Epinastine HCl

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|Epinastine HCl

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Epinastine HCl

Pronouncation: (epp-ih-NAS-teen HIGH-droe-KLOR-ide)
Class: Antihistamine, Ophthalmic

Trade Names:
Elestat
- Ophthalmic solution 0.05%

Mechanism of Action

Pharmacology

Direct H 1 -receptor antagonist that inhibits release of histamine from the mast cell.

Pharmacokinetics

Absorption

Low systemic exposure.

Distribution

Plasma protein binding approximately 64%.

Metabolism

Less than 10% metabolized.

Elimination

Terminal plasma elimination t ½ is about 12 hr. Mainly excreted unchanged (after IV dosing about 55% in urine and 30% in feces). Renal elimination via active tubular secretion.

Indications and Usage

Prevention of itching associated with allergic conjunctivitis.

Contraindications

Standard considerations.

Dosage and Administration

Adults and children 3 yr and older

Ophthalmic 1 gtt in each eye bid, continuing treatment throughout the period of exposure (until pollen season is over or until exposure to offending allergen is terminated) even when symptoms are absent.

General Advice

  • For topical ophthalmic use only. Not for injection or oral use.
  • If using other topical ophthalmic drugs, separate each medication by at least 5 min.

Storage/Stability

Store ophthalmic solution at controlled room temperature (59°F to 77°F). Keep tightly closed.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache (1% to 3%).

EENT

Burning sensation in eye, folliculosis, hyperemia, pruritus (1% to 10%); rhinitis, sinusitis, pharyngitis (1% to 3%).

Respiratory

Upper respiratory infection (10%); increased cough (1% to 3%).

Miscellaneous

Symptoms of cold (10%).

Precautions

Monitor

Ocular/Systemic reactions

Monitor patient for ocular (eg, burning, stinging) and systemic (eg, headaches) reactions. Inform health care provider if noted and significant.

Ophthalmic symptoms

Assess ophthalmic symptoms (eg, itching) before and periodically throughout therapy. Notify health care provider if symptoms are not controlled with medication.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children under 3 yr.

Patient Information

  • Advise patient to read patient instruction sheet that accompanies each bottle of azelastine.
  • Explain name, dose, action, and potential side effects of drug.
  • Advise patient that usual dose is 1 gtt instilled into the affected eyes bid.
  • Teach patient proper technique for instilling eye drops: wash hands; do not allow dropper tip to touch eye. Tilt head back, look up; pull lower eyelid down; instill prescribed number of gtt. Close eye for 1 to 2 min and apply gentle pressure to bridge of nose for 3 to 5 min. Do not rub eye.
  • Advise patient that medication should be used daily during the period of exposure to allergens in order to prevent symptoms from recurring.
  • Advise patient that if symptoms are not controlled not to increase the dose but to inform health care provider.
  • Advise patient that if more than 1 topical ophthalmic drug is being used, to administer the drugs at least 10 min apart.
  • Advise patient who wears contact lenses not to wear lenses if eyes are red.
  • Advise patient who wears contact lenses, and whose eyes are not red, to remove lenses before instilling this medicine and to wait at least 10 min after instilling eye drops before inserting lenses.
  • Inform patient that temporary redness, itching, burning, or stinging of the eye are the most common side effects and to contact health care provider if they occur and are bothersome.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Caution patient not to take any prescription or OTC medications or dietary supplements unless advised by health care provider.




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