Dacrolux 10Ml

Dacrolux (3 Mg / Ml + 1 Mg / Ml Eye Drops Solution 1 Bottle 10 Ml)

ACTION AND MECHANISM

- Eye lubricant. Hypromellose and dextran increase tear viscosity and contact time with the ocular mucosa.

PHARMACOKINETICS

Ophthalmic route:

- Absorption: no significant absorption through the cornea is to be expected.

INDICATIONS

- Relief of [EYE DRYNESS] when the eye is subjected to irritants that cause dry eyes and discomfort.

POSOLOGY

- Adults: 1-2 drops in each affected eye. Administration may be repeated under medical criteria.

- Children and adolescents <18 years: safety and efficacy have not been evaluated.

- Elderly: does not require dosage adjustment.

DOSAGE IN KIDNEY INSUFFICIENCY

No specific dosage recommendations have been made.

DOSAGE IN LIVER INSUFFICIENCY

No specific dosage recommendations have been made.

RULES FOR CORRECT ADMINISTRATION

Care should be taken to avoid contaminating the eye drops throughout the administration of the drug. To do this, hands should be washed before administration, and the dropper should not come into contact with any surface of the body, including the eyelids and surrounding areas.

"Rules for administration of eye drops"

1. Tilt your head back.

2. Pull the lower eyelid with an index finger and look up.

3. Instill a drop into the conjunctival sac, keeping the bottle vertical with the dropper pointing down.

4. Once the drop is applied, blink repeatedly to distribute the eye drops. To reduce possible systemic absorption, it is recommended to press the lacrimal sac for one minute or close the eyelids tightly for 2-3 min, immediately after the administration of the eye drops.

If other ophthalmic medications are being used, it is recommended to distance the administrations at least 5 min. The most viscous forms, such as ophthalmic ointments, are recommended last.

CONTRAINDICATIONS

- Hypersensitivity to any component of the drug.

PRECAUTIONS RELATING TO EXCIPIENTS

- Because it contains benzalkonium chloride, it can cause eye irritation.

- It can cause discoloration and alterations in soft contact lenses, so it is recommended to avoid contact with them. Contact lenses have to be removed prior to application and wait at least 15 minutes before putting them back in.

ADVICE TO THE PATIENT

- Consult your doctor and / or pharmacist if symptoms worsen or do not improve within 72 hours, or if you experience pain, eye irritation or visual disturbances.

- Containing benzalkonium chloride (excipient) may cause eye irritation.

- Due to this content, it can cause discoloration and alterations in soft contact lenses, so it is recommended to avoid contact with them. Contact lenses have to be removed prior to application and wait at least 15 minutes before putting them back in.

INTERACTIONS

No interaction studies have been performed.

PREGNANCY

Animal safety : no data available.

Safety in humans : There are no adequate and well-controlled studies in humans. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks. Hypromellose does not appear to be significantly absorbed.

Effects on Fertility : No specific studies have been performed in humans.

LACTATION

Animal safety : no data available.

Safety in humans : it is not known if it is excreted with milk, and the consequences it could have for the infant. Hypromellose does not appear to be significantly absorbed.

CHILDREN

Safety and efficacy have not been evaluated in children and adolescents under 18 years of age, therefore no dosage recommendations can be made.

SENIORS

No specific problems have been described in the elderly that require a dosage adjustment.

EFFECTS ON DRIVING

It does not appear to affect the ability to drive significantly. However, like any other drug for ophthalmic administration, blurred vision may appear immediately after use. It is recommended to avoid driving until vision is normal.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, being considered very common (> 10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%) , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Allergic: frequency unknown [HYPERSENSITIVITY REACTIONS].

- Ophthalmological: infrequent [BLURRED VISION], [EYE ITCHING], [EYE PAIN], [EYE IRRITATION].

ADVERSE REACTIONS RELATING TO EXCIPIENTS

- Containing benzalkonium chloride may cause [EYE IRRITATION].

OVERDOSE

Symptoms : there is no clinical experience. The risk of overdose does not seem important due to its route of administration and low absorption.

Treatment : not required.

Doping

Dextran 70 is a prohibited substance both in and out of competition.

It is considered a specific substance and, therefore, a violation of the rule in which this substance is involved may lead to a reduction in the penalty as long as the athlete can demonstrate that the use of the specific substance in question was not intended to increase their sports performance.

Dacrolux Leaflet  (3 Mg / Ml + 1 Mg / Ml Eye Drops Solution 1 Bottle 10 Ml)