EndaCof PD

Brompheniramine Maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilatation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.

Dextromethorphan Hydrobromide acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

Pseudoephedrine Hydrochloride acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.

EndaCof PD is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) Inhibitor therapy.  Antihistamines are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer, and during an asthma attack.

Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

General

General: Before prescribing medication to suppress or modify cough, identify and provide therapy for the underlying cause of cough and take caution that modification of cough does not increase the risk of clinical or physiologic complications. Dextromethorphan should be used with caution in sedated or debilitated patients and in patients confined to supine positions. Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus and prostatic hypertrophy.

Information for Patients

Information for Patients: Avoid alcohol and other CNS depressants while taking these products. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Patients sensitive to sympathomimetic amines may notice mild CNS stimulation. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Patients should be warned accordingly.

Drug Interactions

Drug Interactions: Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers. The cough-suppressant action of dextromethorphan and narcotic antitussives are additive. Dextromethorphan is contraindicated with monoamine oxidase inhibitors (MAOI), (See Contraindications section.)

Pregnancy

Use in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with this product.  It is not known whether this product can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to pregnant women only if clearly needed.

Nursing Mothers

Nursing Mothers: It is not known whether the drugs in this product are excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the use of this product, taking into account the importance of the drug to the mother.

Special Risk Patients: Use with caution in patients with hypertension or ischemic heart disease and persons older than 60 years of age.

No information is available as to specific results of an overdose of this product. The signs, symptoms and treatment described below are those of H1 antihistamine, ephedrine and dextromethorphan overdose.

Symptoms:   Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, predominant symptoms are excitation, hallucination, ataxia, incoordination, 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.

Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea, and abdominal cramps.

Dextromethorphan may cause respiratory depression with a large overdose.

Treatment:  The stomach should be emptied promptly by emetics and/or gastric lavage. The installation of activated charcoal also should be considered. Cardiac function and serum electrolytes should be monitored and treatment initiated if indicated. If convulsions or marked CNS excitement occurs, diazepam may be used.

EndaCof PD Drops is supplied in bottles of 1 fl. oz. (30 mL), NDC 68047-010-30. Calibrated, shatter-proof dropper enclosed in each carton.

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F). [See USP Controlled Room Temperature.]

EndaCof PD contains safety seal under bottle cap. Pharmacist, dispense in original container.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Distributed by:

LARKEN LABORATORIES, INC

Canton, MS 39046

Rev. 10/08

Do not use brompheniramine, dextromethorphan, guaifenesin, and phenylephrine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure this medicine is safe for you, tell your doctor if you have:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• a blockage in your digestive tract (stomach or intestines);

• high blood pressure, heart disease;

• liver or kidney disease;

• glaucoma;

• cough with mucus, or cough caused by emphysema or chronic bronchitis;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor);

• overactive thyroid; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether brompheniramine, dextromethorphan, guaifenesin, and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Tell your doctor about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking brompheniramine, dextromethorphan, guaifenesin, and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.