Bromfenac, Dimetapp Allergy, Lodrane 24, LoHist 12D, Nasahist B, ND-Stat, TanaCof-XR, Vazol

Pharmacologic class: Histamine antagonist

Therapeutic class: Antihistamine

Pregnancy risk category C


Antagonizes effects of histamine at histamine1-receptor sites, but doesn't bind to or inactivate histamine. Also shows anticholinergic, antipruritic, and sedative activity.


Capsules (liquigels): 4 mg

Elixir: 2 mg/5 ml

Suspension: 12 mg/5 ml

Tablets: 4 mg, 8 mg, 12 mg

Tablets (extended-release): 8 mg, 12 mg

Indications and dosages

Symptomatic relief of allergic symptoms caused by histamine release; severe allergic or hypersensitivity reactions

Adults and children ages 12 and older: 4 to 8 mg P.O. three to four times daily, or 8 to 12 mg extended-release tablets P.O. two or three times daily. Maximum dosage is 36 mg/day.

Children ages 6 to 12: 2 mg P.O. q 4 to 6 hours as needed, not to exceed 12 mg/day

Children ages 2 to 6: 1 mg P.O. q 4 to 6 hours p.r.n., not to exceed 6 mg/day


• Hypersensitivity to drug
• Coronary artery disease
• Urinary retention
• Pyloroduodenal obstruction
• Peptic ulcer
• MAO inhibitor use within past 14 days
• Breastfeeding


Use cautiously in:
• angle-closure glaucoma, hepatic disease, hyperthyroidism, hypertension, bronchial asthma
• elderly patients
• pregnant patients.


• Give with food if GI upset occurs.
• Don't break or crush extended-release tablets.
• Shake oral suspension well before measuring dose.

Check elixir and suspension doses carefully, because the mg/ml varies widely between the two liquids.

Adverse reactions

CNS: drowsiness, sedation, dizziness, excitation, irritability, syncope, tremor

CV: hypertension, hypotension, palpitations, tachycardia, extrasystole, arrhythmias, bradycardia

EENT: blurred vision, nasal congestion or dryness, dry or sore throat

GI: nausea, vomiting, constipation, dry mouth

GU: urinary retention or hesitancy, dysuria, early menses, decreased libido, impotence

Hematologic: hemolytic anemia, hypoplastic anemia, thrombocytopenia, agranulocytosis, leukopenia, pan-cytopenia

Respiratory: thickened bronchial secretions, chest tightness, wheezing

Skin: urticaria, rash

Other: increased or decreased appetite, weight gain


Drug-drug.CNS depressants (including opioids and sedative-hypnotics): additive CNS depression

MAO inhibitors: intensified, prolonged anticholinergic effects

Drug-diagnostic tests.Allergy tests: false results

Granulocytes, platelets: decreased counts

Drug-behaviors.Alcohol use: increased CNS depression

Patient monitoring

• Monitor respiratory status.
• Stay alert for urinary retention, urinary frequency, and painful or difficult urination. Discontinue drug if these problems occur.
• With long-term use, monitor CBC.
• Monitor elderly patient for dizziness, sedation, and hypotension.
• If patient takes over-the-counter antihistamines, monitor him closely to avoid potential overdose.

Patient teaching

• Advise patient to take drug with meals if GI upset occurs.
• Instruct patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Caution patient to avoid alcohol while taking drug.
• Urge patient to tell all prescribers which drugs and over-the-counter preparations he's taking.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.


An analgesic NSAID used for acute pain management, which was withdrawn from the market following multiple reports of liver failure.
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References in periodicals archive ?
InSite Vision is advancing two product candidates that utilize low-concentrations of bromfenac enabled by DuraSite.
075%) of the non-steroidal anti-inflammatory (NSAID) bromfenac (BROMDAY([TM])/Xibrom (bromfenac ophthalmic solution) 0.
Without limiting the foregoing, but by way of example, statements contained in this press release relating to ISTA's 2010 expected financial results, ISTA's expectation to begin a Phase 3 study for ISTA's new formulation of bromfenac in 2010 and complete the formulation of bepotastine nasal and initiate full-scale clinical development during the year are forward-looking statements.
In addition, we are evaluating a new formulation and lower concentrations of bromfenac called REMURA(TM) for the potential treatment of dry eye which is now in Phase 3 clinical studies.
These results were presented in poster sessions at the 6th International Conference on the Tear Film & Ocular Surface in Florence, Italy, in poster presentations titled "Bromfenac Ophthalmic Solution for Treating the Signs of Dry Eye Disease" and "Alleviation of Dry Eye Disease Symptoms with Bromfenac Ophthalmic Solution.
We also made progress toward our Phase 3 lower concentration bromfenac dry eye study, an additional product candidate in our Xibrom family of anti-inflammatory eye care products.
In addition to XiDay, the Company's pipeline includes a bromfenac formulation for dry eye and a bepotastine formulation for nasal allergy.
ISV-101 is being developed to treat dry eye disease, and combines a low dose of bromfenac with the DuraSite technology.
Study results showed that the mean concentration of bromfenac in the aqueous humor of patients in BromSite's group was more than twice greater compared to those patients in Bromday's group with a P-Value of p=0.
Included in the year-end cash balance estimate is $20 million to $25 million in reserved bromfenac royalties.
ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co.