Desmopressin Acetate (Page 4 of 4)

DOSAGE AND ADMINISTRATION

Central Diabetes Insipidus

The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal desmopressin acetate therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of desmopressin acetate tablet therapy to assure adequate antidiuretic response. Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover. Fluid restriction should be observed (see WARNINGS ; PRECAUTIONS , Pediatric Use and Geriatric Use).

Adults and Children

It is recommended that patients be started on doses of 0.05 mg (½ of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis. See Pediatric Use subsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY , HumanPharmacokinetics ; CONTRAINDICATIONS ; and PRECAUTIONS , Geriatric Use).

Primary Nocturnal Enuresis

The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to response. Patients previously on intranasal desmopressin acetate therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients age 6 years and older is 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response. Fluid restriction should be observed, and fluid intake should be limited to a minimum from 1 hour before desmopressin administration, until the next morning, or at least 8 hours after administration (see WARNINGS and PRECAUTIONS , Pediatric Use and Geriatric Use).

HOW SUPPLIED:

Desmopressin acetate tablets are available as follows:

0.2 mg – white to off-white, round-shaped tablets debossed with the numbers “93” on one side and scored between the two numbers, debossed “7317” on the other side of the tablets. They are available as follows:

NDC 51079-446-03 — Unit dose blister packages of 30 (3 cards of 10 tablets each).

Store at 20 o to 25 o C (68 o to 77 o F). [See USP Controlled Room Temperature.] Avoid exposure to excessive heat or light.

Manufactured in Israel by:
Teva Pharmaceutical Ind. Ltd
Jerusalem, 91010, Israel

Manufactured for:
Teva Pharmaceuticals USA
Sellersville, PA 18960

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-10837 R1
2/13

Principal Display Panel — 0.2 mg

NDC 51079-446-03

Desmopressin
Acetate
Tablets
0.2 mg

30 Tablets (3 x 10)

Each tablet contains:
desmopressin acetate 0.2 mg

Dosage and Administration: See
package insert for full prescribing
information.

Store at 20 o to 25 o C (68 o to 77 o F). [See
USP Controlled Room Temperature.]
Avoid exposure to excessive heat or light.

Manufactured in Israel by:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 91010, Israel

Manufactured for:
Teva Pharmaceuticals USA Sellersville, PA 18960

Rx only

S-10764 R1

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Desmopressin Acetate 0.2 mg Tablet Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)
DESMOPRESSIN ACETATE desmopressin acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-446(NDC:0093-7317)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESMOPRESSIN ACETATE (DESMOPRESSIN) DESMOPRESSIN ACETATE 0.2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
STARCH, CORN
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 9;3;7317
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-446-03 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-446-01)
1 NDC:51079-446-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-446-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077122 12/26/2007 11/30/2017
Labeler — Mylan Institutional Inc. (039615992)

Revised: 10/2017 Mylan Institutional Inc.

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