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TussiCaps
Overview
What is TussiCaps?
Each full-strength TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsule contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. Each half-strength TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsule contains hydrocodone polistirex equivalent to 5 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg of chlorpheniramine maleate. TussiCaps extended-release capsules provide up to 12-hour relief per dose. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. TussiCapsextended-release capsules are for oral use only.
Hydrocodone Polistirex: sulfonated styrene-divinylbenzene copolymer complex with 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one.
Chlorpheniramine Polistirex: sulfonated styrene-divinylbenzene copolymer complex with 2-[-chloro-α-[2-(dimethylamino)ethyl]-benzyl]pyridine.
Inactive Ingredients: Butyl alcohol, dehydrated alcohol, gelatin, iron oxide black JPE, isopropyl alcohol, microcrystalline cellulose, propylene glycol, purified water, SDA 3A alcohol (27 CFR), shellac, shellac glaze-45% in SD-45 alcohol, strong ammonia solution, titanium dioxide, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2 aluminum lake, FD&C blue #2/indigo carmine aluminum lake, and FD&C red #40/allura red AC aluminum lake.
What does TussiCaps look like?
What are the available doses of TussiCaps?
Sorry No records found.
What should I talk to my health care provider before I take TussiCaps?
Sorry No records found
How should I use TussiCaps?
TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules are indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.
Adults and Children 12 Years and Older
One (1) full-strength TussiCaps extended-release capsule (hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate) every 12 hours; .
Children 6 to 11 Years of Age
One (1) half-strength TussiCaps extended-release capsule (hydrocodone polistirex equivalent to 5 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg of chlorpheniramine maleate) every 12 hours; .
This medicine is contraindicated in children under 6 years of age (
).
What interacts with TussiCaps?
TussiCaps extended-release capsules are contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.
The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.
What are the warnings of TussiCaps?
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Head Injury and Increased Intracranial Pressure –
Acute Abdominal Conditions –
Obstructive Bowel Disease –
Pediatric Use
The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age (
).
In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering TussiCapsextended-release capsules to pediatric patients 6 years of age and older. Overdose or concomitant administration of TussiCaps extended-release capsules with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup) (
).
What are the precautions of TussiCaps?
General
Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy.
Special Risk Patients –
Information for Patients
As with all narcotics, TussiCaps extended-release capsules may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly. TussiCapsextended-release capsules must not be diluted with fluids or mixed with other drugs as this may alter the resin-binding and change the absorption rate, possibly increasing the toxicity.
Keep out of the reach of children.
Cough Reflex –
Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with TussiCaps extended-release capsules may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity and reproductive studies have not been conducted with TussiCaps extended-release capsules.
Pregnancy
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Array
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Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.
Labor and Delivery
As with all narcotics, administration of TussiCaps extended-release capsules to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from TussiCaps extended-release capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age (
).
TussiCaps extended-release capsules should be used with caution in pediatric patients 6 years of age and older (
).
Geriatric Use
Clinical studies of hydrocodone polistirex and chlorpheniramine polistirex extended-release did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
What are the side effects of TussiCaps?
Gastrointestinal Disorders
Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of TussiCaps extended-release capsules may produce constipation.
General Disorders and Administration Site Conditions
Death
Nervous System Disorders
Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes.
Renal and Urinary Disorders
Ureteral spasm, spasm of vesical sphincters, and urinary retention have been reported with opiates.
Respiratory, Thoracic and Mediastinal Disorders
Dryness of the pharynx, occasional tightness of the chest, and respiratory depression (
).
TussiCaps extended-release capsules may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (
). Use of TussiCaps in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with TussiCapsextended-release capsules in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.
Skin and Subcutaneous Tissue Disorders
Rash, pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals, North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using TussiCaps?
TussiCaps extended-release capsules are contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.
The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.
Respiratory Depression –
see
Head Injury and Increased Intracranial Pressure –
Acute Abdominal Conditions –
Obstructive Bowel Disease –
Pediatric Use
The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age (
).
In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering TussiCapsextended-release capsules to pediatric patients 6 years of age and older. Overdose or concomitant administration of TussiCaps extended-release capsules with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup) (
).
What might happen if I take too much TussiCaps?
Signs and Symptoms –
Treatment –
How should I store and handle TussiCaps?
ArrayFull-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01Full-Strength: 10 mg/8 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “ECR” on the cap and “HP/CP” over “10/8” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01Half-Strength: 5 mg/4 mg TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “ECR” on the cap and “HP/CP” over “5/4” on the body. Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, and physical and psychological dependence.
Chlorpheniramine is an antihistamine drug (H receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.
Hydrocodone and chlorpheniramine release from TussiCaps® extended-release capsules is controlled by use of an ion-exchange polymer matrix.
Following multiple dosing with hydrocodone polistirex and chlorpheniramine polistirex extended-release suspension, hydrocodone mean (S.D.) peak plasma concentrations of 22.8 (5.9) ng/mL occurred at 3.4 hours. Chlorpheniramine mean (S.D.) peak plasma concentrations of 58.4 (14.7) ng/mL occurred at 6.3 hours following multiple dosing. Peak plasma levels obtained with an immediate-release syrup occurred at approximately 1.5 hours for hydrocodone and 2.8 hours for chlorpheniramine. The plasma half-lives of hydrocodone and chlorpheniramine have been reported to be approximately 4 and 16 hours, respectively.
Non-Clinical Toxicology
TussiCaps extended-release capsules are contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.
Respiratory Depression –
see
Head Injury and Increased Intracranial Pressure –
Acute Abdominal Conditions –
Obstructive Bowel Disease –
Pediatric Use
The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age ( ).
In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering TussiCapsextended-release capsules to pediatric patients 6 years of age and older. Overdose or concomitant administration of TussiCaps extended-release capsules with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup) ( ).
Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy.
Special Risk Patients –
Gastrointestinal Disorders
Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of TussiCaps extended-release capsules may produce constipation.
General Disorders and Administration Site Conditions
Death
Nervous System Disorders
Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes.
Renal and Urinary Disorders
Ureteral spasm, spasm of vesical sphincters, and urinary retention have been reported with opiates.
Respiratory, Thoracic and Mediastinal Disorders
Dryness of the pharynx, occasional tightness of the chest, and respiratory depression ( ).
TussiCaps extended-release capsules may produce dose-related respiratory depression by acting directly on brain stem respiratory centers ( ). Use of TussiCaps in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with TussiCapsextended-release capsules in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.
Skin and Subcutaneous Tissue Disorders
Rash, pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals, North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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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