LoHist PD

LoHist PD Pediatric Drops is a cherry flavored, clear liquid antihistamine/decongestant.

Each dropperful (1 mL) for oral administration contains:

Brompheniramine Maleate . . . . . . . . . . . . . . . . . . . . . . 1 mg

Pseudoephedrine HCl . . . . . . . . . . . . . . . . . . . . . . . . 12.5 mg

Inactive Ingredients: Cherry flavor, citric acid, glycerin, sodium benzoate, propylene glycol, purified water, sodium saccharin, and sorbitol.

Brompheniramine Maleate is an antihistamine with the chemical name 2-Pyridinepropanamine, γ-(4-bromophenyl)-N,N-dimethyl-, (±)-, (Z) -2-butenedioate (1:1). Its structure is as follows:

C16H19BrN2 • C4H4O4                             M.W. 435.31

Pseudoephedrine Hydrochloride is a nasal decongestant with the chemical name:

benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)]-, hydrochloride. Its structure is as follows:

C10H15NO • HCl                                 M.W. 201.69

LoHist PD is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients, patients taking monoamine oxidase (MAO) inhibitors or for two weeks after stopping the MAOI drug (see PRECAUTIONS, Drug Interactions section), patients with narrow-angle glaucoma, urinary retention, peptic ulcer, severe hypertension, severe coronary artery disease, patients with breathing problems such as emphysema or chronic bronchitis, or nursing mothers. Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a physician. If symptoms do not improve within 7 days or are accompanied by fever, consult a physician.

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery, and may impair mental alertness in children. In the young child, they may produce excitation.

Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Patients sensitive to antihistamines may experience mild sedation. Sympathomimetic drugs have been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension.

Possible side effects of antihistamines are drowsiness, restlessness, dizziness, weakness, dry mouth, anorexia, nausea, headache, nervousness, blurring of vision, heartburn, dysuria and very rarely dermatitis. Patient idiosyncrasy to adrenergic agents may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Applies to brompheniramine / pseudoephedrine: oral capsule, oral capsule extended release, oral elixir, oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Nervous system

A few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of brompheniramine extended over a period of up to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms in these patients. Spasmodic torticollis has been reported in a child given brompheniramine over an eight month period.[Ref]

Nervous system side effects of brompheniramine have included central nervous system (CNS) depression, resulting in drowsiness and sedation in nearly 50% of patients treated. This effect has often been transient and ceased with continued use. Motor skills have be impaired and patients should be advised to avoid tasks which require attention. Patients should also avoid concomitant use with alcohol and other sedative-hypnotic drugs. Dyskinesias have rarely been reported following chronic use of brompheniramine. Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects of brompheniramine have include nausea, dry mouth and constipation. Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients receiving pseudoephedrine.[Ref]

Cardiovascular

Cardiovascular effects of brompheniramine have included hypotension, tachycardia, and palpitations. Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients taking pseudoephedrine have developed hypertension and/or arrhythmias.[Ref]

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (stimulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]

Ocular

Ocular side effects of brompheniramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Hematologic

Hematologic side effects of brompheniramine have included rare cases of hemolytic anemia, thrombocytopenia, and agranulocytosis.[Ref]

Hypersensitivity

Hypersensitivity side effects in patients receiving pseudoephedrine have included fixed drug eruptions.[Ref]

Genitourinary

Genitourinary side effects of brompheniramine have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention.[Ref]

Some side effects of LoHist-PD may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.