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MINIRIN NASAL SPRAY (DESMOPRESSIN ACETATE): PRESCRIBING INFORMATION

DESCRIPTION

Minirin (Desmopressin Acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:

Molecular weight: 1183.34

Empirical formula: C46H64N14O12S2 x C2H4O2 x 3H2OSCH2CH2

1-(3-Mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.

Minirin Nasal Spray is provided as an aqueous solution for intranasal use.

Each ml contains:

  • Desmopressin Acetate 0.1 mg
  • Chlorobutanol 5.0 mg
  • Sodium Chloride 9.0 mg
  • Hydrochloric Acid to adjust pH to approximately 4

    The Minirin Nasal Spray compression pump delivers 0.1 mL (10 mcg) of desmopressin acetate per dose.


    CLINICAL PHARMACOLOGY

    Minirin Nasal Spray clinical pharmacology


    INDICATIONS AND USAGE

    Minirin Nasal Spray indications and usage


    CONTRAINDICATIONS

    Minirin (Desmopressin Acetate) Nasal Spray is contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of this medication.


    DOSAGE AND ADMINISTRATION

    Minirin Nasal Spray dosage and administration


    WARNINGS

  • Minirin (Desmopressin) Nasal Spray is for intranasal use only.
  • In very young and elderly patients in particular, fluid intake should be adjusted downward in order to decrease the potential occurrence of water intoxication and hyponatremia. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.


    PRECAUTIONS

    Minirin Nasal Spray precautions


    USE IN SPECIAL POPULATIONS

    Minirin Nasal Spray use in special populations


    ADVERSE REACTIONS

    Minirin Nasal Spray adverse reactions


    OVERDOSAGE

    In case of overdosage by Minirin (Desmopressin Acetate) Nasal Spray, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for Desmopressin Acetate or Minirin Nasal Spray.

    An oral LD50 has not been established. An intravenous dose of 2 mg / kg in mice demonstrated no effect.


    STORAGE / HOW SUPPLIED

    Minirin (Desmopressin) spray nasal is available as a 5 ml bottle with spray pump delivering 50 doses of 10 mcg.

    Store refrigerated 2 to 8°C (36 to 46°F).

    When traveling, product will maintain stability for 3 weeks when stored at controlled room temperature, 20 to 25°C (68 to 77°F).

    Rx only

    Keep out of the reach of children.

    Manufactured and distributed by Ferring pharmaceutical company and its divisions.

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