Generic Name

Composition

Therapeutic Category

Division

Oxymetazoline

Oxymetazoline 0.05% w/v Nasal Drops

Oxymetazoline 0.025% w/v Nasal Drops

Nasal Decongestant

COSMO

    BRAND COMPOSITION DESCRIPTION
    T- ZOLINE A

    Each ml of nasal drop contains:

    Oxymetazoline Hydrochloride USP           0.05%w/v

    Clear colorless solution filled in a 13.2 ml overflow capacity gamma sterilized lupolene vials plugged with gamma sterilized inner seal and capped with gamma sterilized caps
    T- ZOLINE P

    Each ml of nasal drop contains:

    Oxymetazoline Hydrochloride USP           0.025%w/v

    Clear colorless solution filled in a 13.2 ml overflow capacity gamma sterilized lupolene vials plugged with gamma sterilized inner seal and capped with gamma sterilized caps
     

    PATIENT INFORMATION

    Administration:

    • Use the nasal drops as directed in the label
    • Avoid sneezing or blowing your nose for at least a few minutes after using the nose drops.

    Pregnancy: Category C

    Storage: Store at room temperature protected from light, heat and moisture; Do not freeze; Keep out of reach of children.

    Missed dose: Take the missed dose as soon as you remember; Skip the missed dose if it is almost time for your next scheduled dose; Do not use extra medicine to make up the missed dose

    PHARMACOLOGY

    Pharmacotherapeutic Group: Nasal decongestant; direct acting sympathomimetic agent

     Pharmacodynamic properties: T-ZOLINE (Oxymetazoline) is a direct acting alpha-adrenoceptor agonist which on binding with the α1 adrenergic receptor causes constriction of mucosal blood vessels when applied topically and in turn reduces oedema of the nasal mucosa and relieves nasal congestion.

     Pharmacokinetic properties:

    Onset of action: within minutes and lasts 6-8 hours.Duration of actionUp to 12 hr.

     INDICATIONS

    Symptomatic relief of congestion of the upper respiratory tract due to the common cold, hay fever and sinusitis.

     DOSE

    Adult: Instill 0.05% solution1-3 drops into each nostril 2-3 times daily.

    Child≥6 yr: Instill 0.025% solution 1-3 drops into each nostril 2-3 times daily.

     CONTRAINDICATIONS

    Hypersensitivity; Narrow angle glaucoma; Phaeochromocytoma; Children

     SPECIAL PRECAUTIONS

    Pregnancy, lactation; Difficulty in urination secondary to prostate enlargement; Heart disease (including angina), hypertension, advanced arteriosclerotic conditions; Hyperthyroidism; Diabetes Mellitus.

     ADVERSE DRUG REACTIONS

    Local stinging or burning, sneezing, dryness of mouth and throat. Prolonged or frequent use may cause rebound congestion. Headache, insomnia, tachycardia, hypertension, nervousness, nausea, dizziness, palpitation, arrhythmia.

     DRUG INTERACTIONS

    Potentially Fatal: Hypertensive crisis with MAOIs.

     PRESENTAION

    T- ZOLINE A: Each vial contains 10ml of solution

    T-ZOLINE P: Each vial contains 10ml of the solution