Cyclopentolate

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other eye drops that dilate the pupil such as atropine (Aztreza, IsoptoAtropine)
• carbachol (Miostat, Carbastat)
• pilocarpine (Salagen, Isopto Carpine, Pilocar, Ocusert Pilo)

This is not a complete list of cyclopentolate drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with cyclopentolate including the following:

• psychotic reactions and behavioral changes. These reactions are more likely to occur in children. Tell your healthcare provider right away if you have some or all of the following symptoms of psychotic reactions and behavioral changes:
  • incoherent speech
  • restlessness
  • hallucinations
  • hyperactivity
  • seizures
  • disorientation as to time and place
  • failure to recognize people

Other toxic manifestations of anticholinergic drugs such as cyclopentolate are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, urinary retention, diminished gastrointestinal motility, and decreased secretion in salivary and sweat glands, the throat, and nasal passages.

Cyclopentolate can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how cyclopentolate affects you.

Do not take cyclopentolate if you:

• are allergic to cyclopentolate or to any of its ingredients
• have narrow angles due to glaucoma or any other cause

Use cyclopentolate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• This medicine will be given to you by a doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Change in how you act.
• Trouble speaking.
• Seizures.
• Change in balance.
• Restlessness.

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine.

Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.

General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma.

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the solution. A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination.

Drug Interactions

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of Cyclopentolate Hydrochloride Ophthalmic Solution USP.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Cyclopentolate. It is also not known whether Cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered to a pregnant woman 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 Cyclopentolate hydrochloride is administered to a nursing woman.

Pediatric Use

Use of Cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to Cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination. Observe infants closely for at least 30 minutes (See WARNINGS).

Geriatric Use

No overall differences in safety or effectiveness between elderly and younger patients.

NDC 61314-396-03

Cyclopentolate Hydrochloride 0phthalmic Solution, USP
1%

Rx only

STERILE
15 mL

SANDOZ
a Novartis company

INGREDIENTS: Each mL contains: Active: Cyclopentolate hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

USUAL DOSAGE: Instill one or two drops in the eye which may be repeated in five to ten minutes if necessary.
Read enclosed insert.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

STORAGE: Store at 8° to 25°C (46° to 77°F).

Manufactured by Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc. 
Princeton, NJ 08540

Printed in USA

Rev. 10/2015

9012233-0915

LOT:

EXP.:

NDC 61314-396-03

Cyclopentolate Hydrochloride 0phthalmic Solution, USP
1%

FOR TOPICAL OPHTHALMIC USE ONLY

Rx only

STERILE   15 mL

SANDOZ

INGREDIENTS: Each mL contains: Active: Cyclopentolate hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, potassium chloride, edetate disodium, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water.

The pH range is between 3.0 and 5.5.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

Rev. 10/2015

USUAL DOSAGE: Instill one or two drops in the eye which may be repeated in five to ten minutes if necessary. Read enclosed insert.

STORAGE: Store at 8° to 25°C (46° to 77°F).

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc. 
Princeton, NJ 08540

Printed in USA

H14037-0915

LOT/EXP.: