Canadian Brand Name

Accel-clonazePAM

APO-clonazePAM

Clonapam

CO-clonazePAM

DOM-clonazePAM

Mylan-clonazePAM

PRO-clonazePAM

Riva-clonazePAM

Rivotril

Sandoz-clonazePAM

Teva-clonazePAM

Zym-clonazePAM

Description

Clonazepam is used alone or together with other medicines to treat certain seizure disorders (eg, Lennox-Gastaut syndrome, akinetic, myoclonic, and absence seizures). It is also used to treat panic disorder. Clonazepam is a benzodiazepine that works in the brain to prevent seizures. Benzodiazepines are central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

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

This product is available in the following dosage forms:

Tablet, Disintegrating

Tablet

Before Using

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clonazepam in children with seizure disorders. However, safety and efficacy in children with panic disorder have not been established.

Geriatric

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

Breastfeeding

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.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Flumazenil

Isocarboxazid

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.

Acepromazine

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aripiprazole

Aripiprazole Lauroxil

Asenapine

Baclofen

Benperidol

Benzhydrocodone

Bromazepam

Bromopride

Buprenorphine

Buspirone

Butabarbital

Butalbital

Butorphanol

Calcifediol

Calcium Oxybate

Cannabidiol

Cannabis

Carbamazepine

Carbidopa

Carbinoxamine

Carisoprodol

Carphenazine

Ceritinib

Cetirizine

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Clobazam

Clomipramine

Clorazepate

Clozapine

Codeine

Cyclobenzaprine

Cyproheptadine

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Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone

Desipramine

Ginkgo

Rifapentine

Ritonavir

St John's Wort

Theophylline

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

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:

Alcohol or drug abuse or dependence, or history of or

Depression, history of or

Lung or breathing problems or

Porphyria—Use with caution. May make these conditions worse.

Glaucoma, narrow angle, acute or

Liver disease—Should not be used in patients with these conditions.

Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

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. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole with water.

If you are using the disintegrating tablet (wafer), make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may take a sip of water.

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 forms (tablets or disintegrating tablets):

For seizures:

Adults and children 10 years and older—At first, 0.5 milligram (mg) 3 times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.

Children up to 10 years or 30 kilograms (kg) of body weight—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.01 to 0.03 mg per kg of body weight per day, given in 2 or 3 divided doses. However, the dose is usually not more than 0.05 mg per kg of body weight. Your doctor may adjust your dose as needed.

For panic disorder:

Adults—At first, 0.25 milligram (mg) 2 times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4 mg per day.

Children—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

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

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.

Precautions

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to allow for changes in the dose. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may cause drowsiness, trouble with thinking, trouble with controlling movements, or trouble with seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

If you develop any unusual and strange thoughts or behavior while you are taking clonazepam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

If you have been taking this medicine for a long time, do not stop taking it without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, including actions that are out of control, anxiety, blurred vision, decreased awareness or responsiveness, discouragement, dizziness, environment seems unreal, feeling of unreality, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, mimicry of speech or movements, mutism, negativism, nervousness, peculiar postures or movements, mannerisms or grimacing, seeing, hearing, or feeling things that are not there, sense of detachment from self or body, seizures, severe sleepiness, talking, feeling, and acting with excitement, trouble concentrating and sleeping.

Symptoms of an overdose include: change in consciousness, changes in patterns and rhythms of speech, hallucinations, lack of coordination, loss of consciousness, loss of strength or energy, mood or mental changes, muscle pain or weakness, nightmares, sleepiness or unusual drowsiness, shakiness and unsteady walk, slurred speech, trouble in speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, unusual excitement, nervousness, restlessness, or irritability, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of these products while you are 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.

