Lypressin

Lypressin is an analogue of vasopressin which is usually prepared synthetically or may be extracted from the posterior lobes of pituitary glands of mammals. Lypressin is used in the treatment of diabetes insipidus due to deficiency in antidiuretic hormone (ADH).

Lypressin is primarily indicated in conditions like Diabetes insipidus.

Lypressin is contraindicated in conditions like Renal diseases.

The severe or irreversible adverse effects of Lypressin, which give rise to further complications include Hypersensitivity reactions. The symptomatic adverse reactions produced by Lypressin are more or less tolerable and if they become severe, they can be treated symptomatically, these include Headache, Diarrhea, Sweating, Cramps, Tremor, Nausea and vomiting, Pallor.

In late 2007, FDA reported results of a review of 61 postmarketing cases of hyponatremic-related seizures associated with use of desmopressin. In 55 cases, sodium concentrations ranged from 104–130 mEq/L during the seizure event. Two of these 55 cases were fatal; both patients experienced hyponatremia and seizures. However, direct contribution of drug to fatalities not clear. Intranasal formulations were used in 36 cases; 25 of these cases involved pediatric patients (i.e., patients <17 years of age). Most commonly reported indication for use in the 25 pediatric patients was nocturnal enuresis. In 39 of the 61 cases, patients received at least one concomitant drug or disease that also may be associated with hyponatremia and/or seizures. As a result, use of intranasal preparations for treatment of primary nocturnal enuresis no longer is approved by FDA; other approved indications for individual intranasal preparations were not changed. Reserve intranasal preparations for situations in which oral therapy is not feasible. Use with caution in patients at risk for water intoxication with hyponatremia. Hyponatremia reported very rarely during international postmarketing surveillance. Desmopressin is a potent antidiuretic and use may result in water intoxication and/or hyponatremia; hyponatremia may be fatal unless properly diagnosed and treated. Fluid restriction recommended; careful medical supervision required. Carefully adjust fluid intake downwards, particularly in pediatric and geriatric patients, to reduce the risk of potential water intoxication and hyponatremia. Observe all patients for signs and symptoms associated with hyponatremia (i.e., headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, appetite loss, irritability, muscle weakness, spasms or cramps, abnormal mental status [e.g., hallucinations, decreased consciousness, confusion]); severe symptoms may include seizure, coma, and/or respiratory arrest. Consider the possibility of a rare occurrence of a substantial decrease in plasma osmolality that may result in seizures, which may lead to coma. Use with caution in patients with habitual or psychogenic polydipsia and in patients who are receiving certain drugs (e.g., tricyclic antidepressants, SSRIs) as these patients may be more likely to drink excessive amounts of water resulting in an increased risk for hyponatremia. (See Specific Drugs under Interactions.) Do not use in patients with type 2B or platelet-type (pseudo) von Willebrand disease † because of the risk of platelet aggregation and thrombocytopenia. (See von Willebrand Disease under Uses.) Severe allergic reactions reported rarely. Anaphylaxis reported rarely with IV and intranasal administration, including isolated cases of fatal anaphylaxis with IV administration. Not known whether antibodies to drug are produced after repeated administration. Changes in BP resulting in either a slight increase in BP, which may respond to dosage reduction, or a transient decrease in BP and a compensatory increase in heart rate reported infrequently. Thrombotic events (e.g., thrombosis, acute cerebrovascular thrombosis, acute MI) reported rarely in patients predisposed to thrombus formation; causal relationship to drug not determined. Use with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease or in patients predisposed to thrombus formation. Use with caution in patients with conditions