Valid Ghana · FDA Ghana

XOLAMOL U.D OPTHALMIC SOLUTION (Each ml contains Dotzolamide Hydrochloride/ Trimolol Maleate

Dotzolamide Hydrochloride/ Trimolol Maleate

FDA/SD.255-1244002 Dotzolamide Hydrochloride/ Trimolol Maleate 22.25mg/6.83mg

What it does

Dorzolamide is a medication used to lower eye pressure in certain eye conditions.

Commonly used for: glaucoma, ocular hypertension

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.255-1244002
Registration date
2025-12-31
Expiry date
2030-12-31
Status
Valid
Active ingredient
Dotzolamide Hydrochloride/ Trimolol Maleate
Strength
22.25mg/6.83mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Jamjoom Pharmaceuticals
Applicant / LTR
PHARMASYMBROSIS LIMITED
Country of origin
SAUDI ARABIA
Manufacturer location
Jeddah 1st Industrial City, Jeddah 21442, Saudi Arabia

Source: Food and Drugs Authority · fetched 2026-05-08 08:00:27 · updated 2026-10-20 04:00:07

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About dotzolamide

Dorzolamide is a medication used to lower eye pressure in certain eye conditions.

What it treats

  • glaucoma
  • ocular hypertension

How it works

Dorzolamide works by reducing the amount of fluid produced in the eye, which helps to lower eye pressure.

Who it's for

This medication is for adults and children who have increased pressure in the eyes due to conditions like glaucoma.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About trimolol

Timolol is a medicine used to lower pressure in the eyes and help with certain heart conditions.

What it treats

  • glaucoma
  • ocular hypertension
  • high blood pressure (hypertension)
  • heart problems

How it works

Timolol works by reducing the amount of fluid in the eye and lowering heart rate and blood pressure.

Who it's for

This medication is for people with eye pressure issues or certain heart conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: dotzolamide

Dorzolamide is a carbonic anhydrase inhibitor used primarily in the treatment of glaucoma and ocular hypertension. It reduces intraocular pressure by decreasing the production of aqueous humor in the eye.

Indications

  • Glaucoma
  • Ocular hypertension

Dosage

Children: Refer to the BNF for Children for paediatric dosing recommendations.

Adults: Refer to professional guidelines or specific protocols for adult dosing.

Mechanism of action

Dorzolamide inhibits carbonic anhydrase II, an enzyme that catalyzes the formation of bicarbonate from carbon dioxide and water. By inhibiting this enzyme in the ciliary body of the eye, dorzolamide decreases the secretion of bicarbonate, leading to reduced aqueous humor production and subsequently lowering intraocular pressure.

Pharmacodynamics

Dorzolamide exhibits a dose-dependent reduction in intraocular pressure. It is well absorbed after topical administration, and its effects can be observed within 1 to 2 hours, peaking around 2 hours post-application. The duration of action lasts for approximately 8 to 12 hours.

Pharmacokinetics

Dorzolamide is primarily absorbed through the conjunctival route and has a systemic bioavailability of less than 1%. It is metabolized mainly in the liver, with minimal renal excretion of unchanged drug. The elimination half-life of dorzolamide is about 4 months, and it is excreted in urine primarily as metabolites.

Contra-indications

  • Hypersensitivity to dorzolamide or any of its components
  • Severe renal impairment
  • Hyperchloraemic acidosis
  • Hypokalaemia

Adverse effects

  • Burning or stinging sensation in the eyes
  • Bitter taste
  • Allergic reactions including rash and urticaria
  • Conjunctivitis
  • Corneal deposits
  • Visual disturbances
  • Dry eye

Interactions

  • Concurrent use with other carbonic anhydrase inhibitors may increase risk of systemic side effects
  • May enhance the effects of other diuretics
  • Use with caution in patients taking medications that may cause metabolic acidosis

Precautions

  • Monitor for signs of metabolic acidosis
  • Use with caution in patients with a history of renal stones
  • Caution in patients with hepatic impairment
  • Not recommended for use in patients with a history of respiratory acidosis

Pregnancy

Dorzolamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data on its safety in pregnant women are available.

Breast-feeding

Dorzolamide is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Do not freeze. Keep out of reach of children.

Formulations

  • Ophthalmic solution 2% (as dorzolamide hydrochloride)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: trimolol

Trimolol is a non-selective beta-adrenergic antagonist (beta-blocker) primarily used in the management of hypertension and certain types of glaucoma. It works by blocking the action of catecholamines on beta-adrenergic receptors, leading to a decrease in heart rate, myocardial contractility, and overall cardiac output. Additionally, it reduces intraocular pressure by decreasing aqueous humor production in the eye.

Indications

  • Hypertension
  • Angina pectoris
  • Heart failure
  • Migraine prophylaxis
  • Glaucoma
  • Intraocular hypertension

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing information.

Adults: Refer to the BNF for specific dosing information.

Mechanism of action

Trimolol exerts its effects by binding to and inhibiting beta-1 and beta-2 adrenergic receptors. This blockade results in a decrease in heart rate and myocardial contractility, which lowers blood pressure. In the eye, it reduces aqueous humor production, thereby lowering intraocular pressure, making it useful in the treatment of glaucoma.

Pharmacodynamics

Trimolol's pharmacodynamic effects include a reduction in heart rate, myocardial contractility, and conduction velocity through the atrioventricular node. It also causes bronchodilation in the lungs due to beta-2 receptor blockade, although this action may be less pronounced than in selective beta-2 agonists. The reduction of intraocular pressure is particularly important in the management of glaucoma, where it helps to prevent optic nerve damage.

Pharmacokinetics

Trimolol is absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism, leading to variable bioavailability. It is protein-bound to a significant extent and has a relatively long half-life, allowing for once or twice daily dosing. The drug is metabolized in the liver, and its metabolites are excreted primarily via the kidneys. The pharmacokinetic profile may be influenced by factors such as age, liver function, and concomitant medications.

Contra-indications

  • Hypersensitivity to trimolol or any of its components
  • Severe bradycardia
  • Heart block greater than first degree
  • Cardiogenic shock
  • Uncontrolled heart failure
  • Asthma or history of bronchial asthma
  • Severe chronic obstructive pulmonary disease (COPD)

Adverse effects

  • Bradycardia
  • Hypotension
  • Dizziness
  • Fatigue
  • Depression
  • Nausea
  • Diarrhea
  • Shortness of breath
  • Worsening of heart failure
  • Cold extremities

Interactions

  • Other antihypertensive agents may enhance the hypotensive effect
  • Calcium channel blockers may increase the risk of bradycardia and hypotension
  • NSAIDs may reduce the antihypertensive effect
  • Insulin and oral hypoglycemic agents may mask symptoms of hypoglycemia

Precautions

  • Use with caution in patients with diabetes, as it may mask hypoglycemic symptoms
  • Monitor cardiac function in patients with pre-existing heart conditions
  • Caution in patients with hepatic impairment
  • Discontinue gradually to avoid rebound hypertension

Pregnancy

Trimolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult appropriate guidelines.

Breast-feeding

Trimolol is excreted in breast milk, and caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Ophthalmic solution
  • Oral tablet

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.