chlorpheniramine/hydrocodone (TussiCaps, Tussionex PennKinetic, Vituz)

Dosing and uses of TussiCaps, Tussionex PennKinetic (chlorpheniramine/hydrocodone)

• Adult
• Pediatric

 

Adult dosage forms and strengths

chlorpheniramine/hydrocodone

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)

 

Cough/Rhinorrhea

Capsule ER: 1 capsule PO q12hr; not to exceed 2 capsules/day

Solution: 5 mL PO q4-6hr PRN; not to exceed 20 mL/day

Suspension ER: 5 mL PO q12hr; not to exceed 10mL/day

 

Pediatric dosage forms and strengths

chlorpheniramine/hydrocodone

capsule extended release: Schedule II

• 4mg/5mg (TussiCaps Half Strength)
• 8mg/10mg (TuissiCaps Full Strength)

suspension: Schedule II

• (8mg/10mg)/5mL (Tussionex Pennkinetic)

 

Cough/Rhinorrhea

Capsules ER half strength

• 6-12 years: 1 capsule PO q12hr; not to exceed 2 capsules/24hr

Capsules ER full strength

• >12 years: 1 capsule PO q12hr; not to exceed 2 capsules/24hr

Oral suspension

• 6-12 years: 2.5 mL PO q12hr; not to exceed 5 mL/day
• >12 years: 5 mL PO q12hr; not to exceed 10 mL/day

Oral solution

• <18 years: Safety and efficacy not established

 

TussiCaps, Tussionex PennKinetic (chlorpheniramine/hydrocodone) adverse (side) effects

Frequency not defined

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

Contraindications

Hypersensitivity to opioids or chlorpheniramine

Use of extended release in children < 6 years

 

Cautions

Ingredients and dosage could change; ALWAYS check labeL

Use with caution in acute pancreatitis, Addison disease, cardiac arrhythmias, drug abuse/dependence, emotional lability, gallbladder disease, pseudomembranous colitis, GI surgery, head injury, myxedema, intracranial HTN, toxic psychosis, urethral stricture, seizures, acute alcoholism, emphysema, narrow angle glaucoma, asthma, prostatic hypertrophy, hypercapnia, renal/hepatic impairment, elderly debilitated patients

Respiratory depressant effects of narcotics and capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure; narcotics produce adverse reactions, which may obscure clinical course of patients with head injuries

Administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions

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

MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone

May cause dose-related respiratory depression (risk increased in children)

May impair ability to operate heavy machinery

 

Pregnancy and lactation

Pregnancy category: C; D if used for a prolonged period of time or in large doses near term; withdrawal symptoms or respiratory depression may be seen in babies born to mothers taking opioids

Lactation: Excretion in milk unknown/not recommended

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of TussiCaps, Tussionex PennKinetic (chlorpheniramine/hydrocodone)

Mechanism of action

Chlorpheniramine: Histamine-1 receptor antagonist on effector cells in blood vessels, gastrointestinal tract, and respiratory tract

Hydrocodone: Opioid agonist; elicits antitussive effect; suppresses cough in medullary center; alters perception and response to pain; produces generalized CNS depression

 

Absorption

Peak plasma time

• Chlorpheniramine: 6.3 hr
• Hydrocodone: 4-8 hr

Peak plasma concentration

• Chlorpheniramine: 58.4 ng/mL
• Hydrocodone: 22.8 ng/mL

Peak plasma time

• Hydrocodone: 1-2 hr (solution); 3 hr (capsules)
• Chlorpheniramine: 2-3 hr

Distribution

• Chlorpheniramine: 4-7 L/kg (children); 6-12 L/kg (adults)

Protein binding

• Chlorpheniramine: 33%

 

Elimination

Half-life

• Chlorpheniramine: 10-13 hr (children); 14-24 hr (adults)
• Hydrocodone: 4-5 hr

Excretion

• Hydrocodone: Urine