DCP Drops

Antitussive, Antihistaminic, Nasal decongestant actions.

Dextromethorphan HBr: Dextromethorphan HBr is a nonopiod antitussive agent. It suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan HBr has no significant analgesic or sedative properties. It does not depress the respiration or predispose an individual to addiction with usual doses. In therapeutic dosage, Dextromethorphan HBr does not inhibit ciliary activity. The onset of action is typically within 30 minutes and the duration of actions can be up to 6 hours. Dextromethorphan is rapidly and extensively metabolized by the liver. It is primarily excreted in the kidneys as unchanged Dextromethorphan and demethylated metabolites including dextrophan, an active metabolite.

Phenylephrine Hydrochloride: Phenylephrine HCl, a nasal decongestant, is a potent postsynaptic alpha-receptor agonist with little effect on the beta receptors of the heart and no effect on the beta-adrenegic receptors of the bronchi or peripheral blood vessels. Therapeutic doses of phenylephrine HCl may cause vasoconstriction. It increases resistance and, to a lesser extent, decreases capacitance of blood vessels. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Local vasoconstriction and hemostasis occur following infiltration of phenylephrine HCl into tissues. The main effect of phenylephrine HCl on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of the heart which can cause arrhythmias. Cardiac output is decreased slightly. Phenylephrine HCl increases the work of the heart by increasing peripheral arterial resistance. Phenylephrine HCl has a mild central stimulant effect. Following oral administration of Phenylephrine HCl, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. This may occur within 15 or 20 minutes and may persist for up to 4 hours.

Chlorpheniramine Maleate: Chlorpheniramine Maleate possesses H1 antihistaminic activity and mild anticholinergic and sedative effects.

Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage.

Signs and Symptoms: Overdosage with Dextromethorphan HBr may produce CNS excitement and mental confusion. Overdosage with sympathomimetic amines can cause hypertension, headache, convulsions, cerebral hemorrhage and vomiting may occur. Premature ventricular beats and short paroxysms of ventricular tachycardia may also occur. Headache may be a symptom of hypertension. Bradycardia may also be seen early in Phenylephrine HCl overdosage. Excessive CNS stimulation may result in excitement, tremor, restlessness, and insomnia. Other effects may include pallor, mydriasis, hyperglycemia, and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions, or delirium, but in some individuals, there may be CNS depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift in potassium rather than by its depletion. Should antihistamine effects predominate, central action constitutes the greatest danger. In a small child, symptoms include excitation, hallucination, ataxia, lack of coordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon, excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspirations must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive.

FOR ORAL USE ONLY

Children 6 to under 12 years of age:
2 dropperfuls (2.0 mL)
Children 2 to under 6 years of age:
1 dropperful (1.0 mL)
Children under 2:
As directed by a physician

May be repeated every 4-6 hours if required for relief. Not to exceed 4 doses in 24 hours. In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.

Applies to chlorpheniramine / dextromethorphan / phenylephrine: oral liquid, oral solution, oral syrup, oral tablet

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.