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Dorzolamide hydrochloride ocular

Presentation

Eye drops containing dorzolamide hydrochloride (preservative containing and preservative-free).

Drugs List

  • dorzolamide 20mg/ml eye drops
  • dorzolamide 20mg/ml eye drops preservative-free
  • dorzolamide 20mg/ml eye drops preservative-free 0.2ml unit dose
  • EYDELTO 20mg/ml eye drops
  • TRUSOPT 20mg/ml eye drops
  • TRUSOPT 20mg/ml single dose eye drops
  • VIZIDOR 20mg/ml eye drops
  • Therapeutic Indications

    Uses

    Elevated IOP in ocular hypertension - adjunctive therapy
    Elevated IOP in ocular hypertension - alternative to beta-blockers
    Elevated IOP in open-angle glaucoma - adjunctive therapy
    Elevated IOP in open-angle glaucoma - alternative to beta-blockers
    Elevated IOP in pseudoexfoliative glaucoma - adjunctive therapy
    Elevated IOP in pseudoexfoliative glaucoma - alternative to beta-blockers

    Dosage

    Adults

    As monotherapy
    Instil 1 drop into the affected eye(s) three times a day.

    As adjunctive therapy with an ophthalmic beta blocker
    Instil 1 drop into the affected eye(s) twice daily.

    Children

    Limited data exists for use in paediatric patients.

    Dorzolamide has not been studied in patients less than 36 weeks gestational age and less than 1 week of age. Hence, because of possible metabolic acidosis risk, patients with significant renal tubular immaturity should only receive dorzolamide after careful consideration of the risk/benefit balance.

    Raised intra-ocular pressure in primary and secondary glaucoma (monotherapy) (unlicensed)
    Instil 1 drop into the affected eye(s) three times a day.

    Raised intra-ocular pressure in primary and secondary glaucoma (in combination with a beta-blocker) (unlicensed)
    Instil 1 drop into the affected eye(s) twice daily.

    Patients with Renal Impairment

    Dorzolamide has not been studied in patients with severe renal impairment (CrCI < 30ml/minute) or with hyperchloraemic acidosis. Dorzolamide and its metabolites are excreted predominantly by the kidney.

    In post marketing data, metabolic acidosis in the very young particularly with renal immaturity/impairment has been reported.

    Additional Dosage Information

    If switching to dorzolamide from another anti-glaucoma product, instil the doses of other product one day, then commence instilling the dorzolamide doses the following day.

    Contraindications

    Breastfeeding
    Hyperchloraemic acidosis
    Pregnancy
    Renal impairment - creatinine clearance below 30 ml/minute

    Precautions and Warnings

    Children under 18 years
    Neonates
    Wearing of contact lenses
    Chronic corneal disorder
    Hepatic impairment
    History of intra-ocular surgery
    History of nephrolithiasis

    Advise patient blurred vision may affect ability to drive/operate machinery
    Contains benzalkonium chloride
    Some formulations may contain traces of silver - risk of hypersensitivity
    Administer other ophthalmic products at least 10 minutes apart
    Increased risk of choroidal detachment with use post filtration procedures
    Discontinue if hypersensitivity reactions occur
    Advise patient to avoid touching the eye/other surfaces with container tip
    If soft contact lenses worn,insert them 15 minutes after using eye drops

    Pregnancy and Lactation

    Pregnancy

    Dorzolamide is contraindicated during pregnancy.
    Manufacturers advise that this medication is not recommended during pregnancy. At the time of writing there is limited published experience concerning the use of dorzolamide during pregnancy. In rabbits, dorzolamide produced teratogenic effect at maternotoxic doses. Schaefer concludes that eye drops may generally be used during pregnancy for the appropriate indications and if there are compelling treatment indications they should not be withheld but the dosage kept as low as possible (Schaefer 2015).

    Lactation

    Dorzolamide is contraindicated during breastfeeding.
    Manufacturers advise that this medication is not recommended during breastfeeding. At the time of writing there is little published experience concerning the use of dorzolamide during breastfeeding. It is not known whether dorzolamide is excreted in human milk. In lactating rats receiving dorzolamide, decreases in the body weight gain of offspring were observed. Schaefer concludes that in general eye drops are compatible with breastfeeding as minimal amounts are absorbed systemically (Schaefer 2015).

    Side Effects

    Angioedema
    Asthenia
    Bitter taste
    Blurred vision
    Bronchospasm
    Burning and stinging of the eyes
    Choroidal detachment (following filtration surgery)
    Conjunctivitis
    Contact dermatitis
    Corneal decompensation
    Corneal oedema
    Dizziness
    Dry mouth
    Dyspnoea
    Epistaxis
    Eye pain
    Eyelid inflammation
    Eyelid reaction
    Fatigue
    Headache
    Hypersensitivity reactions
    Iridocyclitis
    Lid margin crusting
    Metabolic acidosis
    Myopia (transient)
    Nausea
    Ocular hypotony
    Ocular irritation
    Ocular itching
    Palpitations
    Paraesthesia
    Pruritus
    Rash
    Reddening of eyes
    Sensation of foreign body in eye
    Shortness of breath
    Stevens-Johnson syndrome
    Superficial punctate keratitis
    Tearing
    Throat irritation
    Toxic epidermal necrolysis
    Urolithiasis
    Urticaria

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: October 2017

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Eydelto 20mg/ml eye drops solution. Aspire Pharma Ltd. Revised April 2017.

    Summary of Product Characteristics: Trusopt 20mg/ml Eye Drops, solution. Santen Oy. Revised February 2017.

    Summary of Product Characteristics: Trusopt Preservative-Free 20mg/ml eye drops solution, single dose container. Santen Oy. Revised February 2017.

    Summary of Product Characteristics: Vizidor 20mg/ml eye drops solution. Bausch & Lomb UK Ltd. Revised January 2021.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 July 2021

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Dorzolamide. Last revised: December 27, 2007
    Last accessed: August 05, 2009

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