May be habit forming. 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 hydrocodone bitartrate and homatropine methylbromide, and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs (see DRUG ABUSE AND DEPENDENCE).
Hydrocodone 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.
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.
The administration of hydrocodone or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
In young pediatric patients, 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 pediatric patients with respiratory embarrassment (e.g., croup).
There is currently no manufacturer warning information available for this drug.
This product contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally acting narcotic antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage. Each 5 mL (one teaspoonful) contains:
Hydrocodone Bitartrate …………………… 5 mg
Homatropine Methylbromide …………… 1.5 mg
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 494.490, and may be represented by the following structural formula:
Hydrocodone Bitartrate
Homatropine methylbromide is a 3α-hydroxy-8-methyl-1αH, 5αH-tropanium bromide mandelate; a white crystal or fine white crystalline powder, with a molecular weight of 370.28.
Homatropine Methylbromide
Inactive Ingredients: Artificial Cherry Flavor, Citric Acid, D&C Red #33, FD&C Blue #1, FD&C Red #40, Methylparaben, Propylene Glycol, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Citrate, Sucrose.
