Cyclopentolate Hydrochloride 10 mg/mL
Cyclopentolate Hydrochloride · SOLUTION · Sandoz Inc.
Cyclopentolate Hydrochloride is a solution containing cyclopentolate hydrochloride at 10 mg/mL, taken ophthalmic. Manufactured by Sandoz Inc..
Key Facts
- Brand Name
- Cyclopentolate Hydrochloride
- Generic Name
- Cyclopentolate Hydrochloride
- NDC Code (Product)
61314-396- Manufacturer
- Sandoz Inc.
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA084110
- Marketing Start
- 08/22/2002
Recall History
Bausch & Lomb, Inc.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Cyclopentolate hydrochloride ophthalmic solution is used to produce mydriasis and cycloplegia.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adults: Instill one or two drops of 1% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 1% solution in the eye, which may be repeated five to ten minutes later by a second application of 1% solution if necessary. Individuals with heavily pigmented irides may require higher strengths.
Warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION. This preparation may cause Central Nervous System (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger cyclopentolate hydrochloride solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of a 1% cyclopentolate solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation. Mydriatics may produce a transient elevation of intraocular pressure.
Contraindications
CONTRAINDICATIONS Hypersensitive to any component of this preparation.
Drug Interactions
Drug Interactions: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Adverse Reactions
ADVERSE REACTIONS Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. This drug produces reactions similar to those of other anticholinergic drugs, but the CNS manifestations as noted above are more common. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, necrotizing enterocolitis (in preterm infants), unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at …
Frequently Asked Questions
What is Cyclopentolate Hydrochloride used for?
Cyclopentolate Hydrochloride contains Cyclopentolate Hydrochloride. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is Cyclopentolate Hydrochloride a controlled substance?
Cyclopentolate Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Cyclopentolate Hydrochloride?
The generic name for Cyclopentolate Hydrochloride is Cyclopentolate Hydrochloride. There are 4 other brand versions of Cyclopentolate Hydrochloride.
What is the NDC code for Cyclopentolate Hydrochloride 10 mg/mL?
The NDC (National Drug Code) for Cyclopentolate Hydrochloride 10 mg/mL is 61314-396, listed by Sandoz Inc..