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Tussigon

Generic Name: hydrocodone bitartrate and homatropine methylbromide
Dosage Form: tablet

ANTITUSSIVE

Rx only

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS, PRECAUTIONS - Drug Interactions). Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

Tussigon Description

Tussigon tablets contain hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting opioid antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.

Each Tussigon tablet contains:

Hydrocodone Bitartrate, USP 5 mg

Homatropine Methylbromide, USP 1.5 mg.

Tussigon tablets also contain: Colloidal Silicon Dioxide NF, FD & C Blue No. 1 Aluminum Lake, Lactose Monohydrate NF, Microcrystalline Cellulose NF, Pregelatinized Starch NF, Stearic Acid NF, Talc USP.

The hydrocodone component is 4,5α- epoxy-3-methoxy-17-methylmorphinan -6-one-tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder which is derived from the opium alkaloid, thebaine, has a molecular weight of (494.50) and may be represented by the following structural formula:

C18H21N03 ∙ C4H606 ∙ 2½H20

Hydrocodone Bitartrate

Homatropine methylbromide is 8-Azoniabicyclo[3.2.1]octane, 3-(hydroxyphenylacetyl)oxy-8, 8-dimethyl-, bromide, endo-, a white crystal or fine white crystalline powder, with a molecular weight of (370.29).

C17H24BrN03

Homatropine Methylbromide

Dissolution testing of Tussigon tablets is performed using Test 2 from USP <711>.

Tussigon - Clinical Pharmacology

Hydrocodone is a semisynthetic opioid 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.

Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/ml. Maximum serum levels were achieved at 1.3± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α and 6-β-hydroxymetabolites.

Indications and Usage for Tussigon

Tussigon tablets are indicated for the symptomatic relief of cough in adults and children 6 years of age and older.

Contraindications

Tussigon tablets should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

Warnings

Risks from Concomitant Use with Benzodiazepines or other CNS Depressants

Concomitant use of opioids, including Tussigon tablets, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol (see PRECAUTIONS - Drug Interactions).

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.

Advise both patients and caregivers about the risks of respiratory depression and sedation if Tussigon tablets are used with benzodiazepines, alcohol, or other CNS depressants (see PRECAUTIONS - Information for Patients).

Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of Tussigon tablets and it should be prescribed and administered with the same degree of caution appropriate to the use of other opiod drugs (see DRUG ABUSE AND DEPENDENCE).

Respiratory Depression

The use of Tussigon tablets are not recommended for use in children less than 6 years of age because of the risk of fatal respiratory depression (see ADVERSE REACTIONS –Respiratory Depression). Tussigon tablets produce dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.

Head Injury And Increased Intracranial Pressure

The respiratory depression properties of opioids 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, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of Tussigon tablets or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Pediatric Use

In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of opioid cough suppressants in a dose-dependent manner. Caution should be exercised when administering Tussigon tablets to pediatric patients 6 years of age and older because of the potential for fatal respiratory depression. Overdose or concomitant administration of Tussigon tablets with other respiratory depressants may increase the risk of respiratory depression inpediatric patients. Benefit to risk ratio should be carefully considered especially in the pediatric population with respiratory embarrassment (e.g., croup) (see PRECAUTIONS).

Precautions

General

Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is provided.

Special Risk Patients

Tussigon tablets should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal functions, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma.

Information for Patients

Inform patients and caregivers that potentially fatal additive effects may occur if Tussigon tablets are used with benzodiazepines or other CNS depressants, including alcohol. Because of this risk, patients should avoid concomitant use of Tussigon tablets with benzodiazepines or other CNS depressants, including alcohol (see Warnings, Precautions - Drug Interactions).

Hydrocodone 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. The patient using Tussigon tablets should be cautioned accordingly.

Keep out of the reach of children.

Drug Interactions

The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with Tussigon tablets may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided (see Warnings).

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of Tussigon tablets in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with Tussigon tablets. It is also not known whether Tussigon can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tussigon tablets should be given to a pregnant woman only if clearly needed.

