Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/795
| Predicate | Object |
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| rdf:type | |
| rdfs:label |
Tussigon (Tablet)
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| dailymed-instance:dosage |
Adult:: One (1) tablet every 4 to 6 hours as needed; do not
exceed six (6) tablets in 24 hours.<br/>Children 6 to 12 years of age:: One-half (1/2) tablet every 4 to 6 hours as needed;
do not exceed three (3) tablets in 24 hours.
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| dailymed-instance:descripti... |
Tussigon contains hydrocodone (dihydrocodeinone)
bitartrate, a semi-synthetic centrally-acting narcotic 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. The hydrocodone component is 4,5��-
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: CHN0���CH���2��H Hydrocodone Bitartrate Homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane,
3-[(hydroxy phenylacetyl)oxy]-8, 8-dimethyl-,bromide, endo-, a white
crystal or fine white crystalline powder, with a molecular weight
of (370.29). CHBrN0 Homatropine Methylbromide
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| dailymed-instance:clinicalP... |
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. 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
0-demethylation, N-demethylation and 6-keto reduction to the corresponding
6-��and 6-��-hydroxymetabolites.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
TUSSIGON should not be administered to patients
who are hypersensitive to hydrocodone or homatropine methylbromide.
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| dailymed-instance:supply |
Each blue, scored tablet contains 5 mg hydrocodone
bitartrate and 1.5 mg homatropine methylbromide and is available in: Bottles of 100 NDC 61570-081-01 Bottles of 500 NDC 61570-081-05 Store at controlled
room temperature 15�����30��C (59�����86��F).
Oral prescription where permitted by state law. Prescribing Information as of October 2006. Distributed for: Monarch Pharmaceuticals, Inc. Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: King Pharmaceuticals, Inc. Bristol, TN
37620 For more information call 1-888-358-6436
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| dailymed-instance:activeMoi... | |
| dailymed-instance:precautio... |
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.<br/>Special Risk Patients:: TUSSIGON 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.<br/>Information for Patients:: Hydrocodone may 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
should be cautioned accordingly.<br/>Drug Interactions:: Patients receiving narcotics, antihistamines, antipsychotics,
antianxiety agents or other CNS depressants (including alcohol) concomitantly
with TUSSIGON 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 antidepressants or hydrocodone.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of TUSSIGON in animals to evaluate the carcinogenic
and mutagenic potential and the effect on fertility have not been
conducted.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category C: Animal reproduction studies
have not been conducted with TUSSIGON. It is also not known whether
TUSSIGON can cause fetal harm when administered to a pregnant woman
or can affect reproduction capacity. TUSSIGON should be given to a
pregnant woman only if clearly needed.<br/>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.<br/>Labor and Delivery: As with all narcotics, administration of TUSSIGON
to the mother shortly before delivery may result in some degree of
respiratory depression in the newborn, especially if higher doses
are used.<br/>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, 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.<br/>Pediatric Use: Safety and effectiveness of TUSSIGON in children
under six have not been established.
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| dailymed-instance:overdosag... |
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 may, in addition, result in acute
homatropine intoxication.<br/>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 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.
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.
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| dailymed-instance:genericMe... |
Hydrocodone bitartrate and homatropine methylbromide
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| dailymed-instance:fullName |
Tussigon (Tablet)
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| dailymed-instance:adverseRe... |
Central Nervous System:: Sedation, drowsiness, mental clouding, lethargy,
impairment of mental and physical performance, anxiety, fear, dysphoria,
dizziness, psychic dependence, mood changes.<br/>Gastrointestinal System:: Nausea and vomiting may occur; they are more frequent
in ambulatory than in recumbent patients. Prolonged administration
of TUSSIGON may produce constipation.<br/>Genitourinary System:: Ureteral spasm, spasm of vesicle sphincters and urinary
retention have been reported with opiates.<br/>Respiratory Depression:: TUSSIGON may produce dose-related respiratory depression
by acting directly on brain stem respiratory centers .<br/>Dermatological:: Skin rash, pruritus.
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| dailymed-instance:warning |
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 and it should be prescribed and administered with the
same degree of caution appropriate to the use of other narcotic drugs
.<br/>Respiratory Depression:: TUSSIGON produces 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.<br/>Head Injury And Increased Intracranial Pressure:: The respiratory depression properties 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.<br/>Acute Abdominal Conditions:: The administration of TUSSIGON or other narcotics
may obscure the diagnosis or clinical course of patients with acute
abdominal conditions.<br/>Pediatric Use:: In young children, 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 children with respiratory embarrassment (e.g.
croup).
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| dailymed-instance:indicatio... |
TUSSIGON is indicated for the symptomatic relief
of cough.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Tussigon
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