Adult Dosing

Cough and Upper respiratory symptoms

• 8 mg/10 mg (chlorpheniramine/hydrocodone) PO bid; Max: 16 mg/20 mg (chlorpheniramine/hydrocodone)/day

Vituz

• 5 mL PO every 4 to 6 hours; Max: 20 mL in 24 hours

Pediatric Dosing

Cough and Upper respiratory symptoms

• Children >12 yrs: 8 mg/10 mg (chlorpheniramine/hydrocodone) PO bid; Max: 16 mg/20 mg (chlorpheniramine/hydrocodone)/day
• Children 6-11 yrs: 4 mg/5 mg (chlorpheniramine/hydrocodone) PO bid; Max: 8 mg/10 mg (chlorpheniramine/hydrocodone)/day

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of cough and upper respiratory symptoms associated with allergy or cold

• Hypersensitivity to any of the ingredients of the product
• Pediatric patient <6 yrs

• N/A

Renal Dose Adjustment

• Severe renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Severe hepatic impairment: Use with caution; dose adjustments not defined

• Hydrocodone can produce dose-related respiratory depression when used in high doses or in sensitive patients, by acting directly on the brain stem respiratory center. Use cautiously in patients with pulmonary disease, or whenever ventilatory function is depressed. Use naloxone hydrochloride and other supportive measures if respiratory depression occurs
• Use of narcotics in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure, can markedly increase respiratory depression and elevate cerebrospinal fluid pressure. Adverse reactions may obscure the clinical course of patients with head injuries
• Administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions
• Prolonged use of narcotics may cause obstructive bowel disease, especially in patients with underlying intestinal motility disorder
• Pediatric patients are at increased risk of respiratory depression, hence hydrocodone is contraindicated in children aged <6 years. Use cautiously in pediatric patients aged 6 years, especially in pediatric patients with respiratory embarrassment (eg, croup)
• The therapy can cause drug dependence and tolerance may develop on recurrent administration
• Therapy should not be administered concomitantly with anticholinergics as it may produce paralytic ileus. Coadministration with tricyclic antidepressants may increase the effect of either the antidepressant or hydrocodone
• Treatment may obscure the clinical course of acute abdominal conditions

Cautions: Use with caution in

• Renal impairment
• Hepatic impairment
• Narrow-angle glaucoma
• Asthma
• Hypothyroidism
• Addison's disease
• Prostatic hypertrophy
• Urethral stricture
• Pulmonary diseases
• Head injury
• Increased intracranial pressure
• Intracranial lesion
• Elderly
• Alcohol abuse
• Elderly patients
• Debilitated patients

Pregnancy Category:C

Breastfeeding: Chlorpheniramine: Small occasional doses of chlorpheniramine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause adverse effects in the infant or interfere with lactation, particularly when used in combination with a sympathomimetic agent or when lactation is not well established. The nonsedating antihistamines should be preferred. Hydrocodone: Maternal use of maximum dosages of oral narcotics while breastfeeding can cause infant drowsiness in breastfed infants, particularly newborns are sensitive to even small dosages of narcotic analgesics, in the first week of life, however small volumes of colostrum is secreted in the first 2 to 3 days postpartum hence newborn's dosage is limited. Once the mother's milk comes in, it is best to avoid oral hydrocodone (and combinations) and administer nonnarcotic analgesic if necessary. Maximum recommended dosage is 30 mg/day. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, immediately contact the physician if baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 March 2011). Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from chlorpheniramine/hydrocodone, manufacturer recommends decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

• GI: Nausea, vomiting, constipation
• CNS: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes
• GU: Ureteral spasm, spasm of vesical sphincters, urinary retention
• RESP: Respiratory depression, dryness of the pharynx, tightness of the chest
• DERM: Rash, pruritus
• MISC: Death, drug abuse and dependence

Chlorpheniramine

• Antihistamine; blocks the action of endogenous histamine by binding to the histamine H1 receptor thus leading to temporary relief of the negative symptoms brought on by histamine
• Extensively metabolized by liver
• Renally excreted
• Half-life: 16 hrs

Hydrocodone

• Semisynthetic narcotic antitussive and analgesic; binds to opiate receptor in the CNS, thus alters the perception of and response to painful stimuli while producing generalized CNS depression
• Mostly metabolized by the liver and also intestinal mucosa
• Excreted in urine (50-60% as metabolites, 15% as unchanged drug)
• Half-life: 4 hrs

US Trade Name(s)

• Tussicaps
• Tussionex Pennkinetic
• Vituz

US Availability

chlorpheniramine/hydrocodone (generic)

• ESUSP: [8 mg/10 mg]/5 mL

Tussicaps (chlorpheniramine/hydrocodone)

• ECAPS: 8 mg/10 mg
• ECAPS: 4 mg/5 mg

Tussionex Pennkinetic (chlorpheniramine/hydrocodone)

• ESUSP: [8 mg/10 mg]/5 mL

Vituz (chlorpheniramine/hydrocodone)

• SUSP: [4 mg/5 mg]/5 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations

Drug Name: TussiCaps (chlorpheniramine 4 MG / hydrocodone bitartrate 5 MG) Extended Release Capsule

Ingredient(s): Chlorpheniramine mixture with Hydrocodone

Imprint: M;HP;CP;5;4

Color(s): White, White

Shape: Capsule

Size (mm): 16.00

Score: 1

Inactive Ingredient(s): butyl alcohol / gelatin / ferrosoferric oxide / isopropyl alcohol / cellulose, microcrystalline / propylene glycol / water / shellac / ammonia / titanium dioxide / d&c yellow no. 10 / indigotindisulfonate sodium / fd&c blue no. 2 / fd&c blue no. 1 / aluminum oxide / fd&c red no. 40 / alcohol / methyl alcohol

Drug Label Author:
Mallinckrodt Inc.

DEA Schedule:
CIII

Drug Name: TussiCaps 10/8 (hydrocodone bitartrate / chlorpheniramine) Extended Release Capsule

Ingredient(s): Chlorpheniramine mixture with Hydrocodone

Imprint: M;HP;CP;10;8

Color(s): White, White

Shape: Capsule

Size (mm): 20.00

Score: 1

Inactive Ingredient(s): butyl alcohol / gelatin / ferrosoferric oxide / isopropyl alcohol / cellulose, microcrystalline / propylene glycol / water / shellac / ammonia / titanium dioxide / d&c yellow no. 10 / aluminum oxide / fd&c blue no. 1 / fd&c blue no. 2 / indigotindisulfonate sodium / fd&c red no. 40 / alcohol / methyl alcohol

Drug Label Author:
Mallinckrodt Inc.

DEA Schedule:
CIII