DRUG INTERACTIONS
Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine, and veratrum alkaloids.
Other CNS Depressants: Patients receiving other opioid analgesics, sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics, phenothiazines or other tranquilizers, or alcohol concomitantly with this product may exhibit additive depressant effects on the central nervous system. When such combination therapy is contemplated, the dose of one or both agents should be reduced. Concomitant use of dihydrocodeine and antihistamines with alcohol and other CNS depressants may have an additive effect.
Monoamine Oxidase Inhibitors: Dihydrocodeine, like all opioids, interact with monoamine oxidase inhibitors causing central nervous system excitation and hypertension. MAO inhibitors and beta-adrenergic blockers increase the effects of sympathomimetics.
Information for Patients:
Patients receiving this product should be given the following information:
- This product may inhibit mental or physical abilities required for the performance of potentially hazardous tasks such as driving a care or operating machinery.
- Report any adverse experiences occurring during therapy.
- Do not adjust the dose of this product without consulting the prescribing professional.
- Do not combine this product with alcohol or other central nervous system depressants.
- Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug use during pregnancy on themselves and their unborn child.
- Patients should be advised that this product is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
Pregnancy:
Pregnancy Category C: Animal reproduction studies have not been conducted with this product. It is also not known whether this combination product can cause fetal harm when administered to pregnant women or can effect reproduction capacity in males and females. This combination product should be given to a pregnant woman only if clearly needed especially during the first trimester.
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 the maternal opioid use or dose, There is no consensus on the best method of managing withdrawal.
Chlorpromazine 0.7-1.0 mg/kg q6h, phenobarbital2 mg/kg q6h, and paregoric 2-4 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with dosages decreased as tolerated.
Labor and Delivery:
This product is not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn.
Nursing Mothers:
Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.
Pediatric Use:
This product is not recommended for use in children under two years of age. Children under two years may be more susceptible to respiratory arrest, coma, and death. Use of antihistamines is not recommended in infants. This age group may be at higher risk than other age groups because of an increased susceptibility to Anticholinergic effects, such as CNS excitation, and increased tendency toward convulsions. In older children taking antihistamines, a paradoxical reaction characterized by hyperexcitability may occur. Very young children may be more susceptible to the effects, especially the vasopressor effects of sympathomimetic amines.
Geriatric Use:
This product should be given with caution to the elderly.
Hepatic Impairment: This product should be given with caution to patients with hepatic insufficiency. Since dihydrocodeine is metabolized by the liver the effects of this combination product should be monitored closely in such patients.
Renal Impairment: This product should be used with caution and at reduced dosage in the presence of impaired renal function.
Pancreatic/biliary Tract Disease:
Opioids may cause spasms of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including pancreatitis.
|
OVERDOSAGE
An overdose of this product is a potentially lethal overdose situation, and consultation with a regional Poison Control Center is recommended. A listing of the Poison Control Center can be found in a standard reference such as the Physician's Desk Reference.
Signs and Symptoms:
Symptoms of an overdose include pinpoint pupils, respiratory depression, extreme somnolence progressing to stupor, loss of consciousness or coma, skeletal muscle flaccidity, cold and clammy skin and other symptoms common with narcotic overdosage. Convulsions, cardiovascular collapse, and death may occur. A single case of acute rhabdomyolysis associated with an overdose of dihydrocodeine has been reported.
Recommended Treatment:
Immediate treatment of an overdose of this product includes support of cardiovascular function and measures to reduce further drug absorption. Vomiting should be induced with syrup of ipecac. If the patient is alert and has adequate laryngeal reflexes, oral activated charcoal should follow. The first dose should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids.
Endotracheal intubation and artificial respiration may be necessary. The pure opioid antagonist naloxone or nalmexone is a specific antidote against respiratory depression that results from opioid overdose. Opioid antagonists should be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including dihydrocodeine. In such cases, an abrupt or complete reversal of opiod effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of there proper use.
|
CONTRAINDICATIONS
This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, or any of the active or inactive components listed above, or in any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitation equipment), acute or sever bronchial asthma or hypercapnia, and paralytic ileus. Antihistamines are contraindicated in patients receiving antihypertensive or antidepressant drugs containing monoamine oxidase inhibitors (MAOI) since these agents may prolong and intensify the anticholinergic and CNS depressant effects of antihistamines (see Drug Interactions).
Antihistamines should not be used to treat lower respiratory tract symptoms or be given to newborn infants.
Sympathomimetic agents are contraindicated in patients with severe hypertension, severe coronary artery disease, patients with narrow angle glaucoma, bronchial asthma, urinary retention, peptic ulcer, and during an asthmatic attack. This product is contraindicated in women who are pregnant.
|
DRUG ABUSE AND DEPENDENCE
This combination product is subject to the provisions of the Controlled Substances Act and has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeat administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid medications. Symptoms of dihydrocodeine withdrawal consist of irritability, restlessness, insomnia, diaphoresis, anxiety, and palpitations.
|
