

Indalpine

Iprindole

Isoflurophate

Isoniazid

Isopropamide

Ketamine

Ketotifen

Levocabastine

Levomilnacipran

Levorphanol

Lidocaine

Lindane

Lisdexamfetamine

Lithium

Lofepramine

Loxapine

Mebeverine

Mebhydrolin

Meclizine

Mefenamic Acid

Melitracen

Melperone

Mepenzolate

Meperidine

Mestranol

Methamphetamine

Methantheline

Methdilazine

Methicillin

Methixene

Methotrimeprazine

Methylphenidate

Metopimazine

Mezlocillin

Milnacipran

Morphine

Nalbuphine

Nalidixic Acid

Neostigmine

Niaprazine

Nortriptyline

Olopatadine

Opipramol

Orphenadrine

Oxacillin

Oxatomide

Oxycodone

Oxymorphone

Penicillin G

Penicillin V

Pentazocine

Perazine

Periciazine

Phenindamine

Pheniramine

Phenylpropanolamine

Phenyltoloxamine

Physostigmine

Pinaverium

Piperacillin

Pipotiazine

Pirenzepine

Pivampicillin

Pizotyline

Polyestradiol Phosphate

Procaine

Promazine

Promestriene

Propantheline

Propicillin

Propiverine

Propizepine

Propoxyphene

Pyrilamine

Quinestrol

Remifentanil

Rivastigmine

Scopolamine

Sibutramine

Sufentanil

Sulbenicillin

Sultamicillin

Tacrine

Tapentadol

Temocillin

Theophylline

Thiethylperazine

Thiopropazate

Thioproperazine

Thonzylamine

Tianeptine

Tibolone

Ticarcillin

Timiperone

Tiotropium

Tramadol

Trifluoperazine

Triflupromazine

Trimeprazine

Tripelennamine

Triprolidine

Tropicamide

Trospium

Umeclidinium

Valethamate

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.

Relate drugs

How to use Ruzurgi

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide and patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

The tablets may be divided in half at the score (line at the center) if you need less than a full tablet to get the right dose.

If you or your child are unable to swallow the tablets whole, you may prepare a suspension:

Ruzurgi®: Mix 3 tablets with 30 milliliters (mL) of water in a 30-mL container, then shake the mixture well for 30 seconds. You may give the dose using an oral dosing syringe or feeding tube. Shake well before giving each dose.

Firdapse®: Mix the tablet with 10 mL of sterile water for each tablet in a 50 to 100 mL container, wait for 5 minutes. Shake well for 30 seconds. You may give the dose using an oral dosing syringe or feeding tube. Shake well before giving each dose.

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 oral dosage form (tablets):

For Lambert-Eaton myasthenic syndrome:

Fidarpse®:

Adults and children 6 years of age and older weighing 45 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. At first, 15 milligrams (mg) to 30 mg given in 3 to 4 divided doses per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.

Children 6 years of age and older weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. At first, 5 mg to 15 mg given in 3 to 4 divided doses per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.

Children younger than 6 years of age—Use and dose must be determined by your doctor.

Ruzurgi®:

Children 6 to 16 years of age weighing 45 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. At first, 15 milligrams (mg) to 30 mg given 2 to 3 divided doses per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.

Children 6 to 16 years of age weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. At first, 7.5 mg to 15 mg given 2 to 3 divided doses per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.

Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Store Ruzurgi® tablets at room temperature for up to 3 months.

You may store the mixture in the refrigerator for up to 24 hours. Throw away any unused liquid after 24 hours.

Warnings

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly.

This medicine may increase your risk for seizures and should not be given to patients who have had seizures.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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