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AMANTADINE HYDROCHLORIDE
Overview
What is Amantadine HCl?
Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride.
Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform.
Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug.
Each capsule intended for oral administration contains 100 mg amantadine hydrochloride and has the following inactive ingredients: Yellow Iron Oxide, gelatin, glycerin, hydrogenated vegetable oil, lecithin-bleached, soybean oil, sorbitol, sorbitan, mannitol, titanium dioxide, white beeswax, vegetable shortening, simethicone and iron oxide (black imprint ink).
What does Amantadine HCl look like?
What are the available doses of Amantadine HCl?
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What should I talk to my health care provider before I take Amantadine HCl?
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How should I use Amantadine HCl?
Amantadine Hydrochloride Capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
Influenza A Prophylaxis:
Following vaccination during an influenza A outbreak, Amantadine Hydrochloride Capsules, USP prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response.
Influenza A Treatment:
There is no clinical evidence indicating that Amantadine Hydrochloride Capsules, USP are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains.
The following points should be considered before initiating treatment or prophylaxis with Amantadine Hydrochloride Capsules, USP:
Parkinson's Disease/Syndrome:
Drug-Induced Extrapyramidal Reactions:
The dosage of Amantadine Hydrochloride Capsules may need to be reduced in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function (see ).
What interacts with Amantadine HCl?
Amantadine Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in Amantadine Hydrochloride Capsules.
What are the warnings of Amantadine HCl?
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Deaths due to drug accumulation (overdose) have been reported in patients with renal impairment, who were prescribed higher than recommended doses of SYMMETREL (amantadine) for their level of renal function (see and ).
Suicide Attempts:
CNS Effects:
Patients receiving amantadine hydrochloride capsules who note central nervous system effects or blurring of vision should be cautioned against driving or working in situations where alertness and adequate motor coordination are important.
Other:
Patients with Parkinson's disease improving on amantadine hydrochloride capsules should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis.
Because Amantadine Hydrochloride Capsules has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma.
What are the precautions of Amantadine HCl?
Amantadine Hydrochloride should not be discontinued abruptly in patients with Parkinson's disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. The dose of anticholinergic drugs or of amantadine hydrochloride should be reduced if atropine-like effects appear when these drugs are used concurrently. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech.
Neuroleptic Malignant Syndrome (NMS):
NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia; neurologic findings including muscle rigidity, involuntary movements, altered consciousness; mental status changes; other disturbances such as autonomic dysfunction, tachycardia, tachypnea, hyper- or hypotension; laboratory findings such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin.
The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring, and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene are often used in the treatment of NMS, however, their effectiveness has not been demonstrated in controlled studies.
Renal disease:
Liver disease:
Care should be exercised when administering amantadine hydrochloride to patients with liver disease. Rare instances of reversible elevation of liver enzymes have been reported in patients receiving amantadine hydrochloride, though a specific relationship between the drug and such changes has not been established.
Impulse Control/Compulsive Behaviors
Postmarketing reports suggest that patients treated with anti-Parkinson medications can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges. Patients may be unable to control these urges while taking one or more of the medications that are generally used for the treatment of Parkinson’s disease and that increase central dopaminergic tone, including amantadine hydrochloride. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with amantadine hydrochloride. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking amantadine hydrochloride.
Melanoma:
Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, is unclear.
For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using amantadine hydrochloride for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).
Other:
Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Amantadine hydrochloride has not been shown to prevent such complications.
Information for Patients
Patients should be advised of the following information:
Blurry vision and/or impaired mental acuity may occur.
Gradually increase physical activity as the symptoms of Parkinson's disease improve.
Avoid excessive alcohol usage, since it may increase the potential for CNS effects such as dizziness, confusion, lightheadedness and orthostatic hypotension.
Avoid getting up suddenly from a sitting or lying position. If dizziness or lightheadedness occurs, notify physician.
Notify physician if mood/mental changes, swelling of extremities, difficulty urinating and/or shortness of breath occur.
