HYTAN  - hydrocodone and chlorpheniramine tannate suspension 
Prasco Laboratories

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HyTan™ Suspension
(hydrocodone tannate 5 mg and chlorpheniramine tannate 4 mg)
per 5 mL

11  DESCRIPTION

Each teaspoonful (5 mL) of HyTan™ Suspension contains 5 mg Hydrocodone Tannate and 4 mg of Chlorpheniramine Tannate.

HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension provides up to 12-hour relief per dose.

HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension is for oral use only.

Hydrocodone is a centrally-acting narcotic antitussive. Chemically it is 4,5-Epoxy-3-methoxy-17-methyl-morphinan-6-one Tannate.

Chlorpheniramine is an antihistamine. Chemically it is 2-[p-chloro-α-(2-dimethyl-aminoethyl)benzyl]pyridine Tannate.

Inactive Ingredients: aspartame, citric acid, deionized water, glycerin, methylparaben, peach flavoring, pineapple flavoring, propylene glycol, propylparaben, potassium citrate, potassium sorbate, FD&C yellow #10, FD&C yellow #6, xanthan gum.

12  CLINICAL 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, physical and psychological dependence. Chlorpheniramine is an antihistamine drug (H1 receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of respiratory mucosa.

1  INDICATIONS & USAGE

HyTan™ (hydrocodone tannate and chlorpheniramine tannate) Suspension is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold.

4  CONTRAINDICATIONS

Known allergy or sensitivity to hydrocodone or chlorpheniramine or its ingredients.

WARNINGS

Respiratory Depression: As with all narcotics, HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension produces 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 HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension is 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: 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. Benefit to risk ratio should be carefully considered especially in pediatric patients with respiratory embarrassment (e.g., croup) (see PRECAUTIONS).

PRECAUTIONS

General: Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma or prostatic hypertrophy.

Special Risk Patients: As with any narcotic agent, HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Information for Patients: As with all narcotics, HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension 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. Keep out of the reach of children.

Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when HyTan™ (hydrocodone tannate and chlorpheniramine tannate) Suspension is used postoperatively, and in patients with pulmonary disease.

Drug Interactions: Patients receiving narcotics, antihistaminics, antipsychotics, antianxiety agents or other CNS depressants (including alcohol) concomitantly with HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension 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 HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension.

Pregnancy: Teratogenic Effects – Pregnancy Category C. Hydrocodone has been shown to be teratogenic in hamsters when given in doses 700 times the human dose. There are no adequate and well-controlled studies in pregnant women. HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: 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 HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension 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 HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension, 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: Safety and effectiveness of HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension in pediatric patients under six have not been established (see WARNINGS).

Geriatric Use: 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. Reported clinical experience has not identified differences in response between the elderly and young patients.

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 the 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.

Phenylketonurics: Contains Phenylalanine: 12.5 mg per 5 mL.

6  ADVERSE REACTIONS

Central Nervous System: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes.

Dermatologic System: Rash, pruritus.

Gastrointestinal System: Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension may produce constipation.

Genitourinary System: Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.

Respiratory Depression:

HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).

Respiratory System: Dryness of the pharynx, occasional tightness of the chest.

9  DRUG ABUSE AND DEPENDENCE

HyTan™ (hydrocodone tannate and chlorpheniramine tannate) Suspension is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension is used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy.

10  OVERDOSAGE

Signs and Symptoms: Serious overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. Although miosis is characteristic of narcotic overdose, mydriasis may occur in terminal narcosis or severe hypoxia. In severe overdosage apnea, circulatory collapse, cardiac arrest and death may occur. The manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation.

Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of hydrocodone in the formulation may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

2  DOSAGE & ADMINISTRATION

Shake well before using.

Adults: 2 teaspoonfuls (10mL) every 12 hours. Not to exceed 4 teaspoonfuls in 24 hours.

Children: Age 6-12 years: 1 teaspoonful every 12 hours. Not to exceed 2 teaspoonfuls in 24 hours.

Not recommended for children under 6 years of age (see PRECAUTIONS).

16  HOW SUPPLIED

HyTan™ (hydrocodone tannate 5 mg and chlorpheniramine tannate 4 mg) per 5 mL Suspension is a peach colored, tropical fruit flavored Suspension available in tampered sealed, 4 oz bottles: NDC 66993-502-55.

Shake well before dispensing. Dispense in a well-closed container. Store at (15°-30°C) 59°-86°F.

Mfd. For: Prasco Laboratories

Cincinnati, OH 45249 USA

Mfd. By: Great Southern Laboratories

Houston, Texas 77099 USA

Rev. 05/06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

e2323407-figure-01

HYTAN 
hydrocodone and chlorpheniramine tannate   suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)66993-502
Route of AdministrationORALDEA ScheduleCIII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCODONE (HYDROCODONE) HYDROCODONE5 mg  in 5 mL
CHLORPHENIRAMINE TANNATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE TANNATE4 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
Product Characteristics
ColorORANGE (peach) Score    
ShapeSize
FlavorTROPICAL FRUIT PUNCH (tropical fruit) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
166993-502-55118 mL In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/31/200612/31/2007

Labeler - Prasco Laboratories (065969375)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553MANUFACTURE
Revised: 02/2011Prasco Laboratories