Classes
DEA Class; Rx
Common Brand Names; TussiCaps, Tussionex PennKinetic, Vituz
- Antitussives, Narcotic Combos
Description
Combined oral antihistamine and semisynthetic opiate agonist antitussive
Used to relieve cough and upper respiratory symptoms associated with allergic rhinitis or the common cold in adults
Not indicated in pediatric patients under 18 years of age; contraindicated in neonates, infants and children less than 6 years of age
Indications
Indicated for the relief of cough and upper respiratory symptoms associated with allergic rhinitis or the common cold.
Contraindications
Hypersensitivity to opioids or chlorpheniramine
Use of extended release in children < 6 years
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Adverse Effects
- Chest tightness
- Syncope
- Agitation
- Coma
- Depression
- Dizziness
- Dysphoria
- Euphoria
- Faintness
- Mental clouding
- Nervousness
- Restlessness
- Sedation
- Seizures
- Flushing
- Pruritus
- Sweating
- Urticaria
- Warmness of the face/neck/upper thorax
- Constipation
- Dry mouth
- Nausea
- Vomiting
- Respiratory/circulatory depression
- Shock
- Urinary retention
- Blurred vision
- Visual disturbances
- Diplopia
- Xerostomia
- Dysuria
- Ureteral spasm
Warnings
Ingredients and dosage could change; ALWAYS check label
Use with caution in acute pancreatitis, Addison disease, cardiac arrhythmias, emotional lability, gallbladder disease, pseudomembranous colitis, GI surgery, myxedema, toxic psychosis, urethral stricture, seizures, acute alcoholism, emphysema, narrow-angle glaucoma, asthma, prostatic hypertrophy, hypercapnia, renal/hepatic impairment, elderly debilitated patients
Use with caution extended-release suspension in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, or urethral stricture for possibility of respiratory depression
The two active ingredients in the drug combination may produce marked drowsiness and impair mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery; advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of medication; avoid concurrent use with alcohol or other central nervous system depressants as additional impairment of central nervous system performance may occur
Dosage should not be increased if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease
Dosing errors can result in accidental overdose and death; to reduce risk of overdose and respiratory depression, ensure that the dose is communicated clearly and dispensed accurately; advise patients to always use accurate milliliter measuring device when measuring and administering drug; inform patients that household teaspoon is not accurate measuring device and could lead to overdosage and serious adverse reactions; for prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate calibrated measuring device and provide instructions for measuring correct dose
Pregnancy and Lactation
Not recommended for use in pregnant women, including during or immediately prior to labor; prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome
There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; however, data are available with hydrocodone and chlorpheniramine
Maximum Dosage
10 mL extended-release suspension/24 hours PO or 2 full-strength ER capsules/24 hours PO; polistirex dose forms provide the equivalent to hydrocodone bitartrate 20 mg/day PO; chlorpheniramine maleate 16 mg/day PO.
10 mL extended-release suspension/24 hours PO or 2 full-strength ER capsules/24 hours PO; polistirex dose forms provide the equivalent to hydrocodone bitartrate 20 mg/day PO; chlorpheniramine maleate 16 mg/day PO.
Safety and efficacy have not been established.
6 years and older: Safety and efficacy have not been established.
Less than 6 years: Use is contraindicated.
Use is contraindicated.
How supplied
Hydrocodone Bitartrate/Chlorpheniramine Maleate
capsule extended release: Schedule II
- 4mg/5mg (TussiCaps Half Strength)
- 8mg/10mg (TussiCaps Full Strength)
oral suspension extended release: Schedule II
- (8mg/10mg)/5mL (Tussionex Pennkinetic)
oral solution: Schedule II
- (4mg/5mg)/5mL (Vituz)