Desmopressin Acetate Tablets

DDAVP® Tablets (desmopressin acetate) are 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: C46H64N14O12S2•C2H4O2• 3H2O

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

DDAVP Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone.

Infrequently, large doses of the intranasal formulations of DDAVP (desmopressin acetate tablets) and DDAVP (desmopressin acetate tablets) Injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage.

Central Diabetes Insipidus: In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of DDAVP (desmopressin acetate tablets) Tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite continued use of DDAVP (desmopressin acetate tablets) Tablets.

Primary Nocturnal Enuresis: The only adverse event occurring in ≥ 3% of patients in controlled clinical trials with DDAVP (desmopressin acetate tablets) Tablets that was probably, possibly, or remotely related to study drug was headache (4% DDAVP (desmopressin acetate tablets) , 3% placebo).

Other: The following adverse events have been reported; however their relationship to DDAVP (desmopressin acetate tablets) has not been established: abnormal thinking, diarrhea, and edema-weight gain.

See WARNINGS for the possibility of water intoxication and hyponatremia.

Post Marketing: There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

Desmopressin is a man-made form of a hormone that occurs naturally in the pituitary gland. This hormone is important for many functions including blood flow, blood pressure, kidney function, and regulating how the body uses water.

Desmopressin is used to treat bed-wetting, central cranial diabetes insipidus, and increased thirst and urination caused by head surgery or head trauma.

Desmopressin may also be used for other purposes not listed in this medication guide.

It is very important to reduce your intake of water and other fluids while you are taking desmopressin. Drinking too much water can cause your body to lose sodium, which may lead to a serious, life-threatening electrolyte imbalance.

Fluid restriction is especially important in children and older adults taking desmopressin. Follow your doctor's instructions about the type and amount of liquids you should drink.

You should not use this medication if you have severe kidney disease or if you have ever had hyponatremia (low sodium levels in your body).

Before taking desmopressin, tell your doctor if you have heart disease, coronary artery disease, congestive heart failure, kidney disease, cystic fibrosis, high or low blood pressure, an electrolyte imbalance, or a psychological disorder that causes extreme or unusual thirst.

To be sure desmopressin is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with this medication. Do not miss any scheduled appointments.

You should not take this medication if you are allergic to desmopressin, or if you have:

• severe kidney disease; or
• if you have ever had hyponatremia (low sodium levels in your body).

Before taking desmopressin, tell your doctor if you are allergic to any medications, or if you have:

• heart disease, coronary artery disease;
• congestive heart failure;
• kidney disease;
• cystic fibrosis;
• high or low blood pressure;
• an electrolyte imbalance; or
• a psychologic disorder that causes extreme or unusual thirst.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take desmopressin.

FDA pregnancy category B. This medication is not expected to harm an unborn baby. Do not use desmopressin without telling your doctor if you are pregnant.

It is not known whether desmopressin passes into breast milk, or if it could harm a nursing baby. Do not use desmopressin without telling your doctor if you are breast-feeding a baby.

Your pharmacist can provide more information about desmopressin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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