Amring Pharmaceuticals Inc.

2.1 Recommended Dosage

The recommended dose of Tranexamic Acid Tablets for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic Acid Tablets may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.

2.2 Renal Impairment

In patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).

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 therapy to assure adequate antidiuretic response. Modification 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 antidiuretic. 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, 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 (adults up to 45 years of age and children 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 acetate administration, until the next morning, or at least 8 hours after administration. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Hemophilia A and von Willebrand's Disease (Type I): DESMOPRESSIN ACETATE Injection 4 mcg/mL is administered as an intravenous infusion at a dose of 0.3 mcg DESMOPRESSIN ACETATE/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If DESMOPRESSIN ACETATE Injection 4 mcg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.

The necessity for repeat administration of DESMOPRESSIN ACETATE or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.

Fluid restriction should be observed. (See   WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection. DESMOPRESSIN ACETATE Injection 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

The usual dosage range in adults is 0.5 mL (2.0 mcg) to 1 mL (4.0 mcg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal DESMOPRESSIN ACETATE and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.

Fluid restriction should be observed. (See  WARNINGS,   PRECAUTIONS, Pediatric Use and Geriatric Use.)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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, Human Pharmcokinetics,  CONTRAINDICATIONS, and   PRECAUTIONS, Geriatric Use.)

Directions for use of One Point Cut (OPC) Ampules for DESMOPRESSIN ACETATE Injection: