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DDAVP NASAL SPRAY (DESMOPRESSIN ACETATE): PRESCRIBING INFORMATION

DESCRIPTION

DDAVP Nasal Spray (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 3H2O

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

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

Each ml contains:

  • Desmopressin Acetate 0.1 mg
  • Sodium Chloride 7.5 mg
  • Citric Acid Monohydrate 1.7 mg
  • Disodium Phosphate Dihydrate 3.0 mg
  • Benzalkonium Chloride Solution (50%) 0.2 mg

    The DDAVP Nasal Spray compression pump delivers 0.1 mL (10 mcg) of DDAVP (Desmopressin Acetate) per spray.


    CLINICAL PHARMACOLOGY

    DDAVP Nasal Spray clinical pharmacology


    INDICATIONS AND USAGE

    DDAVP Nasal Spray indications and usage


    DOSAGE AND ADMINISTRATION

    DDAVP Nasal Spray dosage and administration


    CONTRAINDICATIONS

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

    This medication is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 ml / min).

    DDAVP is contraindicated in patients with hyponatremia or a history of hyponatremia.


    WARNINGS

    DDAVP Nasal Spray warnings


    PRECAUTIONS

    DDAVP Nasal Spray precautions


    USE IN SPECIAL POPULATIONS

    DDAVP Nasal Spray use in special populations


    ADVERSE REACTIONS

    DDAVP Nasal Spray adverse reactions


    OVERDOSAGE

    Signs of overdose by DDAVP (Desmopressin Acetate) spray nasal may include drowsiness, confusion, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. In case of overdosage, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition.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 DDAVP Nasal Spray.

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


    STORAGE / HOW SUPPLIED

    DDAVP Nasal Spray is available in a 5 ml bottle with spray pump delivering 50 sprays of 10 mcg. Desmopressin Acetate is also available as DDAVP Rhinal Tube, a refrigerated product with 2.5 ml per bottle, packaged with two rhinal tube applicators per carton.

    Store at Controlled Room Temperature 20 to 25°C (68 to 77°F).

    Store bottle of DDAVP (Desmopressin Acetate) in upright position.

    Keep out of the reach of children.

    Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.

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