Ddavp injection 4 mcg ml

Name: Ddavp injection 4 mcg ml

Description

DDAVP Injection (desmopressin acetate) 4 µg/mL 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:

Mol. Wt. 1183.34

Empirical Formula: C 46 H 64 N 14 O 12 S 2 ·C 2 H 4 O 2 ·3H 2 O

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

DDAVP Injection 4 µg/mL is provided as a sterile, aqueous solution for injection.

Each mL provides:

  Desmopressin acetate           4.0 µg

  Sodium chloride                   9.0 mg

  Hydrochloric acid to adjust pH to 4

The 10 mL vial contains chlorobutanol as a preservative (5.0 mg/mL).

Warnings

When DDAVP Injection is administered to patients who do not have need of antidiuretic hormone for its antidiuretic effect, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia with accompanying signs and symptoms (headache, nausea/vomiting, decreased serum sodium and weight gain).

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.

DDAVP should not be used to treat patients with Type IIB von Willebrand's disease since platelet aggregation may be induced.

Adverse Reactions

Infrequently, DDAVP has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasionally, injection of DDAVP has produced local erythema, swelling or burning pain. Occasional facial flushing has been reported with the administration of DDAVP. DDAVP Injection has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall and a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with DDAVP Injection .

See WARNINGS for the possibility of water intoxication and hyponatremia.

There have been rare reports of thrombotic events (acute cerebrovascular thrombosis, acute myocardial infarction) following DDAVP Injection in patients predisposed to thrombus formation.

Overdosage

(See ADVERSE REACTIONS .) In case of overdosage, the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition.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 Injection 4 µg/mL.

An oral LD 50 has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

How Supplied

DDAVP Injection 4 µg/mL is available as a sterile solution in cartons of ten 1 mL single-dose ampules (NDC 0075-2451-01) and in 10 mL multiple-dose vials (NDC 0075-2451-53), each containing 4.0 µg DDAVP per mL.

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

Rx Only.

Keep out of the reach of children.

Manufactured for

Aventis Pharmaceuticals Inc.

Bridgewater, NJ 08807

By Ferring AB, Soldattorpsvägen 5

SE-200 61 Limhamn, Sweden

US Patents 5,500,413; 5,596,078; 5,763,407

Rev. December 2002

© 2002 Aventis Pharmaceuticals Inc.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.

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