ISOPTO CARPINE Pilocarpine Hydrochloride 20mg / mL (2.0%) Sterile Ophthalmic Solution 15mL
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Features
- Pilocarpine
Description
Indications/Uses
Dosage/Direction for Use
Overdosage
In case of overdose, symptoms of toxicity may include: headache, salivation, sweating, syncope, bradycardia, hypotension, abdominal cramps, vomiting, asthma and diarrhoea.
Treatment of overdose is supportive. In cases of severe systemic toxicity, therapy with anticholinergics may be necessary.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Warnings
Retinal detachment has been reported when miotics are used in susceptible individuals, such as young patients with myopia or patients with history of retinal detachment.
Miotics should be avoided in acute inflammatory diseases of the anterior chamber.
A paradoxical rise in intraocular pressure may be observed in patients with severely compromised trabecular outflow.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Special Precautions
Caution is advised in the presence of corneal or conjunctival damage to avoid excessive penetration which can produce systemic toxicity.
PILOCARPINE hydrochloride (ISOPTO* CARPINE) Sterile Ophthalmic Solution should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, gastro-intestinal spasm, Parkinson's disease, urinary tract obstruction, recent myocardial infarction, hypertension and hypotension due to the risk of exacerbating these conditions.
PILOCARPINE hydrochloride (ISOPTO* CARPINE) Sterile Ophthalmic Solution contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to the application of PILOCARPINE hydrochloride (ISOPTO* CARPINE) Sterile Ophthalmic Solution and wait at least 15 minutes before reinsertion.
Effects on Ability to Drive and Use Machines: PILOCARPINE hydrochloride (ISOPTO* CARPINE) Sterile Ophthalmic Solution has a major influence on the ability to drive and use machines. Miosis may cause blurred vision and difficulty in dark adaptation. Patients should be advised to exercise caution while driving at night or while performing hazardous tasks in poor light.
Use In Pregnancy & Lactation
Use in Pregnancy: There are no or limited amount of data from the use of PILOCARPINE hydrochloride (ISOPTO* CARPINE) Sterile Ophthalmic Solution in pregnant women. Animal studies have, however, showed harmful effects of systemic pilocarpine exposure with respect to reproductive toxicity in rats.
Use in Lactation: It is unknown whether pilocarpine is excreted in human milk; however excretion in breast milk should be expected. There is also no information on the safety of pilocarpine ophthalmic formulations used during breast-feeding. However, a risk to the suckling child cannot be excluded.
Adverse Reactions
The following adverse reactions have been reported during clinical trials with PILOCARPINE hydrochloride (ISOPTO* CARPINE) Sterile Ophthalmic Solution and are classified according to the subsequent convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 1.)