associated with fluid and electrolyte imbalances (e.g., cystic fibrosis, heart failure, renal disorders); these patients are prone to hyponatremia. Diabetes Insipidus or Polyuria and Polydipsia Associated with Head Trauma or Surgery: Monitor urine volume and osmolality, and in some cases, plasma osmolality. Primary Nocturnal Enuresis: Monitor serum electrolytes at least once if therapy is continued for >7 days. Hemophilia A: Monitor factor VIII and factor VIII/ristocetin cofactor (von Willebrand factor) activities, factor VIII antigen concentrations, and aPTT. Determine factor VIII coagulant activity prior to initiating therapy for hemostasis; do not rely upon drug if factor VIII coagulant activity is <5% of normal. von Willebrand Disease: Monitor factor VIII and factor VIII/ristocetin cofactor activities and factor VIII/von Willebrand factor antigen concentrations to ensure an adequate response is being achieved; determination of skin bleeding time also may be useful. Category B. Not known whether drug is distributed into milk; use with caution. Carefully restrict fluid intake in pediatric patients to prevent possible hyponatremia and water intoxication. Intranasal therapy has no effect on growth hormone, prolactin, or LH concentrations in children. Diabetes Insipidus: Desmopressin tablets have been used safely for up to 44 months in pediatric patients ≥4 years of age with diabetes insipidus. In younger pediatric patients, adjust dosage according to individual need to prevent excessive decrease in plasma osmolality resulting in hyponatremia and possible seizures. Safety and efficacy of desmopressin injection not established in pediatric patients <12 years of age with diabetes insipidus. Carefully adjust dosage of oral therapy or nasal solution (containing 0.1 mg of drug per mL) according to individual needs and tolerance in pediatric patients with diabetes insipidus, with particular attention to the risk of an extreme decrease in plasma osmolality and resulting hyponatremia or seizures in young children. Occasional change in response to nasal solution containing 0.1 mg of drug per mL in pediatric patients with diabetes insipidus reported (e.g., decreased responsiveness, shortened duration of effect), usually after periods >6 months. No evidence that change in responsiveness results from development of binding antibodies; may result from local inactivation of peptide. Intranasal drug preferred to vasopressin injection and oral antidiuretic agents (e.g., chlorpropamide) because of frequency of adverse effects of these agents in pediatric patients with diabetes insipidus. Nocturnal Enuresis: Desmopressin tablets have been used safely for <6 months in pediatric patients ≥6 years of age with primary nocturnal enuresis. Interrupt therapy during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (e.g., systemic infections, fever, recurrent vomiting or diarrhea) and under conditions associated with increased water intake (e.g., extremely hot weather, vigorous exercise). Hemophilia or von Willebrand Disease: Do not use the nasal solution containing 1.5 mg of drug per mL for the treatment of hemophilia A or von Willebrand disease in pediatric patients <11 months of age; safety and efficacy established in pediatric patients 11 months to 12 years of age. Do not use desmopressin injection for the management of hemophilia A or von Willebrand disease in pediatric patients <3 months of age. Carefully restrict fluid intake in geriatric patients to prevent possible hyponatremia and water intoxication. Hyponatremia and fluid overload reported during postmarketing surveillance. Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. Other reported clinical experience has not identified differences in response between geriatric patients and younger adults. Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy. Substantially eliminated by kidneys; risk of toxic reactions may be greater in patients with impaired renal function. Monitor renal function and adjust dosage accordingly since geriatric patients are more likely to have decreased renal function. Contraindicated in patients with moderate to severe renal impairment (Cl cr <50 mL/minute).

