Croma™ Ophthalmic Solution contains sodium Cromoglycate which is a mast cell stabilizer and
an anti-allergic agent. It helps to ease the symptoms of conjunctivitis caused by an allergy. It works
by reducing the body's response to the allergy which helps to relieve symptoms such as itchy,
watery eyes. Tetrahydrozoline hydrochloride is the second component in Croma™, it is a
sympathomimetic agent with alpha-adrenergic activity and is useful as a conjunctival
decongestant. It acts as a local vasoconstrictor reducing the swelling and congestion in the mucous
membranes of the conjunctiva.
Croma™ is prescribed for the prevention and treatment of chronic allergic conjunctivitis and
hayfever (acute allergic conjunctivitis). Croma™ Eye Drops prevent the itching, inflammation and
watering eyes often experienced with hayfever.

Croma™ is to be used only as eye drops. Instill 1-2 drops in to the conjunctival sac of the eye(s)
three to four times daily or as directed by the physician.

Do not use Croma™ Eye Drops  If you know that you have had a reaction to any of its ingredients.  if you have one of the following diseases: o Glaucoma or other serious ophthalmic diseases, o Hypertensivity, hyperthyroidism and diabetes.  This medicine should be given to children only under close supervision of a physician. Sodium Cromoglicate Patients with known hypersensitivity to any of the ingredients. Tetrahydrozoline Hydrochloride Known hypersensitivity to tetrahydrozoline or any ingredient in the formulation Pediatric Use Safety and effectiveness in children below the age of 4 years have not been established.

Sodium Cromoglycate
Patients may experience a transient stinging or burning sensation following application of
Cromolyn Sodium Ophthalmic Solution.
Tetrahydrozoline Hydrochloride
Ask a doctor before use if you have narrow angle glaucoma
When using this product
 pupils may become enlarged temporarily
 overuse may cause more eye redness
 remove contact lenses before using
 do not use if this solution changes color or becomes cloudy
 do not touch the tip of container to any surface to avoid contamination
 replace cap after each use
 Driving and using machines
All eye drops can cause a short term blurring of vision when first used so you should wait until
your eyes are clear before driving or using machines.
 Important information about some of the ingredients of Croma™
If you wear soft contact lenses. Do not use the drops while your contact lenses are in your eyes.
Wait 10 -15 minutes after using the eye drops before putting your lenses back into your eyes. A
preservative in Croma™ (benzalkonium chloride) can affect soft lenses.

None known

Pregnancy
Teratogenic Effects
Cromolyn sodium
Pregnancy Category B. Reproduction studies with cromolyn sodium administered
subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m )
and 164 mg/kg (984 mg/m ), respectively, and intravenously to rabbits at a maximum daily dose
of 485 mg/kg (5820 mg/m ) produced no evidence of fetal malformation. These doses represent
approximately 57, 35, and 205 times the maximum daily human dose, respectively, on mg/m
basis. Adverse fetal effects (increased resorption maximum daily human dose, respectively, on
mg/m basis. Adverse fetal effects (increased resorption and decreased fetal weight) were noted
only at the very high parenteral doses that produced maternal toxicity. There are, however, no
adequate and well-controlled studies in pregnant women. Because animal reproduction studies
are not always predictive of human response, this drug should be used during pregnancy only if
clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in
human milk, caution should be exercised when Cromolyn Sodium Ophthalmic Solution USP, 4%
is administered to a nursing woman.
Tetrahydrozoline Hydrochloride
Pregnancy: Category C.
Lactation: Not known whether tetrahydrozoline is distributed into milk.101 a Caution if used in
nursing women.101 a
Pediatric Use: Safety and efficacy of ophthalmic solution not established in children <6 years
of age. Accidental ingestion of OTC ophthalmic solutions or nasal sprays containing
imidazoline derivatives (i.e., tetrahydrozoline, naphazoline, oxymetazoline) in children has
resulted in serious adverse events requiring hospitalization, including nausea, vomiting,
lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation,

somnolence, mydriasis, stupor, hypothermia, drooling, and coma.1001 Respiratory depression,
CNS depression, and/or lethargy reportedly occurred in infants following accidental ingestion
of small amounts (≤6 mL) of 0.05% tetrahydrozoline ophthalmic solution.1002 1007 Keep out of
reach of children.1001 (See Advice to Patients.)

