brompheniramine/dextromethorphan/phenylephrine

Brompheniramine/dextromethorphan/phenylephrine is a combination drug used to relieve symptoms of the common cold, flu, hay fever, allergies, and respiratory conditions such as sinusitis and bronchitis. The combo medication temporarily relieves symptoms such as cough, runny nose, nasal congestion, sneezing, itchy nose or throat, and itchy/watery eyes due to minor throat and bronchial irritation, and makes breathing easier. The drug is available over the counter (OTC) in the U.S.

Each medication in the combination works in a different way, and when combined they are more effective in relieving symptoms than with monotherapy of just one of the drugs.

• Brompheniramine works by blocking the activity of histamine, a natural compound in the body that causes allergy symptoms. Histamine is released by mast cells and basophils, types of immune cells, in response to allergen exposure. Brompheniramine binds to histamine H1 receptors in blood vessels, respiratory tract, and gastrointestinal tract, preventing their activation by histamine and the resultant allergic reaction.
• Dextromethorphan suppresses cough by reducing the sensitivity of cough receptors in the brain region that stimulate the cough reflex and prevent the transmission of cough impulses. Dextromethorphan is a non-opioid drug derived from levorphanol, an opioid painkiller (analgesic), and is structurally similar to opioid drugs such as codeine, however, it does not have analgesic or addictive properties.
• Phenylephrine is an alpha1 agonist that works by stimulating the activity of alpha1 adrenergic receptors, protein molecules that signal to the smooth muscles around blood vessels to contract. The smooth muscle contraction narrows the blood vessels, limiting blood flow to the swollen respiratory mucous tissue, reducing nasal and bronchial congestion, and making breathing easier.

• Do not use brompheniramine/dextromethorphan/phenylephrine in patients with hypersensitivity to brompheniramine, dextromethorphan, phenylephrine or any of the components in the formulation.
• Do not use brompheniramine/dextromethorphan/phenylephrine in patients with any of the following conditions:
  • Severe hypertension, coronary artery disease or ischemic heart disease
  • During an acute asthma attack
  • Treatment of asthma or other lower respiratory tract conditions
  • Narrow-angle glaucoma, an eye condition with high intraocular pressure that progressively damages the optic nerve
  • Urinary retention
  • Peptic ulcer
• Do not use brompheniramine/dextromethorphan/phenylephrine to treat nursing mothers.
• Do not use to treat full term or premature newborn infants.
• Use with caution in children and do not use the drug to make children sleepy, misuse can result in death in young children.
• Use with caution in children who are prone to allergic reactions (atopic).
• At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur, especially in infants and small children. Antihistamine overdose may cause hallucinations, convulsions, and death.
• Do not use concurrently or within 14 days of treatment with monoamine oxidase inhibitors (MAOIs), a class of antidepressants.
• Use with caution in patients with:
  • Chronic obstructive pulmonary disease (COPD)
  • Shortness of breath or difficulty breathing
  • High blood pressure
  • Cardiovascular disease
  • Diabetes mellitus
  • Thyroid disease
  • Difficulty in urination due to prostate enlargement
  • History of bronchial asthma, narrow-angle glaucoma, gastrointestinal obstruction, or urinary bladder-neck obstruction
• Use with caution in patients with persistent cough related to smoking, asthma or emphysema, or cough with excessive phlegm. A persistent cough may indicate a serious condition that should be appropriately diagnosed and treated.
• In case a hypertensive crisis occurs, discontinue the drug immediately and institute therapy to lower blood pressure.
• Do not use concurrently with other sedative drugs or alcohol.

Common side effects of brompheniramine/dextromethorphan/phenylephrine include:

• Dry mouth, nose and throat
• Thickening of mucus in nose and throat
• Drowsiness
• Dizziness
• Headache
• Excitability
• Restlessness
• High blood pressure (hypertension)
• Reflex increase in heart rate (tachycardia)
• Constriction of peripheral and abdominal (visceral) blood vessels

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Oral Solution

• 1 mg/5 mg/2.5 mg/5 mL

Relief of Cold Symptoms

Adult:

4 teaspoons (20 mL) orally every 4 hours; not to exceed 120 mL/24 hours

Pediatric:

Children below 6 years

• Not recommended

Children 6-12 years

• 2 teaspoons (10 mL) orally every 4 hours

Children above 12 years

• 4 teaspoons (20 mL) orally every 4 hours

• Brompheniramine/dextromethorphan/phenylephrine overdose can cause severe adverse reactions with symptoms that include agitation, confusion, flushing, hallucinations, large pupils, muscle twitching, and seizures.
• In children, the drug may initially have an excitatory effect, which may be followed by loss of coordination, drowsiness, loss of consciousness and seizures.
• Overdose treatment may be supportive and symptomatic care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of brompheniramine/dextromethorphan/phenylephrine include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • phenelzine
  • procarbazine
  • rasagiline
  • selegiline transdermal
  • safinamide
  • selegiline
  • tranylcypromine
• Brompheniramine/dextromethorphan/phenylephrine has serious interactions with at least 58 different drugs.
• Brompheniramine/dextromethorphan/phenylephrine has moderate interactions with at least 303 different drugs.
• Brompheniramine/dextromethorphan/phenylephrine has mild interactions with at least 36 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

• Neither animal reproductive studies nor controlled studies in pregnant women have been conducted on the safety of brompheniramine/dextromethorphan/phenylephrine use during pregnancy. It is not known if the combination drug can cause fetal harm or affect reproductive capacity. Use with caution in pregnant women only if maternal benefits clearly outweigh possible risk to the fetus.
• The combination drug contains brompheniramine, an antihistamine. There is a higher risk of antihistamine intolerance in small infants, avoid use in nursing mothers.
• If you are pregnant or breastfeeding, consult your healthcare provider before taking any OTC drug.

• Take brompheniramine/dextromethorphan/phenylephrine exactly as prescribed, or as per label instructions if taking OTC drug. Do not take higher or more frequent doses than recommended.
• Stop taking the medication and see your physician if:
  • Your symptoms include fever, rash, or persistent headache or do not get better within 7 days
  • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache,
  • You develop sleeplessness, nervousness, or dizziness
• The antihistamine component in the drug may impair physical and mental abilities; avoid activities such as driving and operating heavy machinery.
• Tell your doctor ahead of time if you have taken this drug within the previous a few days, if surgery or medical tests need to be performed.
• This combo medication can reduce sweating. Avoid becoming overheated or dehydrated during exercise and hot weather, it may increase the risk of heat stroke.
• Avoid drinking alcohol while taking brompheniramine/dextromethorphan/phenylephrine.
• Do not administer OTC brompheniramine/dextromethorphan/phenylephrine to children younger than 2 years.
• Store safely out of reach of children.
• In case of overdose, seek medical help or call Poison Control.