Tusscough DHC

Rx Only

CIII

Tusscough DHC™ is contraindicated in patients with known hypersensitivity to any of the ingredients. Do not use in patients with severe hypertension, severe coronary artery disease, prostatic hypertrophy, patients on MAO inhibitor therapy (or for 14 days after stopping MAOI therapy), ventricular tachycardia, pheochromocytoma, or breast-feeding mothers. Also contraindicated in newborns, premature infants, patients with narrow angle glaucoma, stenosing peptic ulcer, asthma, bladder neck obstruction, or pyloroduodenal obstruction. Because of its drying effect on lower secretions, this product is not recommended in the treatment of bronchial asthma.

General

Use caution in the presence of hypertension, cardiovascular disease, hyperthyroidism, diabetes, bronchial asthma, emphysema, chronic pulmonary disease, heart disease, thyroid disease, increased intraocular pressure, or prostatic hypertrophy.

Information for Patients

Tusscough DHC™, like all narcotics, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly.

Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Cough Reflex

Dihydrocodeine suppresses the cough reflex. As with all narcotics, caution should be exercised when Tusscough DHC™ is used postoperatively and in patients with pulmonary disease.

Drug Interactions

Patients receiving other narcotic analgesics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Tusscough DHC™ 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 for 14 days after stopping MAOI therapy), or tricyclic antidepressants with dihydrocodeine preparations may increase the effect of either the antidepressant or dihydrocodeine. The concurrent use of anticholinergics with dihydrocodeine may produce paralytic ileus.

Antihistamines may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.

MAO inhibitors (or for 14 days after stopping MAOI therapy) and beta adrenergic blockers increase the effect of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids.

Usage in Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Tusscough DHC™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1 mg/kg q 6h, and paregoric 2 to 4 drops/kg q 4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosage decreased as tolerated.

Labor and Delivery

As with all narcotics, administration of Tusscough DHC™ 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 Tusscough DHC™ is excreted in human milk. Because many drugs are excreted in human milk and because potential for serious adverse reactions in nursing infants from Tusscough DHC™, 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.

Codeine Warning

When physicians prescribe codeine-containing drugs to nursing women, they should inform their patients about the potential risks and the signs of morphine overdose. Nursing women taking codeine need to carefully watch their infants for signs of morphine overdose and seek medical attention immediately if the infant develops increased sleepiness (more than usual), difficulty breastfeeding or breathing, or decreased tone (limpness). Nursing mothers may also experience overdose symptoms such as extreme sleepiness, confusion, shallow breathing or severe constipation. When prescribing codeine to nursing mothers, physicians should choose the lowest effective dose over the shortest period of time and should closely monitor mother-infant pairs.

Drug metabolism is a complex process involving multiple genetic, environmental and physiologic factors. Limited evidence suggests that individuals who are ultra-rapid metabolizers (those with a specific CYP2D6 genotype) may convert codeine to its active metabolite, morphine, more rapidly and completely than other people. In nursing mothers, this metabolism can result in higher than expected serum and breast milk morphine levels. One published case report of an infant death raises concern that nursing babies may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of the drug.

Pediatric Use

Safety and effectiveness in the pediatric population, under 12, have not been established.

Dihydrocodeine Bitartrate; Signs and Symptoms

Serious overdose with dihydrocodeine 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 or hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

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 is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including dihydrocodeine. Therefore, an appropriate dose of naloxone hydrochloride (see package insert) should be administered, preferably by the intravenous route, and simultaneously with efforts at respiratory resuscitation. Since the duration of action of dihydrocodeine may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.