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

Body aches or pain

chills

cough

difficulty breathing

discouragement

dizziness

ear congestion

feeling sad or empty

fever

headache

irritability

lack of appetite

loss of interest or pleasure

loss of voice

poor coordination

runny or stuffy nose

shakiness and unsteady walk

sleepiness or unusual drowsiness

sneezing

sore throat

tiredness

trouble concentrating

trouble sleeping

unsteadiness, trembling, or other problems with muscle control or coordination

unusual tiredness or weakness

Less common

Being forgetful

bladder pain

bloody or cloudy urine

change in speech

decrease in frequency of urination

diarrhea

difficulty in passing urine

difficult, burning, or painful urination

frequent urge to urinate

general feeling of discomfort or illness

joint pain

loss of appetite

lower back or side pain

mood or mental changes

muscle aches and pains

nausea

nervousness

problems in urination or increase in the amount of urine

shivering

slurred speech

sore throat

sweating

trouble speaking

vomiting

Rare

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

changes in skin color

chest pain, discomfort, or tightness

cold sweats

colds

confusion

cough or hoarseness

difficulty with sleeping

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

excessive dreaming

excessive muscle tone

excitement

falling

fast, irregular, pounding, or racing heartbeat or pulse

feeling mad

feeling of unreality

flu-like symptoms

headache, severe and throbbing

lack of feeling or emotion

lack or loss of self-control

muscle stiffness, tension, or tightness

nightmares

pain, inflammation, or swelling in the calves, shoulders, or hands

pain or swelling in the arms or legs without any injury

pain, tenderness, or swelling of the foot or leg

partial or slight paralysis

scaling

sense of detachment from self or body

shakiness in the legs, arms, hands, or feet

skin rash

swelling around the eyes

swelling of the face, ankle, foot, or knees

thoughts of killing oneself changes in behavior

trembling or shaking of the hands or feet

uncaring

vision changes

Incidence not known

Anxiety

black, tarry stools

bleeding gums

blood in the urine or stools

change in consciousness

chest congestion

difficulty with coordination

double vision

drowsiness

dry mouth

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

hyperventilation

irregular, fast, slow, or shallow breathing

irregular, twisting uncontrolled movement of the face, hands, arms, or legs

loss of interest or pleasure

loss of memory

loss of strength or energy

loss of voice

muscle weakness

pale or blue lips, fingernails, or skin

pinpoint red spots on the skin

problems with memory

restlessness

severe mood or mental changes

sores, ulcers, or white spots on the lips or in the mouth

stomach pain or fullness

swollen glands

trouble breathing

uncontrolled eye movements

unusual behavior

unusual bleeding or bruising

unusual weakness

vivid dreams

weight loss or gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

change in consciousness

changes in patterns and rhythms of speech

confusion

loss of consciousness

loss of strength or energy

mood or mental changes

nightmares

shakiness and unsteady walk

sleepiness or unusual drowsiness

slurred speech

talkativeness

trouble speaking

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual excitement, nervousness, restlessness, or irritability

unusual weak feeling

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:

Less common

Decreased interest in sexual intercourse

difficulty with swallowing

dryness or soreness of the throat

heavy bleeding

hives

inability to have or keep an erection

longer than usual time to ejaculation of semen

loss in sexual ability, desire, drive, or performance

pain or tenderness around the eyes and cheekbones

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

voice changes

Rare

Acid or sour stomach

ankle, knee, or great toe joint pain

belching

bleeding after defecation

blistering, burning, crusting, dryness, or flaking of the skin

bloated

blurred or loss of vision

change in color perception

cracks in the skin at the corners of the mouth

decrease or change in vision

difficulty moving

double vision

dryness of the eyes

earache

excess air or gas in stomach or intestines

feeling of constant movement of self or surroundings

feeling of warmth

frequent bowel movements

full feeling

hair loss or thinning of the hair

halos around lights

heartburn

increased watering of the mouth

indigestion

irregularities in menstruation

itching in the genital or other skin areas

itching, scaling, severe redness, soreness, or swelling of the skin

joint stiffness or swelling

leg or muscle cramps

loss of taste

night blindness

nosebleeds

overbright appearance of lights

pain in the breasts or pelvic area

pain in the leg, nape, or back

passing gas

red, sore eyes

redness of the face, neck, arms, and occasionally, upper chest

redness or swelling in the ear

sensation of spinning

smaller amount of semen ejaculated than usual

sore on the edge of the eyelid

soreness or redness around the fingernails and toenails

stomach discomfort, upset, or pain

thickening of the tongue

thirst

tooth disorder

toothache

tunnel vision

twitching of the eyes

uncomfortable swelling around the anus

worsening of acne

Incidence not known

Burning feeling in the chest or stomach

difficulty having a bowel movement (stool)

increased appetite

increased hair growth, especially on the face

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

sore gums

tenderness in the stomach area

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.