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 opioids, administration of Tussigon tablets 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 Tussigon tablets, 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 Tussigon tablets in pediatric patients under six have not been established. The use of Tussigon tablets in children less than 6 years of age has been associated with cases of fatal respiratory depression (see ADVERSE REACTIONS – Respiratory Depression). Tussigon should be used with caution in pediatric patients 6 years of age and older (see WARNINGS – Pediatric Use).

Adverse Reactions

Central Nervous System

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

Gastrointestinal System

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of Tussigon tablets may produce constipation.

Genitourinary System

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

Respiratory Depression

Tussigon may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE. Use of Tussigon tablets in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with Tussigon tablets in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.

Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression.

Postmarketing events seen in patients older than 6 years of age include accidental overdose, cardiorespiratory arrest, death due to drug toxicity, non-accidental overdose, and overdose.

Dermatological

Skin rash, pruritus.

Drug Abuse and Dependence

Tussigon tablets are Schedule II opioids. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of opioids; therefore, Tussigon tablets should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when Tussigon tablets are 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, assume clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opiod therapy.

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. In severe overdosage apnea, circulatory collapse, cardiac arrest and death may occur. The ingestion of very large amounts of Tussigon tablets may, in addition, result in acute homatropine intoxication.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. 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.

Tussigon Dosage and Administration

Adults and Adolescents 12 Years of Age and Older

One (1) tablet every 4 to 6 hours as needed; do not exceed six (6) tablets in 24 hours.

Children 6 to 11 Years of Age

One-half (1/2) tablet every 4 to 6 hours as needed; do not exceed three (3) tablets in 24 hours.

How is Tussigon Supplied

Each blue, scored tablet contains 5 mg hydrocodone bitartrate and 1.5 mg homatropine methylbromide and is available in:

Bottles of 100 NDC 61570-102-01

Store at controlled room temperature 68°F to 77°F (20°C to 25°C).

Keep Tussigon tablets in a tightly closed, child-resistant container and out of the light.

Oral prescription where permitted by state law.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0732-3.0
January 2017

