Dihydrocodeine, Brompheniramine, Pseudoephedrine

Drug Class: Dihydrocodeine, Brompheniramine , Pseudoephedrine > Dihydrocodeine > Ethers Of Morphine > Opioids > Opioid Agonist > Analgesic.

Uses

Doctors prescribe combination products containing dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride to relieve a patient’s cough and nasal congestion due to allergies or upper respiratory tract infections like the common cold.

General Drug Information

Dihydrocodeine bitartrate is an opioid cough suppressant, sometimes called a narcotic antitussive. Dihydrocodeine is a semi-synthetic drug related to codeine.

Brompheniramine maleate is an anti-histamine that relieves irritation of nasal tissue. Pseudoephedrine hydrochloride is a nasal decongestant that makes it easier for the consumer to breathe through his nose.

JayMac Pharmaceuticals offers dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride in a combination drug known as J-COF DHC in a grape-flavored syrup form for oral use. This preparation contains 7.5 mg of dihydrocodeine bitartrate, 3 mg of brompheniramine maleate and 15 mg of pseudoephedrine hydrochloride.

Administration/Dosage

Doctors prescribe the initial dose of dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride according to the severity of the patient’s cough and congestion, and then adjust the dosage based on the patient’s response to treatment.

Physicians may increase dosage as the patient becomes tolerant to the effects of this drug, especially dihydrocodeine. Someone who has not been taking dihydrocodeine is “opioid-naïve” and sensitive to its effects. With continued use at therapeutic doses, the consumer becomes opioid-tolerant and less sensitive to these effects; an opioid-tolerant person must take larger doses of dihydrocodeine more often to achieve the same effects.

The typical dosage for adults and children over the age of 12 years is one to two 5 mL teaspoons every four to six hours as needed to control cough and congestion. A pediatrician might prescribe one-half to one teaspoonful every four to six hours as needed for children 6 - 12 years old. Dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride is not appropriate for children under the age of six years.

Action

Dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride work in different ways to provide relief from cough and nasal congestion.

Dihydrocodeine bitartrate suppresses the cough reflex in the area of the brain responsible for coughing, the medulla. Opioids like dihydrocodeine also depress respiratory centers to decrease the brain’s urge to breathe. In other actions in the brain, dihydrocodeine depresses the central nervous system, or CNS, to relieve pain and cause sedation, relaxation and a pleasant sense of euphoria.

Dihydrocodeine and other opioids stiffen smooth muscles to make them less functional. Smooth muscles in the intestines push stool through the digestive tract; smooth muscles in the biliary tract control the flow of bile and pancreatic juices into the small intestine.

Opioids, including dihydrocodeine, widen blood vessels; this vasodilation lowers blood pressure.

Warnings

Patients with diabetes, high blood pressure and some types of heart disease or thyroid, prostate or eye problems should use this combination drug with considerable caution. Elderly people and debilitated patients are more likely to suffer adverse reactions to this drug.

Antihistamines like brompheniramine can cause excitability, especially in children. Taking larger than recommended doses of this drug can result in sleeplessness, nervousness or dizziness.

Respiratory Depression

Opioids can slow respiratory drive in the brain to the point of respiratory depression, a dangerous breathing condition in which slow, shallow and irregular breathing patterns prevent the lungs from adequately exchanging spent carbon dioxide for fresh oxygen. Respiratory depression can result in oxygen starvation and high carbon dioxide levels. Therapeutic antitussive doses of dihydrocodeine bitartrate rarely cause serious respiratory depression.

Respiratory depression occurs most frequently in elderly or debilitated patients, especially in opioid-naïve patients receiving high initial doses or when combined with other drugs that depress breathing. Patients with the serious breathing problem COPD or the heart problem cor pulmonale should exercise caution when using this combination product, as should those with diminished lung capacity, high carbon dioxide or low oxygen levels, or pre-existing respiratory depression.

