Name: Alamast

Alamast Pharmacokinetics



Following topical application to both eyes (0.1% solution 4 times daily for 2 weeks), peak plasma concentrations were attained within about 25 minutes, but were substantially lower than those following a single (10 mg) oral dose.1


Elimination Route

10–15% of topical ophthalmic dose excreted unchanged in urine.1


About 4.5 hours.1

Before Using Alamast

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


This medicine has been tested in children 3 years of age and older and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.


There is no specific information available comparing the use of pemirolast in the elderly with use in other age groups.


Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Contact lens–related irritation—Pemirolast should not be used to treat this condition

Precautions While Using Alamast

You should avoid wearing contact lenses when your eyes are red and irritated from your allergies.

For patients who continue to wear contact lenses and whose eyes are not red, be certain to wait at least 10 minutes after applying pemirolast to your eyes before replacing any contact lenses normally worn.

Indications and Usage for Alamast

Alamast® ophthalmic solution is indicated for the prevention of itching of the eye due to allergic conjunctivitis. Symptomatic response to therapy (decreased itching) may be evident within a few days, but frequently requires longer treatment (up to four weeks).


For topical ophthalmic use only. Not for injection or oral use.

Adverse Reactions

In clinical studies lasting up to 17 weeks with Alamast® ophthalmic solution, headache, rhinitis, and cold/flu symptoms were reported at an incidence of 10–25%. The occurrence of these side effects was generally mild. Some of these events were similar to the underlying ocular disease being studied.

The following ocular and non-ocular adverse reactions were reported at an incidence of less than 5%:

Ocular: burning, dry eye, foreign body sensation, and ocular discomfort.

Non-Ocular: allergy, back pain, bronchitis, cough, dysmenorrhea, fever, sinusitis, and sneezing/nasal congestion.


NDC 68669-711-98

(pemirolast potassium
ophthalmic solution) 0.1%


2.5 ml


pemirolast potassium solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68669-711
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pemirolast potassium (pemirolast) pemirolast potassium 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzododecinium chloride 0.05 mg  in 1 mL
glycerin 18 mg  in 1 mL
sodium phosphate, dibasic 2.4 mg  in 1 mL
sodium phosphate, monobasic 0.07 mg  in 1 mL
sodium hydroxide  
phosphoric acid  
# Item Code Package Description
1 NDC:68669-711-10 10 mL in 1 BOTTLE
2 NDC:68669-711-98 2.5 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021079 05/01/2000
Labeler - Vistakon Pharmaceuticals LLC (004060273)
Revised: 03/2010   Vistakon Pharmaceuticals LLC

For the Consumer

Applies to pemirolast ophthalmic: ophthalmic solution

Along with its needed effects, pemirolast ophthalmic (the active ingredient contained in Alamast) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking pemirolast ophthalmic:

Less common
  • Cough (mucus-producing)
  • headache (severe)
  • stomach pain and cramping
  • pain and tenderness around eyes and cheekbones
  • painful menstrual bleeding
  • runny or stuffy nose
  • tightness in chest
  • troubled breathing

Some side effects of pemirolast ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Chills
  • cough
  • fever
  • sneezing
  • sore throat
Less common
  • Back pain
  • burning feeling in eye
  • eyelid swelling
  • eye dryness
  • foreign body feeling in eye
  • general feeling of eye discomfort
  • increased itching of the eye
  • redness of the eye

Pemirolast ophthalmic Breastfeeding Warnings

There are no data on the excretion of pemirolast ophthalmic into human milk. It is excreted into rat milk at concentrations higher than in plasma. Pemirolast undergoes low systemic absorption after ocular administration (0.8 ng/mL). The manufacturer recommends caution when administering pemirolast ophthalmic to nursing women.

Pemirolast Levels and Effects while Breastfeeding

Summary of Use during Lactation

Although no published data exist on the use of pemirolast during lactation, maternal milk levels are likely to be very low after the use eye drops.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.