In late 2007, FDA reported results of a review of 61 postmarketing cases of hyponatremic-related seizures associated with use of desmopressin. In 55 cases, sodium concentrations ranged from 104–130 mEq/L during the seizure event. Two of these 55 cases were fatal; both patients experienced hyponatremia and seizures. However, direct contribution of drug to fatalities not clear. Intranasal formulations were used in 36 cases; 25 of these cases involved pediatric patients (i.e., patients <17 years of age). Most commonly reported indication for use in the 25 pediatric patients was nocturnal enuresis. In 39 of the 61 cases, patients received at least one concomitant drug or disease that also may be associated with hyponatremia and/or seizures. As a result, use of intranasal preparations for treatment of primary nocturnal enuresis no longer is approved by FDA; other approved indications for individual intranasal preparations were not changed. Reserve intranasal preparations for situations in which oral therapy is not feasible. Use with caution in patients at risk for water intoxication with hyponatremia. Hyponatremia reported very rarely during international postmarketing surveillance. Desmopressin is a potent antidiuretic and use may result in water intoxication and/or hyponatremia; hyponatremia may be fatal unless properly diagnosed and treated. Fluid restriction recommended; careful medical supervision required. Carefully adjust fluid intake downwards, particularly in pediatric and geriatric patients, to reduce the risk of potential water intoxication and hyponatremia. Observe all patients for signs and symptoms associated with hyponatremia (i.e., headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, appetite loss, irritability, muscle weakness, spasms or cramps, abnormal mental status [e.g., hallucinations, decreased consciousness, confusion]); severe symptoms may include seizure, coma, and/or respiratory arrest. Consider the possibility of a rare occurrence of a substantial decrease in plasma osmolality that may result in seizures, which may lead to coma. Use with caution in patients with habitual or psychogenic polydipsia and in patients who are receiving certain drugs (e.g., tricyclic antidepressants, SSRIs) as these patients may be more likely to drink excessive amounts of water resulting in an increased risk for hyponatremia. (See Specific Drugs under Interactions.) Do not use in patients with type 2B or platelet-type (pseudo) von Willebrand disease † because of the risk of platelet aggregation and thrombocytopenia. (See von Willebrand Disease under Uses.) Severe allergic reactions reported rarely. Anaphylaxis reported rarely with IV and intranasal administration, including isolated cases of fatal anaphylaxis with IV administration. Not known whether antibodies to drug are produced after repeated administration. Changes in BP resulting in either a slight increase in BP, which may respond to dosage reduction, or a transient decrease in BP and a compensatory increase in heart rate reported infrequently. Thrombotic events (e.g., thrombosis, acute cerebrovascular thrombosis, acute MI) reported rarely in patients predisposed to thrombus formation; causal relationship to drug not determined. Use with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease or in patients predisposed to thrombus formation. Use with caution in patients with conditions associated with fluid and electrolyte imbalances (e.g., cystic fibrosis, heart failure, renal disorders); these patients are prone to hyponatremia. Diabetes Insipidus or Polyuria and Polydipsia Associated with Head Trauma or Surgery: Monitor urine volume and osmolality, and in some cases, plasma osmolality. Primary Nocturnal Enuresis: Monitor serum electrolytes at least once if therapy is continued for >7 days. Hemophilia A: Monitor factor VIII and factor VIII/ristocetin cofactor (von Willebrand factor) activities, factor VIII antigen concentrations, and aPTT. Determine factor VIII coagulant activity prior to initiating therapy for hemostasis; do not rely upon drug if factor VIII coagulant activity is <5% of normal. von Willebrand Disease: Monitor factor VIII and factor VIII/ristocetin cofactor activities and factor VIII/von Willebrand factor antigen concentrations to ensure an adequate response is being achieved; determination of skin bleeding time also may be useful. Category B. Not known whether drug is distributed into milk; use with caution. Carefully restrict fluid intake in pediatric patients to prevent possible hyponatremia and water intoxication. Intranasal therapy has no effect on growth hormone, prolactin, or LH concentrations in children. Diabetes Insipidus: Desmopressin tablets have been used safely for up to 44 months in pediatric patients ≥4 years of age with diabetes insipidus. In younger pediatric patients, adjust dosage according to individual need to prevent excessive decrease in plasma osmolality resulting in hyponatremia and possible seizures. Safety and efficacy of desmopressin injection not established in pediatric patients <12 years of age with diabetes insipidus. Carefully adjust dosage of oral therapy or nasal solution (containing 0.1 mg of drug per mL) according to individual needs and tolerance in pediatric patients with diabetes insipidus, with particular attention to the risk of an extreme decrease in plasma osmolality and resulting hyponatremia or seizures in young children. Occasional change in response to nasal solution containing 0.1 mg of drug per mL in pediatric patients with diabetes insipidus reported (e.g., decreased responsiveness, shortened duration of effect), usually after periods >6 months. No evidence that change in responsiveness results from development of binding antibodies; may result from local inactivation of peptide. Intranasal drug preferred to vasopressin injection and oral antidiuretic agents (e.g., chlorpropamide) because of frequency of adverse effects of these agents in pediatric patients with diabetes insipidus. Nocturnal Enuresis: Desmopressin tablets have been used safely for <6 months in pediatric patients ≥6 years of age with primary nocturnal enuresis. Interrupt therapy during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (e.g., systemic infections, fever, recurrent vomiting or diarrhea) and under conditions associated with increased water intake (e.g., extremely hot weather, vigorous exercise). Hemophilia or von Willebrand Disease: Do not use the nasal solution containing 1.5 mg of drug per mL for the treatment of hemophilia A or von Willebrand disease in pediatric patients <11 months of age; safety and efficacy established in pediatric patients 11 months to 12 years of age. Do not use desmopressin injection for the management of hemophilia A or von Willebrand disease in pediatric patients <3 months of age. Carefully restrict fluid intake in geriatric patients to prevent possible hyponatremia and water intoxication. Hyponatremia and fluid overload reported during postmarketing surveillance. Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. Other reported clinical experience has not identified differences in response between geriatric patients and younger adults. Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy. Substantially eliminated by kidneys; risk of toxic reactions may be greater in patients with impaired renal function. Monitor renal function and adjust dosage accordingly since geriatric patients are more likely to have decreased renal function. Contraindicated in patients with moderate to severe renal impairment (Cl cr <50 mL/minute).

1 to 2 sprays (1.5 (1.5)) 6 hourly IN —

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

No data regarding the interactions of Lypressin was found.

Inj, Nasal Soln Do not Freeze.