Do not take more medication than prescribed because of the risk of overdose. If there is no improvement in a few days, or if medication appears less effective after a few weeks, discuss with a physician.
Consult physician before discontinuing medication.
Seek medical attention immediately if it is suspected that an overdose of medication has been taken.
Drug Interactions
Careful observation is required when amantadine hydrochloride is administered concurrently with central nervous system stimulants.
Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine.
Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson's disease, however, it is not known if other phenothiazines produce a similar response.
Coadministration of Dyazide (triamterene/hydrochlorothiazide) resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine hydrochloride 100 mg TID for Parkinson's disease.It is not known which of the components of Dyazide contributed to the observation or if related drugs produce a similar response.
Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%.
The concurrent use of amantadine hydrochloride with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of amantadine hydrochloride, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of amantadine hydrochloride.
Carcinogenesis and Mutagenesis
Long-term animal studies designed to evaluate the carcinogenic potential of amantadine hydrochloride have not been performed. In several assays for gene mutation, amantadine hydrochloride did not increase the number of spontaneously observed mutations in four strains of (Ames Test) or in a mammalian cell line (Chinese Hamster Ovary cells) when incubations were performed either with or without a liver metabolic activation extract. Further, there was no evidence of chromosome damage observed in an test using freshly derived and stimulated human peripheral blood lymphocytes (with and without metabolic activation) or in an mouse bone marrow micronucleus test (140 to 550 mg/kg; estimated human equivalent doses of 11.7 to 45.8 mg/kg based on body surface area conversion).
Impairment of Fertility
The effect of amantadine on fertility has not been adequately tested, that is, in a study conducted under Good Laboratory Practice (GLP) and according to current recommended methodology. In a three litter, non-GLP, reproduction study in rats, amantadine hydrochloride at a dose of 32 mg/kg/day (equal to the maximum recommended human dose on a mg/mbasis) administered to both males and females slightly impaired fertility. There were no effects on fertility at a dose level of 10 mg/kg/day (or 0.3 times the maximum recommended human dose on a mg/mbasis); intermediate doses were not tested.
Failed fertility has been reported during human fertilization (IVF) when the sperm donor ingested amantadine 2 weeks prior to, and during the IVF cycle.
Pregnancy
Teratogenic Effects: Pregnancy Category C:
2
2
2
Nursing Mothers
Amantadine hydrochloride is excreted in human milk. Use is not recommended in nursing mothers.
Pediatric Use
The safety and efficacy of amantadine hydrochloride in newborn infants and infants below the age of 1 year have not been established.
Usage in the Elderly
Because amantadine hydrochloride is primarily excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of amantadine hydrochloride should be reduced in patients with renal impairment and in individuals who are 65 years of age or older. The dose of Amantadine Hydrochloride Capsules may need reduction in patients with congestive heart failure, peripheral edema, or orthostatic hypotension (see ).
What are the side effects of Amantadine HCl?
The adverse reactions reported most frequently at the recommended dose of amantadine hydrochloride (5 to10%) are: nausea, dizziness (lightheadedness), and insomnia.
Less frequently (1 to 5%) reported adverse reactions are: depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue.
Infrequently (0.1 to 1%) occurring adverse reactions are: congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, and visual disturbance, including punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve palsy.
Rare (less than 0.1%) occurring adverse reactions are: instances of convulsion, leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes, suicidal attempt, suicide, and suicidal ideation (see ).
Other adverse reactions reported during postmarketing experience with amantadine hydrochloride usage include
Nervous System/Psychiatric
Cardiovascular
Respiratory
Gastrointestinal
Hematologic
Special Senses
Skin and Appendages
Miscellaneous
Laboratory Test
To report SUSPECTED ADVERSE REACTIONS, contact Banner at 1866-231-1749 or FDA at 1-800-FDA-1088 or
What should I look out for while using Amantadine HCl?
Amantadine Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in Amantadine Hydrochloride Capsules.