Transient stinging or blurring of vision may occur on instillation of the drops.
Do not drive or use machinery until normal vision is restored.

You may experience some or all of the following side effects during the use of Croma™
Temporary burning sensations, occasional pupil dilation, systemic absorption effects
(hypertension, heart disorders, and hyperglycemia), increased intraocular pressure, transient
headache, nausea.
Sodium Cromoglicate
The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic
solution, on the basis of reoccurrence following re-administration, is transient ocular stinging or
burning upon instillation.
The following adverse reactions have been reported as infrequent events. It is unclear whether they
are attributable to the drug:
Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation;
and styes.
Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema and
rash.
To report any side effect(s):
• Saudi Arabia:
- The National Pharmacovigilance and
Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2340.
• Toll free phone: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc
• Other GCC States:
− Please contact the relevant competent authority.

Non Stated

5.1 Pharmacodynamic properties
Cromolyn sodium
In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of
sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium acts by
inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the
mast cell.
Another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the
degranulation of non-sensitized rat mast cells by phospholipase A and the subsequent release of
chemical mediators.
Another study showed that cromolyn sodium did not inhibit the enzymatic activity of released
phospholipase A on its specific substrate. Cromolyn sodium has no intrinsic vasoconstrictor,
antihistaminic or anti-inflammatory activity.
Cromolyn sodium is poorly absorbed. When multiple doses of cromolyn sodium ophthalmic
solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn
sodium is absorbed into the systemic circulation (presumably by way of the eye, nasal passages,
buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the cromolyn sodium
dose penetrate into the aqueous humor and clearance from this chamber is virtually complete
within 24 hours after treatment is stopped. In normal volunteers, analysis of drug excretion
indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to
the eye.
Tetrahydrozoline Hydrochloride
Structurally and pharmacologically related to naphazoline, oxymetazoline, and xylometazoline.
Directly stimulates α-adrenergic receptors; exerts little or no effect on β-adrenergic receptors.
Conjunctival application constricts small arterioles and temporarily relieves conjunctival
congestion.
 

Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses
up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 52.6
mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37
weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per
week) showed no neoplastic effects. The average daily maximum dose levels administered in these studies were 192.9 mg/m for mice, 47.2 mg/m for hamsters and 385.8 mg/m for rats. These doses
correspond to approximately 6.8, 1.7 and 14 times the maximum daily human dose of 28 mg/m.
Cromolyn sodium showed no mutagenic potential in the Ames Salmonella/microsome plate
assays, mitotic gene conversion in Saccharomycascerevisiae and in an in vitro cytogenetic study
in human peripheral lymphocytes.
No evidence of impaired fertility was shown in laboratory reproduction studies conducted
subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m) in males and 100
mg/kg/day (600 mg/m) in females. These doses are approximately 37 and 21 times the maximum
daily human dose, respectively, based on mg/m.
Tetrahydrozoline Hydrochloride
Bioavailability
Absorption may occasionally be sufficient to produce systemic effects.
Onset
Following ocular administration, local vasoconstriction usually occurs within minutes.
Duration
Local vasoconstriction may persist for 4–8 hours

Non Stated

Benzalkonium Chloride
Disodium Edetate
Hydroxypropylmethyl Cellulose
Sodium Dihydrogen Phosphate Monohydrate
Sodium Hydroxide
Water for Injection

Not applicable.

36 months

Do not store above 30°C.
Discard after 30 days of opening

Croma™ Ophthalmic Solution 10 ml filled in LDPE bottle.

Discard after 30 days of opening.