Daltifen (Drops) Instructions for Use

Marketing Authorization Holder

Micro Labs Limited (India)

ATC Code

S01GX08 (Ketotifen)

Active Substance

Ketotifen (Rec.INN registered by WHO)

Dosage Form

Daltifen

Ophthalmic drops 0.05%: 5 ml dropper bottle.

Dosage Form, Packaging, and Composition

Ophthalmic drops in the form of a transparent, colorless or almost colorless solution.

Excipients: disodium edetate dihydrate – 1 mg, polyvinyl alcohol – 14 mg, benzalkonium chloride 50% solution – 0.2 mg, sodium chloride – 5.61 mg, hydrochloric acid or sodium hydroxide – q.s. to pH 4.6-5.4, purified water – up to 1 ml.

5 ml – polyethylene dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

An antiallergic drug for topical use in ophthalmology

Pharmacotherapeutic Group

Antiallergic agent – mast cell membrane stabilizer

Pharmacological Action

Antiallergic agent. The mechanism of action is associated with inhibition of the release of histamine and other mediators from mast cells, blockade of histamine H₁-receptors, and inhibition of the enzyme phosphodiesterase, resulting in an increased level of cAMP (cyclic adenosine monophosphate) in mast cells. Suppresses the effects of PAF (platelet-activating factor).

It does not relieve bronchial asthma attacks but prevents their occurrence and helps reduce their duration and intensity, and in some cases, they disappear completely. Facilitates sputum discharge.

Pharmacokinetics

After oral administration, it is almost completely absorbed from the gastrointestinal tract. Concurrent food intake does not affect the degree of absorption of ketotifen. It is 50% metabolized during the first pass through the liver. C_max in blood plasma is reached within 2-4 hours. Plasma protein binding is 75%.

It is eliminated in two phases. T_1/2 in the initial phase is 3-5 hours, in the terminal phase – 21 hours. It is excreted by the kidneys, 60-70% as metabolites, 1% unchanged.

Indications

Atopic bronchial asthma (as part of complex therapy), allergic rhinitis, conjunctivitis.

ICD codes

Dosage Regimen

Instill one drop into the affected eye(s) twice daily, every 12 hours.

Use the solution regularly to achieve the full prophylactic effect against allergic conjunctivitis.

Wash hands thoroughly before use.

Avoid allowing the dropper tip to contact the eye, eyelids, or any other surface to prevent contamination of the solution.

If using other topical ophthalmic medications, maintain an interval of at least 5 minutes between instillations.

Apply eye gels or ointments last.

Remove contact lenses before application, as the preservative benzalkonium chloride may be absorbed by soft lenses.

Lenses may be reinserted after 15 minutes following instillation.

The duration of therapy is determined by the physician based on clinical response.

Adverse Reactions

Infections: infrequently – cystitis.

Immune system disorders: very rarely – severe skin reactions, erythema multiforme exudativum, Stevens-Johnson syndrome.

Metabolism and nutrition disorders: rarely – increased body weight.

Psychiatric disorders: possible (especially at the beginning of treatment) – agitation, irritability, insomnia, anxiety (especially in children), nervousness, increased fatigue, drowsiness.

Nervous system disorders: infrequently – dizziness, headache; rarely – sedative effect (relaxation, slowed reaction time); very rarely – convulsions.

Gastrointestinal disorders: infrequently – dry mouth, nausea, vomiting, diarrhea.

Hepatobiliary disorders: very rarely – increased activity of liver enzymes, hepatitis.

Contraindications

Hypersensitivity to ketotifen; first trimester of pregnancy, breastfeeding period; children under 3 years of age – depending on the dosage form.

With caution second and third trimesters of pregnancy, epilepsy, history of seizures, hepatic insufficiency.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

Ketotifen penetrates into breast milk, therefore, if its use is necessary during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Should be used with caution in patients with hepatic insufficiency.

Pediatric Use

Can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the ketotifen drug leaflets regarding contraindications for the use of specific ketotifen dosage forms in children of different ages.

Geriatric Use

Can be used in elderly patients according to indications, in recommended doses.

Special Precautions

Ketotifen is not used to relieve an attack of bronchial asthma.

Treatment with ketotifen is long-term; the therapeutic effect is achieved after several weeks of therapy. The duration of therapy should be at least 2-3 months, especially in patients who did not show an effect in the first weeks. Discontinuation of ketotifen treatment should be gradual, over 2-4 weeks, to avoid the risk of exacerbation of bronchial asthma.

Ongoing anti-asthmatic therapy should be continued for at least 2 weeks after starting ketotifen.

When ketotifen and bronchodilators are used simultaneously, the dose of the latter can sometimes be reduced.

Ketotifen lowers the threshold for convulsive activity, so it must be prescribed with particular caution to patients with a history of seizures.

In patients simultaneously taking oral hypoglycemic drugs, the number of peripheral blood platelets should be monitored.

Effect on ability to drive vehicles and operate machinery

Patients taking Ketotifen should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Drug Interactions

With simultaneous use of ketotifen and oral antidiabetic agents, there is a risk of developing reversible thrombocytopenia.

Ketotifen may enhance the effects of other drugs that depress the central nervous system (sedatives, hypnotics).

Concomitant use of ketotifen with other antihistamines may lead to mutual enhancement of their effects.

Alcohol consumption should be avoided during treatment with ketotifen, as it enhances the depressant effect of ketotifen on the central nervous system.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.