Hypotensive Effect

The vasodilation associated with dihydrocodeine lowers blood pressure, sometimes to the point of serious hypotension in patients already having trouble maintaining an adequate blood pressure, either because they have lost a lot of blood or because they received another drug that causes hypotension.

Healthcare providers should use caution when administering dihydrocodeine products to shock patients; vasodilation produced by dihydrocodeine can worsen the condition of these patients by causing further hypotension or by lowering the quantity of blood the heart pumps in each beat.

Dihydrocodeine can cause orthostatic hypotension, or blood pressure that dives when the person stands up quickly.

Precautions

Dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride can make the consumer feel dizzy or drowsy, or impair her physical and mental performance. The user should not drive or operate heavy machinery until she knows how her body responds to this drug. Alcohol and some other medications can enhance the effects of dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride.

Contraindications

This product is not right for everyone. Individuals who are hypersensitive to dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride should not use this combination drug.

This drug is not appropriate for patients already suffering respiratory depression in unmonitored settings or in a location without resuscitation equipment. Patients with severe asthma or high carbon dioxide levels should not use this medication. This drug is not safe for those suffering the serious type of bowel obstruction known as paralytic ileus.

Pregnancy, Labor and Delivery, Breastfeeding

The FDA classifies dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride preparations as Pregnancy Category C, meaning there are no adequately controlled studies to determine how this drug affects a pregnant woman or a fetus, or how it might affect reproductive capabilities in males and females. Pregnant women should take this combination drug only when the benefits clearly outweigh any risks, especially during the first three months of pregnancy.

A baby born to a woman who takes dihydrocodeine regularly during pregnancy may be born opioid-dependent and suffer withdrawal symptoms in the first days or weeks of life. These babies are more irritable, cry excessively and suffer hyperactive reflexes, tremor, rapid breathing, vomiting, increased stools, yawning, sneezing and fever. The intensity of the newborn’s symptoms does not necessarily reflect the duration of the mother’s opioid use or her typical dosage. Medical scientists have not yet come to a consensus about the best way to treat these young patients.

Dihydrocodeine products are not appropriate for use during labor and delivery as they may cause respiratory depression in the newborn.

Dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride may pass intro human milk and onto a nursing baby. Mothers taking this product should not breastfeed.

Special Risk Consumers

Physicians should consider reduced doses for elderly or debilitated patients, and monitor these consumers closely.

Brompheniramine is not safe for use in infants because babies are more vulnerable to excitation of the central nervous system and have an increased tendency towards seizures. Dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride is not appropriate for children younger than two years, as children in this age group are more susceptible to respiratory depression, coma and death. Very young children may be sensitive to the way pseudoephedrine affects blood pressure. Older children may suffer a reaction to antihistamines like brompheniramine and become hyper-excited.

Physicians should closely monitor the effects of dihydrocodeine on the liver in patients with liver dysfunction. Doctors should reduce dosages in patients with kidney problems; these patients should use this product with care. This combination drug can cause biliary spasms - individuals with biliary tract problems like pancreatitis should use this drug cautiously.

Drug Interactions

Dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride combinations can interact with other drugs in harmful or unwanted ways.

Dihydrocodeine can interact with other CNS depressants to enhance the way both medicines depress the central nervous system. Other CNS depressants include alcohol, other opioids, sedatives, tranquilizers, muscle relaxants, general anesthetics, anti-psychotics and some drugs that ease nausea and vomiting. Using alcohol along with dihydrocodeine and another CNS depressant further enhances the depressant effects. Doctors should consider reducing the dosage of one or both medications when a patient needs both dihydrocodeine and another CNS depressant.

Many people take monoamine oxidase inhibitors, or MAOIs, to treat high blood pressure or depression. MAOIs can interact with dihydrocodeine to excite the central nervous system and increase blood pressure.

MAOIs and another heart medication, beta-blockers, can increase the effects of pseudoephedrine hydrochloride. Pseudoephedrine can reduce the effectiveness of some drugs prescribed to treat high blood pressure.

Side effects

All drugs, including dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride, can cause side effects in some consumers.

