DrugindexOnline^{2nd edition}

Pronouncation: (brom-fen-AIR-uh-meen MAL-ee-ate/SUE-doe-eh-FED-rin HIGH-droe-KLOR-ide)
Class: Respiratory agent

Trade Names:
Lodrane
- Liquid 4 mg brompheniramine/60 mg pseudoephedrine

Trade Names:
Lodrane 12 D
- Tablets 6 mg brompheniramine/45 mg pseudoephedrine

Trade Names:
Lodrane LD
- Capsules 6 mg brompheniramine/60 mg pseudoephedrine

Mechanism of Action

Pharmacology

Brompheniramine

Competitively antagonizes histamine at H ₁ receptor sites.

Pseudoephedrine

Causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic stimulation, which promotes nasal drainage.

Indications and Usage

Temporary relief of symptoms associated with seasonal and perennial allergic rhinitis and vasomotor rhinitis, including nasal congestion.

Contraindications

Hypersensitivity to any ingredients of product; nursing mothers, severe hypertension; severe coronary artery disease; narrow-angle glaucoma; urinary retention; peptic ulcer, asthma attack; MAOI therapy or for 2 wk after stopping MAOI therapy.

Dosage and Administration

Adults and Children over 12 yr of age

PO Lodrane extended-release tablet 1 or 2 tablets every 12 h. Lodrane liquid: 1 tsp (5 mL) every 4 to 6 h (max, 4 doses/24 h).

Children 6 to 12 yr of age

PO Lodrane extended-release tablet: 1 tablet every 12 h. Lodrane liquid: ½ tsp (2.5 mL) every 4 to 6 h (max, 4 doses/24 h).

Children 2 to 6 yr of age

PO Lodrane liquid: ¼ tsp (1.25 mL) every 4 to 6 h (max, 4 doses/24 h).

Children less than 2 yr of age

PO Lodrane liquid: as recommended by health care provider.

General Advice

• Use dosing spoon or syringe for pediatric doses of liquid.
• Do not cut, chew, or crush tablet. Swallow whole.

Storage/Stability

Store tablets and liquid at 59° to 86°F. Protect tablets from light and moisture. Keep liquid tightly closed.

Drug Interactions

Alcohol, barbiturates (eg, phenobarbital), tricyclic depressants (eg, amitriptyline), other CNS depressants

Effects may be enhanced by brompheniramine.

Antacids

Rate of pseudoephedrine absorption may be increased.

Antidepressants, antihypertensives

Do not use in patients receiving antidepressants or antihypertensive agents or within 14 days of stopping such treatment.

Digitalis

Increased ectopic pacemaker activity can occur with pseudoephedrine.

MAOIs (eg, isocarboxazid)

Do not use in patients receiving MAOI therapy or within 14 days of stopping such treatment. May prolong and intensify the effects of brompheniramine and increase the effects of pseudoephedrine.

Mecamylamine, methyldopa, reserpine, veratrum alkaloids

Antihypertensive effects may be reduced by pseudoephedrine.

Tricyclic antidepressants (eg, amitriptyline)

May prolong or intensify the anticholinergic effects of brompheniramine.

Laboratory Test Interactions

May interfere with diagnostic test results for skin tests using allergen extracts.

Adverse Reactions

Cardiovascular

Palpitation; tachycardia; angina; elevated BP; circulatory collapse.

CNS

Drowsiness; confusion; restlessness; anorexia; dizziness; headache; insomnia; anxiety; tension; weakness; stimulation.

Dermatologic

Rash; sweating.

GI

Nausea; vomiting; gastric distress; abdominal cramps.

Genitourinary

Dysuria.

Miscellaneous

Vertigo; mydriasis.

Precautions

Monitor Assess for allergy symptoms (eg, rhinitis, nasal congestion, sneezing, itching, watery eyes) before and periodically throughout therapy. Monitor patient for nervousness, dizziness, and insomnia. If noted hold therapy and notify health care provider.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Lodrane extended-release tablets: Safety and efficacy in children less than 6 yr of age not established. Lodrane liquid: Safety and efficacy in children less than 2 yr of age not established.

Elderly

More likely to cause dizziness, sedation, hyperexcitability, anticholinergic side effects (eg, urinary retention), confusion, hallucinations, seizures, CNS depression, and hypotension in the elderly.

Special Risk Patients

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus, prostatic hypertrophy, bronchial asthma.

Abuse

Pseudoephedrine is a CNS stimulant and has been abused.

Overdosage

Symptoms

Brompheniramine

Hallucination, convulsions and death, dizziness, sedation, hypotension

Pseudoephedrine

Cardiac arrhythmias, cerebral hemorrhage, pulmonary edema, palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, hallucination, delirium.

Patient Information

• Advise patient to take tablet dose every 12 h as needed with a full glass of water. Liquid dose is taken every 4 to 6 h as needed, up to 4 times daily.
• Advise caregiver to use dosing spoon or syringe when giving liquid dose to children.
• Advise patient to take with food or milk if GI upset occurs.
• Caution patient to not cut, chew, or crush tablet and to swallow whole.
• Advise patient to take last dose late in the afternoon or early evening to reduce chance of drug causing sleeplessness.
• Advise patient that if a dose is missed to take as soon as remembered unless it is nearing time for the next dose. Caution patient to not double the dose to catch up.
• Advise patient that if allergy symptoms are not controlled not to increase the dose of medication but to inform their health care provider.
• Caution patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Advise patient to avoid alcohol and other CNS depressants due to risk of excessive sedation.
• Caution patient not to take any OTC antihistamines or decongestants while taking this medication unless advised to do so by their health care provider.
• If patient is to have allergy skin testing, advise to not take the medication for at least 6 days before the skin testing.
• Instruct patient to stop taking drug and immediately report any of these symptoms to health care provider: nervousness, dizziness, or sleeplessness.