Tussicaps
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Questions & Answers
Side Effects & Adverse Reactions
Respiratory Depression – As with all narcotics, TussiCaps® extended-release capsules produce dose-related respiratory depression by directly acting on brain stem respiratory centers. Hydrocodone affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Caution should be exercised when TussiCaps® extended-release capsules are used postoperatively and in patients with pulmonary disease, or whenever ventilatory function is depressed. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated (see OVERDOSAGE).
Head Injury and Increased Intracranial Pressure – The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions – The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Obstructive Bowel Disease – Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder.
Pediatric Use – The use of TussiCaps® extended-release capsules are contraindicated in children less than 6 years of age (see CONTRAINDICATIONS).
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 TussiCaps® extended-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) (see PRECAUTIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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. TussiCaps® extended-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-[p-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.
Sources
Tussicaps Manufacturers
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Physicians Total Care, Inc.
![Tussicaps (Hydrocodone Polistirex And Chlorpheniramine Polistirex) Capsule, Extended Release [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tussicaps | Physicians Total Care, Inc.
DOSAGE AND ADMINISTRATIONAdults 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; do not exceed 2 capsules in 24 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; do not exceed 2 capsules in 24 hours.
This medicine is contraindicated in children under 6 years of age (see CONTRAINDICATIONS).
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Ecr Pharmaceuticals
Tussicaps | Torrent Pharmaceuticals Limited
2.1 OCD (Obsessive Compulsive Disorder)The recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum therapeutic benefit, not to exceed 300 mg per day.
Capsules should not be crushed or chewed.
2.2 Pediatric Patients Naïve to Fluvoxamine MaleatePhysicians should consider that the lowest available dose of fluvoxamine maleate extended-release capsules may not be appropriate for pediatric patients na ve to fluvoxamine maleate.
2.3 Dosage for Elderly or Hepatically Impaired PatientsElderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to titrate slowly following the initial dose of 100 mg in these patient groups.
2.4 Maintenance/Continuation of Extended TreatmentAlthough the efficacy of fluvoxamine maleate extended-release capsules beyond 12 weeks of dosing has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. The benefit of maintaining patients with OCD on immediate-release fluvoxamine maleate tablets after achieving a response for an average duration of about 4 weeks in a 10-week single-blind phase during which patients were titrated to effect was demonstrated in a controlled trial (see CLINICAL TRIALS [14.2]). Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluvoxamine maleate extended-release capsules. Conversely, at least 14 days should be allowed after stopping fluvoxamine maleate extended-release capsules before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS [4.1]).
2.6 Use of Fluvoxamine Maleate Extended-Release Capsules with Other MAOIs such as Linezolid or Methylene BlueDo not start fluvoxamine maleate extended-release capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS [4.1]).
In some cases, a patient already receiving fluvoxamine maleate extended-release capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluvoxamine maleate extended-release capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluvoxamine maleate extended-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS AND PRECAUTIONS [5.2]).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluvoxamine maleate extended-release capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS AND PRECAUTIONS [5.2]).
2.7 Discontinuation of Treatment with Fluvoxamine Maleate Extended-Release CapsulesSymptoms associated with discontinuation of other SSRIs or SNRIs have been reported (see WARNINGS AND PRECAUTIONS [5.10]). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the health care provider may continue decreasing the dose but at a more gradual rate.
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Valeant Pharmaceuticals North America Llc
Tussicaps | Valeant Pharmaceuticals North America Llc
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; do not exceed 2 capsules in 24 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; do not exceed 2 capsules in 24 hours.
This medicine is contraindicated in children under 6 years of age (see CONTRAINDICATIONS).
![Tussicaps (Hydrocodone Polistirex And Chlorpheniramine Polistirex) Capsule, Extended Release [Ecr Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f8d38c5f-1ecb-49e2-8e37-032ed84a9c8a&name=fluvoxaminercapsules-figure-04.jpg)
![Tussicaps (Hydrocodone Polistirex And Chlorpheniramine Polistirex) Capsule, Extended Release [Valeant Pharmaceuticals North America Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=571c1b83-2fde-4339-be0c-cac0dedaf76c&name=image-03.jpg)
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