Deaths:
Deaths due to drug accumulation (overdose) have been reported in patients with renal impairment, who were prescribed higher than recommended doses of SYMMETREL (amantadine) for their level of renal function (see and ).
Suicide Attempts:
CNS Effects:
Patients receiving amantadine hydrochloride capsules who note central nervous system effects or blurring of vision should be cautioned against driving or working in situations where alertness and adequate motor coordination are important.
Other:
Patients with Parkinson's disease improving on amantadine hydrochloride capsules should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis.
Because Amantadine Hydrochloride Capsules has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma.
What might happen if I take too much Amantadine HCl?
Deaths have been reported from overdose with amantadine hydrochloride. The lowest reported acute lethal dose was 1 gram. Because some patients have attempted suicide by overdosing with amantadine, prescriptions should be written for the smallest quantity consistent with good patient management.
Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension. Pulmonary edema and respiratory distress (including adult respiratory distress syndrome-ARDS) have been reported; renal dysfunction including increased BUN, decreased creatinine clearance and renal insufficiency can occur. Central nervous system effects that have been reported include insomnia, anxiety, agitation, aggressive behavior, hypertonia, hyperkinesia, ataxia, gait abnormality, tremor, confusion, disorientation, depersonalization, fear, delirium, hallucinations, psychotic reactions, lethargy, somnolence and coma. Seizures may be exacerbated in patients with prior history of seizure disorders. Hyperthermia has also been observed in cases where a drug overdose has occurred.
There is no specific antidote for an overdose of amantadine hydrochloride. However, slowly administered intravenous physostigmine in 1 and 2 mg doses in an adult at 1- to 2-hour intervals and 0.5 mg doses in a child at 5- to 10-minute intervals up to a maximum of 2 mg/hour have been reported to be effective in the control of central nervous system toxicity caused by amantadine hydrochloride. For acute overdosing, general supportive measures should be employed along with immediate gastric lavage or induction of emesis. Fluids should be forced, and if necessary, given intravenously. The pH of the urine has been reported to influence the excretion rate of amantadine hydrochloride. Since the excretion rate of amantadine hydrochloride increases rapidly when the urine is acidic, the administration of urine acidifying drugs may increase the elimination of the drug from the body. The blood pressure, pulse, respiration and temperature should be monitored. The patient should be observed for hyperactivity and convulsions; if required, sedation, and anticonvulsant therapy should be administered. The patient should be observed for the possible development of arrhythmias and hypotension; if required, appropriate antiarrhythmic and antihypotensive therapy should be given. Electrocardiographic monitoring may be required after ingestion, since malignant tachyarrhythmias can appear after overdose.
Care should be exercised when administering adrenergic agents, such as isoproterenol, to patients with an amantadine hydrochloride overdose, since the dopaminergic activity of amantadine hydrochloride has been reported to induce malignant arrhythmias.
The blood electrolytes, urine pH and urinary output should be monitored. If there is no record of recent voiding, catheterization should be done.
How should I store and handle Amantadine HCl?
