Cyclomydril

Name: Cyclomydril

Cyclomydril Drug Class

Cyclomydril is part of the drug classes:

  • Opthalmic anticholinergics

  • Adrenergic and dopaminergic agents

  • Sympathomimetics

  • Sympathomimetics excl. antiglaucoma preparations

  • Sympathomimetics used as decongestants

  • Sympathomimetics, combinations excl. corticosteroids

  • Sympathomimetics, plain

What is the most important information I should know about Cyclomydril (cyclopentolate and phenylephrine ophthalmic)?

You should not receive this medicine if you have untreated narrow-angle glaucoma.

How is Cyclomydril (cyclopentolate and phenylephrine ophthalmic)given?

This medicine is given as an eye drop placed into one or both eyes. A healthcare provider will place the drops in your eye.

Tell your doctor at once if you have severe burning, stinging, or irritation in your eyes.

After the drops are placed in your eye, gently press your finger to the inside corner of the eye for 2 to 3 minutes, to keep the liquid from draining into your tear duct. This will help prevent your body from absorbing too much of this medicine. Do not rub the eye.

If a child has been treated with this medicine, avoid allowing the child to rub or wipe the eyes. Closely watch the child for at least 30 minutes after the drops were placed in the eyes. This is to make sure the medicine does not cause any serious side effects by being absorbed through the tear duct.

Wash your hands after touching your eyes. If any of this medicine gets on a child's hands, wash them with soap and water. This will help prevent any medicine from accidentally reaching the child's mouth.

What happens if I miss a dose?

Because you will receive cyclopentolate and phenylephrine in a clinical setting, you are not likely to miss a dose.

Uses For Cyclomydril

Ophthalmic atropine, homatropine, and scopolamine are used to dilate (enlarge) the pupil of the eye. They are used before eye examinations, before and after eye surgery, and to treat certain eye conditions, such as uveitis or posterior synechiae.

These medicines are available only with your doctor's prescription.

What do I need to tell my doctor BEFORE I take Cyclomydril?

  • If you have an allergy to cyclopentolate, phenylephrine, or any other part of Cyclomydril (cyclopentolate and phenylephrine).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have narrow-angle glaucoma.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cyclomydril with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Cyclomydril) best taken?

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

  • For the eye only.
  • Your doctor will give Cyclomydril.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some other side effects of Cyclomydril?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Eye irritation.
  • Burning.
  • Blurred eyesight.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Principal display panel

NDC 0065-0359-05

Alcon
Cyclomydril®
(cyclopentolate hydrochloride, phenylephrine hydrochloride ophthalmic solution)

5 mL Sterile

Rx Only

Sterile Ophthalmic Solution

USUAL DOSAGE: Instill one drop in each eye every five to ten minutes. Read enclosed insert.

FOR TOPICAL OPHTHALMIC USE ONLY

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

INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, boric acid, hydrochloric acid and/or sodium carbonate (to adjust pH), purified water.

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

©2004, 2010, 2013 Novartis

9009878-0713

Alcon®
a Novartis company

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA

LOT:

EXP.:

NDC 0065-0359-05

Alcon
Cyclomydril®
(cyclopentolate hydrochloride, phenylephrine hydrochloride ophthalmic solution)

Sterile 5 mL

Rx Only

INGREDIENTS: Each mL contains: Actives: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, boric acid, hydrochloric acid and/or sodium carbonate (to adjust pH), purified water.

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

USUAL DOSAGE: Instill one drop in each eye every five to ten minutes. Read enclosed insert.

STORAGE: Store at 8°-25°C (46°-77°F).

Printed in USA
©2004, 2013 Novartis

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

LOT:

EXP.:

H12853-0713

Cyclomydril 
cyclopentolate hydrochloride and phenylephrine hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-0359
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOPENTOLATE HYDROCHLORIDE (CYCLOPENTOLATE) CYCLOPENTOLATE HYDROCHLORIDE 2 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
EDETATE DISODIUM  
BORIC ACID  
HYDROCHLORIC ACID  
SODIUM CARBONATE  
WATER  
Packaging
# Item Code Package Description
1 NDC:0065-0359-02 2 mL in 1 BOTTLE, PLASTIC
2 NDC:0065-0359-05 5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084300 06/30/1958
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Research Ltd 007672236 MANUFACTURE(0065-0359)
Revised: 08/2011   Alcon Laboratories, Inc.

What are some side effects that I need to call my doctor about right away?

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.
  • A fast heartbeat.
  • Fever.
  • Very bad headache.
  • Flushing.
  • Trouble passing urine.
  • Feeling confused.
  • Hallucinations (seeing or hearing things that are not there).
  • Seizures.
  • Change in balance.
  • Trouble walking.
  • Slurred speech.
  • Restlessness.
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