Tussigon

Hydrocodone is a narcotic cough medicine.

Homatropine is a drug that works against the narcotic to prevent an overdose of this medication.

Homatropine and hydrocodone is a combination medicine used to treat cough.

Homatropine and hydrocodone may also be used for purposes not listed in this medication guide.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydrocodone.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how homatropine and hydrocodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

In the U.S.

• Hycodan
• Hydromet
• Tussigon

Available Dosage Forms:

• Tablet
• Solution
• Syrup

Therapeutic Class: Antimuscarinic/Antitussive Combination

Pharmacologic Class: Homatropine

Chemical Class: Hydrocodone

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Upset stomach or throwing up.
• Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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>.

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.

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

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

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

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.

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).