Dihydrocodeine consumers most commonly report feeling lightheaded, dizzy, drowsy or complain of headache, fatigue, sleepiness, sweating, constipation, nausea and vomiting, itching and skin reactions. Except for constipation, most of these side effects disappear as the consumer becomes opioid-tolerant.

Dihydrocodeine bitartrate may cause respiratory depression, orthostatic hypotension, suppression of a necessary cough, confusion, pinpoint pupils, stomachache and indigestion, diarrhea, loss of appetite, dry mouth, biliary spasm and urinary retention. Dihydrocodeine may cause addiction or physical dependence.

Rarely, dihydrocodeine consumers suffer hypersensitivity reactions including the serious type of allergic reaction known as anaphylaxis, vivid dreams or serious kidney problems.

Patients may have an adverse reaction to brompheniramine maleate or pseudoephedrine hydrochloride and exhibit extreme fatigue, nausea, giddiness, dry mouth or irregular heartbeat. These ingredients may cause the consumer to feel increased irritability or excitement, especially children.

Overdose

Overdose of prescription drugs like dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride is a serious and sometimes fatal medical emergency. Prescription painkiller overdose killed nearly 15,000 Americans in 2008, more than triple the number of people killed in prescription drug overdoses in 1999.

Symptoms of a dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride overdose include respiratory depression, limp muscles, sleepiness that worsens to unconsciousness or coma, pinpoint pupils and cold, clammy skin. The victim may have a seizure or suffer failure of the circulatory system; death may occur.

Prescription painkiller abuse sends about a half million Americans to the hospital each year. Emergency department workers establish an airway or place the patient on a mechanical ventilator to help him breathe. Nurses will start intravenous fluids to stabilized blood pressure. Nurses may ask the patient to drink ipecac to induce vomiting before they introduce charcoal into the stomach to absorb excess medication and administer drugs to stimulate bowel movements. Nurses might pump the patient’s stomach. Physicians may order naloxone or other medicines to counteract respiratory depression; these drugs may cause withdrawal symptoms in opioid-dependent patients, complicating overdose treatment.

Abuse

Recreational drug abusers target preparations containing dihydrocodeine because of the euphoria opioids produce. Dihydrocodeine is a DEA class III drug, meaning it poses the same relative risk for abuse as Tylenol with codeine or the bodybuilding drugs, anabolic steroids. To reduce its availability to drug abusers, dihydrocodeine is available only with a prescription.

Drug abuse increases the chances the consumer will suffer side effects, overdose, addiction or physical dependence and withdrawal.

Withdrawal

An opioid-dependent person will suffer withdrawal symptoms when he stops using dihydrocodeine suddenly. These withdrawal symptoms include anxiety, insomnia, irritability, restlessness, excessive sweating and irregular heartbeat.

To avoid withdrawal, physicians recommend tapering dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride use gradually over the course of several days. This tapering method works for most people but persistent and severe withdrawal symptoms prevent many individuals from discontinuing this drug at the appropriate time.

Detox

According to statistics cited by the Institute of Addiction Medicine, almost 2 million Americans are opioid-dependent. In response to the growing number of people who need help overcoming withdrawal symptoms, many local healthcare institutions now offer detoxification services. Detoxification specialists give the patient drugs to counteract the effects of dihydrocodeine then administer medications to deal with the ensuing withdrawal symptoms.

Many informed consumers now choose rapid detox, a more humane and efficient approach to detoxification. Rapid detox anesthesiologists sedate and anesthetize the patient before administering the standard detoxification and anti-withdrawal drugs so the patient dozes in a comfortable “twilight sleep” during the procedure. Rapid detox allows the patient to focus on other aspects of opioid dependence rather than struggle with withdrawal symptoms.

Storage

Healthcare providers should store dihydrocodeine bitartrate, brompheniramine maleate and pseudoephedrine hydrochloride at temperatures between 59 and 86 degrees Fahrenheit in a tightly closed, light-resistant container. Caregivers should store this and all medications out of the reach of children.