Desmopressin Acetate

WARNINGS:

• For intranasal use only.
• Desmopressin nasal spray solution 0.01% should only be used in patients where orally administered formulations are not feasible.
• Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with desmopressin acetate. Desmopressin acetate is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required.
• When desmopressin nasal spray solution 0.01% is administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward in order to decrease the potential occurrence of water intoxication and hyponatremia (See PRECAUTIONS, Pediatric Use and Geriatric Use.) All patients receiving desmopressin nasal spray solution 0.01% therapy should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. 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.
• Desmopressin nasal spray solution 0.01% should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.

PRECAUTIONS:

General:

Central Cranial Diabetes Insipidus:

Information for Patients:

Laboratory Tests:

Drug Interactions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy:

Nursing Mothers:

Pediatric Use:

Geriatric Use:

ADVERSE REACTIONS:

Post Marketing:

OVERDOSAGE:

DOSAGE AND ADMINISTRATION:

Central Cranial Diabetes Insipidus:

Geriatric Use:

CLINICAL PHARMACOLOGY, Human Pharmacokinetics CONTRAINDICATIONS, PRECAUTIONS, Geriatric Use

HOW SUPPLIED:

Storage:

Keep out of reach of children



Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.

PATIENT INSTRUCTION GUIDE

Desmopressin Nasal Spray Solution, USP 0.01%

A better way to deliver desmopressin nasal spray solution, USP 0.01%

Delivering desmopressin nasal spray solution, USP 0.01% more efficiently



CAUTION:

Ensure that in children administration is under adult supervision in order to control the dose intake.



Using your Desmopressin Nasal Spray Solution 0.01% Pump

1. Remove protective cap.

2. The spray pump must be primed prior to the first use. To prime pump, press down five (5) times.

3. Once primed, the spray pump delivers 10 micrograms of medication each time it is pressed. To ensure dosing accuracy, hold bottle upright.

To administer a 10 micrograms dose, place the spray nozzle in nostril and press the spray pump once. If a higher dose has been prescribed, spray half the dose in each nostril. The spray pump cannot be used for doses less than 10 micrograms or doses other than multiples of 10 micrograms.

4. Replace the protective cap on bottle after use, and store in refrigerator. The pump will stay primed for up to one week under refrigeration. If the product has not been used for a period of one week, re-prime the pump by pressing once.

Storage:




Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL

NDC 62756-161-91
Desmopressin Nasal Spray Solution, USP 0.01%
0.1 mg/mL
5 mL
REFRIGERATE
Rx only
FOR INTRANASAL USE ONLY.
50 doses of 10 mcg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON

NDC 62756-161-91
Desmopressin Nasal Spray Solution, USP 0.01%
0.1 mg/mL
(0.01 mg/Spray)
FOR INTRANASAL USE ONLY.
Rx only
5 mL
50 doses of 10 mcg
SUN PHARMA

Desmopressin Acetate Desmopressin Acetate SOLUTION Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-161 Route of Administration NASAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength desmopressin acetate DESMOPRESSIN 0.1 mg Inactive Ingredients Ingredient Name Strength CHLOROBUTANOL HEMIHYDRATE SODIUM CHLORIDE HYDROCHLORIC ACID water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 BOTTLE, PUMP 2 NDC:62756-161-91 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077212 2012-04-14