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Hycodan

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Hycodan

Hycodan

WARNINGS

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 HYCODAN (hydrocodone bitartrate and homatropine methylbromide) and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs (see Drug Abuse And Dependence).

Respiratory Depression

The use of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is 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). HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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.

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 HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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 HYCODAN (hydrocodone bitartrate and homatropine methylbromide) to pediatric patients 6 years of age and older because of the potential for fatal respiratory depression. Overdose or concomitant administration of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) with other respiratory depressants may increase the risk of respiratory depression in pediatric 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

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with HYCODAN (hydrocodone bitartrate and homatropine methylbromide) . It is also not known whether HYCODAN (hydrocodone bitartrate and homatropine methylbromide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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 HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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 HYCODAN (hydrocodone bitartrate and homatropine methylbromide) , 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 HYCODAN (hydrocodone bitartrate and homatropine methylbromide) in pediatric patients under six have not been established. The use of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) in children less than 6 years of age has been associated with cases of fatal respiratory depression (see ADVERSE REACTIONS - Respiratory Depression). HYCODAN (hydrocodone bitartrate and homatropine methylbromide) should be used with caution in pediatric patients 6 years of age and older (see WARNINGS - Pediatric Use).

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

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Hycodan - User Reviews

Hycodan User Reviews

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