Store at 20° to 25°C (68° to 77°F); see USP controlled room temperature.Protect from light. Do not freeze.Store at 20° to 25°C (68° to 77°F); see USP controlled room temperature.Protect from light. Do not freeze.Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride. Each capsule is imprinted with "A1" in black ink.Bottle of 10 - 68788-9530-1Bottle of 14 - 68788-9530-4Bottle of 20 - 68788-9530-2Bottle of 30 - 68788-9530-3Store at 20 to 25°C (68 to 77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP. Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride. Each capsule is imprinted with "A1" in black ink.Bottle of 10 - 68788-9530-1Bottle of 14 - 68788-9530-4Bottle of 20 - 68788-9530-2Bottle of 30 - 68788-9530-3Store at 20 to 25°C (68 to 77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP. Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride. Each capsule is imprinted with "A1" in black ink.Bottle of 10 - 68788-9530-1Bottle of 14 - 68788-9530-4Bottle of 20 - 68788-9530-2Bottle of 30 - 68788-9530-3Store at 20 to 25°C (68 to 77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP. Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride. Each capsule is imprinted with "A1" in black ink.Bottle of 10 - 68788-9530-1Bottle of 14 - 68788-9530-4Bottle of 20 - 68788-9530-2Bottle of 30 - 68788-9530-3Store at 20 to 25°C (68 to 77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP. Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride. Each capsule is imprinted with "A1" in black ink.Bottle of 10 - 68788-9530-1Bottle of 14 - 68788-9530-4Bottle of 20 - 68788-9530-2Bottle of 30 - 68788-9530-3Store at 20 to 25°C (68 to 77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP. Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride. Each capsule is imprinted with "A1" in black ink.Bottle of 10 - 68788-9530-1Bottle of 14 - 68788-9530-4Bottle of 20 - 68788-9530-2Bottle of 30 - 68788-9530-3Store at 20 to 25°C (68 to 77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP. Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride. Each capsule is imprinted with "A1" in black ink.Bottle of 10 - 68788-9530-1Bottle of 14 - 68788-9530-4Bottle of 20 - 68788-9530-2Bottle of 30 - 68788-9530-3Store at 20 to 25°C (68 to 77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action: Antiviral
Antiviral Activity:
in vitro
Drug Resistance:
in vitro
in vitro
in vitro
Mechanism of Action: Parkinson's Disease
Non-Clinical Toxicology
Amantadine Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in Amantadine Hydrochloride Capsules.Deaths:
Deaths due to drug accumulation (overdose) have been reported in patients with renal impairment, who were prescribed higher than recommended doses of SYMMETREL (amantadine) for their level of renal function (see and ).
Suicide Attempts:
CNS Effects:
Patients receiving amantadine hydrochloride capsules who note central nervous system effects or blurring of vision should be cautioned against driving or working in situations where alertness and adequate motor coordination are important.
Other:
Patients with Parkinson's disease improving on amantadine hydrochloride capsules should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis.
Because Amantadine Hydrochloride Capsules has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma.
Careful observation is required when amantadine hydrochloride is administered concurrently with central nervous system stimulants.
Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine.
Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson's disease, however, it is not known if other phenothiazines produce a similar response.
Coadministration of Dyazide (triamterene/hydrochlorothiazide) resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine hydrochloride 100 mg TID for Parkinson's disease.It is not known which of the components of Dyazide contributed to the observation or if related drugs produce a similar response.
Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%.
The concurrent use of amantadine hydrochloride with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of amantadine hydrochloride, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of amantadine hydrochloride.
Amantadine Hydrochloride should not be discontinued abruptly in patients with Parkinson's disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. The dose of anticholinergic drugs or of amantadine hydrochloride should be reduced if atropine-like effects appear when these drugs are used concurrently. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech.
Neuroleptic Malignant Syndrome (NMS):
NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia; neurologic findings including muscle rigidity, involuntary movements, altered consciousness; mental status changes; other disturbances such as autonomic dysfunction, tachycardia, tachypnea, hyper- or hypotension; laboratory findings such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin.
The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring, and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene are often used in the treatment of NMS, however, their effectiveness has not been demonstrated in controlled studies.
Renal disease:
Liver disease:
Care should be exercised when administering amantadine hydrochloride to patients with liver disease. Rare instances of reversible elevation of liver enzymes have been reported in patients receiving amantadine hydrochloride, though a specific relationship between the drug and such changes has not been established.
The adverse reactions reported most frequently at the recommended dose of amantadine hydrochloride (5 to10%) are: nausea, dizziness (lightheadedness), and insomnia.
Less frequently (1 to 5%) reported adverse reactions are: depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue.
Infrequently (0.1 to 1%) occurring adverse reactions are: congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, and visual disturbance, including punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve palsy.
Rare (less than 0.1%) occurring adverse reactions are: instances of convulsion, leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes, suicidal attempt, suicide, and suicidal ideation (see ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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