KlonoPIN Wafers (Oral)

Clonazepam is used on its own or with other medicines to treat certain seizure disorders (for example, Lennox-Gastaut syndrome, akinetic, myoclonic, and absence seizures). It is also used to treat panic disorder. Clonazepam is a benzodiazepine that acts in the brain to stop 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.

It is very important that your doctor checks your progress at regular visits to see if KlonoPIN Wafers (Oral) 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 KlonoPIN Wafers during the later stages of pregnancy may cause problems in your newborn baby (e.g., 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 KlonoPIN Wafers, tell your doctor right away.

KlonoPIN Wafers 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.

KlonoPIN Wafers may cause drowsiness, trouble thinking, trouble controlling movements, or trouble seeing clearly. Make sure you know how you react to KlonoPIN Wafers 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 or 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 KlonoPIN Wafers are similar to those seen in people who drink alcohol and then act in a way 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 KlonoPIN Wafers 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, feeling that the 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 walking, slurred speech, trouble speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness or feeling sluggish, unusual excitement, nervousness, restlessness, or irritability, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

KlonoPIN Wafers 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 KlonoPIN Wafers.

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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide.

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research has not shown any specific problems that would limit the use of clonazepam in children with seizure disorders. However, safety and effectiveness in children with panic disorder have not been established.

Geriatric

Research has not identified any specific problems in the elderly that would limit the use of clonazepam. However, older patients may be more likely to experience confusion and severe drowsiness, or may have age-related heart, liver, or kidney issues, which could require careful monitoring and dose adjustments for those taking clonazepam.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the possible risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been identified based on their potential significance and are not necessarily all-inclusive.

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

• Flumazenil

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may change the dose or frequency of 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
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clarithromycin
• Clobazam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Dantrolene
• Daridorexant
• Darunavir
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Droperidol
• Enflurane
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Isoflurane
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melperone
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Midazolam
• Mirtazapine
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Tenofovir Alafenamide
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Valproic Acid
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both of the medicines.

• Amiodarone
• Desipramine
• Ginkgo
• Nevirapine
• Rifapentine
• Ritonavir
• St John's Wort
• Theophylline

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is generally not recommended but may be necessary in some cases. If used together, your doctor may change the dose or frequency of this medicine or provide special instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, 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 worsen these conditions.

• Glaucoma, narrow angle, acute or
• Liver disease—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. Effects may be stronger due to slower removal of the medicine from the body.

Along with its necessary effects, a medicine can also cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require 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.

In the U.S.

• KlonoPIN
• KlonoPIN Wafers

In Canada

• Accel-clonazePAM
• APO-clonazePAM
• Clonapam
• CO-clonazePAM
• DOM-clonazePAM
• Mylan-clonazePAM
• PRO-clonazePAM
• Riva-clonazePAM
• Rivotril
• Sandoz-clonazePAM
• Teva-clonazePAM
• Zym-clonazePAM

Available Dosage Forms:

• Tablet, Disintegrating
• Tablet

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

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.

• Is clonazepam a controlled substance?