This Medication Guide has been approved by the U.S. Food and Drug Administration.
MEDICATION GUIDE
Tussigon (tuh-se-gone)
(Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, C-II
What is the most important information I should know about Tussigon tablets?
  • Taking Tussigon tablets with benzodiazepines or other central nervous system depressants, including alcohol can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
  • Tussigon tablets can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with Tussigon tablets.
  • Women who breastfeed should talk to their healthcare provider before taking Tussigon tablets.
  • Call your healthcare provider or get emergency medical help right away if anyone taking Tussigon tablets has any of the symptoms below:
  • increased sleepiness
  • confusion
  • difficulty breathing
  • shallow breathing
  • limpness
  • your baby has difficulty breastfeeding
  • Keep Tussigon tablets in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Tussigon tablets , get emergency medical help right away.
  • Tussigon tablets can cause serious side effects including death.
  • Take Tussigon tablets exactly as prescribed by your healthcare provider. If you take the wrong dose of Tussigon tablets, you could overdose and die.
  • Tussigon tablets are not for children under 6 years of age.
What are Tussigon tablets?
  • Tussigon tablets are a prescription medicine used to treat a cough in adults and children 6 years and older. Tussigon tablets contain hydrocodone and is a narcotic cough suppressant.
  • Tussigon tablets are federal controlled substance (C-II) because they contain hydrocodone that can be abused or lead to dependence. Keep Tussigon tablets in a safe place to prevent misuse and abuse. Selling or giving away Tussigon tablets may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
  • Tussigon tablets are not for children under 6 years of age.
Who should not take Tussigon tablets?
  • Do not take Tussigon tablets if you are allergic to hydrocodone or homatropine methylbromide. See the end of this Medication Guide for a complete list of ingredients.
Before you take Tussigon tablets, tell your healthcare provider about all of your medical conditions, including if you:
  • have a drug dependence
  • have lung or breathing problems
  • have had a head injury
  • have pain in your stomach-area (abdomen)
  • have a history of severe or persistent cough
  • have prostate problems
  • have problems with your urinary tract (urethral stricture)
  • plan to have surgery
  • drink alcohol
  • have kidney or liver problems
  • have diabetes
  • have thyroid problems, such as hypothyroidism
  • are pregnant or plan to become pregnant. It is not known if Tussigon tablets will harm your unborn baby. You and your healthcare provider should decide if you should take Tussigon tablets while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Tussigon passes into your breast milk. You and your healthcare provider should decide if you will take Tussigon tablets or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking Tussigon tablets with certain other medicines can cause side effects or affect how well Tussigon tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you:
  • take pain medicines such as narcotics
  • take cold or allergy medicines that contain antihistamines or cough suppressants
  • take medicines for mental illness (anti-psychotics, anti-anxiety)
  • drink alcohol
  • take medicines for depression, including monoamine oxidase inhibitors (MAOIs) and tricyclics
    Ask your healthcare provider if you are not sure if you take one of these medicines.
How should I take Tussigon tablets?
  • Take Tussigon tablets exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how many Tussigon tablets to take and when to take it. Do not change your dose without talking to your healthcare provider.
  • If you take too many Tussigon tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking Tussigon tablets?
  • Tussigon tablets can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with Tussigon tablets.
  • Avoid drinking alcohol during treatment with Tussigon tablets. Drinking alcohol can increase your chances of having serious side effects.
What are the possible side effects of Tussigon tablets?
Tussigon tablets may cause serious side effects, including:
  • See "What is the most important information I should know about Tussigon tablets?"
  • Breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you are sleeping more than usual, have shallow or slow breathing, or confusion.
  • Physical dependence or abuse. Take Tussigon tablets exactly as your healthcare provider tells you to take it. Stopping Tussigon tablets suddenly could cause withdrawal symptoms.
  • Bowel problems including constipation or stomach pain.
  • Increased intracranial pressure.
The most common side effects of Tussigon tablets include:
  • sleepiness
  • confusion
  • nausea and vomiting
  • difficulty urinating
  • trouble breathing
These are not all the possible side effects of Tussigon tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Tussigon tablets?
  • Store Tussigon tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Tussigon tablets in a tightly closed, child-resistant container and out of the light.
  • Keep Tussigon tablets and all medicines out of the reach of children.
General information about the safe and effective use of Tussigon tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tussigon tablets for a condition for which they were not prescribed. Do not give Tussigon tablets to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about Tussigon tablets that is written for health professionals.
What are the ingredients in Tussigon tablets?
Active ingredients: hydrocodone bitartrate and homatropine methylbromide.
Inactive ingredients: Colloidal Silicon Dioxide NF, FD & C Blue No. 1 Aluminum Lake, Lactose Monohydrate NF, Microcrystalline Cellulose NF, Pregelatinized Starch NF, Stearic Acid NF, Talc USP.
Distributed by: Pfizer Inc, New York, NY 10017.
For more information, go to www.pfizer.com.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0834-1.0
January 2017

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 61570-102-01

Tussigon®
(hydrocodone bitartrate and
homatropine methylbromide)
CII

5 mg/1.5 mg

EACH TABLET CONTAINS:
Hydrocodone bitartrate 5 mg
Homatropine methylbromide 1.5 mg

100 TABLETS

Rx only

Tussigon 
hydrocodone bitartrate and homatropine methylbromide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61570-102
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg
HOMATROPINE METHYLBROMIDE (METHYLHOMATROPINE) HOMATROPINE METHYLBROMIDE 1.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
LACTOSE MONOHYDRATE  
HYDROGENATED TALLOW ACID  
TALC  
MICROCRYSTALLINE CELLULOSE  
STARCH, CORN  
FD&C BLUE NO. 1  
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code DP;082;Tussigon
Contains     
Packaging
# Item Code Package Description
1 NDC:61570-102-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088508 07/30/1985
Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)
Revised: 08/2017
 
Pfizer Laboratories Div Pfizer Inc
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