DESMOPRESSIN ACETATE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

থেকে পাওয়া:

REMEDYREPACK INC.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. Desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. Desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention. Desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. Desmopressin acetate tablets are contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min). Desmopressin acetate tablets are contraindicated in patients with hyponatremia or a history of hyponatremia.

পণ্য সারাংশ:

Desmopressin Acetate Tablets 0.2 mg are available for oral administration as white to off-white, round shaped, debossed "HP above 319" on one side and bisect on other side. They are supplied as follows: NDC: 70518-3493-00 NDC: 70518-3493-01 PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Avoid exposure to excessive heat or light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
REMEDYREPACK INC.
----------
DESMOPRESSIN ACETATE TABLETS
RX ONLY
DESCRIPTION
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 1-(3-Mercaptopropionic acid)-8-D-arginine
vasopressin
monoacetate (salt) trihydrate. The structural formula is as follows:
EMPIRICAL FORMULA: C
H
N
O
S
• C
H
O
• 3H
O
MOLECULAR WEIGHT: 1183.34
Desmopressin acetate tablets, for oral administration, contain either
0.1 or 0.2 mg
desmopressin acetate. Inactive ingredients include: corn starch,
lactose monohydrate,
magnesium stearate and povidone.
CLINICAL PHARMACOLOGY
Desmopressin acetate tablets contain as active substance, desmopressin
acetate, a
synthetic analogue of the natural hormone arginine vasopressin.
CENTRAL DIABETES INSIPIDUS
Dose response studies in patients with diabetes insipidus have
demonstrated that oral
doses of 0.025 mg to 0.4 mg produced clinically significant
antidiuretic effects. In most
patients, doses of 0.1 mg to 0.2 mg produced optimal antidiuretic
effects lasting up to
eight hours. With doses of 0.4 mg, antidiuretic effects were observed
for up to 12
hours; measurements beyond 12 hours were not recorded. Increasing oral
doses
produced dose dependent increases in the plasma levels of desmopressin
acetate.
The plasma half-life of desmopressin acetate followed a
monoexponential time course
with t
values of 1.5 to 2.5 hours which was independent of dose.
The bioavailability of desmopressin acetate oral tablets is about 5%
compared to
46
64
14
12
2
2
4
2
2
1/2
intranasal desmopressin acetate, and about 0.16% compared to
intravenous
desmopressin acetate. The time to reach maximum plasma desmopressin
acetate levels
ranged from 0.9 to 1.5 hours following oral or intranasal
administration, respectively.
Following administration of desmopressin acetate tablets, the onset of
antidiuretic effect
occurs at around 1 hour, and it r