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.
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).
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.
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).
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.
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.
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.
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.
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.
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).
Central Nervous System
Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.
Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of TUSSIGON tablets may produce constipation.
Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.
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.
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.
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.
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 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
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).
Dissolution testing of TUSSIGON tablets is performed using Test 2 from USP <711>.
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.
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
|This Medication Guide has been approved by the U.S. Food and Drug Administration.|
(Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, C-II
What is the most important information I should know about TUSSIGON tablets?|
What are TUSSIGON tablets?|
Who should not take TUSSIGON tablets?|
|Before you take TUSSIGON tablets, tell your healthcare provider about all of your medical conditions, including if you:|
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:
How should I take TUSSIGON tablets?|
What should I avoid while taking TUSSIGON tablets?|
What are the possible side effects of TUSSIGON tablets?|
TUSSIGON tablets may cause serious side effects, including:
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?|
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.