Alamast

Name: Alamast

Pemirolast Ophthalmic Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • severe burning or discomfort in your eyes after using the drops.

Common side effects may include:

  • headache; or
  • runny nose, cold or flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects

In clinical studies lasting up to 17 weeks with ALAMAST® (pemirolast potassium ophthalmic solution) 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.

Alamast Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.1 Not for injection or oral use.1

Avoid contamination of the solution container.1

Dosage

Available as pemirolast potassium; dosage expressed in terms of the salt.1

Initiate therapy before and continue throughout pollen season.4 5 6 7

Pediatric Patients

Allergic Conjunctivitis Ophthalmic

Children ≥3 years of age: 1 or 2 drops of a 0.1% solution in the affected eye(s) 4 times daily.1

Symptomatic response (i.e., decreased itching) may be evident within a few days following initiation but frequently requires up to 4 weeks of therapy.1 2 3

Adults

Allergic Conjunctivitis Ophthalmic

1 or 2 drops of a 0.1% solution in the affected eye(s) 4 times daily.1

Symptomatic response (i.e., decreased itching) may be evident within a few days following initiation but frequently requires up to 4 weeks of therapy.1 2 3

Alamast Side Effects

Along with its needed effects, a medicine 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:

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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Alamast Description

Alamast® (pemirolast potassium ophthalmic solution) is a sterile, aqueous ophthalmic solution with a pH of approximately 8.0 containing 0.1% of the mast cell stabilizer, pemirolast potassium, for topical administration to the eyes.

Pemirolast potassium is a slightly yellow, water-soluble powder with a molecular weight of 266.3.

The chemical structure is presented below:

C10H7KN6O

Chemical name

9-methyl-3-(1 H-tetrazol-5-yl)-4H-pyrido[1 ,2-α] pyrimidin-4-one potassium

Each mL contains

ACTIVE: pemirolast potassium 1 mg (0.1 %); PRESERVATIVE: lauralkonium chloride 0.005%; INACTIVES: glycerin, dibasic sodium phosphate, monobasic sodium phosphate, phosphoric acid and/or sodium hydroxide to adjust pH, and purified water. The osmolality of Alamast® ophthalmic solution is approximately 240 mOsmol/kg.

Precautions

Information for patients

To prevent contaminating the dropper tip and solution, do not touch the eyelids or surrounding areas with the dropper tip. Keep the bottle tightly closed when not in use.

Patients should be advised not to wear contact lenses if their eye is red. Alamast® should not be used to treat contact lens related irritation. The preservative in Alamast®, lauralkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling Alamast® before they insert their contact lenses.

Carcinogenesis, mutagenesis, impairment of fertility

Pemirolast potassium was not mutagenic or clastogenic when tested in a series of bacterial and mammalian tests for gene mutation and chromosomal injury in vitro nor was it clastogeric when tested in vivo in rats.

Pemirolast potassium had no effect on mating and fertility in rats at oral doses up to 250 mg/kg (approximately 20,000 fold the human dose at 2 drops/eye, 40 µL/drop, QID for a 50 kg adult). A reduced fertility and pregnancy index occurred in the F1 generation when F0 dams were treated with 400 mg/kg pemirolast potassium during late pregnancy and lactation period (approximately 30,000 fold the human dose).

Pregnancy

Teratogenic effects

Pregnancy Category C

Pemirolast potassium caused an increased incidence of thymic remnant in the neck, interventricular septal defect, fetuses with wavy rib, splitting of thoracic vertebral body, and reduced numbers of ossified sternebrae, sacral and caudal vertebrae, and metatarsi when rats were given oral doses ≥250 mg/kg (approximately 20,000 fold the human dose at 2 drops/eye, 40 µL/drop, OID for a 50 kg adult) during organogenesis. Increased incidence of dilation of renal pelvis/ureter in the fetuses and neonates was also noted when rats were given an oral dose of 400 mg/kg pemirolast potassium (approximately 30,000 fold the human dose). Pemirolast potassium was not teratogenic in rabbits given oral doses up to 150 mg/kg (approximately 12,000 fold the human dose) during the same time period. There are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Alamast® ophthalmic solution should be used during pregnancy only if the benefit outweighs the risk.

Non-teratogenic effects

Pemirolast potassium produced increased pre- and post-implantation losses, reduced embryo/fetal and neonatal survival, decreased neonatal body weight, and delayed neonatal development in rats receiving an oral dose at 400 mg/kg (approximately 30,000 fold the human dose). Pemirolast potassium also caused a reduction in the number of corpus lutea, the number of implantations, and number of live fetuses in the F1 generation in rats when F0 dams were given oral dosages ≥250 mg/kg (approximately 20,000 fold the human dose) during late gestation and the lactation period.

Nursing Mothers

Pemirolast potassium is excreted in the milk of lactating rats at concentrations higher than those in plasma. It is not known whether pemirolast potassium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Alamast® ophthalmic solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Overdosage

No accounts of Alamast® ophthalmic solution overdose were reported following topical ocular application.

Oral ingestion of the contents of a 10 mL bottle would be equivalent to 10 mg of pemirolast potassium.

Adverse Effects

1-10%

Burning

Dry eyes

Foreign body sensation

Ocular discomfort

Allergy

Bronchitis

Cough

Sneezing

Nasal congestion

Pregnancy

Information about this pemirolast-ophthalmic-route
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.

Drug Interactions

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.

(web3)